Category Archives: From the Desk of the Chairman

Protection Against Intention Adulteration is High Priority for FDA

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Dear Readers,

Edward A. Steele

Welcome to the October issue of EASeNews, the free newsletter for industries regulated by FDA.

If you missed it FDA has released an online Food Defense Plan tool which will help companies think through the important requirements and action steps of developing this important protection against Intentional Adulteration. If you missed our webinar on Food Defense in September, our Independent Advisor for FSMA, Charles Breen and Independent Consultant, Kathy Knutson, Ph.D. did a fantastic job laying out FDA’s expectations, who is expected to comply and how to begin developing a food defense plan. I invite you to watch it free On-Demand.

Additionally, on the food front, a reminder to firms exporting seafood products from the U.S. to the EU that FDA updated three Export Listing Module (ELM) requirements. Effective September FDA has fully transitioned to the ELM for the EU dairy export list and all export lists maintained for Chile and China.

U.S. establishments that are currently included on the EU collagen, gelatin, or seafood export lists should submit applications in the ELM if they wish to remain on these lists and effective immediately, any U.S. establishment that wishes to be included on any FDA-maintained export list for food products should apply in the ELM. Contact EAS with any questions.

FDA also published final Guidance for medical device companies seeking to file a 510(k) based on Safety and Performance Criteria and draft guidance on a pilot program assessing consistency and predictability of premarket reviews for medical devices through a voluntary conformity assessment initiative, called the Accreditation Scheme for Conformity Assessment (ASCA) Pilot. More information on both, as well as other FDA initiatives, can be found in the Drug Device Corner.

We have a very interesting issue of the month article written by Greg Weilersbacher that discusses the importance of equipment change control. How often do we purchase a new piece of equipment without fully vetting the additional or different requirements on utilities. Planning for these upgrades before they are installed can save countless hours, additional cost and frustration later.

Our Ask the Expert is answered by Cathryn Sacra and discusses the importance of restaurant menu labeling compliance. As you know EAS has a labeling team that helps clients with food and dietary supplement labeling issues. Our labeling team also includes experts in restaurant menu labeling, and services run the gamut of identification of qualified labs to reviewing product specs for label development and accuracy verification.

EAS is exhibiting and speaking at numerous trade shows and conferences this month, the details of which you’ll find in the EAS in Action section. I would also like to remind you of our complimentary webinars coming up on navigating Customs and Border Patrol for imported FDA products; a look at FDA observations related to dietary supplement compliance; a continuation of our food fraud webinar with a closer look at analytical tools; and an in-depth overview of what it takes to be a expert witness in legal proceedings. All of this information can be found in EAS in Action as well.

Lastly, if you have not already registered for our November food labeling, dietary supplement labeling and dietary supplement GMP seminars taking place in Irvine, CA I encourage you to do so. Seats are still available. We also have a one-day dietary supplement GMP refresher training in November in Long Island. You may find registration information on the EAS website.

Thank you as always for your interest in EAS and please reach out to me with any questions.

Sincerely,

Edward A. Steele Signature

Ed

FDA Begins Enforcement of FSVP

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Dear Readers,

Edward A. Steele

Welcome to the September 2019 edition of EASeNews, the free news publication dedicated to FDA regulated industries.

FDA issued its first warning letter related to FSVP Final Rule enforcement of FSMA. The industry has long been anticipating FDA’s enforcement vs educational-based approach to FSVP. After two years of working to ensure importers of foreign foods and foreign food ingredients understand their requirements to verify supplier safety policies and track records, the Agency will now begin cracking down on those firms still not in compliance. EAS’ Team FSMA offers comprehensive services in the area of FSMA and FSVP. From desk audits of current policies to mock-FDA inspections of facilities, our experts help you to identify gaps and develop actions plans to mitigate risks. Learn more about our services by viewing our short promotional videos and reviewing our industry services sheets.

