Tamika Cathey

Tamika Cathey

Tamika Cathey

Tamika Cathey provides regulatory compliance services pertaining to safety and quality of pharmaceuticals and dietary supplements. She evaluates client compliance readiness, executes mock GMP/FDA audits, performs risk assessments and gap analyses per FDA regulations and creates improvement programs based on findings. Cathey consulted with EAS from 2012-2016 and we are very pleased that she is again able to offer her expertise to our clients.

EAS’s 2018 Year in Review and Expectations for 2019 – Evolving FSMA, Anticipation for TPMPs

By Amy Scanlin, M.S.

As we reflect on 2018, we are again honored that so many look to EAS as their regulatory solution to a complicated world of FDA requirements. FDA’s continued focus on safety as well as the industry’s embrace of regulations that often challenge their old methods of doing business can only mean continued improvements and communications in the name of public health. In 2018, the Food Safety Modernization Act (FSMA) again dominated the news as numerous compliance dates arrived. We received questions from all over the world, particularly on issues pertaining to the Foreign Supplier Verification Program (FSVP). As of June 1, 2018, FDA had completed 256 inspections of foreign firms resulting in the issuance of 483s. Based on that, one of the primary concerns our callers have is understanding what constitutes an FSVP in FDA’s eyes and whether their documentation or documentation they were in the process of preparing, would qualify as compliant. Questions on what is a Qualified Individual and how EAS can assist in that regard with foreign suppliers are also a concern.

Our Independent Advisor for FSMA, Charles Breen, stayed busy preparing updates on FSMA compliance as part of our EAS-e-News monthly column “FSMA Perspective” and he, as well as all of our consultants who work in Foods, collaborated on numerous webinars and articles helping the industry to gain a greater understanding of FDA expectations. We even conducted our first webinar in Spanish presented by Gustavo Gonzalez, Ph.D., “FSVP – What Does it Mean for Your Business?” which is available on-demand free of charge on the EAS website. More recently, Charles presented a webinar on FSVP for the National Customs Brokers and Forwarders Association of America.

It wasn’t just FSMA that got industry’s attention. New labeling regulations for food and dietary supplements have kept food and supplement manufacturers busy. From sugars to fibers to new requirements of what and how to include nutritional information, our Food Labeling and Dietary Supplement Labeling seminars have been very well attended. (Our spring series is scheduled for Philadelphia and hyperlinks here point to registration information should you be interested in joining us). In addition, EAS published articles on the subject and is pleased to be in the final preparation stages for a webinar on December 6th where James Hoadley, Ph.D. one of our expert labeling consultants and trainers will discuss the new dietary fiber regulations with two members of FDA’s CFSAN for the Institute for Food Technologists. These labeling issues are requiring firms to rethink how products are not only labeled but marketed and our Product Development and Labeling team is enjoying the challenge of helping firms navigate new requirements as they find solutions that meet both business and FDA expectations.

The dietary supplement industry continues to be challenged by GMPs dictated in 21 CFR 111 as evidenced by 2018 statistics indicating the top observations issued are still Specifications and Testing, Master Manufacturing Records and Batch Production Records, Quality Unit Responsibilities, and Complaints; the same as they have been since 2010 when the 21 CFR 111 regulations applied to all sizes of dietary supplement firms. Following is a graph prepared by the Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., which summarizes the posted FDA statistics through 2017 and clearly illustrates this never-ending trend. If there is one bright spot, it is that the percentage of firms getting an Official Action Indicated (OAI) or Voluntary Action Indicated (VAI) is down to 54%. It has been significantly higher in previous years.

TOP FDA Observations: 2010 - 2017

RankCitationDescriptionNumber of Times Cited
201020112012201320142015201620172010-2017
121 CFR 111.75Testing541112262871881441952161421
221 CFR 111.70Specifications321041762342041542142511369
321 CFR 111.205MMRs28539411782678794622
421 CFR 111.255BPRs1852749371717287538
521 CFR 111.103QU Operations1843476647455576397
621 CFR 111.553Product Complaints1534427036283163319
721 CFR 111.453Holding & Distribrution618294732273046235
Total Observations631132819642211154912941625184212444

In medical devices, FDA’s decision to expand the use of the De Novo submission pathway was welcomed by industry. De Novo applications are appropriate in cases where it appears that the device meets the statutory standards for classification into Class I or Class II under section 513(a)(1) of the FD&C Act, and when the sponsor has determined that the device does not fall within any existing classification regulation. EAS authored an article for MedTech Intelligence on the subject.

EAS expanded its services into the area of cannabis GMPs in 2018. This newly evolving industry, regulated by some states as a food, others a dietary supplement and in some cases as a pharmaceutical, is challenged in many regards with how to set up, validate and verify a quality system. Quality is one of EAS’ many strong capabilities and our team of consultants is rising to the challenge of assisting this newer industry. Tara Couch presented a webinar “Quality Systems for the Cannabis Industry” and for the first time, we incorporated cannabis applicability into our two-day dietary supplement GMP seminar for a special presentation. We were also frequent contributors to the Cannabis Industry Journal including Gabe Miller who authored an article on Food Safety in the cannabis industry and Celia Schebella who discussed designing cannabis edibles in the state of California.

As we look ahead to 2019 there are a few notable things on the horizon that EAS consultants are watching for:

On the Tobacco front, the Center for Tobacco Products’ director Mitch Zeller, announced at the annual Tobacco Merchants Association (TMA) meeting that the agency is actively working on developing its own set of GMP protocols for the tobacco industry, called Tobacco Product Manufacturing Practices (TPMPs). In an effort to help tobacco firms begin forward thinking in these terms, EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. and President and COO, Dean Cirotta presented a webinar in partnership with TMA (now available on-demand) on how to prepare for these TPMPs based on the long-standing GMPs for the dietary supplement industry.

In addition, OTC Monograph reforms have been underway for some time and it is anticipated that 2019 will bring these new requirements to light. Independent Consultant Norma Skolnik prepared an article for EAS-e-News on expectations earlier in the year and EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, will present a five-part webinar series on the subject starting January 16. She’ll discuss why these reforms are necessary, are being undertaken now, and how OTC drug companies can expect those changes to impact their labels.

In the Dairy world, FDA has fast-tracked a review of how the words “milk” and “cheese” are used in dairy substitutes. The Dairy industry is also anticipating enforcement of the new Appendix T of the PMO which will implement FSMA-like requirements aimed at preventive measures to improve safety. More information on both of these as they unfold.

On the home office front, the EAS staff was very pleased when the extensive expansion and renovation of our office space was complete, and we think it looks great! This new area enables EAS training hosted in the DC area to move in-house and offers enhanced meeting capabilities, both in-person and remote. If you are in the D.C. area, we invite you to come by! In addition, we completed a major redesign of our website, found at easconsultinggroup.com. We hope you’ll agree that this new digital space is not only improved in appearance but provides easier access to not only information about EAS services and seminars, but also regulatory information prepared by our independent consultants and distributed through a variety of professional trade journals and organizations.

We also welcomed 24 new consultants, re-welcomed three consultants who returned to EAS after a stint in the industry and brought on a new office manager, Jodi Burns. EAS is only as strong as our professional network of skilled and knowledgeable consultants, directors and support staff. We feel we have some of the best in the business!

If it seems like EAS consultants have a wide-reach of educational support, you are right. All told EAS presented 13 two-day public seminars, will have conducted 19 webinars by the end of 2018; published 40 articles, and spoke or moderated at 25 industry events such as IFT, Food Safety Consortium, Supplyside West and a variety of FDLI-hosted events. We also exhibited at important trade shows such as IFT, Supplyside West, Food Defense Conference, IAFP and others.

One trade show event, nearest and dearest to our hearts was the 2018 AdvaMed MedTech Intelligence conference in Philadelphia where Ryan Steele, granddaughter of Chairman and CEO of Ed Steele, and daughter of CFO Brett Steele, was an invited speaker on the main stage sharing her story as just one many who has been positively impacted by the innovation of science and technology, in Ryan’s case with the implantation of a vertical expandable prosthetic titanium rib, which is the only FDA approved device to treat thoracic insufficiency syndrome.

It is stories such as hers that brings home why we all do what we do, designing products that fill a need and a niche and do so safely and effectively. While FDA regulations may feel cumbersome at times, it is those instances, where important decisions with critical outcomes are in front of us, that we can all appreciate FDA’s diligent focus on ensuring only compliant products are available to the US consumer. Here at EAS, we support firms working in all FDA regulated commodities to do just that and we take great pride in our ability to meet their needs.

Thank you for journeying with us in 2018 and we look forward to a peaceful and prosperous 2019. Have a very happy holiday and New Year!

Drug and Device Corner 2018 December

Guidance Document updates on the FDA website:

All centers:

  • Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA Guidance for IndustryOn December 3, 2018, the U.S. Food and Drug Administration (FDA) published the guidance for industry entitled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.” The final guidance provides recommendations to industry on Post-complete response letter (CRL) meetings between the FDA and abbreviated new drug application (ANDA) applicants to clarify deficiencies identified in a CRL to an ANDA submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act.

CDER:

CDER & CBER:

CDRH & CBER:

CBER:

Overcoming Seafood Fraud – a Free EAS Webinar Presented by Tim Hansen

Seafood is largely accepted based on how it is labeled or listed on a menu. This is true for seafood wholesalers, distributors as well as retailers. The financial incentive for unethical practices is huge but measures can be adopted to protect product identity and integrity. Join EAS Independent Consultant and former Director of the Seafood Inspection Program at NOAA, Tim Hansen, for a discussion on various types of fraudulent activity in the seafood industry including where and why fraud can occur in the supply chain. He’ll discuss how seafood operators, buyers, and consumers can protect themselves as well as regulatory issues and possibly short, medium and long-term solutions.

Join Tim on December 18, 2018, at 1:00 pm Eastern for his discussion on Overcoming Seafood Fraud in a complimentary webinar hosted by EAS. Reserve your seat today!

Essential Quality Systems for Own Label Distributors Discussed in Natural Products Insider

Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., has written an article for Natural Products Insider on the intersection of OLD and Quality Systems. “The development and implementation of essential own label distributor quality systems and programs will go a long way to ensure GMP compliance in a contract manufacturer partnership,” she says.

In addition, for those who missed or would like to review the very informative webinar presented by Bruce Elsner, also on OLD responsibilities, it is now available on-demand on the EAS website along with many other complimentary webinars covering a wide range of regulatory topics.

Appendix T Storm is Hitting the Grade A Dairy Industry

Senior Director for Food Consulting Services, Allen Sayler, published an article in Dairy Foods Magazine on FDA’s PMO (Produce Milk Ordinance) new Appendix T, which mirrors FSMA in many ways in that it requires preventive controls for those hazards not already covered in the PMO. This new requirement may well be the dairy industry’s most significant new regulatory challenge for 2019. “One of the major challenges many firms face is the establishment of acceptable written food safety programs and maintenance of required records that demonstrate compliance with Appendix T. The failure of a Grade “A” dairy plant to meet any of these requirements will result in either loss of its Grade “A” designation or a request for the state to remove its Grade “A” designation.”

New Report on the Sources of Foodborne Illnesses Highlights Urgency of FSMA Compliance

By Charles Breen, Independent Advisor for FSMA

The Interagency Food Safety Analytics Collaboration (IFSAC) report, “Foodborne illness source attribution estimates for 2016 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States”, highlights why FSMA is so important a tool in driving the food industry to do more to prevent foodborne outbreaks. Each year in the U.S., an estimated 9 million people get sick, 56,000 are hospitalized, and 1,300 die of foodborne disease caused by known pathogens. IFSAC identified four priority pathogens, Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter that together cause 1.9 million foodborne illnesses each year. In addition to their frequency, these pathogens are also well-known for the severity of the illnesses they can cause, and the fact that targeted interventions can significantly reduce their incidence.

The IFSAC statistical analysis showed 1,255 outbreaks between the years 1998 and 2016 (3,553 in raw data) in which a confirmed or suspected food or foods could be assigned to a single food category: 762 caused or suspected to be caused by Salmonella, 235 by E. coli O157, 37 by Listeria, and 221 by Campylobacter. Using outbreak data, the report estimates:

  • Salmonella: Illnesses came from a wide variety of foods, of which more than 75% of illnesses were attributed to seven food categories: Seeded Vegetables (such as tomatoes), Chicken, Pork, Fruits, Other Produce (such as nuts), Eggs, and Beef.
  • E. coli O157: Nearly 75% of illnesses were linked to Vegetable Row Crops and Beef.
  • Listeria monocytogenes: Illnesses were most often linked to Dairy products and Fruits.
  • Campylobacter: Over 80% of non-Dairy foodborne illnesses were attributed to Chicken, Other Seafood (such as shellfish), Turkey, Other Meat/Poultry (such as lamb or duck), and Vegetable Row Crops, with the majority of illnesses most often linked to Chicken.

Since FSMA’s passage in January 2011, FDA has worked hard to educate stakeholders on the many new food safety requirements covering all foods (with limited exceptions) under FDA’s purview. The message of the newly released IFSAC report strongly suggests that manufacturers and processors of implicated food categories should take special care. If not FDA coming to look, it will be FSIS to check on food safety measures and controls.

For example, the Produce Safety Rule and more recent Guidance for Industry establish science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. Specific requirements include agricultural water (pending further research), biological soil amendments, worker hygiene, building and equipment requirements. Growing sprouts is given special attention because of the inherent risk.

After the largest E. coli O157 outbreak in a decade, the Agency confirmed in early November that three samples of irrigation canal water were found to be contaminated with the H7 strain that sickened so many and killed five. Shortly before this announcement, the Agency released a Draft Guidance for Industry on minimizing food safety hazards for cut produce that discusses how to comply with new Good Manufacturing Practices as well as hazard analysis and risk-based preventive controls.

You may have also want to read EAS Senior Director for Food Consulting Services, Allen Sayler’s recent article in Dairy Foods Magazine on how FDA’s enforcement of Appendix T in the 2017 Pasteurized Milk Ordinance is focusing on FSMA-like requirements. I expect this to be a game changer for the Dairy industry.

Reports such as IFSAC’s find that the majority of severe foodborne illnesses can be mitigated through better controls, and more diligent efforts at safety. We can only be encouraged as FSMA compliance dates tick forward and we learn more of the “whats” and “hows” of preventive controls and better implementation methods. Unfortunately, we also learn much from cases where preventive controls did not work. When that happens, all of the industry should take note, assess their own procedures and make adjustments as needed so that we can collectively continue to create a safer food supply.

Meet Issue of the Month Author Amy Scanlin, M.S.

Amy Scanlin is a marketing coordinator and staff writer for EAS, providing technical support and coordination of EAS educational outreach seminars, webinars, and other communications. She has been with EAS since 2012 and prior had a career in the wellness industry, focusing on management and operations. She has a master’s degree in Health Promotion Management and has been a frequent contributor to industry publications on a variety of topics pertaining to regulations and research.

Laser Products and 510(k) Requirements

By Jerry Dennis

Each month EAS’ Ask the Expert answers questions sent in by readers on a variety of FDA regulatory topics. This month’s question on FDA’s regulation of lasers and 510(k) applications is answered by Jerry Dennis. Jerry is a former member of CDRH where he was responsible for radiation safety standards for laser products, (21 CFR 1040). He also developed regulatory policies and guided CDRH in report review criteria and regulatory policy pursuant to the Radiation Control Act and its regulation on radiation physics and biological effects. Prior to CDRH, he was a manager of high energy laser products for Hadron, Inc. If you would like to ask a question of our experts, click here.

Question: Is the FDA laser standard and product report in addition to the requirement for premarket notification (510k) or premarket approval?

Answer: Yes! And, FDA has additional regulatory requirements not only for laser products that are medical devices but also for other medical devices that generate radiation of any kind, in addition to requirements for certain other kinds of electronic products that generate radiation.

The FDA Center for Devices and Radiological Health (CDRH) has promulgated radiation safety performance standards for the following kinds of medical devices: diagnostic x-ray systems and their major components; radiographic equipment; fluoroscopic equipment; CT equipment; medical laser products; sunlamps and UV lamps for tanning; and ultrasonic therapy products. Additionally, there are such standards for television receivers, cold-cathode gas discharge tubes, microwave ovens, laser products other than medical laser products, and high-intensity mercury vapor lamps (for general illumination).

Manufacturers and/or US importers of products subject to such standards are required by regulation to certify their products’ compliance with the applicable standards, to submit product reports that describe their products and their manner of compliance with the standards and annual reports and to maintain distribution records. Additional portions of the regulations cover notifications and corrections. General requirements under these regulations require reporting of radiation defects or of accidental radiation occurrences for all products that generate radiation whether or not there is an FDA standard. The FDA electronic product radiation safety regulations are in 21 CFR 1000 through 1050. The only exception is that mandatory reporting under part 803 supersedes the reporting of accidental radiation occurrences for electronic products that are also medical devices.

If your company produces a radiation emitting product, contact EAS for assistance with product development and testing protocols, filing reports to FDA and appropriate packaging and insert labeling.

EAS Schedules Five Part Webinar Series on OTC Monograph Regulations

EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, will explore the history of OTC Monographs, why reforms are necessary and being undertaken now, and how OTC drug companies can expect those changes to impact their labels in a five-part complimentary webinar series.

Part 1 (January 16, 2019) will cover OTC Drug Monographs, Past, Present and Future and will discuss what a Monograph is, how it is used and how to interpret the different sections of the monograph.

Part 2 (February 27, 2019) will cover OTC Labeling requirements and Drug listings responsibilities.

FDLI Cannabis Conference Covers Possible Pathways to Regulation

The first annual FLDI Cannabis Conference was held in Washington D.C. on November 2nd. What made this cannabis conference unique for me was not the content or the speakers but the audience attending. I have been part of the cannabis industry for the past four years, from the start of recreational sales in Colorado in 2014, and I have attended many cannabis conferences. They are normally attended by science researchers and cannabis industry people.

However, the FDLI Cannabis Conference was attended by representatives of US federal agencies such as FDA, USDA, Department of Health and Human Services, NIDA, NIH, lobbying groups, think tanks, various large corporations both inside and outside (pharma and tobacco) of the current cannabis businesses and many attorneys. Unfortunately, there was very little industry representation.

The speakers and topics offered both scientific data from published studies and opinions of how the US federal government might regulate cannabis at some point in the future. There was a discussion of legalities currently in place and international treaties that prohibit the DEA from de-scheduling cannabis and hemp on a federal level. I think the industry would have benefited from participating in these discussions and providing their perspectives.

A very useful speaker was a researcher from University of Colorado who detailed the obstacles in her path to performing accredited, scientifically recognized research with cannabis when she only has one source of cannabis plant material, cannot use the university’s pharmacy department storage facilities or their brainpower and experience and cannot administer medication and must trust her subjects to report their use accurately. Study approval is by DEA and NIDA and often takes years to receive. It is commonly recognized that the US has fallen behind in the research and commercialization of cannabis. Israel is the global leader of cannabis research, while Canada leads in the commercialization of cannabis through federal legalization.

This is the only conference that I am aware of that has presented information about cannabis to federal agency representatives, which is a historic first. That said, the information was somewhat one-sided as it appeared those who currently own cannabis companies and work in the industry did not attend this conference. The FDLI Cannabis Conference is a wonderful opportunity to educate both the agencies that would regulate cannabis in addition to the industry on the regulatory issues and challenges. Only if the industry and regulators come together to discuss these very complex issues can progress be made. Perhaps we will see more industry participation next year.

There has been much discussion for the past year regarding the need for the US to find a federally legal way to ensure the safety of consumers and patients who use cannabis through some type of regulation while leaving the choice of participation to individual states. This past election saw the number of recreational states increase to 10 and medical states to 33. It appears that the time will be sooner rather than later, so hopefully, this conference is only the first which attempts to bring all of the parties together to engage in open dialogue to move these issues forward. As we move closer to federal GMP regulations, EAS Consulting Group will be ready to assist the cannabis industry with quality system implementation, laboratory operations, training, procedures and other compliance-related issues that they may face.

Last Chance to Register for the EAS and FDA Presentation on New Dietary Fiber Regulations for IFT

We are just days away from the webinar that EAS is co-presenting with FDA for IFT. Declaring Dietary Fiber in Nutrition Information will be presented by Independent Consultant and labeling expert, James Hoadley, Ph.D., Douglas Balentine, Ph.D., Director at FDA’s CFSAN Office of Nutrition and Food Labeling, and Sarah Gebauer, Ph.D., Nutritionist at CFAN. The webinar will take place December 6, 2018, at 9:00 am EST. Registrations are accepted by the IFT. FDA and EAS will join forces to discuss the policy on labeling dietary fiber and unravel challenges facing the food industry as it considers the path forward.

Meet New Consultant Greg Weilersbacher

With 25 years of industry experience, Greg Weilersbacher has successfully managed Quality Assurance, Quality Control, Analytical Development, Materials Management, GMP Manufacturing, GMP Facilities and Utilities Validation, and Facility Design and Construction Management in CMOs, biotechs and pharmaceutical companies. He has hosted FDA Pre-Approval Inspections and has led numerous European QP inspections of GMP facilities. Mr. Weilersbacher brings practical application of root causes analysis to Deviations and CAPAs and adds significant value to the execution of Supplier Qualifications, Regulatory Audit Preparation, Internal Audits, Training Systems and the evolution of a company’s Quality Systems.

Cannabis – Federal Pathways to Regulation Explored

Dear Reader,

Edward A. SteeleWelcome to the December 2018 edition of EAS-e-News, our free newsletter dedicated to companies regulated by FDA. I am sure you will agree it has been an interesting year thus far– particularly for food companies as FSMA compliance dates continue to arrive, food and dietary supplement labeling regulations continue to evolve, and the determination of what is and is not considered “fiber” raised questions. In addition, the tobacco industry is anxiously waiting on their own version of GMPs and the OTC industry is waiting on a Monograph reform. All of these and more are covered in our annual Year in Review, including, for those who attended the AdvaMed MedTech conference, a reintroduction to my granddaughter Ryan, who spoke on center stage.

Our Ask the Expert is answered by Jerry Dennis and concerns how FDA regulates lasers and radiation emitting devices. From lightbulbs to tanning beds to CT equipment, any radiation emitting device requires certification of compliance with pertinent regulations for their products. Jerry covers some of the basics here.

A special addition to this newsletter comes from one of our cannabis regulatory experts, Charlotte Peyton, who recently attended FDLI’s first annual cannabis conference. She provides her thoughts on the industry as the FDA and DEA grapple with how federal regulations might look in the future for this controversial industry.

Charles Breen’s FSMA Perspective discusses a recently released report on the sources of foodborne illnesses which highlights the urgency of FSMA compliance. Four “priority pathogens”, Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter together cause 1.9 million foodborne illnesses each year.

Speaking of Charles, he presented a webinar for the National Customs Brokers and Forwarders Association (NCBFAA) recently on FSVP and how to protect your business where he showed an example of a worksheet on Supplier Evaluations. Requests for this worksheet have been much in demand. If you are interested in downloading, you may find it on the EAS website.

Registration for our spring seminars is underway. If you need Food Labeling and Dietary Supplement Labeling training, Gisela Leon and James Hoadley, Ph.D. will be instructing March 12-13 (food) and March 14-15, (dietary supplement) in Philadelphia. In addition, our Dietary Supplement GMP seminar will be April 2-3, 2019, also in Philadelphia and is instructed by attorney, Marc Ullman, Of Counsel with Rivkin Radler, Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D.; and Independent Advisor for Quality and Compliance, Robert Fish. We’d love to see you there!

Lastly, I’d like to welcome back consultant Greg Weilersbacher. Greg consulted with EAS some years back assisting our pharmaceutical clients with GMPs. We are pleased to that he has chosen to return!

Thank you for your interest in EAS. If we can be of assistance in your company’s regulatory endeavors, please don’t hesitate to reach out to me.

Sincerely,

Ed

Drug and Device Corner 2018 October

The FDA has announced their FY 2019 Animal Drug User Fee Rates for ADUFA and AGDUFA, please follow link for full information.

Please see the FDA webpage for updates on valsartan recalls.

Guidance Document updates on the FDA website:

All centers:

CDER:

CDER & CBER:

CDRH:

CBER:

Remember to keep up with CDER Product – Specific Guidances for Generic Drug Development. October had 2 new guidances and 23 revisions.

Meet Issue of the Month Author

Bryan Armentrout is an expert in dairy, quality, system development, Safe Quality Foods, (SQF), Hazard Analysis and Critical Control Points (HACCP), design control, auditing, troubleshooting, recall, and crisis management, and process improvement. Prior to consulting he was the Vice President of Quality Assurance and Food Safety with Boulder Brands and the Vice President of Quality Assurance and Food Safety at CSC Sugar, LLC. He has a history of benchmarked success leading companies to more efficient and compliant processes.

EAS Leads Efforts of Regulatory Compliance Training

Dear Readers,

Edward A. SteeleWelcome to the November edition of EAS-e-News, the free newsletter for industries regulated by FDA.

I am pleased to say that our three October webinars, on Responsibilities of Own-Label Distributors, Preparing for Tobacco TPMPs and Problems with Data Integrity are now available on-demand on the EAS website. These webinars, as well as all of our regulatory webinars, are a great opportunity to dig into a particular topic and do so in under an hour. Feel free to peruse our current offerings and join us for one of our newly scheduled webinars:

  • Declaring Dietary Fiber in Nutrition Information (presented along with FDA for IFT)
  • Foreign Supplier Verification and How to Protect Your Business (presented for NCBFAA)

Learn more in the EAS-in-Action section of this issue.

We have just announced our Spring compliance seminars which will take place in Philadelphia, PA. Food Labeling will take place March 12-13; Dietary Supplement Labeling will take place March 14-15 and Dietary Supplement GMP will take place April 2-3. With FDA’s new requirements for food and dietary supplement labels including fiber, there have been many questions on how to comply. Additionally, FDA’s continued enforcement of GMPs requires hyper-vigilance by industry. We hope you’ll join us!

We welcome two new consultants and a new regulatory intern from Georgetown University. Welcome to consultants Charlotte Peyton who is an expert on cannabis GMPs and Steven Kurtz, an expert in dairy. In addition, our new regulatory intern Neha Mookuparambil is completing an M.S. in Biotechnology.

EAS just completed a major office expansion and redesign which includes photographs of our hometown, historic “Old Town” Alexandria, VA, taken by award-winning photographer, Carol Jean Stalun. I invite you to learn more about Ms. Stalun in this issue as well as stop by our newly redesigned offices whenever you are in the D.C. area.

As FDA is increasing its numbers of FSMA and FSVP inspections as well as issuing warning letters and 483s, we focus our attention on the subject of FSMA in our Issue of the Month, written by Bryan Armentrout who discusses common pitfalls when choosing new testing methods; Ask the Expert on how to respond to food recalls under FSMA; as well as our FSMA Perspective, where Charles Breen shares more information on FDA’s decision to release retailer information in some circumstances during a food recall. The industry is certainly a-buzz now that the effective date of the new FSMA rules has passed, (minus some very small businesses), and firms are assessing which rules apply to them and how to comply. If EAS can help with your FSMA readiness please feel free to reach out me.

I am very pleased to announce that EAS President and COO Dean Cirotta was an invited speaker to the United Nations, speaking to the SIDS DOCK IWON on EAS regulatory capabilities. Dean was accompanied to the UN by Tara Lin Couch, Ph.D., Senior Director of Dietary Supplement and Tobacco Services and Heather Fairman, EAS Independent Consultant and SIDS DOCK IWON Advisor and Technical Coordinator and Lisa Cirotta, who assists in EAS accounting department. If you have not already read our press release, it is included in this issue for your information.

Thank you as always for choosing to subscribe to EAS-e-News. We invite any comments that you may have and feel free to share this issue with colleagues.

Sincerely,

Ed

EAS to Exhibit, Present at SupplySide West in Las Vegas

EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., Independent Consultant Heather Fairman and President and COO, Dean Cirotta will represent EAS at the upcoming Supplyside West show November 6-10, 2018 in Las Vegas. You may find EAS at booth #5641. EAS is also well represented in the SupplySide West technical sessions as Tara will discuss Effectively Partnering with a Contract Laboratory as part of a panel on Wednesday, November 7 from 1:30–4:30 pm; and Tara and Heather together will present on Contract Manufacturing scheduled for Saturday, November 10 from 8:30 am–11:30 am. In addition, President and COO, Dean Cirotta will moderate a panel as part of the 7thannual AHPA Botanical Congress in Cooperation with ABC on how 21 CFR 111 applies to the Dietary Supplement industry.

EAS to Present Two Sessions at Food Safety Consortium

EAS will be presenting two sessions at the upcoming Food Safety Tech’s Food Safety Consortium taking place November 13-15, 2018 in Schaumburg, IL. Independent Consultant Andrea Yablunoksy will present on Recall Readiness: Understanding Requirements, Similarities & Differences in a USDA and FDA Program and Kathy Knutson, Ph.D. will discuss Lessons Learned in Food Safety and Applied to Cannabis-infused Edibles as part of the Cannabis Quality track. Both presentations take place on November 15th.

How to Prioritize Planning for Food Safety Emergencies

By Charles Breen

Charles Breen

This month’s Ask the Expert is on how to prioritize planning for food safety emergencies, particularly in light of the challenges of not only the emergency itself but recovering from it with your company’s reputation intact. It is answered by Charles Breen, EAS Independent Advisor for FSMA and Stacey Stevens, a Senior Vice President at FoodMinds, a division of Padilla. FoodMinds is EAS’ newest cooperative partner, and together our services help our clients working in the food industry to tackle regulatory and public relations challenges.

Question: As part of FSMA I am working to develop our company’s food safety contingency plans. How do I prioritize and plan for the first steps we need to take – investigations, recall communications and managing our public relations?

Answer: Great question and one worthy for all companies to consider, especially, as you point out on the regulatory side, FSMA mandates include both a hazard analysis risk assessment and if hazards in need of control exist, a recall plan. In addition, every company strives to mitigate harm to its reputation in the face of public scrutiny. So, how does one go about developing a comprehensive plan and assigning tasks on both sides of the coin? First, on the safety front:

In the interest of public safety, whenever a food safety issue has been reported, whether by FDA, another food safety authority or the public, unless you can unequivocally rule out your product as the culprit, initiate a recall. While the FDA and other food safety authorities could be wrong, they very rarely are. This will help to limit further harm, particularly in the case of Class 1 recalls which have a high likelihood of injury or death. Make sure management, as well as legal representatives, are informed of the decision to recall.

Next, per regulation, file a Reportable Food Registry report on FDA’s website. This must be completed within 24 hours of learning of the problem. It’s OK to have incomplete information to start, you must update the file as more information becomes available.

Keep good records and implement your Trace Back and Trace Forward action plan – match ingredients and sources with bills of lading so that you can attempt to identify the source of the problem. Establish the last documented evidence before the problem arose, the time the problem became known, and documentation that it was controlled. You’ll also need to identify recipients of the product and alert them directly. If those recipients cannot be accurately identified, the recall will grow exponentially larger, more expensive, and harder to manage.

Next, on the communications front, remember to take control of the messaging and communicate early and often. The public will want to know what you are doing to protect them now and how you will do things differently in the future. Be empathetic, forthcoming, and express an understanding of the seriousness of the situation. Don’t forget social and on-line media, websites and microsites – post brief updates in real time to keep everyone informed from line employees to key stakeholders and consumers.

In many cases, companies involved in a food safety emergency will enlist the assistance of qualified and experienced third-party consultants to help them through the crucial regulatory and safety steps as well as strategic public relations messaging.

Meet New EAS Intern, Neha Mookuparambil

EAS is very pleased to welcome our new intern from Georgetown University, Neha Mookuparambil, who is completing an M.S. in Biotechnology.  Her career interests include the fields of Drug Regulatory Affairs, Clinical Research, and Biopharmaceutical Business Development. Prior to Georgetown, she completed a PharmD degree at the Bharati Vidyapeeth University in Pune, India.  She has worked as a healthcare blogger and intern clinical pharmacist at the Bharati Hospital and Research Centre. 

Overcoming Seafood Fraud – a Free EAS Webinar Presented by Tim Hansen

Seafood is largely accepted based on how it is labeled or listed on a menu. This is true for seafood wholesalers, distributors as well as retailers. The financial incentive for unethical practices is huge but measures can be adopted by processors, wholesalers, and retailers to protect product identity and integrity. Join EAS Independent Consultant, and former head of NOAA Fisheries, Tim Hansen, for a discussion on various types of fraudulent activity in the seafood industry including where and why fraud can occur in the supply chain. He’ll discuss how seafood operators, buyers, and consumers can protect themselves as well as regulatory issues and possibly short, medium and long-term solutions.

Join Tim on December 5, 2018, at 1:00 pm Eastern for his discussion. Reserve your seat today!

EAS to Offer Five Part Webinar Series Looking at OTC Monograph Regulations

Join EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, as she explores the history of OTC Monographs, why reforms are necessary and being undertaken now, and how OTC drug companies can expect those changes to impact their labels in the future in a five-part series starting January 16, 2019.

Part 1 of the series, OTC Drug Monographs, Past, Present, and Future will discuss what a Monograph is and how it is used. She’ll dive into reading and interpreting the different sections of the monograph and discuss what the future might hold as Congress considers changes to the system. Join Susan on January 16, 2019, at 1:00 pm Eastern for part 1.

Later sessions will include topics such as what makes a drug an OTC and the Monographs Compliance System; OTC Labeling requirements and Drug listings responsibilities; Understanding the FDA and FTC Labeling and Claim Requirements for Cosmetic products, Homeopathic products in the OTC market; as well as OTC Drugs and Your GMP Obligations – Understanding how the GMPs are Applied and Preparation for FDA Inspection.

FDA Proposes Releasing Retailer Names in Most Serious Recalls

Charles BreenBy Charles Breen, Independent Advisor for FSMA

In an effort at greater transparency as well as consumer safety, FDA issued Draft Guidance this month proposing how and when FDA would publicize the identities of retail consignees that may have received recalled human or animal foods. This release of retailer information would only occur in cases where a food recall presents a serious adverse health consequence or death to humans or animals (SAHCODA), i.e., Class I recalls. The intention is to provide information to consumers to take a closer look at their purchases should they recognize that they shop at a particular location.

There is typically no single source that FDA can access to readily obtain a list of retail consignees of a recalled food product, therefore the decision to list retail consignees requires information obtained from multiple entities throughout a supply chain, including the recalling firm and its intermediate distributors – no small task. In addition, FDA may not be able to fully verify the accuracy or completeness of the information it receives from recalling firms or distributors so its available information may be over and under-inclusive In other words, FDA may not identify every retailer who received recalled product, and might inadvertently identify retailers who, in fact, did not receive the recalled item.

Currently, FDA routinely provides labeling information, product descriptions, lot numbers, and photographs, and if available to FDA – geographic or retail-related distribution information. It also lists all FDA-regulated recalls in the FDA Enforcement Report.

As noted in the Draft Guidance, the release of retailer information is authorized under Section 206 of the 2011 FDA Food Safety Modernization Act, ‘which directs the Agency, in conducting recalls under the section to “consult the policies of the Department of Agriculture regarding providing to the public a list of retail consignees receiving products involved in a Class I recall and shall consider providing such a list to the public,” when FDA considers the release to be appropriate (21 U.S.C. § 350l(g)(2)). The Department of Agriculture (USDA) policy is to make publicly available the names and locations of retail consignees of recalled meat or poultry products that USDA compiles in connection with a recall where there is a reasonable probability that the use of the product could cause serious adverse health consequences or death (Class I recalls). 9 CFR 390.10.’

FDA will consider two specific criteria that may warrant the release of retail consignee information, including when a recalled food is related to a foodborne illness outbreak, and where the information would be most useful to consumers. Examples of such foods are fruits, nuts, vegetables, and rawhide chews sold in bulk bins with no UPC or barcode, raw meat or deli products, or when the food product lacks a lot number, or other identifiers, which consumers can use to readily identify the product as one being recalled.

While there is some understandable concern regarding the publication of consignees and suppliers due to possible disclosure of confidential information, the Agency assures all that it will consider carefully the release of any additional retailer information, weighing risks to consumer health and safety. While FSMA has many facets that aim to proactively improve our food safety, no system is completely fool-proof. In cases where FDA and food manufacturer efforts at preventive controls fail, the additional release, as necessary of retailer information included in a recall will help to ensure the public has a greater awareness of contamination and can avoid the consumption of such products.

Meet New EAS Consultants

Charlotte Peyton has 30 years of industry experience in analytical chemistry working under FDA, EPA and Colorado Marijuana Enforcement Division regulations. She has been a bench chemist, method development chemist and overseen quality management. She has extensive laboratory experience as well as experience with stability programs, cleaning validations, process validations, and SOPs.

Steven Kurtz supports EAS dairy clients with the interpretation of regulations and development of policies to maintain compliance with FDA, USDA and state requirements. He has an in-depth understanding of dairy equipment and processes including NCIMS, 3-A Sanitary Standards.

EAS Consultants Present FSVP Webinar for NCBFAA

EAS Independent Advisor for FSMA, Charles Breen and EAS Independent Consultant, Bryan Armentrout are presenting a webinar focusing on FSVP requirements for the National Customs Brokers and Forwarders Association, NCBFAA.  Titled “Foreign Supplier Verification and How to Protect Your Business”the webinar is open to members and non-members of NCBFAA and will take place November 8, 2018, from 12-1 pm Eastern.

FDA’s recently increased inspections of importers to evaluate their compliance with FSVP requirements is a reflection of FDA’s commitment to making FSVP work. FDA inspections are also revealing that a significant number of importers do not understand what is needed to comply nor how. Customs brokers and freight forwarders, if not importers themselves, can help clients know what FDA is looking for, and who can assist them. Learn actionable steps and protect not just your food, but your business as well.  The cost of registration is $50.00 for members of NCBFAA and for non-members, $75.00.  For more information or to register, visit the NCBFAA registration page.

Four Common Mistakes When Selecting a Rapid Method for Environmental Testing

By Bryan Armentrout

We are now firmly in the era of the Food Safety Modernization Act. It’s no longer theoretical, it’s real world, and FDA is auditing and asking questions about what they are seeing.

I think we can all agree on one thing. The way we looked at environmental pathogen testing in the past is out the window. Gone are the days of testing the same 10 sites every few months for generic Listeria and calling it good. Sometimes, you would get a hit and do an investigation, but that was the extent of the excitement.

You now need a robust program that looks at multiple pathogens and takes them all the way out to speciation. Some companies are even going further and developing a “microbiological map” of their processing areas. The technology is overwhelming, but one factor is still critical, and that’s time.

No one has the time to put all their product on hold while waiting for five days to a week for results. Of course, that assumes that nothing comes back as a presumptive positive. If it does, you can wait a few days longer while logistics breathes down your neck, and customers have empty shelves. What to do?

You need a new program to test for your environmental pathogens. But, how do you choose? Instead of evaluating the ever-changing landscape of tests available, it might be more useful to list four rules you need to follow for your decision-making process. This is an expensive decision, so make the right one as you are going to be living with it for a long time.

You need a fast turnaround, and in most cases, that means you are now considering something that wasn’t even possible in the past -testing samples and releasing in-house. The first step is to get out there and see the amazing new micro testing world that is at your fingertips.

  1. Don’t get sold by a fancy presentationYou begin your journey by attending a trade show and marveling at the technology available. You strike up a conversation with a salesperson and after ten minutes, you are convinced that this new whiz-bang machine is the wave of the future. If you place your order today, you can get a huge discount and get one of the few machines that are even available. You can also add in a low monthly payment program. It does everything you want, and more in an hour and costs pennies to operate. It’s amazing, and you are in love.Not so fast, partner. It’s just like when you buy a car. The salesman at the dealership does everything to move you toward a purchase. How? By using your emotions. People buy on emotion and use logic to rationalize their decision after the fact.The thing the salesman wants you to forget is that this is a commodity and another similar model is available just down the street. Remember, any attempt to pressure you into a purchase should be met with a knowing smile. The deal they quote is not a once in a lifetime opportunity, and it will be there once you have time to make a decision in the calm light of rational thought. Be cool, try to find a technical representative of the company to talk with in addition to the sales or marketing staff. Remember it’s a piece of equipment, and one that is equally as good or even better is just around the corner. Add this piece of equipment to your list of possible testing methods and move on down the trade show to the next one.
  2. Not using a validated methodologyThis goes with the first point. You need a method and technology that are approved for your application. It needs to be benchmarked back to reference methodologies. Has it been used on your product matrix? Peanut butter will likely react very differently to the test than yogurt. Everything on your list needs to clear these hurdles before you even consider it. Don’t accept “the approval will happen in two weeks” line or something similar. You are in control of the validation and benchmarking process and must have a test and equipment that hold up to regulatory scrutiny.Ask the following questions as you look at the candidates:
    1. Has it been validated for my product matrix by one of the following?
      • A recognized independent organization such as AOAC, AFNOR, MicroVal or
      • A US regulatory body (FSIS MLG, FDA BAM or an ISO Method?
    2. Is the method?
      • Fit for the purpose and application
      • Performed under validated conditions by a lab that assures the quality of analytical results
    These questions come from the USDA Food Safety Inspection Service. They have compiled a list of validated methods that you can use as a starting point. It’s forty-six pages long! Cross off any candidates that didn’t make your list, realizing that FDA utilizes the BAM as their reference for acceptable analytical methods.
  3. Not testing in-house before you buyNever, ever buy a new testing method without trying it out first – for a long period of time. Any reputable company will have a loaner machine you can use. If they balk, cross them off the list and move on.Decide if you can test as a group or one at a time. This is a question of resources and how many people can do what. Don’t use the results for actual product release. Keep that the same as you are doing now.Another good idea is to test at the point of use in the plants. Don’t test at the corporate lab. You lose too many variables that need to be accounted for at the plant.Test it with every permutation you can think of. Analyze enough samples so you can make sure the results are repeatable. Find out the limits of detection for your product. What are the false positive and false negative rates? What is the turnaround time for results? See if your technicians can screw up the test. Make your test as foolproof as you can.Also ask yourself: Can you get test supplies in a reasonable period of time? What is the minimum order quantity? What is the breakpoint for discounts? Are your supplies expiring before you can use them? Are there other uses for this equipment?This list is not inclusive by any stretch; its a starting point. Create the list and stick to it. Don’t change it as you go along as it will bias the results toward the newest test. Be consistent.Remember, you may need to defend the test results in court one day. This is the litmus test for acceptance that you must always keep in mind in the age of FSMA. Send back any that don’t make the cut and cross them off the list.
  4. Not researching the companyGreat! Your list is down to the top two testing methods. They are both reliable and repeatable, have fast turnaround time, dependability and a decent cost per test. How do you decide now?The test is only as good as the company supporting it. If they are new to the scene, will they be here in five years? Will they come up with a new test and abandon the old one, leaving you with an expensive paperweight? Do they have references you can talk to? Can you talk to references who have had challenges with the test?Are they willing to work with you on price? Can you get other perks such as free service calls? How will they support you and the warranty? Just like the test, you need a huge list of questions to hit them with.

