• 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.
  • Yesterday, FDA’s Center for Veterinary Medicine (CVM) released the results of its evaluation of the Food Additive Petition (FAP) and GRAS Notification (GRN) review programs. The evaluation was launched in August 2024 and included soliciting public comments, conducting 14 external engagement sessions, holding internal CVM staff interviews, and analyzing feedback across program areas. 
  • CVM announced that it is implementing “several targeted process improvements” that aim to “deliver faster, more predictable outcomes for submitters.” These are summarized in the evaluation summary and include the following commitments:
    • Improve clarity on disclosure and confidentiality requirements during meetings with notifiers.
    • Update internal best practices to improve consistency and reduce reviewer burden.
    • Implement earlier review timelines which will communicate any issues to notifiers earlier in the process.
    • Create a second amendment opportunity during the GRN review process.
    • Publish a Program Policy and Procedures Manual (PPM) with a GRN timeline.
    • Expand data flexibility, including extrapolation of data across species, where appropriate.
    • Collaborate with the International Cooperation for the Convergence of Technical Requirements for the Assessment of Feed Ingredients (ICCF) to improve alignment with international standards.  
  • CVM published PPM 1244.3425: Animal Food Generally Recognized as Safe (GRAS) Notice Evaluation Timeline to address commitment #5. The document is intended to turn an informal understanding on the review timeline into a publicly available commitment. The timeline in the document includes a 30-day pre-filing evaluation, a response letter within 215 days of filing if there is no second amendment, and a response letter within 270 days of filing if there are two amendments (each amendment corresponds to a round of CVM questions). Therefore, the document contemplates that all reviews will be completed within a maximum of 300 (calendar) days (30 days pre-filing + 270 days post-filing).
  • Plaintiffs’ lawyers are continuing to file class action lawsuits alleging that “zero sugar” claims on products containing allulose are misleading consumers, with products ranging from dietary supplement gummies to candies to baking mixes being hit in the past week.
  • As we have previously blogged, FDA has stated its intent to exercise enforcement discretion for the exclusion of allulose from the amount of total and added sugars on the label. However, a recent federal court decision in Illinois found that because allulose is considered a sugar, its inclusion in a product precludes the product from being labeled with claims such as “zero sugar” or “no added sugar.”
  • Allulose is a monosaccharide that is used as a sugar substitute in various foods and beverages and that meets the definition of “sugar” in FDA’s nutrition labeling regulations at 21 CFR 101.9(c)(6)(ii). However, in FDA’s enforcement discretion guidance, the Agency explained that because allulose does not behave like other sugars in the body, it does not need to be declared as a sugar or added sugar. In FDA’s regulations governing the use of nutrient content claims for the calorie content of foods at 21 CFR 101.60, “sugar free” and “no added sugar” type claims may be made if, among other requirements, the food contains less than 0.5 g of sugar or no amount of sugars, respectively.
  • The recent lawsuits allege that reasonable consumers take the claims at face value and “wouldn’t know that allulose is an added sugar.” According to the plaintiffs, because allulose meets FDA’s definition of “sugar,” products containing the sweetener do not qualify for these claims.
  • One complaint references FDA’s enforcement discretion guidance but notes that the discretion “creates no rights and binds neither the agency nor the public” and is “pending a rulemaking that never occurred.” The plaintiff further alleges that FDA confirmed in an amicus brief in the decision cited above that the definition of sugar includes allulose and that “[a]n agency’s decision not to enforce its own regulation is not a federal ‘requirement’ . . . and it does not authorize a nutrient content claim that the regulation forbids.” Therefore, according to the plaintiff, FDA’s enforcement discretion does not permit companies to make such claims on products containing allulose.
  • Keller and Heckman will continue to report on lawsuits targeting sugar claims on products containing allulose.
  • Representative Diana Harshbarger (R-TN) recently introduced the Dietary Supplement Innovation Act (H.R. 10336), legislation that would amend the Federal Food, Drug, and Cosmetic Act’s drug preclusion provisions. The bill is intended to encourage dietary supplement innovation and preserve consumer access to ingredients that may otherwise be excluded from the supplement market due to prior or ongoing drug development activities.
  • Under the proposal, an ingredient would no longer be automatically precluded from use in food or dietary supplements if all Phase 2 or Phase 3 clinical investigations involving the substance have been inactive, withdrawn, or both for at least seven continuous years, or if the sponsor has publicly announced the discontinuation of drug development activities. This provision is designed to prevent abandoned pharmaceutical development programs from indefinitely blocking the marketing of ingredients as dietary supplements.
  • The legislation directs FDA to consider factors such as route of administration, dosage, concentration, composition, and safety differences when determining whether a substance marketed as a dietary supplement should be treated the same as a drug for preclusion purposes.
  • The bill has received backing from several major dietary supplement trade associations, which have criticized FDA’s interpretation of drug preclusion as overly restrictive. If enacted, the legislation could significantly reshape the relationship between dietary supplement regulation and pharmaceutical development by creating a clearer pathway for certain ingredients to remain available to consumers while preserving FDA’s authority over active drug development programs.
  • Keller and Heckman will continue to monitor legislative and regulatory developments related to drug preclusion and dietary supplement ingredient eligibility.