• On October 8, 2026, the U.S. Food and Drug Administration (FDA) issued draft guidance addressing the exemption for small retail food establishments (RFEs) and restaurants under Section 1.1305(i) of the Food Traceability Rule.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  • FDA also noted in its press release of the draft guidance that it is actively considering additional flexibilities for regulated entities and will hold a public meeting on November 6, 2026, to discuss implementation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.
  • 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.