Additionally, FDA has indicated that drug firms that do not certify updated information or that no changes have taken place since the last renewal cycle can expect FDA to begin delisting products which can lead to misbranding. FDA has been taking an educational-based​ approach to the enforcement of product and facility renewals, however in a constituent update dated August 13, 2019, the Agency confirmed firms can expect greater hardships for not complying. EAS offers assistance with registrations and listings of both facilities and products as well as proactive annual updates and renewals. We invite you to contact us to learn more about our services and how we may assist you.

I am pleased that EAS has been invited to participate in educational sessions at a number of industry events this month. From FDLI to CHPA to NCBFAA to a keynote speaker at an international dairy event in Turkey, our experts will be traveling the globe in September ensuring FDA compliance is at the top of everyone’s agenda.

Additionally, we are offering a number of complimentary regulatory webinars with topics ranging from Food Defense, (September 12); to Quality Management Systems for medical devices (September 25) and a reintroduction to our expert witness training via webinar on November 6. There is always something new happening at EAS and we look forward to your participation in any of our regulatory events.

Our issue of the month is written by Tom Jonaitis and discusses common pitfalls with GRAS submissions. If you missed our recent webinar on GRAS submissions, presented by Robin Guy and Robert Kapp, you may now view it on demand. EAS has a dedicated team of toxicologists and regulatory scientists who regularly assist EAS clients with both GRAS and independent GRAS submissions.

Finally, we welcome new consultant, Penny Vyskocil, an expert in food safety in a variety of product types, from cereal, snacks, dry meals, IQF vegetables, Low Acid Canned Food (LACF) and milling.

Thank you for your interest in EAS and as always please feel free to contact me if you have any questions or if EAS can be of assistance.

Sincerely,

Edward A. Steele Signature

Ed

Expediting Imports at U.S. Ports of Entry

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Dear Readers,

Edward A. Steele

Welcome to the August issue of EASeNews, the free newsletter for industries regulated by FDA. We had numerous questions after the brief mention of FDA’s new requirements for identifying and communicating information on high-risk foods. Our Independent Advisor for FSMA, Charles Breen is shedding light on the subject in this month’s Ask the Expert when he answers our most frequently received question – How is the risk-base of a high-risk food determined?

Bill Scopa, who was formerly with Customs and Border Patrol, has provided a very interesting article on CPB and steps firms importing products into the U.S. marketplace should take to ensure expeditious entry. As you know, EAS Consulting Group is frequently called upon to assist firms which have detained products for any number of reasons. EAS acts as a U.S. Agent for foreign firms and can assist you with import requirements per FDA and USDA regulations. Contact us to learn more about these services.

Registration for our November 6 Expert Witness seminar is underway. Expert Witnesses are relied upon for their opinion reports and testimony as cases are adjudicated through arbitration, mediation and trials. Our Independent Consultant, Ron Levine, who is also General Counsel at Herrick Feinstein will conduct a one-day seminar to help those interested or already acting as an Expert Witness to improve their skills and positioning as an expert when called upon to act in this capacity. Learn more and register here.

We also invite you to join us August 22 for a complimentary webinar on GRAS submissions. This will cover pertinent information that must be included in a GRAS submission, as well as pitfalls firms face when preparing the dossier. Additionally, there will be a discussion on the process once submitted and expectations for working with FDA’s OFAS during their review. For more information, and to register click here.

Lastly, we welcome Rebecca Harter to the EAS team of independent consultants. Rebecca has a unique skillset with her background in sensory experience including blending for optimal texture development and quality, flavor development and product stability.

Thank you for your interest in EAS and as always please feel free to contact me with any questions and to share this newsletter with your colleagues.

Sincerely,

EAS Signature Ed

Ed

FDA Strengthens Commitment to Defining High-Risk Foods, FSMA Enforcement

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Dear readers,

Welcome to the July edition of EAS-e-News, the free newsletter for industries regulated by FDA. FDA took an important step this month when it agreed to settle a lawsuit filed by the Center for Science and commit to defining a designated list of “high-risk” foods as well as a proposed rule for high-risk food record keeping requirements by September 8, 2020. Additionally, the final rule will be established no later than November 7, 2022. Originally, Congress mandated that FDA designate high-risk foods by January 2012 and propose recordkeeping requirements for facilities that handle those foods by January 2013, so this renewed effort is welcomed as an important protection against food-borne illnesses which sickens countless annually.

