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This update includes FDA updates, USDA updates, lawsuits, and other articles of interest, including the new guidance on allergen labeling requirements, the FDA’s suspension of quality control programs for milk, PFAS testing results for bottled water, and more.

FDA Updates

FDA Publishes New Guidance on Allergen Labeling Requirements
April 1:  The FDA released updated guidance for businesses on allergen labeling requirements. The new guide, titled “Questions and Answers Regarding Food Allergens, Including the Food Labeling Requirements of the Federal Food, Drug, and Cosmetic Act,” is intended to help the food industry comply with regulations for listing major food allergens on labels. These allergens include milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame.  The guide contains information related to sesame as a major food allergen and includes expanded interpretations of milk and eggs as major allergens. Several tree nuts, including coconut, are no longer considered major food allergens under the revised guidance. More information can be found here.

FDA to Reduce Inspections Due to Layoffs
April 2:  The FDA is planning to cut back on routine food and drug inspections due to layoffs in its support staff. Approximately 170 workers were cut from the FDA’s Office of Inspections and Investigations. While the FDA’s inspectors themselves were not directly impacted, the loss of administrative staff has caused delays and forced the agency to reprioritize its workload. This includes trimming routine surveillance inspections in favor of more urgent tasks, such as addressing safety risks and follow-up visits. The office’s travel operations division was also eliminated and a pilot program for unannounced foreign inspections has been paused. More information can be found here.

FDA Extends Comment Period on Poppy Seed Industry Practices
April 9:  The Food and Drug Administration (FDA) extended the comment period for its request for information regarding industry practices related to poppy seeds. The extension allows stakeholders additional time to provide input on the growing, harvesting, processing, and distribution of poppy seeds, including industry practices to reduce opiate alkaloid content.  The FDA intends to use the information to determine potential actions to ensure poppy seed products are safe for consumption. Interested parties can submit their comments electronically or via mail by June 16, 2025.  More information can be found here.

FDA Releases PFAS Testing Results for Bottled Water
April 14:  The FDA published the final results of its testing for per- and polyfluoroalkyl substances (PFAS) in bottled water. The FDA analyzed 197 samples of domestic and imported bottled water, including purified, artesian, spring, and mineral waters, collected between 2023 and 2024. Ten samples had detectable levels of PFAS, but none exceeded the Environmental Protection Agency’s (EPA) maximum contaminant levels (MCLs) for PFAS in public drinking water. The FDA continues to monitor PFAS levels in bottled water to ensure consumer safety and will share further results as they become available.  More information can be found here.

FDA to Phase Out Petroleum-Based Synthetic Dyes
April 22:  The FDA and HHS announced a plan to phase out petroleum-based synthetic dyes from the nation’s food supply as part of the “Make America Healthy Again” campaign. This initiative includes establishing standards for replacing petrochemical dyes with natural alternatives, revoking authorizations for Citrus Red No. 2 and Orange B, phasing out six remaining synthetic dyes by the end of next year, and fast-tracking the approval of new natural color additives such as calcium phosphate, Galdieria extract blue and butterfly pea flower extract. Additionally, the FDA will partner with the National Institutes of Health to research the impact of food additives on children’s health and will request food companies remove FD&C Red No. 3 sooner than the 2027-2028 deadline previously required. The FDA plans to issue guidance and provide regulatory flexibility to industry to voluntarily stop using the dyes.  The plan appears to lack details on what action the agencies will take if food companies fail to remove the dyes by the end of 2026. More information can be found here and here.

FDA Halts Milk Quality Tests Amid Workforce Reductions
April 22:  The FDA suspended its quality control program for testing fluid milk and other dairy products due to reduced capacity in its food safety and nutrition division. This suspension follows the termination and departure of 20,000 employees from the Department of Health and Human Services, including the FDA.  The FDA also paused programs ensuring accurate testing for bird flu in milk and cheese and pathogens like Cyclospora in other food products. According to the FDA, the testing program was suspended because FDA’s Moffett Center Proficiency Testing Laboratory is unable to provide necessary support for proficiency testing and data analysis.  Despite these changes, the agency confirmed that dairy product testing will continue during the transition to a new laboratory. More information can be found here.

