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This update includes FDA updates, FDA warning letters, USDA updates, lawsuits, and other articles of interest, including the appointment of Robert F. Kennedy Jr. as Health Secretary, the release of paused funding to U.S. farmers, testing of raw milk for avian flu, and more.

FDA Updates

Robert F. Kennedy Jr. Appointed Health Secretary Amid Mixed Reactions
February 17:  Robert F. Kennedy Jr. was confirmed by the Senate to lead the Department of Health and Human Services. Kennedy, a controversial figure due to his promotion of various conspiracy theories, wants to tackle the chronic disease epidemic and reform the nation’s health care systems. Despite lacking a professional background in medicine, his stance against chemical additives and “Big Pharma” has received support from many, especially mothers. Sen. Mitch McConnell was the only Republican to oppose Kennedy’s confirmation, citing his history of spreading dangerous conspiracy theories. Conversely, food activist Vani Hari praised the nomination as a historic change for American health. Kennedy’s first major initiative, the President’s Make America Healthy Again Commission, will focus on investigating the root causes of America’s health crisis, particularly childhood chronic diseases. The commission is expected to produce an assessment within the first 100 days. 

FDA Deputy Commissioner Resigns Amid Mass Firings
February 18:  Jim Jones, deputy commissioner at the FDA, resigned after the “indiscriminate firing” of nearly 90 staff members. Jones criticized the Trump administration’s actions, saying it was “fruitless” to continue in his role. The firings included experts in infant formula safety and food ingredient reviewers.  Jones became the FDA’s first deputy commissioner for human foods in 2023 and helped to establish the human foods program after the 2022 baby formula shortage. Jones’ resignation follows Robert F. Kennedy Jr.’s appointment as Health and Human Services secretary, a position that oversees the FDA. Kennedy has said that food companies and regulators are sickening Americans, and he has vowed to address what he calls corruption within the FDA.

FDA Delays Implementation of New “Healthy” Food Labeling Rule
February 24:  The FDA postponed the enforcement of a new rule requiring food manufacturers to meet updated criteria to label their products as “healthy.” According to a FDA notice, the final rule, which was originally set to take effect on February 25, is now delayed until April 28. This delay follows an executive order by President Trump to freeze pending regulatory actions. The final rule, issued in December 2024, updated the definition of “healthy,” and aligns with the Dietary Guidelines for Americans and the latest scientific evidence supporting the updated Nutrition Facts label. To qualify as “healthy,” foods must include certain amounts from specified food groups such as fruits, vegetables, protein foods, dairy, and grains. Additionally, these foods must adhere to limits on saturated fat, sodium, and added sugars.

FDA Appoints Kyle Diamantas as Acting Deputy Commissioner for Human Foods
February 28:  The USDA named Kyle Diamantas, a food and beverage attorney, as the new acting deputy commissioner for human foods. Diamantas replaces Jim Jones, who resigned in protest of staffing cuts. In his new role, Diamantas will oversee all FDA nutrition and food safety activities, including resource allocation, risk-prioritization, policy initiatives, and major response activities. He will also serve as a key liaison between the FDA, the Department of Health and Human Services, and The White House.  More information can be found here.

FDA Stops Contaminated Clams at U.S. Borders
February 28:  The FDA added several Chinese companies to its Import Alert 99-48, Detention without Physical Examination of Foods Due to Chemical Contamination, preventing the entry of processed clams contaminated with per- and polyfluoroalkyl substances (PFAS) into the U.S. market. The FDA detected elevated levels of PFAS, notably perfluorooctanoic acid (PFOA), in samples of clams from the companies. As the FDA continues sampling activities at the border, additional firms may be added to the import alert and shipments will be automatically held at the border without inspection. The FDA is also conducting seafood surveys and analyzing foods to better understand PFAS levels and ensure food safety. More information can be found here.

