• On January 15, 2026, Senator Dick Durbin reintroduced the Dietary Supplement Listing Act of 2026 (S.3677), which would require dietary supplement manufacturers to register their products with the U.S. Food and Drug Administration (FDA).  Currently, FDA has authority to regulate dietary supplements under the Dietary Supplement Health and Education Act (DSHEA), though registration with FDA is not required under DSHEA.
  • Senator Durbin previously pushed for a mandatory product listing in 2022 and 2024, though both bills ultimately failed to pass Congress.
  • In Senator Durbin’s press release, he stated that, “FDA—and consumers—should know what dietary supplements are on the market and what ingredients are included in them. This is FDA’s most basic function, and the first step to protecting consumers.” 
  • The press release went on to state the following regarding the supplement industry: “More than 75 percent of American adults use a dietary supplement. However, no product is without risk. In 2023, FDA received more than 2,000 adverse event reports related to dietary supplements. However, due to significant underreporting, FDA has estimated the actual annual number of adverse events is more than 50,000. Over the last 30 years, annual dietary supplement sales increased from $4 billion to more than $50 billion.”
  • The Council for Responsible Nutrition (CRN) has expressed its support for the proposed legislation, stating that the bill marks “a significant milestone in CRN’s years-long effort to modernize oversight of the dietary supplement marketplace through a federal dietary supplement registry.”  The bill was also backed by, Consumer Federation of America, United States Pharmacopeia, and United States Public Interest Research Group.
  • Keller and Heckman will relay any updates related to the proposed legislation.
  • A class-action lawsuit was filed against 7Tabz on January 23, 2026, for alleged false and deceptive marketing practices related to the sale of what Plaintiff describes as “kratom” products.  Specifically, the complaint (Law360 Subscription required) alleges that the company conveys that “the Products are natural, safe, and suitable for ingestion” by “prominently displaying plant imagery and natural flavor descriptors,” when in fact there is a significant risk of addiction and toxic effects from consumption of the product.
  • The Plaintiffs characterize the main ingredient of the 7Tbaz products as “kratom,” but the product packages included in the complaint do not use the word “kratom.” Instead, they advertise the products as a source of 7-hydroxymitragynine (7-OH), which is an opioid-like chemical found in the kratom plant. However, online materials indicate that the 7Tabz products are kratom extracts (7-OH is also synthetically produced) and that they are also advertised as kratom products (e.g., “Experience fast-acting, ultra-potent kratom extract” and “great-tasting kratom experience”).
  • FDA has taken the position that Kratom products are adulterated when used in conventional food or dietary supplements (see e.g., FDA and Kratom | FDA). However, in July 2025, FDA commissioner Dr. Makary indicated that the focus on the agency is “not on Kratom” but “on 7-OH” (see also “We’re not targeting the Kratom leaf or ground-up kratom. We are targeting a concentrated synthetic product that is an opioid.”).
  • FDA also voluntarily dismissed a long-running seizure civil forfeiture action against a company selling kratom products earlier this month and its news release related to 7-OH similarly indicates that the agency intends to target products with concentrated 7-OH, but that it is “not focused on  natural kratom leaf products.”
  • Jocko Fuel (Law360 subscription required) has been sued for allegedly falsely marketing its protein shake products as containing only “premium protein and functional ingredients” that are tested for safety despite being contaminated with or at risk of being contaminated with unsafe levels of cadmium.  
  • According to the complaint, the product’s labels bear statements such as “meets the highest standard” and “Third Party Tested: Integrity is non-negotiable.” In addition, the defendant “specifically lists the ingredients in the Product on the labeling; however, Defendant fails to disclose that the Product contains, or is at risk of containing, cadmium.”
  • The complaint states that independent testing found that the product purchased by the plaintiff is contaminated with cadmium, causing it to be unsafe for consumption. According to the plaintiff, they would not have purchased the protein shakes if they had been aware that they contain cadmium.
  • Keller and Heckman will continue to monitor this and other litigation related to food labeling and safety.
  • FDA has released its Human Foods Program 2026 Priority Deliverables, outlining a broad set of planned regulatory, policy, and scientific initiatives the agency intends to focus on over the coming year.
  • Key areas identified in the 2026 agenda include:
    • Post-Market Review of Chemicals: FDA indicates that it intends to expand and formalize post‑market safety reviews of chemicals already used in food and food contact applications. Planned activities include continued reassessments of substances of consumer concern and further development of FDA’s systematic post‑market assessment framework and internal review capacity.
