• On January 6, 2025, FDA released two final guidance documents concerning food allergens. The guidance documents represent the Agency’s current thinking related to producing and labeling food products with both major food allergens and non-listed food allergens.
  • Final Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5) revises previous versions of guidance on food allergen labeling, consolidating and finalizing the draft and final guidance published in November 2022. The final guidance contains questions and answers about food allergen labeling requirements. Some changes from the draft guidance include:
    • Expanding FDA’s historical interpretation of the terms “milk” and “eggs” for the purposes of the definition of a “major food allergen.” In the food allergen context, FDA now considers “milk” as milk from domesticated cows, goats, sheep, or other ruminants, and “eggs” as eggs from domesticated chickens, ducks, geese, quail, and other fowl.
    • Revising the list of tree nuts that FDA considers as major food allergens. “Tree nuts” include almond, black walnut, Brazil nut, California walnut, cashew, filbert/hazelnut, heartnut/Japanese walnut, macadamia nut/Bush nut, pecan, pine nut/pinon nut, pistachio, and English and Persian walnut. Notably, FDA no longer considers coconut to be a tree nut in this context. Other nuts removed from the list of tree nuts include beech nut, butternut, chestnut, chinquapin, gingko nut, hickory nut, pili nut, and shea nut.
    • Revising several questions and answers to update and clarify information in previous editions.
  • Final Guidance for FDA Staff and Interested Parties: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act provides FDA’s general approach when evaluating the public health importance of food allergens other than a “major food allergen,” including identifying the scientific factors and other information relevant to labeling and production, as well as recommendations for how to identify and evaluate the body of evidence of a non-listed food allergen.
  • Keller and Heckman will continue to monitor and report on FDA’s activities relating to food allergen labeling requirements.
  • On December 2, 2024, the United States District Court for the Northern District of California vacated and remanded the Animal and Plant Health Inspection Service’s (APHIS or the Agency) final rule on regulating the movement of certain genetically engineered organisms (GE organisms).  This ruling primarily affects GE plants but also includes other organisms that meet the definition of a plant pest, in the case of National Family Farm Coalition v. Vilsack.
  • As we’ve previously blogged, the U.S. Department of Agriculture’s (USDA) APHIS, after nearly 15 years of multiple rulemaking proposals, published a Final Rule in 2020 for Part 340 of the Code of Federal Regulations (CFR).  This rule regulates the “Movement of Certain Genetically Engineered Organisms” that may pose a plant pest risk under the authority of the Plant Protection Act of 2000.  The act authorizes the Secretary of Agriculture, who has delegated authority to APHIS, to regulate plant pests and noxious weeds.  
  • Historically, APHIS regulated GE plants as “plant pests” if they were developed by inserting genes using plant pests as the vector, which covered most GE plants for many years.  However, modern techniques enable genetic modifications without using plant pests, meaning GE plants may no longer fall under the scope of Part 340 as “plant pests.”
  • In 2004, APHIS published a notice of intent to open public comment and begin an environmental impact study of potential changes to Section 340 to include the scope of the noxious-weed authority to regulate GE plants that may pose risks.  In 2007, the Agency published a report titled “Lessons Learned and Revisions under Consideration for APHIS Biotechnology Framework.” Following this, the 2008 Farm Bill directed the USDA to update its regulations for GE organisms by addressing each issue the Agency identified in its 2007 report, leading to a new proposed rule.  
  • In the 2008 proposed rule, APHIS proposed incorporating its noxious-weed authority under the PPA (21 C.F.R. Part 360) into its Part 340 regulations.  This change would allow APHIS to evaluate any noxious weed risks associated with GE plants.  However, this proposed rule was withdrawn after extensive public comments were submitted.
  • In 2017, similar to the 2008 rule, APHIS proposed another rule aiming to address the issues from the 2007 report about GE organisms, by again proposing to use its noxious-weed authority to assess GE plants.  In the proposed rule, the Agency stated that the “current regulatory structure, which entails evaluating such plants solely for plant pest risk, is not sufficient to properly identify all risks that these plants present to other plants and plant products.”  This rule was also withdrawn after extensive comments were submitted.
  • Then, following another proposed rule published in 2019, APHIS issued its final rule in 2020, “Movement of Certain Genetically Engineered Organisms,” shifting the focus from the method used to create GE organisms to the traits of the GE organisms themselves.  The 2020 rule exempts certain GE plants that could have been developed through conventional breeding and those unlikely to pose a plant pest risk, among other risk-based regulatory streamlining provisions.  Furthermore, in the final rule, the Agency reversed its position and decided not to incorporate noxious-weed authority into Part 340 despite the 2008 and 2017 proposed rules.