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FDA Warning Letters

Foreign Supplier Verification Program (FSVP):  The FDA issued a warning letter to three food importers for violations of FSVP regulations as they did not develop, maintain, and follow an FSVP.

A database of warning letters can be found here.

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USDA Updates

USDA Confirms Ongoing Support for Global Nutrition and Education Initiatives
February 7:  The U.S. Department of Agriculture (USDA) confirmed that the Foreign Agricultural Service is continuing activities for projects funded by the McGovern-Dole International Food for Education and Childhood Nutrition Program and the Food for Progress Program.  More information can be found here.

Brooke Rollins Sworn in as New U.S. Secretary of Agriculture
February 13:   Brooke Rollins was sworn in as the 33rd U.S. Secretary of Agriculture after being confirmed by the Senate with a 72-to-28 vote.  Rollins expressed her commitment to serving American farmers, ranchers, and the broader agricultural community.  She wants to revitalize rural America and ensure the continued excellence of U.S. agriculture. Rollins holds a degree in agricultural development from Texas A&M University, as well as a Juris Doctor from the University of Texas School of Law and brings extensive experience from her roles in the America First Policy Institute and the first Trump administration. More information can be found here.

USDA Secretary Highlights Key Challenges and Commitment to Rural Communities
February 13:  In a letter addressed state, local, and tribal government partners, U.S. Secretary of Agriculture Brooke Rollins emphasized the USDA’s commitment to supporting rural communities. The letter highlighted several challenges facing the agricultural sector, including a significant trade deficit, a decline in the number of farms, increased production costs, and the impact of avian flu. The Secretary expressed a dedication to refocusing the USDA on its core mission of serving farmers and ranchers, ensuring food safety, and promoting economic opportunities in rural areas. The letter also encouraged participation in the agency’s “Laboratories of Innovation” initiative to propose innovative solutions to address these issues.  More information can be found here.

USDA Secretary Rollins Unveils Vision for Enhanced Nutrition Programs
February 14:  U.S. Secretary of Agriculture Brooke Rollins shared her vision for the USDA’s nutrition programs in a notice to state leaders encouraging them to participate in pilot programs to reform the food stamp program (SNAP). In particular, she outlined principles of reform, such as establishing more robust work requirements, and emphasized a commitment to integrity, accountability, and innovation. Rollins stressed the need for modernized systems, connecting America’s farmers to nutrition assistance programs, and encouraging healthy choices and outcomes. More information can be found here.

USDA Releases $20 Million in Paused Funding to Support Farmers
February 20:  U.S. Secretary of Agriculture Brooke Rollins announced the release of the first tranche of funding that was paused for review under the Inflation Reduction Act (IRA). USDA is releasing approximately $20 million in contracts for the Environmental Quality Incentive Program, the Conservation Stewardship Program, and the Agricultural Conservation Easement Program. Rollins emphasized the importance of supporting American farmers and ranchers, criticizing previous administration policies for over-regulation and misallocated funds. She assured that the USDA will honor existing contracts and continue to review IRA funding to ensure it benefits farmers and ranchers. More information can be found here.

USDA Allocates $1 Billion to Combat Avian Flu and Lower Egg Prices
February 26:  The USDA announced a $1 billion investment to tackle highly pathogenic avian influenza (HPAI), protect the U.S. poultry industry, and lower egg prices. USDA Secretary Brooke Rollins revealed a comprehensive strategy that includes $500 million for biosecurity measures, $400 million in financial relief for affected farmers, $100 million for vaccine research, and regulatory adjustments such as reducing regulatory burdens on the chicken and egg industry and consider temporary import-export options to reduce costs on consumers.  More information can be found here.

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Other Articles of Interest

GAO Urges Unified Approach to Strengthen U.S. Food Safety
February 3:  The Government Accountability Office (GAO) released a report emphasizing the need for a unified food safety system in the United States to help improve the safety of the food supply. The report reveals that most goals to reduce foodborne illnesses have not been met and that the current system lacks coordination and efficiency. The GAO recommends a national food safety strategy to streamline efforts and improve public health outcomes. The report also notes that key agencies, such as the FDA and FSIS, have failed to meet their targets, with some goals seeing significant setbacks.  More information can be found here.

