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

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FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities

May 6: The FDA announced plans to increase unannounced inspections at foreign manufacturing facilities that produce food, essential medicines, and other medical products for U.S. consumers. This initiative builds on a pilot program in India and China to ensure foreign companies receive the same level of regulatory oversight and scrutiny as domestic manufacturers. The FDA will also evaluate the agency’s policies and practices for improvements to the foreign inspection program. The FDA hopes this move will expose violations more effectively, strengthen enforcement, and improve product safety before items reach the U.S. market. More information can be found <a href="https://www.fda.gov/news-events/press-announcements/fda-announces-expanded-use-unannounced-inspections-foreign-manufacturing-facilities" target="_blank">here</a>.

FDA Extends Comment Period for Front-of-Package Nutrition Information

May 9: The FDA extended the public comment period for its proposed rule on Front-of-Package Nutrition Labeling, originally proposed by the Biden administration and published in the Federal Register on January 16, 2025. The initial comment period deadline was May 16, 2025. Stakeholders now have until July 15, 2025 to submit feedback. This extension is in response to requests from interested parties for additional time to submit comments. More information can be found <a href="https://www.federalregister.gov/documents/2025/05/09/2025-08204/food-labeling-front-of-package-nutrition-information-extension-of-comment-period" target="_blank">here</a> and <a href="https://www.foodsafetynews.com/2025/05/fda-delays-implementation-of-rule-that-would-require-new-nutrition-labeling/" target="_blank">here</a>.

FDA and NIH Announce Joint Nutrition Science Program

May 9: The FDA and National Institute of Health (NIH) have partnered to create the Nutrition Regulatory Science Program to study diet-related chronic diseases. The FDA and NIH will accelerate nutrition research that will provide critical information to shape food and nutrition policies so Americans can have access to healthier food and diets. The initiative will focus on ultra-processed foods, food additives, and early-life nutrition to inform future food policies and improve public health. More information can be found <a href="https://www.fda.gov/news-events/press-announcements/fda-and-nih-announce-innovative-joint-nutrition-regulatory-science-program" target="_blank">here</a>.

FDA Approves Calcium Phosphate as a Color Additive in Select Foods

May 12: The FDA finalized a rule allowing the use of calcium phosphate as a color additive exempt from certification in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. This action is in response to a color additive petition filed by Innophos, Inc. The rule is effective June 26, 2025. More information can be found <a href="https://www.federalregister.gov/documents/2025/05/12/2025-08249/listing-of-color-additives-exempt-from-certification-calcium-phosphate" target="_blank">here</a>.

FDA Expands Use of Butterfly Pea Flower Extract as a Color Additive

May 12: The FDA expanded the use of butterfly pea flower extract as a color additive exempt from certification in ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips, plain corn chips, tortilla chips, and multigrain chips at levels consistent with good manufacturing practice. This action is in response to a color additive petition submitted by Sensient Colors, LLC. The rule is effective June 26, 2025. More information can be found <a href="https://www.federalregister.gov/documents/2025/05/12/2025-08248/listing-of-color-additives-exempt-from-certification-butterfly-pea-flower-extract" target="_blank">here</a>.

FDA Approves Galdieria Extract Blue as a Natural Color Additive in Foods

May 12: The FDA finalized a rule permitting the use of Galdieria extract blue, a natural color derived from unicellular red algae (Galdieria sulphuraria), as a color additive exempt from certification in various food categories at levels consistent with good manufacturing practice. The extract can now be used in foods such as non-alcoholic beverages and beverage bases, fruit drinks and smoothies, flavored milk and milk alternatives, yogurt and yogurt-based drinks, frostings, ice cream, frozen desserts, breakfast cereals and snack foods. This action is in response to a color additive petition submitted by Fermentalg. The rule is effective June 26, 2025. More information can be found <a href="https://www.federalregister.gov/documents/2025/05/12/2025-08250/listing-of-color-additives-exempt-from-certification-galdieria-extract-blue" target="_blank">here</a>.

FDA Investigates Salmonella Outbreak Linked to Cucumbers

May 14: The FDA and CDC are investigating a Salmonella outbreak tied to whole cucumbers grown by Bedner Growers, Inc. and distributed by Fresh Start Produce Sales, Inc. between April 29 and May 19. As of June 2025, 45 cases have been reported across 18 states, with 16 hospitalizations. More information can be found <a href="https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-cucumbers-may-2025" target="_blank">here</a>.

