• FDA and the Department of Health and Human Services (HHS) have launched a public Request for Information (RFI) to “identify and eliminate outdated or unnecessary regulations” in alignment with President Donald Trump’s Executive Order 14192.
  • Under the RFI, HHS Secretary Robert F. Kennedy, Jr. has committed to rescinding at least ten existing regulatory actions for every new regulation proposed. The effort is intended to “lower the cost of living, remove bureaucratic barriers, and allow health care providers to devote more time and resources to patient care.”
  • HHS intends to implement the following measures under the Executive Order:
    • The 10-to-1 rule: Eliminate at least ten existing regulations for every new regulation introduced.
    • Regulatory cost cap: The total cost of all new regulations in fiscal year 2025 must be significantly less than zero.
    • Expanded scope: The order applies to guidance documents, memoranda, policy statements, and similar directives, in addition to formal regulations.
    • Radical transparency: HHS will publish annual reports detailing estimated regulatory costs and the specific rules being offset.
  • According to FDA Commissioner Marty Makary, “[t]his initiative is about restoring common sense to health care regulation. . . .We welcome public input to help identify reforms that truly make a difference.”
  • During an FDA Update session at the Food and Drug Law Institute’s (FDLIs) Annual Meeting in Washington, D.C., FDA officials reiterated the Agency’s commitment to transparency and complying with the Executive Order while also working toward FDA’s priorities. For example, the Agency has moved forward with approving new uses for three non-certified color additives as part of the Agency’s strategy to phase out certified color additives, as we previously blogged.
  • The RFI’s 60-day public comment period opened May 13, 2025. Comments may be submitted through regulations.gov under docket AHRQ-2025-0001 or at regulations.gov/deregulation.
  • Keller and Heckman is available to assist in submitting public comments and will continue to monitor other FDA developments.
  • On May 15, 2025, FDA announced a three-part agenda “to increase transparency and ensure the safety of chemicals in our food.” This step follows from the Agency’s post-market activities last fall, where FDA published a discussion paper and held a public meeting to outline its plan for developing a robust post-market review process for chemicals in food and to seek input from stakeholders. It is unclear from the announcement to what extent the comments submitted to FDA in January 2025 have been considered, following FDA’s public meeting on the development of a post-market assessment program.
  • Regarding its current proposal, FDA’s initiative will include the following elements: (1) a modernized, evidence-based prioritization scheme for reviewing existing chemicals; (2) a final, systematic post-market review process shaped by stakeholder input; and (3) an updated list of chemicals under review. FDA will continue to share information about the status of this work on its public website as part the Agency’s push for greater transparency.
  • FDA’s updated list of substances in the food supply undergoing review includes butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), and azodicarbonamide (ADA). All three of these substances have been targeted by Vani Hari, aka the Food Babe, indicating what appears to be an increase in her influence of the Make America Healthy Again (MAHA) agenda. The Agency also stated it will take steps to expedite substances currently under review, including titanium dioxide, for which FDA had determined in 2024 does not present a safety concern when used as a color additive for foods, phthalates, and propylparaben.
  • FDA’s announcement was concurrent with a presentation by Mark Hartman, Director of FDA’s Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI) at the Food and Drug Law Institute’s (FDLI’s) Annual Meeting in Washington, DC, where Hartman reassured the audience that, although a substance may undergo post-market review, this does not mean it is destined to be deemed unsafe. The OFCSDSI Director also relayed during his presentation that FDA is actively working on a rulemaking regarding self-GRAS determinations, a directive from HHS Secretary Kennedy on March 10, 2025. In this regard, Hartman shared that FDA is considering whether new chemicals should be allowed to continue to operate under a voluntary system or require mandatory GRAS Notice submissions, and which regulatory approaches should be used to address the lack of visibility on past self-GRAS positions.
  • Keller and Heckman is continuing to monitor these and other FDA developments. 

  • Yesterday Texas Attorney General Ken Paxton announced that it had sent General Mills a Civil Investigative Demand as part of a new investigation regarding the company’s marketing of its cereal products as “healthy” and a “good source” of vitamins and minerals despite containing what Texas calls “petroleum-based food colorings.”