New Strain of Bird Flu Detected in Nevada Dairy Herds
February 6:  A new strain of the H5N1 bird flu virus, known as D1.1, has been detected in milk samples from dairy herds in Nevada. This marks the first time this strain has been found in dairy cows. The USDA reported that the virus, previously circulating in wild birds, was identified through the National Milk Testing Strategy launched in December 2024.  So far 36 states are testing milk for bird flu. The affected herds have been quarantined, and efforts are underway to prevent further spread. More information can be found here.

Cannabis Cocktails: Wisconsin’s New THC Drink Craze
February 11:  Wisconsin is experiencing a surge in popularity of legal THC-infused drinks. These beverages, which contain Delta-9 THC derived from hemp, are now available in various locations, including bars, liquor stores, and even coffee shops. The drinks range in potency, from 2.5mg to over 50mg of THC per can. This trend stems from the 2018 Federal Farm Bill, which allows THC products from hemp to be sold legally. Entrepreneurs in the state have embraced this opportunity, with some businesses seeing significant growth in sales. More information can be found here.

Senator Questions USDA Secretary Nominee on Rising Egg Prices Amid Bird Flu Outbreaks
February 11:  Sen. Martin Heinrich (D-NM) raised concerns with Brooke Rollins, the USDA secretary-designate, regarding the escalating cost of eggs due to a severe bird flu outbreak. In a letter dated February 7, Heinrich suggested the USDA develop and administer vaccines for highly pathogenic avian influenza (HPAI) to help reduce egg prices. He emphasized that the flu outbreak is severely impacting egg and poultry producers and straining family budgets. Heinrich highlighted the USDA’s role in maintaining an affordable food system and supporting markets for American farmers. He urged Rollins to outline her plans for managing vaccination logistics and costs, as well as enhancing flock surveillance to lower consumer prices. Egg prices have surged by 65% in 2024, with further increases expected in 2025. More information can be found here.

Republicans Advocate for USAID Food Program Amid Budget Cuts
February 11:  Congressional Republicans from farm states are working to preserve a $1.8 billion food-aid program administered by the U.S. Agency for International Development (USAID). The program, which purchases U.S. agricultural products for distribution to countries in need, is facing potential budget cuts. The GOP proposal suggests moving oversight of the program to the U.S. Department of Agriculture to ensure its continuation and effectiveness. Farm groups, worried about the impact of pausing federal funds that generate revenue for farmers, supported the legislation.  More information can be found here.

Wisconsin to Test Raw Milk for Avian Flu Under National Strategy
February 21:  Wisconsin dairy producers and processors will soon be required to test raw milk for avian flu as part of the National Milk Testing Strategy, which seeks to eliminate the virus from dairy herds. The state’s Department of Agriculture, Trade and Consumer Protection (DATCP) announced participation in the program. The USDA Animal and Plant Health Inspection Service initiated the voluntary program to gather data on the spread of highly pathogenic avian influenza (HPAI). To date, the virus has been confirmed in over 970 herds across 17 states. Wisconsin officials plan to use existing milk samples for testing to streamline the process. DATCP created a document for industry in the event of an avian flu detection on a dairy farm. More information can be found here and on DATCP’s Avian Influenza website.

FDA Reinstates Staff After Mass Firings
February 25:  Barely a week after mass firings at the FDA, some probationary staffers received news that the government wants them back. FDA employees overseeing food ingredients were notified that their terminations had been rescinded effective immediately. At least 10 staffers in the food program were offered their jobs back, with no explanation or advance notice given to their immediate supervisors. This reversal comes after the same employees were previously told they were “not fit for continued employment.”  More information can be found here.