Final Thoughts

Congratulations! This was a big decision, but you made the right one for you. The method and the test you selected are the cornerstones of your new environmental testing program. You are finding out where pathogens hide in your plant and eradicating them. You have a clear record of identification and correction that any auditor will be happy to review. You sleep easy at night knowing that you made the right decision, and you have the ability to defend it if you need to.

Be proud of your work and welcome to the new age of FSMA!

Reference: FSIS List of Foodborne Pathogen Test Kits Validated by independent Organizations

Crozier-Dodson Article on Pathogen Control in Poultry Processing Published in Meating Place

Beth Crozier-Dodson published an article in Meating Place discussing top tips for proactive pathogen control in poultry processing. “One of the most significant aspects of any poultry food safety plan is the implementation of pathogen control measures at each critical control point identified in the processing plant. Those who do this in a proactive manner will be able to reduce the risk of microbial contamination that could prompt a costly recall.”

EAS and FDA Present Webinar on New Dietary Fiber Regulations for IFT

EAS Independent Consultant and labeling expert, James Hoadley, Ph.D. will present a webinar focusing on Declaring Dietary Fiber in Nutrition Information along with Douglas Balentine, Ph.D., Director, Office of Nutrition and Food Labeling, and Sarah Gebauer, Ph.D., Nutritionist at the Center for Food Safety and Applied Nutrition, FDA. The webinar will take place on December 6, 2018, at 9:00 AM – 10:00 AM CT and will be hosted by the Institute for Food Technologists (IFT).

FDA’s release of two Guidance documents in 2018 on labeling of dietary fiber, as well as the prior publication of a scientific review of non-digestible carbohydrates being evaluated for the physiological benefit, have created a need for clarification of these guidance documents to solve industry confusion. Most of the fiber ingredients currently used by industry and declared on labels as fiber have been acknowledged as fiber either by regulation or by enforcement discretion, but what next?  FDA, EAS, and IFT will join forces to discuss the policy on labeling dietary fiber and unravel challenges facing the food industry as it considers the path forward. The webinar is free for IFT members, non-members may register for $20. Join us!

Photos of Old Town Alexandria Put Final Touch on EAS Office Expansion

EAS Headquarters has just undergone a renovation to add additional space to its headquarter offices in the heart of Old Town Alexandria. Included in the buildout is more office space to accommodate expanding staff and the inclusions of a larger conference and training room equipped with state of art audio visual equipment. EAS now has the facility to hold in-house training course and to conduct video training programs and conferences with clients throughout the world. The office is conveniently located across from the King Street Metro Station within minutes of Reagan Airport and downtown Washington.

The corridors are lined with photographs taken of historic Old Town Alexandria by a local award-winning photographer, Carol Jean Stalun. Ms. Stalun was recently invited to the office to view her work and to thank her for her contribution to the appearance of our new headquarters. Her photographs can be viewed at https://www.caroljeanstalun.com/.

We welcome all of you to visit us whenever you are in the area. We would be happy to show off our updated space and to meet you in person.

 

Being a Third-Eye in a Plant with a Problem – Discussions on Listeria and Salmonella Protection in Food Safety Magazine

Carl Custer wrote about the challenges of Listeria, Salmonella, extraneous materials and worse in an article published in Food Safety Magazine. Carl also shared some of his experiences at problem-solving both while at FSIS and working with clients as a consultant, observing plant practices as “third-eye” in order to solve food safety problems.

Food and Dietary Supplement Labeling and Dietary Supplement GMP Compliance Seminars Coming to Philly

We have just scheduled our spring compliance seminars for Philadelphia, PA. Join us March 12-13 for the Food Labeling Compliance Seminar; March 14-15 for the Dietary Supplement Labeling Compliance Seminar and April 2-3 for the Dietary Supplement GMP Compliance Seminar. These are great opportunities to learn the new details of FDA labeling requirements as well as how to comply with GMP provisions for dietary supplements. Early-bird discounts apply as do multiple employees from the same company. Visit our registration pages to learn more.

Medical Device Regulatory Landscape Discussed in Post AdvaMed MedTech Wrap Up

Senior Director for Pharmaceuticals and Medical Devices, Bryan J. Coleman discussed innovations and the regulatory landscape in an AdvaMed MedTech blog. Bryan shared his thoughts as FDA continues to harmonize and leverage existing regulatory approaches in increasingly more creative ways that allow the industry to grow and flex along with innovation. Still based in sound science and documented evidence, FDA expects sponsor and contract manufacturers to tighten controls over raw materials and component quality equal to internal design and production. Now more than ever companies must plan and prepare for meeting quality requirements and ensure quality measures are weaving design, supporting technologies, supply chain and feedback mechanisms into one cohesive program.

FDA Announces Export Certifications and Fees for Certain Food Products

By Charles Breen, Independent Advisor for FSMA

On August 31, 2018, FDA announced a new voluntary export certification option for certain foods as authorized under FSMA, similar to that available for qualified pharmaceuticals and medical devices. This new export certification program and its associated fees will allow the agency to collect up to $175 for export certifications for food for human consumption, with the exception of dietary supplements, medical foods, and foods for special dietary use. The issuance and collection of these fees begin October 1, 2018, and are in effect for two new types of food certificates, the “Certificate to a Foreign Government” and “Certificate of Exportability.”

Prior to this announcement, CFSAN issued only a “Certificate of Export” for seafood, food additives, and food contact substances and a “Certificate of Free Sale” for foods other than seafood, dietary supplements, infant formula, medical foods, and foods for special dietary use.

Per the FDA’s Constituent Update, the “Certificate to a Foreign Government” will be available for products that meet the applicable requirements of the FD&C Act and will certify that a product (or products) may be marketed in and legally exported from the United States. The “Certificate of Exportability” will be available for export only products and will certify that a product or products meet(s) the requirements of section 801(e)(1) of the FD&C Act and may be legally exported. FDA anticipates that the new certificates will help facilitate exports by assisting industry in fulfilling importing country requirements for certification by FDA of FDA-regulated food products.

Requests for written export certification for FDA regulated products are common from foreign customers or foreign governments. In the case of food products, FDA provides, though does not require, written certification for exports in the form of certificates and lists of eligible exporters for specific products or destinations. Those U.S. companies which export foods are required to follow U.S. laws and regulations as well as those specific to the countries the products are being exported to. It is important to note that laws vary across countries and FDA does not provide any guidance for laws outside of the U.S. that companies must follow.

Most CFSAN export certificates may be obtained by completing an online application through the FDA Unified Registration and Listing Systems (FURLS) Certificate Application Process (CAP). These take several weeks to process with no expedited review option. Some foreign governments require the additional step of verifying the export certificate via apostille or authentication from the U.S. Department of State or, in cases where the certificate was issued after April 2016, a unique Certificate ID, printed in the top left corner of every certificate, may be used to independently verify whether the export certificate was issued by FDA.

EAS offers U.S. import assistance as well as assistance for companies exporting product to foreign countries via the application of a certificate of export as well as obtaining apostille from the U.S. Department of State. Contact us for more information.

Fairman Discusses Tips to Ensure Compliance with Audits in Natural Products Insider

EAS Independent Consultant Heather Fairman discussed Own Label Distributor audits of contract manufacturers as well as steps for ensuring their compliance in the Natural Products Insider. “Own label distributors performing contract supplier and/or contract manufacturer audits often have critical blind spots that may result in products not meeting specifications or their quality and safety expectations,” she says.

Couch Shares Dietary Supplement OLD Responsibilities in AgroFOOD Industry HI Tech

Senior Director Tara Lin Couch, Ph.D. shared Own Label Distributor (OLD) responsibilities in a recent article published in Technoscienze – AgroFOOD Industry HI Tech. Regardless of whether an OLD is domestic or international, the FDA is clear that the OLD is responsible for compliance with the regulatory requirements in 21 CFR 111, she says. “The development of critical OLD processes should include procedures such as qualification of OLD contractors; demonstration that the quality unit is fulfilling obligations of finished product specifications; a complaint system for evaluating all reported consumer concerns for the identification and reporting of Serious Adverse Events (SAEs) to FDA; and change control processes to ensure revisions are tracked and monitored.”

Skolnik Discusses AERs in Natural Products Insider

Norma Skolnik discussed Adverse Events Reporting (AER) requirements for the dietary supplement industry in Natural Products Insider. The requirements as well as the Guidance for Industry: Questions & Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as required by the Dietary Supplement & Nonprescription Drug Consumer Protection Act,” published in 2007 cover SAE reporting for manufacturers and OLDs as well as FDA notification to companies when FDA receives an SAE involving one of their products.

EAS to Exhibit, Present at SupplySide West in Las Vegas

EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., Independent Consultant Heather Fairman, and President and COO Dean Cirotta will represent EAS at the upcoming SupplySide West show November 6-10, 2018 in Las Vegas. You may find EAS at booth #5641. EAS is also well represented in the SupplySide West technical sessions as Tara will discuss Effectively Partnering with a Contract Laboratory as part of a panel on Wednesday, November 7 from 1:30-4:30 pm; and Tara and Heather will present on Contract Manufacturing scheduled for Saturday, November 10 from 8:30am-11:30 am. In addition, President and COO, Dean Cirotta will moderate a panel as part of the 7thannual AHPA Botanical Congress in Cooperation with ABC on how 21 CFR 111 applies to the Dietary Supplement industry.

Cirotta to Moderate Panel at FDLI Conference Focusing on Tobacco and Nicotine Products

Dean Cirotta will moderate a panel at the upcoming FDLI Tobacco and Nicotine Products Regulation and Policy Conference concerning “The Latest on Product Standards and Other Potential Regulatory Action”. The conference, which takes place October 25-26, 2018 in Washington, D.C., will address issues of effectively regulating the broad spectrum of tobacco and nicotine products both in the U.S. and globally.

Planning for Emergencies – Document, React and Manage all Aspects When the Worst Happens

Dear Readers,

Welcome to the October 2018 edition of the EAS-e-News, a free news publication for industries regulated by FDA. I’d like to invite you to view our latest video discussing EAS services in the infant formula industry. These short videos are a few minutes in length and designed to give you a better understanding of EAS capabilities and expertise of our many talented consultants. You may find all of our capability videos at the bottom of the page under the food tab of the EAS website.

We have a number of new webinars planned for the month of October and early November that we invite you to sign up for. From Preparing for Tobacco TPMPs, to Own Label Distributor Responsibilities and Pharma Data Integrity our complimentary webinars offer the latest regulatory information in a concise one-hour format with time for Q&A.

Independent Consultant, Priya Jambhekar will be speaking at FDLI’s Introduction to Biologics and Biosimilars Law and Regulation on the Regulation of Biological Marketing. This event is being held October 3-4, 2018 in Washington, D.C.. Dean Cirotta will be moderating a panel at the upcoming FDLI Tobacco and Nicotine Products Regulation and Policy Conference which is also being held in Washington, D.C. on October 25-26, 2018. Independent Advisor for OTC Drugs and Labeling, Susan Crane, will be presenting a session as part of the CHPA Academy’s OTC 101 course on OTC drug labeling regulations. This course is being offered in Wilmington, DE October 9-10, 2018.

Our Issue of the Month article is written by Independent Consultant Norma Skolnik and is on the legislation to reform the OTC Drug Monograph System called the OTC Drug Safety, Innovation, and Reform Act. EAS has a strong team of consultants who have in-depth knowledge of the OTC monograph process as well as the Rx to OTC switch. Our FSMA Perspective written by EAS Independent Advisor for FSMA, Charles Breen is on FDA’s new fee-based program Export Certifications for certain food products.

We hope you enjoy this issue of EAS-e-News and we hope that you’ll join us at one of our many webinars and presentations in the coming weeks. It is always a pleasure to meet those who also have a vested interest in ensuring the safety and compliance of FDA Regulated products. We welcome your questions and comments and please feel free to share this newsletter with your colleagues.

Sincerely,

Edward A. Steele

EAS Webinar Series Continues with Topics Ranging from Tobacco TPMPs, Own Label Distributors and Pharmaceutical Data Integrity

EAS is offering a number of complementary regulatory webinars this fall. Please join us for these live sessions or view one of our On-Demand webinars found under the Resources tab of our website.

Preparing for Tobacco TPMPs – October 9, 2018, at 1:00 pm Eastern

Join EAS President and COO, Dean Cirotta and Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. for a discussion of expectations for FDA’s in-development Tobacco TPMP Rule and how you can assess your current quality systems in preparation. This webinar is hosted in Cooperation with the Tobacco Merchants Association.

Own Label Distributor Responsibilities – October 11, 2018, at 1:00 pm Eastern

As more and more OTC drug and dietary supplement companies are contracting out manufacturing, packaging, laboratory testing, and distribution services, it is imperative that those in responsible positions for OLDs gain a full understanding of FDA’s requirements for knowing what and how these contracted activities are performed. Learn more about your “OLD” responsibilities and how to document that you are meeting them with EAS Independent Consultant, Bruce Elsner.

Problems with Pharma Data Integrity – October 18, 2018, at 1:00 pm Eastern

FDA takes data Integrity very seriously and their many Warning Letters and Import Alerts to dosage form and Active Pharmaceutical Ingredient (API) manufacturers in the past several years indicate that validation is a consistent problem. Join EAS Independent Consultant Brian Nadel to better understand the Agency’s expectations for data integrity as well as how your company can assess your compliance. Learn critical strategies and processes that each firm should undertake to limit data integrity risk and demonstrate reliable data every time.

Breen Co-Authors Article in Food Quality and Safety Magazine on Responding to Food Safety Emergencies

Independent Advisor for FSMA, Charles Breen has co-authored an article with Stacey Stevens, Senior Vice President of FoodMinds, a food PR firm with which EAS has a collaborative partnership on responding to a food safety emergency. The article, published in Food Quality and Safety magazine discusses the many issues of responding to an emergency and how to focus messaging on that response.

Legislation to Reform the OTC Drug Monograph System: The OTC Drug Safety, Innovation, and Reform Act

By Norma Skolnik, Independent Consultant

With the aim of overhauling the regulation of over-the-counter (OTC) monograph drugs, U.S. Senators Johnny Isakson and Bob Casey recently sponsored bipartisan legislation, the Over-the-Counter Drug Safety, Innovation, and Reform Act of 2018, S.2315. The bill, which has already passed in the House of Representatives, was approved by the Senate Health, Education, Labor, and Pensions committee on April 24, 2018, and was received by the Senate at large on July 17, 2018. A previous bill, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2017, authored by Representative Bob Latta (R-OR) and others, was introduced over a year ago.

As most people know, the current monograph system, which was implemented in 1972, has received much criticism and there have been several prior efforts to revise what’s been called an outdated “broken system”. The current monograph system’s drawbacks include the slow rulemaking process (many OTC drugs are marketed under incomplete monographs), the inability to swiftly and promptly address safety issues, and barriers to innovation (eligibility is largely limited to active ingredients that were marketed before 1972). In addition, FDA has acknowledged that it currently lacks the resources to effectively regulate all OTC monograph products.

The proposed bill is intended to speed up the current slow and time-consuming regulatory procedures by introducing the administrative order process to replace the current rulemaking procedures. It provides options for manufacturers to request administrative orders and for FDA to initiate administrative orders on its own initiative as well as in response to a citizens’ petition.

The S2315 bill would also establish a process for the introduction of new OTC products that are marketed without an approved New Drug Application. This legislation would authorize the agency to grant 2 years of product differentiation and exclusive market protection for certain qualifying OTC drugs, thus delaying the entry of other versions of the same qualifying OTC product.

The bill also includes provisions that would provide FDA with the authority to take rapid action in the event of safety issues with OTC drugs and requires that FDA re-evaluate the OTC cold and cough monograph with respect to children under the age of six and report annually to Congress on the progress of this evaluation. This was prompted by a 2007 internal review that linked the deaths of 54 children younger than 6 years to the use of OTC decongestants and cough medications.

Additionally, the new legislation will help manufacturers who wish to develop innovative products, for example, by adding new ingredients or creating new dosage forms of existing OTC drugs. It should provide a more streamlined regulatory pathway for review of innovations within the OTC Monograph system, accommodating marketplace innovations, such as new uses for ingredients, dosage forms, and other advancements. It should also provide a mechanism to encourage investment in data needed for significant innovations.

Reforming the OTC monograph system should benefit consumers and give FDA the resources that it needs to provide effective oversight of these widely used drug products.

The proposed legislation updates the monograph process by specifically adding a new section to the Federal Food, Drug, and Cosmetic Act (FFD & C) to implement the following:

  • Move away from the cumbersome current monograph finalization process to an “administrative order” procedure. The system for future changes to Monographs would be through the administrative order procedure with an opportunity for development meetings or other consultations, comment on proposed orders, and dispute resolution protections
  • Include by reference existing OTC Review Final Monographs and deem final all existing Tentative Final Monographs by statute
  • Create new pathways to innovation for monograph products, where none currently exits
  • Ensure that the new drug approval pathway and other nonprescription drugs otherwise lawfully marketed are not affected
  • Create a mechanism for faster OTC drug safety label changes;

Importantly, the bill provides FDA with the authority to collect user fees to help cover much of the costs of updating the regulatory system and provide the necessary resources to evaluate and monitor the OTC drug market. It’s hoped that the user fees will provide FDA with the funding and staff required to better oversee OTC drug compliance and build a critical IT/electronic infrastructure. This bill differs from previous versions because of its’ exclusivity provision.

The OTC Drug Safety, Innovation, and Reform Act is now awaiting Senate action. There is a great deal of bipartisan support for this bill, including from the American Academy of Allergy, Asthma & Immunology, the American Dental Association, and the American Academy of Pediatrics, who have urged passage because of the need to overhaul and modify pediatric dosing for OTC drugs, particularly OTC cough and cold drugs. It’s also been supported by the Consumer Healthcare Products Association (CHPA), the leading U.S. trade association representing OTC drug manufacturers and marketers. However, although it has widespread support and appears likely to pass, this is not a “must pass” bill like other existing user fee legislation. When it does pass, this legislation will have an enormous impact on the OTC drug industry in this country.

Issue of the Month Author, Norma Skolnik

This month’s Issue of the Month on Serious Adverse Events Reporting is written by Independent Consultant, Norma Skolnik. Norma has over 35 years of regulatory experience working with the pharmaceutical, OTC drug, and dietary supplement industries. Prior to consulting, she served as Director of Regulatory Affairs for the Americas for Cadbury Adams until her retirement. She also held the positions of Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company.

Drug and Device Corner 2018 September

EAS would like to remind clients, the FDA FY 2019 establishment registration renewal period begins this month. With reference to Drug Establishments, please make sure you are aware of your obligations under the Drug Supply Chain Security Act (DSCSA) during this drug listing certification period. The FDA has released several guidance documents to assist.

In the event you not already seen the Statement from FDA Commissioner Scott Gottlieb, M.D, EAS highly recommends you read this to understand the FDA’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities. The statement includes a link to the FDA’s published internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections.

In addition, FDA recently announced a Special 510(k) Program Pilot, which aims to expand upon the types of changes eligible for the Special 510(k) Program to improve the efficiency of 510(k) review. FDA is working to simplify the review of certain 510(k)s for industry and FDA staff using efficient practices consistent with least burdensome principles. As part of this pilot, certain design or labeling changes that previously were reviewed as a Traditional 510(k) may be eligible to be reviewed through the Special 510(k) pathway instead. The Agency believes that the reliance on design control requirements and previous Agency review of detailed information can reduce review times and still protect the public health. This pilot is part of ongoing efforts to simplify the 510(k) process and help promote timely access to safe, effective, and high-quality medical devices.  EAS offer 510(k) review and submission assistance. Please contact us for more information.

Guidance Document updates on the FDA website:

All centers:

Postapproval Changes to Drug Substances

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

CDER:

Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers

Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy

Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

Allergic Rhinitis: Developing Drug Products for Treatment

Nonallergic Rhinitis: Developing Drug Products for Treatment

Physiologically Based Pharmacokinetic Analyses — Format and Content

Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development

Technical Specifications—Comparative Clinical Endpoint Bioequivalence Study Analysis Datasets for Abbreviated New Drug Applications

FDA Product-Specific Guidances for Generic Drug Development webpage

FDA in Brief: FDA issues 54 product-specific guidances to promote generic drug access and drug price competition 

CDER & CBER:

Hematologic Malignancy and Oncologic Disease: Considerations for User of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development

Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products – Content and Format

CDRH:

Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing

Recognition and Withdrawal of Voluntary Consensus Standards

510(k) Third Party Review Program

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions

What Exactly is an FSVP?

By Allen Sayler

Ask the Expert offers a chance for our readers to submit questions to EAS regarding areas of regulatory confusion. This month’s question is answered by Allen Sayler, Senior Director of Food Consulting Services. If you’d like to submit a question, please use the “contact us” link on our website.

Question: FDA is cracking down on enforcement of the Foreign Supplier Verification Program (FSVP) through inspections of US-based FSVP importers with almost 200 FDA 483s issued stating “failure to develop an FSVP” which allows FDA to designate the imported food as “adulterated” and demand it be removed from the US marketplace. FDA has budgeted over 2000 foreign inspections/investigations during the coming year so “failure to develop an FSVP” is likely to become more common, forcing FDA’s hand to strengthen its regulatory enforcement. The question is, “When will FDA remove the “soft glove”, training and educational approach and move toward active enforcement of the FSVP regulation?” The second related question is, “How does the FSVP Importer know if their FSVP meets FDA expectation?”

Answer: Interesting questions and one thing I have learned during my long regulatory career is that one can never accurately predict when FDA will publish a new regulation, direct their field investigators to intensify their regulatory effort or ramp-up compliance enforcement. In trying to determine the general time period when FDA may start to take more aggressive regulatory action against US-based FSVP Importers, it is important to look at “signs”. One sign is the recent statistics indicating as of mid-June 2018, the number of FSVP-focused inspections the Agency has conducted is nearly equal to the total number for all of the calendar year 2017. In more detail, well over half of the number of FSVP inspections so far have resulted in the issuance of Form 483s, noting that the FSVP Importer has failed to develop an FSVP program including a written hazard analysis plan, an effective and written supplier management program and the correct foreign supplier documentation available for FDA review at the US-based FSVP Importer’s office. Another sign is when the Agency believes it has fully trained most or all of those field investigators so they are equipped to conduct the on-site FSVP investigations. It appears this has been completed or is near completion for the FSVP regulation. Additionally, foodborne illness outbreaks are a key sign, and over the past year, the incidence of foodborne illness from imported foods does not appear to have increased significantly so this “sign” does not appear to be pushing FDA to strengthen FSVP enforcement, although one serious foodborne illness outbreak attributed to imported foods will immediately change this “sign”. All of these together, indicate that the Agency is preparing for more aggressive FSVP enforcement which will likely mean those importers with inadequate or missing FSVP programs will have their products blocked from import. If one had to guess, we anticipate this stronger FSVP enforcement of FDA to start sometime in late 2018 to early 2019 for human foods.

How can firms ensure that they have a developed FSVP that meet’s FDA’s expectations? As Sharon Mayl, Senior Advisor for Policy in the Office of Foods and Veterinary Medicine at FDA, said in an interview, “FSVP inspections are based on the review of records, rather than observations of food production. In addition to an onsite visit, FSVP inspections may include a documentation review of materials sent to FDA upon request. The investigator will review these materials for deficiencies.

One way to address this is to contract for the services of a qualified consultant to perform the FSVP Qualified Individual responsibilities. This would also solve the second question for US-based FSVP Importers, “How does the FSVP Importer know if their FSVP meets FDA expectation?” The other way is to hire a Qualified Individual that as the credentials identified in the FSVP regulations. Either way, you need a knowledgeable, well trained “Qualified Individual.” EAS has a number of food safety experts available to serve as the Qualified Individual, should you decide to contract out this important responsibility.

EAS Presents Webinar on Preparing for Tobacco TPMPs in Cooperation with TMA

TMAEAS President and COO, Dean Cirotta and Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D. will present a free webinar on October 9, 2018, at 1:00 PM Eastern on Preparing for the Tobacco Product Manufacturing Practices Rule (TPMPs). This webinar is hosted in cooperation with the Tobacco Merchants Association. Since CTP Director, Mitch Zeller’s announcement at the 2018 TMA Annual Meeting that the Agency is prioritizing a TPMPs, the industry has been speculating regarding what these rules may encompass. Join us October 9th for this informative webinar, which will provide an overview of expectations for the TPMP rule and how you can begin assessing your current quality systems.

Couch Discusses Contract Manufacturing Partnerships in Natural Products Insider Podcast

Senior Director for Dietary Supplements, Dr. Tara Lin Couch was interviewed for a Natural Products Insider podcast on contract manufacturing partnerships. Dr. Couch is one of two EAS presenters for the upcoming SupplySide West trade show taking place in Las Vegas. Stay tuned for more information on EAS presentations by Dr. Couch and EAS Independent Consultant Heather Fairman.

EAS Offers Training Solutions for GMPs, Food, and Dietary Supplement Labeling Issues

Companies looking to ensure employees understand of the most up to date FDA requirements may look to EAS for their training solutions. With three upcoming seminars

Our expert trainers will provide a detailed approach to complicated and often confusing challenges enabling take-aways that can be readily applied to improve compliance. Training seminars can also be offered in-house and customized to specific needs.

Meet New Office Manager Jodi Burns

Jodi Burns

Office Manager, Jodi Burns, has extensive management experience in non-profits and for-profit firms, overseeing projects, human resources and developing policies and procedures. She has worked for organizations such as Clear Chanel Radio, Noell Clevenger & Company, CBS Radio, Loving Couples, Loving Children, Inc., among others in her career. Jodi is the front-line manager of the EAS home office and provides assistance to both consultants and clients in a variety of areas.

 

 

EAS to Exhibit, Speak at CPhI North America in Philadelphia

EAS Consulting Group is proud to be an invited speaker at the upcoming CPhI North America, April 24-26, 2018 in Philadelphia. You can find EAS at exhibit booth 856 where Senior Director for Pharmaceuticals and Medical Devices, Bryan J. Coleman and Regulatory Specialist, Victoria Pankovich will be available to discuss questions and concerns surrounding your business. We also invite you to attend Bryan’s session as part of the CPhI technical program on Regulatory Considerations, Strategy and Best Practices for Choosing a CMO which will be Tuesday, April 24th at 3:30 pm.

EAS Consultants to Present at Two Upcoming FDLI Events

Andrea Yablunosky will be speaking on Food Labeling: Nutrient Content, Health, and Other Claims on September 24, 2018 at the upcoming FDLI Introduction to Food Law and Regulation which will be held in Washington, D.C. She’ll discuss a variety of claims including Natural, Organic and Fresh as well as the effects of state law litigation on use of Health Claims.

Priya Jambhekar will be presenting the session on Regulations of Biologics Manufacturing on October 4, 2018, at the FDLI Introduction to Biologics and Biosimilars, taking place in Washington, D.C. She’ll discuss standards of inspections, the scope of pre-approval inspections as well as responding to FDA 483 forms and warning letters.

Tajkarimi and Sayler Discuss RTEs in Natural Products Insider

Independent Consultant Mehrdad Tajkarimi and Senior Director Allen Sayler co-wrote an article for Natural Products Insider discussing Cause, Effect and Impact of RTE Operations on complying with FDA’s draft Listeria guidance. Food manufacturers are expected to operate within an entirely new scheme of “design out” of potential entry and harborage of Listeria, develop “hygienic zoning”, enhance monitoring and record keeping for cleaning and sanitizing a food processing facility and more. As FDA inspectors use draft FDA guidance for Control of Listeria Monocytogenes in Ready to Eat Foods during routine and targeted investigations, these new criteria, as well as others found in the guidance, will become the new benchmark of safety against Listeria in RTE operations.

FDA Ramping Up FSVP Inspections, Finding Issues with FSVP Development

Dear Readers,

Edward A. SteeleWelcome to the EAS-e-News, a free newsletter for FDA-regulated industries. I am very pleased to report that the new EAS website, a project, that we have been working on for some time, is now live. We invite you to visit it at the same URL as our previous website – easconsultinggroup.com. There are a number of new features here which I am sure you will agree, provide for easier navigation, improved access to our and the Agency’s information as well as a more attractive design. For example, those who work in the food industry will find our short videos which highlight just some of EAS services are easily accessible on the main Food Services tab. In addition, a newly created tab called Resources includes the latest press releases, recalls and enforcement reports from the Agency as well as valuable regulatory information authored by EAS staff and independent consultants and published in industry trade journals as well as current and past issues of what I hope is your favorite go-to regulatory newsletter, EAS-e-News. Please visit our new website! I hope you find this new layout to be easy to navigate and a great resource of information!

Our issue of the month article written by Independent Consultant James Evans covers Mutual Recognition Agreements (MRAs). Recently annexed in 2016, these MRAs between EU countries and the U.S. allow for better distribution of resources in cases where an EU country’s facility inspection standards are equitable to FDA’s. In such cases, more focus can be applied to those facilities that warrant a closer eye. These MRAs by no means suggest that Quality and GMP vigilance can be lessened in those facilities operating in countries with MRAs. EAS offers a thorough inspection and audit program specific to the requirements of pharmaceuticals and all FDA regulated industries. These audits, in some cases, are offered as “mock-FDA” inspections assist companies in understanding not only their responsibilities under the law but, also how they can improve areas of need to create a robust operational structure.

Our FSMA Perspective discusses the FSMA Preventive Controls, which are now beginning to see enforcement actions taken by the Agency. It is always the right time to assess compliance with these important safety protocols which aim to eliminate potential sources of contamination before they have a chance to enter into processing and production facilities. This is good for public health, operational efficiency, required by law and of course, the right thing to do.

Our Ask the Expert includes a question from one of our readers that sees a real challenge in the food industry about how to comply with the FSVP rules under FSMA. FDA is rapidly and significantly ramping up their inspections of FSVP requirements and finding that in many cases firms are failing to develop a foreign supplier verification program. This month’s question gets to the heart of the challenge – what exactly is an FSVP?

We introduce new consultants Norris Alderson, Ph.D., Carl Custer, John Sawyer, Randy White and John Ziobro. EAS continues to recruit the best in regulatory talent to join our team of independent consultants enabling us to maintain our reputation as a leading consulting firm for FDA regulated industries. In addition to our new consultants, we welcome Jodi Burns, our new Office Manager and the voice behind the phones when calling the EAS home office as well as Shachi Shah, our regulatory intern. I invite you to read more about their backgrounds in the Who’s Who section of this issue.

Thank you all for your interest in EAS and our EAS-e-News. I invite you to share any feedback on this issue or our website. As always, please feel free to share this newsletter with your colleagues.

Sincerely,

Ed

Meet New EAS Consultants

Norris Alderson, Ph.D.

Norris Alderson, Ph.D.

Norris Alderson is an expert in the approval process for veterinary products and assists clients with understanding FDA guidance for data requirements for animal drugs to include additives for animal feeds and process for review by FDA. He also helps clients understand processes for interacting with FDA in the development of products and has experience in managing and understanding functions of institutional review boards including the National Nanotechnology Coordination Office. Prior to consulting, Dr. Alderson spent his career at FDA, most recently as the Associate Commissioner for Science and the Director of the Office of Science and Health Coordination.

Carl Custer

Carl Custer

Carl Custer is an expert in HACCP, microbiology of dried meat products and special processes for retail foods and spent his career at USDA/FSIS investigating foodborne outbreaks. He consults in problem-solving on issues including contamination by Listeria spp., Salmonella, and foreign materials and serves as an expert witness for legal firms on spoilage factors.

John Sawyer

John Sawyer

John Sawyer is a regulatory and quality professional with over 30 years of experience in the medical device, electronic and aerospace industries. He is a Senior Member of ASQ and a registered Lead Quality Management Systems Auditor with the International Register of Certificated Auditors out of London. His current work focuses on providing FDA QSR, ISO-13485-2016, EU MDD, EU MDR, CMDCAS and other regulatory/quality consulting services.

Randy White

Randy White, Ph.D.

Randy White is a consultant for medical devices, pharmaceuticals, biologics, nutritional supplements. Prior to consulting he worked for WuXi AppTec and Baxter Healthcare Corporation overseeing the performance of toxicology and safety studies to include testing strategy, study design, and animal model development, as well as preparation of toxicology reviews for regulatory submissions and toxicity/risk assessments, study director for GLP studies. He has a Ph.D. in Animal Science Nutrition from Oregon State University.

John Ziobro

John Ziobro

John Ziobro is an experienced professional in the medical device industry. His expertise includes engineering and new product development from concept-through-completion, design controls, design traceability, technical files including 510(k) submissions, device history records, and design dossiers. John’s background includes vast experience in electromechanical design, verification and validation; component selection and vendor audits.

Preventive Controls – A New Ballgame for Food Safety Compliance

By Charles Breen, Independent Advisor for FSMA

With the recent issuance of a Warning Letter citing violations of Part 117 subpart C (preventive controls), implementation of FDA’s Preventive Controls rule takes its next step – FDA will cite food facilities for preventive control failures. Everyone paying any attention to FSMA knew this would happen, and as long as it happens to someone else, it can be a low pain, high gain learning opportunity.

For example, we now know FDA objects to food facilities that make a ready to eat products, have multiple positive Salmonella results from an environmental sampling program, and yet do not consider Salmonella a hazard in need of one or more controls as part of a food safety plan. Equally, FDA objects to having corrective actions that are not implemented when a problem arises for which the corrective action was planned. And failing to verify that sanitation procedures are properly performed is worthy of citation in a Warning Letter.

No matter how much FDA educates, theoretical agency definitions of unacceptable conditions or practices are no substitute for concrete examples. These first few are obvious, but we can expect more, and more finely detailed, citations in the future.

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods and Animal Foods lays out expectations for the prevention of contaminated foods in all areas of processing, packing, holding and transporting. Food facilities must have plans in place that address hazards reasonably likely to occur in the absence of one or more controls.

As noted in the recent Warning Letter, implementation of controls, verification, and monitoring can be lacking. This challenges many companies because writing written procedures is one thing, properly implementing them is another. Practicing accountability from start to completion is often overlooked, leaving many facility managers ill prepared just when and where they need it most. Performing practiced implementation for when things go awry is one critical way of preparing for the inevitable and doing so with measured success.

Firms are busy and time is money. When a production line is down, a product is not being made, customer demand is not met and earnings suffer. In maximizing efficiency, the devil in the details can get lost and we miss steps. Some missed steps may even seem innocuous at the time, after all – we are in a hurry, but they compound each other leading to a failure.

Let’s take the case of the requirement for pathogen swabbing, (shameless plug – EAS is offering a complimentary webinar on swabbing for environmental pathogens September 21). FDA requires that facilities producing foods that have been associated with outbreaks of foodborne illness or pathogen contamination, or produce ready-to-eat foods for that does not include a kill step after packaging, establish environmental sampling programs.

When there is an identified environmental pathogen hazard requiring a preventive control, environmental monitoring is required at regular intervals. At some point, there will be a positive result. If you never find any positives, FDA may suggest your sampling program is not robust enough. As you have read before in this column, no matter how comprehensive your sanitizing procedures, at some point you’ll have a result that requires further assessment, cleaning, evaluation of the previous production, and whether your food safety plan needs revision. When that positive result first comes to light – what next?

This is when copies of Wanting Letters are useful. Comparing what you have to what FDA found inadequate can reassure you, or point to things that need attention.

Another resource that is becoming more useful is FDA’s Technical Assistance Network (TAN). Begun in September 2015, the TAN responds to inquiries related to all FSMA rules. As of May 2018. they have received 9,030 inquiries, indicating at least two things. First, this is an industry that largely wants to do the right thing, and second, it is an industry that needs specific answers to many varied specific questions.

The TAN recently published answers to 172 frequently asked questions (https://www.fda.gov/food/guidanceregulation/fsma/ucm247559.htm). There are insights into FDA thinking to be found among the answers.

Be mindful that a similar question does not mean FDA would give a similar answer. Details matter. Each food facility must tailor its plan to individual facility operations. The expectations behind FSMA and Preventive Controls are laid out in great detail and the Preventive Controls requirements are the hallmark of food safety. Look broadly at first, then focus in. Flow-charts can be helpful with “if-then” scenarios. If a positive result is found, then what? Which zones of the production area should be included in these tests and once the positive result is confirmed, then what? Product recall? Who should the results be reported to? FSMA spells out that these scenarios must be developed and documented so that when disaster strikes a haphazard plan isn’t created in a moment of panic.

Now comes the often overlooked part: Once the plan is made, the real work begins. Practice. It’s easy to spell things out on paper (or digitally) but how practical are the steps? Does everyone understand the process or is there room for interpretation which can lead to confusion and those missteps we spoke of earlier? Much like the requirement for FSMA training which must be in a language that each employee can understand, the same true for PC steps. Make sure all, no matter who is in charge at every step of the process, understands and can perform those activities expected of them.

Lastly, ask for help when needed. Whether it is through the FDA and their TAN, FSMA training videos and fact sheets or through reputable consulting firms such as EAS, your ability to follow PC rules depend on your complete understanding of detailed, documented steps and practicing these steps so that they are seamlessly executed when needed.

Meet New EAS Intern Shachi Shah

Shachi Shaw

Shachi Shah is an intern at EAS and a graduate from the Georgetown University BioBusiness Master’s Program. Her coursework focused on bioinformatics, Molecular Medicine, cGMPs. Shachi will begin her career in the fall when she begins working at a biotechnology company that develops vaccines protective against malaria.

EAS Authors AHPA Report Article on Botanical Submissions – NDI Versus GRAS in a Post-DSHEA World

EAS authored an article discussing options for dietary supplement ingredient submissions – New Dietary Ingredient (NDIs) and Generally Recognized as Safe (GRAS) on August 8, 2018, of the AHPA Report (AHPA membership required to view). Botanical chemicals may be isolated and also sold as dietary supplements, and in some cases, FDA’s interpretation of botanical and plant parts would qualify them for an NDI submission. In some cases, GRAS is a more appropriate submission for this unique category of botanicals. EAS can discuss your particular situation and help you to determine the right path for your product.

EAS Webinar – Don’t Wait for FDA, Conduct Your Own Swab-a-Thon!

EAS Independent Consultant, Kathy Knutson, Ph.D. will host a complimentary webinar on the importance of Environmental Monitoring on September 17, 2018, at 11:00 PM Eastern. Given the hot-button issue of pathogen contamination, even with the best of safety controls, it is imperative that companies have a robust environmental monitoring program that includes vigilant and regular testing. Join Dr. Knutson for this complimentary webinar!

Meet Issue of the Month Author, James Evans

James Evans

James Evans has more than 30 years of experience as an FDA auditor and specializes in pharmaceuticals, medical devices, biologics, and biotechnology. His expertise includes pharmaceutical inspections, antibiotics, radiopharmaceuticals, parenteral, sterilization, clinical/non-clinical (GLP) laboratory studies, and computer systems validation and pharmacology. In addition, he is well-versed in HACCP inspections for low-acid canned food and infant food manufacturing operations.

FDA Mutual Recognition Agreements

By James Evans

FDA has been implementing the Safety and Innovation Act since it was passed by Congress in 2012. The Act requires FDA to establish Mutual Recognition Agreements (MRAs) which are agreements between two or more countries to recognize a specific process or procedure of the other country. The FDA’s MRA was preceded by the 1998 signing of the U.S. and the EU Agreement on Mutual Recognition which included a Pharmaceutical Annex providing for recognition of each other’s GMP inspections. Unfortunately, this Annex was never fully implemented.

Effective in 2017, the amended Sectoral Annex to the 1998 U.S.-EU MRA allowed for inspection reports and other related information obtained during drug manufacturing facility inspections, conducted by either an EU inspectorate or by FDA, to help determine whether a facility is manufacturing high-quality drugs. If more information is necessary beyond this assessment, FDA or the EU can then require additional inspections or take other action in the interest of protecting the public.

