This update includes FDA updates, FDA warning letters, USDA updates, lawsuits, and other articles of interest, including the Executive Order pausing FDA rulemaking, new guidance on evaluating non-major food allergens, guidelines urging healthier beverage choices for children, and more.
FDA Updates
Rules Status:
President Trump Issues Regulatory Freeze Executive Order Pausing FDA Rulemaking
President Trump issued a Regulatory Freeze Pending Review Executive Order, effective January 20, 2025 that prohibits the FDA from proposing or issuing any new rules until they have been thoroughly reviewed and approved by an agency head appointed by President Trump. Any rules that have been sent to the Office of the Federal Register but not yet published must be withdrawn for review. In addition, the FDA is instructed to consider postponing for 60 days the effective dates of any rules that have been published but have not yet taken effect to allow for review regarding questions of fact, law, and policy that the rules may raise. During the 60-day postponement, agencies may open a comment period for public input and reevaluate pending petitions.
FDA Rulemaking at the End of the Biden Administration
The FDA issued the following rules and proposed rules during the last weeks of the Biden Administration. These rules could either move forward, be withdrawn, or be subject to additional rulemaking activities, pursuant to President Trump’s Regulatory Freeze Executive Order.
- Myoglobin as a color additive: The FDA amended the color additive regulations to provide for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products in response to a color additive petition submitted by Motif FoodWorks, Inc. This order is effective February 19, 2025. More information can be found here.
- Red No. 3: The FDA issued an order to revoke the authorization for the use of FD&C Red No. 3 in food and ingested drugs, effective January 15, 2027. More information can be found here.
- Front-of-Package Nutrition Labeling: The FDA issued a proposed rule to require a front-of-package (FOP) nutrition label on most packaged foods to provide accessible, at-a-glance information so consumers can easily identify how foods can be part of a healthy diet. Written comments on the proposed rule must be submitted by May 16, 2025. More information can be found here.
- Sanitation Programs for Low-Moisture Ready-To-Eat Human Foods: The FDA released a draft guidance for industry entitled “Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event.” The draft guidance explains FDA’s thinking on establishing a routine sanitation program for low-moisture ready-to-eat human foods that can help prevent contamination of food or a food-contact surface with a pathogen and corrective actions to remediate contamination of food-contact surfaces if prevention fails. Written comments on the draft guidance must be submitted by May 7, 2025. More information can be found here.
FDA Revokes Temporary Market Testing Permit for Ultrapasteurized Liquid Eggs
January 2: The FDA revoked the temporary permit issued to M.G. Waldbaum Co., a subsidiary of Michael Foods Egg Co., to market test “ultrapasteurized liquid whole eggs” and “ultrapasteurized liquid whole eggs with citric acid” because the need for the temporary permit no longer exists. More information can be found here.
FDA Ends Effectiveness of 35 PFAS Food Contact Notifications
January 3: The FDA announced that 35 food contact notifications (FCNs) related to per- and polyfluoroalkyl substances (PFAS) are no longer effective as of January 6, 2025. These FCNs previously authorized grease-proofing coatings for paper and paperboard packaging. This decision is due to the abandonment of these FCNs by manufacturers or suppliers who have ceased production, supply, or use of the substances. Manufacturers agreed to phase out sales of PFAS-containing grease-proofing substances by February 2024. The FDA established a compliance date of June 30, 2025, for exhausting existing stocks of affected food packaging. More information can be found here.
FDA Releases Draft Guidance on Labeling Plant-Based Alternatives to Animal-Derived Foods
January 6: The FDA released a draft guidance for industry titled “Labeling of Plant-Based Alternatives to Animal-Derived Foods.” This guidance, once finalized, will offer recommendations on best practices for naming and labeling plant-based foods that serve as alternatives to animal-derived products, especially in the absence of a common or usual name for the product. Written comments on the draft guidance must be submitted by May 7, 2025. More information can be found here.
FDA Releases Final Food Allergen Labeling Guidance
January 7: The FDA announced the availability of a revised final guidance for industry entitled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry.” The new guidance has been updated based on comments submitted to the draft guidance and consists of questions and answers about food allergen labeling requirements, including the labeling of tree nuts, sesame, milk, eggs, incidental additives, highly refined oils, dietary supplement products, and the packing and labeling of individual units within a multiunit package. More information can be found here.