Lawsuits

Minnesota’s PFAS Ban Upheld by Federal Judge
February 25:  A federal judge for the US District Court for the District of Minnesota ruled that Minnesota can enforce its law banning intentionally added per- and polyfluoroalkyl substances (PFAS) in consumer products. The Cookware Sustainability Alliance’s attempt to block the law was denied, as they failed to show it violated the Constitution’s commerce clause or caused irreparable harm. At issue is a 2023 Minnesota law known as Amara’s Law, which bans intentionally added PFAS from consumer products. The cookware industry group argued that Amara’s Law discriminates against out-of-state interests because it only applies to out-of-state manufacturers. The judge disagreed, stating that the law is not discriminatory in intent or effect and its benefits to Minnesotans outweigh the effects on individual businesses.

Class Certification Granted in Walmart Avocado Oil Lawsuit
February 28:  A federal judge granted class certification in a lawsuit against Walmart Inc., alleging that its Great Value Avocado Oil is blended with low quality or cheaper oils but marketed as pure. Judge R. Gary Klausner of the US District Court for the Central District of California certified the California consumer class. Klausner rejected Walmart’s argument that the plaintiff needed to prove the oil was adulterated before class certification. He also rejected Walmart’s claim that the class action was not the best way to resolve the issue.  Walmart argued that the claims would require bottle-by-bottle testing. However, Klausner noted that common adulteration allegations do not require bottle-by-bottle testing. While the judge did not accept the consumer’s full refund model for damages, he approved a price-premium model to demonstrate the predominance of common issues among class members.

This Regulatory Update covers information from February 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.

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.

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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

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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.

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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.

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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.

This update includes FDA updates, FDA warning letters, USDA updates, lawsuits, and other articles of interest, including mandated accredited labs for mycotoxin testing, new EU import requirements for honey, PFAS test results for clams, and more.

FDA Updates

FDA Mandates Accredited Labs for Mycotoxins Testing Starting December 2024
December 1:  The FDA is reminding owners and consignees of certain imported foods that they will be required to use accredited laboratories under the Laboratory Accreditation for Analysis of Foods (LAAF) program when conducting mycotoxins analyses beginning December 1, 2024. More information on the LAAF final rule and the LAAF Dashboard can be found here.

FDA Updates Retail Food Regulatory Standards for 2024
December 3:  The FDA released the 2024 edition of the Voluntary National Retail Food Regulatory Program Standards, which defines the key elements of an effective retail food regulatory program for state, local, tribal, and territorial food regulatory agencies. These standards include recommendations for designing and managing retail food initiatives, as well as recognizing programs that show progress in implementing the standards. The 2024 edition incorporates updates from the 2023 Conference for Food Protection Biennial Meeting, such as re-standardization frequency updates, new courses, audit procedure updates, and new terminology. More information can be found here.

FDA Files Leprino Nutrition Food Additive Petition
December 4:  The FDA filed a petition, submitted by Leprino Nutrition. The petition proposes to amend the food additive regulations to provide for the safe use of ultraviolet light for the reduction of microorganisms in whey products. More information can be found here.

FDA and FSIS Seek Input on Food Date Labeling Practices
December 4:  The FDA and USDA issued a joint Request for Information (RFI) on food date labeling, including terms like ‘Sell By,’ ‘Use By,’ and ‘Best By.’ The RFI seeks information on industry practices and preferences for date labeling, research results on consumer perceptions of date labeling, and the impact of date labeling on food waste and grocery costs. It includes questions about which products have date labels, criteria for choosing phrases and dates, consumer interpretation of date labels, and the relationship between date labels, food waste, and household expenses. The deadline for public comment is February 3, 2025. More information can be found here.  Further information on how to submit a comment can be found here.

