• On September 3, 2025, and in response to a food additive petition filed by Cargill, FDA published an expansion to the secondary direct additive clearance for hydrogen peroxide in 21 CFR 173.356. The previous version of Section 173.356 permitted the use of hydrogen peroxide as an antimicrobial agent in the production of modified whey at a level not to exceed 0.001% by weight of the whey. The revised version more broadly permits the use of hydrogen peroxide at levels consistent with GMP as an antimicrobial agent, oxidizing and reducing agent, bleaching agent, and to remove sulfur dioxide.
  • The revised regulation maintains the requirement to remove residual hydrogen peroxide. FDA does not expect the expanded uses authorized by the regulation to increase dietary exposure to hydrogen peroxide because of this removal requirement and the inherent instability of hydrogen peroxide.
  • FDA is also updating the regulation to cross-reference the specifications in the hydrogen peroxide monograph in the 14th edition of the Food Chemicals Codex (FCC) instead of the previously listed 7th edition. However, this is just a technicality, and the FCC monograph for hydrogen peroxide has not changed between editions.
  • Hydrogen peroxide is also affirmed as GRAS in 21 CFR 184.1366 for a variety of other uses. The GRAS affirmation was issued pursuant to 21 CFR 184.1(b)(2), which purports to require a food additive regulation for any extension of use.
  • Florida Natural Growers, Inc., was recently sued for allegedly falsely representing its Florida’s Natural orange juice products as being exclusively made from premium Florida orange juice despite being blended with juice from other countries. The plaintiff claims that Florida Natural knew that consumers would rely on Florida representations made on the label and be willing to pay more for Florida orange juice.
  • According to the complaint, labeling on the front of the package claiming “Owned by Florida Farmers” next to an American flag, as well as language on the side panel of the package about why the company is “different,” imply that the orange juice is made exclusively from Florida oranges. Further, the American flag is claimed to be an implied “Made in the USA” claim, which is regulated by the Federal Trade Commission and only permissible where “all or virtually all ingredients . . . are made and sourced in the United States.” 16 CFR 323.2.
  • The complaint also alleges that there is a strong connection between Florida and the citrus industry such that “consumers overwhelmingly preferred Florida orange juice” and are willing to pay a premium of approximately 50% for 100% Florida orange juice.
  • However, according to the plaintiff, because of a decline in citrus groves in Florida due to plant diseases, Florida Natural began including orange juice from Mexico and Brazil in its products beginning in 2022. Thus, the plaintiff claims, the claims on the orange juice label are misleading and deceptive.
  • Keller and Heckman will continue to monitor this case and other class action lawsuits related to food labeling.
  • The U.S. Food and Drug Administration (FDA) has announced a three-day virtual public meeting and listening session series focused on food allergen thresholds and their potential applications, scheduled for November 18–20, 2025.
  • Food allergies affect an estimated 32 million Americans, and even trace amounts of allergens can trigger severe reactions. To help consumers avoid unintended exposure, some food manufacturers voluntarily include allergen advisory statements (AAS), such as “may contain” or “produced in a facility that also processes” on product labels. However, there are currently no specific FDA requirements governing when or how AAS should be used.
  • A 2024 Food and Agriculture Organization (FAO) consultation panel recommended adopting the use of risk-based thresholds, which refers to a scientifically determined level of an allergenic substance below which the vast majority of allergic individuals are unlikely to experience an adverse reaction. While FDA has issued guidance documents addressing allergen risk assessment and management, it has not established or endorsed any specific threshold levels to date.
  • Registration for the public meetings is required for all sessions. While registration for the November 18 meeting will remain open until the event begins, those wishing to join the listening sessions must register by November 3, 2025.
  • Keller and Heckman will continue to monitor developments related to allergen thresholds.
  • Following Brazil’s first outbreak in May 2025, the European Union (EU) officially recognized the country as free from bird flu, beginning negotiations to resume chicken imports to the EU.  EU Commissioner for Animal Health and Welfare Oliver Varhelyi stated that Brazilian authorities had provided sufficient data to demonstrate the country’s bird flu-free status, which will allow EU member states to begin discussions to gradually lift the bans and restrictions on exports from Brazil.
  • Through June, the EU imported 125,300 metric tons (mts) of chicken meat from Brazil, which was a 20.8% year-over-year increase despite the restrictions.  Brazil is one of the world’s largest poultry exporters.  The outbreak in Brazil was the country’s first encounter with bird flu, prompting multiple countries to impose import bans as a precautionary measure.
  • Several countries have since lifted the import restrictions, although one of the major chicken importers, China, has maintained those trade restrictions.  The EU’s approach of gradually lifting restrictions reflects standard EU procedures for restoring trade relationships following animal health incidents.
  • Keller and Heckman will continue to monitor and report on food safety developments.
