• A food safety law firm recently released a draft citizen petition asking the U.S. Food and Drug Administration (FDA) to require warning labels on cheeses made with raw milk, following multiple outbreaks linked to these products in recent months. 
  • The petition points to multiple outbreaks of foodborne illnesses linked to raw-milk cheese starting in 2024, including the most recent E. coli outbreak from Sierra Nevada Cheese Company’s aged raw milk cheddar and jack cheeses.
  • Currently, FDA prohibits the interstate sale of raw milk and raw milk products, though certain soft-ripened cheeses made with unpasteurized milk may enter interstate commerce if they have been cured higher than 35 degrees F for at least 60 days.  The petition suggests that consumers are entitled to labeling that explains this exemption.
  • Specifically, the petition requests the following from FDA:
    • Require the warning for all raw-milk cheese, domestic or imported;
    • Complete its 2015 reevaluation of the 60-day aging requirement for raw-milk cheese; and
    • Publish its delayed raw-milk cheese sampling data
  • The firm requests public input on the draft citizen petition by October 15, 2026, before submitting to FDA.  Keller and Heckman will continue to monitor any developments related to raw milk and raw milk products.
  • Yesterday, FDA’s Office of Coordinated Outbreak Response, Evaluation, & Emergency Preparedness (CORE+EP) released its annual report summarizing outbreaks of foodborne illness and certain adverse events in FDA-regulated human foods. The office’s “CORE” team responds to acute outbreaks and certain adverse events, while the “EP” team is focused on food defense, traceability, and supply chain monitoring activities not necessarily linked to an acute outbreak or adverse event. The report highlights that CORE-EP played a central role in policy-related activities and implementation of FDA’s food defense rule at 21 CFR Part 121.
  • The investigations summarized in the report were conducted in collaboration with the Centers for Disease Control (CDC) as well as state and local partners. CORE-EP maintains a table of its investigations, both active and closed. The table does not include outbreak investigations related to shellfish (managed by FDA’s Division of Seafood Safety), animal food (managed by CVM), or USDA regulated products. The largest portion of the 26 outbreak responses that were initiated by CORE in 2025 stemmed from produce vegetables (35% of responses), followed by multi-ingredient foods (29% of responses).
  • This year CORE-EP launched “Executive Incident Summary (EIS) Abstracts,” which provide high level summaries of the steps taken by the Response Team. CORE-EP also published two “Foodborne Outbreak Overview of Data (FOOD) Reports,” which provide information on food-pathogen pairs that have been linked to repeated outbreaks of foodborne illness. Other CORE publications related to its outbreak investigations can be found at CORE Publications | FDA.
  • Keller and Heckman will continue to monitor outbreaks of foodborne illness and FDA’s response to them.  
  • Starbucks is being sued over its “sugar-free” protein beverages (Law360 subscription required), which plaintiffs claim are deceptively labeled due to containing 13 to 21 g of sugar per venti-size beverage from naturally occurring lactose in milk.
  • According to the plaintiffs, Starbucks is misleading consumers seeking to reduce or avoid sugar by labeling its beverages as “sugar-free” despite containing up to 25 times the amount of sugar permitted in a product making that claim. In accordance with 21 CFR 101.60(c)(1), a “sugar-free” claim may only be made on a food that contains less than 0.5 g of sugar per reference amount customarily consumed.
  • The plaintiffs cited the recent Franco v. Chobani decision, in which the court determined that allulose is a sugar in accordance with FDA regulations, as we have previously blogged. There has been a large uptick in lawsuits targeting products that contain allulose and make “sugar-free” or “zero sugar” claims, highlighting the interest in these claims. Here, the products do not contain any allulose. According to the complaint, lactose’s status as a sugar is even more clear than allulose because FDA expressly lists lactose as a sugar in 21 CFR 101.9(c)(6)(ii).  Starbucks says the sugar in the protein drinks comes from the protein-boosted milk and Starbucks does not add sugar but uses a sugar-free syrup for flavor.
  • The complaint also alleges that Starbucks violates the mandatory calorie disclaimer for a food labeled as “sugar-free,” but clarifies that the “case is about false and misleading product names.”
  • Keller and Heckman will continue to report on lawsuits targeting sugar claims.
  • The U.S. Food and Drug Administration (FDA) announced on September 30, 2026, a nationwide effort to recruit scientific experts, technical professionals, and consumer representatives to serve on FDA advisory committees. The agency simultaneously published two Federal Register notices seeking nominations for current and anticipated vacancies across its advisory committee system.