I am pleased to say that EAS is an invited training partner for two upcoming events. First, Tara Lin Couch, Ph.D., Senior Director for Dietary Supplements and Tobacco Services will present a workshop on dietary supplement GMPs along with long-time training partner Marc Ullman, Of Counsel at Rivkin Radler, at the upcoming AHPA Hemp-CBD Congress taking place in Denver, August 14-15, 2019. Additionally, EAS will bring its popular Dairy Processing 101 seminar to the Process Expo in Chicago, October 8-11, 2019. More information on both of these seminars can be found in the EAS in Action section of this issue.

Additionally, EAS is announcing a new training seminar that we are very excited about. Coming on November 6, 2019, EAS Independent Consultant and General Counsel at Herrick Feinstein, Ronald Levine, will instruct a full-day event in Alexandria, VA on how to become, and strengthen skills, in the important service of providing Expert Witness services for FDA litigation, arbitration and mediation matters. EAS has over 30 consultants who serve in the capacity of Expert Witness. This important and critical component, as part of a comprehensive legal team, has become a critical factor in the demonstration of compliance expectations.

We invite you to join EAS at the International Association of Food Protection Annual Meeting, July 21-24, 2019 in Louisville, KY. EAS will be exhibiting at booth #319 and additionally independent consultant PC Vasavada will be speaking as part of an esteemed panel, along with Senior Director Allen Sayler, on FSMA compliance and FDA enforcement. You may wish to also view our recent webinar, Understanding the Food Fraud Puzzle, available on-demand on the EAS website.

I am pleased to welcome two new independent consultants, Rama Narasimhan and Angel Suarez. I am always impressed with the caliber of independent consultants who choose to work with EAS for the benefit of our clients. I invite you to learn more about both in the Who’s Who section of this issue.

I hope you enjoy this issue and please feel free to share with friends and colleagues who may also have interest.

Sincerely,

EAS Signature Ed

Ed

Challenges with Implementing Pharma Cleaning Validation

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Edward A. Steele

Dear Reader,

Welcome to the June 2019 issue of EASeNews, the free newsletter for FDA regulated industries. FDA has been busy with initiatives this month. As you’ll see in our What’s New at FDA section, two of these include FDA’s finalized Guidance for abbreviated drug submissions as well as food contact notifications products that come into contact with infant formula and human milk. Additionally, FDA announced the decision to extend the registration period for the Voluntary Qualified Importer Program (VQIP) for fiscal year 2020 until July 31, 2019. Annual benefits will then take effect beginning October 1. VQIP is a voluntary fee-based program established by the FDA FSMA that provides for expedited review and importation of human and animal foods into the US for approved applicants who achieve and maintain a high level of control over the safety and security of their supply chains. If you feel your company qualifies for VQIP or would like an assessment or assistance completing the application process, please feel free to contact me.

I am happy to say EAS has announced our fall line-up of compliance seminars taking place in Irvine, CA. We are offering Dietary Supplement Labeling November 12-13, 2019 Food Labeling November 14-15 and Dietary Supplement GMPs November 14-15. We invite you to register now for early-bird pricing.

We welcome two new consultants this month, Tom Jonaitis and Veronica Ortiz de Montellano, both of whom will be of invaluable assistance particularly to clients working with both USFDA and Health Canada as well as firms operating in Mexico who export products to the US.

Our issue of the month is written by Miguel Montalvo and discusses some of the many challenges with pharmaceutical Cleaning Validation. This article is a condensed version of a full-length feature published by the International Society of Pharmaceutical Engineering’s website, ISPE iSpeak. EAS consultants are pleased to provide monthly articles for ISPE iSpeak readers on a variety of topics pertaining to the pharmaceutical and OTC-drug industry. Our Ask the Expert is written by Robert Fish, Independent Advisor for Quality and Compliance and discusses Adverse Events Reporting requirements; and our Did you Know covers EAS capabilities with Contract Research Organizations (CROs) which are heavily utilized and a lifeblood for companies conducting safety studies in the preparation of food additive submissions.