FDA Expands Oversight on Food Additives and Preservatives

May 15: The FDA launched a post-market review program for chemicals in the U.S. food supply to enhance food safety and transparency. The review program will include a modernized prioritization process for evaluating existing food chemicals, an updated list of chemicals under review, accelerated reviews of high-profile substances, and public updates on chemical evaluations. The FDA’s expanded review of food additives will include the preservatives BHT and BHA, as well as azodicarbonamide (ADA) which is a whitening agent used in cereal flour and as a dough conditioner. The agency will also accelerate evaluations of substances such as phthalates and titanium dioxide. More information can be found <a href="https://www.fda.gov/news-events/press-announcements/fda-advances-robust-transparent-post-market-chemical-review-program-keep-food-supply-safe-and" target="_blank">here</a>.

FDA Re-Opens Comment Period for New Guidance on Sanitation for Low-Moisture Ready-to-Eat Foods

May 29: The FDA reopened the comment period for its draft guidance on sanitation programs for low-moisture ready-to-eat (LMRTE) foods to allow stakeholders more time to provide feedback before the agency finalizes the guidance. Comments must be submitted by July 28, 2025. More information can be found <a href="https://www.federalregister.gov/documents/2025/05/29/2025-09653/establishing-sanitation-programs-for-low-moisture-ready-to-eat-human-foods-and-taking-corrective" target="_blank">here</a>.

FDA Confirms Effective Date for Myoglobin as a Color Additive

May 29: The FDA confirmed February 19, 2025, as the effective date for its final order allowing the use of myoglobin as a color additive in ground meat and poultry analogue products. This decision, originally published on January 17, 2025, ensures that myoglobin can safely be used to enhance the appearance of plant-based meat alternatives. Myoglobin is now officially listed under 21 CFR 73.297 for use in food products. More information can be found <a href="https://www.federalregister.gov/documents/2025/05/29/2025-09680/listing-of-color-additives-myoglobin-confirmation-of-effective-date" target="_blank">here</a>.

Foreign Supplier Verification Program (FSVP): The FDA issued a warning letter to Country Flavor, Inc., a NY food importer, for failing to comply with federal food safety regulations under the FSVP. During a follow-up inspection, FDA found that the company had not developed, maintained, or followed an FSVP for any of the food products it imports.

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Adulterated Seafood: The FDA issued warning letters to 4 companies for violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation and violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Regulations (CGMP &amp; PC rule). FDA inspections determined the products were adulterated.

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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">here</a>.

Screwworm Threat Prompts USDA to Halt Live Animal Imports at Southern Border

May 11: In response to the rapid spread of the New World Screwworm (NWS) in Mexico, U.S. Agriculture Secretary Brooke Rollins has suspended live cattle, horse, and bison imports through ports of entry along the southern border, effective immediately. NWS has been detected as far north as Oaxaca and Veracruz, approximately 700 miles from the U.S. border. Despite ongoing collaboration with Mexican authorities to eradicate NWS, the agency determined that stronger action was needed to protect U.S. livestock and food security. The suspension will be reviewed monthly and applies to animals originating from or transiting through Mexico. Livestock already in holding will be processed under strict inspection and treatment protocols. More information can be found <a href="/Users/RVE/AppData/Roaming/iManage/Work/Recent/209165-0001%20(General%20Advice%20and%20Counseling%20-%20FaB%20Wisconsin)/n%20response%20to%20the%20rapid%20spread%20of%20the%20New%20World%20Screwworm%20(NWS)%20in%20Mexico,%20U.S.%20Agriculture%20Secretary%20Brooke%20Rollins%20has%20suspended%20live%20cattle,%20horse,%20and%20bison%20imports%20through%20ports%20of%20entry%20along%20the%20southern%20border,%20effective%20immediately%201." target="_blank">here</a>.

Wisconsin Begins Mandatory Milk Testing for Avian Flu

May 21: Wisconsin dairy farms will undergo monthly milk testing for avian flu (H5N1) as part of a national surveillance program. The Wisconsin Department of Agriculture, Trade and Consumer Protection (DATCP) is rolling out its plan for monthly, farm-level sampling which integrates testing into existing milk quality verification processes to minimize disruption for farmers. Wisconsin’s approach differs from other states, opting for farm-level sampling rather than testing at dairy processing plants, which allows for faster identification of affected farms. More information can be found <a href="https://www.wpr.org/news/wisconsin-mandatory-milk-testing-avian-flu" target="_blank">here</a>.

USDA Increases Funding for State Food Safety Inspection

May 27: U.S. Secretary of Agriculture Brooke Rollins announced a $14.5 million funding increase to reimburse states for meat and poultry inspection programs, ensuring states have the resources to maintain food safety standards, particularly for small and medium-sized producers. The Trump administration’s 2026 budget proposal calls on Congress to address long-term funding needs for state inspection programs. Agricultural leaders have welcomed the decision, highlighting its role in supporting farmers, processors, and consumers. More information can be found <a href="https://www.usda.gov/about-usda/news/press-releases/2025/05/27/secretary-rollins-increases-funding-reimburse-states-food-safety-inspections" target="_blank">here</a>.

