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
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.





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.