  • In National Family Farm Coalition v. Vilsack, the plaintiffs argued that the 2020 rule reduced federal oversight of GE plants without proper explanation.  The Court found that APHIS had reversed its position from the administrative record on incorporating noxious-weed authority into its Part 340 regulations without explanation.  Despite the Agency’s previous concerns documented in the administrative record related to the regulations’ insufficiency of only evaluating plant pest risk, the Court noted that “the final rule does not address a single one of these issues.” Thus, the Court deemed this change arbitrary and capricious in violation of the Administrative Procedure Act (APA), which requires agencies to provide a rationale when changing their policy positions. 
  • We note that the Court undertook a Loper analysis and found that APHIS had not exceeded its statutory authority in promulgating the regulation – rather, the regulation was vacated under the APA under a standard arbitrary and capricious analysis.  
  • Following the court ruling, APHIS is reverting to the pre-May 2020 regulatory framework by re-establishing pathways for authorizing regulated activities, commercializing products, and providing compliance oversight.  APHIS will also restart the “Am I Regulated” process, allowing stakeholders to inquire if their GE organisms meet the definition of a regulated article.  APHIS will resume issuing permits under the 2019 framework and will provide further guidance on the notification process in the coming weeks.
  • Keller and Heckman will continue to monitor and report on developments related to the regulation of GE organisms and challenges to agency rulemakings.
  • FDA has set a uniform compliance date of January 1, 2028, for new food labeling rules issued between January 1, 2025, and December 31, 2026. This does not change existing compliance dates for regulations published before January 1, 2025.
  • FDA periodically issues uniform compliance dates to lessen the economic impact on the food industry of responding separately to each new food labeling rule. The uniform compliance date allows for an adjustment period, providing the food industry sufficient lead time to use existing labels and create new labels.
  • FDA will set separate compliance dates for certain new labeling regulations when necessary. Regardless of compliance date, the Agency generally encourages the food industry to comply with new regulations as quickly as is feasible.
  • Keller and Heckman will continue to monitor and report on new food labeling regulations.
  • On December 19, 2024, FDA released the pre-publication of the final rule updating the definition for the implied nutrient content claim, “healthy.” The final rule will be published in the Federal Register on December 27.  The final rule revises the requirements for making a healthy claim on human food products. FDA’s labeling rule is part of a broader initiative aimed at reducing diet-related disease and promoting health equity as part of the White House National Strategy on Hunger, Nutrition, and Health.  
  • This rule finalizes the 2022 proposed rule and updates the definition of “healthy” which was last defined at 21 CFR 101.65 thirty years ago.  The previous definition was based on outdated nutrition science and did not account for the latest dietary guidelines.
  • Under the final rule, for a food product to bear a “healthy” (or any derivative e.g., “healthful”) claim the food product must:
    • (1) Contain a certain amount of food from one of the Food Group Equivalents (FGE) established by the Dietary Guidelines, 2020-2025 (vegetables, fruits, dairy, grains, protein foods, and oils); and
    • (2) Adhere to specified limits related to saturated fat, sodium, and added sugar.
  • For example, for a vegetable product to make a “healthy” claim it must:
    • Contain at least ½ cup equivalent vegetable and
    • Contain no greater than 2% of the Daily Value (DV) of added sugar, no more than 10% of the DV of sodium, and no more than 5% of the DV of saturated fat.
  • In addition to the six categories of FGE’s established above, there are distinct requirements for mixed products, main dishes, and meal products:
    • Mixed Products: Must contain at least one total Food Group Equivalent (FGE) with no less than 1/4 FGE from at least two food groups and added sugars content must be no greater than 10% DV, sodium content must be no greater than 15% DV, and saturated fat content (excluding inherent fats in seafood, nuts, seeds, and soy products) must be no greater than 10% DV.
    • Main Dish: Must contain at least one total FGE with no less than 1/4 FGE from at least two food groups and the added sugars content must be no greater than 10% DV, sodium content must be no greater than 15% DV, and saturated fat content (excluding inherent fats in seafood, nuts, seeds, and soy products) must be no greater than 10% DV.
