Insights into FDA’s Interpretation and Enforcement of Medical Foods

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

Armstrong Discusses FSMA One Year Later in FDLI Update

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

EAS Announces Expansion of Collaboration with FoodMinds

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

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

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

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

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

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

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

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

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

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


Ed Steele
Chairman and CEO

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

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

Adverse Events, Serious or Not?

By Norma Skolnik

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

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

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

Meet Issue of the Month Author, Susan Crane

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

March 2018 FDA Drug / Medical Device Activity

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

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

Guidance Document updates on the FDA website:

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




OC: Distributed for Comment Purposes Only


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

By Charles Breen, Independent Advisor for FSMA

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

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

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

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

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

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

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

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

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

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

Homeopathy – What Does the Future Hold?

By Susan Crane, Independent Advisor for OTC Labeling

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Some draft Codex standards now under development are inconsistent with U.S. laws and regulations. For example, the agenda of the Codex Committee on Nutrition and Foods for Special Dietary Uses (which includes dietary supplements),, has been particularly controversial in recent years, with the nitrogen to protein conversion factor issue pitting dairy interests against vegetable protein interests and the US against the EU in the areas of infant formula and other special dietary food standards. The agenda for the November 2017 meeting can be found at

Food manufacturers may also wish to keep a special eye on the Codex Committee on Food Labeling, Canada, which hosts and chairs the Committee on Food Labeling,, is formally proposing its own national regulations for front-of-pack nutrition rating symbols, The issue has already been placed on the agenda for the Codex Committee on Food Labeling, In contrast to Canada, the U.S. Food and Drug Administration (FDA) supports a voluntary front-of-pack nutrition-labeling program developed by the Grocery Manufacturers Association and the Food Marketing Institute.

The U.S. Codex Office regularly announces public meetings, held in the Washington, D.C. area, to formulate the position that the U.S. government will take at Codex meetings held in the U.S. and overseas. Companies and trade associations have an opportunity to express their views to USDA, FDA, Office of the U.S. Trade Representative, and other relevant U.S. government agencies. Participants can offer comments in written or oral form and speak directly with leading U.S. government officials that will attend official Codex meetings.

For example, on March 15, 2018, a U.S. government preparation session for the forthcoming meeting of the Codex Committee on Pesticide Residues was held in the Washington metro area,

Other open meetings of the U.S. government delegation to Codex committee meetings will follow later this year. In addition to the Codex Committee on Nutrition and Foods for Special Dietary Use, and the Codex Committee on Food Labeling, key Codex committees include the Codex Committee on Food Additives, with over 400 food additives being considered for inclusion or deletion including those for fish, chocolate, wine, a number of dairy products. Also anticipated is an initial resolution of a stalemate between the EU block and the US and its allies on a significant number of colors and sweeteners, stalled from adoption for almost 6 years. The November 2017 report of the Codex Committee on Food Hygiene can be found at, with significant rewrites of a number of Codex Hygiene documents including the HACCP Appendix for the Codex General Principles for Food Hygiene. The upcoming agenda for the Codex Committee on Contaminants in Foods and be found at, with lead levels and dioxins in foods, among a number of important topics to be discussed.

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

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

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

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