• 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.
  • Today, September 17, 2026, the U.S. Food and Drug Administration (FDA) released its 2026 FDA Food Code, which provides a model set of food safety regulations for retail and food service that state, local, tribal, and territorial agencies may adopt and implement in their own jurisdictions.  The last Food Code edition was released in 2022.
  • According to FDA’s press release, the 2026 Food Code is intended to improve public safety with updates such as “an exception to allow for double gloving under specific circumstances; a new requirement for written employee illness policies that are maintained and available; and the establishment of an alternative cooling process for foods at retail.”  It also addresses various food safety topics like “sanitizer temperatures, consumer advisories, revised food establishment definition, new mobile food establishment definition, allergen cross-contact clarification… and updates to the food establishment inspection report form.”  Each of the changes can be reviewed more closely at FDA’s Summary of Changes.
  • The Food Code is updated on a biennial cycle to reflect advances in food safety science, regulatory practice, and emerging industry trends.  In drafting the Food Code, FDA receives input from the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), the Centers for Disease Control and Prevention (CDC), and the Environmental Protection Agency (EPA).
  • Keller and Heckman will continue to monitor and relay food regulatory updates.
  • Executive Order (EO) 14425, “Supporting America’s Ranchers” was issued on September 4, 2026, and orders several agency reviews which are intended to develop laws and policies to help American ranchers. The EO notes that the national beef herd is at a 75-year low and that consumer demand for beef has grown by almost 10% over the past decade.
  • The EO orders the Secretary of Agriculture, in consultation with the U.S. Trade Representative (USTR), to “review all statutory and regulatory authorities that may permit the establishment of mandatory country-of-origin labeling for beef products” within 90 days. It also provides that regulations may be issued or amended to require mandatory beef country-of-origin labeling consistent with the resulting report, or else that legislative recommendations regarding such labeling be developed. Mandatory country-of-origin labeling for beef was repealed in 2015 after the World Trade Organization (WTO) determined that such labeling violated US WTO obligations.
  • Among other things, the EO also more broadly orders the Secretary of the Interior, the USTR, the Commissioner of Food and Drugs, and the Administrator of the Small Business Administration to submit a report to the President that assesses all agency actions “affecting ranchers and that provides recommendations for action to promote financial viability and enhanced market access for American ranchers.”
  • Keller and Heckman will monitor and report on proposed changes to mandatory country-of-origin labeling.
  • Another cereal company has been hit with a lawsuit (Law360 subscription required) for labeling its product using the claims “0g total sugars,” “0g added sugar” and “no added sugar” despite containing allulose. According to the lawsuit, Magic Spoon is “healthwashing” its cereal product, or making the product appear healthier than it is, by making these claims.
  • The lawsuit was filed in Illinois, where the Seventh United States Circuit Court of Appeals in June found that allulose is considered a sugar under federal regulations, as we previously blogged. According to the Court in that decision, because the inclusion of allulose in the calculation of sugars would cause the sugar content to exceed the “less than half a gram of sugar” requirement for a “sugar free” label, the product at issue—yogurt—did not qualify to use the claim.
  • Here, the plaintiff alleges that Magic Spoon’s labeling indicates that the cereals contain between five and ten grams of allulose per serving, depending on flavor. Thus, according to the plaintiff, the products do not qualify for a “sugar free” or “0g Total sugar” claim.
  • Notably, FDA has stated that it intends to exercise enforcement discretion for the exclusion of allulose from the amount of “total sugars” and “added sugars” on the label.
  • Keller and Heckman will continue to monitor this lawsuit and others that target sugar claims on products containing allulose.
  • The European Food Safety Authority (EFSA) has completed its re-evaluation of the food additive salt of aspartame-acesulfame (E 962), concluding that its authorized uses do not raise safety concerns. E 962 is used in a variety of sugar-free and reduced-calorie foods and beverages and dissociates into aspartame (E 951) and acesulfame K (E 950) after ingestion.
  • The opinion is notable because it follows years of debate regarding the safety of aspartame, including the International Agency for Research on Cancer’s 2023 classification of aspartame as “possibly carcinogenic to humans.” That determination generated significant media attention and renewed scrutiny of artificial sweeteners. More recently, aspartame has been identified in a number of U.S. food policy initiatives, including Louisiana’s ingredient disclosure law and discussions surrounding ultra-processed foods and food additive reform.
  • However, in its re-evaluation, EFSA reviewed newly available human and animal studies on cancer, cardiovascular disease, diabetes, developmental effects, neurotoxicity, and other health endpoints, and found no basis for changing its previous safety conclusions.
  • EFSA confirmed the acceptable daily intake (ADI) for aspartame of 40 mg/kg body weight per day and relied on the recently revised ADI for acesulfame K of 15 mg/kg body weight per day.  According to the agency, dietary exposure estimates for all age groups remain below these limits.
  • Although EFSA identified no safety concerns, the Panel recommended updates to EU specifications for E 962 and a review of arsenic and lead limits in specifications for aspartame (E 951).
  • Keller and Heckman will continue to monitor developments related to sweetener safety assessments.
  • On August 31, 2026, more than 250 food retailers signed a letter to the United States Department of Agriculture (USDA)  to delay its implementation of its final rule on Updated Staple Food Stocking Standards for Retailers in the Supplemental Nutrition Assistance Program (SNAP) by six months.
  • If no action is taken, USDA’s new policy is set to go into effect on November 4 and key changes include:
    • Increase in required varieties: Retailers must now stock at least seven varieties in each of the four staple food categories, up from three.
    • Updated definition of “variety”: USDA has issued detailed guidance regarding what constitutes a distinct variety within each staple food category. For example, different dairy products such as milk, yogurt, cheese, and infant formula may count as separate varieties, and certain categories have been further subdivided.
    • Perishable food requirement: Retailers must offer at least one perishable variety in at least three of the four staple food categories.
    • Minimum stocking units remain: Each qualifying variety must still be stocked in the required minimum quantities, and retailers must maintain the required inventory on a continuous basis.
    • Accessory foods excluded: USDA clarified that certain products, including snack bars, jerky, cheese dip, fruit spreads, butter, and similar items, do not count toward the staple food stocking requirements, even though they may remain SNAP-eligible for purchase.
  • Historically, retailers generally needed to stock at least three varieties of staple foods in each of the four staple food categories (fruits/vegetables, dairy, protein, and grains/breads), while also meeting minimum stocking quantity requirements for each qualifying item.
  • On September 4, 2026, USDA published new guidance and examples illustrating compliant stocking configurations.  USDA also stated additional guidance is forthcoming.
  • A coalition of Plaintiffs, including non-profit organizations and unions representing USDA employees, filed suit against USDA and USDA Secretary Rollins in the U.S. District Court for the Northern District of California, alleging that USDA’s planned reorganization is unlawful.
  • The lawsuit alleges that USDA sought congressional authorization for the reorganization and was expressly rejected but nevertheless proceeded with the reorganization plan. It also alleges that the reorganization was arbitrary and capricious because the decisions were made without any analysis of their impact on the agency’s functions and ability to meet its statutory mandates. It alleges that the reorganization plan, which relocates offices, anticipates that many employees will not relocate and is intended to reduce the size of the USDA workforce.
  • Plaintiffs filed another lawsuit, AFGE v. Trump, No. 25-cv-03698-SI (N.D. Cal.), earlier this year which more broadly challenged the Trump administration’s reorganization of the federal government. This lawsuit was filed after the court presiding that case determined that the USDA reorganization claims should be brought as a separate suit.
  • Keller and Heckman will continue to monitor and report on USDA’s reorganization and any challenges to it.