• The U.S. District Court of the Western District of Texas issued a preliminary injunction last week blocking enforcement of Section 9 of Texas Senate Bill 25, which requires food manufacturers to include the following conspicuous warnings for 44 listed ingredients, subject to certain exceptions: “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.”  We have previously blogged about the bill and the challenge to it.
  • The Court held that the Section 9 warning requirement was a content-based regulation of speech and therefore was subject to strict scrutiny requiring the government to show that the law is “justified by a compelling government interest and is narrowly drawn to serve that interest.”  Texas, which had argued that intermediate scrutiny should be applied, did not meet this burden. The Court also indicated that the law would have failed intermediate scrutiny, in part because the law did not directly advance the state interest in supporting the health and well-being of its citizens, nor was it narrowly tailored to serve the government interest (e.g., the government could have conducted an advertising campaign to promote public health). 
  • The Court, however, declined to hold that the confusing preemption provision in Section 9 is unconstitutionally vague. That provision establishes various conditions under which the warning would not be required, including when a law or regulation issued by the U.S. Food and Drug Administration “determines an ingredient or class of ingredients is safe for human consumption.” This preemption provision seems to nullify Section 9’s warning requirement with respect to any of the listed ingredients that are the subject of an FDA food additive regulation or GRAS regulation. The Court also held that Plaintiffs had not met their burden with respect to their argument that Section 9 was preempted by the Federal Food, Drug, and Cosmetic Act, and the Nutrition Labeling and Education Act.
  • On February 15, 2026, Health and Human Services Secretary Robert F. Kennedy Jr. appeared on 60 Minutes, along with former FDA Commissioner Dr. David Kessler, to discuss plans to reform the so-called “generally recognized as safe (GRAS) loophole.”
    • In 1958, Congress amended the Federal Food, Drug, and Cosmetic Act to define the term “food additive.” Congress specifically excluded GRAS substances from the definition of “food additive” because such substances are “generally recognized, among experts qualified by scientific training and experience to evaluate [their] safety, as having been adequately shown . . . to be safe under the conditions of [their] intended use.”
    • Under the 1958 amendments, firms can make a GRAS determination without notifying FDA that a substance meets the requirements of the statute and regulations. Even under a “self-determined” GRAS position, a substance is still subject to the same safety standard as a food additive, i.e., “reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use.” 21 CFR 170.3.
  • Kennedy stated that the GRAS exemption was “hijacked by the [food] industry” and used to introduce “thousands upon thousands” of ingredients into the U.S. food supply. He repeated the common misperception that there are only 400 food ingredients permitted in Europe, while estimates show that there are between 4,000 and 10,000 ingredients used in food in the U.S. Further, according to Kennedy, “[t]here is no way for any American to know if a product is safe if it is ultraprocessed.”
    • The “10,000” number originates from a 2011 research paper that overestimated the total number of substances used in food in the U.S., including pesticides, processing aids, and food contact materials and counted many substances more than once. On the other hand, the “400” number represents only a subset of food additives with an “E number” used in the European Union and does not include food contact materials, flavors and flavor preparations, colors from food, processing aids, pesticide residues, novel foods and foods grandfathered under the novel food regulation, i.e., those from before 1997. When counting the same categories of substances permitted in the U.S. and Europe, the numbers are similar. See “Debunking the U.S.-EU ‘Additive’ Divide: 10,000 Falsehoods.”
    • As mentioned above, all substances used in food in the U.S. are subject to the same safety standard, regardless of whether they are subject to a food additive regulation, GRAS regulation, GRAS notification, or self-determined GRAS position. 
  • Kessler stated that the prevalence of ultraprocessed foods in the American diet is “as large, if not larger” of a public health crisis compared to tobacco. He discussed his pending citizen’s petition calling for FDA to revoke the GRAS status of several processed refined carbohydrates, stating that certain ingredients are “subject to industrial processing” so that “our system can’t handle it.” Specifically, he called out corn syrup, corn solids, maltodextrin, dextrose, xylose, and high fructose corn syrup. Each of these ingredients is recognized as GRAS in the U.S.
  • Regarding Kessler’s petition, Kennedy stated that FDA intends to take action to answer its questions and review GRAS ingredients.
  • On February 11, 2026, Sen. Padilla introduced SB 1033, which would establish new state-level testing and heavy metal disclosure requirements for bulk and packaged protein products sold in California.
  • If passed, commencing on January 1, 2028, manufacturers of bulk protein products or packaged protein products being sold into the state would be required to test a representative sample of each lot of product for heavy metals (arsenic, cadmium, lead, and mercury) and provide results to the California Department of Public Health.  Brand owners would be required to publicly disclose lot-specific heavy metal testing results on their websites.  Additionally, on-package and online statements would be required, directing consumers to the testing information.