  • The announcement alleges, without pointing to evidence, that a host of negative health outcomes can be attributed to these synthetic food colorings and voices support for the Trump administration’s battle against such colorings.
  • This move follows the Trump administration’s announcement of its planned phase-out of the use of synthetic dyes last month as well as a similar investigation against Kellogg by Texas, which was announced last month.
  • FDA and the Department of Health and Human Services (HHS) have announced the next steps in “Operation Stork Speed,” a program intended to enhance the “quality, safety, and nutritional adequacy” of infant formula products, as we have previously blogged. FDA issued a Request for Information (RFI) to begin the required nutrient review process for infant formula, which must meet minimum and maximum levels of certain nutrients.
  • Through the RFI, FDA is seeking public input regarding “whether existing nutrient requirements should be revised based on the latest scientific data, including international,” as well as potential adjustments to existing levels, additional nutrients to consider, and how these changes may improve health outcomes. Comments will be due 120 days after the RFI is published in the Federal Register, which is scheduled for May 14, 2025.
  • FDA will also increase testing for heavy metals and other contaminants in infant formula and food for children and is encouraging companies to work with the Agency on “enhancing transparency and improving labeling clarity.” FDA intends to convene a publicly accessible expert panel in June as part of the Operation Stork Speed initiative.
  • Keller and Heckman will continue to monitor the program and other developments related to infant formula.
  • On May 9, 2025, FDA and the National Institutes of Health (NIH) announced the launch of the new Nutrition Regulatory Science Program, a joint initiative to research diet-related chronic diseases and inform food and nutrition policy.
  • FDA and NIH touted the program as “a key element in fulfilling U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr.’s commitment to Make America Healthy Again.” The Agencies stated that the program will allow them to “invest in gold standard science, prioritize a better understanding of the root causes to end the diet-related chronic disease crisis and safeguard the health of America’s children.”
  • The program is intended to answer (arguably leading) questions related to diet-related chronic disease such as:
    • How and why can ultra-processed foods harm people’s health?
    • How might certain food additives affect metabolic health and possibly contribute to chronic disease?
    • What is the role of maternal and infant dietary exposures on health outcomes across the lifespan, including autoimmune diseases?
  • FDA will contribute regulatory science expertise to the program, while NIH will provide infrastructure for scientific research, with experts in chronic disease, nutrition, toxicology, risk analysis, behavioral science, and chemistry contributing to the program. The Agencies said that they will work together to develop a research agenda and ensure that all research is fair, independent, and free of conflicts of interest.
  • Keller and Heckman will continue to report on developments related to the new program.
  • On May 9, 2025, the U.S. Food and Drug Administration (FDA) announced the approval of three new food color additives derived from natural sources.  This development follows the agency’s late-April announcement of its intension to collaborate with industry stakeholders to phase out the use of petroleum-based synthetic food dyes.  As part of this broader initiative, FDA had committed to authorizing new natural color additives and expediting the review process for others already under consideration.  
  • The newly approved color additives include:
    • Galdieria extract blue, derived from the red algae Galdieria sulphuraria, was originally petitioned September 9 2021 (86 Fed Reg 50495). It is now approved for its use in a wide range of products including nonalcoholic beverages, fruit drinks, smoothies, juices, yogurt products, breakfast cereal coatings, candy, and other desserts.
    • Butterfly pea flower extract, originally approved in September 2021 for limited uses such as beverages and confections at 21 CFR 73.69, was petitioned for expanded use February 8, 2024 (89 Fed Reg 8537). It is now approved for expanded uses including ready-to-eat cereals, crackers, snack mixes, hard pretzels, and various forms of chips.
    • Calcium Phosphate, a white color additive derived from a naturally occurring mineral, was petitioned February 27, 2023 (88 Fed Reg. 12281) and has now been approved for use in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies.
  • Notably, during the press hearing, the agency had indicated it would authorize four new color additives.  However, only three were ultimately approved, with gardenia blue not included in the announcement for the newly authorized colors.
  • Keller and Heckman will continue to monitor developments related to the authorization or revocation of color additives.