We have two complimentary webinars coming up in June – on June 18 independent consultant Mehrdad Tajkarimi, PH.D. and Leann Chuboff of SQFI will discuss the food fraud puzzle. This webinar is co-sponsored by Food Safety News magazine. On June 20 Bryan J. Coleman, Senior Director for Drugs and Devices will present on GMPs for OTCs and how to improve compliance. We hope that you join us for these and watch any of our previous webinars available on-demand on the EAS website, including May’s webinars on cosmetics claims and how FDA views certain terms when considering whether a product to be a cosmetic or unapproved new drug; and compliance with 21 CFR Part 11.

Thank you as always for your interest in EAS and please feel free to share this newsletter with your colleagues.

Sincerely,

Edward A. Steele Signature

Edward A. Steele

Pharma’s Big Data, Real World Evidence and The Digital Revolution

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Dear Reader,

Edward A. Steele

Welcome to the May 2019 edition of EAS-e-News, the free newsletter dedicated to FDA regulated industries. It has been a busy month at EAS, with the release of new complimentary On-Demand webinars, announcements of new training seminars, publication of numerous articles on a wide-variety of subjects as well as a fantastic attendance at the EAS booth during the recent Supplyside East. For those of you who had an opportunity to meet with Tara Couch, our senior director for dietary supplements and Heather Fairman, one of our expert independent consultants I am sure you came away with a lot of great information on EAS and how we can begin to assist your company with any number of FDA requirements. For those who were unable to attend, I invite you to take a look at our quick reference information sheets to learn more about EAS. We are always glad to speak with you about your GMP questions or concerns.

If you will be in Geneva for Vitafoods Europe, May 7-9 we invite you to come by the EAS booth, B149, to meet Tara Couch and Charles Breen, our Independent Advisor for FSMA. In addition to exhibiting at Vitafoods, EAS is a proud training partner for the show, offering a one-day comprehensive look at GMPs for the dietary supplement industry. Registration for this seminar, taking place May 6, the day before the official start of Vitafoods, is being handled through Vitafoods directly. In addition, Charles Breen will be speaking as part of the technical sessions on hygienic commitments for food safety.

FDA has OMB approval to initiate a short voluntary survey of the cosmetics industry, which will assess a variety of GMP aspects. This survey is important to help FDA gain a better understanding of the current state of industry GMPs, and the results provided to FDA will have no identifying information, nor will responses be used by the agency to initiate enforcement actions. A Federal Register notice regarding the survey can be found here and we encourage cosmetics firms to participate in this effort.

In other FDA news, a new effort to bolster the collaboration between FDA and the Customs and U.S. Border Patrol (CBP) is underway to better protect against illegal and harmful products from gaining entry into the U.S. through the mail system, or other ports of entry. More information on this effort can be found in the What’s New at FDA section of this edition.

As mentioned earlier, we are pleased that numerous compliance seminars are both approaching and new on the horizon. Our next GMP One-day Refresher training will take place in Denton, TX on May 7, and then Andover, MA on August 13, just outside of Boston. This one-day session is designed as an opportunity to outsource your department’s GMP refresher training. At just $300 per registration it is a great and cost-effective opportunity for your entire team to learn from our experts. More information can be found on the EAS website.

Additionally, we have two complimentary webinars coming up in May. On May 7 join Norma Skolnik for a look at how FDA eyes certain cosmetics claims and on May 14 join Jeff Roberts for a look at compliance with 21 CFR Part 11. Also, on June 13 we invite you to join EAS Senior Director for Pharmaceuticals and Devices, Bryan Coleman for a look at GMPs for OTCs.

Our issue of the month is written by John Brennan and looks at pharma big data, real world evidence and the Digital Revolution and our Ask the Expert on FDA’s plans to revamp the 510(k) process is answered by George Yanulis. Finally, I am pleased to welcome a new independent consultant, Dennis Gaalswyck and a new office manager, Kate Gibson. Learn more in our Who’s Who section of this edition.

As always, thank you for your interest in EAS and we invite you to share this newsletter with your colleagues.

