• On May 30, 2025, FDA issued a draft guidance titled “Replacing Color Additives in Approved or Marketed Drug Products.” 
  • Neither the draft guidance nor FDA’s Federal Register notice announcing its availability refers explicitly to the recent effort by HHS and FDA to encourage food manufacturers to discontinue the use of certified color additives in food or to FDA’s revocation of its regulations authorizing the use of FD&C Red 3 in foods and ingested drugs.  However, the draft guidance will be helpful to any drug manufacturer wishing to replace color additives for any reason.   
  • Unlike other inactive ingredients in drug products, color additives must be used only in accordance with a regulation issued by FDA authorizing their use.  The color additives that are authorized by FDA for use in drugs can be found in 21 CFR part 74, subpart B (those that are subject to batch certification) and 21 CFR part 73, subpart B (those that are exempt from batch certification).  Color additives that are provisionally listed for use in drugs can also be found in 21 CFR part 82.
  • Ordinarily, the holder of an approved new drug application (NDA) or an approved abbreviated new drug application (ANDA) must submit a prior approval supplement (PAS) to FDA asking FDA to approve any changes to their drug formula (even if just replacing one inactive ingredient with a new one).
  • This draft guidance proposes that holders of approved NDAs and ANDAs would generally be able to submit a “changes-being-effected supplement” (CBE-30) prior to making a color additive change to their drug formula. The CBE-30 gives FDA 30 days’ notice of a proposed color additive change, but holders of an approved NDA or ANDA can implement that change without waiting for FDA to approve it. Effectively, FDA is downgrading the regulatory hurdle from PAS to CBE-30 for color additive changes.
  • Importantly, this change only applies to drugs marketed under an approved NDA or ANDA. Drugs marketed under an OTC monograph do not have approved applications, so those manufacturers would not submit a CBE-30. However, manufacturers without approved applications still must meet other requirements, as noted in the draft guidance.
  • Keller and Heckman will continue to monitor regulatory developments related to color additives. 
  • Anyone can comment on FDA guidance at any time. To ensure comments on this draft guidance are considered before FDA prepares a final version, they must be submitted by July 29, 2025.
  • On May 26, 2025, the Texas House passed SB 25 with bipartisan support. SB 25, also known as the ‘Make Texas Healthy Again’ bill, focuses on promoting nutritional awareness and physical education in schools and improving food labeling practices. The bill would also establish a Nutrition Advisory Committee to help establish, develop, and maintain nutritional guidance within the State.
  • SB 25 also requires food manufacturers to either remove prohibited ingredients listed within the bill­­—such as Red 40 and titanium dioxide—or place a warning label on the product that reads: “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 language was amended from what was reported on in a previous blog post. The latest version of the bill makes clear that it does not apply to dietary supplements (among other listed situations).
  • Notably, the bill removed high fructose corn syrup from the list of prohibited ingredients following opposition from numerous food companies after it was introduced. The industry’s opposition letter also urged legislators to remove the warning label requirement, but the proposed amendment did not pass through the House.
  • SB 25 is now heading to Governor Greg Abbott’s desk to be signed into law. The bill would take effect on September 1, 2025.
  • As we previously blogged on May 23, 2025, the Make America Healthy Again (MAHA) Commission published its report detailing what it claims to be the main causes of chronic diseases. The report is receiving increased scrutiny after News of the United States (NOTUS), a nonprofit digital news site, published an article on Thursday, May 29 stating that many of the citations in the report either had large errors or even cited nonexistent studies. Some cited authors who were contacted by NOTUS were surprised to hear of their citation and denied ever working on the studies referred to in the MAHA Report.
  • Both The Washington Post and The New York Times published articles later that same day referring to even more errors and inaccuracies. The Washington Post article quoted artificial intelligence experts who suspect that many of the citations in the MAHA Report were likely produced by AI. Indeed, no authors are identified for the MAHA Report itself, which leaves considerable questions as to the scientific accuracy of its findings. The article points to the use of the text “oaicite” (OpenAI Cite) in some of the citation URLs within the report, which is “a marker indicating use of OpenAI, a U.S. artificial intelligence company.” This suggests that the conclusions reached in the report may have preceded the citations.
