• On June 22, 2025, Texas Governor Greg Abbott signed SB 25 into law to require on-pack warning labels for food and beverage products that contain any of the substances listed within the bill, including titanium dioxide and FDA approved food colors such as Red 40. As we previously reported, the Texas House passed SB 25 on May 26, 2025, with bipartisan support and backing from the Department of Health & Human Services Secretary Robert F. Kennedy, Jr.
  • The law adds Sections 431.0815, 431.0816, and 431.0817 to Subchapter D, Chapter 431 of the Texas Health and Safety Code. The law requires companies to either remove or place a warning label “in a prominent and reasonably visible location” on any product that contains any of the 44 listed substances. The warning label must read: “WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom.” This requirement applies to food product labels “developed or copyrighted” on or after January 1, 2027. In addition to seeking an injunction, the Attorney General may impose a civil penalty of up to $50,000 per day for each individual food product that violates this requirement.
  • Notably, the law includes a federal preemption provision (Section 431.0817) that should limit the law’s impact on warning label requirements. The provision states that a warning label is not required if FDA or USDA have (1) prohibited the use of the ingredient, (2) imposed conditions on the use of the ingredient (including the requirement of a warning or disclosure statement), or (3) determined an ingredient or class of ingredients is safe for human consumption by federal law or regulation promulgated by the FDA. A warning label is also not required if a federal law or regulation requires a labeling statement relating to ultra-processed or processed foods. This language was included in SB 25 following an amendment made by Representative Gary VanDeaver.
  • Based on the federal preemption provision’s language, if FDA has implemented a regulation authorizing the use of an ingredient, it will not require a warning label. For example, sodium hydroxide (also known as lye) is generally recognized as safe (GRAS) as a direct human food ingredient by FDA (21 CFR 184.1763). Sodium hydroxide is also approved for use in the European Union, United Kingdom, Australia, and Canada.
  • The law will take effect on September 1, 2025. Keller and Heckman will continue to monitor and post updates on similar state legislation requiring ingredient disclosures or labels.
  • On June 18, 2025, FDA announced its proposed “method for post-market assessments of chemicals in the food supply.” This “Post-market Assessment Prioritization Tool” will give chemicals an overall score that will be used to rank each post-market chemical assessment in order of priority. We previously reported on FDA’s proposed systematic process for post-market assessment of chemicals in foods, which had its comment period extended to January 21, 2025.
  • According to FDA’s proposed method, a chemical’s overall score will be calculated from a Multi-Criteria Decision Analysis (MCDA) which will use four Public Health Criteria and three Other Decisional Criteria. The Public Health Criteria are toxicity, change in exposure, effects on a susceptible subpopulation (e.g., children), and availability of new scientific information. The Other Decisional Criteria are external stakeholder attention, other government decisions, and public confidence in the U.S. food supply.
  • The total score of the Public Health Criteria is given equal weight to that of the Other Decision Criteria, as they both get a score of 1-9 and then the two are averaged to calculate the chemical’s overall score. FDA’s press release points to how the Environmental Protection Agency (EPA) similarly prioritizes certain substances for risk evaluation, though notably the EPA criteria are already specified in the Toxic Substances Control Act (TSCA) § 2605(b)(1)(B) and are “without consideration of costs or other nonrisk factors.”
  • The proposed prioritization method will be open to public comments until July 18, 2025 under Docket No. FDA-2025-N-1733. In a departure from past practice, there is no Federal Register notice announcing the establishment of this docket for receipt of public comments, only a link in FDA’s announcement to the docket on www.regulations.gov.  By way of contrast, see FDA’s August 2024 Federal Register notice announcing a public meeting and soliciting public comment on FDA’s Post-Market Assessment of Chemicals in Food (89 Fed. Reg. 65633, Aug. 12, 2024). 
  • Keller and Heckman would be happy to prepare comments and we will continue to monitor and relay updates on FDA’s post-market review process.
  • On June 10, the House Appropriations Committee released the full committee markup of Fiscal Year 2026 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Bill. A summary of the bill can be found here.
