• The U.S. Food and Drug Administration (FDA) announced on February 28, 2023, that it would be withdrawing the 2005 proposed rule, “Food Standards; General Principles and Food Standards Modernization,” in response to comments received in 2005 after publication of the proposed rule and in 2020 after the FDA reopened the comment period for the proposed rule.  The proposed rule was intended to establish a set of general principles for FDA and the U.S. Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) to use when considering whether to establish, revise, or eliminate a food standard.
  • Stakeholders stated in FDA’s 2018 and 2019 public meetings that, because of advancements and changes in manufacturing, technology, market trends, and nutrition science since 2005, FDA should solicit new data when determining next steps for the proposed rule.  FDA responded by reopening the comment period in February 2020, for FDA-specific aspects of the rule.
  • Many of the submitted comments suggested that the general principles be revised and consolidated to make them easier to understand and implement.  FDA and USDA-FSIS have agreed to withdraw the proposed rule to reconsider how best to approach the general principles to ensure any future revisions are consistent with the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Federal Food, Drug, and Cosmetic Act.  An effort to publish a new proposed rule was included in the Fall Unified Agenda.
  • Keller and Heckman will continue to monitor and report on any developments.
  • As we have previously blogged, last September FDA released a proposed rule with criteria for making “healthy” claims. In the proposed rule, FDA requested “comment on the eligibility of calorie-free beverages, coffee, and tea to bear the ‘healthy’ claim.”
  • Responding to this request for comment, various groups within the coffee industry, including the National Coffee Association, submitted comments to FDA which made the case for allowing healthy claims on coffee products. The comments cited a body of literature which indicates that coffee consumption is associated with many health benefits including reduced risk of cardiovascular disease and cancer, among others. The comments also note that the 2020-2025 Dietary Guidelines for Americans reference coffee consumption as part of a healthy dietary pattern when consumed with minimal sweeteners and/or creamers.
  • The American Heart Association also submitted comments which indicated its support for allowing coffee products to bear healthy claims provided that FDA is able to develop criteria which exclude coffee products which do not contribute to a healthy diet, such as those with added sugars or heavy creams.
  • We will continue to monitor and report on developments regarding the criteria for healthy claims.
  • FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) routinely publish a list of possible new topics for guidance documents or revisions to existing guidance documents that will be a priority during the next 12 months.  Guidance documents on the list are characterized as “Level 1,” meaning they involve FDA’s thoughts on significant new regulatory requirements or substantial changes to an earlier regulatory interpretation or policy, and complex scientific or highly controversial issues. 
  • On February 23, 2023, FDA released the list of draft and final guidance topics that are a priority for possible action before January 2024.  FDA’s 2023 list includes categories of food topics and items for prioritization as follows:
  • Allergens – following the addition of sesame to the list of major food allergens, effective January 1, 2023, as a result of the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021, FDA may:
    • Finalize “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5),”released November 2022;
    • Finalize “Draft Guidance on Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act,” released April 2022;
    • Add additional draft guidance to the existing “Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-contact;”
  • Dietary Supplements – FDA may:
    • Update the existing draft guidance, “New Dietary Ingredient (NDI) Notifications and Related Issues,” released October 2016, with new information on “NDI Notification and Timeframes;”
  • Food Additives – FDA may:
    • Issue draft guidance for industry on “Premarket Consultation on Cultured Animal Cell Foods,” following the November 16, 2022 completion of its first pre-market consultation for a human food made from cultured animal cells, discussed here. 
  • Food Safety – FDA may:
    • Issue draft guidance for industry on “Foods Derived from Plants Produced Using Genome Editing;”
    • Finalize industry guidance on “Inorganic Arsenic in Apple Juice: Action Level,” released July 2013;
    • Issue draft guidance for industry on “Detention Without Physical Examination (DWPE) of Fish and Fishery Products Due to the Appearance of Adulteration by Bacterial Pathogens, Unlawful Animal Drugs, Scombrotoxin (Histamine), or Decomposition – Evidence Recommended for Release of Goods Subject to DWPE and Removal of a Foreign Manufacturer’s Goods from DWPE;”
    • Finalize “Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food,” released as draft guidance on February 2008;
  • Food Safety Modernization Act (FSMA) – FDA may:
    • Update its draft guidance on “Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes” at Appendix 1: Potential Hazards for Foods and Processes, Chapter 11: Food Allergen Controls, Chapter 16: Validation of Process Controls, Chapter 17: Classifying Food as Ready-To-Eat or Not Ready- to-Eat, and Chapter 18: Acidified Foods; and
    • Finalize “Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations,” released as draft guidance in January 2017.
  • Labeling – FDA may:
    • Finalize guidance for industry on “Labeling of Plant-Based Alternatives to Animal-Derived Foods,” released in draft in February 2023, as discussed here;
    • Issue draft guidance for industry on “Questions and Answers About Dietary Guidance Statements in Food Labeling.” 