FDA Updates Requirements for ‘Healthy’ Content Claims on Food Labels to Promote Better Dietary Choices
December 19:  The FDA issued a final rule updating the nutritional requirements and criteria a food must meet to use the claim “healthy” on the package to help consumers identify foods that support a healthy diet. Manufacturers can voluntarily use this “healthy” claim starting on February 25, 2025, if their products meet the updated criteria, which align with current nutrition science and the Dietary Guidelines for Americans. The updated criteria include limits on saturated fat, sodium, and added sugars, and require certain amounts of recommended food groups such as fruits, vegetables, grains, protein foods or dairy. Nuts and seeds, olive oils, higher-fat fish and eggs would qualify as “healthy” under the updated criteria. The FDA is also exploring a standardized symbol for the “healthy” claim on food labels. Manufacturers have three years to comply with the new criteria. More information can be found here.

FDA Warns Against Use of Amanita Muscaria in Conventional Foods
December 18:  The FDA issued a letter to food manufacturers stating that Amanita muscaria (A. muscaria), its extracts, and certain constituents (muscimol, ibotenic acid, and muscarine) are not authorized for use in conventional food due to safety concerns. These ingredients, often found in “psychedelic edibles,” do not meet the Generally Recognized as Safe (GRAS) standard and are considered unapproved food additives that may be harmful. The FDA advises against consuming foods containing these ingredients. The FDA is also assessing the use of these ingredients in dietary supplements and encourages manufacturers to meet safety standards. More information can be found here.

FDA Releases Inventory of Voluntary Premarket Meetings for Genome-Edited Plant Foods
December 16:  The FDA released a new inventory of voluntary premarket meetings with developers of foods from genome-edited plant varieties. These meetings, outlined in FDA guidance, allow developers to voluntarily engage with the FDA before marketing their food products from genome-edited plants, based on the food’s risk characteristics. The FDA distinguishes these meetings from voluntary premarket consultations. The FDA encourages consultations for foods with higher safety or regulatory concerns. All genome-edited plant foods must meet standard food safety requirements. The FDA plans to update the inventory as more meetings occur. More information can be found here.

FDA Announces New EU Import Requirements for Honey and Apiculture Products
December 17:  The FDA announced new European Union (EU) requirements for importing honey and other apiculture products, effective November 29, 2024. All establishments importing these products into the EU must register in the EU’s Trade Control and Expert System (TRACES). Exporters need an on-site assessment by the USDA Agricultural Marketing Service (AMS) before applying for registration. After passing the assessment, exporters should apply for inclusion on the export list through the FDA’s Export Listing Module. The FDA will maintain and update a list of compliant establishments and plans to send an initial list to the EU by December 31, 2024. More information can be found here.

FDA Extends Comment Period for Export Lists on Human Food Products
December 23:  The FDA extended the comment period for the Request for Information on export lists for human food until February 21, 2025. As previously reported, the FDA is seeking public input on the listing requirements of other countries and the agency’s approach to helping U.S. industry comply with these requirements through export certification. The Request for Information intends to gather feedback from stakeholders to help the FDA Human Food Program improve the export certification process. More information can be found here.

FDA Files Food Additive Petition for Vitamin D2 Mushroom Powde
December 26:  The FDA filed a petition, submitted by Monterey Mushrooms, LLC, proposing that the food additive regulations for vitamin D2 mushroom powder be amended to provide for an additional method for producing the additive. More information can be found here.

FDA Sets January 1, 2028, as Uniform Compliance Date for New Food Labeling Regulations
December 31:  The FDA announced that January 1, 2028, will be the uniform compliance date for final food labeling regulations published between January 1, 2025, and December 31, 2026. All food products introduced into interstate commerce on or after January 1, 2028, must meet the new labeling standards. Special circumstances may warrant different compliance dates, which will be specified when final regulations are issued. More information can be found here.

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FDA Warning Letters

Adulterated Breads:  The FDA issued a warning letter to two manufacturers of ready-to-eat breads, rolls, and buns, following an inspection of their manufacturing facilities in Michigan and Florida. The FDA found several violations of the Current Good Manufacturing Practice and Preventive Controls regulations. As a result, the FDA determined that the products are adulterated because they were prepared, packed, or held under insanitary conditions, potentially making them harmful to health.