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USDA Updates

FSIS Delays Salmonella Testing for Not-Ready-to-Eat Breaded Stuffed Chicken Products
April 11:  The U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) announced a six-month delay in its verification sampling and testing program for Salmonella in not ready-to-eat (NRTE) breaded stuffed chicken products. Originally scheduled to begin on May 1, 2025, the program will now start on November 3, 2025. This extension allows establishments additional time to reassess their Hazard Analysis and Critical Control Point (HACCP) plans for these products. FSIS also needs this additional time to finalize instructions for inspectors, prepare inspection program personnel and laboratories for the new sampling and testing procedures, and provide industry guidance on holding and controlling products pending sampling results.  More information can be found here.

FSIS to Update Allergen Programs Following FDA Guidance on Coconut
April 18:  FSIS plans to revise its allergen-related programs and documentation in response to the FDA’s updated guidance (discussed above), “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).” A key change includes the removal of coconut from the list of tree nuts considered major food allergens. As part of this update, FSIS will revise its Allergen Sampling Verification Program and the directive “Ongoing Verification of Product Formulation and Labeling Targeting the Big 9 Allergens” to eliminate references to coconut as a tree nut allergen. FSIS laboratories will also discontinue coconut testing under the Allergen Sampling Verification Program. The updates are expected to be published in Spring 2025.

FSIS Publishes Findings from PFAS Sampling Initiative
April 24:  FSIS published an article, titled “A Survey of the Levels of 16 per- and Polyfluoroalkyl Substances in Meat, Chicken, and Siluriformes Fish, 2019 to 2023,” in the peer-reviewed journal Food Protection Trends. The article describes results from FSIS’ exploratory sampling program that analyzes samples for 16 different per- and polyfluorinated alkyl substances (PFAS), including perfluorooctanoic acid and perfluorooctane sulfonate. FSIS first began testing for PFAS residues in 2020. FSIS found that PFAS compounds are rarely detected in meat, poultry, and farm raised catfish. Wild-caught domestic catfish were frequently shown to contain at least one PFAS compound, though at lower levels compared to other surveys of freshwater fish in the U.S.  More information can be found here.

USDA Withdraws Proposed Salmonella Framework for Raw Poultry Products
April 25:  FSIS withdrew its proposed rule titled “Salmonella Framework for Raw Poultry Products.” Initially published on August 7, 2024, the framework sought to reduce Salmonella illnesses by establishing standards for Salmonella levels in raw poultry products. The proposal included requirements for microbial monitoring programs and electronic submission of sampling results. FSIS received over 7,000 comments during the public comment period. The withdrawal follows extensive feedback from stakeholders, including concerns from small poultry producers about the potential burden of the proposed regulations. FSIS is evaluating alternative approaches to address Salmonella contamination in poultry products and will continue to engage with stakeholders to develop effective food safety strategies. More information can be found here.

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Other Articles of Interest

Listeria Outbreak Linked to Frozen Supplement Shake
April 1:  A multi-state listeria outbreak in 2024 was linked to frozen supplement shakes distributed under the brands Lyons ReadyCare and Sysco Imperial. These shakes were manufactured by Prairie Farms and primarily sold to long-term care facilities. The outbreak caused 38 illnesses, 37 hospitalizations, and 11 deaths. The FDA and CDC investigated the outbreak, finding Listeria monocytogenes in environmental samples at the Prairie Farms Dairy facility.  The shakes were recalled in February 2025. More information can be found here.

Congressional Hearing Highlights FDA Inaction on Hemp and Vapes
April 9:  Federal health officials’ inaction on flavored vapes and hemp-derived consumables has led to a proliferation of loosely regulated products, according to testimony at a U.S. House Committee hearing. Jonathan Miller from U.S. Hemp Roundtable criticized the FDA’s lack of regulation for hemp-derived CBD, while Guy Bentley from the Reason Foundation highlighted the slow approval process for flavored e-cigarettes. The hearing emphasized the need for clear federal regulations to ensure product safety and quality. More information can be found here and here.

