• On January 14, 2025, the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) on manufacturing processes and ingredients used to make high-protein yogurt, Greek yogurt, or Greek-style yogurt (collectively, “high-protein yogurt”).  These products are cultured with Lactobacillus delbrueckii, subspecies bulgaricus, and Streptococcus thermophilus, among others.  FDA is requesting information because the existing yogurt standard of identity (SOI) may not align with certain manufacturing processes and ingredients used to concentrate protein to manufacture high-protein yogurt.
  • The current SOI for yogurt can be found under 21 CFR § 131.200, though there is not a separate SOI for high-protein yogurt.  Industry has raised concerns that the existing SOI does not accommodate certain practices or technologies for manufacturing high-protein yogurt.  The comments were submitted in response to the 2019 Public Meeting on Horizontal Approaches to Food Standards of Identity Modernization and after the reopening of comments on the FDA 2005 proposed rule.
  • FDA is seeking information from all interested parties to understand current manufacturing practices and ingredients used to make high-protein yogurt.  FDA is also seeking information regarding the usage of various names for high-protein yogurt (e.g., Greek yogurt, Greek-style yogurt), including specific company practices, trade convention, and consumer studies.  Comments must be submitted by April 15, 2025.
  • Today FDA announced that it is revoking the color additive authorizations for Red No. 3 in food (including dietary supplements) and ingested drugs based on evidence showing that Red No. 3 is carcinogenic to male rats (not humans, or even female rats) and the so-called “Delaney Clause” of the Federal Food, Drug, and Cosmetic Act (FD&C Act) which prevents the agency from authorizing an additive that has been found to cause cancer in humans or animals. The Delaney Clause as it pertains to color additives can be found in section 721(b)(5)(B) of the FD&C Act (21 USC 379e(b)(5)(B)) and a similar provision pertaining to food additives can be found in section 409(c)(3)(A) (21 USC 348(c)(3)(A)).
  • FDA’s announcement makes clear that the currently available scientific information does not support safety concerns regarding the use of Red No. 3 and that its decision was one it feels it was required to make based on the extremely broad scope of the Delaney Clause, which was added to the FD&C Act over 60 years ago and has not been updated since to keep up with new scientific understandings of cancer.
  • More specifically, consistent with its prior statements on Red No. 3, FDA concluded that Red No. 3 causes cancer in male rats at high doses by increasing the levels of a thyroid hormone (TSH). However, this mechanism of action is not relevant to humans; rats are much more sensitive to changes in TSH levels and studies in humans have not demonstrated that Red No. 3 changes thyroid hormone levels, including TSH. Finally, carcinogenicity of Red No. 3 has not been observed when female rats were tested, or when either sex of mice, gerbils, or dogs were tested.
  • The decision will be published in the federal register tomorrow (01/16/2025), but a pre-publication version of the federal register notice is available here. Manufacturers using Red No. 3 in food will have until January 15, 2027 to reformulate their products while manufacturers using Red No. 3 in ingested drugs will have until January 18, 2028 to reformulate.
  • This follows California’s ban of Red No. 3 with the signing of the California Food Safety Act in 2023 by Gov. Gavin Newsom which will go into effect in 2027 as well.
  • On January 14, 2025, FDA issued a pre-publication version of a proposed rule requiring a front-of-package (FOP) nutrition label on most packaged foods. The proposed FOP nutrition label would highlight the amount of saturated fat, sodium, and added sugars in a serving of food, as well as interpret the relative amounts of these nutrients, to help consumers quickly and easily identify how foods can be part of a healthy diet.
  • At a high level, the proposed rule would add 21 CFR 101.6, requiring the inclusion of a Nutrition Info box on the principal display panel of most foods that are required to display the Nutrition Facts label. In addition, the proposed rule would revise the requirements for the nutrient content claims “low sodium” and “low saturated fat.”
  • The proposed Nutrition Info box is intended to provide interpretive nutrition information in a convenient format. The Nutrition Info box format is similar in style to the Nutrition Facts Panel and would be required to be placed on the upper third of the principal display panel. The box would be required to include:
    • The title “Nutrition Info;”
    • A “Per serving” subheading and a statement of the serving size in household measure only;
    • A percent daily value subheading above the declaration of the quantitative percent daily value and the interpretive “Low,” “Med,” and “High” descriptions; and
    • Information on only saturated fat, sodium, and added sugars.
  • The interpretive descriptions are set at a proposed range of 5% daily value or less for “Low;” 6% to 19% daily value for “Med;” and 20% daily value or more for “High.” These ranges are based on longstanding consumer and nutrition education initiatives and existing regulatory definitions for nutrient content claims.
  • The proposed rule includes exemptions for foods exempt from nutrition labeling under 21 CFR 101.9(j). FDA also considered an exemption for products with insignificant amounts of saturated fat, sodium, and sugar, but ultimately declined to propose that exemption.
  • FDA is accepting comments on the proposed rule until May 16, 2025, at regulations.gov under docket number FDA-2024-N-2910. Keller and Heckman would be happy to prepare comments and will continue to monitor and relay updates on FDA’s proposed FOP labeling.