  • The bill puts forth the proposed 2026 budget for several federal agencies including the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). Currently, the bill provides roughly $6.7 billion for FDA and $22 billion for USDA.
  • The act highlights restrictions on how the allocated money can be spent and what the money can be spent on. For example, FDA is prohibited from promoting any new guidelines or regulations applicable to food manufacturers for Listeria monocytogenes until FDA considers the available new science in updating Compliance Policy Guide (CGP), Sec. 555.320. FDA is also prohibited from developing new long-term guidelines on sodium reduction until it considers the impact of its short-term sodium reduction targets.
  • The bill also clarifies that until the compliance date of the new healthy rule (February 25, 2028), industry may rely on either the previous or the new requirements, and that states are preempted from enacting any different requirements.
  • Among the provisions related to animal feed, the bill provides that all ingredients listed in the AAFCO Official Publication Chapter 6 are GRAS unless FDA has made a contrary determination. Separately, FDA would be directed to develop standards for “natural” claims for animal food.
  • The bill also places protections on the hemp industry by forbidding the use of any funds allocated by this act to prohibit the “transportation, processing, sale, or use of hemp … within or outside the State in which the hemp is grown or cultivated.”  It would also narrow the definition of “hemp” to cover only products with a total tetrahydrocannabinol (THC) concentration of not more than 0.3% on a dry weight basis (as opposed to the current definition’s focus only on the delta-9 THC content).
  • This bill is, of course, subject to change as the appropriations process moves ahead. Keller and Heckman will continue to monitor activities involving FDA’s funding for FY26.
  • U.S. Secretary of Agriculture Brooke Rollins is continuing to approve waivers that allow states to prohibit certain food items from qualifying under the Supplemental Nutrition Assistance Program (SNAP). In May 2025, we reported that Nebraska received the first-ever waiver that allows the state to restrict the purchase of certain “junk” foods and beverages, such as candy and soda. Five additional states have now received SNAP waiver approvals, including Arkansas, Idaho, Indiana, Iowa, and Utah.
  • Idaho and Indiana restrict the purchase of both soft drinks and candy, while Utah only restricts the purchase of soft drinks. Arkansas—in addition to restricting soft drinks and candy—also restricts the purchase of fruit and vegetable drinks with less than 50% natural juice and “unhealthy drinks.” With the exception of Arkansas whose implementation date is July 1, 2026, SNAP restrictions in other states begin on January 1, 2026.
  • The language of Iowa’s SNAP waiver is unique in that it “restricts all taxable food items as defined by the Iowa Department of Revenue except food producing plants and seeds for food producing plants.” Some of the taxable food items that will face restrictions include candy, chewing gum, carbonated and non-carbonated soft drinks, sweetened naturally or artificially sweetened water, and dried fruit leathers.
  • Several other states, including Colorado, Louisiana, Montana, Texas, and West Virginia, have submitted SNAP waivers to prohibit the purchase of certain food and beverage items and are pending approval. Arizona and Kansas had also introduced legislation to restrict SNAP funding for certain products, but both bills have been vetoed.
  • Keller and Heckman will continue to monitor developments related to SNAP.
  • On June 10, 2025, FDA Commissioner Marty Makary and FDA CBER Director published an article in JAMA that listed their “priorities for a new FDA.” These priorities included accelerating drug development, using AI for scientific review, “healthier food for children,” “harnessing big data,” and reducing patient costs.
  • The JAMA article pointed to FDA’s “phase-out” of synthetic food dyes as an example of the agency already taking action to address an “increasingly chemically manipulated diet” in the US. As a practical matter, FDA has of yet not taken any regulatory action with respect to synthetic colors (outside of Red No. 3). The article also called attention to a hastily assembled FDA Expert Panel on Talc that occurred on May 20, and stated that FDA had started working to define ultra-processed foods (UPFs).
