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

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Meet Elsa: FDA’s New AI Tool

June 2: The U.S. Food and Drug Administration (FDA) launched Elsa, a generative AI tool designed to help employees work more efficiently. Elsa modernizes agency functions and leverages AI capabilities to better serve the American people. Built within a secure GovCloud environment, Elsa empowers FDA employees, including scientific reviewers and field investigators, with capabilities such as summarizing adverse events, accelerating clinical protocol reviews, shortening the time needed for scientific evaluations, and identifying high-priority inspection targets. More information can be found <a href="https://www.fda.gov/news-events/press-announcements/fda-launches-agency-wide-ai-tool-optimize-performance-american-people" target="_blank" rel="noopener">here</a>.

Wildtype’s Lab-Grown Salmon Receives FDA Approval

June 12: The FDA has approved Wildtype’s cultivated salmon, making it the first lab-grown seafood available in the U.S. Grown from Pacific salmon cells. The cultivated salmon offers sushi-grade taste without the environmental downsides of traditional fishing. The fish is produced by growing cells from living Pacific salmon. They are later harvested and combined with plant-based ingredients to mimic the appearance of conventional fish filets. The salmon debuted at Portland’s Kann restaurant. While some states have banned lab-grown meat, Wildtype continues to advocate for food innovation and sustainability. More information can be found <a href="https://www.fooddive.com/news/wildtype-lab-grown-salmon-fda-clearance/750518/" target="_blank" rel="noopener">here</a>.

FDA Extends Testing for Olive Oil-Based Cheese

June 18: The FDA amended and extended the temporary permit issued to Bongards’ Creameries to market test pasteurized process cheese made with extra virgin olive oil as the slice anti-sticking agent, a deviation from the standard identity for pasteurized process cheeses. The updated permit allows up to 20 million pounds of product and invites other manufacturers to join the test. More information can be found <a href="https://www.federalregister.gov/documents/2025/06/18/2025-11209/cheese-products-deviating-from-standard-of-identity-temporary-permit-for-market-testing" target="_blank" rel="noopener">here</a>.

FDA Extends Chobani’s Yogurt Market Test Permit

June 18: The FDA extended a temporary permit for Chobani to continue market testing yogurt products that deviate from the standard of identity by using ultrafiltered nonfat milk as a basic ingredient. The extension supports Chobani’s petition to formally update the yogurt standard and allows up to 150 million pounds of product annually. Other manufacturers are invited to join the test. More information can be found <a href="https://www.federalregister.gov/documents/2025/06/18/2025-11208/yogurt-products-deviating-from-standard-of-identity-temporary-permit-for-market-testing" target="_blank" rel="noopener">here</a>.

FDA Seeks Input on New Method for Ranking Chemicals in the Food Supply

June 18: The FDA is seeking public input on a proposed Post-Market Assessment Prioritization Tool that would help rank chemicals in the food supply. Using a Multi-Criteria Decision Analysis approach, the tool determines a score for each chemical based on evaluating substances against a pre-determined set of criteria, similar to the approach used by the U.S. Environmental Protection Agency for prioritizing chemicals. The FDA’s method considers factors specific to exposure from food and uses a scoring method similar to FDA’s Risk Ranking Model for Traceability. Comments are due July 18, 2025. More information can be found <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-seeks-input-new-method-ranking-chemicals-food-post-market-assessments" target="_blank" rel="noopener">here</a>.

FDA Updates Food Labeling Compliance Program

June 24: The FDA has updated its food labeling compliance program, now titled General Food Labeling Requirements and Labeling-Related Sample Analysis – Domestic and Import, to reflect current regulations and enforcement priorities. This update replaces the previous 2010 version. Key changes include recognizing sesame as the ninth major allergen, updated guidance on gluten-free labeling, and alignment with the 2016 Nutrition Facts label revisions. This update strengthens oversight of both domestic and imported foods and provides clearer inspection protocols to ensure labels are truthful and compliant with federal regulations. More information can be found <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-updates-general-food-labeling-requirements-compliance-program" target="_blank" rel="noopener">here</a>.

