• Yesterday, on March 8, 2023, the U.S. Food and Drug Administration (FDA) sent a letter to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula, asking for them to share current safety information and to take action to improve processes for the protection of infants.
  • Last year, safety concerns at one of the largest infant formula manufacturing facilities in the U.S. prompted a nationwide recall and temporary pause in production, leading to a national infant formula shortage.  Since then, FDA has issued multiple guidance documents intended to help facilitate the availability of safe and nutritionally adequate infant formula through enforcement discretion.  The Agency has also developed a cronobacter prevention strategy, enhanced inspection activities, increased engagement with the industry, and has pursued regulatory action in some cases.
  • In the recent months, FDA food safety staff have been meeting regularly with the powdered infant formula manufacturers to further develop the prevention strategy to help prevent cronobacter illness.  The letter reflects the information gained during these meetings, as well as the latest available science.
  • In its update, FDA calls on all members of the infant formula industry to use the information in the letter to take prompt action to improve processes and programs for infant protection.  FDA will continue to inspect and work with the industry to advance research and regulatory activities included in the prevention strategy.
  • Keller and Heckman will continue to monitor and report on any developments in this area.
  • On March 3, 2023, Judge Buchwald of the U.S. District Court for the Southern District of New York permanently tossed a proposed class action claiming that Pervine Foods’ FitCrunch protein bars are fraudulently advertised as healthy, ruling that a reasonable consumer wouldn’t look at the label, which features an image of desserts like Oreo cookies, and believe the bars were healthy.  See Cade Seljak et al. v. Pervine Foods LLC, case number 1:21-cv-09561.
  • Plaintiffs argued that they believed the FitCrunch bars were healthy even though the terms “healthy” or “health” do not appear on any of the products’ labels or in any of Pervine Foods’ advertisements. The customers’ sole belief that the protein bars were healthy was entirely premised on the use of the term “fit” in the products’ name which, they argued, is synonymous with “healthy.” Further, the customers claimed they were misled into thinking the bars were healthy when the products actually contain between 8 and 18 grams of fat.
  • According to Judge Buchwald’s opinion granting defendant’s motion to dismiss, Pervine Foods, which sells FitCrunch protein bars and FitBar energy bars, did not falsely advertise its products as “healthy.” The Pervine Foods products contain high levels of protein and come in flavors that sound like desserts, including milk and cookies, chocolate chip cookie dough, apple pie and chocolate peanut butter. The FitCrunch label states that the product is a “whey protein bar” with a “soft cookie center.” Further, the number of calories represented on many of the FitCrunch product labels, which ranges from 190 to 380 calories, is higher than the number of calories found in an average candy bar.
  • “[B]efore even turning to the ingredient label, a reasonable consumer viewing this label simply would not believe that FitCrunch products are ‘healthy’ . . . [i]ndeed, such a belief is plainly inconsistent with the face of the package, and with common sense,” said Judge Buchwald. The judge further concluded that, even assuming that the defendant’s use of the word “fit” could be interpreted to mean “healthy,” the ingredients listed on the back of the product’s wrapper include the bar’s fat content and could easily cure that confusion.
  • Keller and Heckman will continue to monitor consumer class actions regarding misleading product labels.
  • Yesterday, FDA launched its new Dietary Supplement Ingredient Directory which contains a list of ingredients used in dietary supplements along with links to FDA’s actions and communications regarding the ingredients.
  • The Ingredient Directory will contain information on the two types of ingredients found in dietary supplements: “dietary ingredients” and “other ingredients.” A “dietary ingredient” is defined (in 21 USC § 321(ff)) as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the preceding categories. “Other ingredients” include ingredients such as fillers, binders, excipients, preservatives, sweeteners, and flavoring, and are listed separately on the label.
  • The Ingredient Directory will be periodically updated. However, it is not intended to be a comprehensive list of all ingredients used in dietary supplements and may not include all actions that the FDA has taken on a particular ingredient. For example, some duplicative actions or actions that no longer reflect the FDA’s current position may not be listed.
  • FDA’s Dietary Supplement Advisory listserv has been retired, but anyone subscribed to that list will receive updates to the Ingredient Directory.
  • We have previously discussed a series developed by FDA last year of Prevention Strategies to Enhance Food Safety.  Prevention Strategy documents contain recommendations for the prevention of future foodborne illness for food-hazard pairings where emerging patterns can be identified and targeted.  The first two Prevention Strategy documents were: (1) Bulb Onion Strategy Document (July 2022) targeting Salmonella contamination of bulb onions, and (2) Imported Enoki and Imported Wood Ear Mushroom Strategy Document (September 2022) targeting Listeria monocytogenes and Salmonella contamination of imported specialty mushrooms. 
  • A third Prevention Strategy document has since been released.  Powdered Infant Formula Strategy Outline (November 2022) targets the prevention of Cronobacter sakazaki illnesses associated with consumption of powdered infant formula, and seeks to:
    • Broaden scientific knowledge and understanding of Cronobacter sakazakii and public health interventions for controlling it;
    • Improve oversight of safe production of powdered infant formula; and
    • Enhance communications and engagement with industry, consumers, federal, state, local, and other public health partners about infant formula safety. 
  • FDA’s Prevention Strategy Documents table will likely soon be updated again to add an additional resource for enoki mushrooms.  Specifically, on March 1, 2023, FDA announced the expansion of a country wide import alert (IA) for enoki mushrooms from the Republic of Korea, noted earlier as a resource for the Prevention Strategy document, to also cover enoki mushrooms from China.  The expanded IA #25-21 “Detention Without Physical Examination of Enoki Mushrooms from the Republic of Korea and China due to Listeria Monocytogenes” follows multiple recalls linked to contaminated enoki mushrooms from China and a recent FDA multi-state outbreak investigation that linked three cases of listeriosis to enoki mushrooms labeled as a product of China. 
  • 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.