- 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.