FDA Releases New Guidance on Evaluating Non-Major Food Allergens
January 7: The FDA announced the availability of a final guidance for FDA staff and interested parties entitled “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act.” This guidance document provides FDA’s approach when evaluating the public health importance of a food allergen other than one of the major food allergens (i.e., milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybean, and sesame) listed in the Federal Food, Drug, and Cosmetic Act. More information can be found here.
FDA Issues Final Guidance on Lead Limits in Baby and Toddler Foods
January 7: The FDA released a final guidance for industry entitled “Action Levels for Lead in Processed Food Intended for Babies and Young Children.” The guidance establishes action levels for lead in certain processed foods intended for babies and young children less than 2 years old and it is intended to set achievable action levels that will help further reduce lead in the food supply. More information can be found here.
FDA Issues Request for Information on Poppy Seeds
January 15: The FDA issued a Request for Information to better understand industry practices related to poppy seeds. The FDA is seeking information on growing, harvesting, processing and distribution of poppy seeds, including industry practices to reduce the opiate alkaloid content of poppy seeds. This action follows reports of adverse events linked to poppy seed products, which may contain varying levels of opiate alkaloids. The goal is to determine necessary actions to ensure poppy seed products are safe for consumption. Information must be submitted by April 15, 2025. More information can be found here.
FDA Issues Request for Information on High-Protein Yogurt
January 15: The FDA issued a Request for Information regarding the manufacturing processes and ingredients used to make high-protein yogurt, including Greek yogurt and Greek-style yogurt. This action is partly due to concerns that the current yogurt standard of identity does not align with the methods used to concentrate protein in these products. The FDA is seeking input from the industry and other interested parties to understand current practices and the use of various names for high-protein yogurt. The information gathered will help determine if any regulatory actions are needed. Comments are due by April 15, 2025. More information can be found here.
FDA Warning Letters
Adulterated Breads: The FDA issued a warning letter to a Utah manufacturer of ready-to-eat breads, following an inspection of their manufacturing facility. The FDA determined that the products are adulterated because they were prepared, packed, or held under insanitary conditions, potentially making them harmful to health. In addition, the FDA determined the owner, operator or agent of the facility failed to comply with preventive controls provisions of the Current Good Manufacturing Practice and Preventive Controls rule.
A database of warning letters can be found here
USDA Updates
FSIS and FDA Extend Food Date Labeling Comment Period
January 3: FSIS and FDA have extended the comment period by 30 days for a joint Request for Information (RFI) on food date labeling practices, consumer perceptions, and the impact on food waste and grocery costs. The new deadline is March 5, 2025. The extension, requested by an industry association, aims to give stakeholders more time to prepare their comments. The request for information can be found here.
FSIS Announces Changes in Leadership Positions
January 3: FSIS made several recent changes to its leadership team including the Offices of Public Health Science, Field Operations, Employee Experience and Development, and the Chief Financial Officer. More information about FSIS leadership can be found on the FSIS Programs & Offices webpage.
FSIS Releases Report on Listeria Outbreak Linked to Boar’s Head Provisions
January 10: The FSIS released a report on the Listeria monocytogenes outbreak linked to Boar’s Head Provisions Co., Inc. The report outlines steps FSIS plans to take, including immediate actions and those requiring significant policy and scientific review. FSIS reviewed extensive documents, data, and conducted assessments of Boar’s Head facilities, identifying key areas for improvement such as sampling, inspector training, and regulatory policy. Immediate steps were announced in December 2024, with long-term actions aimed at preventing future outbreaks. More information can be found here.
FSIS Updates Guidance on Controlling Retained Water in Meat and Poultry Products
January 17: The FSIS updated its guidance for controlling retained water in meat and poultry products entitled “The FSIS Guideline for Retained Water.” This update follows the initial publication on April 1, 2024, and includes responses to public comments, clarifications on arithmetic errors in Retained Water Protocol (RWP) reviews, and additional information on addressing statistical variability. FSIS encourages establishments to review the new recommendations to ensure their data are reproducible and statistically verifiable. Establishments must submit revised RWPs by March 3, 2025, and make necessary label changes by January 1, 2026. The Office of Field Operations will begin reviewing retained water protocols on October 1, 2025. More information can be found here.