  • When asked about the NOTUS article and the potential reliance on AI, White House press secretary Karoline Leavitt referred to any inaccuracies as “minor citation and formatting errors.” The MAHA Report has since been updated to remove the incorrect citations at issue in the NOTUS article.
  • Separately, following public complaints from a number of grower groups regarding the MAHA Report, The America First Policy Institute (AFPI), a nonprofit think tank that was founded in 2021 by current Secretary of Agriculture Brooke Rollins, released its “Farmers First agenda for responsible nutrition policy” Driving Responsible Nutrition Policy on May 29.
  • The AFPI paper outlined the following principles:
    • Federal programs should allow states to incentivize healthier eating.
    • Federal government must ensure our domestic food supply is transparent, safe, and upholds nutritional integrity.
    • Federal nutrition programs must be reserved for the truly needy and must aim to restore the dignity of work.
    • Government and the private sector must collaborate to reduce food loss and waste.
    • Driving responsible nutrition policy also means supporting the domestic specialty crop sector, including fruit and vegetable farmers.
  • Keller and Heckman will continue to monitor developments related to the MAHA report. 

  • On May 2, 2025, the Swiss Federal Supreme Court ruled that designations referring to animal species are not allowed to label plant-based meat substitutes (here is the official press release, in French, 2C_26/2023). The full judgment is not yet available, so we cannot provide a more in-depth analysis of the arguments of Switzerland’s supreme judges, and the information below is based solely on the press release.
  • In 2021, the Zurich Cantonal Laboratory banned a company from labelling its pea protein meat substitutes with names referring to animal species; the company appealed this ban, and the Administrative Court of the Canton of Zurich decided in its favor in 2022, allowing the use of references to animal meat in its products. However, in its judgment of May 2, 2025, the Federal Supreme Court upheld the appeal filed by the Federal Department of Home Affairs, annulling the first instance decision of the Zurich Administrative Court and thus ruling against the company.
  • According to the press release, food products destined for consumers made exclusively with vegetable proteins (i.e., those usually defined as ‘plant-based meat’) cannot be designated by names of animal species, even if these are accompanied by an indication specifying the vegetable origin of the product, such as ‘planted chicken,’ ‘chicken-like,’ ‘pork-like,’ ‘vegan pork,’ or ‘vegan chicken.’ In fact, the term ‘chicken’ refers to poultry; therefore, it cannot be used for products that do not contain a meat component, as it would be misleading for consumers. In other words, plant-based products alternative to meat must be labelled in such a way as to enable the consumer to recognize the type of foodstuff and to differentiate it from products that they aim to substitute.
  • On May 1, Montana Governor Greg Gianforte signed HB401, which bans the sale, distribution, and manufacture of “cell-cultured edible products.”  HB 401 defines the term “cell-cultured edible product” as “the concept of meat, including but not limited to muscle cells, fat cells, connective tissue, blood, and other components produced via cell culture, rather than from a whole slaughtered animal.”  Violations of the ban are punishable by a fine of up to $250, imprisonment for not more than 3 months, or both.  Mont. Code § 50-31-506.
  • On May 6, Indiana Governor Mike Braun signed HB 1425, which begins a two-year moratorium on the sale and manufacture of “cultivated meat products,” which are defined as “animal protein grown in a facility from extracted animal stem cells and arranged in a similar structure as animal tissues to replicate the sensory and nutritional profiles of meat products.”  The moratorium will be in force from July 1, 2025 to June 30, 2027.  Following the temporary ban, cultivated meat products may be sold within the state, but they must be advertised, labeled, and sold in a manner that clearly indicates that the product is a cultivated meat product.  In particular, the words “this is an imitation meat product” must be on the package.  Violations of the ban are punishable by fines of up to $10,000.