  • FDA announced a proposed order which would revoke the color additive authorization for the use of Orange B (21 CFR 74.250). The existing regulation permits its use in the coloring of casings or the surfaces of frankfurters and sausages at up to 150 ppm in the finished food.
  • The cited rationale for the order is abandonment. Orange B is a batch-certified color additive, requiring FDA to test and certify every batch prior to marketing. FDA indicates that it has not certified nor has received a request for certification for a batch of Orange B since 1978, and therefore concludes that the color additive is no longer used. The abandonment of the color additive also allows FDA to avoid much more cumbersome notice and comment rulemaking that would otherwise be required to revoke the authorization. FDA indicates that the proposed order is consistent with President Trump’s executive orders directing agencies to eliminate regulations determined to be unnecessary and/or burdensome.
  • Orange B is among the synthetic color additives the department of Health and Human Services (HHS) and FDA previously announced were to be phased out of the food supply. In those cases where FDA does not remove color additive authorizations from its regulations, the phase outs will be voluntary. 
  • Comments on the proposed order are due within 30 days (by October 17th).  FDA proposes that any final order based on today’s proposal be effective 45 days following its publication. 
  • California has passed Assembly Bill 1264 to define ultra-processed foods (UPF) and phase certain “UPFs of concern” out of school meals. The bill was introduced earlier this year by a bipartisan group of California lawmakers, as we previously blogged.
  • AB 1264 defines UPF as “any food or beverage that contains a substance described in paragraph (2) and either high amounts of saturated fat, sodium, or added sugar . . . or a nonnutritive sweetener or other substance . . . .” The substances in paragraph 2 include the following categories of ingredients:
    • Surface-active agents;
    • Stabilizers and thickeners;
    • Propellants, aerating agents, and gases;
    • Colors and coloring adjuncts;
    • Emulsifiers and emulsifier salts;
    • Flavoring agents and adjuvants; and
    • Nonnutritive sweeteners.
  • The bill clarifies that salt, sodium chloride, spices or other natural seasonings and flavorings, and natural color additives listed in 21 CFR Part 73 will not cause a food or beverage to be categorized as a UPF. In addition, the following are excluded from the UPF definition:
    • A commodity food specifically made available by the U.S. Department of Agriculture;
    • A raw agricultural commodity;
    • An unprocessed locally grown or locally raised agricultural product;
    • Minimally processed prepared foods, which may include foods in whole, cut, sliced, diced, canned, pureed, dried, and pasteurized forms;
    • Class 1 milk;
    • Alcoholic beverages;
    • Medical foods; and
    • Infant formula.
  • High amounts of saturated fat, sodium, or added sugar are defined to mean 10 percent or greater of total energy from saturated fat, a ratio of milligrams of sodium to calories equal to or greater than 1:1, and 10 percent or greater of total energy from added sugars. Nonnutritive sweeteners include those defined in 21 CFR 170.3(o)(19): D-sorbitol, erythritol, hydrogenated starch hydrolysates, sucralose, isomalt, lactitol, Luo Han fruit concentrate, maltitol, steviol glycosides, thaumatin, and xylitol.
  • The California Office of Environmental Health Hazard Assessment is directed in the bill to define “UPFs of concern,” which will be phased out of use in school foods by July 1, 2035. The department will consider factors such as whether the substance is banned or required to bear a warning label in other jurisdictions; is linked to adverse health consequences; is considered hyperpalatable or linked to food addiction; has been modified to be high in saturated fat, added sugar, or salt; meets the requirements for FDA’s definition of the term “healthy”; and is a common natural additive.
  • The bill is now awaiting a signature from California Governor Gavin Newsom. Keller and Heckman will continue to monitor this bill and other state legislation related to UPFs.
  • On September 12, 2025, the U.S. Food and Drug Administration (FDA) expanded its public health alert concerning ground cinnamon products after detecting elevated levels of lead in several brands. This action is part of the agency’s ongoing investigation into lead contamination in food, which now includes Jiva Organics ground cinnamon. Testing revealed that this product contained 2.29 parts per million (ppm) of lead.
  • This is the second expansion of a recall that was initiated on March 6, 2024, and subsequently expanded on July 25, 2024. 
  • These alerts follow intensified FDA testing prompted by a 2023 incident involving lead-contaminated cinnamon applesauce pouches marketed to children. That event resulted in over 400 cases of lead poisoning among infants and young children.
  • Lead is a toxic heavy metal that can accumulate in the body over time, particularly in children, where it may cause developmental delays, behavioral issues, and reduced IQ. In response, FDA has identified elevated lead levels in at least 11 ground cinnamon brands, with concentrations ranging from 2.03 to 7.68 ppm. (See our previous blogs: FDA Issues Warning Letter to Austrofoods S.A.S and FDA Continues Response to Contaminated Applesauce Pouches.)