USDA Announces Key Presidential Leadership Appointments
January 21: The USDA announced the names of the following individuals who will hold senior staff positions in Washington, D.C.:
- Kailee Tkacz Buller will serve as Chief of Staff of the USDA.
- Preston Parry will serve as Deputy Chief of Staff of the USDA.
- Jennifer Tiller will serve as Chief of Staff to the Deputy Secretary and Senior Advisor to the Secretary for Food, Nutrition and Consumer Services.
- Ralph Linden will serve as the Principal Deputy General Counsel of the USDA.
- Audra Weeks will serve as Deputy Director of Communications of the USDA.
- Dominic Restuccia will serve as the White House Liaison for the USDA.
More information can be found here.
Other Articles of Interest
FDA Seeks Public Comments on NARMS Strategic Plan
January 17: The FDA is seeking public comments on the new 2026-2030 National Antimicrobial Resistance Monitoring System (NARMS) Strategic Plan. The FDA Request for Comments includes specific questions and information requests to guide input from interested parties. Comments are due by March 26, 2025. The plan’s development will be discussed at a NARMS public meeting in Spring 2025. NARMS is a collaborative partnership involving USDA agencies, the CDC, the FDA, and state and local public health departments to monitor antimicrobial resistance in certain intestinal bacteria. More information can be found here.
GAO Calls for Stronger USDA Oversight on Meat and Poultry Products
January 22: The U.S. Government Accountability Office (GAO) has urged the USDA to enhance its oversight of meat and poultry products. Despite being on the GAO’s “High Risk List” since 2007, the USDA continues to face significant regulatory gaps, particularly in pathogen control. The GAO report highlights the USDA’s narrow focus on Salmonella standards for raw poultry, neglecting other critical areas such as pork and beef. The absence of updated pathogen standards for beef, turkey, and pork leaves these products vulnerable to contamination, posing ongoing public health risks. The report calls for updated pathogen standards and better risk assessment to protect public health. More information can be found here.
New Guidelines Urge Healthier Beverage Choices for Kids
January 30: A coalition of health and nutrition organizations, including the American Academy of Pediatrics and the American Heart Association, has issued new guidelines recommending that children and teens primarily consume water and plain milk. The guidelines advise against beverages with added sugars, artificial sweeteners, and caffeine, which are prevalent in many drinks marketed to kids, such as energy drinks and flavored coffees. The recommendations highlight the potential health risks of these beverages, including delayed sleep, increased anxiety, and other mental health issues. The coalition also suggests limiting plant-based milks unless necessary for dietary restrictions, as they often lack the nutritional benefits of cow’s milk. More information can be found here.
Lawsuits
Judge Allows Protein Content Deception Lawsuit Against Dave’s Killer Bread to Proceed
January 13: A federal judge ruled that a lawsuit alleging Dave’s Killer Bread Inc. misrepresented the amount of protein per serving in over a dozen of its products can proceed with most of the claims. The lawsuit, filed in the US District Court for the Northern District of Illinois, alleges that Dave’s Killer Bread overstated the amount of digestible protein on the front labels of its products without including a corrected percent daily value in the nutrition facts, as required by the FDA. While the plaintiffs claim for injunctive relief was dismissed without prejudice due to a failure to plead future harm, the judge allowed other claims against Dave’s Killer Bread to proceed, including violations of consumer protection statutes and fraud. The judge also noted that federal law does not preempt these claims, as they are based on traditional state law principles of liability, such as breach of express warranty and fraud, which predate the relevant FDA requirements.
Environmental Groups Sue FDA Over Use of Toxic Phthalates in Food Packaging
January 19: Environmental groups filed a lawsuit against the FDA accusing the agency of endangering public health by allowing phthalates in plastic food packaging despite evidence of the chemicals’ harmful effects. Environmental advocates argue the FDA ignored scientific evidence linking phthalates in plastic packaging to health risks, especially in children. The European Union has banned or restricted some phthalates in food contact materials, but U.S. regulations remain limited. The lawsuit follows an eight-year effort to ban phthalates from food packaging, with the FDA repeatedly siding with industry claims that the chemicals are safe. The lawsuit seeks to order the FDA to ban all phthalates from food contact materials. The FDA has not yet responded to the lawsuit. More information can be found here.