  • As previously reported, Alabama, Florida, and Mississippi have also enacted bans on the sale or manufacture of lab-grown meat.
  • On May 21, Senator Tom Cotton (R-Arkansas) introduced a bill titled the “Study And Framework for Efficiency in Food Oversight and Organizational Design Act of 2025” or the “SAFE FOOD Act of 2025” which would direct the Secretary of Agriculture to conduct a study on the consolidation of federal agencies with a “primary role in ensuring food safety in the United States” into a single agency.
  • The bill explicitly lists the Food Safety and Inspection Service (FSIS), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) as agencies targeted for consolidation. (More realistically, the food regulatory components of FDA and the CDC would be considered for consolidation with FSIS.) FDA and CDC are within the Department of Health and Human Services (HHS) while FSIS is within the U.S. Department of Agriculture (USDA). FDA has broad authority to regulate food and food additives under the Federal Food, Drug, and Cosmetic Act, while USDA-FSIS regulates meat, poultry, and egg products under the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. CDC, in collaboration with FDA and other partners, plays a critical role in responding to foodborne illness outbreaks.
  • Senator Cotton claimed that spreading food safety oversight “across multiple federal, state, and local agencies . . . decreases efficacy, creates gaps, and slows response times to potential public health risks” and that his bill “is a commonsense step to expanding government efficiency and enhancing public health protection by unifying our food safety agencies.” As readers likely know, this is not the first time a single food agency has been considered. It probably will not be the last time either.   
  • After a slowdown in FDA inspections during the first quarter of 2025 and the mass departure of over 3,500 employees, FDA is pivoting to state authority and generative AI technology to help the agency “do more with less.” FDA currently has contracts with forty-three states and plans to expand this program to have more states conduct FDA inspections of food and beverage facilities.
  • Following the shift in responsibility, food and drug manufacturers have recently seen an uptick in inspection notices. Foreign facilities are experiencing more unannounced inspections as FDA seeks to treat foreign firms like domestic firms with less lead time before inspections, as we previously blogged.
  • FDA Commissioner Marty Makary has also directed FDA centers to begin using AI for premarket scientific reviews, giving the agency an “aggressive timeline” of full integration by June 30, 2025. Makary claims that the use of AI will reduce the amount of “non-productive busywork” that consumes a large part of the scientific review process.
  • FDA has announced that they will be releasing additional details about the use of AI later in June. Keller and Heckman will continue to report on these developments.
  • Yesterday, the Make America Healthy Again (MAHA) Commission, released its “Make Our Children Healthy Again” report outlining its priorities for improving the health of American children. President Trump requested the report in a February executive order establishing the MAHA Commission.  The report targets “ultra-processed foods” (UPFs), exposure to environmental chemicals (microplastics, pesticides), a decline in physical activity, and “overmedicalization” as some of the main drivers of an increase in childhood chronic diseases such as obesity and cancer. The MAHA Commission is set to issue further policy recommendations in August.
  • The report loosely defined UPFs as those that are high in added sugars, refined grains, unhealthy fats (such as seed oils), and sodium while low in fiber and essential nutrients. The report also identifies certain food additives, including food colorings (such as Red 40), titanium dioxide, propylparaben, butylated hydroxytoluene (BHT), and artificial sweeteners (such as aspartame, sucralose, saccharin).