A database of warning letters can be found here.

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USDA Updates

FSIS Issues Request for Information on Food Date Labeling
December 4:  As reported above, FSIS and FDA are seeking public input on food date labeling. This Request for Information seeks information on industry practices and preferences for date labeling, research results on consumer perceptions of date labeling, and any impact date labeling may have on food waste. Comments will be accepted until February 3, 2025. More information can be found here.

USDA Launches National Milk Testing Strategy to Combat H5N1 in Dairy Herds
December 6:   The USDA launched the National Milk Testing Strategy (NMTS) to enhance surveillance of highly pathogenic avian influenza (HPAI) H5N1 in dairy cattle. This initiative follows the first detection of H5N1 in dairy cattle in March 2024. A new Federal Order mandates nationwide collection and testing of raw milk samples to monitor the virus.  The NMTS seeks to identify affected states and herds, implement biosecurity measures, and protect farmworkers from exposure. The Federal Order requires raw milk sample sharing, epidemiological information from herd owners, and reporting of positive test results. Testing began in December 2024, with California, Colorado, Michigan, Mississippi, Oregon, and Pennsylvania initially participating. The NMTS includes five stages, from nationwide silo monitoring to demonstrating long-term freedom from H5N1. The USDA will work with states to implement the strategy and provide resources for effective biosecurity practices. More information can be found here.

On December 17, 2024, the USDA announced the second round of states joining the NMTS. The seven states included in the second round are Indiana, Maryland, Montana, New York, Ohio, Vermont, and Washington. More information on the second round of states can be found here.

2025 Dietary Guidelines Committee Report Now Available
December 10:  The Scientific Report of the 2025 Dietary Guidelines Advisory Committee is now available on DietaryGuidelines.gov and provides evidence-based findings to inform the USDA and U.S. Department of Health and Human Services on the development of the Dietary Guidelines for Americans, for the period 2025-2030. This report emphasizes health equity, considering factors like socioeconomic status, race, ethnicity, and culture. It also includes strategies to promote healthy dietary patterns across the lifespan. The guidelines seek to prevent diet-related chronic diseases and promote overall health, serving as the foundation for national nutrition programs and policies. A 60-day public comment period was opened on December 11, 2024. Public comments will be accepted until February 10, 2025. A virtual public meeting will also be held on January 16, 2025. More information on submitting public comments and attending the virtual public meeting can be found here.  More information about the Scientific Report can be found here.

FSIS Announces New Measures to Combat Listeria monocytogenes and Ensure Food Safety
December 17:  The FSIS announced new measures to strengthen its oversight of food processing facilities and ensure food safety. These steps are part of the agency’s ongoing efforts to protect public health through science-based regulation, strong enforcement, and a prevention-first approach to eliminating foodborne illness. Recent outbreaks and recalls of ready-to-eat meat and poultry products due to Listeria monocytogenes have prompted FSIS to review its processes. In response, FSIS announced several improvements and initiatives to improve its inspection and oversight capabilities. These actions will help FSIS proactively identify and address systemic issues that could lead to outbreaks. The changes FSIS announced fall into three categories: 1) enhancing its science-based approach to mitigate foodborne pathogens, with a focus on Listeria monocytogenes; 2) improving training and tools for its inspection workforce; and 3) evolving its oversight of regulated facilities, with an emphasis on data review and state inspection agreements. In January 2025, FSIS will also begin testing for a broader range of listeria species in all meat samples and will conduct food safety assessments at meat plants. More information on the new measures can be found here.