  • The FDA’s prioritization of AI reviews follows the recent launch of its new generative AI tool “Elsa,” which is part of Commissioner Makary’s initiative to use AI throughout the agency by June 30. According to the JAMA article, FDA has already completed its first AI-assisted scientific review. However, the New York Times reported that the new AI tool was far from perfect, as it is limited in the number of characters it can review and sometimes hallucinates and produces false information.
  • Separately, Regulatory Focus, an online news publication, reported that Commissioner Makary sent an agency-wide letter to FDA staff on June 11 announcing his plans to “centralize and enhance key operational functions.” This would include consolidating various departments such as human resources, acquisitions, and communications.

Keller and Heckman will continue to monitor FDA regulatory developments.

  • Yesterday, the U.S. Food and Drug Administration (FDA) unveiled two educational videos and a supplemental fact sheet to help the dietary supplement industry with the New Dietary Ingredient Notification (NDIN) review process. These educational materials are the latest release among several resources the FDA has put forth since the 1997 Final Rule: Premarket Notification for a New Dietary Ingredient. The full list of resources for the NDIN process can be found here.
  • The NDIN review process follows the Federal Food, Drug, and Cosmetic Act (the FD&C Act) requirement that manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” notify the FDA about these ingredients (subject to a narrow exception).
  • The new supplemental fact sheet lists 5 commonly observed issues FDA sees manufacturers and distributors make during the NDIN submission process. FDA hopes highlighting these issues will make it easier for manufacturers and distributors to successfully file an NDIN and avoid delays or negative responses that often follow submission issues.
  • The new educational videos titled, “Important Aspects of the NDIN Process” and “Correspondence Between FDA and the Notifier,” work together to provide an overview of the entire NDIN process. The first video, “Important Aspects of the NDIN Process,” walks through what an NDIN should and should not include, and common mistakes made during the NDIN submission process. The second video, “Correspondence Between FDA and the Notifier,” explains what the notifier can expect following the submission of an NDIN.
  • Keller and Heckman will continue to monitor developments related to the NDIN process.
  • Yesterday, the New York Times reported that the FDA, in collaboration with USDA and other government agencies, plans to establish a new definition of “ultraprocessed foods” (UPFs) that will be released over the next “coming months.” The article reports that FDA will seek public comment on the definition, but it is not clear as to the regulatory pathway FDA will take in proposing a definition (e.g., rulemaking or guidance).
  • The article comes the same day as FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, director of FDA’s Center for Biologics Evaluation and Research (CBER), published “Priorities for a New FDA,” indicating that FDA has “begun work on defining ultraprocessed foods.” However, the report does not offer any timeline for agency action.
  • Per the New York Times article’s quotes attributed to Dr. Makary, FDA does not seek to ban ultraprocessed foods, but rather to define them “so that markets can compete based on health.” Dr. Makary predicts that the new UPF definition will encourage food manufacturers to entice customers by touting their food products as “non-ultraprocessed.”  
  • FDA’s reported plans for a new UPF definition are not surprising given that the Make America Healthy Again (MAHA) Commission recently acknowledged the absence of a “single, universally accepted definition of UPFs” in its MAHA Report.
  • A new UPF definition could have a broad impact on federal and state regulation. For example, it could restrict foods covered under the Supplemental Nutrition Assistance Program (SNAP) and encourage states to harmonize the patchwork of UPF definitions found in state laws, proposed and passed.
  • Keller and Heckman will continue to monitor developments related to UPFs.
  • On June 2-4, 2025, the World Health Organization (WHO) hosted a series of webinars celebrating World Food Safety Day 2025. Leading voices from WHO and other institutions discussed the role of science in food safety progression as part of the theme of this year’s campaign, “Food Safety: Science in Action.”
  • During a webinar that discussed the role of science in protecting public health, panelists emphasized the need to create systems that can “credibly” and “rapidly” turn scientific evidence into meaningful impact. For example, Dr. Moez Sanaa from the Department of Nutrition and Food Safety at WHO said that “the next step is action, creating rules and systems that are flexible enough to handle new things like lab-grown meat or new ways of testing food safety without animals.”