  • The report also criticizes the Dietary Guidelines for Americans (DGA) for not specifically addressing UPFs in its dietary recommendations and “remaining largely agnostic to how foods are produced or processed.” The report is also critical of the DGA and nutrition research at large claiming they are being improperly influenced by the food industry, citing an analysis that found $60 billion in industry funding for nutrition research, without acknowledging the significant cuts to research funding undertaken by the administration in the last several months. (Pages 30-32)
  • The report goes on to criticize other government programs. It claims that children who are Supplemental Nutrition Assistance Program (SNAP) participants consume more unhealthy food and beverages than income-eligible non-participants, leading to worse health outcomes. The report further claims that the National School Lunch Program (NSLP) fails to limit UPF consumption and allows food companies to make minor ingredient adjustments to qualify their products for the Smart Snack program. (Pages 32-34)
  • Cumulative chemical exposure, increased use of technology, and overtreatment/overdiagnosis of common illnesses are all claimed to be drivers of chronic disease. The report calls for studies on the effect of cumulative exposure to chemicals including PFAS, phthalates, bisphenols, microplastics, fluoride, electromagnetic radiation, and crop protection tools (e.g., pesticides, herbicides, and insecticides).  (Pages 43-44)
  • The report made a single reference to GRAS Oversight reform, recommending that independent studies are funded to evaluate “the health impact of self-affirmed GRAS food ingredients.” (Page 72)
  • Yesterday, a proposed false advertising class action was filed in California against Handel’s, alleging the ice cream retailer claims its frozen treats are “homemade,” use “the best ingredients,” and follow “original methods and recipes” dating back to 1945, though the products reportedly contain artificial food dyes and polypropylene glycol.  (Law360 subscription required.)
  • In the complaint, the plaintiff claims that Handel’s advertises that its “homemade ice cream” uses fresh, high-quality ingredients, but that its strawberry ice cream, for example, contains carrageenan, ethyl alcohol, propylene glycol, citric acid, and synthetic food dyes like Blue 1 and Red 40.  The complaint also alleges that these synthetic ingredients are hidden, because the company does not list or disclose its ingredients in its stores or website.  Additionally, Handel’s claims on its storefronts, merchandise, signage, napkins and packaging that its ice creams are made fresh daily, or made fresh daily at each location, according to the complaint.
  • The suit asserts several causes of action against Handel’s, including violations of California’s Consumer Legal Remedies Act, False Advertising Law, and Unfair Competition Law, as well as breaches of express and implied warranties, unjust enrichment, and common law fraud.
  • The complaint explicitly makes reference to California’s School Food and Safety Act, which passed last year.  As we previously reported, California’s AB 2316 became the nation’s first-ever bill banning public schools in the state from serving foods to children that contain Red 40 and various other synthetic food dyes.  Other states have followed suit and the “Make America Healthy Again” (MAHA) movement aims to phase out synthetic, petroleum-based food dyes in the US food supply.
  • Keller and Heckman LLP will continue to monitor developing legislation and litigation surrounding artificial food dyes.
  • In a Warning Letter posted yesterday (but issued in April), FDA warned Gluten Free Remedies LLC that one of their dietary supplement products was adulterated because it declared sulbutiamine as a dietary ingredient.
  • Section 201(ff) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 USC 321 (ff)) defines a dietary supplement in part as a product (other than tobacco) intended to supplement the diet that bears of contains one or more of the following dietary ingredients: A) a vitamin; B) a mineral; C) an herb or other botanical; D) an amino acid; E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in A – E.
  • Sulbutiamine is a synthetic derivative of thiamine (vitamin B1) and so does not fit in the A – D dietary ingredient categories. In its New Dietary Ingredient Notifications and Related Issues draft guidance, FDA addresses the circumstances under which it would consider a synthetically produced substance to be a dietary ingredient, including in the context of substances in dietary ingredient category E (see pp. 37-38). FDA takes the position that a substance fitting the category E dietary ingredient criteria must be part of the human diet, and in the context of synthetic substances, requires the synthetic copy to have been lawfully marketed in the conventional food supply. Vanillin and cinnamic acid are offered as examples of such synthetic dietary ingredients.
  • FDA has previously objected to the use of other substances that it has concluded do not meet the dietary ingredient definition. For example, it has taken the position that methylsynephrine, a synthetic stimulant, does not meet the dietary ingredient definition. See e.g., Methylsynephrine in Dietary Supplements | FDA.
  • The terms in dietary ingredient category E are not defined in the FD&C Act (FDA’s interpretation in the draft guidance draws from dictionary definitions) and may be more susceptible to challenge since the Supreme Court overturned Chevron deference to agency decisions in Loper Bright Enterprises v. Raimondo.