  • In Sen. Padilla’s press release, he cites to various reports finding unsafe levels of heavy metals in protein products, noting that, “[d]espite these risks, protein powders and protein beverages remain largely unregulated at the federal level.”  While FDA regulates dietary supplements under the current good manufacturing practice regulations, manufacturers are responsible for ensuring that their products meet specifications before they are released to the market.
  • Keller and Heckman will continue to monitor the legislative process and provide any relevant updates.
  • On February 3, 2026, Rep. Mike Lawler introduced the GRAS Oversight and Transparency Act, which, if passed, would require a newly-created Board to review all “covered GRAS designations.” 
  • “Covered GRAS designations” are defined in the bill as substances that were designated by their manufacturers as generally recognized as safe (GRAS) prior to 2000.  Voting members of the Board would include the Secretary of Health and Human Services, the Secretary of Agriculture, and other staff members from those agencies; a toxicologist from the Environmental Protective Agency; a representative from the food manufacturing industry; and an academic expert in food toxicology.
  • If passed, manufacturers would need to identify “covered GRAS designations” within 90 days.  The Board would then assign each substance to one of three categories based on its priority for review.  The Board would be required to notify the Secretary and Congress of any determination that a substance has not been shown to be safe within 90 days of completing the review.
  • The issue of GRAS substances has been the center of recent state and federal-level action.  As we’ve previously blogged, FDA sent a proposed rule related to GRAS to the Office of Management & Budget (OMB) in December of 2025, but the timing, scope, and substance of the rulemaking remain uncertain.  Additionally, states continue to pursue their own regulatory approaches, raising the potential for a more fragmented compliance landscape.
  • Keller and Heckman will continue to report on developments regarding GRAS designations.
  • On February 10, 2026, FDA announced the launch of a “comprehensive re-assessment of butylated hydroxyanisole (BHA)” to “consider whether BHA is safe under its current conditions of use in food and as a food contact substance.” On February 11, the Agency published a request for information (RFI) in the Federal Register on the current uses and safety of BHA in human food and as a food contact substance.
  • BHA was initially added to the List of Select Chemicals in the Food Supply Under FDA Review in August 2025. BHA is currently used in food and food contact applications as an antioxidant, subject to specified limitations, based on a variety of regulatory pathways including GRAS listings, food additive authorizations, and prior sanctions. These are detailed in the RFI.
  • FDA’s press release announcement linked above takes a more negative tone than the Federal Register notice. 
  • The RFI lists 12 specific areas in which FDA seeks information, generally concerning the use, use levels, dietary exposure, and safety of BHA used in food and as a food contact substance. Responses to the RFI are due by April 13, 2026.
  • A New York federal judge has dismissed a lawsuit (Law360 subscription required) claiming that Dunkin’ falsely advertised its “Refresher” beverages as containing real fruit. According to the judge, menu labels such as “mango pineapple” describe flavors, not ingredients.
  • The lawsuit, filed in December 2024, alleged that Dunkin’s menu represented that the company’s seven fruit-flavored beverages contained the represented fruits, arguing that “the presence of fruit in the Products is central to [their] identity.” However, the plaintiff contended that the products do not in fact contain any juice from the named fruits, but instead are formulated to “mimic the flavor of the represented fruits with ‘Flavor Concentrates’ made predominantly from water and sugar.”
  • According to the judge, the plaintiff failed to plausibly allege a claim because the “menu board contains no language to suggest the Products are ‘made with’ the actual fruits for which they are named.” Instead, the menu board lists only the available flavors, the option to add green tea or coconut milk to the products, and a photo of the beverage with no indication that the products are made with or otherwise contain real fruits.
  • Similarly, the judge dismissed claims for breach of warranty because the plaintiff “failed to plausibly allege that the defendants misrepresented the products.” Rather, according to the judge, the plaintiff relied on “the bare conclusion” that the products contain real fruit based solely on their names on the menu board.
  • Keller and Heckman will continue to monitor litigation related to food labeling.
  • State‑level scrutiny of the Generally Recognized as Safe (GRAS) framework continues, with recent legislative activity in both New York and New Jersey signaling sustained interest in chemical disclosure and food additive oversight.
  • In New York, Senate Bill S01239, the Food Safety and Chemical Disclosure Act, was introduced in January 2025 during the 2025–2026 legislative session and has since been amended and advanced through multiple committees.
    • It would prohibit certain specified food additives in products sold in New York and impose state‑level reporting requirements for substances manufacturers determine to be GRAS, while limiting reliance on FDA GRAS recognition as a defense in state enforcement actions. Although S01239 passed the New York Senate in June 2025, it stalled in the Assembly and was returned to the Senate at the start of the 2026 legislative year. Momentum resumed this week, when the Senate again passed the bill on February 5, 2026, sending it back to the Assembly for renewed consideration.
  • In New Jersey, a parallel proposal has also reemerged. Senate Bill S3277, which would require food manufacturers to disclose certain new food additives that have not been reported to the FDA, was introduced in prior sessions under different bill numbers, including S4748 and A4640. Those earlier versions ultimately failed to advance before the close of the legislative session. The bill was formally re‑introduced on February 2, 2026.