The 2017 Annex provides for greater efficiency in the drug inspection process, eliminating the redundancies of duplicate facility inspections, particularly those with a strong record of compliance. By utilizing each other’s inspection reports and related information, the FDA and EU are able to reallocate resources towards inspection of drug manufacturing facilities with potentially higher public health risks across the globe, benefiting patients and reducing adverse public health outcomes.

FDA’s determination as to whether an MRA is appropriate is made first via an assessment of internal audits in a particular EU country to ensure that their inspectorate is functioning properly and not deviating in any significant way from EU law and guidance.

These audits include observations of drug manufacturing facility inspections conducted by the audited inspectorates and utilize the 78 indicators based on the Pharmaceutical Inspection Co-operation Scheme (PIC/S) compliance assessment program with an EU addendum. PIC/S is an internationally recognized cooperative arrangement between 49 regulatory authorities, including the FDA. The goal of PIC/S is to harmonize inspection procedures worldwide and develop common standards in the field of good manufacturing practices.

In addition, FDA considers any conflict-of-interest policies, specific legislation related to good manufacturing practices, samples of inspection reports, inspector training records, inventory of drug manufacturing facilities, surveillance program, and numerous standard operating procedures to evaluate a pharmaceutical inspectors’ credentials as part of the capability assessment of each EU country. In this way, FDA can ascertain whether the inspection authorities are trained and qualified and have the skills and knowledge to identify manufacturing practices that may lead to patient harm. Maintenance provisions are also included in the Annex to ensure that each capable country continues to meet FDA requirements.

Thanks to this MRA, there is a greater ability of the Agency to appropriately allocate its resources to focus on those facilities where initial audits raise red flags that warrant further inspection, either by continual deficiencies in inspection findings by a country’s own internal audit system or by adverse events reports or other means. One of those means is the “Drug Quality Sampling and Testing (DQST)- Human Drugs Compliance Program 7356.008”, which is a surveillance program that samples and tests pharmaceutical products manufactured both in the U.S. and foreign countries. Surveillance under the DQST is prompted in part by recommendations from CDER and ORA headquarters and FDA district offices based on their intelligence and reported consumer complaints.

The goal of the DQST compliance program is to protect the public health by minimizing exposure to non-compliant and/or poor-quality drugs. Testing is undertaken on finished dosage forms, APIs, and excipients and the samples chosen are based on risk-based selection criteria and a risk-based model. Due to the globalization of pharmaceutical products increasing consumer risk, the surveilled domestic and international products have expanded under this program to include prescription and OTCs, compounded drugs, drug products with approved an NDA or ANDA as well as unapproved drug products and others. This program, in combination with other quality assurance compliance programs, is an integral part of the Agency’s overall post-marketing surveillance strategy. Fortunately, the majority of drugs FDA independently tests meet their specifications. From 2003 to 2013, FDA tested nearly 4,000 of drug samples. During that decade, FDA laboratories found that 1.1% of the drug products analyzed deviated from acceptable standards.

FDA takes its oversight of the domestic and foreign pharmaceutical program very seriously as any safety deviations in these products could have a significant impact on public health. Companies may wish to proactively perform quality assessments and gain an understanding of their current compliance status through independent third-parties such as qualified consulting firms who offer expertise in pharmaceuticals conducted by persons with a strong background in Agency regulations and safety standards. Once a needs assessment has been conducted, a proactive remediation plan of deficiencies can begin.

More information on FDA’s pharmaceutical surveillance programs can be found on the Agency’s website and we invite you to view EAS-produced on-demand webinars focusing on a variety of GMP tools on the EAS website. Should EAS be of service to your firm either in an assessment of compliance status or to assist with an FDA announced facility inspection, please contact Bryan J. Coleman, Senior Director of Pharmaceuticals and Medical Devices.

Latest EAS On-Demand Webinars Posted to EAS Website

We had an overwhelming response to our recent webinar “Quality Systems for the Cannabis Industry” presented by Tara Lin Couch, Ph.D., Senior Director for Dietary Supplement and Tobacco Services. Independent Consultant, Peter Saxon, presented a webinar for foreign firms to understand how to manage FDA inspections. Also, April Kates presented a webinar on Temporary Marketing Permits Opportunity and pitfalls of the Specialized FDA Application. All recordings are available on the EAS website under the On-Demand Webinars tab and are available for viewing.

Sayler Discusses Fast Tracking FDA FURLS in Food Safety Tech

Senior Director for Food Consulting Services, Allen Sayler, has written an article for Food Safety Tech on FDA Fast-Track Unified and Listing Systems (FURLS) program and whether it is expediting or impeding access to overseas markets. “The FDA recently released a notification that their FURLS system has been updated to include an Export Listing Module (ELM),” he says. This allows U.S. food manufacturers to electronically submit, and for FDA to receive and process requests for inclusion on the export lists for FDA-regulated food products and present these lists to countries that require them, whether a company is participating in this program or is looking for new markets outside the U.S.

Tajkarimi Writes of Food Safety Training as a Solution for FSMA Challenges

Mehrdad Tajkarimi discusses the importance of food safety training as a solution to FSMA challenges in Part One of a three-part series for Food Safety Magazine. “There are several challenges ahead for proper food safety training at all levels,” he says. “These challenges include, but are not limited to, numbers of training hours, type, content, and facilitation procedures.” The types and applications of training have dramatic impacts on food safety management systems, improvements in FSMA compliance, and employee productivity.

Drug and Device Corner 2018 August

The FDA recently sent a reminder email to registered drug establishments regarding the Drug Supply Chain Security Act’s (DSCSA) impending requirements. Production of a prescription drug that meets the definition of “product” (see section 581(13) of the FD&C Act noted below), now requires manufacturers to affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced into commerce by November 28, 2018. A product identifier should include the product’s NDC, unique serial number, lot number and expiration date (see section 581(14) of the FD7C Act) in human- and machine-readable formats. The machine-readable format shall be a 2-dimensional (2D) data matrix barcode when affixed to or imprinted on a package or a linear or 2D data matrix barcode when affixed to or imprinted onto a homogeneous case of the product (see section 582(a)(9) of the FD&C Act).

Section 581(13): “(13) Product.–The term ‘product’ means a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution), but for purposes of section 582, does not include blood or blood components intended for transfusion, radioactive drugs or radioactive biological products (as defined in section 600.3(ee) of title 21, Code of Federal Regulations) that are regulated by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 274 of the Atomic Energy Act of 1954 (42 U.S.C. 2021), imaging drugs, an intravenous product described in clause (xiv), (xv), or (xvi) of paragraph (24)(B), any medical gas (as defined in section 575), homeopathic drugs marketed in accordance with applicable guidance under this Act, or a drug compounded in compliance with section 503A or 503B.”

More information about the DSCSA can be found on FDA’s website.

We would like to remind our clients, that beginning 1 October 2018, VMF sponsors will be required to use eSubmitter to submit all animal drug applications to the agency. The FDA has been hosting webinars to teach interested parties on the process. You can download the eSubmitter program from the FDA website and find recordings of the instructional webinars, when available, here.

Manufacturers of sunscreen products have an opportunity to offer FDA comments on SPF testing and drug facts labeling through 18 October 2018, please see instructions at the Federal Register notice docket# FDA-2011-N-0449.

On 10 August 2018, the FDA published a revision to the Manual of Policies and Procedures (MAPP 5240.5), ANDA Suitability Petitions – link will bring you to the document for review.

The FDA has announced via the Federal Register Vol 83, No. 163, their determination that Danocrine (danazol) capsules, 50 mg, 100 mg and 200 mg were not withdrawn from sale for reasons of safety or effectiveness, except with respect to the indication of fibrocystic breast disease that was withdrawn for reasons of safety or effectiveness. As a result, the FDA will not be suspending approval of ANDAs that refer to this drug product as long as the applications have removed the indication for fibrocystic breast disease. This determination will also allow the FDA to continue to approve ANDAs that refer to this drug as long as they meet relevant legal and regulatory requirements.

Per the FDA Reauthorization Act of 2017, the FDA has identified a list of Medical Device accessories proposed to be classified as class I, and distinct from other devices. The FDA welcomes public comment until 16 October 2018 on their proposal. Full details and information on how to comment can be found by following this link to the Federal Register notification.

The FDA has announced several public meetings that may be of interest to our readers, please see details below.

The FDA will hold a public hearing with an opportunity for public comment on the future format of the National Drug Code (NDC). With the availability of 5-digit labeler codes nearing capacity, the FDA is open to input from stakeholders on their perspectives regarding the impact of any future changes made to the length and format of the NDC. The hearing is to be held 5 November 2018 from 8:30 am to 5:00 pm EST. Registration for online attendance is available. If you wish to attend in person or present at the public hearing, you must register no later than 15 October 2018. Further information and a registration link can be found here.

Public Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee will be held 20 September 2018, at FDA’s White Oak Campus, in Silver Spring, MD. The FDA plans to provide a live webcast of this meeting. The morning session will focus on the modernization of assessing drug applications through a Knowledge-Aided Assessment and Structured Application (KASA) initiative. The afternoon session will focus on in-vitro/in-vivo relationship standards and will seek input on establishing patient-focused dissolution standards for oral solid modified-release dosage forms. Complete details can be found at the Federal Register Vol. 83, No. 158.

There will be a public meeting entitled “Standardized Data for Pharmaceutical Quality / Chemistry Manufacturing and Control (PQ/CMC)” on 19 October 2018 from 9 am to 4 pm EDT. The purpose is to provide members of the pharmaceutical industry, and other interested parties, an opportunity to discuss with FDA and provide input on related topics and issues. Please see the Federal Register Notice for complete details.

The FDA has published the following user fee rates for their FY2019 which runs from 1 Oct 2018 – 30 Sept 2019:

Generic Drug User Fee Rates for Fiscal Year 2019

Medical Device User Fee Rates for Fiscal Year 2019

Prescription Drug User Fee Rates for Fiscal Year 2019

Outsourcing Facility Fee Rates for Fiscal Year 2019

Biosimilar User Fee Rates for Fiscal Year 2019

Guidance Document updates on the FDA website:

All centers:

Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices and Biological Products for Treatment

CDER:

Fluticasone Propionate Draft Guidance

Nonclinical Testing of Orally Inhaled Nicotine – Containing Drug Products

Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances

Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of drugs for Medication – Assisted Treatment

Quality Attribute Considerations for Chewable Tablets

Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations

CDER & CBER:

Elemental Impurities in Drug Products

Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics

CDRH:

Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions

Medical Device User Fee Small Business Qualification and Certification

Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices

CBER:

Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis

OOPD: (office of orphan products development)

Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases

Lavieri Highlights the Impact of the Human Element in Food Safety Programs in Food Safety News

Robert Lavieri authored a guest column in Food Safety News on the important and often overlooked “human element” to food safety planning and programs. Companies spend much time and effort designing and cross-checking procedures to protect against food safety issues, but the human element or employee training and assurance of appropriate training to the job function is equally important. Make sure you “test, verify and regularly evaluate and hold accountable the human elements as you do your equipment i.e. Process Control, Automatic Sampling, CIP, Calibrations, etc,” he says.

September 2018

In this Issue

FDA 483 Responses – Missing the Mark?

By Cindy Beehner, Independent Consultant

In recent months, it appears more companies are having difficulties meeting the requirements of FDA Form 483, List of Observations, response. The inspection situation is very stressful and if it ends with the dreaded “483”, it can be positively overwhelming. However, when the initial reaction is over, it’s time to rally the staff and prepare the corrective and preventative action strategy that will be presented in the response within the allotted time frame. It is also critical to understand what is expected of the response letter.

The 483 is a list of inspectional observations that is the result of what the inspectors viewed while in your facility. It is a legal document from federal agents performing a law enforcement function where the evidence is the collection of documents and data that the agents evaluated at the company. All of the observations should first be reviewed for accuracy. Hopefully, any discrepancies or misunderstandings were discussed during the closing meeting and resolved, but if they were not found until after the inspectors left the facility, they will need to be addressed in the response. The 483 response is also a legal document so the tenor and exact wording used are critical. It must demonstrate that the company understands the issues, has made the necessary corrective and preventative actions, and that there is documented evidence to verify the latter.

Each observation requires a response and that response must describe the associated corrective and preventative actions are taken. It should be thorough and detailed and written to present steps in the order taken. Procedures and related documents prepared and implemented during these actions must also be included. It is not enough to only describe actions, there must be documented evidence of the correction such as photographs, procedures, training records, specific forms, and other types of documentation. Many Warning Letters are issued by the FDA because a company’s response letter did not include evidence of the corrective and preventative actions taken for the FDA to evaluate to determine if the situation was appropriately addressed.

Consider three potential categories of actions to be taken for each observation; immediate, short-term and long-term. Think of this from a medical emergency perspective where initial triage occurs to keep the patient’s condition from getting worse, additional short-term actions are needed to stabilize the patient, and then long-term actions may be needed to deal with any underlying problems. A systematic issue will have to be addressed with preventative measures. It is also important to review the observations collectively, in addition to individual, to determine if other underlying systemic issues exist. These too will have to be addressed with corrective and preventative actions.

Please note that, unlike an FDA Warning Letter, a response to a 483 is not legally required. However, it is strongly recommended that a 483 response be provided to the FDA within 15 business days. Some observations can be appropriately addressed and the actions concluded within this time frame, but others, particularly systematic issues, may require more time. When that is the case, all of the planned corrective and preventative actions should be described in the initial response, immediate and short-term actions should be taken, and completion dates for long-term items provided. It is important that these proposed dates be aggressive, yet reasonable and obtainable. Monthly updates to the FDA stating the progress made on these long-term items, with supportive documented evidence included, should then follow. This strategy may prevent the FDA from escalating enforcement actions and issue a Warning Letter.

Confirmation that the FDA is satisfied with the 483 response will be provided by the issuance of an Establishment Inspection Report (EIR) which states that all of the corrective and preventative actions will be evaluated upon “the next inspection.” The EIR is also a more detailed summary of the inspectional findings and it is wise to use this as an opportunity to further review operations, controlled processes, and the overall quality system. Look at these findings from a systems approach; facilities and equipment, materials, production, packaging and labeling, laboratory controls and, of course, the most important and critical one – the quality incident system. The entirety of the inspection and the inspectional review should also be another piece to the internal audit program, make the experience work to improve compliance and not just an exercise in writing letters to the FDA.

For assistance in understanding FDA 483 findings as well as developing an appropriate response and corrective actions contact EAS.

Are Plant-Based Proteins Milking Dairy?

By Allen Sayler, Senior Director for Food Consulting Services

When FDA announced recently that the agency is seeking public comment for standards of identity overhaul that will focus in part on plant-based products that are marketed as “milk” substitutes, manufacturers of those products as well as the consumers who enjoy them were left wondering how this review and any future changes would affect them. Consumers of soy, almond, rice, coconut and other plant-based “milk” enjoy these dairy alternative products for any number of reasons, but in some cases, their consumption decisions are based on incomplete or inaccurate information and may result in a diet deficient in certain nutrients found in dairy milk but not the substitute protein. This issue is of interest to others outside of the US as Canada, the European Union and Codex all have laws, regulations and beverage standards that limit the use of the term “milk” to only beverages where dairy “milk” is the major or characterizing ingredient.

There are nearly 300 standards of identity on the books at FDA, and these plant-based proteins which use qualified terms as part of their “milk”, “yogurt” and “cheese” product names aren’t in-fact “milk” as we have come to know it. Based on this technical violation of the standard of identity for “milk” and a concern regarding consumer misunderstanding of the nutritional value of plant-based beverages, FDA has decided to look at the term milk as part of its overall effort of modernizing standards of identity and improving information provided to consumers and their physicians so that the nutritional composition and benefits of products is clear.

FDA is currently seeking information on how consumers understand the term “milk” and whether the nutritional differences between dairy-based and plant-based “milk” products is understood. FDA is also trying to understand if the use of the term “milk” in non-dairy products is misleading and if that lack of understanding plays a role in less informed dietary choices. Stakeholder feedback is actively recruited by the agency and, based on initial comments gathered, FDA will provide an additional request for information in late summer or fall targeted more directly towards consumer awareness and understanding of the use of milk and other dairy terms on plant-based alternatives, including a focus on nutritional impact. The agency will use this feedback to refine its policy for these standards of identity and will issue new guidance for industry as well as their compliance and enforcement approach (no timeline is currently established). 

In addition to gaining an understanding of milk products, the agency is additionally seeking feedback on how the agency should consider food technology, nutritional science, fortification practices and marketing trends for not only dairy but all foods as part of their standards of identity review to gain an understanding of how each may enhance or stymie innovation or nutritional improvements.

As manufacturers of foods, standards of identity can at times protect the consumer and food industry from misleading or fraudulent foods, food ingredients, and labels, but they can also hinder efforts at product innovation, use of new ingredients and processing technologies and restriction on modification of the standard to improve nutritional content. Understanding food labels, content, nutritional value and product claims are all critical for consumers to make informed choices today. It is equally important for food manufacturers, who are committed to providing cleaner food labels while trying to deliver more nutritionally sound food into the US marketplace.

Regulatory opportunities, headwinds, and challenges will be facing the Agency as it begins to review and potentially revise the current food standards of identity. As the agency seeks comment, now is the time for food firms to provide their input and begin the conversation as to how technology, fortification, and sound science need to be considered in the review and revision process, to the benefit of the consumer, food industry and FDA. As an innovation for a healthier food supply continues to evolve, the ability to clearly communicate an improved and clear message of food content and nutritional value will enhance consumer understanding and allow for more informed choices. Formulating agency feedback can help to effectively lead awareness of those opportunities and challenges. Incorporating sound scientific assessments, food processing technologies and market research on consumer perceptions and trends incorporated into well-written comments can enhance a firm’s position. EAS independent consultants, toxicologists, microbiologists who are experts in dairy, plant-based beverages and FDA food standards of identity and labeling can help you to formulate your position and develop agency comment.

Drug and Device Corner 2018 July

EAS would like to bring to your attention the Draft Guidance released by the FDA for ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA. This guidance describes the significant difference between GDUFA I and GDUFA II Amendments and the timelines associated with their review. The FDA considers all submissions to an ANDA to be an amendment, they will be classified based on the content and issued a goal date consistent with that classification. Please review the guidance for further details.

In the FDA’s ongoing effort to make generic affordable drugs available to the public, they have published product-specific guidances describing the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference listed drugs. These guidances are hoped to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating the evidence needed to support ANDA approval. Please see the FDA’s Product-Specific Guidances for Generic Drug Development webpage for more details.

The FDA issued a press release regarding its recent actions on bulk drug substances used for compounding. Their Bulk Drug Substances Nominated for Use in Compounding lists for 503A Category drugs and 503B Category drugs have been updated as of 23 July 2018. Included in the update are the changes to the lists and when the changes became effective. Please see the press release for full details. 

The Food and Drug Administration (FDA) announced a public hearing to solicit input from the public on how to facilitate greater availability of biosimilar and interchangeable products while retaining the balance between competition and innovation. The hearing will be held on Tuesday 4 September 2018, from 9 a.m. to 5 p.m. at the Food and Drug Administration’s White Oak Conference Center. If you would like to participate and weigh in on this hearing, more information on how to register for the meeting or the live webcast can be found in the Federal Register Notice.

Guidance Document updates on the FDA website

All centers

Use of Electronic Health Record Data in Clinical Investigations

CDER

Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations

Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention

Q3D(R1) Elemental Impurities

Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs

Innovative Approaches for Nonprescription Drug Products

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations

Use of Liquids and / or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations

CDER & CBER

Assessing User Fees Under the Biosimilar User Fee Amendments of 2017

Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products – Content and Format

E17 General Principles for Planning and Design of Multiregional Clinical Trials

Field Alert Report Submission Q & A

Labeling for Biosimilar Products

Inborn Errors of Metabolism That use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development

Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies

E17 General Principles for Planning and Design of Multiregional Clinical Trials

CDRH

Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions

CBER

Human Gene Therapy for Retinal Disorders

Long-Term Follow-Up After Administration of Human Gene Therapy Products

Human Gene Therapy for Rare Diseases

Chemistry, Manufacturing and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)

Human Gene Therapy for Hemophilia

Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up

Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)

CVM

Antimicrobial Animal Drug Sales and Distribution Reporting

#257 Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species

August 2018

  • From the Desk of the Chairman: Dietary Supplement GMP Compliance Includes Application to the Cannabis Industry
  • Issue of the Month: FDA 483 Responses – Missing the Mark?
  • Who’s Who at EAS
    • Meet Issue of the Month Author and New Independent Consultant, Cindy Beehner
    • Meet New EAS Consultants
  • Standards of Identity: Are Plant-Based Proteins Milking Dairy?
  • Drug and Device Corner
    • Recent FDA Drug / Medical Device Activity
  • What’s New on FDA’s Website
  • EAS in Action
    • Dietary Supplement GMP Seminar to Take Place in Dallas, TX
    • EAS Offers Official FSPCA Preventive Controls for Human Foods and FSVP Seminars
    • New Webinar on Environmental Monitoring Added to EAS’ Summer Compliance Line-Up
    • EAS Offers Complimentary Webinars on Cannabis, Foreign FDA Inspections, Temporary Marketing Permits and more
    • Crane Returns as a Presenter at CHPA’s OTC Academy
    • Yablunosky and Knutson to Speak at Upcoming Food Safety Consortium
    • EAS Consultants Invited Speakers at Two FDLI Conferences
    • EAS Co-Authors Article for FDLI Update on the Benefits of Consultants as Part of a Legal Team
  • Useful Publications and Regulatory Tools

EAS Co-Authors Article for FDLI Update on the Benefits of Consultants as Part of a Legal Team

EAS joined forces with Ronald J. Levine, co-chair on Herrick, Feinstein LLP’s Litigation Department to author an article published in the Food Drug Law Institute Update Magazine on how the use of consultants can benefit a legal team. Consultants provide unique insights, given their detailed expertise in a particular subject matter, offering context and in-depth understanding of FDA regulations and intent of guidance documents. Consultants are frequently engaged, particularly during the discovery and trial stages for the planning and execution of a legal strategy. While the benefits they provide cannot be underestimated, the same due diligence for choosing the right consultant for the particular project must also not be taken lightly. Read more here.

EAS Consultants Invited Speakers at Two FDLI Conferences

EAS is pleased to be invited speakers at two upcoming Food Drug Law Institute (FDLI) Events. Andrea Yablunosky will speak at an in-house event held at FDA CFSAN on Food Labeling: Nutrient Content, Health, and Other Claims on August 7th. Bruce Silverglade will speak on the same subject as part of the Intro to Food Law conference which will be held in Washington, D.C. September 24-25, 2018. For more information on the Intro to Food Law event, click here.

Yablunosky and Knutson to Speak at Upcoming Food Safety Consortium

EAS Independent Consultants, Andrea Yablunosky and Kathy Knutson are invited speakers at the upcoming Food Safety Consortium. Yablunosky will speak on food recalls, discussing the USDA/FSIS recall committee, as well as roles district offices play in a recall. She’ll then move on to the steps in a recall and important to-dos such as the drafting of a recall press release. Yablunosky is a former Director of Government Affairs at ConAgra Foods where she advised the company business units on implications of FDA and USDA policy objectives. With a background in food science and nutrition she is well-versed in policy development, product reformulations and promotions, recall preparedness and effective recall management.

Kathy Knutson, Ph.D. will speak on Lessons Learned in Food Safety and Applied to Cannabis-infused Edibles. She will discuss GMPs as the foundation of food safety and how HACCP builds on GMPs. Dr. Knutson is a microbiologist and certified lead instructor for Preventive Controls for Qualified Individuals through the Food Safety Preventive Controls Alliance. She consults with companies in meeting FSMA requirements, including manufacturers in the cannabis industry and she educates on issues surrounding cannabis-infused food products for sale in states with medical and recreational use legislation.

Food Safety Consortium will take place November 13-15, 2018 in Schaumburg, IL.

Crane Returns as a Presenter at CHPA’s OTC Academy

Susan Crane, Independent Advisor for OTC Drugs and Labeling will be presenting a session at the upcoming Consumer Healthcare Products Association OTC Academy on OTC drug labeling requirements, to include Drug Facts format and content, translating an OTC monograph into a compliant label, as well as covering other regulations that impact OTC drugs, such as child-resistant packaging requirements and Made in USA claims. This year’s OTC Academy will take place in Wilmington, DE October 9-10, 2018.

EAS Offers Complimentary Webinars on Cannabis, Foreign FDA Inspections, Temporary Marketing Permits and More

Quality Systems for the Cannabis Industry – Preparing for State GMPs
August 6, 2018, 1:00pm Eastern

Tara Lin Couch Ph.D., Senior Director for Dietary Supplements and Tobacco Services, will help cannabis firms prepare for cannabis Good Manufacturing Practices (GMPs). While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for putting practices and procedures in place to meet compliance expectations, including those of testing and quality control of in-process materials, finished batches and packaged/labeled products. The time is right for the cannabis industry to begin assessing manufacturing processes and implementing sound and effective quality systems in order to begin preparing for GMP regulations. Reserve your seat by clicking here.

Preparing for Foreign FDA Inspections
August 14, 2018, 1:00pm Eastern

Have you ever wondered why your foreign suppliers: API, intermediates, food ingredients, etc. are suddenly in trouble with regulatory authorities? Did they just go astray or is your auditing program not performing as designed? Actually, there are several things at play. EAS Independent Consultant, Peter Saxon, will shed some light on reasons FDA inspections can “go south” as well as provide insight on how disappointing results can be managed. His insights will provide an opportunity for companies to consider improvements to their internal audit structure to help minimize regulatory risks. Join us for this webinar by clicking here.

Temporary Marketing Permits – Opportunity and Pitfalls of the Specialized FDA Application
August 21, 2018, 1:00pm Eastern

Food Standards are an important component of FDA’s oversight, ensuring honesty and fairness to the consumer through requirements that provide for the basic nature of a standardized food to be uniform in terms of its characteristics as well as the ingredients that it must or may contain. But what happens when a newly developed food or production method warrants consideration of a product category outside of the standard? Petitioning to amend a food standard or to create a new one, is a lengthy and complicated process; however, a temporary solution may be available through a specialized category called a Temporary Marketing Permit (TMP’s). Learn more when EAS Independent Consultant, April Kates, discusses this unique marketing option in a webinar on the opportunities and Pitfalls of Temporary Marketing Permits and learn best practices for a successful TMP application. Reserve your seat by clicking here.

New Webinar on Environmental Monitoring Added to EAS’ Summer Compliance Line-Up

Are Industry-Initiated Environmental Swab-a-Thons a Benefit?
September 17, 2018, 1:00pm Eastern

The emphasis on proactive management of issues that could cause a food safety hazard, per FDA’s Food Safety Modernization Act, requires firms to improve controls for a variety of issues at all levels. One hot-button concern that continues to wreak havoc in the industry is that of pathogen contamination. It is generally understood that contamination in the processing environment will eventually make its way into the product. Even with the best of safety controls, it is imperative that companies have a robust environmental monitoring program that includes vigilant and regular testing. After all, finished product testing gives limited data and is a small snapshot of the entire lot manufactured. FDA can take hundreds of swabs during inspections, does your environmental monitoring meet that level of testing?

EAS Independent Consultant, Kathy Knutson, Ph.D. will host a complimentary webinar on the importance of Environmental Monitoring. Don’t wait for FDA, conduct your own swab-a-thon! Join us September 17, 2018, at 1:00 pm Eastern to learn important ways your company can stay ahead of the curve. Register by clicking here.

EAS Offers Official FSPCA Preventive Controls for Human Foods and FSVP Seminars

EAS Independent Consultant and FSPCA recognized lead instructor, Jenifer Kane, will co-instruct two FSPCA courses with Independent Consultant and trainer Susan Moyers, Ph.D. on the intricacies of Preventive Controls for Human Food as well as the Foreign Supplier Verification Program. Both courses will take place in early October in Alexandria, VA.

The Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (referred to as the Preventive Controls for Human Food Regulation) is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the U.S. and requires that certain activities must be completed by a “preventive controls qualified individual” who has “successfully completed training in the development and application of risk-based preventive controls”. This course meets FDA’s requirement. Join EAS October 1-3, 2018 in Alexandria for this 2.5 intensive training. Earlybird discounts are available through August 14, 2018.

Next, the “Foreign Supplier Verification Program (FSVP)” requires importers to verify that their foreign suppliers of food, food ingredients and food additives imported into the US market are compliant with all parts of the FSMA and its “Preventive Controls for Human Foods (PCHF) and “Preventive Controls for Animal Feeds (PCAF”) regulations. EAS’ two-day intensive FSVP Compliance Seminar will explain in detail FSVP rules, risk exposure by importers as well as US-based food processors using foreign sources of foods, food ingredients and food additives. Join us October 3-4, 2018 for this 1.5-day training. Earlybird rates are in effect through August 14, 2018.

Dietary Supplement GMP Seminar to Take Place in Dallas, TX

EAS Consulting Group will offer its two-day intensive Dietary Supplement GMP seminar September 26-27, 2018 in Dallas. Instructed by EAS Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D., EAS Independent Advisor for Quality and Compliance, Robert Fish and back by popular demand, Marc Ullman, Of Counsel at Rivkin Radler, LLP, this next GMP course will include a new section on how quality and compliance applies to the emerging cannabis industry. Early-bird registration rates are in effect through August 5, 2018. In addition, we are pleased to offer members of the American Herbal Products Association (AHPA) an extended early-bird rate of $1,000.00. For more information or to reserve your seat, click here.

Meet New EAS Consultants

Tamika Cathey

Tamika Cathey provides regulatory compliance services pertaining to safety and quality of pharmaceuticals and dietary supplements. She evaluates client compliance readiness, executes mock GMP/FDA audits, performs risk assessments and gap analyses per FDA regulations and creates improvement programs based on findings. Cathey consulted with EAS from 2012-2016 and we are very pleased that she is again able to offer her expertise to our clients.

Beth Ann Crozier-Dodson, Ph.D.

Dr. Dodson is an international consultant for food safety issues and an invited speaker and trainer on the topics of rapid methods for testing and bacterial identification and food safety. She is a member of numerous professional and honor societies and has received a USDA Commendation for Contribution to Public Health. Her areas of specialty include teaching and training in microbiology, laboratory setup, environmental testing, aeromicrobiology, validation testing, consulting, and plant and facility audits.

Meet Issue of the Month Author and New Independent Consultant, Cindy Beehner

Cindy Beehner has worked as a consultant since 1997, specializing in GMP requirements for food, dietary ingredients, dietary supplements and pharmaceuticals. Ms. Beehner performs due diligence assessments as well as procedures and documentation required for certifications for groups such as Therapeutic Goods Administration (TGA), World Health Organization (WHO), United States Pharmacopeia (USP) and National Food Producers Association (NFPA). She has a Bachelor of Science, Chemistry and Clinical Psychology from Moravian College, Bethlehem, PA.

Dietary Supplement GMP Compliance Includes Application to the Cannabis Industry

Dear Readers,

First, for those whom we had a chance to meet at the recent Institute for Food Technologists Annual Meeting held in Chicago, I am sure you will agree with me that this year’s event was one of the best. With so many changes at FDA with the implementation of FSMA, many timely topics on Food Defense and more, I am sure everyone in attendance returned to their firms with good ideas worth implementing. The two sessions that EAS moderated, PCHF – Successes and Challenges for FDA and the Food Industry and Food Importing: Green Light Strategies for Compliance with Game-Changing FSVP Requirements were both well attended with lively discussions. We’d like to thank the panelists who joined us – JoAnn Givens from FDA, Jeff Acker from DFA who participated in the PCHF session, Bob Brackett from IIT and EAS Independent Consultant, Susan Moyers, who participated in both PCHF and FSVP sessions and Erika Daniel from our Italian partner Almater who participated in our FSVP session.

I am pleased that EAS is presenting the next Dietary Supplement Good Manufacturing Practices seminar in cooperation with the American Herbal Products Association (AHPA). It will include an updated content section on how GMPs have application to the cannabis industry. The early bird rate runs through August 5, 2018, and this rate is extended to members of AHPA for the duration of the registration period. We hope you’ll join us in Dallas, TX on September 26-27, 2018 for this informative and updated seminar!

We welcome new consultant Beth Ann Crozier-Dodson, Ph.D., and re-welcome Tamika Cathey and Cindy Beehner, two consultants who have been a part of the EAS family previously and who are increasingly available to EAS clients. Dr. Dodson is an international consultant for food safety issues and an invited speaker and trainer on the topics of rapid methods for testing and bacterial identification and food safety. Tamika Cathey provides regulatory compliance services pertaining to safety and quality of pharmaceuticals and dietary supplements and Cindy Beehner specializes in GMP requirements for food, dietary ingredient, dietary supplements and pharmaceuticals. Cindy is also the author of this month’s issue of the month on how to appropriately respond to FDA 483s.

We hope that you enjoy this edition of EAS-e-News! As always feel free to reach out if you have any questions and thank you for your interest in EAS.

Sincerely,

Ed

Produce Safety Rule’s July Compliance Dates

By Charles Breen, Independent Advisor for FSMA

Those closely watching FSMA compliance dates will note that July 26, 2018 marks a significant date for FSVP and the Produce Safety Rule. Specifically,

  • importers with Small Business Foreign Suppliers will now be required to comply with sprout requirements of Produce Safety Rule;
  • importers with Small Business Foreign Suppliers that are farms producing sprouts are eligible for a Qualified Exemption under the Produce Safety Rule; and
  • importers with Large Foreign Suppliers are required to comply with Produce Safety Rule;

with an exception for importers of food contact substances who now have an additional two years to comply with the FSVP requirements.

FDA is postponing an enforcement regarding written assurances in certain cases when a manufacturer/processor does not control a hazard requiring a preventive control. Originally, an additional two years to comply with the above specific requirements were to be granted based on written assurances from their customer that they will either manufacture the food in accordance with applicable food safety requirements or sell only to someone that agrees to do so. Sellers must notify commercial customers that hazards are not controlled, but sellers do not now need to obtain written assurances from customers as a condition of sale. FDA says in this context, “customer” does not mean “consumer.”

FDA provided a decision tree to assist affected firms in their understanding of the details for enforcement discretion of the written assurances provisions.

What does all this mean for your business? Plenty – particularly in light of the recent food safety outbreaks of Listeria monocytogenes which illustrate that even when preventive controls are applied, food emergencies can still occur. Managing a safe food supply requires serious vigilance at all times. Unfortunately, even the most diligent will likely see, at some point, some type of food safety event requiring immediate action, whether it is an unsanitary method of transportation, storage or production, worker hygiene, use of contaminated water or a large number of additional factors.

As part of the Produce Safety Requirement, you may recall our January 2018 FSMA Perspective which discussed the agricultural water testing and safety requirements. After much industry feedback that the numerical criteria for microbial water quality in the final rule are too complex, FDA issued a proposed rule to extend the compliance dates for the agricultural water requirements for produce other than sprouts. If finalized, the earliest compliance date for most agricultural water provisions would be January 2022 for the largest farms. Once finalized the specific requirements with regards to water testing leave no room for interpretation as to what constitutes a safe supply and FDA will request access to water testing data history for their own assessments of safety. Of course, prior to finalization, agricultural entities would be wise to begin or continue documented monitoring to gain a complete understanding of water quality used for irrigation and worker hygiene in order to provide FDA required data at the time of an inspection. Even though enforcement of FDA’s agricultural water provisions has been pushed back, they should still be considered a suitable benchmark for testing purposes. Any results found to be out-of-specification (OOS) should be retested followed by an assessment and correction of procedures leading to those OOS results.

Firms should also take a look at their entire organization’s policies and procedures, including the very important, and required by FSMA, training. Employees must understand what is required of them and why, and it is management’s responsibility to ensure that all required training is conducted in a language and manner that employees understand. This may mean conducting various types of training in a variety of languages.

Look closely at operations to assess whether they are meeting the requirements of the Produce Safety Rule. Start thinking: What training do we need? What may we have to adjust in our work processes to meet FDA’s standards?

An audit of all practices is a good idea in order to get an accurate picture of how current operating procedures match FSMA requirements allowing for the identification of needed improvements, planning, and execution. Additionally, some buyers require private audits (which may or may not have the same standards as FSMA requirements) so being able to demonstrate results from internal and/or third-party audits or mock-FDA inspections can only enhance one’s demonstration of efforts to meet or exceed standards.

In short, the compliance date for the Produce Safety Rule is right around the corner for importers with large business foreign suppliers as well as some small. It is always the right time to assess one’s current status and plan for improvements, though as FSMA continues to take shape and enforcement dates move forward, the urgency has never been greater.

EAS Consultants to Present in Two Technical Sessions at the IFT 2018 Annual Meeting

EAS Independent Advisor Charles Breen is the panel moderator for two technical sessions at IFT – one on the Preventive Controls for Human Foods and another on the Foreign Supplier Verification Program. Esteemed panelists include for PCHF, Joann Givens, Director of the Office of Human and Animal Food Operations-West, Office of Regulatory Affairs at FDA, Robert Brackett, Director of Illinois Institute for Technology and Vice President of Institute for Food Safety and Health, Jeffrey Acker, Vice President of Food Safety and Compliance, Dairy Farmers of America and Susan Moyers, EAS Independent Consultant. Panelists for the FSVP include Susan Moyers, Robert Brackett and Erika Daniel with Almater, an Italian food technology and consulting firm with which EAS partners to assist European companies wishing to export food products to the U.S.

If you are attending IFT we invite you to stop by the EAS booth, S322 and attend these two sessions. PCHF – Successes and Challenges for FDA and the Food Industry will take place on Monday, July 16, 2018 at 10:30 am – 12:00 pm; and Food Importing: Green Light Strategies for Compliance with Game-Changing FSVP Requirements will take place Tuesday, July 17, 2018, at 10:30 am – 12:00 pm. Both will be held in room S502AB at the McCormick Place, the 2018 Annual Conference venue.

Please contact Allen Sayler at asayler@easconsultinggroup.com to set up an appointment to speak with EAS at the trade show.

Meet Issue of the Month Author Charles Otto, III

Charles Otto is a former Environmental Health Officer and Deputy Chief at the CDC where he provided guidance on all aspects of environmental health to the CDC Vessel Sanitation Program staff, member cruise lines, shipyards, and other global collaborators for the prevention of environmentally-related illnesses. He has worked at FDA as the Assistant Director in the Division of Cooperative Programs as well as the Retail Food Protection Branch where he developed national Hazard Analysis Critical Control Point (HACCP) implementation strategies for retail food protection, interstate travel programs, milk safety, and shellfish sanitation programs and furnished comprehensive field training on proper interpretation and implementation of the model food code standardization exercises conducted in every region of the U.S.

EAS Short Videos Describe Services to the Food Industry

EAS offers a wealth of regulatory consulting capabilities in all FDA commodity areas, as well as USDA and some state regulatory services as they pertain to food and dietary supplement products. EAS is creating short clips that discuss our capabilities and is posting them on our website. We invite you to learn more about our Product Development and Labeling services, FSMA, food and dietary supplement labeling as well as food additive services through these videos. We’ll be adding additional so stay tuned.

Dixon Helps Tobacco Firms Prepare for FDA Inspections in the Tobacco Reporte

Karen Dixon discusses critical points for helping tobacco firms prepare for FDA Inspections in this month’s issue of the Tobacco Reporter, including FDA’s inspection authority and how companies should prepare internally, including a having a detailed inspection plan in place. It is important to note that FDA inspections are not always preannounced, so companies in all industries are encouraged to have written and detailed SOPs as well as ready access to critical information that would be pertinent and requested as part of FDA’s inspection.

Probiotics Here to Stay Says DeMuri in Natural Products Insider

EAS Independent Consultant Steve DeMuri authored an article in Natural Products Insider on Probiotic health benefits of natural foods and supplements. With many reported health benefits currently being studied, “Probiotics are here to stay and now is the time for companies to conduct new product development to incorporate probiotics into the “tinkering process” that is part of all food technology and product development efforts,” he says.

Elizabeth Campbell and April Kates Discuss Clean Labels in Natural Products Insider

EAS Independent Advisor Elizabeth “Betty” Campbell and Independent Consultant, April Kates have co-written an article on how to keep “clean label” claims legal for Natural Products Insider. “Marketing a clean label can be a great way to for brands to connect to consumers,” they say, “but they need to ensure their statements don’t run afoul of a legal claim.”

EAS Presents Summer Webinar Series on Regulatory Topics Pertaining to Cannabis, Foreign FDA Inspections and Temporary Marketing Permits

Quality Systems for the Cannabis Industry – Preparing for State GMPs

Tara Lin Couch Ph.D., Senior Director for Dietary Supplements and Tobacco Services, will present a webinar on August 6, 2018, at 1:00 pm Eastern to help cannabis firms prepare for cannabis Good Manufacturing Practices (GMPs). Titled “Quality Systems for the Cannabis Industry, Preparing for State GMPs”, she will discuss how GMPs applications to this unique industry cannot be understated. While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for putting practices and procedures in place to meet compliance expectations, including those of testing and quality control of in-process materials, finished batches and packaged/labeled products. The time is right for the cannabis industry to begin assessing manufacturing processes and implementing sound and effective quality systems in order to begin preparing for GMP regulations. Stay ahead of the curve, standardize your product quality and be a leader in your industry. Join Tara on August 6, 2018, at 1:00 pm Eastern for this free webinar by clicking here.