    • Meal Products: Must contain at least one total FGE with no less than 1/4 FGE from at least two food groups and added sugars content must be no greater than 10% DV, sodium content must be no greater than 15% DV, and saturated fat content (excluding inherent fats in seafood, nuts, seeds, and soy products) must be no greater than 10% DV.
  • The new rule makes modifications for certain foods that contain healthy fats such as fish and nuts that were before unable to qualify for the healthy claim.  For example, the final rule makes a note for seafood, nuts, seeds, and soy products that the DV limit established by the rule excludes saturated fat inherent in the food product. Further, the updated rule introduces specific limits on added sugars. Now, foods high in added sugars, which do not align with current nutrition science and dietary guidelines, can no longer be labeled as “healthy.”
  • These changes are designed to help consumers make better-informed choices and promote healthier eating patterns.  FDA is also developing a “healthy” symbol that manufacturers can use on food packaging to help consumers quickly identify products that meet the “healthy” criteria.
  • The rule goes into effect 60 days after publication in the Federal Register, which is expected to be published on December 27, 2024, and the compliance date is February 25, 2028. Keller and Heckman will continue to monitor developments related to the final rule’s implementation and enforcement.
  • On December 18, 2024, the U.S. Food and Drug Administration (FDA) shared its latest test results for per- and polyfluoroalkyl substances (PFAS) in clams as follow up to its findings in the 2022 PFAS in seafood survey.  The results of FDA’s testing are used to help the agency better understand PFAS in commercially available foods and identify foods or types of foods that would benefit from targeted surveys, to help ensure a safe and nutritious food supply.
  • In the 2022 seafood survey, FDA detected high levels of perfluorooctanoic acid (PFOA) in samples of canned clams from China and determined that the estimated exposure was likely a health concern.  Between October 2022 and September 2024, FDA collected and analyzed 12 samples of processed clams with China as the country of origin.  All 12 samples had detectable levels of at least one type of PFAS, and PFOA was detected in all samples.  Three shipments were refused entry into the US.
  • In 2023, FDA also conducted a survey of domestically acquired clam samples.  All but one of nine samples had PFOA concentrations under the method detection limit and the products remained on the US market.
  • The agency is actively engaging with both imported and domestic clam firms to better understand potential sources of contamination and ways in which PFOA concentrations may be reduced.  FDA also recently issued a request for information to help fill data gaps that remain regarding PFAS in seafood and is conducting two ongoing surveys, focused on molluscan shellfish and other commonly consumed seafood.  FDA will release results of the surveys after completion.
  • Earlier this month, the National Association of Manufacturers (NAM) and more than 100 manufacturing associations sent a letter to President-Elect Trump making the case that increased regulatory compliance obligations have created a challenging business environment in the U.S. and outlining a list of de-regulatory actions that they believe will support industrial growth.
  • The letter outlines regulatory proposals across a wide range of industrial sectors and regulations, including environmental, chemical, labor and employment, and intellectual property regulations, as well as FDA’s food traceability rule applicable to certain higher risk foods (21 CFR part 1, subpart S).
  • In regard to the food traceability rule, the letter requests that the Trump administration “make these requirements more flexible and streamlined,” extend the 2026 compliance deadline by at least 3 years, and collaborate with industry on pilot projects.
  • This follows significant concerns expressed by the food industry over practical difficulties with the rule’s requirements, including concerns expressed at an October 7, 2024, virtual public meeting hosted by the Reagan-Udall Foundation. Industry comments at that meeting highlighted the complexity of the rule and difficulty in implementation, particularly with challenges related to overhauling IT systems, which are currently unsynchronized throughout the supply chain.  
  • On December 16, 2024, FDA released a new inventory of voluntary premarket meetings that the Agency has held with developers of foods from new genome-edited plant varieties. FDA holds voluntary premarket meetings to ensure the safety and lawfulness of foods from genome-edited plant varieties when a voluntary premarket consultation is not warranted based on the food’s risk-based characteristics.
  • The inventory of premarket meetings will list all voluntary premarket meetings between FDA and genome-edited plant variety developers. FDA intends to add to the inventory on an ongoing basis as the agency holds more meetings.
  • Voluntary premarket meetings are one process outlined in FDA’s Guidance for Industry on Premarket Engagement for Foods Derived from Plants Produced Using Genome Editing, which we discussed previously on this blog. Voluntary premarket meetings are not intended to represent an FDA evaluation of a developer’s food safety assessment. Voluntary premarket consultations are advised for products that are more likely to raise safety questions. Foods from genome-edited plants must meet the same food safety requirements as other foods.