Sincerely,

Edward A. Steele Signature

Ed Steele
Chairman and CEO

Crossing T’s and Dotting I’s – Preparing for a FDA Preventive Controls Inspection

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Dear Reader,

Welcome to the April 2019 edition of EASeNews, the free newsletter for industries regulated by FDA.

Edward A. Steele

We are pleased to announce our latest short video describing the many services that EAS provides. This month our regulatory specialist, Victoria Pankovich, shares the various FDA requirements for company registrations and product listings. As you may know, the complexities of registrations differ by product category, and not all commodities are required to list their products. EAS helps you to sort through what is required and what information is needed to comply with FDA regulations in this regard. Should you wish to outsource this annual or biannual requirement, EAS is available to help.

If we missed you at our recent food and dietary supplement labeling compliance seminars in Philadelphia, it is not too late to purchase the companion handbook for the seminar. The Food Labeling Handbook and the Dietary Supplement Labeling Handbook were written by instructor Gisela Leon and share points on how to ensure label accuracy, from what and how information must be covered to more detailed specifics of FDA compliance. To purchase your copy please visit the EAS store.

If you haven’t registered for our one-day seminar Ensuring Regulatory Compliance of GMP Laboratories seminar which will be taught by Senior Director Tara Lin Couch, Ph.D. in Denver on April 23, there is still time. This one-day intensive program will discuss FDA’s current GMP requirements for Research and Development and Quality Control Laboratories and will highlight FDA issues of concern with emphasis placed on recent FDA regulatory or administrative actions. All of this will allow participants to gain an understanding of the importance of laboratory GMPs and how to meet FDA’s requirements. Please join us in Denver!

Our issue of the month author is Joe Famiglietti who discusses preparing for a FDA Preventive Controls inspection. Our Ask the Expert is answered by Tim Hansen and discusses how seafood importers can protect themselves from unscrupulous suppliers. Lastly our new section, Did you Know? covers EAS expert witness considerations, an area in which EAS is proud to have deep roots with our over 50 independent consultants who can act in an expert witness capacity.

We welcome a number of new consultants this month: Robert Post, Heidi Stuttz, Jan Janson, William Scopa and Joel Martinez. I invite you to learn more about their backgrounds in Who’s Who.

Thank you as always for your interest in EAS and please feel free to forward this newsletter onto a colleague or link with us on LinkedIn.

Sincerely,

Edward A. Steele Signature

Ed Steele
Chairman and CEO

Will Pathogens Cause FDA to Suspend Your Food Facility Registrations?

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Dear Reader,

Welcome to the March 2019 issue of EASeNews, the free newsletter for industries regulated by FDA. It is hard to believe it is already March and with spring right around the corner, if you haven’t already signed up for your “spring training” I invite you to join EAS at one of our upcoming regulatory compliance seminars. Food and Dietary Supplement Labeling will be held in Philadelphia beginning March 12, 2019; the Dietary Supplement GMP two-day seminar will be held April 2-3, 2019 also in Philly; the Compliance with GMP Requirements for Dietary Supplement Laboratories seminar will take place April 23, 2019 in Denver and May 7 begins our four Dietary Supplement GMP One-day Refresher Series. The first Refresher takes place in Denton, TX, just outside of Dallas on May 7th, and the second takes place in Riverside, CA on May 14th. We invite you to join us!

In addition to seminars, we have a number of complimentary webinars this spring, with two new topics recently added. What Does the 2018 Farm Bill Mean for the Cannabis Industry? will take place on March 13, 2019, and Dietary Supplements and FSMA Compliance – Fallacy or Fact? will take place April 16, 2019. As you know, we take great pride in bringing you important regulatory information which can help you develop and improve practices to meet FDA requirements. To learn more about these two newest webinars or to see our entire line up of spring EAS webinars, please visit the webinars page of the EAS website. From OTCs, to Cosmetics, to Cannabis to Dietary Supplements, we have something for you.

I am very pleased to welcome a number of esteemed colleagues who are new EAS Independent Consultants. This month we welcome Janet Collins, Sophia Lily, Jay Mansour, Jeffrey Roberts, and George Yanulis. You may read more in the Who’s Who section of this issue. 

