FDA Announces Launch of a Post-Market Chemical Review Program
On May 15, 2025, FDA announced that it is “taking a major step to increase transparency and ensure the safety of chemicals in our food” by “launching a stronger, more systematic review process for food chemicals already on the market.” This step appears to be in line with the Agency’s announcement of its plans to establish a systematic post-market review program last fall, which included the publication of a discussion paper, a public meeting to outline its plan for developing a robust post-market review process for chemicals in food, and a request for comment from stakeholders.
Regarding its current proposal, FDA’s initiative will include the following elements:
- A modernized, evidence-based prioritization scheme for reviewing existing chemicals;
- A final, systematic post-market review process shaped by stakeholder input; and
- 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).
The Agency also stated it will take steps to expedite substances currently under review, including phthalates, propylparaben, and titanium dioxide, this last for which an unidentified FDA spokesperson is quoted by the publication, Food Navigator, as saying in late 2022 that “available studies do not demonstrate safety concerns” when used as a color additive for foods. See SPECIAL REPORT: FDA doubles down on titanium dioxide safety as CSPI raises concerns; Skittles lawsuits dismissed. FDA is currently evaluating a Color Additive Petition (CAP) filed by Environmental Defense Fund and others in April 2023, seeking to revoke the clearance at 21 CFR 73.575, which authorizes titanium dioxide as a color additive at levels up to 1% in foods.
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 Annual Meeting in Washington, D.C., 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.