New Charter Defines FDA and USDA Jurisdiction for Animal Biologicals
December 20:  The FDA and USDA announced a new charter to clarify the regulatory jurisdiction of certain animal biologicals. This charter builds on a 2013 Memorandum of Understanding (MOU) between the two agencies, which initially outlined their respective regulatory responsibilities. Due to scientific advancements since 2013, some products now fall into a gray area not clearly covered by the MOU. The new charter includes a flowchart to help determine which agency will regulate specific products and provides guidance on how to request a jurisdiction determination from the FDA and USDA. More information can be found here.

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Other Articles of Interest

Potential Overhaul of U.S. Food Packaging Regulations Under Trump’s FDA
December 4:  The next four years could bring significant changes to U.S. food packaging regulations. President-elect Trump has chosen Marty Makary to lead the FDA, which will operate under a Department of Health and Human Services potentially headed by Robert F. Kennedy Jr. They seek to address harmful chemicals in the food supply and chronic diseases. Kennedy has expressed a desire to crack down on food additives and possibly reorganize the FDA. The FDA, known for regulating food safety and drugs, also oversees packaging materials that contact food. With the FDA already undergoing reorganization, the new administration may further change its operations, potentially reviewing long-used chemicals in packaging. This could lead to new regulations and procedural changes, requiring more resources for the agency. More information can be found here.

FDA Nears Decision on Banning Carcinogenic Red Dye No. 3 in Foods
December 6:  The FDA is expected to finalize its decision on banning the carcinogenic food dye FD&C Red No. 3 (Red 3) in foods soon. During a Senate hearing, FDA Deputy Commissioner Jim Jones acknowledged the delay in evaluating Red 3 and mentioned a pending petition to revoke its authorization. A letter from 22 members of Congress, led by Rep. Rosa DeLauro, urged the FDA to ban Red 3, citing its known carcinogenic effects and the availability of alternatives. The FDA banned Red 3 in cosmetics in 1990 due to cancer risks in rats, and the Delaney Clause of the Federal Food, Drug, and Cosmetic Act requires banning any food additive causing cancer in humans or animals. Despite a petition from food safety organizations, the FDA has not yet ruled on it. More information can be found here.

FDA Chief Calls for More Research and Funding to Address Food Safety and Obesity
December 6:  Dr. Robert Califf, the outgoing head of the FDA, highlighted America’s issues with obesity, ultra-processed foods, and food chemicals during a Senate hearing. He emphasized the need for more research to determine the safety of food ingredients, noting that the FDA’s funding requests have been largely ignored. Without sufficient scientific evidence, the FDA cannot legally ban harmful substances. Califf cited Red 3, a food dye linked to cancer in animals, as an example. Despite its risks, the FDA cannot ban Red 3 without conclusive evidence of its harm to humans. Califf urged for better funding to conduct necessary long-term studies. More information can be found here.

RFK Jr. Endorsement Fuels Wisconsin’s Raw Milk Debate Amid Health Risks
December 12:  The raw milk movement in Wisconsin may gain momentum with President-elect Donald Trump’s pick for Health and Human Services Secretary, despite health risks and past illness outbreaks. Unpasteurized milk, endorsed by Robert F. Kennedy Jr., has been linked to H5N1 virus contamination, raising concerns in the dairy industry. Rebekah Sweeney of the Wisconsin Cheese Makers Association urges caution, citing the dangers of pathogens like E. coli and Salmonella in raw milk. Wisconsin law currently restricts raw milk sales, but a recent bill to legalize it failed. Advocates argue raw milk has health benefits, while opponents highlight the risks. Past outbreaks in Wisconsin and other states underscore the potential dangers. The debate continues as raw milk remains available through private clubs and cooperatives. More information can be found here.

IFSAC Highlights Major Foodborne Illness Sources in Latest Report
December 13:  The Interagency Food Safety Analytics Collaboration (IFSAC) released its latest annual report, “Foodborne illness source attribution estimates for Salmonella, Escherichia coli O157, and Listeria monocytogenes – United States, 2022.” IFSAC, a partnership between the CDC, FDA, and FSIS, was established in 2011 to enhance federal food safety analytics. The report highlights that Salmonella, E. coli O157, Campylobacter, and Listeria monocytogenes cause nearly two million foodborne illnesses annually in the U.S. These updated estimates help shape agency priorities and inform targeted interventions to reduce foodborne illnesses. They also aid in assessing the effectiveness of prevention measures. More information can be found here.