    • New Jersey’s S3277 focuses on disclosure and reporting obligations to the Department of Health rather than prohibitions on specific additives. The bill would require annual reporting for new GRAS determinations, including intended use, safety data, and the basis for the GRAS conclusion.
  • It remains unclear how these state‑level initiatives will ultimately intersect with federal action. As we’ve previously blogged, FDA sent a proposed rule related to GRAS to the Office of Management & Budget (OMB) in December of 2025, but the timing, scope, and substance of the rulemaking remain uncertain. In the interim, states continue to pursue their own regulatory approaches, raising the potential for a more fragmented compliance landscape.
  • Keller and Heckman will continue to monitor developments at both the state and federal level related to GRAS.
  • On February 5, 2026, FDA announced via a letter to food manufacturers that the Agency intends to exercise enforcement discretion regarding certain voluntary claims relating to the absence of certified colors used in foods intended for human consumption.
  • Specifically, FDA does not intend to take enforcement action if the following claims are made on labels or labeling of foods that do not contain colors listed in 21 CFR Part 74:
    • “Made without artificial food colors/colorings”
    • “No artificial color/colors/coloring”
    • “No added artificial color/colors/coloring”
  • This differs from FDA’s prior position in which all color additives, even if derived from natural sources, are considered “artificial,” as described in Compliance Policy Guide Section 587.100 (Label Declaration of Certification-Exempt Color Additives) and Use of the Term Natural on Food Labeling. The new approach is intended to align with FDA’s Make America Healthy Again (MAHA) agenda. According to FDA Commissioner Marty Makary, “calling colors derived from natural sources ‘artificial’ might be confusing for consumers and a hindrance for companies,” so the enforcement discretion will make it “easier for companies to use these colors in the foods our families eat every day.”
  • In addition to the new approach on artificial color claims, FDA announced that the Agency approved two new color additive petitions:
    • The clearance for spirulina extract is being expanded to permit use in foods generally, except for infant formula, certain foods regulated by USDA, and foods subject to a standard of identity unless such use is authorized by the standard. In addition, the specifications for heavy metals are being lowered and a specification for cadmium is being added.
    • Beetroot red will now be permitted for use in foods generally, except for infant formula, certain foods regulated by USDA, and foods subject to a standard of identity unless such use is authorized by the standard
  • Finally, FDA issued an additional letter “reminding manufacturers of their responsibility to ensure color additive safety.”
  • Keller and Heckman will continue to monitor updates related to FDA’s regulation of color additives.
  • The U.S. Department of Justice (DOJ) filed a lawsuit against the State of Michigan on January 22, 2026, alleging that Michigan’s ban on the sale of eggs produced by hens that do not meet certain animal welfare standards is preempted by the federal Egg Products Inspection Act (EPIA).
  • The Michigan law, among other things, requires Michigan farmers to house hens in cage-free housing systems. Businesses selling eggs are expected to obtain written confirmation from their suppliers that the eggs were produced in environments that comply with the Michigan law.
  • Notably, the DOJ lawsuit does not challenge the authority of Michigan to impose housing requirements for animals raised within the state, but rather only challenges the sales ban, applicable to eggs produced out of state, which it argues “impermissibly imposes standards of quality and condition on eggs themselves” which creates “additional, or different requirements for what constitutes safe, wholesome, and unadulterated eggs entering interstate commerce.”
  • A similar lawsuit was filed against California last year. In contrast to these lawsuits which are based on statutory preemption arguments, the failed challenge to California’s Proposition 12 in National Pork Producers Council v. Ross (2023) was based on the argument that the state law impermissibly burdened interstate commerce, an argument based on an implicit restriction in the constitution referred to as the “Dormant Commerce Clause.”
  • On January 27, 2026, FDA announced the release of the Total Diet Study Interface (TDSi). The tool provides consumers access to findings from the Agency’s Total Diet Study, which monitors levels of nutrients and contaminants in foods eaten in the U.S.
  • The TDSi is intended to “underscore[] FDA’s commitment to transparency and continuous improvement in its food chemical safety programs” and is aligned with the Make America Healthy Again agenda. The tool includes:
    • Comprehensive data visualization through interactive graphics and charts;
    • Enhanced transparency through user-driven access to downloadable detailed analytical results;
    • Historical scope with complete datasets for nutrients and contaminants collected since 2018; and
    • Ongoing updates as additional data becomes available.
  • In addition to the TDSi, FDA released the most recent cycle of Total Diet Study data from the 2021 and 2022 fiscal years. The Total Diet Study is a monitoring program based on foods representing the average U.S. consumer’s diet. FDA intends for the TDSi to provide “critical data to assess cumulative exposure to various contaminants” and support the Agency’s food safety and nutrition oversight responsibilities.

Keller and Heckman will continue to monitor developments from FDA’s Human Foods Program.