FDA Releases CORE 2023 Annual Report on Foodborne Outbreaks

May 6: The FDA released its <a href="https://www.fda.gov/food/outbreaks-foodborne-illness/core-2023-annual-report" target="_blank">annual report</a> summarizing the investigations of foodborne outbreaks and adverse events in FDA-regulated foods for the 2023 calendar year. Every year, CORE evaluates and responds to numerous foodborne outbreaks and adverse events linked to FDA-regulated products. In 2023, CORE evaluated 69 incidents, responded to 25, and issued advisories for 10 incidents. The 2023 annual report highlights outbreaks such as illnesses linked to toxins from morel mushrooms, lead linked to cinnamon in applesauce pouches, and Listeria monocytogenes linked to soft serve ice cream cups. More information can be found <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-releases-core-2023-annual-report-investigations-foodborne-outbreaks-and-adverse-events-fda" target="_blank">here</a>.

FDA Expands AI-Assisted Scientific Review

May 8: The FDA has completed its first AI-assisted scientific review pilot and is now rolling out AI-powered tools internally across all FDA centers by June 30, 2025. The AI tools allow FDA scientists and experts to spend less time on tedious, repetitive tasks that slow down the review process. FDA Commissioner Martin Makary called the technology a “game-changer,” allowing scientists to complete tasks in minutes instead of days. More information can be found <a href="https://www.fda.gov/news-events/press-announcements/fda-announces-completion-first-ai-assisted-scientific-review-pilot-and-aggressive-agency-wide-ai" target="_blank">here</a>.

FDA Food Safety Warnings Stalled Amid Staff Layoffs

May 9: The FDA Human Foods Program experienced a significant slowdown in publishing food safety warning letters following recent staff layoffs. Until this month, at least a dozen letters warning companies on significant violations have been piling up at the agency before they could be publicly posted on the FDA’s website as the task to review and redact the letters was halted in April after the US Department of Health and Human Services laid off staff that handled the agency’s public records. More information can be found <a href="https://www.nbcnews.com/health/health-news/fda-stalls-posting-food-safety-warning-letters-staff-cuts-rcna204879" target="_blank">here</a>.

Maryland Enacts Extended Producer Responsibility Law; Washington Soon to Follow

May 14: Maryland became the sixth state in the nation to enact an Extended Producer Responsibility (EPR) law for packaging and paper products, joining California, Colorado, Maine, Minnesota, and Oregon. Washington may soon be the seventh as its EPR bill has passed both chambers and awaits the Governor’s signature. EPR laws require companies that manufacture, import, distribute, or sell packaged goods to take responsibility for their products' end-of-life management, including collection, sorting, and recycling. Most producers comply through membership in a Producer Responsibility Organization, which coordinates recycling efforts and collects fees to fund the program. Maryland’s EPR bill, <a href="https://mgaleg.maryland.gov/2025RS/bills/sb/sb0901e.pdf" target="_blank">SB 901</a>, covers packaging and paper products sold, imported, or distributed in Maryland, with certain exemptions for hazardous materials packaging and infant formula packaging. Small producers with under one ton annually or with under $2 million in global revenue are exempt. Washington’s EPR bill, <a href="https://lawfilesext.leg.wa.gov/biennium/2025-26/Pdf/Bills/Senate%20Passed%20Legislature/5284-S2.PL.pdf?q=20250430162142" target="_blank">SB 5284</a>, outlines similar requirements for packaging and paper products. Producers with under one ton of material annually and less than $5 million in global revenue are exempt.

MAHA Report Calls for Stricter Oversight of Food Safety and Additives

May 22: The Make America Healthy Again (MAHA) Commission Report, ordered by President Trump, urges stricter regulations on food additives, pesticides, and ultra-processed foods due to their links to conditions such as obesity and diabetes. Chaired by Health Secretary Robert F. Kennedy Jr., the report criticizes the Generally Recognized as Safe (GRAS) system, highlights concern over pesticide exposure and the dominance of ultra-processed foods in federal nutrition programs and recommends a shift toward whole-food diets. The report further warns of corporate influence in food safety research. The recommendations have sparked debate among food manufacturers and agricultural groups who argue that stricter oversight could disrupt the industry. The full report can be viewed <a href="https://www.foodsafetynews.com/files/2025/05/The-MAHA-Report.pdf" target="_blank">here</a> and more information can be found <a href="https://www.foodsafetynews.com/2025/05/trump-ordered-maha-report-urges-stricter-oversight-of-food-safety-and-additives/" target="_blank">here</a>.