  • Panelists also discussed the importance of science and data in informing our understanding of food safety hazards. Dr. Pamela Byrne, the vice chair of the EFSA Management Board and the former Food Safety Authority of Ireland CEO, emphasized the need to revise existing regulatory frameworks to meet evolving food safety risks. As a next step, she said that institutions should utilize more “food consumption data, monitoring, and surveillance to understand how people are exposed to different food safety hazards.” Specifically, she said that we should consider whether what we know about risk allows our regulatory frameworks to be “fit for purpose for the future.”
  • Further, panelists said that in assessing risk, it is important to consider the impact on the population where a hazard is occurring. For example, in Mediterranean countries, the population understands hazards related to sun exposure in the middle of the day, whereas in countries like Poland, the population is more aware of hazards related to poisonous mushrooms in the forest that do not become a risk until added to a plate. To address uncertainty, according to the panelists, we must “creat[e] a framework that is predictable, that has some level of flexibility, but is anchored with risk analysis principles.”
  • The WHO Alliance for Food Safety also emphasized its continued commitment to advance the role of science in developing food safety measures. Specifically, the Alliance aims to integrate “foodborne diseases into national surveillance systems, foster collaboration and capacity across laboratories, and improve data sharing and awareness.”
  • On Thursday, May 29, 2025, Judge John J. Tharp, Jr. at the U.S. District Court for the Northern District of Illinois filed an order granting Chobani’s motion to dismiss a class action lawsuit that alleged “Chobani Zero Sugar” yogurt was misbranded. Chobani’s yogurt contained allulose, a naturally occurring monosaccharide found in figs and raisins, which the plaintiffs argued made any “zero sugar” or “no sugar” claims misleading and deceptive.
  • In its defense, Chobani cited to the Temporary Marketing Permit (TMP) granted by FDA authorizing to the sale of its “Zero Sugar” yogurt that contained “nonnutritive sweeteners.” The Company also referenced FDA Guidance in which FDA stated the agency is exercising enforcement discretion by excluding allulose from the amount of “Total Sugars” on product labels.
  • FDA based its decision on data that showed allulose does not promote cavities, produces a negligible increase in glycemic and insulinemic responses, and substantially reduces the number of total calories in products in which it replaces added sugars.
  • The Court agreed with Chobani that though the guidance is nonbinding, it still represents FDA’s interpretation of how allulose is regulated under 21 C.F.R. § 101.9(c)(6)(ii). This view of the regulation is controlling if it is not “plainly erroneous” or inconsistent with the regulation itself. Because of this, the Court concluded the plaintiff’s claims are expressly preempted by federal law since allulose is not a sugar under the allulose guidance.
  • Keller and Heckman will continue to monitor litigation trends related to product labeling and marketing claims.
  • Earlier this year a bipartisan group of California lawmakers introduced AB 1264, which directs the California Office of Environmental Health Hazard Assessment (OEHHA) to define “ultra-processed foods” (UPFs) and phase out identified prohibited foods from school meals beginning January 1, 2028. The bill also targets certain additives from being used in schools, including Red 40.  The bill broadly defines UPFs as foods that contain one or more of certain functional ingredients, such as colorants, flavorings, sweeteners, emulsifiers, and thickening agents.
  • If passed, beginning July 1, 2035, the bill would prohibit schools from offering meals that include “particularly harmful ultra-processed foods,” and from “selling food or beverages . . . containing those particularly harmful ultra-processed foods,” except for food items sold as part of a school fundraising event.
  • AB 1264 would also require vendors to report the total quantity of food product sold to schools and identify whether the product is “particularly harmful.” OEHHA must submit a report to the California legislature with “recommendations for state and local legislative actions that could reduce the consumption of ultra-processed foods and particularly harmful ultra-processed foods in schools.”
  • As we’ve previously reported, multiple states have proposed bans on various food additives and “ultra-processed foods.”
  • The bill is currently before the California Senate. Keller and Heckman will continue to monitor and relay any legislative updates in this area.