  • FDA advisory committees provide independent recommendations on complex scientific, technical, and public health issues involving FDA-regulated products, including foods, dietary supplements, tobacco products, medical devices, biologics, and pharmaceuticals. Committee members may include physicians, researchers, statisticians, patient advocates, and consumer representatives who review evidence and provide nonbinding recommendations to the agency.
  • According to FDA, nominees for scientific and technical voting-member positions should possess subject matter expertise relevant to one or more advisory committees, the ability to evaluate complex scientific information, and the capacity to provide objective and independent advice. Consumer representatives are expected to have experience with consumer or community organizations and the ability to assess risks, benefits, safety, and effectiveness from a public-interest perspective. Self-nominations are permitted, and members may serve terms of up to four years.
  • The announcement may be of interest to food industry stakeholders given the relatively limited use of food-related advisory committees in recent years compared to other FDA-regulated product areas. Although FDA did not announce the creation of any new food advisory committees, the agency’s broad recruitment effort could expand opportunities for external scientific and consumer participation in future food policy discussions.
  • Keller and Heckman will continue to monitor developments related to FDA advisory committees and other initiatives affecting agency decision-making and stakeholder engagement.
  • Governor Newsom has signed California’s AB 2244, which creates the country’s first voluntary non-ultraprocessed food certification program. 
  • By June 1, 2029, the California Department of Public Health (CDPH) must develop a system to accredit independent certification agents that can certify food products as “Non-Ultraprocessed Certified.”  The “Non-Ultraprocessed Certified” seal (proposed previously to be “California Certified”) may only be used for foods that do not qualify as an ultraprocessed food (UPF), UPF of concern, or a restricted food, as defined by California’s UPF standards introduced in 2025.
  • The program will allow certified products to display the seal on their packaging and will require manufacturers to recertify their products every three years.  CDPH must create and maintain a public database of these certified products.
  • Under the law, retailers with more than 25 individual non-UPF-certified product types and who generate more than $10 million in sales annually will be required to prominently display products with the seal.  Earlier versions of the bill included tighter mandates for how these products are displayed and promoted, but these were removed from the final version.
  • Governor Newsom signed AB 2244 along with other legislation that promote a “holistic healthcare strategy,” including AB 2030 (prohibiting the sale of over-the-counter diet pills or dietary supplements for weight loss or muscle building to persons under 18) and SB 869 (requiring disclosures on restaurant menus for high added sugar content).
  • Keller and Heckman will continue to monitor and report on developments in food-related legislation.
  • Lawmakers from both the House and Senate sent a letter to USDA Secretary Brooke Rollins on September 17, 2026, demanding that the Agency account for the shuttering of the majority of USDA’s Cyclospora research. Cyclospora contamination was the cause of the recent-multi state food-borne illness outbreak linked to iceberg lettuce.
  • The letter, citing a recent Politico story, states that three research programs, which represent nearly all of the Cyclospora research at USDA, are on hold or have been terminated. The research was being conducted at the Beltsville Agricultural Research Center (BARC) in Maryland, which USDA plans to close as part of its reorganization plan.
  • The letter disputes USDA’s funding cuts justification for two of the programs and states that USDA had represented to Congress that the research would continue despite the funding cuts. The third research program is on hold, reportedly because all the researchers involved do not intend to relocate to a new facility in Iowa.
  • The letter requests that USDA immediately reverse its decision to “dismantle Cyclospora research at BARC” and asks USDA to answer questions related to the research, the closure of BARC, and the plan to relocate staff to Iowa.
  • Vive Organic Inc. (Law360 subscription required) has been sued for allegedly deceptively marketing its wellness shots as “immunity boosting” and “doctor crafted” despite a lack of evidence that the product can protect against infection or illness.
  • According to the plaintiff, the product labels bear the words “immunity boost” and “doctor crafted,” as well as an image of a stethoscope in a heart shape and images of three people labeled as doctors and dressed in lab coats. The plaintiff alleges that the marketing of the product is false and unsubstantiated because “no food or dietary supplement can ‘boost’ one’s immune system” and the company “has no medical evidence to substantiate” the representations.
  • The complaint states that Vive Organic only consulted with holistic practitioners and family medicine physicians, rather than immunologists, which misleads consumers regarding the expertise behind the product. The complaint further quotes an article from the American Association of Immunologists stating that immunity-boosting claims are often “too good to be true” and “not based on science or what is known about immune function.”