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Lawsuits

Federal Jury Rules Against R.C. Bigelow Inc. in Misleading Advertising Case
April 9:  A federal jury ruled in favor of consumers who claimed that R.C. Bigelow Inc. misled buyers into believing its tea products were made in the U.S. The verdict, filed in the US District Court for the Central District of California, awarded the consumers more than $2.36 million in compensatory damages but denied punitive damages.  The jury found that Bigelow violated the California Consumers Legal Remedies Act, committed common law fraud, and breached an express warranty. Consumers argued that they relied on Bigelow’s representations that various products were “Manufactured in the USA 100% American Family Owned.” However, the judge clarified before the trial that Bigelow’s tea is grown and processed abroad, making the company’s claims of being “manufactured” or “made” in the US invalid.

This Regulatory Update covers information from April 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 launch of the Chemical Contaminants Transparency Tool, new legislation to ban ultra-processed foods in Wisconsin school lunches, major job cuts at Health and Human Services, and more.

FDA Updates

Mission Barns’ Cultured Pork Fat Cells Pass FDA Safety Review
March 7:  The FDA has completed a pre-market consultation for Mission Barns’ cultured pork fat cells, concluding that the food product is as safe as conventional pork fat. Mission Barns uses belly fat cells from Yorkshire pigs, growing them in a controlled environment to produce cultured pork fat. Through the pre-market consultation process, the FDA evaluates the safety of food made with cultured animal cells before it enters the market. Food products made with cultured pork fat cells must meet the same FDA requirements as conventional pork fat, including facility registration, safety standards, and accurate labeling. The product must also meet USDA regulations.  More information can be found here.

FDA Files Petition to Enhance Color Additive Use in Plant-Based Foods
March 14:  The FDA announced that it has filed a petition, submitted by Impossible Foods, Inc., proposing that the color additive regulations be amended to expand the safe use of soy leghemoglobin as a color additive for use in plant-based meat, poultry, and fish analogue products.  More information can be found here.

FDA Shares Interim Findings on H5N1 in Aged Raw Milk Cheese
March 14:  The FDA released interim results from its ongoing sampling of 60-day aged raw milk cheese. As of March 10, 2025, 110 samples of the planned 299 have been collected. Among these, 96 samples tested negative for H5N1 using PCR, while 14 samples are still being analyzed. Final results are expected later this spring.  Additionally, the research funded by the FDA and New York State, conducted at Cornell University, suggests that aging raw milk cheese for 60 days or longer is not effective at eliminating H5N1. The findings indicate that heat treating raw milk to adequate parameters or manufacturing cheese at or below a pH of 5.0 could effectively inactivate H5N1.  More information can be found here.

FDA to Reconsider GRAS Self-Affirmation for Food Additives
March 17:  The FDA is evaluating the food industry’s use of the GRAS (Generally Recognized As Safe) self-affirmation process. This process allows companies to determine the safety of food additives without FDA oversight. U.S. Health and Human Services Secretary Robert F. Kennedy Jr. raised concerns about the transparency and reliability of this system, viewing the practice as a loophole and prompting the FDA to review the process and propose rulemaking to prevent industry from continuing to self-affirm new ingredients are GRAS.  More information can be found here.

FDA Launches New Tool for Transparency in Food Safety
March 20:  The FDA has launched the Chemical Contaminants Transparency Tool (CCT Tool), an online database that consolidates contaminant levels in human foods, helping to evaluate potential health risks. The tool is part of the FDA’s initiative to modernize food chemical safety and promote transparency.  The CCT Tool provides contaminant levels in one location for easy access to contaminant information and the consolidated list can be filtered by contaminant type. The FDA will continue monitoring the food supply to ensure safety and transparency, reinforcing their commitment to making America healthy again.  More information can be found here.

