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This Regulatory Update covers information from April 2025. Please contact the authors for additional information on regulatory issues that may affect your business.

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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 "<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-food-allergen-labeling-edition-5" target="_blank" rel="noopener">Questions and Answers Regarding Food Allergens, Including the Food Labeling Requirements of the Federal Food, Drug, and Cosmetic Act</a>," 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 <a href="https://www.fda.gov/food/food-allergensgluten-free-guidance-documents-regulatory-information/frequently-asked-questions-food-allergen-labeling-guidance-industry?utm_medium=email&amp;utm_source=govdelivery" target="_blank" rel="noopener">here</a>.

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 <a href="https://www.cbsnews.com/news/fda-food-drug-inspections-layoffs/" target="_blank" rel="noopener">here</a>.

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 <a href="https://www.federalregister.gov/documents/2025/04/09/2025-06049/growing-harvesting-processing-and-distribution-of-poppy-seeds-industry-practices-related-to-opiate" target="_blank" rel="noopener">here</a>.

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 <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-shares-testing-results-pfas-bottled-water" target="_blank" rel="noopener">here</a>.

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&amp;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 <a href="https://www.fda.gov/news-events/press-announcements/hhs-fda-phase-out-petroleum-based-synthetic-dyes-nations-food-supply" target="_blank" rel="noopener">here</a> and <a href="https://www.foodsafetynews.com/2025/04/kennedy-maraky-fail-to-offer-details-of-how-they-plan-to-get-artificial-dyes-out-of-food/" target="_blank" rel="noopener">here</a>.

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 <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-suspends-milk-quality-tests-amid-workforce-cuts-2025-04-21/" target="_blank" rel="noopener">here</a>.

FDA Warning Letters

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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="noopener">here</a>.

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 <a href="https://www.federalregister.gov/documents/2025/04/11/2025-06164/delayed-verification-sampling-of-not-ready-to-eat-breaded-stuffed-chicken-products" target="_blank" rel="noopener">here</a>.

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), “<a href="https://www.fda.gov/media/117410/download" target="_blank" rel="noopener">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>” 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 <a href="https://www.fsis.usda.gov/policy/fsis-directives/7000.6" target="_blank" rel="noopener">Allergen Sampling Verification Program</a> and the directive “<a href="https://www.fsis.usda.gov/policy/fsis-directives/7230.1" target="_blank" rel="noopener">Ongoing Verification of Product Formulation and Labeling Targeting the Big 9 Allergens</a>” 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 <a href="https://www.foodprotection.org/publications/food-protection-trends/archive/2025-05-a-survey-of-the-levels-of-16-per-and-polyfluoroalkyl-substances-in-meat-chicken-and-silurifo/" target="_blank" rel="noopener">here</a>.

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 <a href="https://www.federalregister.gov/documents/2025/04/25/2025-07187/salmonella-framework-for-raw-poultry-products" target="_blank" rel="noopener">here</a>.

Other Articles of Interest

Listeria Outbreak Linked to Frozen Supplement Shakes

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 <a href="https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-listeria-monocytogenes-frozen-supplemental-shakes-february-2025" target="_blank" rel="noopener">here</a>.

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 <a href="https://www.law360.com/articles/2322863/fda-slow-to-act-on-hemp-and-vapes-congress-hears" target="_blank" rel="noopener">here</a> and <a href="https://hempsupporter.com/news/recap-of-u-s-hemp-roundtable-general-counsel-jonathan-miller-testifying-before-house-oversight-committee/" target="_blank" rel="noopener">here</a>.

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.

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 – April 2025

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