Judge Recommends Dismissal of Class Action Over Monkfruit Sweetener Claims
January 22: A proposed class action lawsuit against Saraya USA Inc., alleging deceptive advertising of its monkfruit extract sweetener, should be dismissed, according to a magistrate judge’s recommendation. The lawsuit, filed in the US District Court for the Eastern District of New York by plaintiff Dalit Cohen, claimed that Saraya’s alternative sweetener, which is made from erythritol and monkfruit extract, actually contains 16 calories and 4 net carbohydrates per four grams and was falsely advertised as zero calorie and zero net carbohydrate. The judge stated that Cohen did not provide sufficient evidence to support the allegations that the product’s labeling was false and that the plaintiff’s general claims about “separate studies” and “independent tests” were not adequately substantiated. The judge further stated that reasonable consumers would not likely be misled by the product’s front-label claims, as any ambiguity could be clarified by the nutrition facts on the back of the packaging.
Kraft Heinz Faces Class Action Lawsuit Over Capri Sun’s “All Natural Ingredients” Claims
January 24: Kraft Heinz Food Co. is facing a proposed class action lawsuit alleging that the company falsely advertises its Capri Sun juice pouches as containing “all natural ingredients” when they actually contain the synthetic preservative citric acid. The lawsuit, filed by Alyssa Flexer in the US District Court for the Eastern District of New York, alleges that Kraft Heinz violated state law by misleading consumers into believing that Capri Sun products contain only natural ingredients, which would imply the absence of synthetic substances. According to the complaint, citric acid, commonly used as a preservative in foods and beverages, is not naturally occurring. The lawsuit asserts claims under New York General Business Law for deceptive acts and false advertising, as well as a claim for breach of express warranty.
Arizona Group Sues FDA Over Delayed PFAS Food Safety Action
January 27: The Tucson Environmental Justice Task Force, an environmental justice group in Arizona, filed a complaint in the US District Court District of Arizona against the FDA for delaying action on a citizen petition to set tolerances for PFAS in foods like fruits, vegetables, and eggs. The group argues that the FDA’s inaction allows adulterated foods to remain on the market, posing risks to public health and global trade. The petition, filed in November 2023, requests temporary tolerance levels for PFAS in various foods. PFAS are persistent environmental contaminants that can accumulate in the human body and cause health issues. Despite a follow-up letter in August 2024, the FDA has not responded, prompting the plaintiffs to ask the court to declare the FDA’s delay unreasonable and order the FDA to issue a timely decision on the petition.
Nestlé Wins Dismissal of Fish Oil Supplement Lawsuit
January 29: Nestlé Health Science US LLC successfully defended against a class action lawsuit alleging that Nature’s Bounty fish oil supplements falsely advertised heart health benefits. The US District Court for the Central District of California dismissed the case, with Judge Mark C. Scarsi ruling that the claims were preempted by the federal Food, Drug, and Cosmetic Act. The judge further ruled that the complaint failed to allege that reasonable consumers would be deceived by the heart health label statements. The plaintiff, Yesenia Bowler, argued that the heart health claims were deceptive, but the court found that the studies cited did not prove the statements were false. Additionally, the court noted that the label included disclaimers indicating the claims had not been evaluated by the FDA and were not intended to treat or prevent any disease.
California Health Food Chains Face Lawsuit for Selling Kale Chips with Heavy Metals
January 30: Two health food chains in Southern California, Erewhon and Mother’s Market & Kitchen, are facing a lawsuit for selling kale chips containing heavy metals like lead and cadmium without proper warnings. The lawsuit, filed under California’s Proposition 65 in California Superior Court for Los Angeles County, claims Erewhon sold spicy “California Snax” kale chips with cadmium, while Mother’s Market sold nacho and pizza flavored versions with both lead and cadmium. These toxins are known to cause developmental and reproductive harm. Neither company has responded to the allegations.
This Regulatory Update covers information from January 2025. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.