• At a September Food & Drug Law Institute (FDLI) conference, Mark Hartman, Director of FDA’s Office of Food Chemical Safety, Dietary Supplements and Innovation, indicated that FDA intends to revisit its previously withdrawn draft guidance on the use of fruit juice and vegetable juice as color additives.  
  • An additive that imparts color and meets the regulatory definition of “color additive” requires a color additive authorization, unless it is “used in a way that any color imparted is clearly unimportant insofar as the appearance, value, marketability, or consumer acceptability is concerned.” (21 CFR 70.3). Therefore, the use of fruit and vegetable juice can require a color additive authorization.
  • The draft guidance document, which was issued in 2016, and withdrawn the following year after significant industry pushback, was intended to clarify which ingredients are encompassed by the color additive regulations in 21 CFR 73.250 (“Fruit juice”) and 21 CFR 73.260 (“Vegetable juice”). Among other uncertainties, the regulations include undefined terms such as “mature,” “fresh,” and “edible.”
  • FDA’s now-withdrawn draft guidance interpreted the regulations in a manner that industry declared was inconsistent with the regulations and with industry practice. For example, the withdrawn draft guidance stated that only “minimal processing methods” may be used in the production of color additives from fruit and vegetable juices. However, this term is not used in either regulation, and FDA interpreted it to encompass processing techniques that were ubiquitous and important for food safety (e.g., pasteurization).
  • FDA’s intention to revisit this draft guidance is also reflected on the guidance agenda for FDA’s Human Foods Program as something expected to publish by the end of December 2025.
  • FDA has revised its previous interpretation of a clause of the Federal Food, Drug, and Cosmetic Act (FDCA) that states an ingredient that is first a drug cannot then become a dietary ingredient. In 2022, FDA had reiterated that the definition of a new dietary supplement excludes articles “authorized for investigation as a new drug . . . for which substantial clinical investigation have been instituted and for which the existence of such investigations have been made public,” unless the article was previously marketed as a food or dietary supplement, in its determination that β-Nicotinamide Mononucleotide (NMN) is not a dietary supplement, as we previously blogged.
  • Now, FDA has determined that NMN may be lawfully used in dietary supplements in response to Citizen Petitions from the Natural Products Association, the Alliance for Natural Health USA, and the Council for Responsible Nutrition (CRN). The Agency has determined that the “race-to-market” framework in which a dietary supplement or food must have been lawfully marketed before the approval of a new drug is not the “best reading” of the statute. Thus, FDA will no longer evaluate whether the supplement or food was lawfully marketed when determining its status, but any marketing—legal or not—must have occurred in the U.S.
  • In reevaluating its position on NMN, FDA noted that there is evidence that the substance was marketed in the U.S. as a dietary supplement as early as 2017 (before NMN was authorized for investigation as a new drug and substantial clinical investigations had been made public). As a result, it is not precluded from the dietary supplement definition.
  • While FDA’s decision states clearly that NMN may be legally used in dietary supplements, the Agency left open questions about the wider race-to-market clause. According to CRN, FDA’s response to its petition “fail[ed] to address the core structural problems that sparked the NMN confusion to begin with.”
  • Keller and Heckman will continue to provide updates about FDA’s interpretation of the race-to-market provision and other decisions related to marketing dietary supplements.
  • On September 25, 2025, the U.S. Food and Drug Administration (FDA) finalized amendments to its regulation governing prior notice requirements for imported human and animal food. These changes aim to enhance the agency’s ability to identify and inspect food shipments that may pose risks to public health, particularly those arriving via international mail.
  • Under the new rule, prior notice submissions must now include the name of the mail service and a mail tracking number for food articles sent through international mail. This information will enable FDA to better coordinate with the U.S. Postal Service, Customs and Border Protection, and other agencies to track and inspect potentially hazardous shipments, including those flagged as bioterrorism risks.
  • Additionally, the rule introduces a new requirement for timely submission of prior notice and food facility registration information when a shipment has been refused or placed on hold. By establishing a timeframe for these “post-refusal” and “post-hold” submissions, FDA aims to reduce delays at ports of entry and minimize associated costs.
  • The final rule is part of Docket No. FDA-2011-N-0179 and builds on earlier proposals to strengthen oversight of food imports, particularly those entering the country through less traditional channels like international mail.
  • Keller and Heckman will continue to monitor FDA regulatory developments related to food imports.
  • 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.