FDA Announces Extension of Compliance Date for Food Traceability Rule
March 20:  The FDA intends to extend the compliance date for the Food Traceability Rule by 30 months. This extension will provide additional time for covered entities to fully implement the rule’s requirements, ensuring complete coordination across the supply chain. The Food Traceability Rule, established under the FDA Food Safety Modernization Act, mandates enhanced traceability recordkeeping for entities involved in the manufacturing, processing, packing, or holding of foods listed on the Food Traceability List. The FDA remains committed to the successful implementation of the rule, which is designed to improve food safety and protect public health by enabling faster identification and removal of potentially contaminated food from the market. The extension will allow the FDA to continue working with stakeholders, providing technical assistance and resources to assist industry with implementation.  More information can be found here.

Senate Confirms Marty Makary to Lead FDA
March 25:  The Senate confirmed Marty Makary as the new commissioner of the FDA with a 56-44 vote. Makary, a surgeon and public policy researcher from Johns Hopkins University received bipartisan support. During his confirmation hearing, Makary emphasized his commitment to data-driven decision-making and expressed support for the benefits of vaccines, despite his previous criticisms of federal COVID-19 mitigation policies. Makary expressed willingness to reassess recent firings at the FDA and ensure resources for the agency’s scientists.  More information can be found here and here.

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FDA Warning Letters

Adulterated Seafood:  The FDA issued a warning letter to a Nicaraguan company for violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations. An inspection revealed that the company’s HACCP plan for frozen mahi-mahi fillets lacked critical control points for storage to prevent scombrotoxin (histamine) formation rendering the products adulterated and potentially harmful.

A database of warning letters can be found here.

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USDA Updates

President Trump Disbands Two Key Food Safety Committees
March 7:  The Trump Administration eliminated two long-standing U.S. Department of Agriculture (USDA) food safety advisory committees: the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) and the National Advisory Committee on Meat and Poultry Inspection (NACMPI). These committees provided scientific advice on food safety issues to the USDA, FDA, and CDC. The move has raised concerns among food safety advocates about the future prioritization of food safety.  More information can be found here.

USDA and HHS Update on Dietary Guidelines for Americans
March 11:  The USDA and the Department of Health and Human Services (HHS) provided an update on the development of the 2025-2030 Dietary Guidelines for Americans. Following the inaugural meeting of the Make America Healthy Again Commission, USDA Secretary Brooke Rollins and HHS Secretary Robert F. Kennedy, Jr. emphasized their commitment to releasing the final guidelines by December 31, 2025. The guidelines intend to promote healthy choices and outcomes based on sound science. The agencies are conducting a thorough review of the Scientific Report of the 2025 Dietary Guidelines Advisory Committee, released in 2024. More information can be found here.

USDA Reports Progress on Strategy to Combat Avian Flu and Lower Egg Prices
March 20:  The USDA updated its strategy to combat highly pathogenic avian influenza (HPAI) and reduce egg prices. Significant advancements have been made, including strengthening biosecurity measures at over 130 commercial poultry facilities, increasing the indemnity rate for layer hens to support faster repopulation, and reducing regulatory burdens to expand supply. The USDA secured new egg import commitments from Turkey and South Korea, and discussions are ongoing with other countries to further expand supply in the short term. Additionally, the USDA launched a $100 million funding opportunity for avian flu research and vaccine development. As a result, wholesale egg prices have dropped nearly 50% since late February. More information can be found here.

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Other Articles of Interest

Emulsifiers Used in Food May Pose Health Risks
March 5:  Recent research suggests that emulsifiers, commonly used to improve the texture and stability of foods, may pose health risks. These additives are found in many processed foods ranging from ice cream to whole grain crackers and breakfast cereals.  Studies indicate that consuming emulsifiers may be linked to higher risks of heart disease, Type 2 diabetes, and some cancers because emulsifiers can alter the gut microbiome, leading to inflammation. The widespread use of emulsifiers in ultra-processed foods has drawn increased scrutiny, with health officials investigating their potential impact on chronic diseases.  More information can be found here.

