• On October 19, 2026, FDA released a final guidance document titled “New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI” (Safety Guidance). The Safety Guidance finalizes various sections of the general revised draft guidance on NDI Notifications (General Guidance) (updated in October 2026 to reflect the Safety Guidance).
  • The Safety Guidance is in a question-and-answer format and details the information that manufacturers and distributors should provide in a new dietary ingredient notification (NDIN) and specifically finalizes the following sections of the General Guidance:
    • General Guidance Section VI.A, Identity Information about the NDI and the Dietary Supplement:
      • Finalized as Section IV in the Safety Guidance, this section details the type of identity information that should be included in an NDIN, including the name of the ingredient and its specifications. The Safety Guidance provides further information on what is needed to identify certain ingredients such as salts, covalently modified derivatives of dietary ingredients, botanicals, metabolites, enzymes, ingredients produced by fermentation, and live microbial ingredients.
    • General Guidance Section VI.B, History of Use or Other Evidence of Safety:
      • Finalized in Sections VI and VII in the Safety Guidance, these sections describe the type of information needed to demonstrate an NDI’s safe history of use. FDA recommends a period of at least 25 years of widespread use when relying on history of safe use alone. The Safety Guidance recommends citing to published articles, providing examples of sufficient documentation to establish history of safe use. Other evidence of safety could include things like genetic toxicity tests, animal studies, and human studies. This type of evidence is needed when there is not sufficient history of safe use to support the NDIN. The Safety Guidance further details characteristics of a quality study.
    • General Guidance Section VI.C, Summary of the Basis for Your Conclusion of Safety:
      • Finalized in Section V in the Safety Guidance, this section explains what safety information is required, including what should be included in the “safety narrative.” The safety narrative should contain an “objective evaluation of the history of safe use or other evidence of safety, along with an explanation of how the evidence of safety provides a basis” to conclude the NDI is reasonably expected to be safe. It should include an estimated daily intake of the substance, as well as describe the function of each non-dietary ingredient.
  • Under the Dietary Supplement Health and Education Act of 1994, dietary supplement manufacturers generally do not need FDA premarket approval before marketing a product. However, unless a limited exception applies, manufacturers must submit an NDIN at least 75 days before marketing a dietary supplement containing a dietary ingredient that was not marketed in the United States before October 15, 1994. The notification must contain information supporting the manufacturer’s conclusion that the ingredient can reasonably be expected to be safe under the recommended conditions of use.
  • FDA issued its last major revision to the General Guidance in 2016. Since then, industry and stakeholders have submitted nearly 2,000 public comments, and FDA has issued a series of guidance documents addressing discrete aspects of the NDIN process, including notification procedures and master files. This new Safety Guidance continues the Agency’s phased approach of finalizing discrete sections of the General Guidance.
  • Keller and Heckman will continue to monitor developments related to FDA’s evolving NDIN framework and will provide updates as additional guidance and policy developments become available.
  • The U.S. Food and Drug Administration’s (FDA) proposed rule on infant formula nutrient requirements has advanced to the White House Office of Information and Regulatory Affairs (OIRA) for review. According to the OIRA docket, the proposal, titled “Infant Formula Nutrient Requirements,” was received for review on October 14, 2026, and is being developed as an economically significant proposed rule.
  • The proposed rule is a key component of the Trump Administration’s Operation Stork Speed initiative, launched in 2025 to reevaluate the nutrient composition of infant formula marketed in the United States. As part of that effort, FDA issued a request for information (RFI) seeking data on infant health outcomes, the adequacy of existing nutrient requirements, and whether adjustments to current minimum and maximum nutrient levels may be warranted.
  • Although the contents of the proposed rule have not yet been released publicly, administration officials have previously identified infant formula composition as an area of interest. Public statements by HHS leadership have highlighted concerns around ingredients such as corn syrup solids and seed oils, for example.
  • Any significant revisions to infant formula nutrient requirements could have substantial implications for manufacturers, including potential reformulation efforts, ingredient sourcing considerations, supply chain impacts, and associated costs.
  • While FDA has not announced a publication date, completion of OIRA review is generally one of the final steps before publication of a proposed rule.