  • On May 8, 2025, the U.S. Food and Drug Administration (FDA) extended the public comment period for its proposed rule on front-of-package (FOP) nutrition labeling by 60 days.  Stakeholders now have until July 15, 2025, to submit feedback.
  • The extension comes in response to requests for more time to review and comment on the proposal. The proposed rule, announced January 16, 2025, would require most packaged foods to display a simplified “Nutrition Info” box on the front of the package.  The box would highlight the level of three nutrients of public concern: saturated fat, sodium, and added sugars, using descriptive terms such as “low,” “med,” or “high.”
  • The rule is part of a broader initiative at the agency to reduce diet-related chronic diseases and is intended to provide consumers with a quick and easy way to understand nutrition information related to packaged food products.
  • Comments can be submitted via Regulations.gov under docket number FDA-2024-N-2910. Keller and Heckman can assist in drafting or submitting comments on behalf of interested parties.
  • On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced its intend to expand the use of unannounced inspections at foreign manufacturing facilities that produce food, as well as essential medicines and other medical products intended for American consumers.  This builds upon FDA’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.
  • FDA stated that it will also evaluate the agency’s policies and practices for improvements to the foreign inspection program, which will include clarifying policies for FDA investigators to refuse travel accommodations from regulated industry, including lodging and transportation arrangements.
  • FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries, according to the FDA press release.  While US manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, though FDA supposedly found deficiencies more than twice as often than during domestic inspections. 
  • Despite this announcement, anonymous FDA officials noted that the recent staffing cuts in FDA have made it harder for the inspections teams to keep up with demands. 
  • FDA Assistant Commissioner for Inspections and Investigations Michael Rogers stated that, “FDA’s rigorous, science-based global inspections of manufacturing facilities ensure that the food and drug products that enter the US marketplace, and the homes of American consumers, are safe, trusted, and accessible.  These inspections provide real-time evidence and insights that are essential for making fact-based regulatory decisions to protect public health.”  Michael Rogers will be retiring from FDA on May 14, 2025.
  • Yesterday FDA’s Coordinated Outbreak Response & Evaluation (CORE) Network announced the release its 2023 annual report summarizing food-borne outbreak and adverse events in FDA-regulated foods.
  • In 2023, the CORE Signals and Surveillance Team, which evaluates emerging outbreaks and disease surveillance trends in collaboration with CDC, FDA field offices, and state agencies, evaluated 69 incidents, of which 25 were passed for follow up to an FDA Response Team, and 10 resulted in public health advisories. Of the responses with identified products linked to illness, fruit produce made up the greatest share at 31% (4 cases), followed by other produce at 23% (3 cases).
  • The report notes FDA’s continued partnership with Mexican food safety regulators including exchange of outbreak information through the Binational Outbreak Notification Protocol which was initiated for four CORE responses. FDA also conducted two accompanied, but unannounced inspections of Mexican food facilities.
  • Notable outbreaks identified in the report were the lead-contaminated cinnamon apple sauce pouches traced to a cinnamon supplier in Ecuador, adverse reactions (including death) linked to Morel mushrooms served at a Montana restaurant, and an outbreak of Listeria monocytogenes linked to soft serve ice cream in Brooklyn.
  • The Report predates FDA’s October 2024 reorganization into the Human Foods Program. Since the reorganization, CORE has reorganized into the Office of Coordinated Outbreak Response, Evaluation, & Emergency Preparedness (CORE+EP).
  • FDA is “set to rehire some of the staff that was let go during mass firings in the past three months.” Earlier this year around 3,500 FDA employees, or around 20 percent of its workforce, was let go without cause, and many more left due to retirement, voluntary buyout, and resignation.
  • While FDA and the Department of Health and Human Services have not detailed exactly which positions or programs were cut during the mass layoffs, many included food and medical device reviewers, communications staff, and scientists, as well as travel bookers who coordinate trips for inspectors.
  • Many of the travel bookers have been reported to be on the reinstatement list, according to two anonymous FDA staffers. In addition, food scientists have been told they will be reinstated, and some of the communications staff, including some who worked in the FOIA office, will be rehired.
  • Keller and Heckman will continue to report on staffing and other organizational developments at FDA.