FDA Releases Proposed 2025 Human Foods Program Guidance Agenda

June 30: The FDA published its proposed 2025 Human Foods Program Guidance Agenda, outlining key topics for new or updated guidance documents. Priorities include natural food color additives, new dietary ingredient notifications, and action levels for contaminants like cadmium and opiate alkaloids in food products. More information can be found <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-releases-2025-human-foods-program-guidance-agenda" target="_blank" rel="noopener">here</a>.

FDA Warning Letters

Unapproved New Drugs/Supplements: The FDA issued a warning to Mother Earth Minerals for marketing Calcium, Magnesium, and Silver products with disease treatment claims like cancer and diabetes. The FDA determined these products were unapproved new drugs and they lacked proper usage directions, making them misbranded. The FDA also found manufacturing violations, including missing quality control procedures and inadequate recordkeeping, rendering the supplements adulterated.

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Adulterated Shell Eggs: The FDA issued a warning letter to Milo’s Poultry Farms for failing to prevent Salmonella Enteritidis contamination linked to human illness. The FDA found Salmonella Enteritidis in environmental samples from the poultry house and egg processing facility. Violations include inadequate biosecurity, pest control, and missing safety protocols.  The FDA determined the eggs are adulterated in that they were produced under insanitary conditions.

Adulterated Sprouts: The FDA issued a warning letter to Jack and the Green Sprouts of River Falls, Wisconsin after multiple batches of sprouts tested positive for Listeria monocytogenes, rendering the product adulterated.  Environmental monitoring was insufficient to detect contamination and unsanitary conditions, including rodent presence, were found in the facility.

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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>.

Mindy Brashears Nominated for Second Term as USDA Food Safety Under Secretary

June 17: President Trump nominated Dr. Mindy Brashears for a second term as USDA Under Secretary for Food Safety, a role she previously held from March 2020 to January 2021. During her tenure, she led the Food Safety and Inspection Service, overseeing more than 10,000 inspectors and scientists, and chaired the Codex Alimentarius Policy Committee. Following her first term at USDA, Brashears returned to Texas Tech University as a professor and director of the International Center for Food Industry Excellence. Her nomination is now before the Senate Committee on Agriculture, with a hearing date yet to be scheduled. More information can be found <a href="https://foodsafetytech.com/news_article/trump-nominates-mindy-brashears-to-second-term-as-usdas-under-secretary-for-food-safety/" target="_blank" rel="noopener">here</a>.

FSIS Updates State Meat and Poultry Inspection Listings

June 26: The USDA’s Food Safety and Inspection Service (FSIS) is revising federal meat and poultry inspection regulations to remove lists of states that do not operate their own meat or poultry inspection (MPI) programs. Instead, FSIS will maintain the lists of states with and without MPI programs online, ensuring the public has accurate and timely access to which states operate inspection programs “at least equal to” federal standards. FSIS is also amending regulations to remove or revise related cross-references to the lists. The rule went into effect June 26, 2025. More information can be found <a href="https://www.federalregister.gov/documents/2025/06/26/2025-11816/publication-method-of-lists-of-states-with-and-without-state-meat-or-poultry-inspection-programs" target="_blank" rel="noopener">here</a>.

FSIS Releases New HACCP Models for Egg Products

June 27: FSIS released two new generic HACCP models for egg products: one for <a href="https://www.fsis.usda.gov/guidelines/2025-0002" target="_blank" rel="noopener">dried egg products</a> and another for <a href="https://www.fsis.usda.gov/guidelines/2025-0003" target="_blank" rel="noopener">pasteurized liquid egg products</a>. These models include product descriptions, flow diagrams, hazard analyses, and sample HACCP plans to help establishments meet regulatory requirements. While nonbinding, the models offer guidance for tailoring food safety systems to specific operations and reflect FSIS’ ongoing efforts to modernize inspection practices and support safe egg product production.

FSIS Proposes Dropping “Tripe with Milk” Standard

June 30: FSIS is proposing to eliminate the outdated standard of identity for canned “Tripe with Milk.” Originally established in 1950 without clear justification, the standard for finished canned tripe with milk products is now considered unnecessary. FSIS says removing it will give producers more flexibility while maintaining accurate labeling to prevent misbranding. Comments on the proposed rule are due by July 30, 2025. More information can be found <a href="https://www.federalregister.gov/documents/2025/06/30/2025-12032/removal-of-standard-of-identity-for-canned-tripe-with-milk" target="_blank" rel="noopener">here</a>.