Preparing for Foreign FDA Inspections

Have you ever wondered why your foreign suppliers: API, intermediates, food ingredients, etc. are suddenly in trouble with regulatory authorities? Did they just go astray or is your auditing program not performing as designed? Actually, there are several things at play. EAS Independent Consultant, Peter Saxon, will shed some light on reasons FDA inspections can “go south” as well as provide insight on how disappointing results can be managed. Saxon has personally attended 90 FDA inspections of foreign facilities and another 15 inspections by other regulatory agencies (TGA, WHO, EDQM). His insights will provide an opportunity for companies to consider improvements to their internal audit structure to help minimize regulatory risks. Join us August 14, 2018, at 1:00 pm Eastern for a free webinar on Preparing for FDA Inspections where you will learn where most regulatory problems are found by the FDA, how OAI (Other Action Indicated) results are categorized by the FDA and what you can do to avoid these disappointing results.

Temporary Marketing Permits – Opportunity and Pitfalls of the Specialized FDA Application

Food Standards are an important component of FDA’s oversight, ensuring honesty and fairness to the consumer through requirements that provide for the basic nature of a standardized food to be uniform in terms of its characteristics as well as the ingredients that it must or may contain. But what happens when a newly developed food or production method warrants consideration of a product category outside of the standard? Petitioning to amend a food standard or to create a new one, is a lengthy and complicated process; however, a temporary solution may be available through a specialized category called a Temporary Marketing Permit (TMP’s). With TMP’s companies with novel standardized food innovations may apply to market test a food product that deviates from the standard of identity for that particular food, providing FDA with data needed to consider a future petition to amend the standard. Join Independent Consultant April Kates, on August 21, 2018, at 1:00 pm for this informative webinar on Opportunities and Pitfalls of Temporary Marketing Permits where you’ll learn best practices for submitting a successful TMP application.

FDA Releases Guidance Documents on Dietary Fiber Declarations

Dear Readers,

Welcome to EAS-e-News, a monthly newsletter produced by EAS Consulting Group and dedicated to FDA regulated industries.

We have sad news to share on the passing of Bill Ment who was a long-time friend and consultant to EAS. Please refer to the Who’s Who section of this issue for our tribute to Bill.

The Food Industry received a long-awaited answer to the question of how the agency will regulate dietary fiber when, on June 14, two guidance documents on how isolated or synthetic non-digestible carbohydrates relate to dietary fiber declarations were published. As you will read in this month’s Highlights of What’s New at FDA, written by Independent Advisor for Labeling and Claims, Betty Campbell and Independent Consultant and labeling expert, Gisela Leon, for almost two years industry has been in a state of uncertainty regarding at least 26 non-digestible carbohydrates under FDA’s review. Firms are encouraged to determine whether this new guidance affects the dietary fiber declarations of their products and revise labels as needed.

Our Issue of the Month article is written by Independent Consultant Charles Otto and discusses ten major updates in the 12th edition of FDA’s Food Code. This Code is the basis for food safety regulation of more than a million restaurants, retail food stores, institutional and other food operations in the US and around the world.

We welcome independent consultants Kristen Steel, Philip Scharago, and Beth Ann Crozier-Dodson, Ph.D. Kristen is a regulatory professional with a strong background in compliance and strategic partnerships within healthcare, CPG and foodservice environments. Philip is a pharmaceutical consultant with extensive knowledge of Quality Systems, Risk-Based Auditing, process validation, and equipment qualification for pharmaceutical manufacturing and testing. Beth Ann is an international consultant on food safety issues for industry, academia, and food and diagnostic kit industries. Read more in our Who’s Who section.

We have added two new webinars as part of our summer webinar series – Preparing for Foreign FDA Inspections and Opportunities and Pitfalls of Temporary Marketing Permits. We invite you to reserve your seat today!

EAS is excited to be exhibiting and speaking at IFT this month – please stop by our booth S322 if you will be in attendance. In addition, EAS is also an invited speaker at the International Association of Food Protection conference. Read more about what’s happening at EAS in EAS-in-Action.

I hope you enjoy this issue of EAS-e-News. As always, please feel free to reach out to me with any questions and share this newsletter with your colleagues.

Sincerely,

Ed

July 2018

  • From the Desk of the Chairman: FDA Releases Guidance Documents on Dietary Fiber Declarations
  • Issue of the Month: FDA Food Code 12th edition: What’s New?
  • Who’s Who at EAS
    • In Memoriam: Bill Ment
    • Meet Issue of the Month Author Charles Otto, III
    • Meet New EAS Consultants
  • FSMA Perspective: Produce Safety Rule’s July Compliance Dates
  • Drug and Device Corner
    • Recent FDA Drug / Medical Device Activity
  • Ask the Expert: OTC Monograph System Gets an Update
  • What’s New on FDA’s Website
    • Updated Guidance for Declaration of Dietary Fiber in Nutrition Labels
    • Food Safety Plan Builder Updates Released
  • EAS in Action
    • EAS Consultants to Present in Two Technical Sessions and the IFT 2018 Annual Meeting
    • EAS Present Summer Webinar Series on Regulatory Topics Pertaining to Cannabis, Foreign FDA Inspections and Temporary Marketing Permits
    • Rapid Testing Methods for the Dairy Industry to be Discussed at IAFP
    • Probiotics Here to Stay, Says DeMuri in Natural Products Insider
    • Couch Authors Tablets and Capsules Feature on the Importance of Quality Agreements
    • Elizabeth Campbell and April Kates Discuss Clean Labels in Natural Products Insider
    • Schebella Offers Tips for Designing Cannabis Food Edibles in the State of California in Cannabis Industry Journal
    • Dixon Helps Tobacco Firms Prepare for FDA Inspections in the Tobacco Reporter
    • Fairman Discusses the Potential Effects of Brexit on US-UK Food and Dietary Supplement Trade
    • EAS Short Videos Describe Services to the Food Industry
  • Useful Publications and Regulatory Tools

Meet New EAS Consultants

Philip Scharago is a pharmaceutical consultant with extensive knowledge of ISO 13485, 14971, QSR GMP 820, ICH, MDD/EU, ICH, CGMP, Quality Systems, Risk-Based Auditing, process validation, and equipment qualification for pharmaceutical manufacturing and testing. He has more than twenty-five years working in the Medical Device and Pharmaceutical Industries in the areas of Quality Assurance and Regulatory Affairs and extensive experience developing and improving quality systems to meet FDA requirements and remediation of FDA-483 observations and Warning Letters.

Kristen Steel is a regulatory professional with a strong background in healthcare marketing, compliance and strategic partnerships within healthcare, CPG, and foodservice environments. She works with project and database management, organizational management, FDA/USDA/DSHEA regulatory and labeling requirements, as well as an international framework as it relates to product labeling.

Beth Ann Crozier-Dodson, Ph.D., is an international consultant on food safety issues for industry, academia, and food and diagnostic kit industries. Dr. Crozier-Dodson has spoken in, designed and taught customized microbiology/food safety workshops across the globe. She is a member of numerous professional and honor societies and has received a USDA Commendation for Contribution to Public Health. Her areas of specialty include microbiology, laboratory setup, environmental testing, aeromicrobiology, validation testing, consulting, and plant and facility audits.

Food Safety Plan Builder Updates Released

FDA has released an updated version of the downloadable Food Safety Plan Builder tool designed to help owners and operators of food establishments with the development of a food safety plan that identified hazards requiring preventive controls to prevent foodborne illnesses specific to their facilities. All Food Safety Plans must contain those components that are needed to be in compliance with the 21 CFR part 117, or “CGMP & PC for Human Food rule” requirements in Subpart C – Hazard Analysis and Risk-Based Preventive Controls. A Food Safety Plan is a set of written documents that are based on food safety principles and incorporates hazard analysis and preventive controls, including supply-chain programs and a recall plan; and delineates the procedures to be followed for monitoring, corrective actions, and verification. Those wishing to use the FSPB as their primary tool may wish to have a qualified third-party, such as EAS, review the plan for adequacy.

FDA Food Code 12th Edition – What’s New?

By Charles S. Otto, III, Independent Consultant

The FDA Food Code is used as the basis for food safety regulation of more than a million restaurants, retail food stores, institutional and other food operations in the US and around the world. It is updated every two years through a collaborative process with the Conference for Food Protection where all stakeholders have a voice in what is included in the next edition published by FDA. Allen Sayler, Senior Director for Food Consulting Services, in his March column in the EAS-e-News announced the release of the 2017 edition on February 12, 2018.

This article will focus on the 10 major changes in this 12th edition since the first modern risk- and the science-based code was issued by FDA in 1993. Twelve earlier editions had been published by FDA and the U.S. Public Health Service since 1934 that were more retail segment-specific guidance, i.e. food service, food store or food vending.

FDA Food Code only becomes a regulation when its requirements are adopted by local, state, and federal food programs for their segment of this vast industry. The new provisions also become the de facto standard of prudence for many companies, even before their operations are required by the local regulatory authorities to comply with it.

A summary of the 10 major updates in the 2017 edition of the FDA Food Code is provided below. This release also had many less significant changes and numerous editorial and clarification amendments.

Chapter 2 Management and Personnel
2-102 Certified Food Protection Manager

Required, for the first time, that the Person in Charge of the food establishment be a Certified Food Protection Manager. The program that awards this recognition must be accredited, meaning that it has been evaluated and listed by an accrediting agency, as conforming to national standards for organizations that certify individuals.

2-103 Monitoring of Food Temperatures

Added a new duty for the Person in Charge, ensuring employees are routinely monitoring food temperatures in hot and cold holding.

2-201 Salmonella Typhi and nontyphoidal Salmonella distinctions

Expanded on the changes begun in the 2013 Food Code in emphasizing the importance of nontyphoidal Salmonella (NTS), such as S. enterica serotypes, that cause more than one million domestically acquired foodborne illnesses in the United States each year.

2-401 Bandages, Finger Cots or Finger Stalls

Required the use of a single-use glove to cover a bandage, finger cot or finger stall used on the wrist, hand or finger.

2-501 Written Vomit and Diarrhea Clean-Up Procedures

Required that a written plan be provided for cleanup of these bodily fluid discharges by employees or customers. A very good detailed explanation for the plan elements is provided in Food Code’s Public Health Reasons Annex.

Chapter 3 Food
3-401 Changed Cooking Times

Raised the cooking temperature dwell time for foods like comminuted meats requiring a cooking temperature of 68°C (155°F) from 15 seconds to 17 seconds. Lowered the cooking temperature dwell time for foods like poultry requiring a cooking temperature of 74°C (165°F) or above to < 1 second (instantaneous).

3-502 ROP Frozen Fish Labelling

Added criteria for fish that is reduced oxygen packaged at retail to bear a label indicating that it is to be kept frozen until time of use.

Chapter 8 Compliance and Enforcement
8-201 HACCP Plan

When a Hazard Analysis and Critical Control Points plan is required by a jurisdiction for variances including those for specialized processing at retail, more detailed information is required to be submitted for the jurisdictions review and approval.

8-402 Regulatory Training

Added requirement for the Regulatory Authority to ensure that authorized representatives, who inspect food establishments or conduct plan reviews for compliance with Food Code, have access to training and continuing education, as needed, to properly identify violations and apply the Food Code. You will see in this month’s FSMA Perspective that employee training is also a requirement of FSMA and documentation of that training should be kept and provided to FDA upon request during an inspection.

8-404 Utility Interruption Contingency Plan

Allowed the regulatory authority to agree to continue operations during an extended water or electrical outage, if written operational plans have been approved by the regulatory authority.

As mentioned with the changes outlined in Section 2-501, the Public Health Reasons in Annex 3 provide excellent plain English descriptions of the science and other details behind the requirements of the changed, as well as the older sections of FDA Food Code. Additional information can be provided by the adopting regulatory authority or by the FDA National Retail Food Team. Questions of FDA on the Food Code may be directed to RetailFoodProtectionTeam@fda.hhs.govor should you have questions which you would like to direct to EAS, contact Allen Sayler at ASayler@easconsultinggroup.com

In Memoriam: Bill Ment

Bill Ment who was a long-time friend and consultant to EAS. Bill had a 34-year career at FDA, where in his last agency role he served as the Laboratory Director in Baltimore, MD, with responsibility for a full range of FDA field lab sample analyses and research studies for imported and domestic products. Following FDA retirement in 1999, he began consulting with AAC Consulting Group and Kendle Regulatory Affairs, from which EAS Consulting Group grew. Thanks to Bill’s expertise and outstanding reputation both at FDA and as a consultant, he was quickly asked to join the ranks of EAS Independent Advisors, overseeing GMP Auditing Services. Bill performed many pharmaceutical, laboratory and dietary supplement audits of API and finished product manufacturers, and helped companies improve their laboratory and QC/QA operations. He was also instrumental in the development of the EAS Dietary Supplement Good Manufacturing Practices seminar, which has become an EAS flagship training program. Most importantly, Bill was a great friend to many at EAS where he often mentored new consultants, helping them to make the transition from industry or FDA to the consulting world. He was an easy-going man of great integrity, with an unbelievable work ethic and he will be truly missed. Please keep Bill’s family in your prayers as they go through this difficult time. Should you wish to make a contribution in Bill’s memory, here is a list of charities with meaning to Bill and his family.

OTC Monograph System Gets an Update

By Susan Crane

This month’s Ask the Expert is answered by EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane. Susan specializes in quality and regulatory compliance for over-the-counter (OTC) and dietary supplement products. She has a thorough knowledge of federal regulations pertaining to the marketing, labeling, and distribution of OTC drugs and dietary supplements.

Each month EAS chooses one question sent in by a reader of EAS-e-News. To submit your question, use the Contact Us link on our website.

Question: Why is FDA updating the OTC monograph system?

Crane: The current OTC monograph system has been in use since the 1970’s and has proven to be a lengthy and cumbersome rule-making process for finalizing, or making changes to the monographs. Several monographs have been in the “Tentative Final” stage for 40 years, while hundreds of active ingredients still lack FDA determination as to their safety and effectiveness. The FDA simply lacks the resources to manage the system as it currently exists.

To address the problem, the FDA, in consultation with other stakeholders, worked with Congress to draft legislation. The resulting Over-the-Counter Drug Safety, Innovation, and Reform Act is currently moving through the legislative process with bipartisan support so is expected to pass and be signed into law, hopefully before the mid-term elections in November.

The reforms include, but are not limited to:

  • replacing the current rule-making process with a more efficient “administrative order” process
  • providing FDA with funding through a new user fee program
  • providing mechanisms to allow FDA to more quickly address safety issues that arise
  • encouraging innovation by offering exclusivity to manufacturers for new active ingredients or conditions for use

EAS is monitoring the legislation and will provide details as they become available.

Fairman Discusses the Potential Effects of Brexit on US-UK Food and Dietary Supplement Trade

The U.K.’s departure from the EU sparks uncertainty in future trade agreements with the United States, which may not be finalized until after Brexit occurs, says Heather Fairman in a recent article for Natural Products Insider. “For U.S. supplement companies that currently are actively exporting/importing products to the U.K., a watchful eye should be kept on the Brexit transition.”

Couch Authors Tablets and Capsules Feature on the Importance of Quality Agreements

Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D. has published an article in Tablets and Capsules magazine on the importance of quality agreements for dietary supplement manufacturers. “The dietary supplement industry, like the pharmaceutical and food industries, relies heavily on contractors and subcontractors. However, no matter who does what along the supply chain, the product owner is ultimately responsible for GMP compliance,” she says.

Schebella Offers Tips for Designing Cannabis Food Edibles in the State of California in Cannabis Industry Journal

Independent Consultant Celia Schebella discusses tips for designing a cannabis edible in the state of California that meets customer expectations and regulatory requirements in Cannabis Industry Journal. Designing a cannabis food product with GMPs, local regulations, ingredient sourcing and scalability in mind can help companies succeed, she says.

Rapid Testing Methods for the Dairy Industry to be Discussed at IAFP

Independent Consultant David Blomquist will discuss rapid testing methods for safety and spoilage in the dairy industry at the upcoming International Association of Food Protection’s annual meeting which will take place July 8-10, 2018 in Salt Lake City. IAFP provides an opportunity for professionals to discuss current and emerging food safety issues, the latest science and innovative solutions to new and recurring problems.

Updated Guidance for Declaration of Dietary Fiber in Nutrition Labels

Before 2016, FDA regulations for nutrition labeling did not define the term “dietary fiber” but in 2016, FDA issued regulation defining dietary fiber as two types of fiber: [1] non-digestible soluble and insoluble carbohydrates and lignin that are intrinsic and intact in plants; and [2] isolated or synthetic non-digestible carbohydrates determined by FDA to have acknowledged beneficial physiological effects. The FDA regulation listed 7 ingredients that had been found to have a beneficial physiological effect.

On June 14th, 2018, a little over 18 months before the compliance date for the new nutrition labeling, FDA issued two guidance documents regarding how isolated or synthetic non-digestible carbohydrates relate to the dietary fiber declaration. These guidance documents resolve nearly two years of uncertainty for at least 26 non-digestible carbohydrates under FDA review for their potential beneficial physiological effect.

FDA stated in one guidance document that the agency had found a beneficial physiological effect for 8 more ingredients and would use enforcement discretion to allow manufacturers to immediately reevaluate their fiber ingredients for inclusion in the dietary fiber declaration. The second document contained the scientific evaluation of data showing a beneficial physiological effect for those 8 ingredients.

The list of FDA-approved isolated or synthetic non-digestible carbohydrates with acknowledged beneficial physiological effects now include the following 15 substances:

  1. [beta]-glucan soluble fiber (as described in 101.81(c)(2)(ii)(A))
  2. psyllium husk (as described in 101.81(c)(2)(ii)(B))
  3. cellulose
  4. guar gum
  5. pectin
  6. locust bean gum
  7. hydroxypropyl-methylcellulose
  8. mixed plant cell wall fibers
  9. arabinoxylan
  10. alginate
  11. inulin and inulin-type fructans
  12. high amylose starch (resistant starch 2)
  13. galactooligosaccharide
  14. polydextrose
  15. resistant maltodextrin/dextrin.

The agency describes “Mixed plant cell wall fibers” as a large group of fibers that include cellulose, pectin, β-glucan, and/or arabinoxylan. FDA listed several examples of ingredients that include these fiber components, including apple fiber, citrus fiber, pea hull fiber and many others.

With the evaluation decisions in the new guidance, the list of 26 non-digestible carbohydrates under FDA evaluation as dietary fiber has now been shortened to 9. The ingredients where no determination has been reached include commonly used fibers such as gum acacia, carboxymethylcellulose, karaya gum, pullulan, xanthan gum and some other starches.

With the publication of these new documents, firms are encouraged to verify whether the updated guidance affects the dietary fiber declaration of their products. Nutrition information in recently created Nutrition Facts and Supplement Facts panels might need to be updated. EAS consultants are available to assist in evaluating ingredients in light of the new guidance and revising labels accordingly.

June 2018 Drug and Device Corner

Federal Register Notice Vol 83, No. 108

FDA is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the listed class II devices to reflect this final determination. FDA is publishing this order in accordance with the section of the FD&C Act permitting the exemption of a device from the requirement to submit a 510(k).

FDA Withdraws Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity

[6/21/2018] The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of a draft guidance for industry entitled “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017. The draft guidance, if finalized as written, was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product. After considering public comments that the agency received about the draft guidance, the FDA determined it would withdraw the draft guidance as it gives further consideration to the scientific and regulatory issues involved. Comments submitted to the docket addressed a range of issues that could impact the cost and efficiency of biosimilar development, including the number of reference product lots the draft guidance would recommend biosimilar developers sample in their evaluation of high similarity and the statistical methods for this evaluation. The FDA believes that in better addressing these issues in the future, the agency can advance principles that can promote a more efficient pathway for the development of biosimilar products.

The agency intends to issue future draft guidance that will reflect state-of-the-art techniques in the evaluation of analytical data to support a demonstration that a proposed biosimilar product is highly similar to a reference product.

Guidance Document updates on the FDA website

All Centers

Medical Product Communications That Are Consistent With the FDA-Required Labeling – Q & A

CDER

Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis

Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief

Complicated Urinary Tract Infections: Developing Drugs for Treatment

Assessment of Pressor Effects of Drugs

Complicated Intra-Abdominal Infections: Developing Drugs for Treatment

Major Depressive Disorder: Developing Drugs for Treatment

CDER & CBER

Limited Population Pathway for Antibacterial and Antifungal Drugs

Patient-Focused Drug Development: Collecting Comprehensive and Representative Input

Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials

Development of a Shared System REMS

Waivers of the Single, Shared System REMS

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management – Core Guideline

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management – Annex

Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products

CDRH

Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests

Intravascular Catheters, Wires and Delivery Systems with Lubricious Coatings – Labeling Considerations

Coronary, Peripheral and Neurovascular Guidewires – Performance Tests and Recommended Labeling

Humanitarian Device Exemption (HDE) Program

Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions

CDER & CDRH

Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities Q & A

CDER & CBER

S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Q & A

Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

CVM

General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals

Murphy to Present on Raw Milk and Processed Dairy Products at ADSA

Independent Consultant Steven Murphy will speak at the upcoming June 24-27, 2018 American Dairy Safety Association Annual Meeting in a session called “Time for Change; Indicators of Public Health Concern for Raw Milk and Processed Dairy Products”. Mr. Murphy’s presentation will take place on June 26 at 22:45 pm. Says Murphy, “Regulatory standards used as indicators of conditions considered public health risks for Grade “A” milk and milk products fall under FDA’s Grade “A” Pasteurized Milk Ordinance (PMO). These standards have not changed in decades and this overview will present a perspective based on current science on where changes are warranted.”

Blomquist to Present on Rapid Testing Methods at the IAFP

Independent Consultant, David Blomquist, will speak on “Rapid Testing Methods for Safety and Spoilage in the Dairy Industry – What Is Needed, What Works and What Does Not” on July 9, 2018, at the International Association of Food Protection Conference. Says Blomquist, “The dairy industry has been a leader in sanitation and hygiene for over a century. As food safety becomes more critical for all industries, methods to determine the quality of dairy products rapidly becomes more critical.” This session will focus on different technologies that have the potential to determine low levels of spoilage organisms in a variety of dairy products and will discuss the strengths and weakness of each. If you are attending the IAFP, we hope you will join us for this session.

EAS has much expertise in regulatory assistance to the dairy industry. For more information on our capabilities view our Dairy Industry Services Sheet.

Couch to Present at the CRN Conference on Implementing Compliance Controls

Tara Lin Couch Ph.D.Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., will be speaking at the upcoming Council for Responsible Nutrition Conference on Implementing Compliance Controls to Meet New Sophisticated cGMP Standards. This conference is taking place June 18-20, 2018 in New York City at the InterContinental New York Times Square and Dr. Couch, speaking as part of a panel, will present on June 19 at 4:45 pm. The panel will discuss items such as:

  • Understanding the FDA’s more sophisticated approach to dietary supplement cGMPs
  • Petitioning the FDA for an exemption to the 100% identity requirement for ingredient testing
  • Assessing the impact of program alignment under Dr. Gottlieb
  • Reassessing cGMPs in the context of cleanliness, safety, and testing for raw materials as based on this new approach
  • Identifying the right test for the right ingredient within the context of cGMP standards
  • Comprehending how this potential enforcement ramp-up may lead to an uptick in 483 observations

We hope you’ll join Dr. Couch at this informative event!

Armstrong Authors Article on Mergers and Acquisitions for Natural Products Insider

Steve ArmstrongIndependent Advisor for Food Law and Regulation, Steve Armstrong, has authored an article for Natural Products Insider on buying a 21st-century food company and mergers and acquisitions. “A health and nutrition startup should resolve any potential issues with its quality control, labeling and advertising practices before it is acquired,” he says.

EAS offers a number of services to attorneys working in the area of due diligence and mergers and acquisitions. For more information on these services please review our Food and Drug Attorney Services Sheet.

OTC Monograph Webinar Postponed Due to Pending Legislation

As you may be aware, Congress is currently working on legislation to update the Over-the-Counter (OTC) monograph system. This legislation, the Over-the-Counter Drug Safety, Innovation, and Reform Act, has bipartisan support in Congress as well as the backing of the FDA, industry and other public health organizations. As such, it is expected to pass and be signed into law by the President before the mid-term elections in November.

Due to the significant changes ahead, EAS has decided to postpone the webinar “The OTC Monograph System – Past, Present, and Future originally scheduled for July, and will instead monitor this legislation and present the webinar after the passage of the bill. This will enable us to provide you with better information on how to market your OTC products going forward.

Meet New EAS Consultants June 2018

Charles Otto

Charles Otto is a former Environmental Health Officer and Deputy Chief at the CDC where he provided guidance on all aspects of environmental health to the CDC Vessel Sanitation Program staff, member cruise lines, shipyards, and other global collaborators for the prevention of environmentally-related illnesses. He has worked at FDA as the Assistant Director in the Division of Cooperative Programs as well as the Retail Food Protection Branch where he developed national Hazard Analysis Critical Control Point (HACCP) implementation strategies for retail food protection, interstate travel program, milk safety, and shellfish sanitation programs and furnished comprehensive field training on proper interpretation and implementation of the model food code standardization exercises conducted in every region of the U.S.

Robert Kapp Ph.D.

Robert Kapp, Ph.D. has over 30 years’ experience as a toxicologist involved with the management, development, and safety of new and existing products in a broad spectrum of industries including chemical, petrochemical, food, consumer products, and pharmaceuticals. He has experience in preclinical program study design, study reports, occupational and industrial toxicology, evaluating clinical and product safety data; in training and managing staff in laboratory operations; evaluating contract research organizations and various compliance issues in the US as well as abroad. Dr. Kapp has experience in writing critical position papers, GRAS notifications, 510(k) submissions, US EPA Premarketing Notifications, toxicology profiles, Safety Data Sheets and labels in the US and in global markets. Prior to consulting Dr. Kapp worked as Director, Toxicology Laboratory at Exxon Biomedical Sciences, Inc. He has a Ph.D. in toxicology from George Washington University.

Sanaullah Khan, Ph.D.

Sanullah Khan has a Ph.D. in Analytical Chemistry from the University of Kansas, MBA from Rutgers University and MS in Bioscience Regulatory Affairs from Johns Hopkins University. He has worked in the Pharmaceutical industry since 1996, in the areas of R&D, technical operations and worldwide quality and compliance. His expertise in GLPs and GMPs range from discovery to filing and post-market quality oversight. R&D functions include developing and validating analytical methods to support non-clinical and clinical studies, and Worldwide Quality and Compliance responsibilities have included investigation of out of specification (OOS) and out of trend (OOT) results. As a quality consultant, Dr. Khan provides support for overseeing QC laboratory operations, conducts investigations of OOS results and manufacturing deviations and data integrity. He performs manufacturing and laboratory equipment qualifications, cleaning validation and batch record review, drafting of SOPs, qualification protocols and Master Production Records for pharmaceutical and Biologics companies.

John J. Brennan, Ph.D.

John J. Brennan, Ph.D. is a former Senior Project Leader in Global Pharmaceutical Research and Development at AbbVie in North Chicago, Illinois. At Abbvie he served as the Enterprise Leader for 3 Global Asset Development teams accountable for creating and executing development strategies in several therapeutic disciplines including exocrine pancreatic insufficiency, cystic fibrosis and diabetic nephropathy (SONAR Phase 3 Trial). His areas of interest include First-in-Man, Proof-of-Concept, Proof-of-Principle, and late-stage registration studies and lifecycle management. Prior to joining AbbVie, he worked at Solvay Pharmaceuticals, Inc. in Global Project Management and as a Therapeutic Area Leader in Women’s Health, Men’s Health and Clinical Pharmacology. Dr. Brennan is a graduate of Temple University and received the Ph.D. degree in Pharmaceutical Sciences from the Philadelphia College of Pharmacy and Science (now University of the Sciences).

Robert P. Lavieri

Robert P. Lavieri is an expert in the development and delivery of Governance programs for the development of sustainable compliance systems. His expertise in design, development, and implementation of Standard Operating Procedures, Best Practices, Good Manufacturing Practices (CGMP’s) and technical expertise across a broad range of compliance areas such as OSHA, EPA, FDA (Food Safety), DOT enable him to offer benchmarked results for clients. Mr. Lavieri is also a frequently requested trainer, educating manufacturers on HAZWOPER, Process Safety Management, Risk Management Program, Process Hazard Analysis (HAZOP, FMEA, FMCA, etc.) as well as Hazardous Communication (chemical safety).

Dietary Supplement GMP Online Short Course Available for Purchase

EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., along with attorney Marc Ullman from Rivkin Radler, and EAS Independent Advisor for Quality and Compliance, Robert Fish, held a Dietary Supplement Short Course, consisting of four hours of regulatory content, recently. It is now available to view as an on-demand webinar on the EAS website. This video is $99 to view for non-EAS clients and free to view for EAS clients.

The GMP short course is a great tool for those seeking a broader overview of GMPs, as it covers the basics of working in a GMP environment including personal hygiene, sanitation, the use of Standard Operating Procedures (SOPs), and Good Documentation Practices (GDPs) and addresses the top 5 observations cited in FDA Warning Letters since 2010. To access the short course, click here. EAS clients may use discount code [clientwebinar], non-EAS clients will be billed upon viewing.

May Drug and Device Corner

In the ongoing effort to make more affordable drugs available to the public, FDA Commissioner Scott Gottlieb, MD issued a statement on the FDA’s efforts to assist in this process. Of particular note is the FDA’s commitment to ensuring generic drug developers have access to brand drug samples for their development process. You can read the commissioners statement here.

The U.S. House Energy and Commerce Committee has progressed with legislation to reform and modernize the OTC Monograph System. Included in this reform is a discussion of an OTC user fee program similar to that of PDUFA, GDUFA, and BsUFA. The FDA sees an OTC monograph user fee program as a means of resources that would encourage innovation and fund the necessary regulatory system update. Currently, each ingredient-specific monograph must be finalized through a multi-step public rulemaking process. This new legislation is proposing an administrative order process to replace the current procedures. EAS will keep you updated as this legislation evolves.

We want to bring to your attention the recently released Enforcement Policy – OTC Sunscreen Drug Products Marketed Without an Approved Application Guidance Document. In this guidance, the FDA articulates its enforcement approach for OTC sunscreen drug products that are being marketed without an approved application as well as those included in the final monograph (for which the effective date has indefinitely stayed.) We highly recommend reviewing this document to find out where your sunscreen products fall in regard to the formulation, testing, and labeling requirements and how this new enforcement policy may affect their continued marketing. To read FDA Commissioner Scott Gottlieb, MD’s statement regarding sun exposure and sunscreens, please follow this link.

The FDA has announced in the Federal Register Vol 83, No. 87 their final order regarding the General Hospital and Personal Use Needle Destruction Device. Effective 4 June 2018, this device will be renamed “sharps needle destruction device” and reclassified from a class III device (regulated under product code MTV) into class II (special controls) which will make it subject to premarket notification. The reclassification will lessen the burden on industry for marketing such devices while still ensuring reasonable safety and effectiveness for users.

The FDA has published in the Federal Register Vol 83, No 94 a proposed amendment to regulations concerning the classification of products as biological products, devices, drugs or combination products. The agency will be accepting e-comments on their proposed amendment until midnight ET 16 July 2018.

The FDA has a webpage dedicated to Drug Supply Chain Security Act readiness, please follow the link for further information. There have also been 3 draft guidance documents released in 2018 regarding the Drug Supply Chain Security Act. The link will bring you to the FDA page listing each of these documents.

Guidance Document updates on the FDA website

CDER

CDER & CBER

CVM

New Brewers Need to Know GMPs

By Charles Breen, Independent Advisor for FSMA

The explosion in the numbers of new breweries is a blessing for beer drinkers and their communities. In FDA’s eye, beer is food, and while exempt from preventive control requirements, brewers must comply with good manufacturing practice regulations, GMPs.

The FDA Food Safety Modernization Act (FSMA) is transforming the nation’s food safety system into one that is based on the prevention of foodborne illnesses by putting into place measures that will effectively prevent contamination. As any responsible grower, manufacturer, packer, and transporter know, keeping food safe to eat is paramount, no matter where it is produced, whether conventional or organic, whether the operation is small, medium or large, or whether it’s produce or process. Good Manufacturing Practices are critical to FSMA’s success.

A major new GMP component is the appropriate training of all employees to comply with GMPs. From managers to line staff, no matter the job and no matter the spoken language – everyone must understand and be able to apply those requirements that apply to their role in producing food. In FDA’s view, without this training, education and related experience, an employee is not qualified to act in their role or perform assigned duties. FSMA training encompasses everyone involved in the food industry, including domestic and foreign food producers and domestic importers.

Because the food industry, including brewers, is so varied, it is plain that a one size approach to training does not fit all. The most important goal for FDA is safe food, and the agency expects training programs to contribute to its accomplishment — that training advances knowledge in the food industry to meet FSMA requirements. Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene as appropriate to the food, the facility, and the individual’s assigned duties.

There are a variety of FSMA training options available. FDA has a detailed webpage for many of the options including standardized trainings designed by the Food Safety Preventive Controls Alliance (FSPCA) and coordinated by Illinois Institute of Technology’s Institute for Food Safety and Health which offers technical information to help the domestic and foreign food industry comply with the requirements of the Preventive Controls rules for human and animal food, as well as the rule on Foreign Supplier Verification Programs (FSVP).

Those looking for FSMA compliance training need look no further than EAS. Many EAS Independent Consultants are Lead Instructors and we offer FDA recognized training programs as part of our FSMA educational curriculum.

EAS also hosts and participates in many industry webinars discussing the various aspects of FSMA, specifics of compliance and practical steps to bring facilities and operations into compliance.

Additionally, EAS is often an invited speaker as part of technical sessions at industry events such as the upcoming IFT Annual Meeting (where EAS will be moderating two sessions on FSMA) and the recent Dietary Supplement Regulatory Summit, (where Senior Director for Food Consulting Services, Allen Sayler, spoke on which parts and how FSMA applies to the dietary supplement industry).

EAS Consulting Group is a one-stop shop when it comes to education, assessing readiness, updating GMPs and other SOPs to bring processes into FSMA compliance and more. Our FSMA team takes great pride in the breadth and depth of services we offer.

Should you and your employees seeking FSMA training, look no further than EAS as we have a number of upcoming training seminars and on-demand informative sessions from which to choose.

And numerous On-Demand Webinars including:

Implementing a robust training program as part of your company’s FSMA compliance is a must and EAS Consulting Group offers many tools to help you get there.

EAS to Moderate Two Panels at IFT Annual Meeting, Exhibits at booth #S322

IFTEAS will be well represented at the upcoming IFT Annual Meeting taking place in Chicago, July 15-18, 2018. EAS Chairman and CEO, Ed Steele, President and COO, Dean Cirotta and Senior Director for Food Consulting Services, Allen Sayler, will be manning the EAS booth (#S322) and taking questions from conference attendees about the latest compliance requirements of FSMA as well as new services such as our Strategic Product Development and Labeling and our collaboration with FoodMinds on challenging marketing initiatives.

Charles BreenIn addition, Charles Breen, EAS Independent Advisor for FSMA will moderate two session panels as part of the IFT technical program, one on the Foreign Supplier Verification Program and another on Preventive Controls for Human Food. EAS Independent Consultant Susan Moyers, Ph.D. will be a panelist on both. Both sessions will be held in McCormick Place – S502AB.

The first session, Preventive Controls for Human Foods: Successes and Challenges for FDA and the Food Industry, will take place Monday, July 16 at 10:30-12:00 pm. In addition to Dr. Moyers, panelists will include Jeffrey Acker, Vice President of Food Safety and Compliance, Dairy Farmers of America; Joanne Givens, Director of the Office of Human and Animal Food Operations-West, Office of Regulatory Affairs, Food and Drug Administration and Robert Brackett, Ph.D., Illinois Institute of Technology Vice President and Director of IIT Institute of Food Safety and Health.

The next session, Food Importing – Green Light Strategies for Compliance with Game-Changing FSVP Requirements will take place Tuesday, July 17 at 10:30 am – 12:00 pm. In addition to Dr. Moyers panelists will include Robert Brackett and Gabriel Pascual, Founding Director & Managing Officer, Agency for Development of Export Markets (ADEM).

We look forward to seeing you at IFT and invite you to contact us in advance at asayler@easconsultinggroup.comto set up an appointment at the show to discuss your particular regulatory challenges.

EAS Authors Article in MedTech Intelligence on the New De Novo Pathway

EAS authored an article for MedTech Intelligence on FDA’s new approach to the regulatory pathway for De Novo medical device classification which simplifies the approval process for the class I or class II devices for which there is no one-to-one precedent or predicate. De Novo applications are appropriate in cases where it appears that the device meets the statutory standards for classification into Class I or Class II under section 513(a)(1) of the Food Drug & Cosmetic Act, and when the sponsor has determined that the device does not fall within any existing classification regulation.

EAS offers a number of services to the medical device industry. For more information, click here.

Why is Codex Alimentarius Important to Me?

By Allen Sayler

This month’s Ask the Expert is answered by Senior Director for Food Consulting Services, Allen Sayler, who recently returned from the 50th session of the Codex Committee on Food Additives held in Xiamen, China where 53 countries and 32 food industry observer organizations participated. Mr. Sayler has been an active food industry representative attending various Codex Committee meetings since 1997. Each month EAS experts tackle one question sent in by readers. To ask your question, please use our Contact Us form on the website.

Question: As a small, medium or large food manufacturer, why are Codex food standards important to me? I don’t export outside of the US and I don’t use imported materials in my production.

Sayler: The adoption of Codex food standards is intended to result in a similar change to individual country food standards, so they are similar or identical to Codex standards. This will affect all US food manufacturers, even those that do not export foods to other countries.

While Codex Alimentarius standards are voluntary, all participating governments (approximately 190) have agreed that as Codex adopts food standards, member countries should start changing their food standards to reflect these internationally-recognized Codex standards. If a country like the US does not start the process of changing its food standards to be similar to the Codex standards, and another Codex member country challenges this, the dispute is resolved using the World Trade Organization’s “Dispute Settlement Body”. The loser has to either change its food standards, pay the winner a fee comparable to the lost income from not having access to the loser’s markets or agreed that some of the loser’s food exports will be blocked by the winning country(s). While US government adoption of Codex food standards has been slow, over time, it is likely that US food standards will be changed.

Background Information: The Codex Alimentarius Commission, (meaning “Food Code” in Latin), is a United Nations-supported organization that develops food standards, guidelines, and operational principles in order to protect consumer health and facilitate international trade. These documents range from food quality and safety requirements, pesticide, and vet. drug residues, food additives, food hygiene, food contaminants, labeling as well as new food standards for fruits and vegetables, seafood, dairy products, etc. All Codex documents are intended to be scientifically-based in order to protect the health of those consuming the food. Specific country and regional standards, preferences and non-scientific requirements are not intended to override applicable Codex standards.

Using the recent Codex Committee on Food Additive meeting in China as an example, over 500 new food additive provisions were adopted while another 200 were blocked from adoption or removed from the Codex General Standard for Food Additives (GSFA). In addition, all food additives in the various Codex food standards are being methodically moved into the GSFA, which means some of importance to the food manufacturing industry may be dropped or maximum use level changed. Differences in each country’s food additive regulations are one of the primary reasons for blocking food imports.

There are many examples where Codex standards have been adopted as the national standard of food safety and policy, and even more examples where exporting countries have found that adoption of Codex standards to be a key to success due to its reference in bilateral and plurilateral trade agreements. Countries that wish to adopt Codex standards as their own national standard may receive support in doing so. The important work of the Codex Commission has created a greater worldwide awareness of food safety, quality, and consumer protection issues.

Last month you may have taken the opportunity to read the article written by Bruce Silverglade in EAS-e-News on the US Codex office’s move within the USDA and new opportunities that may provide food companies. Answers to more specific questions on the US Codex Alimentarius Commission or FAO Codex can be addressed to asayler@eassconsultinggroup.com.

Medical Device Innovations and the Regulatory Landscape

Dear Reader,

Edward A. SteeleWelcome to the June edition of the EAS-e-News. Summer is upon us but FDA is not slowing down with updates, enforcement, and impMedical Device Innovations and the Regulatory Landscaperovements to efficiency.

On the OTC monograph front, reforms are moving forward which will allow for a more streamlined regulatory process, faster safety label changes, and resources for agency oversight of OTCs as well as to enable innovation. Approximately 60% of medicines sold in the U.S. are OTCs, according to the Consumer Healthcare Products Association, and improvements to the process of OTC regulation will greatly enhance the industry from both and manufacturer and consumer perspective. You may read more about this reform in the Drug/Device Corner.

EAS has added two new training seminars scheduled for October in Alexandria, VA. The FSPCA Preventive Controls for Human Foods (PCHF)and FSPCA Foreign Supplier Verification Programs (FSVP)will take place October 1-3 and October 3-4 respectively. EAS is proud that many of our independent consultants are lead instructors for this FDA recognized training which meets the FSMA intent of a having a “Preventive Controls Qualified Individual” on staff who is able to oversee FSMA compliance at a facility.

Our FSMA Perspective, written by Charles Breen, our Independent Advisor for FSMA, discusses training requirements for GMPs which apply to all industries and is now mandated under FSMA. Meeting this training requirement can be challenging, particularly to those segments which newly fall under the FSMA umbrella such as the craft beer industry. Charles lays out some important training considerations and EAS offers opportunities to meet the requirements through the FSPCA training, as well as providing webinars which offer a broad overview of regulatory requirements.