    • Food additive and GRAS: FDA signals a significant focus on reforming how substances that are Generally Recognized as Safe (GRAS) are handled. Planned deliverables include proposed regulatory changes, guidance, or procedural updates intended to strengthen FDA’s oversight of food additives, clarify data expectations, and increase transparency within the GRAS notification process.
    •  Nutrition-related initiatives: References planned work to advance nutrition science and public health research, including efforts related to ultra‑processed foods (UPFs).
    • Food labeling and standards: Planned deliverables include continued work on labeling modernization and consumer information initiatives. FDA highlights potential actions related to front‑of‑package nutrition labeling, implementation and evaluation of the “healthy” claim, and policies addressing nutrients of public health concern such as sodium, added sugars, and caffeine, as well as updates to food standards of identity.
  • Additional program areas identified in the 2026 priorities include infant formula oversight, dietary supplement regulation, chemical and environmental contaminants in food (such as microplastics), and other scientific and operational initiatives within the Human Foods Program.
  • Overall, the 2026 Priority Deliverables provide insight into the areas FDA expects to prioritize within the Human Foods Program. The list serves as a general planning signal rather than a definitive roadmap and the scope, timing, and completion of individual deliverables may evolve based on resources, emerging public health needs, and other factors. Keller and Heckman will continue to monitor developments related to FDA’s Human Foods Program priorities and implementation.
  • On January 1, 2026, major restrictions to the Supplemental Nutrition Assistance Program (SNAP) went into effect in Indiana, Iowa, Nebraska, Utah, and West Virginia.  These five states were granted waivers from the U.S. Department of Agriculture (USDA) to restrict what foods can be purchased with the federal food aid benefits, such as candy and soda.  Similar restrictions are set to take effect later this year in at least ten other states, though the types of restricted products differ by jurisdiction.
  • On December 30, 2025, USDA published a policy memo that clarified compliance requirements for retailers serving SNAP customers, reiterating that retailers have a 90-day grace period to comply with a state’s waiver once it is effective.  After the grace period, noncompliant retailers will receive a warning letter triggering a 30-day compliance window, after which noncompliance could result in a loss of the ability for the retailer to accept SNAP payments.
  • However, US grocers are wary of USDA’s enforcement plan.  The National Grocers Association (NGA) and National Association of Convenience Stores (NACS) sent a letter to USDA’s Food and Nutrition Service (FNS), requesting additional clarification on the policy memo and urging USDA “allow for a reasonable margin of error and to ensure that inadvertent, minor mistakes, such as those resulting from labeling changes, seasonal products, or products that fall within ambiguous or overlapping category definitions, do not trigger punitive actions.”
  • The letter warns that the agency has failed to fully consider the complexities retailers face in complying with the new regulations.  The letter requests a six-month period between corrective guidance and formal warnings to give retailers time to fix any outstanding issues, as well as additional guidance regarding Universal Product Code (UPC) lists and definitions.
  • Keller and Heckman will continue to monitor developments related to SNAP.
  • Today FDA announced that it has issued a pre-publication version of a request for information (RFI) regarding labeling and prevention of cross-contact of gluten in packaged foods.
  • FDA’s action is in response to a citizen petition that asks FDA to take certain steps to better protect consumers with celiac disease and other sensitivities or intolerances from exposure to gluten (from wheat, barley, rye, and oats) in the diet. The petition itself asks FDA to (1) undertake rulemaking to require that all ingredients with gluten be listed by name in the ingredient lists of all foods, and (2) add gluten to the list of allergens in Section 555.250 of FDA’s Compliance Policy Guide entitled “Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens.”  
  • The RFI includes requests for information on prevalence, severity, and potency of reactions to non-wheat containing gluten products (wheat is already a major food allergen), data and information on gluten in oats (which the petitioner asserts is often contaminated with gluten from other grains), and data and information on undisclosed ingredients of interest (i.e., ingredients which may be labeled in a way that does not reveal the gluten-containing source).
  • We note that celiac disease itself is not an IgE-mediated food allergy, and in contrast with IgE-mediated reactions, it elicits a delayed hypersensitivity reaction. See e.g. Celiac disease | Food Allergy Research & Resource Program | Nebraska.
  • USDA’s Food Safety and Inspection Service (FSIS) has also shown increased awareness of gluten in the food supply and its latest version of FSIS Directive 7230.1 (“Ongoing Verification of Product Formulation and Labeling Targeting the Nine Most Common (‘Big 9’) Food Allergens”), published in September 2025, adds gluten as an ingredient for which FSIS will be verifying that establishments are accurately controlling and labeling.