  • On January 6, 2025, the U.S. Food & Drug Administration (FDA, or the Agency) issued a final guidance ,“Action Levels for Lead in Processed Food Intended for Babies and Young Children: Guidance for Industry” which aims to regulate lead levels in processed foods for infants and toddlers under two years old.
  • As we have previously blogged, in 2021, FDA initiated its Closer to Zero policy which identified actions the Agency will take to reduce exposure to toxic elements, including lead, to as low as possible while maintaining access to nutritious foods.
  •  As part of this initiative, FDA has also evaluated mercury, cadmium, and arsenic in foods intended for babies and young children, as well as lead in juices.  Under this initiative, FDA has prioritized babies and young children as they are especially vulnerable to lead exposure, which accumulates in the body over time.
  • Lead is naturally present in the environment, but human activities have also released elevated levels of lead, contaminating soil, water, and air.  This contamination can affect crops used in food production.
  • Lead exposures can lead to developmental harm to children by causing learning disabilities, behavioral difficulties, lowered IQ, and may be associated with immunological, cardiovascular, and reproductive and or/developmental effects.
  • To address this concern, FDA established the following action levels in the final guidance for processed foods intended for babies and young children:
    • 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain- and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats;
    • 20 ppb for single-ingredient root vegetables; and
    • 20 ppb for dry infant cereals.
  • If a processed food intended for babies and young children reaches or exceeds the aforementioned levels of lead, the product will be considered adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • After publishing the final action levels, the Agency will establish a timeframe for assessing industry’s progress toward meeting the action levels and resume research to determine whether the scientific data supports efforts to further adjust the action levels.
  • Keller and Heckman will continue to monitor developments related to heavy metals in foods and the Closer to Zero policy.
  • Earlier this week FDA published a draft guidance titled Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event.  (See publication notice at 90 Fed. Reg. 1052 (January 7, 2025)). Examples of low-moisture, ready-to-eat (LMRTE) foods include powdered infant formula, peanut butter, nut butters, powdered drink mixes, chocolate, medical foods in powdered and paste forms, processed tree nuts, milk powders, powdered spices, snack foods such as chips and crackers, granola bars, and dry cereal.
  • The draft guidance is intended to help manufacturers/processers of LMRTE human foods comply with 21 CFR part 117 (Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (HARPC) for Human Food) and, in the case of infant formula manufacturers, the requirements in 21 CFR part 106. In particular, the draft guidance provides FDA’s current thinking regarding:
    • Establishing and implementing a sanitation program and environmental monitoring program
    • Conducting root cause investigations following a pathogen contamination event
    • Applying a sanitizing treatment when remediating a pathogen contamination event
    • Taking steps to identify affected food; and
    • The limitations of relying solely on a product testing program to verify that pathogen contamination has been eliminated
  • The draft guidance includes a discussion of CGMPs necessary to control pathogens in LMRTE foods. Controlling water and maintaining a dry production site is a key feature of FDA’s recommended approach. The draft guidance notes that cleaning— removing residue from a food contact surface (FCS) — is distinct from sanitizing treatments (designed to kill pathogens) and that in dry processing conditions, cleaning and sanitizing is usually done sequentially. The draft guidance cautions that “material flush techniques,” which clean a FCS by pushing product or other materials (e.g., hot oil) through the FCS, are ineffective methods to kill pathogens.   
  • Among the points raised in its discussion of HARPC components applicable to a sanitation program, the draft guidance recommends the identification of Salmonella spp. as a hazard requiring a preventive control for products which are exposed to the environment before packaging and which are not treated. Similarly, the draft guidance recommends the identification of Cronobacter spp. as a hazard in the case of powdered infant formula products exposed to the environment before packaging that do not receive a kill step or other control measure.
  • In its discussion of preventive control step verification activities and root cause analysis, the draft guidance expresses a strong preference for identifying pathogens using whole genome sequencing (WGS) because of its much greater specificity and ability to discriminate between different pathogenic strains. Where WGS is not used, FDA recommends maintaining samples so that they can be characterized by WGS later if necessary (e.g., in a root cause investigation following a contamination event).
  • The draft guidance also indicates in several sections that finished product testing has limitations and should not be solely relied upon for verification of preventive controls or identifying affected food. Finished product testing will be particularly ineffective at identifying hazards which are present at low levels and which are unevenly distributed.
  • Comments to the draft guidance should be submitted by May 7, 2025. Keller and Heckman would be happy to assist in preparing comments.
  • On January 6, 2025, FDA finalized its Guidance For Industry #294: Animal Food Ingredient Consultation (AFIC). The guidance describes FDA’s AFIC process, which is one way FDA intends to work with animal food ingredient developers following the expiration of the Agency’s memorandum of understanding (MOU) with the Association of American Feed Control Officials (AAFCO).
  • AAFCO is a voluntary organization that guides regulators and has long maintained a list of animal food ingredients and definitions. Every state, except Alaska, has some version of the AAFCO model bill and regulations codified under their respective state laws. Historically, FDA participated in the AAFCO ingredient definition request process by providing scientific and technical assistance to AAFCO. In 2007, FDA and AAFCO entered into an MOU to collaborate on animal ingredient definitions to be listed in the AAFCO Official Publication. However, the MOU expired in October 2024 and was not renewed.