Registrations for our upcoming Food Labeling and Dietary Supplement Labelingseminars which are taking place in Kansas City, MO at the end of September are strong. If you are in need of compliance training in these areas please join us. The Food Labeling Compliance Seminar also offers 16 CECs through the Commission on Dietetic Registration.

In our Issue of the Month, Dawn Wydner discusses the regulatory landscape for medical devices saying that new technologies are rapidly changing the way device manufacturers operate. The increase in minimally invasive methods, devices that reduce lengthy recoveries, tissue engineered devices, advances in diagnostic and “smart” products all offer substantially better-informed diagnoses and treatments, as well as unique compliance challenges.

Our Ask the Expert is answered by Senior Director for Food Consulting Services, Allen Sayler, and addresses the question of why Codex standards are important, even when companies don’t export product or import ingredients and materials from outside the U.S. You may remember, Allen recently returned from a Codex food additive meeting in China, where over 500 new food additive provisions were adopted while another 200 were blocked from adoption or removed from the Codex General Standard for Food Additives (GSFA). Paying close attention to Codex standards definitely does matter.

EAS welcomes new Independent Consultants Charles Otto, Robert Kapp, Ph.D., Sanaullah Khan, John J. Brennan, Ph.D. and Robert Lavieri. Charles Otto is a former Environmental Health Officer and Deputy Chief at the CDC where he provided guidance on all aspects of environmental health to the CDC Vessel Sanitation Program staff, member cruise lines, shipyards, and other global collaborators; Robert Kapp is a toxicologist involved with the development and safety of new and existing products in the chemical, petrochemical, food, consumer products, and pharmaceuticals industries; John J. Brennan, Ph.D. is a former Senior Project Leader in Global Pharmaceutical Research and Development at AbbVie; and Robert Lavieri has extensive expertise in the development of SOPs and GMPs as well as technical expertise across a broad range of compliance areas such as OSHA, EPA, and FDA. I invite you to read more about their backgrounds in the Who’s Who section of this issue.

EAS is speaking and moderating in a number of industry events in the next few months, from the American Dairy Safety Association (ADSA), International Association of Food Protection (IAFP), Council for Responsible Nutrition (CRN) to two panels at the Institute for Food Technologists (IFT), EAS continues to be invited speakers, providing the latest regulatory information to a wide industry audience. If you are planning to attend any of these events, please stop by and say hello.

Lastly, I wish to recognize two consultants who have been named to the USDA National Advisory Committee on Microbiological Criteria for Foods, Dr. Omar Oyarzabal, who is a returning member and Dr. Kathy Glass who is a newly elected member. Those who participated in our hugely popular webinar on FSMA’s impact on Acidified Foods will remember Dr. Oyarzabal. This webinar generated so many questions that EAS authored a Q&A published in Food Safety Tech Magazine, based on the presentation. Dr. Glass was one of a panel of presenters that included Mickey Parish, a senior science advisor with FDA CFSAN and Elizabeth Fawell, counsel at the law firm Hogan Lovells in a webinar covering FDA enforcement for Listeria in food processing. Congratulations to both Dr. Oyarzabal and Dr. Glass!

Thank you as always for your interest in EAS and I hope you enjoy this latest edition of EAS-e-News. Please feel free to share this newsletter with your colleagues and please feel free to reach out should you have any questions.

Sincerely,

Ed Steele
Chairman and CEO

USDA Announces Members of NACMCF – Two EAS Independent Consultants are Included

The names of new and returning members of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) have been announced and the committee now includes two EAS Independent Consultants. Returning member, Dr. Omar Oyarzabal who is a professor at the University of Vermont and newly elected member, Dr. Kathy Glass, a professor at the University of Wisconsin at Madison. The NACMCF was established in 1998 by the USDA’s Food Safety and Inspection Service (FSIS), the U.S. Department of Health and Human Services, Food and Drug Administration, Centers for Disease Control and Prevention, the Department of Commerce’s National Marine Fisheries Service, and the U.S. Department of Defense and the committee provides impartial scientific advice on issues pertaining to food safety. Says Sonny Perdue, US Secretary of Agriculture, “The committee members represent a diverse group from academia, consumers, the food industry, laboratories, consultants and government agencies, all of which play an important role in providing scientific advice and expertise to USDA on food safety and wholesomeness.”

FDA Expands Data Dashboard to Include FSMA

A new section of the FDA Data Dashboard has been launched to help importers and manufacturers/processors meet supply-chain requirements under the FDA Food Safety Modernization Act (FSMA) by helping them more easily find compliance and enforcement information related to specific firms. Three of the FSMA rules contain supply-chain requirements: the Foreign Supplier Verification Programs rule, the Preventive Controls for Human Food rule, and Preventive Controls for Animal Food rule.

The Data Dashboard allows users to search multiple databases. The data used to generate the dashboard graphs and search results are based on data already available to the public through the FDA.gov website. The datasets and data include the Inspections Database, Recalls, Import Alerts and selected data elements from the compliance and enforcement related information on FDA.gov. Additional data will be included in future releases of the Dashboard. You may find the location and additional information about each dataset and other data sources by clicking on the Compliance Dashboards or FSMA Data Search options above.

To assist with the evaluation process, FDA created a Supplier Evaluation Resources page to help importers and manufacturers/processors find relevant compliance and enforcement information for their suppliers, but that page required them to search multiple databases.

Preventive Controls for Human Food and Foreign Supplier Verification Program FSPCA Courses Offered

EAS Independent Consultant and FSPCA recognized lead instructor, Jenifer Kane, will co-instruct two FSPCA courses with Independent Consultant and trainer Susan Moyers, Ph.D. on the intricacies of Preventive Controls for Human Food as well as the Foreign Supplier Verification Program. Both courses will take place in early October in Alexandria, VA.

The Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (referred to as the Preventive Controls for Human Food Regulation) is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the U.S. and requires that certain activities must be completed by a “preventive controls qualified individual” who has “successfully completed training in the development and application of risk-based preventive controls”. This course meets FDA’s requirement. Join EAS October 1-3, 2018 in Alexandria for this 2.5 intensive training. Earlybird discounts are available through August 14, 2018.

Next, the “Foreign Supplier Verification Program (FSVP)” requires importers to verify that their foreign suppliers of food, food ingredients and food additives imported into the US market are compliant with all parts of the FSMA and its “Preventive Controls for Human Foods (PCHF) and “Preventive Controls for Animal Feeds (PCAF”) regulations. EAS’ two-day intensive FSVP Compliance Seminar will explain in detail FSVP rules, risk exposure by importers as well as US-based food processors using foreign sources of foods, food ingredients, and food additives. Join us October 3-4, 2018 for this 1.5-day training. Earlybird rates are in effect through August 14, 2018.

Meet Issue of the Month Author Dawn Wydner

Dawn Wydner, consults in pharma and medical devices, providing proactive compliance and application of quality oversight in all aspects of operational strategy, coordination and conduct. Prior to consulting she was the Senior Director of BioResearch, Quality, and Compliance at Janssen Research & Development, LLC where she oversaw GxP regulatory requirements and compliance issues and provided guidance on GCP/GLP mock inspections and audits of clinical investigators, CROs, SMOs, sponsors/monitors, animal laboratories and IRBs. She is a sought-after speaker, sharing her expertise on topics such as Sponsor Monitor Inspection Management and Expectations, Inspection Readiness and FDA Trends, Analytical Risk Management.

Medical Device Innovations and the Regulatory Landscape

By Dawn Wydner, Independent Consultant

I’m amazed as I watch a Health Care System and then a Spectrum commercial to what our future holds with the sophisticated, interactive medical device and technology innovations and how they will enhance the capabilities of diagnosis and treatment. My regulatory mind then kicks in and wonders how these amazing innovations will pose operational and data reliability challenges for both industry and regulators in areas ranging from clinical trials to device design and development, and ultimately to the commercially approved and marketed devices.

For Federal Agencies and other institutions involved in the evaluation, funding, manufacturing, distribution, and clinical use of medical devices, it is clear that the landscape of these activities will be changing in considerable ways. The increase in minimally invasive methods and devices to reduce lengthy recoveries, developments in decentralized care, tissue engineered devices, advances in diagnostic and “smart” products, to the growing sophistication of electronic medical information systems hold for substantially better-informed diagnoses and treatments. Yet, these same developments will generate increased pressure for more effective data capturing systems and methods to handle the data, coupled with concerns related to device accountability, source, supply/availability, and quality.

Regulatory health authorities around the globe are taking steps to be prepared. Are you ready and will you be in compliance when new and upcoming regulations take effect…

Data Acceptance

The FDA issued a final rule, effective Feb. 21, 2019.

Under the new rule, FDA is requiring sponsors and applicants to affirm that clinical investigations outside the United States were conducted in accordance with Good Clinical Practices (GCPs) when the data are submitted for medical device applications.[1] The final rule also amends criteria for investigations conducted within the United States to require applicants and sponsors to state that the investigation complies with FDA regulations for human subject protection, institutional review boards, and investigational device exemptions (IDEs).[2] If an investigation is not conducted in accordance with those regulations, a brief statement of the reason for the noncompliance is required.[3,4]

The US FDA’s new requirements will affect device development strategies, including where to conduct such trials. The necessary patient population in the disease prevalent area of the clinical trial may not have the economic means for network availabilities to fully comply with the use of the sophisticated investigational device product. Education of ex-US trial sites will need to be enhanced, and cost of ensuring trial sites have adequate systems and equipment to effectively run and capture trial data will need to be considered as part of the strategic site selection process without creating bias.

European Union’s (EU) Medical Device Regulation (MDR)

The EU MDR is expected to come into effect in late 2019 or early 2020. This will give national regulators more control and oversight of the medical devices industry. The aim of the new regulation is to ensure that products are effective and safe as well as can be freely and fairly traded throughout the EU. The impact of this regulation can alter the operations of medical device manufacturers most notably on the supply chain and quality management systems of the organizations. It is critical that industry takes steps now to prepare their organizations and start implementing changes.

Data Integrity

Data integrity continues to be a priority and a hot topic. Regulators are focused to detect data integrity, data manipulation, and fraud. They must be able to rely upon the accuracy and completeness of the data and information generated, providing assurances to the products’ safety, identity, strength, purity, and quality which are all dependent on the validity of the data and information obtained.

Conclusion

Regulators are gaining more control and oversight of the medical devices industry. They are taking steps to prepare for the new innovations and enhanced capabilities of diagnosis and treatment with medical devices. It is important for medical device companies to proactively prepare for these changes as their impact could be significant. These include impacts on the cost of implementing changes to organizational prioritization and to internal processes around device accountability/supply, source, availability, and quality. If industry and regulators continue to maintain their role of ensuring compliance, new innovative devices can be made available, safely and effectively for patients, providing for better healthcare outcomes.


[1] US Food & Drug Admin., Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices, 83 Fed. Reg. 7366(Feb. 21, 2018) (hereinafter Medical Device Rule).

[2] See 21 C.F.R. §§ 50, 56, 812.

[3] 21 C.F.R. § 812.27(b)(4)(ii).

[4] Medical Device Rule at 7370.

Gustavo Gonzalez Presents First FSVP Webinar Targeted to Spanish Speaking Audiences

Gustavo Gonzalez, Ph.D., will present EAS’s first Spanish language webinar titled Foreign Supplier Verification Program – What Does it Mean for You? targeted towards foreign firms exporting foods into the U.S. This complimentary webinar will cover FDA requirements and documentation necessary to comply with the increased requirements of the Food Safety Modernization Act. Join us on June 6, 2018, at 1:00 pm Eastern. For more information on this free webinar and to register, click here.

EAS to Exhibit at Food Defense Conference

EAS will be exhibiting at the upcoming fourth annual Food Defense Conference to be held May 22-24, 2018 in Minneapolis. Senior Director for Food Consulting Services Allen Sayler will be in attendance along with experts from around the world to discuss and learn from each other about the current state of food defense.

CTP Updates Provisional Substantial Equivalence Review Process

EAS Consulting Group would like to bring to your attention an FDA Center for Tobacco Products announcement regarding updates to the Provisional Substantial Equivalence review process. Substantial equivalence (SE) is the most commonly used pathway by which tobacco products may obtain premarket authorization. Whether SE reports were submitted Provisionally, (products introduced into commercial distribution between February 15, 2007, and March 22, 2011) or are now submitted Regularly (SE Reports received after March 22, 2011), manufacturers must demonstrate that their new products have the same characteristics as a predicate product, or that any differences do not cause the new tobacco product to raise different questions of public health.

EAS Consulting Group offers a wide range of regulatory services. For assistance with dietary supplement and tobacco questions, including preparation of TPMPs, please contact our Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. at 571-447-5510 or tcouch@easconsultinggroup.com.

FDA Actively Working Tobacco Product Manufacturing Practices

Edward A. SteeleWelcome to EAS-e-News, the free newsletter for industries regulated by the FDA.

I would first like to congratulate our Independent Advisor for Food Law and Regulation, Steve Armstrong, who was presented with the Service to FDLI award at the FDLI Annual Conference. Steve, as many of you know, was the former chief law counsel at the Campbell Soup Company and after retirement joined EAS in a consulting capacity where he provides expert guidance on issues surrounding product development, labeling and claims and more. More information is included in the EAS in Action section of this issue.

The Center for Tobacco Products (CTP) director, Dr. Mitch Zeller, confirmed at TMAs 103rd Annual Meeting held on Tuesday, April 10, 2018, that FDA is actively working on a number of priorities that he called “Foundational Rules and Guidances”. This includes the issuing of the Tobacco Product Manufacturing Practice (TPMP) Rule, which is how CTP terms GMPs. This announcement has been long awaited by industry and firms should begin reviewing processes in preparation for TPMP guidance. You may wish to read more on this announcement in an overview prepared by President and COO, Dean Cirotta.

Additionally, FDA has issued an update to the substantial review process for provisional substantial equivalence for tobacco products in order to work through a huge backlog in applications. More information on both of these developments can be found in the What’s Happening at FDA section of this newsletter.

Fans of our handy EAS pocket guides will be glad to know that we have just released our fourth – this one covering the Foreign Supplier Verification Program and Voluntary Qualified Importer Program. These 4”x6” guides are intended to quite literally fit into your pocket and are a convenient way to have regulations at hand while on the factory floor, allowing you to earmark pages of particular importance, take notes, etc. The FSVP pocket guide is available for $10 on the EAS Products page of our website, along with our other pocket guides covering dietary supplement, and pharmaceutical GMPs and FSMA.

Our new partnership with FoodMinds announced in last month’s EAS-e-News has been gaining traction and media coverage with a recent article in Nutra Ingredients. We invite you to learn more about this innovative collaboration which aims to help food companies with their most challenging product marketing claims.

We welcome new consultants Dawn Wydner, Richard White, Andrea Yablunosky, Dee Duffy, and Bryan Armentrout to our network. I encourage you to read more about their expertise in Who’s Who.

Lastly, if you or your business is on LinkedIn, I encourage you to link with EAS. You’ll be able to learn the latest happenings with us, keep on top of the latest information affecting our industry and collaborate with like-minded folks whose primary interest is keeping our FDA regulated consumer products safe and compliant with applicable laws and regulations.

Thank you for your interest in EAS. As always, please reach out to me with any questions and feel free to share this newsletter with any friends and colleagues.

Sincerely,

Ed Steele
Chairman and CEO

Tara Lin Couch, Ph.D. to Discuss Preparing for Cannabis GMPs

Tara Lin Couch Ph.D., Senior Director for Dietary Supplements and Tobacco Services, will present a webinar on August 6, 2018, at 1:00 pm Eastern to help cannabis firms prepare for cannabis Good Manufacturing Practices (GMPs). As states begin to regulate legalized cannabis, the concern of how GMPs apply to this unique industry cannot be understated. While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for putting practices and procedures in place to meet compliance expectations, including those of testing and quality control of in-process materials, finished batches and packaged/labeled products. The time is right for the cannabis industry to begin assessing manufacturing processes and implementing sound and effective quality systems in order to begin preparing for GMP regulations. Stay ahead of the curve, standardize your product quality and be a leader in your industry. Join Tara on August 6, 2018, at 1:00 pm Eastern for this free webinar by clicking here.

Gabe Miller Discusses Necessity of Food Safety Programs for the Cannabis industry

Gabe Miller, an expert in Food Safety Programs has written an article for the Cannabis Industry Journal on how solid food safety programs can help make cannabis products safer and save businesses a lot of time and money.

Gabe spoke at the upcoming University of Madison Cleaning and Sanitation Short Course on sanitary equipment design on May 1. Gabe is a specialist in troubleshooting food safety and quality problems and has extensive experience in evaluating electrical, mechanical and equipment systems. He is a 3-A Sanitary Standards Inc. Certified Conformance Evaluator (CCE) who works with food processing equipment design and engineering companies to advance hygienic design.

Fairman Authors Articles on Workplace Safety and Golden Rules for Co-Packers

Independent Consultant, Heather Fairman has published two articles recently. One in Food Processing Magazine focuses on the positive impact of workplace safety programs on corporate culture. Next, she wrote about five “golden rules” for co-packers to stay competitive and profitable for Natural Products Insider. In addition to being a gifted writer and expert consultant on quality control and quality assurance issues, Heather serves as a Technical Advisor for the SIDS DOCK Island Women Open Network (IWON), an intergovernmental organization of Small Island Developing States (SIDS), which has all the rights and privileges of a United Nations organization comprised of 32 countries and who are embarking on developing a raw material market for the herbal supply-chain.

Veneziano, Cirotta Speak at FDLI Annual Meeting

Domenic VenezianoEAS is pleased to be invited speakers at two sessions as part of the FDLI Annual Conference. Independent Advisor for Import Operations, Domenic Veneziano, spoke Friday, May 4, 2018, at a session on International Harmonization Efforts. Mr. Veneziano is a former director of the FDA’s Division of Import Operations, where he spent ten years overseeing FDA’s import operations program and providing leadership, guidance, and direction to approximately 1,000 field investigators in more than 320 U.S. ports of entry.

Please join Domenic on June 26, 2018, EAS Webinar on VQIP which will delve more deeply into this option for expedited entry of products to the U.S. market.

Dean CirottaDean Cirotta, President, and COO moderated a May 3, 2018, panel session called FDA Center Directors: Center for Tobacco Products (CTP). The discussion included priorities and goals for the Center as well as feedback on issues facing the industry. As noted in the What’s Happening at FDA section of this EAS-e-News, FDA is actively working on Good Manufacturing Practice equivalents for the tobacco industry, which is called Tobacco Product Manufacturing Practices. EAS has been actively following this development and is able to provide guidance on expected compliance requirements.

Steve Murphy to Present on Raw Materials at ADSA in Knoxville

Steve Murphy will present a session called “Time for Change; Indicators of Public Health Concern for Raw Milk and Processed Dairy Products” at the upcoming American Dairy Science Association Annual Meeting taking place June 24-27, 2018 in Knoxville. Says Murphy, “Regulatory standards used as indicators of conditions considered public health risks for Grade “A” milk and milk products fall under FDA’s Grade “A” Pasteurized Milk Ordinance (PMO). These standards have not changed in decades. This overview will present a perspective based on current science on where changes are warranted.”

EAS Independent Experts Offer Summer Webinar Compliance Series

EAS Consulting Group is offering a full line-up of educational opportunities through our informative webinar series. These 45-minute webinars are an opportunity to get up to the minute regulatory information on the latest topics pertaining to FDA regulated industries, with time for questions after the presentation. Reserve your seat today!

Susan Crane to Host Webinar on the OTC Monograph System – Past, Present and Future

Independent Advisor for OTC Drugs and Labeling, Susan Crane, will host a webinar July 31, 2018, at 1:00 pm Eastern on OTC monographs. Join her for a better understanding of how to read and interpret the different sections of the monograph and translate the required elements into a Drug Facts panel. She’ll also discuss what the future might hold for OTC drugs as Congress considers changes to the monograph system. This webinar is complimentary and you may register by clicking here.

Couch to Speak at Council for Responsible Nutrition Conference on Compliance Controls for GMP Standards

Tara Lin Couch Ph.D.Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., will speak on Implementing Compliance Controls to Meet New Sophisticated cGMP Standards at the June 18-20, 2018 ACI-CRN’s Annual Legal, Regulatory and Compliance Forum on Dietary Supplementsconference which will be held in New York City. Tara will be covering various topics including:

  • Understanding the FDA’s more sophisticated approach to dietary supplement cGMPs
  • Comprehending how this potential enforcement ramp-up may lead to an uptick in 483 observations
  • Reassessing cGMPs in the context of cleanliness, safety, and testing for raw materials as based on this new approach
  • Identifying the right test for the right ingredient within the context of cGMP standards

FDA Confirms to Congressional Representatives that Safety is the Number One Priority for Dietary Supplements

FDA recently responded to a letter from congressional representatives regarding product safety in the dietary supplement industry. In the letter, dated April 12, 2018, the agency states that safety, product integrity, and informed decision-making are the prioritization factors used to determine enforcement and regulatory strategies for the dietary supplement industry which is now a $40 Billion market with up to 80,000 products through a supply chain that includes approximately 7,000 facilities.

The agency stressed that the review of Serious Adverse Events, New Dietary Ingredient notifications, and work with the FTC to remove product and companies from the market that contain undeclared pharmaceutical ingredients and other adulterants when found through inspection, label compliance reviews, and market surveillance is key.

This was sent in a letter to Congressional Representative Andy Harris from MD, Derek Kilmer from WA, and David Young from IA who had previously requested that FDA describe its role and current progress in dietary supplement enforcement and regulation. It is a great glimpse into the current thinking of the Office of Dietary Supplements.

April 2018 FDA Drug / Medical Device Activity

Reminder! 5 May 2018 is the date for DMF (Drug Master File) and IND (Investigational New Drug) applications to comply with eCTD format submission. There has been a delay for Type III DMF files to comply. The FDA announced in April via their Guidance Document Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications that Type III DMF files will have until 5 May 2019 in order to comply with the eCTD format requirements. With the exception of Type III DMFs, all files not submitted in eCTD beginning 5 May 2018 will be rejected. Please see the FDA Drug Master File Tip Sheet for further information. If you have any questions, please do not hesitate to contact EAS.

We would like to bring to your attention the FDA draft Guidance Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria. Please note, comments on this draft are due to the FDA no later than 90 days after publication in the Federal Register(which was 12 April 2018). This draft guidance proposes to provide an optional pathway for certain well-understood device types which the FDA would identify on a list maintained on the FDA website. Rather than a direct comparison to the predicate device for a 510(k) submission, the FDA proposes to provide alternate objective performance criteria that would satisfy demonstrating substantial equivalence for performance relevant to safety and effectiveness. This will comply with the new congressional amendment to the FD & C Act for the “least burdensome” provisions for medical devices.

Guidance Document updates on the FDA website: CDER:

CBER:

CDHR:

CVM:

CDER & CBER:

CDRH & CBER:

Domenic Veneziano to Discuss VQIP Regulations

Independent Advisor for Import Operations and former FDA Director of Import Operations, Domenic Veneziano, will host a webinar focusing on the specific requirements and applications of the Voluntary Qualified Importer Program (VQIP) on June 26, 2018, at 1:00 pm Eastern. VQIP is a fee-based, voluntary application whereby firms who meet certain food safety and import history requirements may receive expedited review and entry of their products into the US market. VQIP will take effect in October 2018 so it is now time to determine eligibility and apply to be included in the program. Join Domenic on June 26th by clicking here. There is a $99 registration fee associated with this webinar.

Clean Label, the Challenges

By Gustavo M. Gonzalez, Ph.D.

So, you decided to have clean labels for your products, now what do you do? You are not alone in your pursuits of this endeavor. A couple of years ago, I was approached by a marketing department when they wanted to make certain claims in their product lines and one of the phrases they used was “we want to say that our labels are clean because our clients want this”, so I asked them, ‘What do you mean by clean?” And of course, having several people in that meeting, I got several different answers! Answers like “no GMO’s”, “Natural”, “Gluten-free”, “No antibiotics”, “No pesticides”, “No Artificial ingredients”, etc. So, the first task at hand was to clarify what the term “clean label” means. At that time, we did not find a definition either from USDA-FSIS or FDA for the term “clean label”, what we found was that the term was probably developed by consumers as an “understandable” claim or answer to ingredients in their food. The Clean Label trend has taken center stage and found its way into many respected scientific meetings. The 2015 Institute of Food Technologist Annual Meeting and Food Expo is just one example of many where the topic of Clean Labels and what that means, was discussed.

When the US-based food retailer, Whole Foods Market, published a list called “Unacceptable Ingredients for Food1” around 2014, they began working with their suppliers on creating products only with natural ingredients as part of their Food Ingredient Quality Standards. Around the same time, Panera Bread published their “No No List2” of ingredients, such as preservatives, sweeteners, flavors, and colors, all from artificial sources, that were no longer allowed in their products. The trend was not just U.S.-focused as many International companies were also working on making their labels more transparent to help consumers make better decisions.

So, what does “clean label” mean? Many definitions exist, and all include the fact that terms such as “no artificial ingredients” and/or “natural” are included on labels as consumers expect transparency by using ingredient names that people can recognize. One of my favorite definitions of a “clean label” came from my wife (not biased!) who said that a clean label is one where she understands ingredients in her food without having to ask me and that the ingredients do not come from artificial sources.

This transparency is a great and noble cause to pursue but what are the challenges? In my opinion, the first challenge facing the technical and scientific community is that functionality in many cases drives the choice of almost all ingredients: things like water retention (phosphates), color additives (FD&C Red No. 3 and 40), color development/enhancement (sodium nitrate in processed meats) and flavor enhancement agents (MSG or Monosodium Glutamate not naturally occurring). Some ingredients already have a natural alternative, like the use of celery powder and sea salt as a source of naturally occurring nitrate-nitrite but we are still working on alternatives for others, creating challenges to R&D scientists and chefs all over the country.

This R&D also creates the second challenge in my opinion: cost. Many of these “clean” ingredients are expensive either because of the amount of these “clean” ingredients required or the increase in demand just in the last couple of years. Before a company decides to reformulate, understand your audience and your clients to ascertain whether they are demanding this change or not. I was surprised when the company asked their marketing group to investigate whether the demand for clean ingredients was universal, that only a small percentage of clients were demanding a change to clean labels. Based on that research they decided to invest time in creating a brand-new line of products to fulfill this need instead of reformulating all products.

In my opinion, some of the questions you need to ask before you start changing formulas are:

  • Are all my clients and/or target markets demanding a clean label?
  • Are they willing to pay for this change?
  • Can I afford the change?
  • Do we change our formula or do we create a new line of products?

Depending on your answers, you will be able to make an informed decision for the future of your company.

Note: This article presents the point of view of the author and does not represent any legal advice.

References

  1. Whole Foods “Unacceptable Ingredients for Food
  2. Panera Bread “No No List

Guidance for Industry on Dietary Supplement Products Containing Highly Concentrated Caffeine

FDA released Guidance for Industry on highly concentrated caffeine in dietary supplements. FDA considers products which only or primarily consist of pure or highly concentrated caffeine and are sold as dietary supplements to be adulterated under section 402(f)(1)(A) of the FD&C Act [21 U.S.C. § 342(f)(1)(A)] due to the significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling or, if no conditions for use are suggested or recommended, under ordinary conditions of use. These products which have been linked to at least two deaths in recent years are considered to present a significant public health threat.

EAS Welcomes New Independent Consultants

Dawn Wydner, Ph.D.

Dawn Wydner, Ph.D., consults in pharma and medical devices, providing proactive compliance and application of quality oversight in all aspects of operational strategy, coordination and conduct. Prior to consulting she was the Senior Director of BioResearch, Quality, and Compliance at Janssen Research & Development, LLC where she oversaw GxP regulatory requirements and compliance issues and provided guidance on GCP/GLP mock inspections and audits of clinical investigators, CROs, SMOs, sponsors/monitors, animal laboratories and IRBs. She is a sought-after speaker, sharing her expertise on topics such as Sponsor Monitor Inspection Management and Expectations, Inspection Readiness and FDA Trends, Analytical Risk Management.

Richard White

Richard White is a former Director of Codex and International Standards Policy at the Grocery Manufacturers Association. Prior to GMA, he had a career serving US public interests as the Senior Director, Sanitary and Phytosanitary Affairs at the Office of the US Trade Representative and as the Senior Advisor for International Activities in the Office of the Assistant Administrator for Prevention, Pesticides and Toxic Substances at the Environmental Protection Agency. As a consultant he provides expert advice and services regarding international standards, national policies and regulations on food safety and animal and plant health with a focus on the activities of the Codex Alimentarius Commission (CAC) and its subsidiary bodies.

 

Andrea Yablunosky

Andrea Yablunosky’s focus is product development, labeling compliance, and risk mitigation for issues pertaining to USDA/FSIS. With a background in food science and nutrition she is well-versed in policy development, product reformulations and promotions, recall preparedness and effective recall management. Prior to consulting Andrea was the Director of Government Affairs at ConAgra Foods where she advised the company business units on implications of FDA and USDA policy objectives.

Dee Duffy

Dee Duffy has over thirty years of experience in regulatory food labeling and a passion for saving companies money by helping them comply with public health information regulatory standards. She has worked with numerous food manufacturers like Johnsonville and Birchwood Foods on products available in grocery outlets like Kroger, Publix, and H-E-B, to help ensure new product packaging can go on shelves with minimal risk.

Bryan Armentrout

Bryan Armentrout is an expert in international CPG, and dairy, quality, system development, Safe Quality Foods, (SQF), Hazard Analysis and Critical Control Points (HACCP), design control, auditing, troubleshooting, recall, and crisis management, and process improvement. Prior to consulting he was the Vice President of Quality Assurance and Food Safety with Boulder Brands and the Vice President of Quality Assurance and Food Safety at CSC Sugar, LLC. He has a history of benchmarked and proven success leading companies to more efficient and compliant processes.

How can implementing a GMP system for regulatory compliance also streamline business at a cannabis facility?

By Kathy Knutson

This month’s Ask the Expert is answered by Independent Consultant, Kathy Knutson, Ph.D. Kathy is a lead instructor for Preventive Controls for Human Food (PCHF); Preventive Controls Qualified Individual (PCQI) and trained in the prevention of Intentional Adulteration (IA). Each month EAS experts tackle one question sent in by readers. To ask your question, click here.

Question: How can implementing a GMP system for regulatory compliance also streamline business at a cannabis facility?

Knutson: I am a food microbiologist with expertise in food safety. I work with the food industry in writing Hazard Analysis and Critical Control Point (HACCP) and food safety plans. I find myself using the same food safety knowledge from the food industry, in the cannabis-infused edibles industry. It makes sense because it is all just food that must be manufactured and be safe for human consumption. Unlike the food industry, currently, there is no federal legislation for the cannabis industry. At the federal level, cannabis is illegal.

Manufacturers of cannabis-infused edibles are legally found in states where legislation has been passed at the state level for either medical or recreational cannabis. It could be argued that edibles sold by way of prescription for medical use need to have a higher level of rigor in food safety than an edible for recreational use. In some states, the manufacturers are inspected like a restaurant. There is the talk of HACCP, but many states are just not there yet. The cannabis industry would do well to learn lessons from the food industry on HACCP from the late 1950s and preventive controls from 2011. Good Manufacturing Practices (GMPs) must be instituted, before making the leap to HACCP or preventive controls. GMPs are the foundation of HACCP and preventive controls. Without GMPs, there is no food safety.

Manufacturers of cannabis-infused edibles can find GMPs in 21 CFR 117 Part B. This is the Preventive Controls for Human Food rule where much of the food industry lives. A quick search for information on GMPs leaves one overwhelmed. There are university extension specialists, HACCP organizations and private businesses which offer GMP training. As a valued partner of EAS Consulting Group, the many experts are here to show you the path to food safety. Like a start-up company in the food industry, manufacturers of cannabis-infused edibles would be wise to start with GMPs. Once the foundation is solid, the manufacturer can build food safety.

Nutrition Facts and Supplement Facts Labels Compliance Dates Extended

The U.S. Food and Drug Administration has issued a final rule to extend the compliance dates for updating Nutrition Facts and Supplement Facts labels, from July 26, 2018, to January 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales will receive an extra year to comply – until January 1, 2021. The agency published a proposed rule to extend the compliance date in September 2017, and this rule finalizes that extension. This approximately 18-month extension will provide sufficient time to transition to the new version of the Nutrition Facts label.

Meet Issue of the Month Author Gustavo Gonzalez, Ph.D.

Gustavo Gonzalez, Ph.D. is a Food safety, regulatory compliance and quality leader with 24 years’ experience driving strategic planning and implementation the policies and procedures that govern food safety and quality programs that align with current and industry food safety, quality, and R&D trends and best practices. He is an expert in a range of food sectors, quality and safety systems and other programs such as allergen control/prevention, auditing functions, distribution systems, environmental monitoring, FSMA, GFSI, retail operations, sanitation, team building, and training. Prior to consulting, Dr. Gonzalez was the Corporate Director of Food Safety and Regulatory Compliance for Jack in the Box, Inc. He has a Ph.D. in Meat Science from Iowa State University.

We invite you to join Dr. Gonzalez on June 6, 2018, at 1:00 pm Eastern when he will present a webinar on the requirements of the Foreign Supplier Verification Program in Spanish. Click here to reserve your seat.

Inflation Adjusted Values for Six FSMA Regulations

The FDA released inflation-adjusted values for six FSMA regulations covering 2016-2017. These values are particularly noteworthy for smaller businesses that may not be covered, may receive an exemption, or have later compliance dates based on their sales being less than the indicated value. In addition, certain businesses subject to the Preventive Controls for Human Food, Preventive Controls for Animal Food, Produce Safety, Foreign Supplier Verification Programs, Sanitary Transportation and Intentional Adulteration Regulations should also refer to the updated values to determine whether they meet the cut-off value for the applicable regulation. Contact Allen Sayler, Senior Director for Food Consulting Services for assistance with FSMA questions at 571-447-5509 or asayler@easconsultinggroup.com

CTP Announces Actively Working Tobacco Product Manufacturing Practices

At TMAs 103rd Annual Meeting held on Tuesday, April 10, 2018, Dr. Zeller confirmed that FDA is actively working on a number of priorities that he called “Foundational Rules and Guidances”. This includes the issuing of the Tobacco Product Manufacturing Practice (TPMP) Rule which is required by Section 906(e) of the Tobacco Control Act addressing Good Manufacturing Practice (GMP) Requirements, which the FDA now calls TPMPs. Mr. Zeller made it clear that the FDA is “hard at work” on this rule.

When asked about when the industry can expect this Foundational Rule and Guidance for TPMPs to be issued by the FDA, Mr. Zeller declined to comment on a specific timeline, however, he did stress that the rule, along with the other foundational rules and guidance, is a priority for CTP. FDA is actively working on these and is committed to issuing the TPMP rule as soon as possible.

The tobacco industry should begin prioritizing manufacturing and quality processes assessments to begin preparing for and implementing quality systems, manufacturing controls, documentation, and SOPs. Based on Mr. Zeller’s presentation, the impending issuance of Tobacco TPMPs in conjunction with FDA’s new priorities indicates this preparation should begin sooner rather than later.

Dietary Supplements vs. Foods — A FSMA Regulatory Challenge

By Tara Lin Couch, Ph.D., EAS Senior Director of Dietary Supplement and Tobacco Services and Allen Sayler, EAS Senior Director for Food Consulting Services

In 1994 the Dietary Supplement Health and Education Act (DSHEA) created a new, legal class of food, called “dietary supplements,” which created a new subcategory of FDA-regulated foods. Many parts of the Food, Drug and Cosmetic Act (FD&C) still apply to dietary supplements; however, DSHEA carved out unique regulatory exemptions and requirements for dietary supplements. Achieving a correct and complete understanding of the FDA regulatory requirements applicable to dietary supplements versus other general foods can be challenging and confusing.

Foods are defined in the FD&C as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article. Dietary supplements are defined as a product taken by mouth that contain a dietary ingredient intended to supplement the diet. Dietary ingredients may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites; or extracts or concentrates of any of these. Dietary supplements can be in many dosage forms such as tablets, capsules, softgels, gelcaps, gummies, liquids, powders, and bars if they do not represent the product as a conventional food or sole item of a meal or diet.

The primary method for identifying a product as a dietary supplement versus a general food is to ensure it meets the definition above and for the product label to declare that the product is a “dietary supplement.” It is also required dietary supplement labels include a Supplement Facts panel, rather than a Nutrition Facts panel, which is required for almost all FDA-regulated foods. Both general foods and dietary supplements must comply with similar and also different labeling requirements, all found in 21 CFR 101, Food Labeling. Both general foods and dietary supplements could be identified by FDA as misbranded when they fail to meet applicable label claims or labeling requirements provided in the 21 CFR 101 regulation. If used, structure/function claims for dietary supplements and general foods must be truthful and not misleading. Specific to dietary supplements, the following disclosure statement is required to ensure that the dietary supplement product also does not represent itself as a pharmaceutical drug.

  • “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Although dietary supplement labels are not required to be pre-approved by FDA, the product owner of a dietary supplement must provide FDA, a notification with the text of the structure/function claim no later than 30 days after marketing the product. General foods have no such FDA notification requirement for product labeling.

DSHEA also requires FDA to promulgate GMPs (good manufacturing practices) for the dietary supplement industry. This resulted in the issuance of 21 CFR 111, “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements” in 2007. Note: FDA issued the “Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements” in December 2010, which also has important information on FDA’s regulatory and enforcement expectations.

The DSHEA regulation itself addresses aspects of the manufacturing, packaging and distribution of a dietary supplement product for distribution to the consumer. The comparable general food regulations are found in the relatively new FDA “Preventive Controls for Human Foods” regulation found in 21 CFR 117.

Comparison of Dietary supplement (21 CFR 111) and General Food Good Manufacturing (21 CFR 117) Requirements

21 CFR 111

Subpart

Description Summary 21 CFR 117 Subpart
B Personnel B – 117.10
C Physical Plant and Grounds B – 117.2, 117.20, 117.35, 117.37, 117.140 a‐d
D Equipment and Utensils B – 117.40, 117.35a, 117.37d,e, 117.40 a‐e
E Production and Process Controls – Specifications B – 117.80; C; G
F Quality Control B – 117.80
G Components, Packaging, and Label Controls B – 117.80
H Master Manufacturing Records B – 117.80 & F
I Batch Production Records B – 117.80 & F
J Laboratory Operations B – 117.40
K Manufacturing Operations B – 117.80
L Packaging and Labeling Operations B – throughout this Subsection
M Holding and Distribution Operations B – throughout this Subsection
N Returned Products NA
O Product Complaints Part of 117.155 but not specifically mentioned –
P Recordkeeping F

Shortly after the beginning of enforcement of 21 CFR 111 by the Center for Food Safety and Applied Nutrition (CSFAN), in 2010, the Food Safety Modernization Act (FSMA) was passed by the United States Congress in 2011. FSMA has been referred to as the most sweeping and significant legislation for the protection of public health regarding safety, efficiency and security of foods, drugs and cosmetics (the mandate of the FDA) since the first set of laws were passed with FD&C in 1938. It was in reaction to numerous cases of food-borne illness and product recalls, particularly for pathogens (undesirable microorganisms) and allergen cross-contact and contamination issues in general foods. Pathogenic microorganisms of most notable concern are Escherichia Coli, Salmonella, Staphylococcus aureusand Listeria monocytogenes. Allergens are foreign substances that, in some consumers, can cause an abnormal immune system response that, at its most dangerous extreme, can result in death. In the United States, by law, eight food allergens must be identified; these are known as the “big eight”, i.e., milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. Seven major regulations have been issued by FDA to support enforcement of FSMA. The most important of these being 21 CFR 117, “cGMP and Hazard Analysis and Risk-Based Preventative Controls for Human Food (PCHF).” Interestingly, dietary supplements are exempt from many of the requirements in these seven FSMA-based regulations, but not all.

The challenge: in late 2018, FDA is committed to full enforcement of all provisions of FSMA-based PCHF and by mid-2019, of the Foreign Supplier Verification Program (FSVP). Both have parts applicable and enforceable on the dietary supplement industry. Which new parts of the PCHF and FSVP regulations will impact the dietary supplement industry? Unfortunately, simply reading both regulations may not provide the insight and understanding necessary for dietary supplement manufacturers to adjust their regulatory programs for these new challenges.

The PCHF regulation, in accordance with 21 CFR 117.5(e), does not apply to any facility with regard to the manufacturing, processing, packaging or holding of a dietary supplement that is in compliance with the requirements in 21 CFR 111. For example, for general foods, Subpart C of 21 CFR 117 states that a hazard analysis must be conducted to identify and evaluate microbiological, chemical and physical hazards. Preventative controls must then be developed and implemented to ensure that these hazards will be significantly minimized or prevented, and the food will not be adulterated or misbranded. Subpart G of 117, also applicable to general foods, requires a written, risk-based supply chain program to ensure control of these same hazards in incoming raw material and other ingredients. Since these are already addressed in the dietary supplement regulations (21 CFR 111, particularly Subpart E), Subparts C and G of 117 are not applicable to dietary supplement manufacturers. Subpart B of 21 CFR 117 is the cGMP for general foods has its counterpart in 21 CFR 111 for dietary supplement manufacturers; however, the cGMPs are enforced by FDA for dietary supplement manufacturers as well as the dietary supplement GMPs found in 11. Allergen control is discussed at length in 21 CFR 117, but 21 CFR 111 never specifically dictates the need for allergen control or testing, however, all components must be demonstrated to meet established limits of potential contaminants, and the big eight food allergens certainly qualify as potential contaminants.