Our issue of the month is written by Kathy Knutson, Ph.D. and concerns a very real problem for the industry – that of the identification and storage of pathogen genomic information in database trackers which can years later reemerge as a problem for a facility, even when the pathogen is not isolated in a finished product. Dr. Knutson raises interesting questions and I encourage everyone to use this article as a starting point to renew your commitment to sanitary facilities and hypervigilance against contaminations.

Our Ask the Expert is answered by Ronald J. Levine, who is both an EAS Independent Consultant and General Counsel at the firm Herrick, Feinstein LLP and discusses the importance of finding an expert witness that will well represent your firm in litigation, mediation matters, the preparation of expert opinion papers and more. EAS has nearly 70 consultants who we recognize as experts who can act as an extension of legal teams. To learn more about our services, please view our industry services sheet which explains some of our capabilities in more detail. You may have also seen our recent press release discussing EAS capabilities acting in the capacity of an expert witness. If you missed it, I invite you to view it on our LinkedIn Page.

Lastly, I am very pleased to announce the release of our new short video discussing FSVP and Qualified Individual Requirementsplaced on the Food industry by FDA. We had a lot of fun putting this together and hope that you find it enjoyable as well as informative. Please, as always let me know if you have any questions on this service or any other that EAS provides.

Thank you,

Ed Steele, Chairman and CEO

2019 February From the Desk of the Chairman

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Dear Reader,

Welcome to the February 2019 edition of EAS-e-News, the free news publication dedicated to FDA regulated industries. I’d like to begin by bringing your attention to our many new educational opportunities. From our many complimentary webinars to regulatory compliance seminars EAS brings the best in regulatory education to you through our extensive network of independent experts. In this issue, you’ll find numerous opportunities to learn in real time in addition to our wealth of on-demand webinars available for viewing at your convenience.

On that note, two recent additions to our complimentary webinar offerings include one on the requirements for Qualified Individuals, hosted by Independent Advisors Domenic Veneziano and Charles Breen, and regulatory challenges and opportunities for companies preparing New Infant Formula Notifications, presented by EAS Independent Advisor Robert Martin, Ph.D., and Independent Consultants Robert Burns, Ph.D. and Timothy Morck, Ph.D.. More information can be found in the EAS in Action section of this issue.

Our Issue of the Month is written by Independent Advisor for FSMA, Charles Breen, and discusses two very similar sounding terms, Qualified Individual and Preventive Controls Qualified Individual, which have two very different meanings. Our Ask the Expert is written by James Hoadley, Ph.D. and discusses the provision in the recently signed Farm Bill which covers “added sugars” and when the “includes X g added sugars” can be omitted from a label.

Also in this issue, we introduce a new section called “Did you Know?” which will provide a brief spotlight of concern to FDA regulatory industries. This month we discuss Slack Fill. Did you know this is a growing area of litigation for food manufacturers? The many regulations surrounding slack fill are confusing at best and EAS is here to help if this issue is one that your firm faces.

Further, EAS has just released our newest Video Short, on cannabis quality issues and how EAS Consulting Group can help companies navigate as the industry pushes for for developing sound Good Manufacturing Practices.

Lastly, we are so pleased that there is at least a temporary solution to reopen the federal government after the longest shutdown in our nation’s history and we hope for a lasting resolution that enables both sides of the aisle to find common ground. The shut down has had numerous negative impacts, including severely curtailing operations at FDA and USDA, are we are thankful, at least for the moment, that our federal employees are able to get back to the business at hand by serving the public.

Thank you as always for your interest in EAS and EASeNews. You are one of the 16,000 who receive our newsletter and we take great pride in bringing you relevant content and compliance solutions. Please let me know if you have any questions on this issue or other areas of FDA compliance.

Sincerely,

EAS Signature Ed

Ed Steele
Chairman and CEO

Government Shut Down Impacts FDA and Industry Operations

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Dear Readers,

Edward A. Steele

Welcome to the January 2019 edition of EASeNews! We hope this year, as with each year, brings a renewed commitment to safety and innovation in the advancement of your product lines and business.