  • Keller and Heckman will continue to monitor lawsuits related to claims on food and dietary supplement products.
  • California continues to be a focal point for food and beverage regulation, with lawmakers advancing new disclosure and labeling requirements affecting restaurants, dietary supplements, and other FDA-regulated products.
  • On September 11, 2026, the California Legislature passed SB 869 and sent the measure to Governor Gavin Newsom for consideration. The bill would require chain restaurants and retail food establishments to include a warning label on menus for beverages containing more than 100% of the FDA Daily Value for added sugars. Under FDA nutrition labeling regulations, the Daily Value for added sugars is 50 grams per day for adults and children four years of age and older. 21 CFR 101.9(c)(9). As a result, beverages containing more than 50 grams of added sugar per serving would be subject to the proposed warning requirement.
  • Under the bill, covered beverages would be identified with an added sugar icon displayed clearly and conspicuously adjacent to the menu item. Restaurants would also be required to provide a statement explaining that the icon signifies the beverage contains or exceeds the total daily recommended limit for added sugar.
  • Seperately, on September 25, 2026, Governor Newsom signed AB 2779, which amends California’s food date labeling law to clarify that a “food item for human consumption” does not include a dietary supplement. The amendment modifies AB 660, which took effect on July 1, 2026 and generally requires packaged foods sold in California to use standardized date labeling phrases, including “Best if Used By” for quality-related dates and “Use By” for safety-related dates. As a result, dietary supplements are excluded from the law’s standardized date labeling requirements. The bill includes an urgency clause and became effective immediately upon the Governor’s signature.
  • Keller and Heckman will continue to monitor developments related to California food labeling, dietary supplement regulation, and menu disclosure requirements, including the status of SB 869 and implementation of AB 2779.
  • Governor Gavin Newsom made California the second state (after New York) to require disclosure of the use of synthetic performers in advertising when he signed SB 1050 on September 16. The law requires a “clear and conspicuous” disclosure whenever an advertisement “prominently” includes a performance by a “synthetic performer.” The law, chaptered as Bus. & Prof. Code § 17610, goes into effect immediately.
  • Under the law, a “synthetic performer” is any “digital figure, voice, or representation created in whole or in part using generative artificial intelligence” where the figure, voice, or representation creates a “realistic impression” of a “human performer who is not recognizable as any identifiable natural person.” Such a performer appears “prominently” when used “in the foreground and demonstrating or illustrating” a product or service, when providing a “narration or commercial message,” or when “illustrating or reacting to” the “narration or commercial message.” Advertisers must disclose their use of generative AI to produce a prominent performance with language “substantially similar to ‘this performance features a synthetic performer’ or ‘no human performer is depicted.’”
  • Failing to include the required disclosure constitutes a violation of California’s False Advertising Law, Bus. & Prof. Code § 17500, et seq. A private right of action for enforcement likely exists under California’s Unfair Competition Law, Bus. & Prof. Code § 17200 et seq.
  • The law also requires advertising media to cease transmission of any advertisements determined by a court to have violated the law once the media are served with a copy of the order making the determination.
  • Keller and Heckman will continue to report on legislative developments regulating the creation and dissemination of advertising, whether using generative artificial intelligence or otherwise.
  • On September 21, 2026, the U.S. District Court for the District of Minnesota ordered Minnesota-based Gold Star Distributions, Inc. and its owner to stop distributing FDA-regulated products until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other federal legal requirements. The consent decree follows a 2025 FDA investigation that found persistent insanitary conditions, including severe rodent and pest infestations that risked contaminating food, drugs, cosmetics, and medical devices.
  • The complaint alleges that Gold Star stored FDA-regulated products in insanitary conditions that risked contamination. It further alleges that they failed to store drugs in accordance with current good manufacturing practice requirements.
  • Federal and state inspections repeatedly identified rodent infestations and insanitary conditions at Gold Star’s facility from 2013 through 2025. During a follow-up inspection in 2025, FDA found extensive rodent and pest activity, contaminated product packaging, and improper waste accumulation that threatened the safety of the FDA-regulated products. The Minnesota Department of Agriculture also issued a notice of embargo and cease and desist order on all food products and operations in November 2025, and revoked Gold Star’s wholesale license.
  • The consent decree requires that Gold Star correct sanitation, pest-control, storage, and structural deficiencies. Gold Star is also required to destroy all FDA-regulated products and pass inspections by independent experts and the FDA. Operations may resume only after receiving written FDA approval.