The other FSMA-based regulation, FSVP is also applicable to dietary supplement manufacturers, in some cases. The rule provides several exceptions to the standard FSVP requirements for certain types of importers. First, for dietary supplements and dietary supplement components/ingredients, importers that establish and verify compliance with certain specifications (concerning dietary supplement components and packaging) under the dietary supplement cGMP regulations will not be required to comply with most of the standard FSVP requirements, including hazard analysis and standard supplier verification activities. The same exception would apply to importers whose customer is required to establish such specifications and verify that they are met, except that the importer would have to obtain written assurance that its customer is complying with those requirements. In contrast, importers of other dietary supplements would be required to comply with most of the standard FSVP requirements, but would not have to conduct hazard analyses, and their supplier verification activities would focus on verifying that the supplier follows the dietary supplement cGMP regulation, rather than verifying that hazards requiring a control are significantly minimized or prevented, as required under the standard supplier verification activity provisions. For foreign suppliers exporting a food ingredient to the United States that could be used as a dietary supplement, all the FSVP requirements apply. If this same supplier exported the same component/ingredients for use only as a dietary component/ingredient, then few of the FSVP requirements apply. However, if FDA discovers that the component/ingredient imported as a dietary ingredient, is being used by general food manufacturers, then it is likely that FDA will take regulatory action against the FSVP Importer and could potentially declare the food that the dietary component/ingredient was used in “adulterated,” which could trigger recalls as well as other FDA regulatory actions.

In addition, the FSVP regulation has a requirement of using a “qualified individual” for general foods also applies to dietary supplement manufacturers conducting the following operations:

  • 506(a)—procedures to ensure the importation of food from approved suppliers
  • 509—identification of the importer at entry
  • 510—recordkeeping
  • 511(c)(2)—procedures to ensure the importation of dietary supplements from approved suppliers
  • 512(b)(5) —recordkeeping by very small importers

A few years into the future we will all have “muscle memory” related to which parts of the FSMA-based regulations apply to dietary supplement manufacturers and understand the regulatory requirement differences between dietary supplements and general foods. Until then, it is important to rely on knowledgeable, experienced people in the industry, FDA and the consulting world as the enforcement threshold is “now,” and any uncertainty could result in noncompliance and FDA actions against dietary supplement manufacturers.

Tara Lin Couch, Ph.D., is an analytical/organic chemist with more than 20 years of diverse laboratory and regulatory experience in academic, field, contract and manufacturing environments. She is a senior consultant with EAS Consulting Group.

Allen Sayler is the senior director for food consulting services at EAS. Sayler’s expertise in the areas of food processing, particularly in the area of dairy processing, infant formula, bakery products, food additives, botanical products and food packaging as well as GSFI Third-Party Certification programs such as Safe Quality Foods (SQF). Allen has spent more than 30 years as a food processing and regulatory expert, with half of the time serving the industry and the other have as a state and federal government employee.

This article was reprinted with permission from Natural Products Insider.

Independent Advisor for Food Law and Regulation, Steve Armstrong, Wins Service to FDLI Award

Steve Armstrong is the winner of the 2018 Service to FDLI award, presented at this year’s FDLI Annual Conference held in Washington, D.C. Steve is the former chief law counsel at Campbell Soup Company and has been consulting with EAS, providing expert opinion and strategy in the areas of product development and labeling since 2016. Steve is a sought-after speaker and writer, particularly on the subject of GMOs and other claims. His contributions to FDLI and the industry through his own efforts and as a representative of EAS facilitate greater industry understanding and promotion of ethical and sound practices.

You may read Steve’s most recent article on due diligence, mergers and acquisitions, and considerations when purchasing a 21st Century Food Company in a recent Natural Products Insider.

Sayler Presents on 21 CFR 117 at the AHPA Dietary Supplement Regulatory Summit

Senior Director for Food Consulting Services, Allen Sayler, will speak on how FSMA impacts the dietary supplement industry during the Dietary Supplement Regulatory Summit, taking place May 16, 2018, in Washington, DC. The Dietary Supplements Regulatory Summit is the collaboration between AHPA, CHPA, CRN, NPA, and UNPA — the trade associations representing the dietary supplements industry and will feature updates and insights from FDA and industry regulatory experts, and will focus on the key regulatory compliance issues facing the dietary supplements industry.

Insights into FDA’s Interpretation and Enforcement of Medical Foods

Independent Advisor for Labeling and Claims, Betty Campbell and Senior Director for Food Consulting Services, Allen Sayer have co-written an article on how FDA interprets and enforces regulations of Medical Foods in Food Safety Magazine. This narrow product category sees a lot of confusion within the industry as to what constitutes a medical food, how it can be labeled and its ingredient requirements.

EAS Offers Final Webinar as Part of CHPA OTC Academy Series

The final webinar as part of the EAS presented series for CHPA’s OTC Academy will take place on April 17, 2018, at 2 pm when Independent Advisor for Quality and Compliance Robert Fish, will discuss Responding to 483s and Warning Letters. Fish says that it is extremely important to promptly respond to any correspondence from FDA, particularly the FDA-483 or a Warning Letter. If a foreign firm receives a Warning Letter from FDA the company will most likely be placed on an Automatic Detention list which means that none of their products will be permitted entry into the U.S. until the issues are corrected and FDA has verified the corrections. This webinar will explain the FDA processes and provide guidance on how to manage these issues.

Armstrong Discusses FSMA One Year Later in FDLI Update

Independent Advisor for Food Law and Regulation, Steve Armstrong discussed how FSMA implementation has impacted food safety systems during its first year of enforcement in the prestigious FDLI Update. Mr. Armstrong is the former Chief Law Counsel for Campbell Soup Company and works with EAS client on product development issues.

EAS Announces Expansion of Collaboration with FoodMinds

Edward A. SteeleWelcome to the EAS-e-News, the free newsletter dedicated to FDA regulated industries.

As international agencies work to find commonalities that would align food safety data where able, FDA and the European Commission are each proposing actions that would open each other’s markets to limited shellfish exports. U.S. shellfish imports have not been allowed by the EC since 2010 and FDA has not permitted the import of live, fresh, or fresh-frozen molluscan shellfish from the EU since the 1980s. FDA is seeking public comment on a proposed determination that the EU food safety control system for raw bivalve molluscan shellfish is equivalent in sanitary protection to that of the U.S. If finalized, shellfish harvested from the Netherlands and Spain and processed by establishments that have been listed on FDA’s Interstate Certified Shellfish Shippers List (ICSSL) may be imported. The European Commission (EC) is also in the process of finalizing proposed equivalence that would permit the importation of shellfish harvested from approved growing areas in the states of Massachusetts and Washington, with additional states possibly being added over time. These announcements come on the heels of our March EAS-e-News issue of the month article written by Tim Hansen, a former director of the seafood division in FDA’s CFSAN and a former director of the seafood inspection program for NOAA Fisheries on the 20th Anniversary of Seafood HACCP and the role it has played in improving the safety of seafood in the U.S..

FDA also released the 2017 edition of the Voluntary National Retail Food Regulatory Program Standards which defines key elements of an effective program for state, local, tribal, and territorial food regulatory agencies. The FDA encourages enrollment in this voluntary standards program for all government agencies with oversight of retail food establishments that sell, serve or vend food directly to the public. Enrollment conveys intent to actively use the Retail Program Standards as a tool to assess and improve regulatory programs.

There is much effort at international collaboration between FDA and like-agencies, including standards developed by the UN food body, Codex Alimentarius Commission, commonly known as Codex. Bruce Silverglade, an attorney with the firm Olsson Frank Weeda Terman Matz, PC and independent consultant to EAS by special arrangement, has written an articleon the US Codex office’s recent relocation within the USDA to the Office of the Undersecretary for Trade and Agricultural Affairs. This move provides new opportunities for the food industry, particularly in the area of food labeling and food additives.

These continued efforts at enhancing food safety are a prime focus area for EAS and our clients in the food industry. Our Independent Advisor for FSMA and author of FSMA Perspective, Charles Breen, discusses EAS services in the area of FSMA in a newly produced video which can be found on the EAS YouTube channel. We invite you to view this along with our other regulatory topics, including free on-demand webinars at your convenience.

Continuing with the theme of harmonization between agencies, FDA is also hard at work developing a set of standards with Health Canada on International Harmonization of technical requirements for pharmaceuticals for human use. FDA is holding a public meeting April 6, 2018, at 10:00 am to provide information and solicit public input on current activities. The meeting will address topics such as Nonclinical Safety Testing in Support of Development of Pediatric Medicines as well as Bioanalytical Method Validation. More information on the public meeting can be found here.

Our Issue of the Monthis written by Independent Advisor for OTC Drugs and Labeling, Susan Crane. She discusses the future of homeopathics after a recent FDA draft guidance document indicating a future where any product labeled as homeopathic could potentially be subject to enforcement action.

Thanks to numerous requests, EAS is bringing back a one-day seminar Food Labeling Regulatory Update covering the new FDA food labeling requirements, which will take place May 31, 2018, in Alexandria, VA, immediately following our two-day Food Labeling Compliance Seminar. This new seminar is a great opportunity to dig deeper into how your company’s products will be affected by the new regulations and can be an independent learning opportunity or in combination with our two-day Food Labeling Compliance Seminar. We have also added two new fall compliance seminars which will take place in Kansas City, MO. Food Labeling Compliance is scheduled for September 24-25 and Dietary Supplement Labeling Compliance is scheduled for September 26-27. We invite you to join us!

Lastly, I am very pleased to announce an expansion of collaboration and services offered by our long-standing partner FoodMinds. This strategic partnership is aimed at helping the food industry navigate complicated issues surrounding the science of food and nutrition, the development of products to meet consumer demand and the many regulatory hurdles of ensuring safe and compliant product-lines. Together EAS and FoodMinds can help identify and mitigate of risks to branding and regulatory compliance as well as the development of forward-thinking strategic plans and operating procedures, engaging the most up-to-date industry guidance, practices, and technology to meet government and customer expectations. More information on this partnership can be found in our Press Release. I am fully confident that this partnership will be of great value particularly to those firms who manufacture high-risk foods as regulatory challenges become more complicated.

Thanks as always for your interest in EAS. We invite your comments and feedback and feel free to share this newsletter with your colleagues.

Sincerely,

Ed Steele
Chairman and CEO

Quality Assurance and Net Profits Discussed in EAS-Authored Article in Dairy Foods Magazine

EAS Independent Consultant, Rudy Westervelt, discussed fulfilling quality assurance potential and generating a net profit in a recent article published in Dairy Foods Magazine. Quality assurance could — and should — drive revenue by providing information that allows plant leadership to control costs, improve operational efficiencies and maximize finished product output, he says. Westervelt specializes in problem-solving related to dairy food quality, loss reduction, employee safety results, throughput and cost control.

EAS Releases Videos on FSMA and Product Development Services

EAS Independent Advisor for FSMA, Charles Breen, hosts a new informational video on EAS services in the complex area of the Food Safety Modernization Act, including FSVP, VQIP and more. FSMA is the largest overhaul to FDA’s food regulations in the last 70+ years and EAS is proud that our assembled team of independent regulatory consultants has such vast expertise in the many areas under the FSMA umbrella.

EAS Independent Advisor for Food Law and Regulation, Steve Armstrong produced a similar video recently on our services in the area of product development and labeling, a challenging area as companies work to build strategic development and marketing strategies in a very competitive international marketplace.

A great number of EAS webinars are available on YouTube channel. Please join us for any of our on-demand webinars on a variety of topics, from SQF to dietary supplement laboratory compliance to drug establishment and registration listing information. As always EAS and our team of over 150 regulatory consultants are here to assist.

Armstrong to Present at Food Law Innovative Conference

Independent Advisor for Food Law and Regulation, Steve Armstrong, will discuss Innovative Claims, as part of a USDA Review at the April 19-20, 2018 third annual CLE Food Law Conference in Denver. His co-presenter is Jeffrey Canavan, Deputy Director, Labeling & Program Delivery with the Food Safety Inspection Services, USDA. Up to 12 Hours of MCLE Credit are available for attending this conference, including one hour of Ethics.

EAS to Exhibit at Upcoming SupplySide EAST in Secaucus, NJ

EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. and Independent Advisor for Dietary Supplements, Timothy Stewart, Ph.D. will attend SupplySide East in Secaucus, NJ April 10-11, 2018. Please come by the EAS exhibit booth, F152, to discuss regulatory challenges impacting your business and opportunities for solutions provided by EAS’ extensive network of over 150 independent consultants.

EAS is Marquee Sponsor of TMA’s 103rd Annual Meeting and Conference

TMAEAS President and COO, Dean Cirotta and Independent Consultant Karen Dixon will attend the Tobacco Manufacturers Association’s Annual Meeting and Conference taking place April 9-11, 2018 in Leesburg, VA. EAS is also a Marquee Sponsor of the event. The meeting will discuss FDA’s new policy direction for the tobacco industry, including a Nicotine Product Standard, the Cigar Exemption, FDA Premarket Submissions, and Harm Reduction.

Adverse Events, Serious or Not?

By Norma Skolnik

This month’s Ask the Expert question on Serious Adverse Events Reporting is answered by Independent Consultant, Norma Skolnik. Norma has over 35 years of regulatory experience working with the pharmaceutical, OTC drug, and dietary supplement industries. Prior to consulting, she served as Director of Regulatory Affairs for the Americas for Cadbury Adams until her retirement. She also held the positions of Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company.

Question: Should you report an Adverse Event if you’re not sure whether or not it’s really “serious”?

Answer: If in doubt, you should always report an adverse event for any prescription drug, OTC drug or dietary supplement. FDA’s definition of “Serious Adverse Event” per 21 CFR 310.305(b) covers “any adverse experience that results in any of the following outcomes: Death, a life-threatening adverse experience, hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.”However, Emergency Room treatment is also often considered to be a serious event and usually reported to the FDA. Furthermore, if a consumer believes an event to be serious, it must be investigated and most likely reported. Many companies are reluctant to report because they’re afraid that submission of a Serious Adverse Event report via the required MedWatch (3500A) form is an admission that your product caused the adverse event but this is not the case.

Meet Issue of the Month Author, Susan Crane

Susan CraneSusan Crane is EAS’ Independent Advisor for OTC Drugs and Labeling. She is an experienced professional in the pharmaceutical industry specializing in quality and regulatory compliance for over-the-counter (OTC) and dietary supplement products and has a thorough knowledge of federal regulations pertaining to the marketing, labeling, and distribution. Susan’s guidance for clients ranges from Good Manufacturing Practices, Labeling, Enforcement Policy (Recalls), Dietary Supplement and Nonprescription Drug Consumer Protection Act, Consumer Product Safety Commission (CPSC) – Poison Prevention Packaging Act, Consumer Product Safety Improvement Act, and OSHA Hazard Communication Standards. She is a frequent instructor for CHPA’s OTC Academy, presents webinars and publishes articles in industry publications on a variety of OTC related issues.

Dietary Supplement Labeling Compliance Seminar to Take Place in Kansas City, MO

Those with oversight of labeling compliance of dietary supplements may wish to register for our next Dietary Supplement Labeling Compliance Seminar which will take place September 26-27, 2018 in Kansas City, MO. Immediately following the food labeling compliance seminar, this intensive two-day session will cover the latest FDA requirements and be taught by our expert trainers James Hoadley, Ph.D. a former FDA Senior Regulatory Scientist in the Office of Nutritional Products, Labeling and Dietary Supplements who participated in the development of NLEA-implementing nutrition labeling and health claim regulations, and Gisela Leon, an internationally recognized expert who has reviewed hundreds of labels for US compliance and helps international products to come into compliance with US regulations.

Food NFP and New Labeling Requirements Regulatory Update Seminar

Due to much industry confusion regarding FDA’s changes to Nutrition Facts Panel, EAS will conduct one-day regulatory update seminar, FDA’s NEW Food Labeling Requirements, on May 31, 2018, in Alexandria, VA. This one day update will immediately follow our two-day Food Labeling Compliance Seminar and can be taken as a stand-alone course or a follow-on after attending the two-day seminar. Instructed by EAS Independent Advisor for Labeling and Claims, Elizabeth Campbell and EAS Independent Consultants, April Kates and Gisela Leon, with invited participation by FDA/CFSAN, this course will offer an interactive forum for a deeper dive into some requirements that have presented particular challenges related to applying the new Nutrition Facts Panel requirements. Early-bird pricing is in effect for both courses through April 15, 2018, and the two-day seminar provides 16 CEU credits through the Commission on Dietetics Registration. We have also recently added a second Food Labeling Compliance Seminar in Kansas City, MO on September 24-25, 2018.

March 2018 FDA Drug / Medical Device Activity

EAS would like to bring to your attention, the Statement from FDA Commissioner Scott Gottlieb, MD regarding drug compounding outsourcing facilities. The Drug Quality and Security Act (DQSA) was enacted by Congress in 2013 in response to a significant safety issue experienced by the public as the result of poor drug compounding practices. As seen with recently issued warning letters, the FDA is also prioritizing enforcement of section 503B of the Federal Food, Drug and Cosmetic Act which allows for compounded drugs which are not FDA-approved and do not undergo premarket review by the FDA for safety, effectiveness, and quality. In the FDA’s ongoing efforts to enact measures to ensure this allowance is exercised only when necessary and appropriate, and in a safe manner with assured product quality, they have released the Draft Guidance Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug and Cosmetic Act. In this guidance, the FDA addresses their plan to formulate the “503B bulks list”, a list of bulk drug substances determined by the FDA as clinically necessary for outsourcing facilities to use for compounding drugs. Follow the links for further information.

Now that the dust has settled with the 2017 FDA requirement to certify all drug listings annually, we would like to bring to your attention the necessity to complete expired listings. Under 21 CFR 207.57(b), registrants must submit updated listing information at each June and December if there is change since the previous listing and they must submit this information to the FDA via electronic format. These changes include any drug recently introduced into U.S. commercial distribution which was not previously listed, any drug which commercial distribution has been ceased, any drug reintroduced in commercial distribution and any material changes in any drug listing information previously submitted. The FDA has communicated that although listings that were not certified by 31 December 2017 have been changed to an expired status, it is still required to ‘complete’ the marketing status and input an ‘end marketing date’ in order to delist the product. EAS is here to assist with any listing issues you may need to be resolved. Please let us know if we can help.

Guidance Document updates on the FDA website:

OC: Immediately in Effect Guidance for Industry and Food & Drug Administration Staff

CDER:

CDHR:

CVM:

OC: Distributed for Comment Purposes Only

 

GMPs and Preventive Controls in Animal Foods – New Rules, New Animal Foods, New Problems in Compliance

By Charles Breen, Independent Advisor for FSMA

Although six months have passed since the compliance date for large animal food facilities to meet Good Manufacturing Practices (GMPs) and Preventive Controls requirements, and for small animal food facilities with fewer than 500 full-time equivalent employees, to meet the GMPs, the pet food industry in particular continues to struggle with the FSMA Final Rule for Preventive Controls for Animal Foods. Despite FDA having indicated that the industry should expect greater inspection activity for GMP compliance after September 18, 2017, numerous recent recalls suggest an excess of complacency on the parts of some, and a challenge in understanding and meeting the requirements of others.

Recent popular trends for raw meat diets in pet food have led to a spike in the frequency of recalls for pathogen contamination. Contamination in pet food and animal food, much like human food, can cause ill effects and even death. In the case of pet food, cross-contamination also has the potential to cause harm to humans.

The final rule requires animal food facilities to have a written food safety plan, including GMPs, and controls in place for any hazards identified as part of a required hazard analysis. In addition, risk-based preventive controls must be in place for processes, as required, to reduce or eliminate the risk of additional contaminations. FDA’s staggered compliance dates are based on the size of a business, with the next compliance date for small businesses to meet preventive controls requirements in September 2018, at which time very small businesses will need to meet CGMPs. Large firms were expected to have preventive controls in place effective September 2017. However, FDA will not begin conducting routine inspections of preventive controls until the fall of 2018, allowing time to ensure companies understand and are able to meet those expectations. FDA also just released draft guidance to help firms determine whether they meet the definition of a small business, which of course directly impacts whether the company is exempt from the human food preventive controls requirements and the animal food preventive controls requirements if they are engaged only in specified low-risk activity/food combinations. Also, small businesses have later compliance dates for parts 117 and 507 than larger businesses.

What is the difference between GMPs and Preventive Controls? Jenny Murphy, a consumer safety officer with FDA’s Center for Veterinary Medicine says in a Q&A that GMPs are more basic, including items one would do in the normal course of business to establish a base to prevent contamination. Preventive controls focus prevention of harm by controlling risks to public health. “Once you have CGMPs in place,” she says, “you can see where you need extra layers of protection. Preventive controls require a food safety plan that includes an analysis of potential biological, chemical or physical hazards and the steps needed to reduce or minimize that risk.”

The written food safety plan is required to have a hazard analysis. Hazards identified as needing preventive controls, such as process controls, sanitation controls, and others, require firms to implement controls to ensure those hazards are reduced or eliminated in all foods the facility manufactures, processes, packs, or holds, and when applicable, supply-chain programs. A recall plan is also required. Preventive Control plans must be prepared by or the preparation overseen by a “preventive controls qualified individual” for animal food.

I’ll bring to your attention a recent webinar hosted by EAS independent consultant, Dr. Omar Oyarzabal, an expert of acidified foods, who recently hosted a webinar on FSMA impacts on Acidified Foods along with Priya Rantham, an FDA Consumer Safety Officer. The process controls of acidifying foods are complex. Dr. Oyarzabal does an excellent job of simplifying the understanding both in this free on-demand webinar and in a Q&A based on the webinar recently published in Food Safety Tech.

In addition, regarding sanitary controls, EAS Independent Consultant Dr. Kathy Glass and Senior Director for Food Consulting Services, Allen Sayler, answered many questions on contamination and control of Listeria monocytogenes. While this information was directed at RTE human foods, much of the information is also applicable to animal foods.

On the subject of EAS resources, you may also be interested in an EAS produced FSMA pocket guide, which contains the 21 CFR Part 117 regulation. This pocket guide is also available digitally as a free download from our website.

The FSMA Final Rule for Preventive Controls for Animal Foods is just one of FDA’s many efforts at requiring and enabling greater control and oversight of safety for all manufacturing, processing and holding facilities of human and animal foods and animal feed. Through a combination of GMPs, hazard analysis and risk-based preventive controls, we can expect greater food safety for all.

Please reach out to EAS if you have any questions on this or other FSMA rules. We offer comprehensive services in this area and would be glad to discuss your firm’s readiness and compliance with FSMA requirements.

Homeopathy – What Does the Future Hold?

By Susan Crane, Independent Advisor for OTC Labeling

It’s been clear for several years that the FDA, as well as the Federal Trade Commission (FTC), are turning up the heat on homeopathic drug products. It culminated in December 2017 when the FDA published a draft guidance document for both FDA staff and industry regarding their new approach to regulating “Drug Products Labeled as Homeopathic”. This followed on the heels of FTC’s “Enforcement Policy Statement Regarding Marketing Claims for Over-the-Counter Homeopathic Drugs” published in 2016.

The practice of homeopathy has been around for more than 200 years and has its share of both critics and adherents. Homeopathy is a form of alternative medicine based on the concept that a disease can be treated with minute quantities of natural substances that would, if given in larger amounts to a healthy person, produce symptoms of the same disease.

Prior to this most recent regulatory action, the FDA regulated homeopathic medicines as drugs under the Federal Food Drug and Cosmetic Act but did not otherwise evaluate their safety and efficacy as long as they were marketed for self-limiting conditions and contained active ingredients listed in the Homeopathic Pharmacopeia of the United States. The enforcement policy was described in a Compliance Policy Guide (“Conditions Under Which Homeopathic Drugs May be Marketed”) that was issued in 1988.

As the homeopathic industry grew, the Agency re-evaluated its position and announced in 2015 that it was going to evaluate the regulatory structure for these products. It hosted a public meeting that spring during which interested parties (manufacturers, health care professionals, industry associations, etc.) could provide input and make suggestions as to whether the current framework was appropriate for ensuring the safe use of these products. As a result of the meeting and FDA’s own evaluation, it determined that a new guidance document, applying a “risk-based” approach to enforcement, would better serve public health and be consistent with the Agency’s general approach to products marketed without FDA approval.

Because there are currently no homeopathic products approved by the FDA, the guidance document, when finalized, would serve notice that any product labeled as homeopathic could potentially be subject to enforcement action. However, the FDA recognizes that some categories of products pose a greater risk to public health and so provided a list that would receive prioritized enforcement. These include:

  • Products with reported safety concerns
  • Products that contain or purport to contain ingredients associated with potentially significant safety concerns
  • Products for routes of administration other than oral or topical
  • Products intended to be used for the treatment of serious and/or life-threatening diseases and conditions
  • Products for vulnerable populations
  • Products deemed to be adulterated under the Food, Drug and Cosmetic Act

As noted earlier, in addition to this increased FDA oversight, the FTC (which monitors marketing and promotional claims) is taking a more proactive approach to homeopathic drugs. In the aforementioned policy statement, it indicated that OTC homeopathic drugs would be held to the same standard as other products with regard to claims. In other words, companies either needed to have competent and reliable scientific evidence to back up the claims OR, alternatively, they could revise their labeling to include disclaimers communicating that “there is no scientific evidence that this product works and that its uses are based on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.” No longer would it be acceptable to rely on statements that the “FDA has not evaluated the product” or that the treatment relied on “homeopathic principles”.

These actions by the FDA and FTC are not encouraging to the homeopathic industry. How strictly this new approach will be enforced is unknown, especially in the current political climate of decreased regulation. However, it’s a safe assumption that any homeopathic product that presents a safety risk or makes egregiously deceptive claims, will likely come under scrutiny and could land the offending company in proverbial “hot water.”

U.S. CODEX Office Relocated Within USDA, New Opportunities for the Food Industry

The Codex Alimentarius Commission (Codex) is a United Nations food standards setting body working under the auspices of the Food and Agriculture Organization and the World Health Organization (WHO). The official mission of Codex is to protect consumers’ health and ensure fair practices in the food trade. Codex standards are relied upon by exporters to set a level competitive playing field. Many countries incorporate Codex standards into their national laws and Codex standards often serve as specifications within the international food trade. Codex standards, ranging from labeling requirements to lists of approved food additives, significantly affect the ability of food manufacturers to export their products around the world.

Since 1994, Codex food safety standards have also played an express role in settling trade disputes over unjustified trade barriers disguised as national food regulatory requirements. Under the World Trade Organization’s (WTO) Agreement on Sanitary and Phytosanitary Measures, nations that wish to apply stricter requirements than those set by Codex must justify those measures scientifically. Not surprisingly, trade disputes have long been intertwined with the Codex standard-setting process.

In response to such controversies, U.S. Secretary of Agriculture Sonny Perdue late last year moved the U.S. Codex Office from USDA’s Food Safety and Inspection Service (FSIS) to the Office of the Undersecretary for Trade and Agricultural Affairs led by Ted McKinney. Food companies and industry trade associations have overwhelmingly supported the decision.

Secretary Perdue announced the creation of the Undersecretary for Trade and Foreign Agricultural Affairs position while reviewing options for improving coordination on trade and international activities. As part of that process, Secretary Perdue determined that the U.S. Codex Office should be moved from FSIS to the new trade mission area. While the U.S. Codex Office mission remains the same, the move is significant.

Food companies and trade associations should take a new look at the agendas of key Codex Committees, http://www.fao.org/fao-who-codexalimentarius/committees/en/ to examine whether the U.S. government positions on specific points can be strengthened. A full list of all active Codex Committees can be found here, http://www.fao.org/fao-who-codexalimentarius/committees/en/. Each Codex committee is considering agenda items that will have an impact on U.S. exports.

Some draft Codex standards now under development are inconsistent with U.S. laws and regulations. For example, the agenda of the Codex Committee on Nutrition and Foods for Special Dietary Uses (which includes dietary supplements), http://www.fao.org/fao-who-codexalimentarius/committees/committee/en/?committee=CCNFSDU, has been particularly controversial in recent years, with the nitrogen to protein conversion factor issue pitting dairy interests against vegetable protein interests and the US against the EU in the areas of infant formula and other special dietary food standards. The agenda for the November 2017 meeting can be found at http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-720-39%252Fnf39_01_rev1e.pdf.

Food manufacturers may also wish to keep a special eye on the Codex Committee on Food Labeling, http://www.fao.org/fao-who-codexalimentarius/committees/committee/en/?committee=CCFL. Canada, which hosts and chairs the Committee on Food Labeling, http://www.fao.org/fao-who-codexalimentarius/committees/committee/en/?committee=CCFL, is formally proposing its own national regulations for front-of-pack nutrition rating symbols, https://www.canada.ca/en/health-canada/programs/consultation-front-of-package-nutrition-labelling-cgi/summary-of-proposed-amendments.html. The issue has already been placed on the agenda for the Codex Committee on Food Labeling, http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-714-44%252FWD%252Ffl44_01e.pdf. In contrast to Canada, the U.S. Food and Drug Administration (FDA) supports a voluntary front-of-pack nutrition-labeling program developed by the Grocery Manufacturers Association and the Food Marketing Institute.

The U.S. Codex Office regularly announces public meetings, held in the Washington, D.C. area, to formulate the position that the U.S. government will take at Codex meetings held in the U.S. and overseas. Companies and trade associations have an opportunity to express their views to USDA, FDA, Office of the U.S. Trade Representative, and other relevant U.S. government agencies. https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/us-codex-alimentarius/public-meetings. Participants can offer comments in written or oral form and speak directly with leading U.S. government officials that will attend official Codex meetings.

For example, on March 15, 2018, a U.S. government preparation session for the forthcoming meeting of the Codex Committee on Pesticide Residues was held in the Washington metro area, https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/us-codex-alimentarius/committees-and-task-forces/general-subject-committees/codex-committee-on-pesticide-residues/ct_index.

Other open meetings of the U.S. government delegation to Codex committee meetings will follow later this year. In addition to the Codex Committee on Nutrition and Foods for Special Dietary Use, and the Codex Committee on Food Labeling, key Codex committees include the Codex Committee on Food Additives http://www.fao.org/fao-who-codexalimentarius/committees/committee/en/?committee=CCFA, with over 400 food additives being considered for inclusion or deletion including those for fish, chocolate, wine, a number of dairy products. Also anticipated is an initial resolution of a stalemate between the EU block and the US and its allies on a significant number of colors and sweeteners, stalled from adoption for almost 6 years. The November 2017 report of the Codex Committee on Food Hygiene can be found at http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-712-49%252FReport%252FREP18_FHe.pdf, with significant rewrites of a number of Codex Hygiene documents including the HACCP Appendix for the Codex General Principles for Food Hygiene. The upcoming agenda for the Codex Committee on Contaminants in Foods and be found at http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-735-12%252FINV-PA%252Fcf12_01e.pdf, with lead levels and dioxins in foods, among a number of important topics to be discussed.

The relocation of the U.S. Codex Office within USDA to the new office for the Undersecretary for Trade and Agricultural Affairs should strengthen the new Administration’s commitment to international trade by providing a broader platform and US presence within the Codex “world” in order that global food standards are supportive and do not hinder US food exports, as they have sometimes done in the past. It’s housing within Trade and Agricultural Affairs should enhance ongoing dialogue and understanding about food regulatory matters domestically and worldwide. US-based food companies and their supporting trade associations should take advantage of this new opportunity and become more active in those Codex issues impacting their food sector by becoming strong Codex advocates and make their views known.

For more information, contact Allen Sayler, Senior Director of Food Consulting Services at asayler@easconsultinggroup.comor 571-447-5509.

EAS and FoodMinds Offer Strategic Solutions to Food Industry Nutrition Marketing Challenges

EAS has teamed up with FoodMinds to offer food firms a new solution to the many product and marketing challenges of this highly regulated and litigious climate. From acceptable claims to new requirements for compliant labels, to how products are marketed, the industry is faced with new challenges daily. EAS and FoodMinds combine the best in regulatory and marketing talent to develop a targeted approach for promoting brand awareness and integrity while meeting the many federal requirements of FDA and/or USDA and FTC. Learn more about this collaboration by reading our Press Release and learn more about how this collaborative effort can benefit your organization.

Sayler to Speak at Oregon Dairy Industry Association’s Annual Meeting

Senior Director for Food Consulting Services, Allen Sayler will present two sessions at the upcoming Oregon Dairy Industry Association’s 107th Industry Conference taking place in Salem, OR April 10, 2018. Allen’s first discussion will be on FDA’s Enforcement of the FSMA Preventive Control, Sanitary Transport and Food Defense Programs in Dairy Plants. Later in the day, he will moderate a breakout session on the Biggest Changes to Grade “A” Dairy Plant Requirements in the last 50 Years.

Dietary Supplements vs. Foods — A FSMA Regulatory Challenge

In 1994 the Dietary Supplement Health and Education Act (DSHEA) created a new, legal class of food, called “dietary supplements,” which created a new subcategory of FDA-regulated foods. Many parts of the Food, Drug and Cosmetic Act (FD&C) still apply to dietary supplements; however, DSHEA carved out unique regulatory exemptions and requirements for dietary supplements. Achieving a correct and complete understanding of the FDA regulatory requirements applicable to dietary supplements versus other general foods can be challenging and confusing.

Foods are defined in the FD&C as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article. Dietary supplements are defined as a product taken by mouth that contains a dietary ingredient intended to supplement the diet. Dietary ingredients may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites; or extracts or concentrates of any of these. Dietary supplements can be in many dosage forms such as tablets, capsules, soft gels, gel caps, gummies, liquids, powders, and bars if they do not represent the product as a conventional food or sole item of a meal or diet.

The primary method for identifying a product as a dietary supplement versus a general food is to ensure it meets the definition above and for the product label to declare that the product is a “dietary supplement.” It is also required dietary supplement labels include a Supplement Facts panel, rather than a Nutrition Facts panel, which is required for almost all FDA-regulated foods. Both general foods and dietary supplements must comply with similar and also different labeling requirements, all found in 21 CFR 101, Food Labeling. Both general foods and dietary supplements could be identified by FDA as misbranded when they fail to meet applicable label claims or labeling requirements provided in the 21 CFR 101 regulation. If used, structure/function claims for dietary supplements and general foods must be truthful and not misleading. Specific to dietary supplements, the following disclosure statement is required to ensure that the dietary supplement product also does not represent itself as a pharmaceutical drug.

  • “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Although dietary supplement labels are not required to be pre-approved by FDA, the product owner of a dietary supplement must provide FDA, a notification with the text of the structure/function claim no later than 30 days after marketing the product. General foods have no such FDA notification requirement for product labeling.

DSHEA also requires FDA to promulgate GMPs (good manufacturing practices) for the dietary supplement industry. This resulted in the issuance of 21 CFR 111, “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements” in 2007. Note: FDA issued the “Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements” in December 2010, which also has important information on FDA’s regulatory and enforcement expectations.

The DSHEA regulation itself addresses aspects of the manufacturing, packaging, and distribution of a dietary supplement product for distribution to the consumer. The comparable general food regulations are found in the relatively new FDA “Preventive Controls for Human Foods” regulation found in 21 CFR 117.

Comparison of Dietary supplement (21 CFR 111) and General Food Good Manufacturing (21 CFR 117) Requirements

21 CFR 111

Subpart

Description Summary 21 CFR 117 Subpart
B Personnel B – 117.10
C Physical Plant and Grounds B – 117.2, 117.20, 117.35, 117.37, 117.140 a‐d
D Equipment and Utensils B – 117.40, 117.35a, 117.37d,e, 117.40 a‐e
E Production and Process Controls – Specifications B – 117.80; C; G
F Quality Control B – 117.80
G Components, Packaging, and Label Controls B – 117.80
H Master Manufacturing Records B – 117.80 & F
I Batch Production Records B – 117.80 & F
J Laboratory Operations B – 117.40
K Manufacturing Operations B – 117.80
L Packaging and Labeling Operations B – throughout this Subsection
M Holding and Distribution Operations B – throughout this Subsection
N Returned Products NA
O Product Complaints Part of 117.155 but not specifically mentioned –
P Recordkeeping F

Shortly after the beginning of enforcement of 21 CFR 111 by the Center for Food Safety and Applied Nutrition (CSFAN), in 2010, the Food Safety Modernization Act (FSMA) was passed by the United States Congress in 2011. FSMA has been referred to as the most sweeping and significant legislation for the protection of public health regarding safety, efficiency and security of foods, drugs, and cosmetics (the mandate of the FDA) since the first set of laws were passed with FD&C in 1938. It was in reaction to numerous cases of food-borne illness and product recalls, particularly for pathogens (undesirable microorganisms) and allergen cross-contact and contamination issues in general foods. Pathogenic microorganisms of most notable concern are Escherichia Coli, Salmonella, Staphylococcus aureus and Listeria monocytogenes. Allergens are foreign substances that, in some consumers, can cause an abnormal immune system response that, at its most dangerous extreme, can result in death. In the United States, by law, eight food allergens must be identified; these are known as the “big eight”, i.e., milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. Seven major regulations have been issued by FDA to support enforcement of FSMA. The most important of these being 21 CFR 117, “cGMP and Hazard Analysis and Risk-Based Preventative Controls for Human Food (PCHF).” Interestingly, dietary supplements are exempt from many of the requirements in these seven FSMA-based regulations, but not all.

The challenge: in late 2018, FDA is committed to full enforcement of all provisions of FSMA-based PCHF and by mid-2019, of the Foreign Supplier Verification Program (FSVP). Both have parts applicable and enforceable on the dietary supplement industry. Which new parts of the PCHF and FSVP regulations will impact the dietary supplement industry? Unfortunately, simply reading both regulations may not provide the insight and understanding necessary for dietary supplement manufacturers to adjust their regulatory programs for these new challenges.

The PCHF regulation, in accordance with 21 CFR 117.5(e), does not apply to any facility with regard to the manufacturing, processing, packaging or holding of a dietary supplement that is in compliance with the requirements in 21 CFR 111. For example, for general foods, Subpart C of 21 CFR 117 states that a hazard analysis must be conducted to identify and evaluate microbiological, chemical and physical hazards. Preventative controls must then be developed and implemented to ensure that these hazards will be significantly minimized or prevented, and the food will not be adulterated or misbranded. Subpart G of 117, also applicable to general foods, requires a written, risk-based supply chain program to ensure control of these same hazards in incoming raw material and other ingredients. Since these are already addressed in the dietary supplement regulations (21 CFR 111, particularly Subpart E), Subparts C and G of 117 are not applicable to dietary supplement manufacturers. Subpart B of 21 CFR 117 is the cGMP for general foods has its counterpart in 21 CFR 111 for dietary supplement manufacturers; however, the cGMPs are enforced by FDA for dietary supplement manufacturers as well as the dietary supplement GMPs found in 11. Allergen control is discussed at length in 21 CFR 117, but 21 CFR 111 never specifically dictates the need for allergen control or testing, however, all components must be demonstrated to meet established limits of potential contaminants, and the big eight food allergens certainly qualify as potential contaminants.

The other FSMA-based regulation, FSVP is also applicable to dietary supplement manufacturers, in some cases. The rule provides several exceptions to the standard FSVP requirements for certain types of importers. First, for dietary supplements and dietary supplement components/ingredients, importers that establish and verify compliance with certain specifications (concerning dietary supplement components and packaging) under the dietary supplement cGMP regulations will not be required to comply with most of the standard FSVP requirements, including hazard analysis and standard supplier verification activities. The same exception would apply to importers whose customer is required to establish such specifications and verify that they are met, except that the importer would have to obtain written assurance that its customer is complying with those requirements. In contrast, importers of other dietary supplements would be required to comply with most of the standard FSVP requirements, but would not have to conduct hazard analyses, and their supplier verification activities would focus on verifying that the supplier follows the dietary supplement cGMP regulation, rather than verifying that hazards requiring a control are significantly minimized or prevented, as required under the standard supplier verification activity provisions. For foreign suppliers exporting a food ingredient to the United States that could be used as a dietary supplement, all the FSVP requirements apply. If this same supplier exported the same component/ingredients for use only as a dietary component/ingredient, then few of the FSVP requirements apply. However, if FDA discovers that the component/ingredient imported as a dietary ingredient, is being used by general food manufacturers, then it is likely that FDA will take regulatory action against the FSVP Importer and could potentially declare the food that the dietary component/ingredient was used in “adulterated,” which could trigger recalls as well as other FDA regulatory actions.

In addition, the FSVP regulation has a requirement of using a “qualified individual” for general foods also applies to dietary supplement manufacturers conducting the following operations:

  • 506(a)—procedures to ensure the importation of food from approved suppliers
  • 509—identification of the importer at entry
  • 510—recordkeeping
  • 511(c)(2)—procedures to ensure the importation of dietary supplements from approved suppliers
  • 512(b)(5) —recordkeeping by very small importers

A few years into the future we will all have “muscle memory” related to which parts of the FSMA-based regulations apply to dietary supplement manufacturers and understand the regulatory requirement differences between dietary supplements and general foods. Until then, it is important to rely on knowledgeable, experienced people in the industry, FDA and the consulting world as the enforcement threshold is “now,” and any uncertainty could result in noncompliance and FDA actions against dietary supplement manufacturers.

Tara Lin Couch, Ph.D., is an analytical/organic chemist with more than 20 years of diverse laboratory and regulatory experience in academic, field, contract and manufacturing environments. She is a senior consultant with EAS Consulting Group.