  • Keller and Heckman will continue to monitor and relay any developments on foods produced from genome-edited plants.
  • On December 11, 2024, the U.S. Food & Drug Administration (FDA) issued updated guidance for industry on the registration and listing of cosmetic product facilities and products.  The guidance provides recommendations and instructions to help individuals and companies comply with the Modernization of Cosmetics Regulations Act of 2022 (MoCRA).  
  • MoCRA mandates that cosmetic companies report serious adverse events to FDA within 15 business days, register their facilities and list their products, ensure product safety before marketing, and comply with FDA’s authority to access records and order recalls if products are found to be unsafe or misbranded.
  • The updated guidance outlines the statutory requirements for submitting cosmetic product facility registrations and product listings.  It finalizes the frequently asked questions (FAQs) in Appendix B (Q1-19) and introduces three new FAQs (Q20-22) for public comment.
    • Q20 outlines the responsibilities of a U.S agent, which includes assisting FDA with communications, responding to product inquiries, helping schedule inspections, and receiving documents on behalf of the foreign establishment;
    • Q21 explains that multiple buildings within three miles can share one FEI number if they are part of the same establishment and management, and can be inspected together; and
    • Q22 indicates that a product listing is generally required for all cosmetic products, including free samples or gifts, unless specific exemptions apply.  
  • The comment period is open until January 13, 2024, and comments can be submitted through the docket.  Keller and Heckman can assist in submitting comments and will continue to monitor developments related to MoCRA and cosmetics regulations.
  • Today, the U.S. Food and Drug Administration (FDA) issued a letter to retailers and distributors of cookware products to inform them that certain imported cookware products made from aluminum, brass, and aluminum alloys (Hindalium/Hindolium or Indalium/Indolium) demonstrate the potential to leach lead into food and that this cookware should not be distributed or sold in the US market.
  • FDA collaborated with the Public Health Department of Seattle and King County (PHSKC), who has tested imported cookware and associated high blood lead levels in resettled refugee populations.  Because cooking with these products showed the potential to leach lead into food, FDA states there is potential for the use of these products to contribute to elevated levels of lead in the blood.
  • Based on information provided by PHSKC, in March 2022, the FDA added the manufacturer of the cookware, Rashko Baba Co. Ltd., to an FDA import alert in an effort to prevent further sale of these products in the domestic US market.  In the spring of 2023, PHSKC was successful in getting some cookware products removed from online retail sites.
  • Keller and Heckman will continue to monitor FDA testing and regulation of cookware products.
  • A lawsuit filed in the Court of Common Pleas of Philadelphia County yesterday has levied a host of allegations related to the sale of “ultra-processed foods” (UPF) against many of the major food companies.
  • At its core, the 148-page complaint alleges that UPF, which are sold by the named defendants (and other companies), are harmful because of their high degree of processing, including the addition of many food additives. The complaint alleges that these harms cannot be attributed solely to the nutritional profile of the foods. The complaint also alleges that the foods are highly addictive and compares them to highly addictive substances like nicotine, cocaine, and methamphetamine. Moreover, the complaint extensively alleges that these foods were intentionally designed to short circuit natural defenses against overconsumption and to be addictive and that marketing campaigns have focused on children to their detriment.
  • The single named Plaintiff alleges that he was diagnosed with type 2 diabetes and non-alcoholic fatty liver disease at 16, both of which he attributes to consumption of UPF. More broadly, he alleges that the incidence of diseases such as these and obesity has dramatically increased since the 1980s, and attributes this to consumption of UPF. Notably, the complaint alleges that “UPF does not increase the risks of other conditions simply because it causes obesity… [but rather] UPF increase the risks of disease because they are ultra-processed.” 
  • The causes of action put forward include negligence, failure to warn, breach of implied and express warranties, negligent misrepresentation, fraudulent misrepresentation, fraudulent concealment, violation of consumer protection laws, unjust enrichment, conspiracy, and concerted action.
  • As we blogged about previously, FDA is conducting a joint workshop with NIH on December 17-18 with UPF among the primary topics to be discussed. In contrast to the allegations of the complaint, FDA’s Jim Jones has maintained that while UPF consumption is correlated with negative health outcomes, causality has not been demonstrated. The unsettled state of the science and the difficulty in defining UPF are likely to pose significant challenges for the Plaintiff.