  • FDA continues to collaborate with state partners to test cinnamon sold directly to retail and at import. These efforts are part of the agency’s broader commitment to food safety and its “Closer to Zero” initiative aimed at reducing exposure to toxic elements in foods consumed by young children.
  • Keller and Heckman will continue to monitor and relay any developments in this area.
  • This year’s annual AAFCO meeting was held August 4-6th in Omaha, Nebraska. Among the meeting’s highlights were the recognition of FDA’s Animal Food Ingredient Consultation (AFIC) process and the passage of two resolutions:
    • Resolution 2025-001-02, which rejects language in any federal bill which would preempt or otherwise limit the authority of state animal feed regulators. It specifically rejects the preemption language which was included in the Pet Food Uniform Regulatory Reform Act of 2025 (PURR Act). The PURR Act was introduced in January but has not advanced.
    • Resolution 2025-002 which relates to the potential development of an AAFCO label review service to review compliance with the AAFCO model bill and rules. AAFCO approved major changes to the model regulations in 2023, although the regulations have no force of law until adopted by states.
  • The AAFCO ingredient updates included moving the definitions for “hemp seed meal mechanical extracted,” “clam meal,” and “alligator” from tentative to official and adding new tentative definitions for “fish” and “pomegranate pomace.”
  • Updates to the AAFCO model bill included adding “lot identifier” language and a new definition for labeling.
  • The meeting minutes for the August meeting have not yet been posted to the online repository.
  • On September 4, 2025, FDA published its Unified Regulatory Agenda, which describes regulations currently under development or recently completed, providing a preview of the Agency’s top regulatory priorities. The agenda includes three significant regulations that could affect food and dietary supplements: a proposed generally recognized as safe (GRAS) substances rule; a final front-of-package (FOP) labeling rule; and a proposed rule finding a specific ingredient is not excluded from the dietary supplement definition.
  • The proposed GRAS rule would amend FDA’s regulations in 21 CFR parts 170 and 570 to “require the mandatory submission of GRAS notices” for substances purported to be GRAS for use in human or animal food. Substances that are currently subject to a GRAS regulation or a “no questions letter” in FDA’s GRAS inventory would be exempt from the rule. The proposed rule would also clarify that FDA maintain a public GRAS notice inventory, as well as the process to determine that a substance is not GRAS. As we previously blogged, FDA recently submitted a collection for information relating to the GRAS notification process, and in early 2025, the Agency was directed to explore a rulemaking to revise the GRAS final rule and related guidance to eliminate the self-affirmed GRAS pathway. The proposed rule is scheduled to be published in October 2025, though this is subject to change.
  • The FOP final rule would require the front labels on food packages to display certain nutrition information to help consumers make more informed dietary choices. FDA issued the proposed FOP rule in January 2025, later extending the comment period to July 15, as we previously blogged. At a high level, the rule would require the inclusion of a Nutrition Info box on the principal display panel of most foods that would display interpretive information on the amount of saturated fat, sodium, and added sugars in the product. FDA received more than 13,000 comments on the proposed rule. The final rule is scheduled to be published in May 2026, though this is subject to change.
  • Finally, the proposed rule related to a dietary supplement ingredient “would find that a specific ingredient would not be excluded from the dietary supplement definition.” Thus, products containing the ingredient could be lawfully marketed as dietary supplements, assuming they otherwise meet the dietary supplement definition. This may be related to nicotinamide mononucleotide, which is the subject of a citizen petition seeking regulatory clarity on its use as a dietary ingredient. The proposed rule is scheduled to be published in January 2026, though, once again, this is subject to change.
  • Keller and Heckman will continue to monitor FDA’s regulatory agenda and provide updates on all proposed and final rules the Agency releases.
  • On September 3, 2025, the Food and Drug Administration (FDA) announced its submission of a proposed information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act.
  • The proposed collection pertains to the FDA Food Safety and Nutrition Survey (FSANS) which assesses consumer knowledge, attitudes, and behaviors related to food safety and nutrition. A total of 5,000 respondents will be surveyed from a sample of approximately 25,000 households.
  • Data from this survey is used to support rulemaking and educational campaigns. The proposed 2025 FSANS will contain many of the same questions and topics as previous surveys and FDA has indicated that updates may be included but specific changes have not yet been disclosed. 
  • Previous FSANS have covered a wide range of topics including nutrition label use, menu labeling awareness, front-of-pack claims, and food safety practices.
  • Public comments on the proposed collection are invited until October 3, 2025. Interested stakeholders can submit feedback via the OMB’s public comment portal under FDA Docket No. FDA-2025-N-3215.
  • Keller and Heckman is happy to submit any comments on behalf of interested stakeholders.