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This Regulatory Update covers information from December 2025. Please contact <a href="mailto:pebenson@michaelbest.com">Paul Benson</a>, <a href="mailto:ttfritsch@michaelbest.com">Taylor Fritsch</a>, or <a href="mailto:lhziemba@michaelbest.com">Leah Ziemba</a> 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 &amp; Friedrich, visit <a href="https://www.michaelbest.com/" target="_blank" rel="noopener">michaelbest.com</a>.

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FDA Proposes Extended Timeline for Food Traceability Rule

December 10: The FDA’s Food Traceability Final Rule creates new recordkeeping requirements for entities handling foods on the Food Traceability List (FTL). The new requirements in the final rule will expedite the identification and removal of potentially contaminated products from the market. Covered firms must maintain Key Data Elements (KDEs) tied to Critical Tracking Events (CTEs) and provide this information to FDA within 24 hours. While the original compliance date was set for January 20, 2026, FDA has proposed extending the date to July 20, 2028, to give industry more time to implement necessary systems and processes. More information can be found <a href="https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods" target="_blank" rel="noreferrer noopener">here</a>.

FDA Issues Industry Letter on DSHEA Disclaimer Requirements

December 11: The FDA issued a letter to the dietary supplement industry outlining its current approach to the placement of the Dietary Supplement Health and Education Act of 1994 (DSHEA) disclaimer on product labels. In response to several deregulatory requests, the FDA is considering amending its regulations to remove the requirement that the disclaimer appear on every panel where a claim is made. In the interim, FDA states it will exercise enforcement discretion on the specific placement requirement. More information can be found <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-issues-letter-industry-dshea-disclaimer" type="link" id="https://www.fda.gov/food/hfp-constituent-updates/fda-issues-letter-industry-dshea-disclaimer" target="_blank" rel="noreferrer noopener">here</a> and <a href="https://www.nbcnews.com/health/health-news/fda-supplements-warning-label-rule-change-rfk-jr-rcna249321" target="_blank" rel="noreferrer noopener">here</a>.

FDA Releases New PFAS Data from Food Testing

December 19: FDA released additional test results for per‑ and polyfluoroalkyl substances (PFAS) in food, adding data from six additional Total Diet Study (TDS) regional collections conducted in 2024. The new results expand FDA’s publicly available PFAS food testing database and are intended to support the agency’s ongoing efforts to better understand PFAS in the U.S. food supply, dietary PFAS exposure and inform future monitoring activities. FDA noted that most samples tested showed no detectable PFAS and that sampling under the TDS is ongoing. More information can be found <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-releases-additional-pfas-results" target="_blank" rel="noreferrer noopener">here</a>.

FDA Releases FY 2023 Pesticide Residue Report

December 22: FDA released its Fiscal Year 2023 Pesticide Residue Monitoring Program Report, which summarizes pesticide residue testing results for FDA‑regulated human and animal foods collected between October 1, 2022, and September 30, 2023. The report provides an overview of FDA’s monitoring and enforcement activities related to pesticide tolerances established by EPA and confirms that the majority of domestic and imported food samples complied with applicable federal requirements. FDA also released a new online data dashboard to provide public access to the underlying monitoring data. More information can be found <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-releases-fy-2023-pesticide-residue-monitoring-report" target="_blank" rel="noreferrer noopener">here</a>.

FDA VQIP Application Portal Now Open for Fiscal Year 2027

December 31: FDA opened the application portal for the Voluntary Qualified Importer Program (VQIP) for fiscal year 2027. The voluntary, fee‑based program allows eligible human and animal food importers that demonstrate strong food safety and supply chain controls to receive expedited FDA review and import entry. The FY 2027 application window runs from January 1 through September 1, 2026. More information can be found <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-opens-vqip-application-portal-fy2027" target="_blank" rel="noreferrer noopener">here</a>.

Infant Botulism Outbreak: The FDA issued warning letters to Target Corporation, The Albertsons Companies Inc, Kroger Company, and Walmart for continuing to sell recalled and adulterated ByHeart Whole Nutrition Infant Formula that was linked to a multistate outbreak of infant botulism.

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A database of warning letters can be found <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters" target="_blank" rel="noreferrer noopener">here</a>.

FSIS Exploring New Approaches to Reducing Salmonella in Poultry

December 2: USDA’s Food Safety and Inspection Service (FSIS) is soliciting stakeholder input as it explores practical strategies to reduce Salmonella illnesses associated with poultry products. FSIS is examining potential approaches, including improved use of data, alternative performance standard parameters, and policy options that balance public health objectives with operational considerations, particularly for small and very small establishments. The initiative follows FSIS’s withdrawal of its prior Salmonella framework proposal and is intended to inform future agency action. Comments are due February 2, 2026.