    • Issue draft guidance for industry on “Use of Nutrient Content Claims for Added Sugars in the Labeling of Human Food Products,” following FDA’s September 28, 2022 announcement that it had issued a proposed rule for when foods can be labeled with the claim “healthy” that includes limits for added sugar, as discussed here. 
  • Other potential action items on FDA’s 2023 list are draft guidances for industry on “Insanitary Conditions at Tattoo Ink Manufacturing and Distribution Facilities” and “Preparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations).” 
  • FDA’s plans to publish all draft and final guidance topics on the 2023 list of priorities before January 2024 are, of course, subject to change.  Public comments on the list, including suggestions for alternatives or recommendations on the topics FDA is considering, be submitted to www.regulations.gov in Docket FDA-2022-D-2088.  Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments. 
  • On February 22, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance to ensure appropriate labeling of plant-based products that are marketed and sold as milk alternatives (plant-based alternatives (PBMA)).
  • The FDA recommends that PBMA products labeled with the term “milk” in their names, such as “soy milk” or “almond milk,” and that have a nutrient composition different than milk, include a voluntary nutrient statement that conveys how the product compares to milk, based on the USDA’s Food and Nutrition Service (FNS) fluid milk substitutes nutrient criteria.  If a PBMA is not labeled with “milk” as part of its name, but instead is labeled with another term like “beverage” and does not make a claim comparing the product to milk, then the voluntary nutrient statement recommendations do not apply.  The draft guidance also clarifies that the common names of some PBMA have been established by common usage, and these names include “almond milk” and “soy milk.”
  • The draft guidance comes after FDA requested comments in 2018 to gain insight into how consumers use PBMA products and how they understand the term “milk” when included in the names of plant-based products.  The agency received more than 13,000 comments.  FDA determined that consumers generally understand that PBMA do not contain milk and choose PBMA because they are not milk, but that consumers may not be aware of the nutritional differences.
  • On a related note, we suspect that the United States will be referencing this guidance during the Codex Committee on Nutrition and Foods for Special Dietary Uses 43rd Session (CCNFSDU43) discussions, in a push for more international policies and guidelines that regulate plant-based alternatives differently than general foods. 
  • Comments on this draft guidance should be submitted within 60 days after publication in the Federal Register.  Keller and Heckman will continue to monitor and report on any developments.
  • A class-action lawsuit was filed last week against the manufacturer of a pomegranate juice (and its parent company) for falsely advertising the product (POM) as “all natural” and healthful where it in fact contained non-natural and potentially dangerous PFAS chemicals.  
  • As many of our readers will know, per- and polyfluoroalkyl substances (PFAS) consist of a large group of fluorinated chemicals which bioaccumulate and have been linked to numerous negative health outcomes. Two types of PFAS, perfluorooctanoate (PFOA) and perfluorooctane sulfonate (PFOS) have been the subject of most the research on the health effects of PFAS.
  • Plaintiffs independently tested Defendant’s pomegranate juice and found it to contain 2.5 parts per trillion (ppt) of “6:2FTS” PFAS and 6.5 ppt of “PFPeA” PFAS. Defendants claim this amount is “significant” based on EPA’s interim updated health advisories for PFOA and PFOS of 0.004 ppt and 0.02 ppt, respectively.
  • The complaint does not justify application of EPA’s health advisory limits for PFOA and PFOS to different types of PFAS nor does it explain how the PFAS might have entered the juice or how Defendants could have known about the presence of PFAS.
  • Keller and Heckman will continue to monitor and report on this lawsuit and other claims targeting the food industry.
  • Last month several nonprofit advocacy organizations filed a lawsuit against FDA for denying a 2016 petition which sought to ban the use of certain medically important antibiotics in livestock and poultry for disease-prevention. Antibiotics are administered for this purpose sub-therapeutically to the herd when the herd faces conditions that could make it more susceptible to disease (e.g., stress from overcrowding).
  • The lawsuit argues that in denying the petition, FDA failed to consider the effect of the use these antibiotics on human health and that the sub-therapeutic use of these antibiotics for disease prevention contributes to the increased prevalence of antibiotic-resistant bacteria, which pose a significant risk to human health. Accordingly, the lawsuit alleges that FDA has not met its statutory mandate to ensure that all animal drugs are safe, i.e., a reasonable certainty of no harm to human health from the proposed use of the drug in food-producing animals. 
  • While the lawsuit acknowledges that industry has phased out the use of antibiotics for growth-promotion and that the use of antibiotics for disease-prevention requires veterinary oversight, it argues that such measures are not sufficient to protect human health, and that the use of antibiotics for disease prevention has increased in the last few years.
  • Keller and Heckman will continue to monitor and report on developments relating to regulatory treatment of drugs used for food producing animals.
  • On February 9, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance to manufacturers of infant formula and laboratories conducting testing on infant formula to assist in the design, conduct, evaluation, and reporting of Protein Efficiency Ratio (PER) rat bioassy studies.
  • Quality of protein is one of many factors FDA considers in evaluating new infant formula submissions. Protein quality is important as infant formula is often a sole source of nutrition for infants.
