• 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.

  • 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.