FDA Releases New PFAS Test Results for Clams
December 18:  The FDA released new testing results for per- and polyfluoroalkyl substances (PFAS) in clams, following up on their 2022 seafood survey. The 2022 survey found high levels of perfluorooctanoic acid (PFOA), a type of PFAS, in canned clams from China, leading to recalls by two distributors. From October 2022 to September 2024, the FDA tested 12 samples of processed clams from China, all of which contained detectable levels of PFAS, including PFOA. Three shipments were refused entry into the U.S. The FDA continues to test for PFAS in human foods and is conducting targeted surveys on molluscan shellfish and the most consumed seafood in the U.S. The FDA also recently issued a request for information to help fill data gaps that remain regarding PFAS in seafood.  More information can be found here.

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Lawsuits

Quaker Oats Wins Round in ‘Simply Granola’ Label Dispute
December 3:  Quaker Oats Co. temporarily defeated a proposed consumer class action alleging that the label on its “Simply Granola Oats, Honey, Raisins, & Almonds” product was deceptive. Plaintiffs claimed the label implied the product contained only the highlighted ingredients, but a judge for the US District Court for the Northern District of Illinois ruled this interpretation was unreasonable. The judge noted that granola does not have a commonly understood ingredient list, and the word “simply” does not mean that the ingredients would be limited by the front label list. Because the plaintiffs did not properly allege the products’ label was false, misleading, or deceptive, all of their claims were dismissed without prejudice. The judge also rejected Quaker Oats’ argument that the claims were preempted by federal law, allowing the plaintiffs until December 17th to file an amended complaint. The case is Hicken v. Quaker Oats Co.

Lawsuit Claims Food Companies Addict Children to Ultra-Processed Foods
December 11:  A class action lawsuit alleges that major food companies like Kraft Heinz, Coca-Cola, and General Mills designed and marketed ultra-processed foods to be addictive to children, leading to widespread health issues. The complaint claims these foods are engineered to be addictive, similar to how the tobacco industry made cigarettes more addictive. The lawsuit, Martinez v. Kraft Heinz Co., filed in Court of Common Pleas of Philadelphia County, accuses the companies of causing health problems like type 2 diabetes and non-alcoholic fatty liver disease in children. Mondelez International Inc., Post Holdings Inc., Pepsico Inc., Nestle USA Inc., Kellanova, WK Kellogg Co., Mars Inc., and Conagra Brands Inc. are also named defendants. The companies argue there is no scientific consensus on what constitutes ultra-processed foods and that labeling foods as unhealthy based on processing alone is misleading. The lawsuit seeks damages for various claims, including negligence and fraudulent concealment. More information can be found here.

Fraud Claims Against Nestle Over Poland Spring Water Move Forward
December 31:  A federal judge for the US District Court for the District of Connecticut ruled that consumers can advance fraud and deception claims against Nestle Waters North America Inc., now Blue Triton Brands Inc., for allegedly misrepresenting Poland Spring bottled water as “spring water.” The consumers in the case Patane v. Nestle Waters North America, claim that Nestle deceptively advertised the bottled water as “100% Natural Spring Water” even though it did not come from natural springs. The court denied Nestle’s motion for summary judgment on common law fraud and unfair trade practices claims but granted it for some state law claims and injunctive relief. The judge stated that consumers do not need to know technical details of a product to claim reliance on misrepresentation. An expert survey supported the consumers’ claim that “spring water” was misleading. Claims for injunctive relief were denied as consumers are now aware of the issue.

This Regulatory Update covers information from December 2024. 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.