Impact of Canada and China Tariffs on U.S. Food Products
March 20:  A recent report by the American Farm Bureau Federation highlights the U.S. food products most affected by retaliatory tariffs from Canada and China. U.S. beverage sales to Canada and beef and sorghum sales to China are expected to be hit hardest. Canada has imposed a 25% tariff on $21 billion worth of U.S. products, with plans for additional tariffs on $87 billion worth of goods. China has announced extra tariffs on various U.S. agricultural products, including wheat, corn, chicken, cotton, soybeans, beef, pork, dairy, fruits, and vegetables.  These tariffs pose significant challenges for U.S. farmers, who export over 20% of their agricultural goods. The increased consumer prices resulting from tariffs are likely to decrease demand in these key export markets.  More information can be found here.

Illinois Pushes for Enforcement of BVO Ban, Challenges Federal Oversight
March 21:  Illinois is advancing the Illinois Food Safety Act to enforce the ban on brominated vegetable oil (BVO) and other additives, highlighting a conflict between state and federal authority over food safety. Although the FDA banned BVO in July 2024, Illinois seeks to enforce that ban at the retail level and address additional chemicals like potassium bromate, propylparaben, and Red Dye No. 3. This move seeks to protect consumers from unsafe additives while potentially setting a precedent for stricter state oversight. The initiative has sparked debate over federal preemption and could lead to legal challenges from manufacturers. More information can be found here.

Study Released Highlighting the Economic Impact of the Food and Agriculture Sector
March 21:  The 2025 Feeding the Economy study, released by 36 food and agricultural trade groups, highlights the critical role of the food and agriculture sector in the U.S. economy. Despite a 1% decline in total output from last year, the food/ag industry now generates $9.53 trillion, accounting for 18.7% of the U.S. gross domestic product. The industry supports nearly 47.2 million jobs and contributes $2.82 trillion in wages. It also drives $182.79 billion in exports and $1.26 trillion in business taxes. The study underscores the importance of ensuring long-term security for producers to maintain the sector’s significant economic impact. More information can be found here.

Wisconsin Lawmakers Target Ultra-Processed Foods in School Lunches
March 26:  Wisconsin lawmakers have introduced new legislation to ban ultra-processed foods in school lunches. Representative Clint Moses and Senator Rachael Cabral-Guevara are leading the initiative, citing concerns over the health impacts of these foods, which make up nearly 70% of children’s diets. The proposed ban targets ingredients like brominated vegetable oil and red dye 3, linked to health issues such as Type 2 diabetes and obesity. The legislation seeks to ensure that government-funded meals are nutritious and safe for consumption.  More information can be found here.

RFK Jr. Announces Major Job Cuts at Health and Human Services
March 27:  Health and Human Services Secretary Robert F. Kennedy Jr. announced a significant reduction of 10,000 full-time jobs within the department, across agencies that respond to disease outbreaks, approve new drugs, and provide insurance to low-income Americans. These cuts are in addition to the nearly 10,000 employees who chose to leave the department voluntarily. This move is part of a broader restructuring effort aimed at addressing chronic illness by focusing on safe food, clean water, and eliminating environmental toxins. The cuts will reduce the department’s workforce from 82,000 to 62,000 employees and include closing half of its regional offices. Key divisions such as the FDA, CDC, and NIH will see substantial workforce reductions. More information can be found here.

States Move to Ban Synthetic Dyes in Food and Candles
March 27:  Several U.S. states are taking action to ban or restrict the use of synthetic dyes in food products like candies and cereals. Lawmakers argue that the federal government has been slow to address the health risks associated with these dyes, which have been linked to neurobehavioral issues in children and other health concerns. West Virginia recently enacted a statewide ban on seven synthetic dyes, with similar measures being considered in over 20 states, including California and Virginia. The National Confectioners Association said the new regulations will make food more expensive, less accessible and lead to less variety on grocery store shelves. More information can be found here.

NSF Launches PFAS-Free Certification Guideline
March 27:  NSF, a global public health and safety organization, launched NSF Certification Guideline 537: PFAS-Free Products for Nonfood Compounds and Food Equipment Materials. This new certification ensures that products are free of per- and polyfluoroalkyl substances (PFAS). PFAS are often used in water-resistant, nonstick, and grease-proof products but are linked to serious health issues, including cancer and liver disease.  The certification involves thorough formulation reviews, comprehensive testing, and rigorous disclosures to confirm the absence of PFAS. Certified products will carry the NSF PFAS-Free mark, providing consumers and businesses with confidence in their safety. More information can be found here.

