CTP Updates Provisional Substantial Equivalence Review Process

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

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

FDA Actively Working Tobacco Product Manufacturing Practices

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

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

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

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

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

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

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

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

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


Ed Steele
Chairman and CEO

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

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

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

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

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

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

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

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

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

April 2018 FDA Drug / Medical Device Activity

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

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

Guidance Document updates on the FDA website: CDER:






Clean Label, the Challenges

By Gustavo M. Gonzalez, Ph.D.

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

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

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

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

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

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

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

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

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


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

Guidance for Industry on Dietary Supplement Products Containing Highly Concentrated Caffeine

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

EAS Welcomes New Independent Consultants

Dawn Wydner, Ph.D.

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

Richard White

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


Andrea Yablunosky

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

Dee Duffy

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

Bryan Armentrout

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

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

By Kathy Knutson

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

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

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

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

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

Nutrition Facts and Supplement Facts Labels Compliance Dates Extended

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

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

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

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

Inflation Adjusted Values for Six FSMA Regulations

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

CTP Announces Actively Working Tobacco Product Manufacturing Practices

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

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

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

Dietary Supplements vs. Foods — A FSMA Regulatory Challenge

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

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

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

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

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

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

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

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

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

21 CFR 111


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

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

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

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

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

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

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

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

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

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

This article was reprinted with permission from Natural Products Insider.