This update includes FDA and USDA updates, warning letters, lawsuits, and other articles of interest, including the debate over the federal definition of ultra-processed food, a reminder about the 2026 FDA registration renewal deadline, an E. coli outbreak related to raw milk cheese, and more.
FDA Updates
FDA Report Identifies Key Food Safety Risks in Retail Delis
September 16: The U.S. Food and Drug Administration (FDA) released a report summarizing findings from its 2019–2022 study of retail food store delis, which found that improper holding times and temperatures and poor personal hygiene were the most observed food safety risk factors. The agency reported that delis with a Certified Food Protection Manager and well-developed food safety management systems demonstrated stronger food safety outcomes and fewer risk-factor violations. FDA said the findings will support future retail food safety initiatives and inform the next round of data collection beginning in October 2026. More information can be found here.
FDA Releases Updated 2026 Food Code
September 17: The FDA released the 2026 edition of the Food Code, updating its model food safety standards for retail and foodservice establishments. Key changes include a new requirement for written employee illness policies, an alternative cooling process for certain foods, and a limited exception allowing double gloving under specified conditions. The update also addresses allergen cross-contact, food donations, mobile food establishments, sanitizer temperatures, dehydration and freeze-drying practices, vending machine controls, and revisions to inspection reporting. The updates are intended to improve public health, regulatory clarity and implementation. More information can be found here.
FDA Reviews Petition to Expand Use of Calcium Sulfate as a Color Additive
September 25: The FDA has filed a color additive petition submitted by Doehler GmbH seeking to amend color additive regulations to permit the use of calcium sulfate in various foods, such as coated candies, dry milk, whey products, powdered creamers, icings, and baked-good fillings, at levels consistent with good manufacturing practice. The notice initiates FDA’s review of the petition. More information can be found here.
FDA Approves Vitamin D2 Inactive Bakers Yeast for Use in Foods
September 25: The FDA issued a final rule authorizing the use of vitamin D2 inactive bakers yeast as a source of vitamin D2 in specific food categories. The ingredient is produced by exposing baker’s yeast to ultraviolet light and then heat-inactivating the yeast. FDA concluded that the approved uses are safe and are not expected to increase overall dietary exposure to vitamin D because they substitute for previously authorized vitamin D2 mushroom powder uses. The rule became effective September 25, 2026. More information can be found here.
FDA Reminds Food Facilities of 2026 Registration Renewal Deadline
September 29: Domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. are required to complete FDA biennial registration renewals between October 1 and December 31, 2026. Facilities must submit renewal information electronically through FDA Industry Systems and include an approved unique facility identifier, currently a DUNS number. Registrations not renewed by the deadline will expire. Qualified facilities must also submit a qualified facility attestation during the same renewal period. There is no fee associated with registration or renewal. For guidance on the renewal process see the Food Facility Registration User Guide: Biennial Registration Renewal. More information can be found here.
FDA Warning Letters
Unapproved New Drugs: The FDA issued a warning letter to Good Stuff Cacao alleging that disease-related claims for products including Goji Berries, Green Tea, Raw Cacao Powder, and Crystallized Raw Honey caused the products to be marketed as unapproved drugs under federal law. FDA cited claims related to conditions such as cancer, diabetes, heart disease, and Alzheimer’s disease, and stated that several products were also misbranded.
Adulterated Dietary Supplements: The FDA issued a warning letter to BioDrive, Inc. alleging that its Evolv GLP-1 Biomimetic dietary supplement is adulterated because it contains EV1-Peptide, a new dietary ingredient for which FDA determined there is inadequate information to demonstrate a reasonable assurance of safety.
A database of warning letters can be found here.
USDA Updates
Executive Orders Target Beef Labeling, Livestock Markets, and Rancher Support
September 9: President Trump signed two executive orders supporting American Ranchers and promoting fair competition in livestock markets and expanding market access for American Meat Producers. The U.S. Department of Agriculture (USDA) announced additional actions under its Ranchers First Initiative. The actions include mandatory country-of-origin labeling for beef, increasing enforcement of livestock market competition laws, and expanding opportunities for small meat processors. These actions build on the Small Processors Action Plan and the Ranchers First Initiative to keep processing capacity and jobs in the communities where livestock is raised. More information can be found here.