As the Government Shut Down continues, FDA recently announced that agency operations will continue to the extent permitted by law, maintaining core functions that address imminent threats to the safety of human life as well as activities funded by carryover user fee funds. FDA will continue to respond to emergencies – such as monitoring for and quickly responding to outbreaks related to foodborne illness and the flu; support high-risk food and medical product recalls when products endanger consumers and patients and pursue civil and criminal investigations as appropriate and continue screening food and medical products that are imported to the U.S.. Mission critical surveillance for significant safety concerns with medical devices and other medical products will also continue.  During this period of lapsed funding, however, FDA does not have legal authority to accept user fees assessed for FY 2019 until an FY 2019 appropriation or Continuing Resolution for the FDA is enacted. This includes regulatory submissions for FY 2019 that require a fee payment and that are submitted during the lapse period.

At EAS we are also committed to ensuring our message of compliance reaches the industry. Most recently, our initiative to create video shorts discussing industry challenges and EAS capabilities is well underway! I am pleased to announce the release of Senior Director of Pharmaceuticals and Medical Devices, Bryan Coleman’s discussion of the importance of good preparation for FDA’s GxP audits as well as our auditing services; and Senior Director of Food Consulting Services, Allen Sayler’s discussion of challenges for the dairy industry, particularly in light of the many oversight organizations, as well as EAS’ dairy capabilities. In December we also released our first Hot Topic Report, a short video with Bryan Coleman discussing CDRH increased numbers of medical device inspections and what that means for the industry. We plan to release new hot topic videos to coincide with important FDA announcements. Watch your inbox for these pertinent updates impacting to your industry.

For those who work in Dietary Supplements I am pleased to announce a new training effort aimed at employees and management who are looking to complete their annual GMP compliance refresher training. EAS will host a series of four one-day GMP Refreshers around the country and we invite you to consider outsourcing your quality department’s training to our experts! Join us at one of our upcoming events taught by our internationally recognized compliance experts and gain a greater understanding of your requirements under FDA’s 21 CFR 111.

For those looking for a deeper dive into GMPs we remind you of our two-day full GMP Compliance seminar, which will take place April 2-3, 2019 in Philadelphia, PA. Earlybird rates will expire on February 2, 2019.

In addition, our Food Labeling and Dietary Supplement Labeling Compliance seminars will also take place in Philadelphia, March 12-13 and March 14-15 respectively. More information is found on our EAS website.

Our Issue of the Month article, written by Independent Consultant Tamika Cathey who works in dietary supplement GMP compliance (and who is our trainer for the August 13 Refresher training in Andover, MA), discusses specifications development – which continues to challenge the manufacturing industry. Our Ask the Expert is written by Steve Armstrong, Independent Advisor for Food Law and Regulation, and discusses FDA’s decision to delist seven synthetic flavors and how that decision impacts those firms still using them. Finally, our FSMA perspective, written by Independent Advisor for FSMA, Charles Breen, reminds all firms, (and specifically those working in produce and sprouts as new compliance dates for these industries arrive at the end of January), that food safety is a diligent and on-going process of review, redevelopment (as needed) and execution of pertinent practices to keep consumers safe.

As always, thank for reading our updates and for your interest in EAS. Feel free to share this newsletter with your colleagues and let me know if you have questions.

Sincerely,

Ed

Cannabis – Federal Pathways to Regulation Explored

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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

EAS Leads Efforts of Regulatory Compliance Training

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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

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

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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

FDA Ramping Up FSVP Inspections, Finding Issues with FSVP Development

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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

Dietary Supplement GMP Compliance Includes Application to the Cannabis Industry

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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

FDA Releases Guidance Documents on Dietary Fiber Declarations

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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

Medical Device Innovations and the Regulatory Landscape

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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

FDA Actively Working Tobacco Product Manufacturing Practices

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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

EAS Announces Expansion of Collaboration with FoodMinds

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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

Voluntary Qualified Importer Program Underway

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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.

Much Movement on FSMA

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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.

Dynamic Year Ahead

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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