  • Comments on FDA’s RFI will be due 60 days after the date of publication in the Federal Register (with publication expected tomorrow, January 22, 2026).  
  • The World Health Organization (WHO) has updated its manuals on strengthening surveillance of and response to foodborne diseases, which support countries in building, assessing, and strengthening national foodborne disease surveillance and response systems.
  • There are four manuals, including an introductory manual, a two-part stage one manual on detecting and investigating foodborne illness events and outbreaks, a stage two manual on strengthening surveillance, and a stage three manual on integrating surveillance data to better understand risks across the food chain. The manuals include tools to assist national authorities in developing their surveillance and response systems and “describe how to integrate laboratory data, environmental assessments, food chain information, and public health investigations.”
  • The manuals were first published in 2017. The updated versions reflect emerging priorities in the food system, including the impact of climate and environmental change on foodborne risks. They are intended to both support national capacity and improve the effectiveness of the global food safety network.
  • Keller and Heckman will continue to monitor developments related to food safety.
  • On January 14, 2026, President Donald J. Trump signed the Whole Milk for Healthy Kids Act of 2025.  This initiative sought to revise requirements for milk provided by the National School Lunch Program of the Department of Agriculture (USDA) to align with the most recent Dietary Guidelines for Americans.
  • The 2025-2030 Dietary Guidelines for Americans was published on January 7, 2026, and the recommendations included a departure from low-fat and fat-free dairy to emphasis full-fat dairy as part of a balanced diet, as we previously blogged.
  • Notably, the Act amended Section 9(a)(2) of the Richard B. Russell National School lunch Act to permit schools to offer 2% milk and whole milk in addition to low-fat and fat-free milk.  This Act supersedes 7 CFR 210.10(d)(1)(i) which only permitted schools to offer fat-free or low-fat milk options. The Act also allows lactose-free milk as well as nondairy beverages that are “nutritionally equivalent” to fluid milk to be offered, such as fortified plant-based milks.
  • Additionally, the Act exempts milk fat in any fluid milk from being calculated as part of the saturated fat content limit of 10 percent of total calories in a school lunch.
  • That same day, the USDA issued program implementation guidance to schools. 
  • As of now, the Act appears to only affect lunches provided by schools, not breakfasts.  Keller and Heckman will continue to monitor and report on USDA regulations related to the Whole Milk for Healthy Kids Act of 2025.
  • On January 13, 2026, FDA announced that the Canadian Food Inspection Agency (CFIA) has updated data requirements for official certificates for imports of FDA-regulated products that contain bovine-, porcine-, or poultry-derived ingredients.
  • CFIA is now requiring the following additional information to be included on an FDA-issued “Certificate to a Foreign Government” (CFG) destined for Canada:
    • Complete name and address of the manufacturer/processor.
    • Complete legal name and physical address of the exporting company.
  • Additional information on the CFIA requirements for CFGs from FDA can be found at can be found at Food Export Library | FDA.
  • Celestial Seasonings, Inc. has been sued (Law360 subscription required) for allegedly falsely advertising its herbal teas as having “All Natural” flavors despite containing citric acid.
  • The complaint targets five specific herbal teas marketed by Celestial Seasonings that are labeled as “Naturally Flavored with Other Natural Flavors” with additional label statements that the company “blends its ‘teas from the finest ingredients with no artificial flavors or colors.’” According to the complaint, Celestial Seasonings also makes several claims on its website related to its ingredients, including “[t]he natural flavors we use are derived from real ingredients and do not contain artificial or synthetic additives.”
  • However, the complaint says that the ingredient list for each of the five teas includes citric acid, which is primarily synthesized using Aspergillus niger, rather than being extracted from fruits and vegetables. The complaint alleges that Celestial Seasonings adds citric acid to its teas as a flavoring agent, rather than as a preservative. Further, according to the plaintiff, because citric acid is listed separately from “natural flavors” in the ingredient list, it is implied to be manufactured, rather than natural, citric acid.
  • Notably, under 21 CFR 101.22(i), a product should bear the characterizing flavor statement “naturally flavored with other natural flavors” where it contains a both characterizing flavor derived from the product whose flavor is simulated and other natural flavor which simulates, resembles, or reinforces the characterizing flavor.
  • Products containing citric acid but labeled as “natural” or containing no artificial ingredients are often targets of similar class action lawsuits, as we have blogged. Keller and Heckman will continue to monitor litigation related to food labeling.