  • According to the guidance, AFIC is intended to be an interim process while FDA reviews the animal Food Additive Petition and GRAS Notification processes. While these programs are still available, AFIC serves as an additional avenue for animal food ingredient developers to consult with FDA regarding the ingredients and their safety. Companies can participate in the AFIC process by submitting the following information:
    • Firm and contact information;
    • Proposed ingredient name and definition;
    • Summary of the request;
    • Ingredient description;
    • Manufacturing information;
    • Purpose of the ingredient, including data to support the intended use;
    • A safety assessment, including target animal and human food safety;
    • Copies of cited literature and reports;
    • Proposed labeling; and
    • Any other relevant information.
  • Pending and completed AFICs will be posted on FDA’s website in accordance with the Agency’s confidentiality obligations. Interested parties will have an opportunity to provide input, including additional data or information, and FDA will complete the consultation process by issuing a “consultation complete” letter summarizing the Agency’s review of the ingredient.
  • The guidance also describes FDA’s enforcement policy for ingredients reviewed using the AFIC policy. FDA does not intend to initiate enforcement action with respect to the food additive approval requirements of ingredients reviewed under the AFIC and subject to a “consultation complete” letter, as long as there continue to be no questions regarding the safety of the ingredient.
  • On January 6, 2025, the U.S. Food and Drug Administration (FDA) released “Labeling of Plant-Based Alternatives to Animal-Derived Foods: Draft Guidance for Industry”, which provides recommendations on best practices for naming and labeling plant-based foods marketed as alternatives to animal-derived products.
  • The guidance covers plant-based alternatives to eggs, seafood, poultry, meat, and dairy products, excluding plant-based milk alternatives, which have their own draft guidance.
  • When labeling plant-based alternatives, the product name must be prominently displayed on the principal display panel (21 CFR 101.3).  The name can be a Standard of Identity (SOI) established by law or regulation, or in the absence thereof, a common or usual name, or an appropriately descriptive statement.  FDA has not established specific Standards of Identity for plant-based alternatives by law or regulation.  Further, many plant-based products use novel food ingredients without a common or usual name, and so are required to use a descriptive statement.
  • FDA recommends that plant-based products should (1) identify the plant source (e.g., soy, almond) and (2) clearly state that the product is not animal-based.  The source of the plant-based ingredients should be part of the name, rather than just stating “plant-based.” Omitting a predominant ingredient may be considered misleading.
  • The Draft Guidance includes several examples of best practices for labeling.  Some examples include the following:
    • If a plant-based alternative food includes the name of a standardized food, such as “cheddar cheese,” the SOI should be qualified by the plant source, such as “soy-based cheddar cheese.”
    • “Pork-less bacon” is insufficient as it does not distinguish between other plant-based alternative products.  “Plant-Based Soy-Bacon” would be a more appropriate name.
    • If a product has multiple plant sources, the predominant sources by weight should be included.  For example, a veggie patty containing black beans, mushrooms, and other vegetables with black beans as the predominant ingredient should be labeled as “Black Bean Mushroom Veggie Patties.”
  • To ensure the FDA considers them, comments on the Draft Guidance must be submitted within 120 days of its publication in the Federal Register, by May 7, 2025. Keller and Heckman can help with submitting comments, which can also be done electronically via the available docket.
  • Keller and Heckman will continue to monitor updates related to plant-based alternatives and FDA labeling requirements.
  • On January 3, 2025, California’s Governor Newsom issued an executive order (Executive Order N-1-25) directing state agencies to recommend potential actions to “limit the harms” associated with “ultra-processed foods” and food ingredients that allegedly may pose health risks.  Specifically, state entities are instructed to do the following, pursuant to the executive order:
    • By April 1, 2025, provide recommendations to the Governor’s Office regarding potential action to limit the harms associated with “ultra-processed foods” and food ingredients that pose a health risk to individuals;
    • Continue investigating the adverse health impacts of synthetic food dyes and identify any additional adverse health impacts by April 1, 2025;
    • By April 1, 2025, recommend actions to reduce the purchase of soda, candy, other ultra-processed foods and/or foods with synthetic food dye or other additives;
    • By April 1, 2025, investigate the feasibility of requiring Medi-Cal Managed Care plans and California hospitals to use their Community Investment dollars and Community Benefit funds to enhance access to fresh, healthy foods, mitigate the impacts of “food deserts,” and otherwise promote public health at the local level;
    • By October 1, 2025, identify areas where California may adopt higher standards for healthy school meals than national standards; and
    • By October 1, 2025, explore developing new standards and partnerships to further protect and expand universal school food programs.
  • The executive order follows a common theme in recent California legislation.  As we previously reported, AB 2316 passed in August 2024, which bans schools from serving foods with Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3.  Additionally, in 2023, AB 418 prohibited the manufacturing, selling, delivering, distributing, holding, or offering for sale a food product that contains brominated vegetable oil, potassium bromate, propylparaben, and red dye 3.
  • Keller and Heckman will continue to monitor and relay any legislative updates in this area.
  • 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.