Skittles Removes Titanium Dioxide Amid Industry Shifts

May 30: Mars Wrigley, the maker of Skittles, will remove titanium dioxide, a whitening agent used in candies and sauces, from its U.S. product line by the end of 2024, in response to consumer demand for cleaner ingredients. Titanium dioxide has faced scrutiny due to concerns about potential DNA damage. While banned in the European Union, titanium dioxide remains legal in the U.S., though consumer advocacy groups have pushed for restrictions. More information can be found <a href="https://www.foodsafetynews.com/2025/05/skittles-quietly-drops-titanium-dioxide-as-food-industry-reduces-chemicals/" target="_blank">here</a>.

Lawsuit Claims Orville Redenbacher’s “Naturals” Popcorn Is not So Natural

May 1: Conagra Brands Inc. was accused in a proposed class action of allegedly misleading consumers by labeling its Orville Redenbacher’s Naturals popcorn as containing “Only Real Ingredients,” despite including synthetic tocopherols. According to the complaint filed in the U.S. District Court for the Eastern District of New York, the labeling falsely suggests the products are entirely natural. Plaintiff Julia Gibson seeks to represent both a nationwide class and a New York subclass, claiming violations of state consumer protection laws and breach of warranty. More information can be found <a href="https://southshorepress.com/stories/671202980-lawsuit-claims-orville-redenbacher-s-naturals-misleads-consumers-with-claims-of-natural-ingredients" target="_blank">here</a>.

California’s Prop. 65 Warning on Acrylamide in Foods Ruled Unconstitutional

May 2: The U.S. District Court for the Eastern District of California ruled that California’s Proposition 65 warning labels for acrylamide, a chemical found in foods like potato chips and French fries, violate the First Amendment commercial speech test and are unconstitutional when applied to food products. Judge Daniel Calabretta issued a permanent injunction, stating the warnings are misleading and not backed by scientific consensus on human cancer risk. The California Chamber of Commerce, which brought the lawsuit, argued that businesses were being forced to make unproven claims that their food causes cancer. The court agreed, noting that while acrylamide causes cancer in lab animals, experts disagree on its effects in humans. More information can be found <a href="https://www.ehs-seminar.com/aws/TCC/pt/sd/news_article/592472/_PARENT/TCC_layout_details/false" target="_blank">here</a>.

Nestlé Faces Lawsuit Over “Natural” Labeling on Sugar-Laden San Pellegrino Drinks

May 9:  Nestlé USA was sued in the U.S. District Court for the Northern District of California over claims that its San Pellegrino sparkling fruit beverages are deceptively marketed as “natural” and healthy, despite containing up to 26 grams of added sugar per can, more than half the FDA’s recommended daily limit. The proposed class action alleges that Nestlé’s branding, including phrases like “Made with Natural Origin” and product labels depicting fresh fruit and leaves, misleads consumers into believing the drinks promote well-being. Plaintiffs argue that the high sugar content contradicts these health claims and that they would not have purchased the beverages had they known the truth about the product.

Elevado Drinks Faces False Advertising Suit Over THC Microdose Claims

May 15:  Elevado Drinks is facing a proposed class action in the U.S. District Court for the Eastern District of California, for misleading consumers by marketing its THC- and CBD-infused sparkling cocktails as “perfectly microdosed.” The complaint alleges that each can contains 5mg of THC which is more than double the typical 1 to 2.5mg microdose. Plaintiffs also argue that THC and CBD are not approved food additives, and they would not have purchased the drinks had they known the cocktails contained an unapproved food ingredient. The suit seeks damages for violations of California consumer protection laws and breach of implied warranty.

Poppi Faces $8.9M Settlement Over Misleading Health Claims

May 27:  VNGR Beverage LLC, a unit of PepsiCo Inc., won preliminary approval for an $8.9 million settlement to resolve claims that its Poppi soda was falsely marketed as gut-healthy. The settlement, granted by the U.S. District Court for the Northern District of California on May 23, applies to all U.S. consumers who purchased Poppi drinks between January 2020 and the settlement notice date. Consumers alleged that Poppi’s “Prebiotic Soda” and “For a Healthy Gut” claims were deceptive, arguing that the drinks lacked sufficient fiber for meaningful health benefits and contained too much sugar, negating any potential benefits.

Chobani Wins Dismissal of “Zero Sugar” Label Lawsuit

May 30:  A federal judge for the US District Court for the Northern District of Illinois dismissed a consumer lawsuit against Chobani LLC, which alleged deceptive marketing of its Zero Sugar yogurt line. The plaintiffs claimed the product contained four grams per serving of allulose, a monosaccharide, despite being labeled "Zero Sugar."  According to the court, the buyers’ claims were preempted by 2020 FDA guidance that says allulose differs from other monosaccharide sugars. The judge ruled that since the FDA does not classify allulose as sugar for nutrition labeling, Chobani’s labeling was compliant. The court dismissed claims that an asterisk in Chobani’s ingredient list implied allulose was treated as sugar. The judge also dismissed two plaintiffs’ claims for lack of jurisdiction.

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

Food & Beverage Regulatory Update – May 2025

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