Other Articles of Interest

Candy Makers Push Back on Aggressive Dye Removal Timeline

June 2: As the FDA pushes for the removal of synthetic food dyes by the end of 2026, candy makers are raising concerns that the timeline is too aggressive. Candy giants such as Mars and Ferrara say reformulating products poses technical and supply challenges. Industry leaders argue that natural alternatives are limited, may affect taste and shelf life, and could trigger allergies. They also worry about consumer backlash, citing past reformulation failures like General Mills’ short-lived switch to natural colors in Trix cereal. More information can be found <a href="https://www.fooddive.com/news/candy-makers-worry-timeline-to-remove-artificial-dyes-too-aggressive/745964/" target="_blank" rel="noopener">here</a>.

Texas Passes MAHA Food Labeling Law

June 2: Texas passed <a href="https://legiscan.com/TX/text/SB25/id/3247967" target="_blank" rel="noopener">Senate Bill 25</a>, requiring warning labels on foods containing over 40 additives and synthetic dyes banned or restricted in countries like Canada and the EU. Backed by Health Secretary Robert F. Kennedy Jr. and part of the federal “Make America Healthy Again” (MAHA) initiative, the law seeks to increase transparency and promote healthier eating. Starting in 2027, products sold in Texas containing identified food additives or other chemical ingredients, must carry a warning label. The bill also mandates nutrition education and physical activity in schools and continuing education for health professionals. Despite strong bipartisan support, the law has drawn opposition from major food companies, who warn it could raise costs and disrupt supply chains. More information can be found <a href="https://www.texastribune.org/2025/06/02/texas-maha-food-labels-vaccines-robert-kennedy/" target="_blank" rel="noopener">here</a>.

California Bill Targets Ultra-Processed Foods in School Lunches

June 4: California could become the first state to ban particularly harmful ultra-processed foods from public school meals with bipartisan legislation approved by the state Assembly. <a href="https://legiscan.com/CA/text/AB1264/2025" target="_blank" rel="noopener">Assembly Bill 1264</a> would phase out foods containing chemical additives like dyes, emulsifiers, and artificial flavors by 2035. The bill directs the state’s environmental health agency to define ultra-processed foods and identify harmful ones to be phased out of school meals by 2032, based on links to conditions like cancer, diabetes, and obesity. Schools would begin reporting and reducing these foods starting in 2027. More information can be found <a href="https://www.foodsafetynews.com/2025/06/california-bill-would-ban-ultra-processed-foods-from-school-lunch-programs/" target="_blank" rel="noopener">here</a>.

Louisiana Passes Nutrition Reforms

June 8: Louisiana passed legislation under the “Make America Healthy Again” initiative to overhaul food standards in schools and restaurants. Louisiana joins several other states, including West Virginia, Utah, Texas, Idaho and Michigan, that have recently passed similar laws. The new law bans artificial dyes, such as Red 40, Yellow 5, and Blue 1, and preservatives like BHA and BHT in school meals starting in 2027. It also requires schools to source at least 20% of their food from local farms. Restaurants must now disclose the use of seed oils, and food products containing certain additives must include QR codes linking to health information. Medical professionals will also be required to complete nutrition training every two years. More information can be found <a href="https://www.wwltv.com/article/news/local/louisiana-passes-nutrition-law-make-america-healthy-again-food-healthy-eating-lunch-schools-dinner-trump/289-6cedff31-6e2d-4e1d-8938-11c1d44cfde9" target="_blank" rel="noopener">here</a>.

FDA To Define Ultraprocessed Food

June 10:  The FDA is preparing to formally define ultraprocessed foods, a category that includes many of the snacks, drinks, and convenience meals dominating the American diet. In clarifying what qualifies as ultraprocessed, the FDA in collaboration with the USDA could examine the chemicals and additives in food, ingredient count, and nutritional value.  The definition could guide school meals, federal nutrition programs, and food labeling. Health experts link ultraprocessed foods to serious conditions like diabetes and heart disease, but debate remains over which products truly qualify. The FDA plans to seek public input before finalizing its approach.