  • Keller and Heckman will continue to monitor developments related to FDA’s infant formula modernization efforts and will provide updates as additional information regarding the proposal becomes available.
  • On October 8, 2026, the U.S. Food and Drug Administration (FDA) issued draft guidance addressing the exemption for small retail food establishments (RFEs) and restaurants under Section 1.1305(i) of the Food Traceability Rule. Established under the Food Safety Modernization Act (FSMA), the Food Traceability Rule imposes additional recordkeeping requirements for establishments that manufacture, process, pack, or hold foods on FDA’s Food Traceability List (FTL). Congress has pushed enforcement of the final rule to July 2028 following concerns raised by industry stakeholders about the time needed to implement the rule’s requirements.
  • Under the current rule, small RFEs and restaurants with average annual food sales of no more than $250,000 over the prior three years are exempt from the Food Traceability Rule’s additional traceability record requirements. If finalized, the guidance provides FDA with “enforcement discretion for all requirements in the Food Traceability Rule for RFEs and restaurants that have an average annual monetary value of food sold or provided during the previous 3-year period of greater than $250,000 but no more than $1,000,000 (on a rolling basis),” adjusted for inflation (emphasis added). The proposed enforcement discretion was written in response to compliance “challenges” brought to FDA’s attention by small RFEs and restaurants following the issuance of the final rule in 2022.
  • FDA also noted in its press release of the draft guidance that it is actively considering additional flexibilities for regulated entities and will hold a public meeting on November 6, 2026, to discuss implementation challenges and potential modifications to lot-level food traceability requirements.
  • Keller and Heckman will continue to monitor updates related to FDA’s Food Traceability Rule.
  • Earlier this month FDA announced ten planned activities to mitigate and prevent future Cyclospora outbreaks. The announcement coincides with the conclusion of the investigation of a multistate outbreak of Cyclospora infections linked to iceberg lettuce.
  • The activities include the planned publication of an outbreak investigation report regarding the recent Cyclospora outbreak in iceberg lettuce, which will include factors contributing to the contamination and recommendations to prevent future outbreaks; increased surveillance of commodities historically associated with Cyclospora; increased public outreach to educate growers on practices to comply with food safety requirements and reduce the risk of Cyclospora contamination; increased collaboration with food regulatory authorities in Mexico; and leveraging foreign supplier verification program (FSVP) inspections to ensure that importers are considering Cyclospora contamination as part of their hazard analysis and supplier verification.
  • Most cyclospora outbreaks originate from imported foods as the disease-causing organism, Cyclospora cayetanensis, is not endemic to the U.S. C. cayetanensis is a single-celled coccidian protozoan parasite, the lifecycle of which requires a human host to grow and reproduce (CDC – DPDx – Cyclosporiasis). Feces containing the organism can contaminate the environment, including food and water, although it is passed in feces in an unsporulated oocyst form which is not infective until it sporulates. The incubation period is typically one week and symptomatic infections typically take the form of watery diarrhea.
  • On October 13, 2026, FDA issued a final rule to permit the use of salt substitutes in foods with standards of identity (SOI) that specify salt (sodium chloride) as a required or optional ingredient. The final rule does not enumerate specific salt substitutes but instead generally allows ingredients to be used as salt substitutes in standardized foods.
  • The final rule is intended to support “efforts to reduce sodium content in standardized foods and may help to improve consumer dietary patterns by reducing sodium consumption.” FDA explained that the rule will provide the potential for ingredient flexibility to reduce sodium content in the food supply, which will in turn serve as a step to reduce diet-related chronic disease risk, including hypertension, heart disease, and stroke.
  • In FDA’s responses to comments on the proposed rule, the Agency explains that the final rule amends 80 SOI directly, as well as an additional 59 SOI through cross-reference for a total of 139 SOI foods that will now be permitted to use salt substitutes.
  • In addition to amending SOI to permit salt substitutes, FDA added a section to 21 CFR Part 130 to define salt substitute to mean “a safe and suitable ingredient (or combination of safe and suitable ingredients) that is used to replace some or all of the added salt (sodium chloride), to reduce sodium in the food, and that serves the function of salt in the food.”
  • Keller and Heckman will continue to report on developments related to FDA’s sodium reduction goals.
  • 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.