  • The guidance makes modifications to the PER rat bioassy method from Association of Official Analytical Chemists (AOAC) International. 
  • Any shareholder comments can be submitted to https://www.regulations.gov by May 11, 2023.  Keller and Heckman will continue to monitor.
  • On February 9, 2023, FDA’s Center for Veterinary Medicine (CVM) held a virtual meeting on FDA’s role in the Association of American Feed Control Officials (AAFCO) feed ingredient definition process. Specifically, the goal of the meeting was to look at how to improve FDA’s role in the ingredient definition process and how FDA could gather stakeholder input on the safety of each pending ingredient definition.
  • The event began with presentations from several CVM speakers, including Tracey Forfa, CVM’s acting director, as well as Austin Therrell, AAFCO’s executive director, and was followed by presentations from various stakeholders.
  • Presentations from FDA discussed the memorandum of understanding (MOU) between FDA and AAFCO (MOU 22507-7001) which formalizes the procedural steps in FDA’s safety review of animal feed ingredients and provides a mechanism for resolving disputes or removing definitions. FDA highlighted that the MOU does not define FDA’s relationship with AAFCO, determine when FDA will engage with AAFCO, or transfer FDA’s authority to AAFCO. On the latter point, FDA was careful to note that enforcement of animal food laws resides only with FDA and state authorities and that all animal feed ingredients are held to the same standard (“a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use”), but that cooperation with AAFCO facilitates regulatory uniformity.
  • FDA noted stakeholders concerns regarding its slow AAFCO ingredient definition review process and indicated that while food additive petitions and GRAS Notifications remained a priority, it had added 12 additional reviewers to its staff in 2020 (almost doubling the staff), which is now allowing it to complete AAFCO ingredient reviews in a timelier manner. FDA also indicated that it was trying to increase the transparency of the process and was considering which information to include online (e.g., a page tracking all pending ingredient definitions) as well as options to allow for stakeholder input. 
  • FDA is accepting comments to docket FDA-2022-N-3122 on regulations.gov until March 4th. Specific questions on which FDA is seeking input can be found on the meeting’s webpage.

Gerber Judge Calls Baby Food False Ad Claim ‘Pretty Weird’  (Law360 Subscription Required)

  • A motion to dismiss hearing was held on February 9, 2023 over a proposed class action lawsuit filed in the US District Court for the Northern District of California that alleges protein content statements on the packages imply that Gerber Products Co.’s foods for infants and toddlers are healthy and this is misleading because the foods contain high amounts of added sugar.  At issue are the statement “2 grams of plant protein” on the front label, and the statement “Nutritious, plant-based, and specifically designed to provide 2 grams of protein” on the back of the package for Gerber products such as Fruit & Yogurt Strawberry Banana pouches.  Gerber asserts that the claims are permitted by FDA’s food labeling regulations, that both statements are factual and neutral, and the back label simply describes the protein. 
  • The judge in the dismissal hearing is quoted by Law360 as saying, “That’s pretty weird, the idea that if you see on the label…’great source of protein,’ I don’t need to check how much sugar is in this,” and adding, “I get why FDA might want to regulate it, but to the extent that you’re saying that this states a fraud claim under state law, I’m not quite there I think.”  The judge is also said to have mentioned muscle milk, protein bars, and bacon as examples of foods that may tout protein content and “are probably net bad for you,” and to have struggled with the idea that stating the protein content on the label will mislead people into thinking that that the product is healthy. 
  • Compliance with FDA’s regulations that are intended to prevent misleading consumers has been an important factor in many fraud cases.  In this regard, FDA defines a nutrient content claim (NCC) as a claim that expressly or impliedly characterizes the level of a nutrient which is of the type required to be in nutrition labeling.  FDA has no regulations that would permit express or implied NCCs for protein in food intended specifically for use by infants and children less than 2 years of age.  FDA has provided “5 grams of fat” as an example of a statement that does not implicitly characterize the level of the nutrient.  FDA has cited “healthy, contains 3 grams (g) of fat,” however, as an example of a factual statement about the grams of a nutrient that when accompanied by a characterizing term, e.g., “healthy,” can misleadingly imply that a food, because of its nutrient content, may be useful in maintaining healthy dietary practices. 
  • The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) has proposed to amend animal disease traceability regulations and require electronic identification for interstate movement of cattle and bison.  The record requirements would also be revised and provide more clarification.
  • APHIS states that electronic identification and clearer records would strengthen the Agency’s ability to quickly respond to significant animal disease outbreaks.  It adds that USDA is committed to implementing a modern system that tracks animals from birth to slaughter using affordable technology that allows for quick tracing of sick and exposed animals to stop disease spread.
  • The proposed rule would require official eartags to be visually and electronically readable for official use for interstate movement of certain cattle and bison.  It would also require official identification device distribution records to be entered into a Tribal, State, or Federal database, and available to APHIS upon request.
  • Stakeholder comments on the proposed rule must be submitted by March 22, 2023.
  • Keller and Heckman will continue to monitor and report on relevant animal disease issues.