New Dietary Guidelines Coming Soon

June 19: Agriculture Secretary Brooke Rollins and Health and Human Services Secretary Robert F. Kennedy Jr. have promised that new federal dietary guidelines will be released ahead of the December 31, 2025 deadline, marking a “dawn of a new day” for American nutrition policy. The 2025–2030 guidelines are expected to be shorter, clearer, and focused on whole foods, while removing ultra-processed foods from the menu. Rollins and Kennedy say the updated recommendations will be based on sound science and not political ideology. More information can be found <a href="https://www.foodsafetynews.com/2025/06/rollins-and-rfk-jr-promise-that-usda-and-hhs-will-issue-new-dietary-guidelines-soon/" target="_blank" rel="noopener">here</a>.

Cereal Giant General Mills Joins Push to Eliminate Artificial Dyes

June 23: General Mills announced plans to eliminate synthetic food dyes from all its U.S. products by the end of 2027, joining other major food companies in response to a request from the Secretary of Health and Human Services. General Mills will focus on removing artificial colors from cereals and school foods first. According to the company, 85% of its products are already dye-free. The move comes amid growing concerns over the health effects of petroleum-based dyes, especially on children, and aligns with federal efforts to phase out artificial additives. More information can be found <a href="https://www.foodsafetynews.com/2025/06/cereal-giant-general-mills-joins-other-companies-in-move-to-remove-food-dyes/" target="_blank" rel="noopener">here</a>.

North Carolina Targets Raw Milk Loopholes Amid Bird Flu Concerns

June 24: North Carolina is moving to tighten its raw milk regulations through <a href="https://www.ncleg.gov/BillLookup/2025/S639" target="_blank" rel="noopener">Senate Bill 639</a>, part of the 2025 Farm Act, in response to concerns over bird flu transmission. Although raw milk sales for human consumption are already banned, loopholes such as labeling it “pet milk” or using herd-share agreements have allowed it to circulate widely. With the avian influenza virus recently detected in raw milk, Agriculture Commissioner Steve Troxler is pushing to eliminate these loopholes, warning that raw milk poses serious health risks and could help the virus spread among humans. If passed, the bill would shut down nearly 100 known raw milk sources in the state and remove legal protections for herd-share participants. More information can be found <a href="https://www.foodsafetynews.com/2025/06/north-carolina-may-close-raw-milk-loopholes-because-it-could-spread-bird-flu/" target="_blank" rel="noopener">here</a>.

Texas Bans Lab-Grown Meat

June 25: Texas became the seventh state to ban lab-grown meat. Governor Greg Abbott signed <a href="https://legiscan.com/TX/bill/SB261/2025" target="_blank" rel="noopener">Senate Bill 261</a>, which prohibits the sale of cell-cultured protein for human consumption starting September 1, 2025. The law cites health concerns, including potential risks from microplastics, and imposes civil and criminal penalties. Unless extended, the ban will expire on September 7, 2027. More information can be found <a href="https://www.foodsafetynews.com/2025/06/texas-is-the-7th-state-to-put-brakes-on-lab-grown-meat/" target="_blank" rel="noopener">here</a>.

Study Finds Synthetic Dyes in One-Fifth of U.S. Packaged Food

June 25: A new <a href="https://www.jandonline.org/article/S2212-2672(25)00166-2/fulltext" target="_blank" rel="noopener">study</a> published in the Journal of the Academy of Nutrition and Dietetics reveals that nearly 20% of packaged foods and beverages sold in the U.S. contain synthetic dyes. Many products marketed to children, such as cereals, candies, and sugary drinks, show even higher rates. Researchers analyzed nearly 40,000 items from top food manufacturers and found that synthetic dyes like Red 40, Yellow 5, and Blue 1 were most common. These additives were also significantly more likely to be high in added sugars and low in nutritional quality. More information can be found <a href="https://www.latimes.com/science/story/2025-06-25/one-in-five-food-and-beverage-products-are-made-with-synthetic-dyes" target="_blank" rel="noopener">here</a>.