FSIS Leadership Changes
September 9: The USDA’s Food Safety and Inspection Service (FSIS) announced several leadership appointments to support its food safety mission and strategic priorities. Jeremy “Todd” Reed was named deputy administrator for Science and Policy. Dr. Gabrial Eddings was appointed assistant administrator of the Office of Public Health Science (OPHS) and Dr. Glenn Tillman became deputy assistant administrator for OPHS. Additional acting leadership assignments were made across the Office of the Administrator, OPHS, and the Office of Public Affairs and Training to support ongoing operations and program oversight. More information about FSIS leadership can be found on the FSIS website.
FSIS Encourages Electronic Label Submissions as Review Backlogs Improve
September 9: The FSIS said it is making progress in reducing label review backlogs, cutting turnaround times by 10 business days and expecting a return to pre-2025 processing times within the next two months. Companies that submit labels electronically through the Labeling Submission and Approval System (LSAS) can track application status online from their dashboard in LSAS. If the label is mailed directly to the Labeling and Program Delivery Staff (LPDS), the company should contact the Distribution Unit at (301) 504-0878. To avoid delays, LPDS recommends using the online web submission process. More information can be found on the LSAS website.
FSIS Updates Allergen and Gluten Verification Sampling Program
September 15: The FSIS issued a directive updating instructions for allergen and gluten verification testing of ready-to-eat meat and poultry products that carry claims such as “allergen-free” or “gluten-free.” The directive expands oversight to products with negative claims related to 13 major allergens and gluten, requires eligible establishments to undergo annual random sampling, and details procedures for collecting and analyzing samples. The update is intended to verify label accuracy and support compliance with allergen control and labeling requirements. More information can be found here.
USDA Ends Dairy Checkoff Funding for ESG Initiatives
September 17: The USDA announced that dairy checkoff funds may no longer be used to support environmental, social, and governance (ESG) initiatives, including projects tied to greenhouse gas reduction and net-zero targets. USDA said the change is intended to refocus producer-funded research and promotion programs that strengthen markets for U.S. dairy products. The agency also directed oversight of other commodity checkoff programs to ensure research and promotion funds are not used to advance ESG mandates. More information can be found here.
Other Articles of Interest
Debate Intensifies Over Federal Definition of Ultra-Processed Foods
September 11: Food industry groups and public health advocates are lobbying the White House as the administration develops a federal definition of “ultra-processed foods” that could shape future research, labeling, and nutrition policy. Industry groups say the science remains unsettled and warn that a definition could increase lawsuits, disrupt supply chains, and raise costs. Public health organizations argue that a clear definition is a necessary first step toward future health policies and cite growing evidence linking ultra-processed foods to adverse health outcomes. More information can be found here. (Subscription may be required.)
Study Finds Thousands of Food-Packaging Chemicals Lack Safety Information
September 16: A recent study highlighted significant data gaps for chemicals used in food packaging, reporting that only a fraction of the roughly 15,000 known food-contact chemicals have been thoroughly evaluated for health effects. Researchers identified 1,222 chemicals with known major health hazards and grouped related substances into 38 priority categories to help regulators and manufacturers assess risks more efficiently and reduce the likelihood of replacing restricted chemicals with structurally similar alternatives that may pose comparable concerns. More information can be found here.
Court Ruling Spurs Wave of Allulose Labeling Claims
September 24: A growing wave of consumer lawsuits is challenging “zero sugar” claims on products containing allulose, a low-calorie sweetener that is chemically classified as a sugar but has minimal effects on blood glucose. The litigation accelerated after a 2026 Seventh Circuit ruling allowed deception claims against Chobani to proceed, prompting nearly 60 similar lawsuits. The cases highlight ongoing tension in food labeling policy that mandates scientific accuracy, with industry stakeholders calling for FDA clarification on how allulose may be labeled given its unique nutritional characteristics. More information can be found here. (Subscription may be required.)
FDA Investigates Multistate E. Coli Outbreak Linked to Raw Milk Cheese
September 25: The FDA and Centers for Disease Control and Prevention (CDC) are investigating a multistate outbreak of E. coli O26:H11 linked to Sierra Nevada Graziers grass-fed raw milk cheeses, including cheddar, Monterey jack, and jalapeño jack varieties. As of September 25, 2026, the outbreak involved 13 illnesses across nine states, resulting in eight hospitalizations and three cases of a type of kidney failure called hemolytic uremic syndrome. Sierra Nevada Cheese Company recalled all Graziers raw milk cheeses, and consumers, retailers, and foodservice operators are advised not to eat, sell, or serve the affected products. More information is available here.