Food Banks Brace for Impact from USDA Funding Cuts
March 28:  The USDA announced a $1 billion funding cut affecting programs that help schools and food banks buy food from local farms. This includes $660 million from the Local Food for Schools program and $500 million from the Local Food Purchase Assistance Cooperative Agreement Program. Food banks, like the Houston Food Bank, are preparing for reduced food distribution and emphasize the need for donor support and advocacy. The International Fresh Produce Association stresses the importance of federal initiatives to increase access to fresh produce.  More information can be found here.

Utah Bans Certain Food Colors in Public Schools
March 31:  Utah has become the fourth state to ban food and beverages containing specific synthetic food colors in public schools, joining California, Virginia, and West Virginia. Utah Governor Spencer J. Cox signed House Bill No. 402 into law on March 27, 2025. The law, effective for the 2026-27 school year, prohibits food items containing Blue No. 1 and No. 2, Red No. 3 and No. 40, Yellow No. 5 and 6, Green No. 3, potassium bromate, and propylparaben from being served in public schools. The synthetic dyes/food colors are found in items such as confectionery, baked foods and beverages.  More information can be found here.

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Lawsuits

Judge Dismisses Class Action Against GNC Over Magnesium Supplement
March 3:  GNC Holdings LLC has temporarily escaped a proposed class action alleging it mislabeled the concentration of its Super Magnesium supplement. The US District Court for the Northern District of Illinois dismissed the suit, stating the plaintiff lacked standing as he did not adequately plead that he purchased a defective product.  The plaintiff claimed independent testing showed the supplement contained only 152 mg of magnesium per serving instead of the advertised 400 mg. However, the complaint failed to provide details on when the testing occurred, who conducted it, or the methodology used. The judge ruled that without these specifics, the allegations did not meet plausibility standards. The suit was dismissed without prejudice, allowing the plaintiff until March 21 to file an amended complaint addressing the deficiencies.

Polar Beverages Faces Class Action Over “Natural” Seltzers
March 3:  A proposed class action accuses Polar Beverages of falsely advertising its “Natural” Seltzers as free from synthetic ingredients. Despite being marketed as “100% natural,” tests revealed that the products contain between 9% and 13% synthetic ingredients. The complaint, filed in the US District Court for the Northern District of California, highlights that further testing found terpineols, chemical compounds used as flavorings, which are often isolated from plants. Consumers argue that while natural flavors are derived from animal or plant sources, the finalized flavors can include up to 250 chemically identified constituents, some of which are artificial. In addition, radiocarbon testing indicated that the seltzers were not entirely biobased carbon, suggesting the presence of synthetic elements. The plaintiffs claim they overpaid for the products or would not have bought them if they had known the “100% Natural” label was misleading. They are pursuing claims for breach of warranty, violations of consumer protection laws in California and New York, and unjust enrichment.

Mondelez Faces Class Action Over Misleading “Climate Neutral” Clif Bar Claims
March 3:  Mondelez International Inc. is accused of deceiving consumers who paid a premium for Clif Kid Zbars, believing them to be climate-friendly snacks. A proposed class action complaint was filed in the US District Court for the Northern District of Illinois alleging that the packaging falsely described the snack bars as “climate neutral.”  The plaintiff claims that the production, marketing, and transportation of Zbars contribute to climate change, thereby negating any environmental benefits. The plaintiff argues that consumers would have paid less or chosen different products if they had known the truth about the misleading advertising.  Mondelez reportedly measures greenhouse gas emissions, sets pollution reduction targets, and supports climate change projects to achieve a “climate neutral” certification. However, the plaintiff contends that the “climate neutral” claim is unsubstantiated and misleading.