Allen Sayler is the senior director for food consulting services at EAS. Sayler’s expertise in the areas of food processing, particularly in the area of dairy processing, infant formula, bakery products, food additives, botanical products, and food packaging as well as GSFI Third-Party Certification programs such as Safe Quality Foods (SQF). Allen has spent more than 30 years as a food processing and regulatory expert, with half of the time serving the industry and the other have as a state and federal government employee.

This article was reprinted with permission from Natural Products Insider.

Heather Fairman Answers Q&A in Natural Products Insider

EAS Independent Consultant Heather Fairman contributed to a Q&A in Natural Products Insider on Successfully Choosing and Maintaining a Contract Manufacturing Partnership. Heather was part of a panel of experts that discussed contract manufacturing aspects that brand owners should evaluate in a potential contract manufacturer, what should be outlined in an agreement and what ongoing quality assurance (QA) checks a brand owner should conduct during the partnership.

Food Quality and Safety Publishes EAS Authored Article on Audits and the Food Safety System

EAS Independent Consultant, Rob Carper, has written an article on how audits are an integral part of the food safety system for Food Quality and Safety Magazine. “Food safety plans must be monitored and verified throughout the year, making sure the entire written food safety program is being supported with detailed records at the right frequency, capturing operational data,” Carper says. Also, he says, annual audits protect the company and the consumer by ensuring products are manufactured using adequate Food Safety Fundamentals (prerequisite programs and other requirements); Food Safety Plans, such as HACCP; and Quality Plans (a requirement for SQF Level 3 certification).

What’s New at FDA

The Center for Food Safety and Applied Nutrition has released the 2017 Food Code Book which includes science-based guidance for reducing known risks of foodborne illness. Originally designed for foods offered at the retail and food service locations, it has been widely adopted by the state, local, tribal and territorial regulatory agencies that regulate restaurants, retail food stores, vending operations and food service operations in schools, hospitals, nursing homes, and child care centers. EAS Consulting Group offers services to the retail and food service industries and would be glad to discuss your specific questions on regulatory compliance and enhanced food safety. Contact Allen Sayer, Senior Director of Food Consulting Services at asayler@easconsultinggroup.com

USDA has launched a new a new electronic data platform that includes Market News Information by commodities such as dairy, fruits and vegetables, livestock and tobacco. The platform also includes resources which are of interest to USDA and FDA regulated industries, such as the pesticide data program, organic reports, and food safety. EAS would be glad to help you to better understand data found them in the reports and how they pertain to your business. Contact Allen Sayler at asayler@easconsultinggroup.com

EAS and HACCP Consulting Group Offer New SQF Course Options

Through EAS’ partnership with HACCP Consulting Group, we are pleased to announce a number of additional SQF courses on Developing and Implementing SQF Systems. Upcoming courses include Stillwater, OK April 10-11and in Philadelphia, PA on May 21-22.

This two-day seminar Developing and Implementing SQF Systems provides instruction, examples, exercises, and tools necessary for successfully implementing an SQF System. It is one step in the qualification process for SQF Practitioners and an excellent choice for all food safety team members.

EAS – CHPA Partner for OTC Focused Webinar Series

EAS staff and independent consultants are presenting numerous topics for Consumer Healthcare Products Association (CHPA)’s OTC Academy Webinar Series.

On March 6th, Senior Director of Dietary Supplements, Tara Lin Couch, Ph.D. will present on Conducting a Scientifically Sound Out of Specification (OOS) Investigation. Our Senior Director for Pharmaceuticals, Bryan Coleman, will present on Managing FDA Inspections on March 27th and EAS Senior Advisor, Robert Fish will discuss Responding to 483s and Warning Letters on April 17th.

Steve Armstrong to Speak on Food Law at Upcoming Innovative Foods Conference

Steve Armstrong will present a session on innovative claims at the third annual law conference in Denver, April 19-20, 2018. Steve will be part an esteemed group of speakers including Susan T. Mayne, PhD, Director, Center for Food Safety and Applied Nutrition (CFSAN) at FDA and US Food and Drug Administration (FDA) and Peter Lurie, MD, MPH, Executive Director and President for the Center for Science in the Public Interest. Learn more about innovative foods and other hot topics in food law.

Voluntary Qualified Importer Program Underway

Edward A. SteeleWelcome to the EAS-e-News, a free newsletter dedicated to those companies who work in FDA regulated industries.

FDA and USDA have been busy with new initiatives this month including a new FSMA Landing Page on the FDA’s website, new CDRH guidance for RTA’s for 510(k)s, a new Food Code Book for the retail sector, a new USDA electronic data platform and of course FDA’s Voluntary Qualified Importer Program (VQIP). More details on the CDRH guidance can be found in this month’s Drug/Device Corner and information on the Food Code Book and USDA electronic Data Platform can be found in the What’s New on FDA’s Website. It goes without saying that EAS independent consultants have been studying the new initiatives and are ready to assist with practical solutions to sometimes complicated questions.

I’ll take just a few moments to highlight the Voluntary Qualified Importer Program (VQIP) here. VQIP, is a voluntary, fee-based program for importers that allows for those enrolled to have expedited review and importation of human and animal foods into the U.S. The VQIP program is only available to those applicants who have a three year unblemished history of importing foods into the U.S., demonstrating achievement and maintenance of a high level of control over the safety and security of their supply chains. VQIP is also only applicable for companies who import foods from a facility (or farm) certified under FDA’s Accredited Third-Party Certification. EAS offers numerous services in the area of FSMA including readiness checks and helping companies prepare for the application and backup documentation for VQIP. The process is stringent, but for those companies who meet FDA’s requirements, the expedition of imports can facilitate smoother business practices and a greater level of transparency of your company’s food safety systems.

Our FSMA Perspective this month discusses additional new initiatives under FSMA, specifically the upcoming March 19th compliance dates for Importers of human food whose Small Business Foreign Supplier is required to comply with Preventive Controls for Human Foods (PCHF); Importers of animal food whose Large Business Foreign Supplier is subject to the Preventive Controls (PC) requirements in PCAF, but not to CGMP requirements; and Importers of animal food whose Small Business Foreign Supplier is subject to PCAF CGMP requirements. Understanding whether your company fits in the spectrum can be tricky and our Independent Advisor for FSMA, Charles Breen, lays out the specifics, as well as some exemptions here.

Our issue of the month is on the Twentieth Anniversary of Seafood HACCP and is particularly timely in light of numerous warning letters related to seafood imports recently. I hope you enjoy Tim Hansen’s trip down memory lane and appreciate the urgency with which these HACCP requirements still apply.

EAS welcomes two new independent consultants this month who work in the food industry: Rudy Westervelt and Kathy Knutson. We are also delighted to have Dr. Robert “Robbie” Burns back with us on a full-time basis. EAS has a long tradition of bringing the best in industry talent on board as independent consultants and these three are no exception. I encourage you to read their bios in the Who’s Who section.

FDA has released several guidance documents related to the Nutrition Facts label final rule, including a final guidance explaining how the FDA evaluates the scientific evidence supporting citizen petitions to add certain isolated or synthetic non-digestible carbohydrates to the regulatory definition of dietary fiber. This Final Guidance for Industry contains information pertinent to those who submit scientific evidence to FDA for use in the determination of whether added non-digestible carbohydrates meet the definition of “dietary fiber” as part of the regulations for nutrition labeling of food for declaring the amount of dietary fiber on the Nutrition and Supplement Facts labels. Final Guidance for Industry was also issued for a number of products where serving sizes can be reasonably consumed in one sitting. Draft Guidance for Industry was also released regarding the agency’s intent to exercise enforcement discretion related to the use in the Nutrition Facts label of a symbol “†” on single-ingredient packages and/or containers of pure honey or pure maple syrup and on certain dried cranberry and cranberry juice products. The comment period for this draft guidance is now open and comments are due to the agency in the next 60 days.

Thank you for your interest in EAS and as always we encourage you to share this newsletter with your colleagues.

EAS Consultants Instructing FDLI Introductory Courses

EAS Consulting Group is honored to be a member of the Food Drug Law Institute and is pleased to be invited speakers to a number of upcoming events.

Independent Consultant, Mark Nelson, will present an introductory session on Overview of U.S. Food Law and Regulation of Food at the Intro to Food Lawon April 10th from 8:35-9:35 am. This event will take place at the law firm of Hogan Lovells US LLP. Mark is the retired Director of Scientific Affairs at Nestle where he oversaw a wide range of FDA and USDA regulated products.

Kaiser Aziz speaking at Introduction to Biologics and Biosimilars on New, Emerging, and Continually Interesting Issues – March 21, 2018, 1:45 pm – 3:30 pm This event will be held at the law firm of Holland and Knight in Washington, D.C. Dr. Aziz has been an independent consultant for EAS since 2012 and spent his career at FDA working his way to the position of Director, Division of Mechanics and Material Science in FDA’s Office of Science and Technology where he developed guidance for FDA bio-mechanical, material and Toxicology Research Testing programs.

Does Our Company Offer Enough Training?

By Karen Dixon

EAS is pleased to introduce a new column in our EAS-e-News called Ask the Expert. Each month our expert consultants and Senior Directors will answer one question sent in by readers (edited if applicable to remove identifying information). If you’d like to submit a question, please use the “contact us” link on our website.

This month’s Ask the Expert question is on training requirements in a manufacturing facility is answered by EAS Independent Consultant, Karen Dixon.

Karen has a strong focus on the development and implementation of FDA readiness programs including processes, compliance considerations, and integration within all levels of an organization. Her unique combination of expertise in operations, training systems, finance, product quality, Quality Management Systems, regulatory affairs, and ISO-9001-2015 makes her a valuable asset to EAS clients. She has held positions such as Manager, Quality Management System at Altria and Philip Morris USA and is a Certified Quality Auditor (CQA) with the American Society for Quality.

Question: How can I ensure our company offers effective training for all levels of employees at our manufacturing facility?

Dixon: In an FDA regulated manufacturing environment, the importance of a solid training program is critical to meeting your quality system requirements. Most manufacturing companies are faced with ‘doing more with less’ and often training is a burden. There are several solutions that can address training efficiencies and enhance the overall knowledge base of your employees. After all, your employees are your most important asset.

First, no training program should be one-size fits all program. Your procedure/process should be designed for flexibility in training delivery while ensuring you meet critical requirements. Developing a level or class system within your training SOP will aid the manufacturing process when there are competing opportunities. For example, a level 1 could be defined as the employees’ immediate job function and the work instructions associated with it. Level 2 would be your ‘read to understand’ material, and/or quality procedures designed for understanding. Level 3 training could be those materials and/or courses developed to enhance employees’ capability, i.e. business writing classes. This categorization would allow the firm to focus priority. Training an employee in their immediate process in order to produce a quality product is more pressing than a continuing education class for example.

For your infrastructure, implement a training procedure with these requirements clearly defined.

  • Type of training (Level 1, 2, 3)
  • Platform (i.e., computer-based, classroom, on-the-job or read-to-understand)
  • Trainer (i.e., buddy system, subject matter expert, certified trainer)
  • Record keeping requirement (roster, training assessment)

It is important to remember that the FDA Inspector will want to see evidence that an employee has been provided the appropriate training for the tasks they are performing; therefore, good documentation is imperative. There are a number of training options, of course. One is a “canned” Learning Management Systems (LMS). Another is attending public courses to meet your training requirements. Depending on the topic, some public courses have been vetted and certified to offer continuing education units (such as EAS Consulting Group’s Food Labeling Compliance Seminar), others, though not providing specific CEUs meet the training requirements required by FDA, (such as EAS’ Dietary Supplement Good Manufacturing Practices Seminar). Still, a third option is to bring outside trainers into your facility to provide a customized approach to your specific business and training needs. Customized programs offer an opportunity to bring in experts familiar with your type of business as well as the federal, state and industry regulations with which you must comply so that those in-house programs developed to meet your needs exactly.

Steps to Achieving Effective Manufacturing Training

No matter the type of learning environment, online, public or in-house, there are some basic steps needed to achieve optimum adult learning:

Here are a few points to consider about each step:

Design: During this phase of development, you should focus on the need for the training or conducting a ‘needs analysis’. Considering the business goals or metrics behind the topic of the training. Create clear learning objectives to uncover topics that are influencing the training.

Develop: Points to consider under development: 1) stay true to the plan developed during the Design phase, don’t drift into another topic or focus area, 2) Gather credible sources of information for the training. Use facts, input from Subject Matter Experts, and guidance from seasoned employees.

Deliver: Consider your audience through a leaner-centric approach. Delivering learner-centric material means you are delivering to adult learners who learn very differently than adolescents. Clients should consider investing in a full-time training developer who has been trained in adult learning principles. Most clients already have an employee or employees dedicated to training, even as part of a job. There are many inexpensive courses available that would enhance their ability on understanding adult learning. Investing in a two to the three-day course would bring a return on investment quickly.

Evaluate / Continuous Improvement: Your training program will never be complete. Continuously evaluating the health of your program through metrics is important. Whether it is a simple measure of percent complete trained, evaluation of non-conforming product incidents, or waste percentages there is always a way to measure the health of your training program. Revisit your initial training material and improve as needed.

To learn more about training design and developing a flexible training program, contact EAS Consulting Group. Our independent consultants can provide a perspective your company needs to ensure processes and procedures are accurately in place to support full compliance with current and future FDA requirements while also providing counsel on how your infrastructure can work for you in meeting production goals.

February 2018 FDA Drug / Medical Device Activity

Medical Device manufacturers and importers, please make note of the upcoming FDA Adverse Event codes update. Per the FDA eMDR System Enhancements website, the list of FDA Adverse Event codes accepted in F10 and H6 will be updated to harmonize with the IMDRF Adverse Event Reporting Terminologies. This update will affect the Device Problem Codes and Manufacturer Evaluation Codes, which correspond to IMDRF Annexes A through D. Future updates will harmonize all remaining FDA adverse event codes with IMDRF as more annexes are published. IMDRF codes are not currently accepted by eMDR, but the new hierarchies posted on FDA.gov include a one-to-one mapping of IMDRF codes to FDA codes. FDA codes that are being retired during this update will be rejected by eMDR once this update is deployed. The current non-harmonized hierarchies and the future IMDRF-harmonized hierarchies are currently posted at MDR Adverse Event Codes. The scheduled date of this production update is 6 April 2018.

Senior Director for Pharmaceuticals and Medical Devices, Bryan J. Coleman has summarized a new agency guidance on Refuse to Accept (RTA)’s for 510(k) Medical Device applications. In this summary, Bryan discusses FDA’s newly produced checklists enabling submitters to ensure all required data is complete prior to submission. This should better facilitate FDA’s ability to complete a substantive review by assuring all preliminary information is included. EAS offers services with 510(k) submissions including the review of data and assistance with compiling submissions to the process of submitting to FDA. Please contact Bryan at bcoleman@easconsultinggroup.com

Guidance Document updates on the FDA website:

CDER:

CDRH:

FSVP – Next Compliance Dates for Some Importers of Human and Animal Foods

By Charles Breen, Independent Advisor for FSMA

The next FSMA/FSVP compliance date is March 19, 2018. FDA enforcement activities begin with:

  • Importers of human food whose Small Business Foreign Supplier is required to comply with Preventive Controls for Human Foods (PCHF);
  • Importers of animal food whose Large Business Foreign Supplier is subject to the Preventive Controls (PC) requirements in PCAF, but not to CGMP requirements;
  • Importers of animal food whose Small Business Foreign Supplier is subject to PCAF cGMP requirements

Importers are already being inspected for the adequacy of their FSVP. A quick look at the most recent FDA inspection citations with data through January 15, 2018, shows nearly 100 Foreign Supplier Verification Program (FSVP) violations since FDA started inspecting importers last year. The citations made show that in many cases there is a clear lack of understanding, not only of the requirements but the implications for lack of compliance. FDA can stop an importer from importing food for which there is no evidence that the food complies with FDA requirements.

For anyone keeping score, March 19th marks the compliance date for 30th, 31st and 32nd FSMA rules, and the seventh, eighth and ninth for FSVP-specific rules so far.

It is important to also note that even though seafood, juice beverages, infant formula, dietary supplements, and Low Acid Canned Foods (LACF) foods may not be subject to significant parts of the FSMA preventive controls regulation, USDA regulated products are completely exempt, no FDA-regulated food has a complete exemption. When companies are producing foods that combine USDA and FDA regulated foods, whichever agency regulates the final food product may not be the only one regulating some of the ingredients of this final food. These companies need to check to be sure their food safety programs meet the requirements of either USDA, FDA or in a few cases, both. EAS has the expertise and regulatory knowledge to assist companies in navigating these sometimes-murky regulatory waters.

USDA’s various inspection Acts, (poultry products, egg products, the Federal Meat Inspection Act) have jurisdiction over these imported products at the time of U.S. entry. While USDA and FDA requirements are gradually coming into closer alignment, each agency’s requirements are still quite different. Understanding both sets of requirements is warranted for those whom this applies.

So, back to the March 19th deadline and what it means for you. First – does your company even need to comply with FSVP? Is your foreign food supplier aware that in order to comply fully with FSVP, they must first comply with the FSMA Preventive Controls regulations (human food and animal foods as applicable)? FDA has developed a handy flow-chart to help you make that determination. Even so, it’s not always so simple to understand the correct regulatory path to compliance – particularly in the case of seafood, juice beverages, infant formula, dietary supplements, and LACF foods – when and what FSVP rules must be followed, comply with FSVP.

The size of a business is a factor in whether companies need to comply, as is the case with those that meet the definition of a “very small businesses” (i.e., earned less than $1 million per year on average in the preceding three calendar years, adjusted for inflation from 2011, in sales of human food combined with the U.S. market value of human food imported, manufactured, processed, packed, or held without sale; or in the case of Animal Food – $2.5 million per year for three years in sales of animal food, combined with the U.S. market value of animal food imported, manufactured, processed, packed, or held without sale (e.g., imported for a fee)). FDA provides a useful tool to help calculate inflation. For example, $1 million in 2011 is adjusted to $1,078,242 in 2016.

There are other exemptions in addition to those mentioned above. Imported food from Canada, New Zealand and Australia are still required to meet FSVP requirements. However, those who import foods from these countries may document FSVP compliance by relying on inspections by officially recognized food safety inspections in those countries. Their food safety systems are deemed to be comparable to that of FDA. Companies must clarify that imported food is within the scope of that official recognition or equivalency determination. For example, baked goods are food by definition, but are regulated by Health Canada. The mutual recognition with Canada is between FDA and CFIA, not HC. The details of this FDA recognition are still being worked out and food companies from Canada, New Zealand and Australia should consult with their US customs agents or EAS for the latest information on this moving target.

The many components of FSMA Preventive Controls regulations and the detailed technical aspects of FSVP alone are challenging to understand and implement. Addressing those challenges from two interwoven US regulations may sometimes require the assistance of outside experts, such as those at EAS, who can help you navigate the requirements and determine a course of action.

EAS offers FSMA services in all areas of food – from Dairy to Juice to Produce, Seafood, LACF, Infant Formula and dietary supplement manufacturers who fall under FSMA and FSVP requirements, workings with manufacturers, processors, holders and packers and transporters of products as well as their retailers.

EAS services in the area of FSMA and FSVP can save time and eliminate confusion. Understanding what rules apply to whom and how to develop compliant procedures can make all the difference when FDA inspectors arrive at your door. Don’t let your company be part of the next FDA inspection citations list or find your company on the FDA Import Alert list. Whether with the help of EAS or working independently with your own internal staff, make sure your FSVP compliance documentation is in good working order.

EAS Welcomes Two New Consultants

Kathy Knutson, Ph.D.

Kathy Knutson, Ph.D. is a microbiologist and certified lead instructor for Preventive Controls for Qualified Individuals through the Food Safety Preventive Controls Alliance. She consults with companies in meeting FSMA requirements, including manufacturers in the cannabis industry as she educates on issues surrounding cannabis-infused food products for sale in states with medical and recreational use legislation. Kathy has a Ph.D. in Food Science from the University of Minnesota and prior to consulting worked as a Food Safety Educator and Proficiency Program Coordinator with the Northland Laboratories.

Rudy Westervelt

Rudy Westervelt works in foods with a particular focus on solving problems related to dairy food quality, loss reduction, employee safety results, throughput, and cost control. Rudy is a Board Member of World Food Trace, Inc., a non-profit creating a tool to instantaneously trace products through the global food supply chain and is a member of the Global Food Traceability Pilot Project which developed a universal coding system for manufactured food products with a searchable database for rapid identification of source in cases of contamination. Rudy has a Masters of Science in Meat Science and Muscle Biology from the University of Connecticut and an undergraduate degree in Animal Science from Cornell University. Prior to consulting, Rudy spent his career at the Kroger Company.

Meet Issue of the Month Author Tim Hansen

EAS Independent Consultant Tim Hansen is a former director of the seafood division in FDA’s Center for Food Safety and Applied Nutrition and a former director of the seafood inspection program for the National Oceanic and Atmospheric Administration (NOAA) Fisheries. He previously served in other roles in NOAA’s seafood program, prior to which he was a product supervisor for the Fleischmann’s Yeast Division, Nabisco Brands, in Sumner, WA. Earlier in his career, he served as a supervisor in the New England Fish Company, Seattle, WA and subsequently as a QA manager for British Columbia Packers in South Bend, WA and in Naknek, Alaska. Tim consults with clients on all matters of HACCP, with a particular focus on seafood.

Have a Cup of Coffee and Pray – It’s the 20th Anniversary of the Seafood HACCP Rule

By Tim Hansen, Independent Consultant

HACCP, of course, stands for Hazard Analysis Critical Control Point, is a highly effective preventive control system for foods and other commodities. “Have a cup of coffee and pray” was how one skeptical USDA union official described HACCP implementation in meat and poultry processing plants when it was implemented in the early 2000’s. It is an example of some of the reservations public health officials had as early as 1980. FDA implemented this systematic control system in seafood effective December 1997. Although controversial its implementation proved to be a tremendous success for the agency and public health in general.

First, let me provide a little history. In the early 1980’s there was a developing trend towards exercise and healthy eating. A nutritionist named Anne Fletcher published a highly popular book about the nutritional benefits from eating seafood entitled Eat Fish, Live Better. This book received a tremendous amount of attention in the media that spurred the consumption of seafood as part of a healthy lifestyle. However, the seafood industry at the time had some systemic quality control problems that allowed significant amounts of low-quality seafood on the market. Most of these quality problems were hygienic in nature and did not pose a food safety problem. However, it did cause concern in the media about seafood safety and the public began to believe that seafood was good nutritionally but not always safe.

Congress at the time also became concerned about seafood safety and offered various legislative bills for so-called mandatory inspection of seafood. Congress also provided money for a Model Seafood Surveillance Project whose mission was to determine what governmental regulations were needed to address these issues. NOAA Fisheries conducted the project and dozens of workshops with industry to garner feedback about what would address the issue of safety and would work best for them. The conclusion of that report was that the implementation of mandatory HACCP was the best way forward. Circa 1990 President H.W. Bush ordered FDA and NOAA Fisheries’ Seafood Inspection Program to work together on a voluntary joint program to implement HACCP principles into the seafood industry and under President Bill Clinton, then FDA Commissioner Kessler decided that FDA would develop its own mandatory program for Seafood HACCP.

The resulting Seafood HACCP rule can be best understood and implemented by referencing the FDA drafted complex guidance document called the Fish and Fishery Products Hazard Guide (FFPHG). It is used worldwide as the, most authoritative, comprehensive guide to the science behind HACCP and FDA policies related to seafood.

While seafood HACCP regulations have been in place for 20 years, there is always work to do and vigilance to keep with regards to the safety of our food sources as the volume of seafood imported to the United States continues to increase. In 2009, 80 percent of the seafood in the U.S. food supply was imported, and by 2015, more than 90 percent was imported. A quick review of FDA warning letters at any point in time demonstrates this challenge, with as of this writing, six out of ten of the most recent FDA warning letters pertaining to seafood HACCP. Challenges such as implementing and verifying that seafood is processed, held and transported insanitary conditions; that regular inspection records verify their safe handling, both before they reach US shores and when they are a domestically distributed are areas where FDA inspectors are working diligently.

Over the years the guidance and FDA policy thinking was refined and the regulation became a tremendous success. Seafood safety and quality improved, scientific thinking was imbued into the seafood industry through the FFPHG which promoted the health of consumers, consumers were less worried about safety issues and seafood HACCP became a template for the Food Safety Modernization Act of 2010 that would apply preventive control principles to the manufacturing of all food commodities. That’s quite an accomplishment. So let’s have a cup of coffee and praise the FDA for their fine work in improving food safety standards for seafood.

Increased Availability for Independent Consultant, Robert Burns, Ph.D., Expert in Infant Formula

Though not a new independent consultant for EAS, we are pleased that Robert “Robbie” Burns, Ph.D., an expert in infant formula is now more readily available to EAS clients after stepping down from the Grocery Manufacturers Association as former Vice President of Health and Nutrition Policy. Dr. Burns is an asset to EAS Clients looking to develop infant formula and his readiness to assist clients greatly enhances our roster of food science experts. Prior to GMA, Dr. Burns was the former Global Nutrition and Scientific Affairs Director at Cadbury Schweppes where he worked to establish consistent global standards and strategies for the improvement of new product pipelines and capacities to reliably deliver nutrition-based product and communication initiatives. Prior to Cadbury, he was at Mead Johnson Nutritionals where he worked with Pediatric Nutritionals. Robbie has a Ph.D. in Nutritional Biochemistry from Queens University in Belfast, Ireland with Postdoctoral Research Fellowships at the Universities of Nottingham and Illinois, Urbana-Champaign. He is the author of nearly 50 papers and articles and has been an invited speaker at dozens of international symposiums and conferences.

EAS On-Demand Webinar on Medical Device Quality Audits

Independent Consultant George Gary Calafactor presents our first EAS On-Demand webinar on Medical Device Quality Audits. Medical Device manufacturers understand the tight FDA regulations and legal obligations surrounding devices. From initial safety and effectiveness study design through Pre-Market Applications (PMAs), Pre-Market Notifications (PMN), registration, Good Manufacturing Practices (GMPs) through reporting of adverse events, every detail must be attended to in a thorough and documented quality system. Quality systems are key indicators of a company’s commitment to producing a safe and effective product as well as a company’s good record keeping practices as records are tested and maintained to provide transparency to FDA inspectors in the case of an audit. This webinar focuses on detailed coverage of Medical Device Quality Auditing including.

  • Learning about the types and purposes of audits
  • How FDA and EU audits differ in scope
  • How quality systems link to other systems within the business practices such as
    • Accounting and Finance
    • Purchasing
    • Customer Service
    • Marketing and Sales
    • Informational Technology
  • FDA’s enforcement requirements of quality systems
  • Quality Assurance
  • Quality Control Testing and Evaluation Against Standards
  • How FDA enforces regulations and gaps found during audits
  • Trends found in FDA enforcement for medical devices in recent years

We invite you to view this free on-demand webinar by clicking here.

Food Labeling Compliance Seminar in Alexandria, VA

Just announced, EAS’s popular Food Labeling Compliance Seminar will take place May 29-30, 2018 in Alexandria, VA. This two-day event, which offers 16 Commission on Dietetic Registration continuing education credits, is an opportunity for greater understanding of the requirements of the new nutrition facts panel. Though FDA has delayed enforcement of the new formatting and chemistry reporting requirements, many companies are finding a strategic benefit in understanding the requirements now so that labels can be updated in advance of the compliance date. Learn more about this seminar here. Earlybird discounts rates are in effect through April 10, 2018.

Dietary Supplement Good Manufacturing Practices Online Short Course

For those seeking a broader overview of GMPs, EAS is offering a new two-part online short course which will cover the basics of working in a GMP environment including personal hygiene, sanitation, the use of Standard Operating Procedures (SOPs), and Good Documentation Practices (GDPs). It will also address the top 5 observations cited in FDA Warning Letters since 2010.

This Short Course, based on the 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, provides a great initial training for personnel unfamiliar with GMPs and can serve as a refresher and annual GMP training requirement.

Each session runs 2.5 hours in length and the dates are February 22nd and March 1st from 1:00-3:30 pm ET and is FREE to EAS clients. Registration is $99 for both sessions for non-clients. Click here for more information and to register.

Ask the Expert February 2018

By Tara Couch

EAS is pleased to introduce a new column in our EAS-e-News called Ask the Expert. Each month our expert consultants and Senior Directors will answer one question sent in by readers (edited if applicable to remove identifying information). If you’d like to submit a question, please use the “contact us” link on our website.

Tara Lin Couch Ph.D.

This month’s question answered by Tara Lin Couch, Ph.D., Senior Director for Dietary Supplement and Tobacco Services and the topic is whether there is a crossover between ISO certifications and GMPs in the laboratory.

QuestionIf a contract Laboratory is ISO certified, can we bypass an onsite audit if we incorporate this statement in our SOPs?

Couch: Absolutely not, ISO certification does not equal GMP compliance. I have seen many labs that are ISO certified and have terrible GMP compliance. Remember, ISO 17025 is not looking at the whole lab, it is looking at a specific test method or operation. It will dictate that the lab can run a particular test, Vitamin C for example, or operate a balance, but does not look at the entire laboratory quality systems. There are certain things that are covered in GMPs that are not covered in ISO, OOS (Out of Specifications) investigations would be one of those. OOS investigations should be conducted in accordance with the FDA, Center for Drug Evaluation and Research (CDER), Guidance for Industry: Out of Specification (OOS) Test Results for Pharmaceutical Production, issued in October of 2006. In this guidance, the FDA states that an investigation must be thorough, timely, unbiased, well-documented, and scientifically sound to be meaningful. There is a quality manual requirement in ISO 17025 that touches on investigations, but it is not near the level of detail that you would find in a GMP environment.

Two Ways to Train on Dietary Supplement Good Manufacturing Practices Compliance (GMPs)

EAS’ popular Good Manufacturing Practices for Dietary Supplements Compliance Seminar has just been announced for April 4-5, 2018 in beautiful downtown Denver, CO. Instructed by Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., EAS Independent Advisor for Quality and Compliance, Robert Fish and Partner at the law firm Rivkin Radler, LLP, Marc Ullman, this is a dynamic opportunity to gain a deeper understanding of GMP requirements, how to develop and update action plans to meet and exceed those requirements as well as FDA’s approach to inspections.

Though the GMPs dictated in 21 CFR 111 have been in place for over a decade, FDA continues to issue numerous Warning Letters for a failure to comply with even the basic tenants of the regulation. Out of 483 inspections conducted in 2015, the agency issued approximately 290 Warning Letters. In light of increased FDA oversight, a thorough review of new industry rules on good manufacturing practices (GMPS) is warranted.

Earlybird rates are in effect through February 15, 2018. Sign up today!

January 2018 FDA Drug / Medical Device Activity

EAS would like to remind all DMF holders that the FDA DEADLINE for eCTD submissions is fast approaching. As of 5 May 2018, the FDA will only accept eCTD submissions to ALL DMF files. If you have not already made plans for conversion, you should do so immediately. If you have any questions, feel free to contact EAS. While on the topic of DMFs Albert Yehaskel, EAS Independent Advisor for Pharmaceutical Submissions, has written a very informative white paper, “An Overview of Drug Master Files”. This has been slightly updated and added to our website, please use this link to access this valuable resource.

The Food and Drug Administration is reopening the comment period for the document published in the Federal Register on September 26, 2017, announcing a public hearing on a potential approach for device sponsors who seek to obtain marketing authorization for their products that are intended for a new use with an approved, marketed drug when the sponsor for the approved, marketed drug does not wish to pursue or collaborate on the new use. Submit either electronic or written comment by February 21, 2018.

In the event you missed the FDA announcement, the agency has created a new platform to request pre-ANDA meetings. This platform, CDER Direct NextGen Collaboration Portal, was designed to help the FDA minimize manual data entry and support the agency’s GDUFA II performance goals. The new technology platform, which will allow the industry to request pre-ANDA meetings for complex generic drug products with the FDA. In just a few steps, potential applicants of abbreviated new drug applications (ANDAs) will be able to initiate requests by uploading a meeting request package. The portal also allows the industry to submit supporting documents, such as meeting presentation materials, requests for additional information made by the FDA, and post-meeting comments. For additional information about the portal, please visit the FDA Pre-ANDA Program webpage.

FDA (or Agency) is announcing the timetable for updates to the FDA Data Standards Catalog for study data submitted electronically in NDAs, ANDAs, BLAs, and certain INDs to CBER and CDER. The initial implementation timetable for submitting standardized study data in electronic format was 24 months for NDAs, ANDAs, and applications, and 36 months for certain INDs after the publication of the final guidance “Providing Regulatory Submissions in Electronic Format–Standardized Study” in December 2014. When future updates to study data standards listed in the FDA Data Standards Catalog (Catalog) occur, these updated standards will be required in studies with a start date no earlier than 12 months after a Federal Register notice announcing such updates is published. When future new study data standards are listed in the Catalog, these new standards will be required in studies with a start date no earlier than 24 months after a Federal Register notice announcing such new standards is published. Please see the FDA Study Data Standards Resources webpage for further information.

Guidance Document updates on the FDA website: CDER:

CDHR:

CBER:

FDA Responds to GAO’s Report on Insufficient Agency Oversight of Recalls

By Charles Breen, Independent Advisor for FSMA

The December 2017 Department of the Inspector General report on FDA’s food recall process included some particularly harsh criticisms of the agency including inadequate authority, oversight and follow-up on voluntary food recalls. These criticisms came as little surprise as a number of issues surrounding agency oversight of recalls has been identified in recent years. A 2012 GAO report indicated that both FDA’s food advisory and recall processes need strengthening and a 2015 report again showed FDA is not keeping pace with foreign inspections.

The 2012 report findings prompted the agency to undertake significant steps in an effort to strengthen recall processes, including a revision of recall procedures published in the Regulatory Procedures Manual to better define recall categories in FDA’s database and to improve information sharing between federal and state agencies that also have oversight of food safety. Other improvement areas identified by GAO remain open, such as final guidance based on public comments on mandatory food recalls, and others that the agency said were impractical to implement.

Based on preliminary findings of the 2017 GAO report, which had been provided to FDA in 2016, the agency responded with the creation of a new management unit, the Strategic Coordinated Oversight of Recall Execution, (SCORE). It is intended to help the agency better investigate those reports of food illness that could pose a significant health hazard to consumers. Though a good start, the GAO recommends taking SCORE a step further to establish measurable performance expectations, such as timeframes, expedited decision-making, and improved electronic recall data. In other words, GAO wants to see scoring for SCORE.

One area of debate is the GAO’s review of 30 of the 1,557 voluntary FDA recalls between the years 2012 and 2015 where GAO determined in many cases FDA did not assess the hazards in a timely manner, nor did it communicate recall and safety concerns effectively. GAO cited, for instance, an extreme example where an affected product was not removed from commerce until 303 days after receipt of FDA’s warning letter prompting a recall. On average, says GAO, companies took 57 days to remove their recalled products. As well, GAO found the recall information captured and maintained in FDA’s electronic recall data system, the Recall Enterprise System (RES) to be deficient. The report noted “Our review found that FDA does not have adequate policies and procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls. This means that dangerous food products may have remained in our nation’s food supply for weeks after FDA was aware of the contamination.”

FDA takes some exception with how the 30 voluntary recalls reviewed were chosen, as GAO self-describes them as “judgementally selected.” In FDA’s view, these companies represent “extreme outliers” and says their own data show that during this 2012-2015 period when FDA “found out about a product problem that eventually resulted in a recall, the recall initiation took place, on average, in less than four days. In the highest risk recalls, when there was a reasonable probability that the use of or exposure to a product would cause serious adverse health consequences or death, recall initiation took place, on average, in less than three days.”

That being said, the agency stresses that it understands the urgency of getting recalls right and is reviewing selected recalls to identify gaps and improve procedures. FDA Commissioner, Scott Gottlieb said in a statement responding to the report, “Making sure the FDA has effective recall practices in place, and that we take immediate action to address unsafe foods, are high priorities of mine. Our recall authorities — and how we deploy them — are a cornerstone of our vital, consumer protection mission.”

HHS Office of the Inspector General rejects the agency’s claim that the 30 selected recalls were “extreme outliers” and says that FDA lacks a reliable tracking system. The current system makes it difficult to capture the recall initiation date and the date FDA became aware of potentially hazardous food products.

Regardless of the back and forth, the importance and urgency of identifying a food safety issue and its subsequent follow-throughs cannot be overstated. Recalls are a unique challenge as a consumer may have already purchased the recalled product.

It is imperative that companies have a robust and well-documented recall plan as part of their standard operating procedures (SOP) and that those plans are routinely practiced, drilling through the process with various scenarios – from a product in the warehouse, in-transit, already on consumer shelves and the type of threat identified.

  • How will your company respond?
  • Who is the internal point of contact/liaison with FDA?
  • How will parties who may be in possession of the product be identified and contacted?
  • How will the return and destruction of a product be identified and tracked?
  • How and by whom will the media be addressed?

There are many aspects to consider, many contingencies to plan for, and only one opportunity to get this right the first time. The safety of the public and the long-term viability of your company may depend on it.

The Food Safety Modernization Act (FSMA) granted FDA the authority to initiate mandatory food recalls. While the agency is working through their requirements to do so and simultaneously monitor voluntary recalls effectively, so should you. EAS offers assistance in preparing recall strategies as part of our holistic regulatory compliance planning services under FSMA. Take steps now and be prepared.

Meet Issue of the Month Author Elizabeth Campbell

Elizabeth CampbellIndependent Advisor for Labeling and Claims, Elizabeth “Betty” Campbell, is a former Acting Director in the FDA’s Office of Food Labeling who played a leading role in writing the regulations implementing the Nutrition Labeling and Education Act (NLEA) in the 1990s. She joined EAS as a vice president in October 2006 after a 35-year career with FDA. In the role of independent advisor, she provides expert consulting advice and guidance to clients on complex labeling and claims issues including foods, medical foods, and infant formula. Betty has also served as an expert witness in numerous high profile labeling cases.

Meet Regulatory Intern, Yuthika Gokaraju

Yuthika Gokaraju is pursuing her Masters in Biotechnology with an emphasis in BioBusiness at Georgetown University, Washington DC. She has an undergraduate degree in Pharmacy from Osmania University in Hyderabad, India. Yuthika has industry experience working as a student trainee at a nutraceutical company and hopes to expand her knowledge of the FDA regulated industries through the assistance of a variety of projects.

FDA’S Policy on Medical Foods

By Elizabeth Campbell, EAS Independent Advisor for Labeling and Claims

“Medical food” is a commonly misunderstood term as it is used on FDA regulated products. Many manufacturers want to market their products as medical foods because medical foods are exempt from the disease statement limitations for health and structure/function claims and are allowed to name the diseased population for whom they are designed. The following paragraphs provide details on FDA’s approach to medical foods, but the policy can be summarized as: a medical food is intended for people who have a disease or condition that results in a distinctive nutritional need which cannot be met by a diet of regular food but is met by the medical food. The disease or condition must be identified, the distinctive nutritional need must be substantiated by data, and it must be demonstrated that the product would meet the identified nutritional need.

Prior to 1972, medical foods were primarily formulas for managing patients with inherited metabolic diseases. They were mainly orphan products for limited populations. They were considered drugs to ensure their use under medical supervision. However, in 1972 the FDA reclassified these products from drugs to foods for special dietary use to enhance their development and availability. In the intervening years, a wide variety of products categorized as medical foods have been developed. Currently, marketed medical foods with a wide variety of claims are used extensively as a life support modality in the management of the critically ill and elderly. They are required to conform only to those regulations dealing with general food safety and labeling to be distributed in the United States.

The 1988 Orphan Drug Act (21 U.S.C. 360ee(b)(3)) provides financial incentives (such as drug application fee exemptions, and market exclusivity) to promote the development of “orphan drugs” for treating rare diseases and conditions. Medical foods were included in the Orphan Drug Act to include dietary therapies, along with pharmaceuticals, as eligible for financial incentives for developing orphan drugs. Medical food was defined within the context of new drug development, not for regulating the use of such products. The Orphan Drug Act did not amend the FD&C Act to add medical foods as a regulatory category.

The Orphan Drug Act definition of medical food is:

A food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.

There are presently no FDA regulations specific to medical foods other than the exemption provisions in the nutrition labeling regulation. The following criteria that clarify the statutory definition of a medical food can be found in FDA’s regulations at 21 CFR 101.9(j)(8). A medical food is exempt from the nutrition labeling requirements of 21 CFR 101.9 only if:

  1. It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube, meaning a tube or catheter that delivers nutrients beyond the oral cavity directly into the stomach or small intestine;
  2. It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone;
  3. It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;
  4. It is intended to be used under medical supervision; and
  5. It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.

FDA published in 1996 an Advanced Notice of Proposed Rulemaking (ANPR) in which the agency discussed its interpretation of the Orphan Drug Act definition of medical food. (https://www.gpo.gov/fdsys/pkg/FR-1996-11-29/pdf/96-30441.pdf) While FDA later withdrew this ANPR due to lack of resources to devote to the subject of medical foods, the agency stated that it still retained the positions described in the document. A subsequent guidance document on medical foods provided advice consistent with positions in the ANPR. (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm054048.htm)

FDA considers the statutory definition of medical foods to narrowly constrain the types of products that fit within the category. Outside of medical foods that have been developed for dietary management of rare diseases, FDA has considered most products marketed as medical foods, not to meet the definition of a medical food. The types of products that have been the target of FDA medical food Warning Letters include products intended for the dietary management of allergies and asthma, lactose intolerance, psoriasis, constipation, Irritable Bowel Syndrome, Crohn’s disease, colitis, arthritis, failure-to-thrive, injury/trauma, pre/post surgery, and prenatal vitamins. The FDA guidance document specifically states that pregnancy and diabetes are not diseases or conditions for which there is a distinctive nutritional need that could only be met by a medical food.