FSMA 204 Compliance Hinges on Supplier Readiness
September 27: Compliance with FDA’s FSMA 204 Food Traceability Rule will require manufacturers to coordinate with suppliers and vendors to provide detailed, electronically sortable traceability records to FDA within 24 hours of a request. Meeting that requirement depends on suppliers and trading partners maintaining compatible data, recordkeeping, and lot-tracking systems. To prepare for the July 20, 2028 compliance deadline, companies should evaluate supply-chain traceability capabilities and ensure systems can support rapid traceback and recall responses. More information can be found here.
Study Finds Healthy Food Labels May Not Reflect Overall Nutrition
September 28: A Cornell University study of nearly 150,000 food and beverage products launched in the U.S. over the past decade found that health-related package claims do not always reflect overall nutritional quality. Using a nutrient profiling model that evaluates multiple dietary factors, researchers found that about two-thirds of products were classified as less healthy overall, even though roughly half carried health-focused claims. Beverages showed some of the largest gaps between front-of-package claims and overall nutritional quality. The study also found that products often achieved a health claim by reducing one ingredient while increasing another. More information can be found here.
Federal Lawmakers Renew Push for PFAS Packaging Ban
September 29: Senators Maggie Hassan and Tommy Tuberville have reintroduced bipartisan bill that would amend the Federal Food, Drug, and Cosmetic Act to prohibit the intentional use of PFAS in food packaging beginning January 1, 2028. The bill follows similar House legislation and comes as more than a dozen states have adopted PFAS packaging restrictions. While PFAS-containing grease-proofing substances are no longer being marketed for food packaging in the U.S., the bill would establish a nationwide statutory ban. More information can be found here.
FDA Nominee Says Agency Needs More Resources for Food Policy Reforms
September 29: Dr. Heidi Overton, President Trump’s nominee to lead the FDA, told senators that the agency will need additional resources to implement food policy initiatives supported by Health Secretary Robert F. Kennedy Jr., particularly a recently proposed rule requiring companies to notify the FDA when asserting that new food ingredients are generally recognized as safe (GRAS). Overton said expanded staffing in the FDA’s Human Foods Program would be needed to manage mandatory notifications and indicated she is open to pursuing a federal standard for ingredient regulation as states adopt their own requirements. More information can be found here.
California Creates Voluntary Non-Ultra-Processed Food Seal
September 29: California enacted a law creating a voluntary “non-ultra-processed certified” seal for qualifying food products. The California Department of Public Health will oversee the certification program through accredited third-party certifiers, and products must be recertified at least every three years. The department must accredit these third-party certifiers no later than June 1, 2029. Foods containing certain additives used to alter taste or quality are ineligible for certification. The law also requires certain large grocery retailers to identify certified products with displays or signage. More information can be found here. (Subscription may be required.)
Lawsuits
Haleon Faces Lawsuit Over “Zero Sugar” Emergen-C Gummies
September 15: A proposed class action filed in the U.S. District Court for the Southern District of California accuses Haleon US Holdings of misleading consumers by labeling Emergen-C Zero Sugar Vitamin C Immune Support Gummies as containing “zero sugar” despite containing allulose, a sweetener the plaintiff argues qualifies as a sugar under FDA regulations. The lawsuit relies in part on a recent Seventh Circuit decision involving similar claims and reflects a growing wave of litigation challenging “zero sugar” and “sugar-free” labeling on products containing allulose. The plaintiff seeks class certification, monetary relief, and changes to product labeling and advertising. A copy of the complaint can be found here.
Conagra Faces Suit Over ‘0g Added Sugar’ Keto Label Claims
September 18: A proposed class action filed in the U.S. District Court for the Northern District of Illinois alleges that Conagra Brands falsely marketed certain Duncan Hines Keto Friendly baking mixes as containing “0g Added Sugar Per Serving” despite including 4 to 5 grams of allulose per serving. The complaint argues that allulose is a sugar under FDA regulations and that the labeling misled consumers into overpaying for the products marketed as having no added sugar. A copy of the complaint can be found here.
Federal Court Enters Consent Decree Against Gold Star Distribution
September 23: The U.S. District Court for the District of Minnesota entered a consent decree of permanent injunction against Gold Star Distribution, Inc. and its owner, Bassam Abu Samrah, following repeated findings by the FDA of severe rodent and pest infestations and other insanitary conditions at the company’s warehouse. The order prohibits the company from receiving, storing, or distributing FDA-regulated products, including food, drugs, medical devices, and cosmetics, until it complies with federal requirements and court-mandated corrective actions. The complaint, filed by the U.S. Department of Justice on behalf of the FDA, states that products were held under conditions that could lead to contamination, injury and adulteration. More information can be found here.
This Regulatory Update covers information from September 2026. 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.