FSIS Issues Updated Guidance on Voluntary “Product of USA” Labeling

December 10: FSIS issued <a href="https://www.fsis.usda.gov/guidelines/2025-0006" target="_blank" rel="noreferrer noopener">updated labeling guidance</a> to support industry implementation of the voluntary “Product of USA” labeling claim, which will take effect January 1, 2026. The updated guidance clarifies eligibility criteria, documentation, and compliance expectations for FSIS‑regulated products derived from animals that were born, raised, slaughtered, and processed in the United States, and reflects stakeholder feedback received on the original guideline. FSIS also released an updated <a href="https://www.fsis.usda.gov/policy/fsis-directives/7221.1" target="_blank" rel="noreferrer noopener">Directive 7221.1</a> on prior label approval. More information can be found <a href="https://www.federalregister.gov/documents/2025/12/10/2025-22378/availability-of-guideline-for-label-approval" target="_blank" rel="noreferrer noopener">here</a>.

Bird Flu Detected in Wisconsin Dairy Herd

December 16: The Wisconsin Department of Agriculture, Trade and Consumer Protection (DATCP) confirmed detection of highly pathogenic avian influenza (HPAI) in a dairy herd in Dodge County, marking the first case identified in dairy cattle in the state. The affected farm has been quarantined, and DATCP is coordinating response efforts with USDA, FDA, CDC, and state partners. According to DATCP, there is no concern for the safety of the commercial milk supply, as pasteurization remains effective and the risk to the public is considered low. USDA has confirmed that the HPAI virus detected in the dairy herd likely resulted from a new wildlife spillover event, rather than spread from previously affected dairy herds. More information can be found <a href="https://datcp.wi.gov/Pages/News_Media/HPAIDetectedWIDairyHerdDodgeCo.aspx" target="_blank" rel="noreferrer noopener">here</a> and <a href="https://www.wisfarmer.com/story/news/2025/12/23/usda-confirms-hpai-case-in-wisconsin-dairy-herd-as-new-wildlife-spillover/87887673007/" target="_blank" rel="noreferrer noopener">here</a>.

Brashears Confirmed to Lead USDA Food Safety Efforts

December 18: Mindy Brashears was confirmed by the U.S. Senate to return as Under Secretary of Agriculture for Food Safety at USDA, filling a vacancy that was open for nearly a year. Brashears, who previously served in the role during the first Trump administration, will again oversee USDA’s food safety programs, including the Food Safety and Inspection Service and U.S. participation in Codex Alimentarius activities. More information can be found <a href="https://www.foodsafetynews.com/2025/12/brashears-is-back-at-the-usdas-top-food-safety-post/" target="_blank" rel="noreferrer noopener">here</a>.

White House Begins Review of FDA Proposal to Strengthen GRAS Process

December 2: The FDA’s <a href="https://www.reginfo.gov/public/do/eoDetails?rrid=1194613" target="_blank" rel="noreferrer noopener">proposed rule</a> to strengthen oversight of substances deemed Generally Recognized as Safe (GRAS) has advanced to the White House for review, the final step before public release. As previously discussed in our September 2025 update, the rule would make GRAS notifications mandatory for most substances, require FDA to maintain a public inventory of notices, and clarify how the agency determines a substance is not GRAS. Initially listed in the <a href="https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202504&amp;RIN=0910-AJ02" type="link" id="https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202504&amp;RIN=0910-AJ02" target="_blank" rel="noreferrer noopener">Unified Agenda</a> for anticipated Spring 2025 publication, the proposal was reportedly delayed by the federal shutdown. The move follows a March 2025 directive from Health Secretary Robert F. Kennedy Jr. to explore eliminating the GRAS pathway, long criticized as a loophole allowing self‑certified ingredients into the food supply.

FDA and FSIS Report Sharp Increases in Food Recall Volumes

December 5: Food recall volumes surged dramatically in Q3 2025, even as the number of incidents stayed relatively steady. FDA recalls rose slightly to 145 events, but the number of affected units jumped nearly 76 percent to 25.17 million. FSIS recalls fell 60% to six events, yet the volume of recalled products skyrocketed to 58.52 million pounds in Q3, its highest level in over 13 years. Experts emphasize these increases reflect broader preventive measures and improved detection rather than declining food safety. Undeclared allergens remained the leading cause of FDA recalls, followed by bacterial contamination, particularly Listeria, while FSIS recalls were driven largely by foreign material contamination. More information can be found <a href="https://www.foodsafetynews.com/2025/12/volumes-of-recalled-food-at-both-the-fda-and-fsis-have-increased-dramatically/" type="link" id="https://www.foodsafetynews.com/2025/12/volumes-of-recalled-food-at-both-the-fda-and-fsis-have-increased-dramatically/" target="_blank" rel="noreferrer noopener">here</a>.