Judge Dismisses Class Claims Against Fiji “Natural” Water Over Lack of Testing
March 3:  A federal judge tossed out class claims against The Wonderful Co. LLC, alleging that its Fiji Water was falsely labeled as “natural” despite containing microplastics. The judge for the U.S. District Court for the Northern District of Illinois ruled that the plaintiffs lacked scientific evidence directly linking Fiji Water to their claims and stated that the lawsuit was too speculative.  The judge indicated that he would enter judgment against the plaintiffs unless they submit a second amended complaint with at least one viable claim. The judge noted that the suit could have been stronger if it included “relatively contemporaneous” testing of Fiji Water. Instead, the complaint referenced testing of other bottled water brands and a study that did not specifically include Fiji Water.  The plaintiffs argued that the term “natural” implies the absence of synthetic substances, which they did not expect in the water. The judge rejected Wonderful’s argument that federal law preempted the claims, allowing the challenge to the “natural” label to proceed.

SunButter Avoids Class Action Over Alleged Cadmium Levels
March 7:  SunButter LLC escaped a proposed class action alleging false advertising of its sunflower butter products as “healthy” and non-toxic despite containing harmful levels of cadmium. The plaintiffs and SunButter, filed a joint stipulation to dismiss the case in the US District Court for the Central District of California. The judge dismissed the plaintiffs’ claims with prejudice and any putative class action claims without prejudice. The plaintiffs had alleged that two SunButter products contained cadmium levels exceeding California’s legal threshold for toxicity warnings under Proposition 65. They claimed the lack of labeling constituted false advertising, unfair business practices, and breach of implied warranty under California and New York consumer protection statutes. The court filings do not indicate if any settlement was reached.

Class Action Alleges Heavy Metals in Girl Scout Cookies
March 11:  A proposed consumer class action has alleged that thirteen types of Girl Scout cookies contain excessive levels of heavy metals such as arsenic, cadmium, and lead. According to the complaint filed in the US District Court for the Eastern District of New York, lab tests revealed the presence of glyphosate and other toxic metals in most cookie samples, which are linked to health issues like cancer and neurological disorders.  The Girl Scouts of the USA, Ferrero USA Inc., and Interbake Foods LLC (ABC Bakers) were named as defendants. The complaint claims that the cookie sales program has generated significant profits for both the Girl Scouts and commercial bakers, who have the capability to produce safer products but prioritize quantity over health.

Premier Nutrition Ordered to Pay $8.3 Million in Joint Juice Case
March 11:  Premier Nutrition Corp. has been ordered to pay $8.3 million in statutory damages to consumers of its discontinued Joint Juice product. A federal judge in the US District Court for the Northern District of California reduced the original $83 million award, deeming it “grossly punitive” and disproportionate to the legislative goals of the state consumer protection statute.  The plaintiff alleged that Premier Nutrition misrepresented the benefits of Joint Juice, violating two sections of the New York General Business Law that prohibit deceptive practices and false advertising. After a nine-day trial in 2022, a jury found Premier Nutrition guilty of these violations.  The plaintiff initially sought an award of $550 per violation, totaling approximately $91 million. However, Premier Nutrition challenged this award on substantive due process grounds. The Ninth Circuit remanded the award for reevaluation, leading the plaintiff to seek $83 million or $500 per violation. The judge ruled that $50 per violation aligned better with the compensatory, deterrence, and punitive goals of the statutes, and reduced the award to $8.3 million.

Judge Dismisses Class Action Against Splenda Naturals Stevia
March 12:  TC Heartland LLC, the maker of Splenda Naturals Stevia sweeteners, convinced a federal judge to dismiss a proposed class action alleging deceptive advertising of the products as “100% Natural.” The US District Court for the Eastern District of New York ruled that the consumers’ claims were insufficient, stating that the intensive manufacturing process does not make the product synthetic. The judge noted that no reasonable consumer would consider a product artificial simply because it is produced using industrial processes, which is common for most consumer goods. The plaintiff, Mete Karabas, had sued in 2024, claiming the sweeteners were falsely advertised as natural despite being made through heavily industrialized methods. However, he failed to specify any chemicals added to the product. The court concluded that the manufacturing process described in the complaint does not transform the stevia leaf extract into a synthetic product, as none of the chemicals used in production end up in the final product.

This Regulatory Update covers information from March 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 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.