Nestlé, Conagra Commit to Removing Artificial Dyes by 2026

June 27: Nestle and Conagra have promised to eliminate artificial colors from their U.S. food and beverages, as requested by the FDA. Conagra said it will remove artificial colors from its frozen foods by the end of this year and will work to discontinue artificial dyes across its entire portfolio by the end of 2027. Nestle has been working in the past decade to remove artificial colors and dyes from its products and 90 percent of its products sold in the U.S. already avoid artificial colors. More information can be found <a href="https://www.foodsafetynews.com/2025/06/nestle-promises-to-ditch-artificial-dyes/" target="_blank" rel="noopener">here</a>.

Concerns Raised Over FDA’s New AI Tool

June 30: The FDA’s new AI assistant, Elsa, was launched to improve efficiency, however, critics are raising flags about its accuracy, transparency, and legal implications. Staff report Elsa often gives incorrect or incomplete results, and there’s confusion over how to use it responsibly. Experts warn that using AI in drug approvals without clear guidelines could jeopardize safety and trust. Legal risks and lack of oversight make Elsa’s rollout a potential cautionary tale in AI adoption. More information can be found <a href="https://www.biospace.com/fda/fdas-ai-rollout-raises-questions-around-readiness-legality" target="_blank" rel="noopener">here</a>.

Fish Oil Lawsuit Against Nordic Naturals Moves Forward

June 5: A federal judge for the US District Court for the Northern District of California allowed key claims to proceed in a proposed class action against Nordic Naturals Inc., which alleges the company falsely markets its fish oil supplements as promoting heart health. The court upheld allegations of false advertising, breach of express warranty, misrepresentation, and quasi-contract, while trimming a few consumer protection claims. Claims tied to states outside California and under the state’s Consumer Legal Remedies Act were dismissed due to lack of standing. A copy of the court order can be found <a href="https://www.govinfo.gov/content/pkg/USCOURTS-cand-5_24-cv-04058/pdf/USCOURTS-cand-5_24-cv-04058-0.pdf" target="_blank" rel="noopener">here</a>.

Judge Allows Labeling Lawsuit Against New Chapter to Proceed

June 5:  New Chapter Inc. failed to dismiss a proposed class action accusing the company of misleading consumers about its fiber gummy supplements. A judge for the US District Court for the Central District of California ruled that claims of false advertising, misrepresentation, and breach of warranty can move forward. Plaintiff Tinamarie Barrales alleges that New Chapter’s labels stating “with 4g of prebiotic fiber” led her to believe each gummy contained four grams of fiber, when in fact that amount applies to a two-gummy serving. She also claims the “Kids” version of the gummies falsely suggests a child-specific formulation, though both products are chemically identical. The court found these claims plausible and not preempted by federal law, rejecting New Chapter’s argument that back-label information clarified any confusion.

Amazon Faces Class Action Over Unapproved Supplements

June 10:  A federal judge for the U.S. District Court for the Western District of Washington ruled that Amazon must face a proposed class action alleging it sells dietary supplements with unapproved health claims and missing FDA-required disclaimers. The lawsuit, brought by four consumers, claims Amazon systematically markets supplements, such as fish oil, turmeric, and multivitamins, without proper labeling through its Fulfilled by Amazon program.  The consumers argued that the supplements at issue sold on Amazon's platform have not been reviewed or pre-approved for sale by the FDA and lack the mandatory disclaimers that are required for unapproved disease or heart-related claims. Judge John H. Chun rejected Amazon’s argument that the plaintiffs lack standing to challenge products they didn’t personally buy, citing a “uniform, systematic practice” of misleading marketing. The case will now proceed toward class certification, spotlighting broader concerns about supplement safety and transparency on major retail platforms.

Naked Whey Faces Class Action Over Alleged Protein Mislabeling

June 18:  Naked Whey Inc., known for its vegan protein powders like Naked PB and Naked Pea, is facing a proposed class action in California federal court for allegedly overstating the protein content of its products. The lawsuit, filed by plaintiff Carol Valenta in the US District Court for the Southern District of California, claims the company misled consumers by labeling its powders with inflated protein values without disclosing the Protein Digestibility Corrected Amino Acid Score, a key measure of protein quality. As protein-rich diets like Keto and Paleo gain popularity, the suit highlights growing scrutiny over how plant-based proteins are marketed. The plaintiff seeks damages and injunctive relief for California consumers who purchased Naked Whey products over the past four years.

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 – June 2025

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