Food Industry Groups Challenge Texas Labeling Mandate

December 8: Food industry groups are suing the state of Texas over Section 9 of the “Make Texas Healthy Again Act,” arguing that its new warning‑label mandate is unconstitutional and forces companies to convey false information about long‑approved food ingredients. The American Beverage Association, Consumer Brands Association, and National Confectioners Association say the law wrongly claims 44 ingredients are “not recommended” by foreign governments, even though many are permitted abroad and have long been safely used in U.S. products. They argue the provision compels misleading, government‑scripted speech in violation of the First Amendment. In addition, Section 9 is vague and interferes with current federal law on ingredient regulation and labeling. The groups also contend that the law burdens interstate commerce by requiring national manufacturers to adopt Texas‑specific labels. More information can be found <a href="https://www.fooddive.com/news/texas-food-industry-lawsuit-ingredient-warning-labels/807497/#:~:text=A%20coalition%20of%20food%20and,false%20and%20misleading%E2%80%9D%20to%20consumers." target="_blank" rel="noreferrer noopener">here</a>.

FDA Food Industry Pushes Back on Ultra‑Processed Food Regulation

December 24: According to a recent POLITICO report, food manufacturers are pushing back against efforts supported by Health and Human Services Secretary Robert F. Kennedy Jr. and the “Make America Healthy Again” (MAHA) movement to regulate ultra‑processed foods, arguing that state‑level ingredient and labeling requirements could raise food costs for consumers. Industry groups and major food companies highlighted affordability concerns and are advocating for a unified federal approach rather than a patchwork of state regulations. More information can be found <a href="https://www.politico.com/news/2025/12/25/ultraprocessed-food-rfk-affordability-maha-00692808" type="link" id="https://www.politico.com/news/2025/12/25/ultraprocessed-food-rfk-affordability-maha-00692808" target="_blank" rel="noreferrer noopener">here</a>.

San Francisco Sues Major Food Companies to Recover Health Care Costs

December 2: San Francisco filed a groundbreaking lawsuit accusing major ultra‑processed food manufacturers, including Kraft Heinz, Coca‑Cola, Conagra, PepsiCo, Kellogg, and Nestlé USA, of designing and deceptively marketing addictive, harmful products in violation of California’s unfair competition and public nuisance laws. The city seeks civil penalties to offset health care costs, alleging the companies used tactics similar to the tobacco industry by targeting children and low‑income consumers. According to City Attorney David Chiu, the suit seeks to halt deceptive marketing and address the public health burden linked to unhealthy processed foods. More information can be found <a href="https://www.npr.org/2025/12/03/g-s1-100212/san-francisco-sues-manufacturers-ultraprocessed-foods" target="_blank" rel="noreferrer noopener">here</a>.

Appeals Court Backs Campbell in Challenge to ‘Air Fried’ Chip Claims

December 10: A divided US Circuit Court of Appeals for the Ninth Circuit upheld Campbell Soup Co.’s victory in a proposed class action challenging the advertising of its Kettle Brand “Air Fried” chips, finding the complaint failed to plausibly allege consumer deception. The majority concluded that the front label clearly states the chips are “Kettle Cooked Air Finished,” describing a two‑step process that includes cooking in oil and air frying, and noted that the ingredient list and product imagery further confirm oil use. Because the packaging does not suggest the chips are exclusively air‑fried or oil‑free, the court held that reasonable consumers would not be misled. In dissent, Judge Salvador Mendoza Jr. argued that the “Air Fried” claim is visually dominant and could lead consumers to believe the chips are made using a healthier, reduced‑oil method. He warned that the majority’s approach risks enabling deceptive practices by allowing manufacturers to obscure key information behind technical jargon. More information can be found <a href="https://dailyjournal.com/articles/388976-9th-circuit-finds-air-fried-label-not-deceptive-affirms-dismissal" target="_blank" rel="noreferrer noopener">here</a>.

Court Temporarily Halts Enforcement of West Virginia Food Color Additives Law

December 24: A federal judge has preliminarily blocked enforcement of a West Virginia law restricting certain color additives in food, finding the measure likely unconstitutionally vague. The law, HB 2354, signed earlier this year, would prohibit the use of specified red, yellow, blue, and green additives deemed “poisonous or injurious to health,” effective January 1, 2028 and earlier for school meals. The U.S. District Court for the Southern District of West Virginia ruled that the statute failed to give manufacturers adequate notice of what additives are considered poisonous or injurious and allowed for arbitrary enforcement. The Court granted a preliminary injunction in a lawsuit brought by the International Association of Color Manufacturers on behalf of its members. More information can be found <a href="https://thehill.com/policy/healthcare/5663866-west-virginia-food-dye-ban-hhs-rfk-jr/" target="_blank" rel="noreferrer noopener">here</a>.

FDA Asks Court for Additional Time to Consider PFAS Limits for Food

December 31: FDA asked the U.S. District Court for the District of Arizona for a six‑month extension, until June 30, 2026, to decide whether to set limits on PFAS substances in food. The request arises from a citizen’s petition and related lawsuit brought by the Tucson Environmental Justice Task Force, which seeks FDA action on PFAS levels in food. FDA cited a change in the plaintiffs’ request, as well as significant staffing reductions and the government shutdown, as reasons additional time is needed. The plaintiffs oppose the extension.

Rows of clear plastic water bottles with blue caps on a production line in a beverage manufacturing facility.

Rows of clear plastic water bottles with blue caps on a production line.

Food & Beverage Regulatory Update – December 2025

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