EAS Offers Webinar Series for CHPA

As part of the series EAS is presenting on behalf of CHPA’s OTC Academy, Norma Skolnik will speak to Serious Adverse Events Reporting on February 20th at 2 pm ET. Serious Adverse Events are an important FDA requirement for over-the-counter (OTC) drugs and dietary supplements in the United States. In this webinar, participants will learn the background and history of SAE reporting regulations, the challenges of deciding what constitutes an SAE, when and how to report an Adverse Event as well as the differences between reporting requirements for OTC drugs and dietary supplements vs. requirements for cosmetics.

On March 6th, Senior Director of Dietary Supplements, Tara Lin Couch, Ph.D. will present on Conducting a Scientifically Sound Out of Specification (OOS) Investigation. More information on both webinars can be found in the hyperlinks or by contacting the Consumer Healthcare Products Association.

Product Development and Labeling Service

Product development is a competitive challenge whereby companies attempt to best posture themselves as an attractive option to consumers, an effective competitor against similar products on retail shelves and do so in a manner that meets FDA, USDA and FTC requirements. EAS’ strategic product development and labeling service help companies with all of these challenges and more, providing a comprehensive and holistic approach to product development from ideation to commercialization. A successful product is about more than designing the right label, it must take into account marketing objectives as well as the current regulatory, compliance, and enforcement environments. EAS is proud of this service and the many companies for which we have provided proactive solutions.

We invite you to view a short video on this Strategic Product Development and Labeling service as well as our Industry Service Sheets detailing some of the many challenges within product development and how a partnership with EAS experts would be of benefit.

EAS President and COO to Speak at Keller and Heckman E-Vapor and Tobacco Law Symposium

Keller and Heckman’s Second Annual E-Vapor and Tobacco Law Symposium take place in Irvine, CA February 6-7, 2018. This comprehensive 2-day course will address regulatory issues relevant to e-vapor, e-liquid and tobacco product manufacturers, distributors and retailers including FDA ingredient listings, premarket applications, business and IP issues, environmental issues, litigation, state laws (including Prop. 56 and 65), CPSC, EU TPD, and global regulations. Topics Include:

  • FDA Deeming Rule and Tobacco Control Act Requirements
  • Business and Intellectual Property Issues for Vapor Companies
  • Environmental Issues
  • Litigation
  • State Laws
  • Global Laws

Click here for more information

Armstrong to Moderate Session at FDLI Webinar on First Amendment Issues in Advertising and Product Packaging

Due to overwhelming response at the December FDLI Enforcement, Litigation, and Compliance Conference on the topic of First Amendment Issues in Advertising and Product Packaging, FDLI will be hosting a webinar on subject February 13, 2018, from 2:00-3:30 pm ET. EAS Independent Advisor Steve Armstrong will moderate and panelists include Johan Verheij, Director, Center for Business Law & Regulation, Case Western Reserve University School of Law, August T. Horvath, Partner, Kelley Drye & Warren LLP, and David A. Kluft, Partner, Foley Hoag LLP. For more information on this webinar, click here.

Much Movement on FSMA

Dear Reader,

Edward A. SteeleWelcome to EAS-e-News, the free news update for FDA regulated industries.

There has been quite a bit of movement from the agency on FSMA, including the creation of FDA’s new FSMA landing page on the FDA website. Those companies which fall under the FSMA compliance rules should make a note and save this new bookmark.

The agency also released draft guidance #245 in the area of Hazard Analysis and Risk-Based Preventive Controls for Animal Foods. This particular draft guidance includes food safety plan requirements; recommendations for conducting a hazard analysis; hazards associated with the manufacturing, processing, packing, and holding of animal food; examples of preventive controls that may be used to significantly minimize or prevent animal food hazards; and preventive control management components. Public comment is due to the agency no later than July 23, 2018.

FDA also released new guidance in January indicating the agency is extending the enforcement for a few very specific parts of FSMA. Specifics include:

  • a two-year extension to complete required documentation for any food manufacturer that relies on their customer to control “reasonably foreseeable hazards”
  • a two-year extension for importers of food contact substances to comply with the Preventive Controls rule
  • September 17, 2018, for all Grade “A” dairy plant’s to be in compliance with the Preventive Controls rule
  • a number of extensions for certain farm-based activities including holding, packing or coloring of raw agricultural commodities as well as cotton ginning and farm water sampling.

One area that the agency will work to improve is addressed in the GAO report indicating the agency’s inadequate oversight and follow-up on voluntary food recalls and is the subject of this month’s FSMA Perspective. FDA’s oversight continues to be a challenging issue for all commodity areas as GAO has also identified challenges in the medical device industry.

Our Issue of the Month article, on how FDA defines Medical Foods is written by our Independent Advisor for Labeling and Claims, Betty Campbell. Medical foods are a very narrow category of foods prescribed by physicians, intended for patients who cannot otherwise meet their nutritional needs and is a commonly misunderstood and misused terms.

I have shared previously in EAS-e-News a new strategic service that we provide to our clients – Product Development and Labeling which combines the resources of some of our most experienced independent consultants to collectively assist companies in determining best paths forward when considering claims such as GMO and other trending claims as well as competitive challenges. There are many second and third order effects to the use of these claims and we at EAS feel that the most successful companies look at these challenges holistically and develop complimentary approaches that consider multiple aspects. I’ll bring to your attention a short video, hosted by EAS Independent Advisor for Food Law and Regulation, and former Chief Food Law Counsel at Campbell Soup, Steve Armstrong which discusses this service. More details can also be found in this issue.

EAS has a number of seminars coming up that we invite you to attend – Dietary Supplement Labeling Compliance, March 5-6 in Logan, UT, and Dairy Processing 101, March 7-9 in Logan, UT, Dietary Supplement GMP Compliance April 4-5, in Denver, CO and Food Labeling Compliance May 29-30 in Alexandria, VA. We are also offering a new GMP Online Short Course based on 21 CFR 111. This two-part online training begins February 22. In addition, through our partnership with HACCP Consulting Group, you’ll find a Developing and Implementing SQF Systems seminar February 26-27 in Dayton, OH.

EAS welcomesour new regulatory intern, Georgetown University student Youthika Gokaraju, who is pursuing a masters degree in Biotechnology with an emphasis in BioBusiness. It has been EAS’ good fortune to have hosted a series of students from this prestigious program over the years and we are pleased to provide a window into the important world of regulatory affairs in the early days of their career.

I’d also like to congratulate EAS Independent Consultant Madhu Soni who was named one of the top five most prolific GRAS experts based on an independent group analysis cited in the prestigious journal Food Chemical Toxicology. The process of submitting a GRAS dossier to FDA can be a daunting process with numerous safety studies and required background documentation. Dr. Soni has been one part of the EAS GRAS team who has facilitated “no objections” for over 18 ingredients and many other self-determinations submitted directly by companies. For a listing of our successful GRAS submissions click here. If your company is considering submitting a GRAS dossier, please consider EAS to help in this process. We would be happy to discuss your project needs and help you to determine the best path forward for your specific situation.

Thank you as always for your interest in EAS and please feel free to reach out to me if you have any comments or questions.

Dietary Supplement Good Manufacturing Practices On-line Short Course

For those seeking a broader overview of GMPs, EAS is offering a new two-part online short course which will cover the basics of working in a GMP environment including personal hygiene, sanitation, the use of Standard Operating Procedures (SOPs), and Good Documentation Practices (GDPs). It will also address the top 5 observations cited in FDA Warning Letters since 2010.

This Short Course, based on the 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, provides a great initial training for personnel unfamiliar with GMPs and can serve as a refresher and annual GMP training requirement.

Each session runs 2.5 hours in length and the dates are February 22nd and March 1st from 1:00-3:30 pm ET and is FREE to EAS clients. Registration is $99 for both sessions for non-clients. Click here for more information and to register.

Ask the Expert 2018 January

By Allen Sayler

EAS is pleased to introduce a new column in our EAS-e-News called Ask the Expert. Each month our expert consultants will answer one question sent in by readers. If you’d like to submit a question, please use the Contact Us link on our website.

Allen Sayler

Today’s question is answered by Allen Sayler, EAS’ Senior Director for Food Consulting Services and pertains to testing of Listeria species or monocytogenes. This question was asked at our recent webinar focusing on Listeria and the full list of questions asked by webinar participants as well as their responses are provided here.

QuestionIs it recommended to test for Listeria species or monocytogenes for all four environmental monitoring zones as well as a finished product for RTE foods?

Sayler: It is not practical or financially possible to establish a finished product testing protocol for RTE foods that is statistically valid. Therefore, a limited finished product testing program that describes taking at least one sample for each day’s production or for each production lot would provide an adequate finished product testing program. It is our opinion that for those processing environments that are associated with moist conditions or the use of water for cleaning the floors, outside of processing equipment, etc.; an environmental monitoring program should be based on detecting Listeria species, with swabbing concentrated on Zone 3 (floors, walls, door knobs, floor drains). Zone 2 should only be included if there are a positive Zone 3 swab and a vectoring strategy implemented to identify the true source. For relatively dry processing environments, it is recommended that Salmonella be the choice for detection of environmental contamination. It is strongly recommended that ATP swabbing is utilized on clean and dry FCS (Zone #1). A calibrated ATP system can provide results within 1 minute and allow the sanitation crew to reclean and re-swab the FCS to ensure it has been effectively cleaned. This approach is “preventive” versus environmental swabbing and testing of Zone #1, which can take up to 48 hours to get results as well as a similar delay it obtaining results for finished product testing for the presence of L. mono. or Salmonella. Microbial testing of Zone #1 and the finished product is “reactive”, not preventive.

EAS Webinar Replays Available for Viewing

Two new webinar replays have been added to the EAS Consulting Group website under the Events tab. We hope that you find these webinars informative. Should you have any questions, please reach out to Senior Director for Food Consulting Services, Allen Sayler.

Unraveling The Impact of FSMA On Acidified Food Regulations presented by EAS Independent Consultant and University of Vermont professor Omar Oyarzabal, Ph.D. and FDA Consumer Safety Officer Priya Rathnam.

Key Changes in SQF 8.0 presented by EAS Independent Consultant Susan Moyers, Ph.D., and SQFI Senior Technical Manager Kristie Grzywinski.

EAS Independent Consultants Offer Pharmaceutical Seminars for CfPIE

We are also pleased to announce the expansion of our regulatory training seminars in the area of pharmaceuticals through a partnership with CfPIE (the Centers for Professional Education and Excellence). CfPIE is a training company focusing on technical aspects of pharmaceutical, medical device, biotech, and cosmetics industries and EAS Independent Consultant Priya Jambhekar and independent Advisor for Pharmaceutical Submissions, Albert Yehaskel will instruct courses on Preparation of FDA Submissions and Communicating with FDA, and Stability Programs for Determining Product Shelf Life. The first offering of these courses will be held at the CfPIE headquarters in Malvern, PA in March, with additional courses to follow throughout the year in Boston, Los Angeles and Berlin. Detailed information can be found on the CfPIE webpage.

FDLI Publishes Article on The Value of FDA Pre-Submission Meetings & Enhancements under PDUFA VI Authored by EAS Regulatory Intern

The prestigious FDLI Update November/December 2017 Student Corner included an article written by EAS Regulatory Intern and recent Georgetown University graduate, Rahul. The article, The Value of FDA Pre-Submission Meetings & Enhancements under PDUFA VI, discusses how pharma companies can manage risks through proper communication with FDA throughout the drug development process.

Dynamic Year Ahead

Edward A. Steele - Chairman and Chief Executive Officer (CEO)Welcome to the January 2018 issue of EAS-e-News, our free news update for industries regulated by the Food and Drug Administration.

As with any new year, we are excited for all it will bring – anticipating new product innovation, compliance dates for regulatory requirements and expectations by the agency on matters affecting our industry.

Speaking of new product innovation, December saw a number of new efforts by the agency including a comprehensive technical framework and regulatory pathway for manufacturers of medical device products created on 3D printers. The agency has even approved its first drug which, through a porous matrix created on a 3D printer, enables patients suffering from seizures to benefit from the drugs more quickly.

This emerging technology is advancing quickly. Scientists at CDER are researching how the 3D printing of drugs impacts inactive ingredients and other drug components and engineers at CDRH are investigating the effects of design changes on safety, performance, fit and functionality. In a Guidance document released in December, FDA clarifies thoughts on 3D printing device design, testing of products and quality system requirements. This is an exciting time in the device industry and we look forward to the innovations in years to come!

Our Issue of the Month article on pharma data integrity is written by Independent Consultant, Brian Nadel. Brian discusses validation concerns and reminds us that electronic data systems must be validated at each site, using company-specific systems. He also reminds us that once FDA finds some of a company’s data to be unreliable, it considers all of the data unreliable. Stay vigilant to avoid problems down the line.

We welcome three new independent consultants – Gustavo Gonzales, Ph.D., Steve Cammarn, Ph.D. and Karen Dixon. Dr. Gonzales has a long history of assisting the food industry with safety and regulatory compliance, having held roles at Sillliker, Specialty Foods Group and Jack in the Box, and Dr. Cammarn is an expert in pharmaceuticals and personal care products with a particular focus on quality assurance of manufacturing, research and development, and Ms. Dixon is a specialist in the area of tobacco who most recently oversaw Quality Management Systems at Altria.

In addition, I would like to congratulate Cathryn Sacra who has been promoted to Director of Labeling and Cosmetics. Cathryn has been with EAS since 2008, serving in roles of increasing responsibility. She is an asset who, in her new role, will have direct oversight of projects focusing on the labeling of foods, dietary supplements, and cosmetics. I’d also like to welcome Susan Catloth who is joining EAS as the office manager.

In this issue, you will read about three expanded partnerships for EAS in the areas of SQF, pharmaceutical, and OTC regulatory training. We look forward to working with HACCP Consulting Group (SQF), CfPIE, (Pharmaceutical) and CHPA (OTC) to bring the best information on regulatory requirements to the widest audience. We look forward to seeing you at one of our upcoming seminars and webinars.

We are also introducing a new section called “Ask the Expert”. We receive numerous questions through the Contact Us link on our website, many of which we feel would be of interest to industry-at-large. In this new section, our Independent Consultants and Senior Directors will answer common questions of concern, removing any company-specific information of course. We hope you’ll find this new section to be of interest and we invite you to submit any questions that you’d like to “Ask the Expert” here.

As always, thank you for your interest in EAS and we invite you to share this newsletter with your colleagues.

Best Wishes for the Holiday Season,

Sincerely,

Ed Steele,
Chairman

EAS Webinar on the Role of Your US Agent

EAS Senior Director for Pharmaceutical and Medical Device Consulting Services, Bryan J. Coleman and Regulatory Specialist, Victoria Pankovich will co-present an EAS webinar on the Role of Your US Agent in a webinar February 27, 2018, at 10:00 am eastern.

Join us to gain a better understanding of the important basic requirements of the US Agent as well as opportunities to enhance your understanding of FDA oversight of foreign facilities.

You may register for this webinar on the Role of a US Agent by clicking here.

Cirotta to speak at Keller & Heckman Forum on e-Vapor and Tobacco

EAS President and COO, Dean Cirotta will speak at the February 6-7, 2018 Second Annual E-Vapor and Tobacco Law Symposium in Irvine, CA. This comprehensive 2-day course will address regulatory issues relevant to e-vapor, e-liquid and tobacco product manufacturers, distributors and retailers including FDA ingredient listings, premarket applications, business and IP issues, environmental issues, litigation, state laws (including Prop. 56), CPSC, EU TPD, and global regulations. Click here for more information.

Validating a Contract Laboratory – Infographic

Natural Products Insider posted an infographic on considerations for validating a contract laboratory with materials compiled from a number of 2017 Supplyside West Presentations, including that of EAS Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D.

Meet Issue of the Month Author, Brian Nadel

Brian Nadel works with domestic and international clients on matters of FDA compliance and Current Good Manufacturing Practice Regulations (GMPs) as they relate to pharmaceuticals (OTC, prescription and APIs). Mr. Nadel conducts quality based audits, mock-FDA inspections and inspection readiness audits to assess site compliance with applicable requirements and assists with FDA-483/Warning Letter remediation and responses as well as general quality system CAPAs. Mr. Nadel has been a consultant since 2012, with prior careers at both FDA and industry. Mr. Nadel was the Senior Director, US Quality & Compliance and GMPs at Sanofi-Aventis, and Senior Compliance Manager, Corporate Quality & Compliance, GMP Compliance Assessment at Forest Laboratories, Inc. Mr. Nadel also worked as a compliance officer and investigator at FDA’s Center for Drug Evaluation and Research.

Pharma’s Problems with Data Integrity

By Independent Consultant, Brian Nadel

Data Integrity needs to be taken seriously in the pharmaceutical industry today and always! The FDA has issued many Warning Letters and Import Alerts to dosage form and Active Pharmaceutical Ingredient (API) manufacturers in the past several years. Manufacturers need to understand that once FDA finds some of your data to be unreliable, then they consider all your data unreliable. Many companies continue to use paper records [21 CFR Part 11 does not require you to use electronic records] and this is acceptable.

Problems have been found recently with the lack of compliance with chromatographic data acquisition systems used in quality control laboratories to test the potency of drugs and API. These data systems such as LIMS and Empower must be validated to comply with the regulations in 21 CFR Part 11. Electronic audit trails include those that track creation, modification, or deletion of data (such as processing parameters and results), those that track actions at the record or system level, such as attempts to access the system or rename or delete a file.

The Data Integrity regulations have been official since 1997. These new regulations have enabled a new industry to sprout, 21 CFR Part 11 compliant hardware and software. In addition to the hardware and software companies, consulting companies specifically focused on Data Integrity Compliance have also arisen. Please use caution as these electronic data systems must be validated at your site, using your systems, to truly claim that these systems are validated. Do not just take the vendor’s word for it that their data systems are compliant with this new regulation.

FDA expects that data to be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks. This should be based upon their process understanding and knowledge management of technologies and business models. In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of Industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health. Not to mention compliance with FDA regulations is the most sound business model for success.

The following statement is taken from a Warning Letter issued to a foreign manufacturer in 2016:

Our inspection revealed that your firm selectively omitted CGMP records directly related to the testing and manufacturing of your products. You are responsible for the accuracy and integrity of the data generated by your firm. A firm must maintain all raw data generated during each testing and manufacturing operation, including graphs, charts, and spectra from laboratory instrumentation. You must properly identify these records to demonstrate that each released batch was manufactured in accordance with validated parameters, was tested appropriately, and met release specifications. Your firm’s executive management is responsible for ensuring the quality and safety of your products. Implementing adequate controls and systems to prevent omission and manipulation of laboratory data is at the foundation of fulfilling this critical responsibility.

FDA’s Guidance for Industry on Data Integrity and Compliance With CGMP is available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/ guidances/ucm495891.pdf

This guidance contains a wealth of information, which will help companies understand the definitions and requirements regarding data integrity. FDA’s Introduction to this guidance is included as follows: The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211. This guidance provides the Agency’s current thinking on the creation and handling of data in accordance with CGMP requirements. These data integrity regulations are included in 21 CFR Part: 11 Electronic Records; Electronic Signatures. This URL includes the 21 CFR Part 11 regulations: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

As always, consultants with expertise in data integrity, such as EAS Consulting Group, can provide the independent third-party validation that your company needs to ensure processes and procedures are accurately testing the data in question and that data is yielding meaningful results needed to verify integrity and validation. As mentioned, once FDA finds some data to be unreliable it considers all data to be unreliable. Full compliance with 21 CFR 11 will enable FDA to have trust that your data results and ultimately products are safe to market in the US, saving time and money.

Ask the Expert January 2018

By Allen Sayler

EAS Webinar on FDA Draft Guidance: “Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry” October 31, 2017

EAS received an overwhelming response to our recent webinar on controlling Listeria monocytogenes in ready-to-eat foods. As a service to the industry, we thought it would be helpful to provide some of the questions generated by webinar participants answered by EAS Senior Director for Food Consulting Services, Allen Sayler. Please understand that these responses do not constitute consulting advice. Should you have questions or require clarification based on your own company’s situation, please reach out to Allen at asayler@easconsultinggroup.com.

Webinar Participant Questions & Answers:

  1. Can comprehensive, high sample rate finished product testing be used in place of FCS swabs? Answer: Unless the finished product testing protocol is statistically valid, it is strongly recommended that ATP swabbing is utilized on clean and dry FCS. A calibrated ATP system can provide results within 1 minute and allow the sanitation crew to reclean and re-swab the FCS to ensure it has been effectively cleaned. This approach is “preventive” versus a finished product sampling plan which is “reactive”.
  2. What do you recommend for a processing plant that produces RTE foods but during processing, there is no exposure to the environment, prior to packaging? Such as our products are in an enclosed system from Raw Material tank to Mixing tanks and to Finished Good tank. Is 21 CFR 117.130 (c)(1)(ii) fully applied?Answer: 21 CFR 117.130 (c) (1)(ii) states the following:“The hazard evaluation required by paragraph (c)(1)(i) of this section must include an evaluation of environmental pathogens whenever a ready-to-eat food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen.” We are of the opinion that all food processing plants, regardless of whether the product is protected from the environment prior to packaging, need some type of environmental monitoring program.
  3. Is there guidance on what “exposed to the environment” means? What about products that are processed in closed system post killing step, then packaged? Answer: The phrase “exposed to the environment” needs to be taken intuitively. However, based on the answer to #2 above, it is not necessary to “dial-in” term “exposed to the environment” as we are of the opinion every food processing plant should have an environmental monitoring program.
  4. Is the recommendation to test Listeria species or monocytogenes for all four zones and finished product testing for RTE foods? Answer: It is not practical or financially possible to establish a finished product testing protocol for RTE foods that is statistically valid. Therefore, a limited finished product testing program that describes taking at least one sample for each days’ production or for each production lot would provide an adequate finished product testing program. It is our opinion that for those processing environments that are associated with moist conditions or the use of water for cleaning the floors, outside of processing equipment, etc.; an environmental monitoring program should be based on detecting Listeria species, with swabbing concentrated on Zone 3 (floors, walls, door knobs, floor drains). Zone 2 should only be included if there is a positive Zone 3 swab and there is need to use vectoring to identify the true source. For relatively dry processing environments, it is recommended that Salmonella be the choice for detection of environmental contamination. It is strongly recommended that ATP swabbing is utilized on clean and dry FCS (Zone #1). A calibrated ATP system can provide results within 1 minute and allow the sanitation crew to reclean and re-swab the FCS to ensure it has been effectively cleaned. This approach is “preventive” versus a finished product sampling plan which is “reactive”.
  5. Is there a good number of vector sponges to take when finding a Listeria hit? Answer: The simple answer is enough to identify the true source of any positive environmental swab, particularly if the positive was found in a floor drain or on a floor source. Some industry “vectoring” plans take swabs at pre-set distances from the source in quadrants. An example might be 5 feet intervals at 0°, 90°, 180°, and 270°. These samples will provide information on the best direction to continue to gather environmental swabs to identify the true source of the environmental contamination.
  6. When an FCS is tested for Listeria, is the recommendation still that all finished product be placed on hold until a negative test result is confirmed? (For all finished product from the production run in progress when FCS testing was performed). Answer: While there is no requirement by FDA, it is common industry practice that whenever any FCS is tested for Listeria(species or monocytogenes), finished products that contain anything that came into contact with the tested FCS be put on hold until such time as the results of the swabbing are known. If such product were to be released to customers or consumers and the FCS swabbing came back positive for Listeria, then an immediate Class I recall with a public press release would be the likely outcome. Utilizing ATP swabbing technology is a much more effective way to routinely detect and correct unclean FCS.
  7. What would you recommend that facilities producing RTE products with a short shelf life (produce, packaged salad kits, etc.) approach Zone 1 testing?Answer: See the answers to #1, #4 & #6. It is our opinion that there should be no direct environmental swabbing of Zone 1 for Listeria or any other human pathogen. ATP technologies work much better and provide an almost immediate feedback so the unclean FCS can be recleaned and sanitized prior to any contact with food ingredients, food packaging or the food itself.
  8. Do these new guidelines apply to frozen vegetables? Answer: In Section III of the draft Guidance document, any process (freezing) needs to be validated to determine whether there is a listeristatic or listericidal effect that will demonstrate that the food is not adulterated. While frozen vegetables originate from fresh produce covered by the FDA FSMA Produce Safety regulation, microbiologically, the Listeria bacteria is not killed by freezing but does not reproduce (listeristatic). Once frozen vegetables contaminated with Listeria is thawed, Listeria starts to grow and become a human health threat so yes, the FDA draft Guidance would also apply to frozen vegetables. On page 32 of the draft guidance, it states the following, “Many foods are stored in a frozen state – e.g., to extend shelf life before retail sale or as a product available to consumers in the frozen state. L. monocytogenes does not grow at temperatures below freezing (Ref. 12 and Ref. 13). Therefore, freezing is a particularly effective temperature control measure to prevent growth during storage. Freezing will not eliminate L. monocytogenes from foods and cannot be relied upon as a control measure for the elimination or reduction of Listeria monocytogenes.”
  9. How does FDA define finding Listeria spp or L. mono. “on occasion?” In other words, what is “too high” a rate of detection. Answer: We are not aware of any FDA-based numerical definition of finding Listeria “on occasion”, or what is “too high” a rate of detection of Listeria in environmental swabs. Of much more importance to FDA and to customers and consumers in general, is the corrective action follow-up and root cause analysis conducted to identify the true cause of the positive Listeria swab and adjust manufacturing operations to eliminate the real source of the contamination.
  10. What is the FDA expectation of Listeria levels in a plant? Answer: We are not aware of any FDA-based numerical expectation of what might be an “acceptable” number of Listeria swabs being positive versus negative. What is of more importance is the frequency of re-occurrence and response to positive samples. If the same swabbing location was positive for Listeria every other month for 6 months, then that indicates a failure to identify the true root cause. We are aware of an unpublished and non-scientific practice where more than 3 positive in 100 samples, regardless of location, may indicate a more thorough corrective action effort is needed. It is very important that all environmental monitoring results be incorporated into some type of trend analysis to determine if patterns of positive results exist that need additional attention.
  11. How does the FDA Draft Lm Guidance relate to the FDA Food Code and application in the retail grocery environment? Answer: All FDA guidance documents represent FDA’s current thinking on a topic. Many times, this guidance is intended to clarify the section of an FDA law or regulation. The draft guidance specifically states that it is not intended to be applicable to retail food operations. The Retail Food Code (applicable to grocery stores and restaurants) is utilized by FDA to provide the requirements for retail food operations. It is essentially a Public Health Code or model, not an FDA law or regulation, intended for adoption by states, counties and local governments. Modification of the Retail Food Code must be done through submittal of proposals to the Conference on Food Protection, which meets approximately once every two (2) years to consider new proposals.
  12. What is the FDA perspective on the risk associated with finding L. monocytogenes in the environment in raw vs. RTE areas? Answer: We are of the opinion that FDA is utilizing a positive environmental swab result for L. monocytogenes in “raw” areas of the processing facility as evidence that this source could find its way into the RTE areas of the processing operations. They are very likely to intensify their efforts to identify L. monocytogenes in RTE areas. If none is found, FDA is likely at a minimum to note the positive L. monocytogenes result in their Form FDA 483 observations.
  13. Is FDA focusing in finding Listeria in raw areas, while using Whole Genome Sequencing, even if processing facilities have implemented adequate raw-RTE separation and controls? Answer: FDA is utilizing pulsed-field gel electrophoresis (PFGE), multiple locus variable number tandem repeat analysis (MLVA), and whole genome sequencing (WGS) as the main tools for the PulseNet’s fingerprinting of food pathogens. It is our understanding that all positive environmental swabs that detect a foodborne human pathogen are analyzed using PFGE at a minimum, regardless of the location of the swabbing.
  14. Does the guidance doc require zone 1 sampling 3-4 hours into production? Or is that for zone 2 and 3? If it is zone 1, what kind of swabbing is required? Listeria spp? or L. mono.? Answer: An FDA Guidance document cannot “require” anything, but as stated in the answer to #11 above, it is the Agency’s most current views. FDA field investigators are not authorized to enforce any FDA Guidance documents but can use the information in such document as a benchmark to measure whether the industry is taking reasonable precautions to ensure their food is safe. On page 37 of the draft guidance, there is a reference to taking environmental samples 3 – 4 hours after the start of production. On page 36 of the draft guidance, it states, “We recommend that even the smallest processors collect samples from at least 5 sites of FCS and 5 sites of non-FCS on each production line for RTE foods. We recommend that larger processors determine the appropriate number of sampling sites based on the size of the plant.”It is our opinion based on answers to previous questions, that any environmental swabbing is conducted primarily on Zones 3 for the detection of Listeria species. This is not the recommendations from FDA found in the draft Guidance document, which states on page 37,
    • Collect environmental samples from specific FCSs on the production lines at least once every week when the plant is in operation; and
    • Test each FCS in the plant at least once each month.
  15. Does the recommendation to test Zone 1 for Listeria apply to high-risk foods only? Do you expect Zone 1 to be tested in low moisture/Aw food plants? Answer: Based on the current statements in the draft Guidance, FDA appears to be making no differentiation between low-risk, medium-risk and high-risk foods regarding the recommendation to gather environmental swabs for FCS (Zone 1).
  16. What is more powerful? Testing finished product based on ICMSF N=20 or more samples or zone 1 testing (but not test finished products)?Answer: A Zone 1 (FCS) positive test for L. monocytogenes should be considered the same as a positive finished product test. It is our opinion that the preferred testing program for RTE food manufacturers focuses on environmental testing as a means to implement preventive controls rather than finished product testing, which is a reactive approach. Sampling should consist of:
    • A credible number of environmental swabs taken primarily in Zone 3, and
    • Effective corrective actions including additional environmental samples and vectoring for any positive environmental samples, and
    • Utilization of ATP swabbing at every production start-up on a representative number of FCS and immediate recleaning if the calibrated ATP result is “positive”, and
    • Accumulating a set of retailed finished product samples (one from each production lot) and storing these to the end of the shelf life of the finished product, and
    • Test a minimum number of finished product samples (one per production run or production day) for foodborne pathogens, which for most foods would be L. monocytogenes and for dry foods, Salmonella.

Produce Safety Requirements for Large Firms

By Charles Breen, Independent Advisor for FSMA

The coming year will be a busy one for food firms as the compliance date for 14 components of the FSMA Final Rule come into effect. FDA has published a helpful tool, Key Dates for Compliance, which runs through 2024 and this quick, color-coded reference offers a handy visual for determining when the compliance date for each area of FSMA goes into effect.

Of particular note is the compliance date of January 26, 2018 for the Produce Safety Requirement for large firms, (except certain water requirements) which applies to growers of fruits and vegetables that are consumed raw, with a few exclusions – specific types of produce that are rarely consumed raw (such as asparagus, coffee beans and pumpkins); those which would undergo further processing reducing the likelihood of contamination by microorganisms that could harm public health; produce which is grown for personal use; farms which have a three year annual sales totaling less than $25,000 and produce which is not a RAC.

A brief review of the water requirements makes clear why the agency is taking more time to find a way to protect consumers that is also practical and efficient for producers. Right now, the Produce Safety requirements and benchmarks for water testing are designed to be flexible, depending on the agricultural use and whether the water is received from municipal sources or other systems that have acceptable established standards, such as valid certificates of compliance that the water meets relevant requirements, or if the water is treated in compliance with the rule. Its very flexibility is leaving many producers wondering what would work best, if at all, in their own particular case.

Agricultural water is estimated to be the most significant pathway of E. coli contamination. So, it is unacceptable for water used in hand washing during and after harvest, water used on food contact surfaces, that comes in direct contact with produce (including ice) during or after harvest, or that is used for sprout irrigation to have any trace of E. coli.

Untreated surface water that is directly applied to growing produce (other than spouts) is considered to be the most vulnerable to external influences. FDA requires farms to do an initial survey, using a minimum of 20 samples, collected as close as is practicable to harvest over the course of two to four years. After that, an annual survey of a minimum of five samples per year is required. Those five newest samples in combination with 15 of the most recent samples will create a “rolling dataset” of 20 samples for use in confirming the safety of the water in use.

For untreated groundwater that is directly applied to growing produce (excluding sprouts) farms must take a minimum of four samples, again collected as close as is practicable to harvest, during the growing season or over a period of one year. After that, a minimum of one sample should be taken annually and that latest sample, combined with three of the previous samples will create the rolling dataset of four samples confirming that the water is appropriate for use.

The water’s safety is calculated using these samples through a complex statistical process with two sets of criteria for microbial water quality called the geometric mean (the average amount of generic E. coli in a water source) and statistical threshold (the amount of variability in the water quality). The sample’s generic mean must be 126 or less CFU of generic E. coli per 100 mL of water and the statistical threshold must be 410 CFU or less of generic E. coli in 100 mL of water. The determination of these statistical analyses may be confusing and FDA is considering the creation of a usable online tool to help make sense of individual data.

In the many US produce growing areas, the only available water for irrigation is untreated surface water that does not and cannot practically be treated to meet the microbiological criteria in the current rule. There is scant evidence of harm to consumers from the use of these water sources in some areas. At the same time, there is ample evidence of the risk that untreated surface water does cause illnesses in human. FDA is taking more time to sort out why what seems to be equally unacceptable agricultural water does cause illness in some situations but not in others.

There are numerous other components to the Produce Safety Rule such as a Biological Soil Amendment, which is somewhat in flux as the agency continues to assess the number of days needed between the applications of raw manure as a soil amendment and crop harvesting in an effort to minimize the risk of contamination. Currently, FDA thinking states that untreated biological soil amendments of animal origin must be applied in a manner so that it does not contact covered produce during application and minimizes the potential for contact with covered produce after application. FDA also feels that the USDA’s National Organic Program standards, which call for a 120-day interval between the application of raw manure for crops in contact with the soil and 90 days for crops not in contact with the soil to be a prudent approach while it continues its own risk assessment.

There is also a provision for working and grazing animals, whereby farmers that allow animal grazing on land where produce is also grown should take every reasonable step to not harvest produce that is likely to be contaminated and should consider (but are not required) to implement waiting periods between grazing and harvesting.

Workers and visitors to the farm or facilities must be educated on and use good hygiene practices such as washing hands, and workers who handle covered produce and food contact substances must have must have training, education, and experience to perform their responsibilities and have adequate tools, equipment and buildings to do so in a manner that prevents contamination such as appropriate storage, maintenance, clean equipment, and tools.

Lastly, sprouts have received much attention as they are particularly susceptible to microbes causing foodborne illness and there are numerous testing requirements under the Produce Safety Requirement, many of which pertain to water usage. Among other requirements, farms must test spent sprout irrigation water from each production batch or in-process sprouts for certain pathogens. In addition, sprouts cannot be allowed to enter commerce until these pathogen test results are confirmed to be negative.

In an agency Q&A on Water Safety Requirements it was noted that the Produce Safety Requirement is anticipated to bring about a reduction of over 60 percent in the risk of contamination from agricultural water, and a reduction of about 20 percent in the total number of foodborne illnesses associated with produce with an expected overall reduction in costs related to foodborne illnesses of $477 million.

What does all this mean? For one, FDA now has enforceable regulations for both domestic and international produce growers for the safe growing, harvesting, packing and holding of fresh produce. The specific requirements with regards to water testing leave no room for interpretation as to what constitutes a safe supply and FDA will request access to that data history for their own assessments of safety. As with any compliance requirement, accurate and complete documentation is necessary to satisfy FDA requirements. Under § 112.161(a)(1), all records required must include, as applicable, the name and farm location, actual values, and observations obtained during monitoring, an adequate description of covered produce applicable to the record, the location of the growing area or other areas applicable to the record, and the date and time of the activity documented, signed and dated. These records must be kept in a safe location, whether electronic or paper storage for a period of time. That time, however, is currently undetermined as FDA has not yet addressed issues related to traceability and additional record keeping of high-risk foods as mandated under FSMA section 204.

Visit FDA’s FSMA Final Rule on Produce Safety for more details on the components of the Produce Safety Rule including Draft Guidance for Industry for the Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption of Sprout Operations.

After January, the next FSMA compliance date will be March 19, 2018, with new requirements for importers of human and animal foods. Stay tuned…

EAS Partners with HACCP Consulting Group on SQF 8.0 Seminars

EAS Consulting Group is pleased to partner with HACCP Consulting Group, a Safe Quality Foods Institute (SQFI) Training Center, for training programs aligned with the SQF Code, edition 8.

The next seminar in Chinese Camp, CA, February 6-7, 2018 followed by Dayton, OH, February 26-27, 2018 is on Developing and Implementing SQF Systems. This course provides instruction, examples, exercises, and tools necessary for successfully implementing an SQF System. This is one step in the qualification process for SQF Practitioners and an excellent choice for all food safety team members.

EAS Welcomes Three New Independent Consultants

Stephen R. Cammarn, Ph.D.

Stephen Cammarn is an expert in pharmaceuticals and personal care products with a particular focus on quality assurance of manufacturing, research and development. Prior to consulting Dr. Cammarn built a career at The Procter & Gamble Company where he oversaw quality assurance and quality control in plants across six continents and had direct oversight in areas such as formulation, process engineering, and technical services. Dr. Cammarn’s doctorate is in Pharmaceutical Science from The University of Cincinnati and his bachelors are in Chemical Engineering from Ohio State University.

Karen Dixon

Karen Dixon consults in the area of tobacco. She has a strong focus on the development and implementation of FDA readiness programs including processes, compliance considerations and integration within all levels of an organization (Regulatory Affairs, Quality System, OSHA, ISO, Sarbanes-Oxley). Her unique combination of expertise in operations, training systems, finance, product quality, Quality Management Systems, regulatory affairs, and ISO-9001-2015 makes her a valuable asset to EAS clients. Karen has held positions such as Manager, Quality Management System at Altria and Philip Morris USA. She has an MBA from Montreat College in North Carolina and is a Certified Quality Auditor (CQA) with the American Society for Quality.

Gustavo Gonzales, Ph.D.

Dr. Gonzales has a long history of regulatory compliance strategic planning. He is an expert in food safety and quality with a particular expertise in meat sciences and has a 24-year track record of implementing policies and procedures that align with industry R&D trends and best practices at companies such as Jack in the Box and Specialty Foods Group. Dr. Gonzales works in a variety of food sectors on programs such as allergen control/prevention, auditing functions, distribution systems, environmental monitoring, FSMA, GFSI, retail operations, and sanitation. He has a Ph.D. in Meat Science from Iowa State University with certifications as a Food Safety Manager, International Dairy Foods Association HACCP, and is a Lead Instructor for FSPCA Preventive Controls for Human Foods.

EAS Partners with CHPA OTC Academy for Webinar Series

EAS is pleased to partner with the Consumer Healthcare Products Association (CHPA) starting in January 2018 for a five-part webinar series focusing on a number of topics of interest to the industry. EAS Independent Consultants will present topics on Managing Foreign FDA Inspections, Adverse Events Reporting, Conducting a Scientifically Sound OOS Investigation, Managing Domestic FDA Inspections and Responding to 483s and Warning Letters, all of which are open to CHPA members and non-members.

January’s webinar on Managing Foreign FDA Inspections is presented by Peter Saxon. He’ll discuss regulatory problems often found in FDA inspections, how OAI (Official Action Indicated) results are categorized by the FDA and the ensuing consequences, and on-going steps companies can take in an effort to maintain good oversight of facilities.

Cathryn Sacra Promoted to Director, Labeling and Cosmetics

Cathryn SacraEAS clients who need assistance in the area of labeling and cosmetics are well familiar with Cathryn Sacra, who was recently promoted to Director of Labeling and Cosmetics. Cathryn has been with EAS since 2008, serving in positions of increasing responsibility. She holds an undergraduate degree from Harvard University.

Susan Catloth Joins EAS as New Office Manager

Susan Catloth recently joined EAS as office manager. Susan brings a wealth of organizational and skills and experience to the team and will assist with various projects as well as provide front-line communication and service for those contacting EAS home office. Prior to EAS, she worked at the Motley Fool where she held the positions of Project Manager, Investing Team, and Video Operations Manager. Susan’s skills in video and content production will enable EAS to expand our digital training platforms.

December 2017 FDA Drug / Medical Device Activity

We would like to highlight one of the Draft Guidance issued by the FDA this month.**The U.S. Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. This proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices. Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product.

With the new drug listing regulation, all companies have been given a renewed opportunity to ensure their listings are complete and accurate. This includes the label uploaded to the drug listing. The FDA recently issued a warning letter to a company whose listing did not match the product in commercial distribution. Do keep in mind that the FDA requires all changes to a drug listing to be reported as soon as possible but no later than the June or December following the change. As of FDA FY 2018, all drug listings must be certified as accurate by 31 December of each year. Any listing that has not been updated or certified as accurate according to the regulation will be considered expired by the FDA in January of the following year.

Guidance Document updates on the FDA website:

CDER:

CDHR:

CBER:

CDRH and CBER: