News

FDA Announces Plans for Post-Market Chemical Review Program

20 May 2025

The U.S. Food and Drug Administration (FDA) recently announced plans to update its post-market food chemical review program.¹ In its announcement, FDA explained that its forthcoming plans will take a proactive approach to post-market reviews and that it plans to release more details soon.

Background

Under the Biden Administration, FDA took several steps to create a more systematic process for post-market assessments of food additives, as well as substances that are generally recognized as safe (GRAS), color additives, food contact substances, and unintentional contaminants. In August 2024, FDA released for public comment a discussion paper² outlining its plan for an enhanced systematic process for post-market assessment of chemicals in food, which included dividing reviews into two tiers: a “focused” assessment, which would be limited in scope and conducted without formal external engagement, and a “comprehensive” assessment, which would be a more complex review that incorporates external engagement. FDA held a public meeting to discuss the proposed framework on September 25, 2024 and comments were due by December 6, 2024.

During the Trump Administration, Department of Health and Human Services Secretary Robert F. Kennedy, Jr. has prioritized greater scrutiny of food additives, including directing FDA to explore possible rulemaking to revise its GRAS rule to eliminate the self-affirmed GRAS pathway³ and announcing plans to phase out certified colors.⁴

This recent announcement is the latest effort in a bipartisan trend towards developing a more systematic process for post-market review of substances in food.

Summary of Plans

FDA announced three key actions to advance a more transparent post-market chemical review program:

Releasing for public comment a draft “modernized, evidence-based prioritization scheme” for reviewing existing chemicals.
Finalizing a systematic, post-market review process shaped by stakeholder input.
Releasing an updated a list of chemicals under review, including butylated hydroxytoluene (BHT), beta hydroxy acids (BHA), and azodicarbonamide (ADA).

FDA noted that it will also take steps to expedite its review of chemicals currently under review like phthalates, propylparaben, and titanium dioxide. Finally, FDA pledged to continue sharing information about the status of this work on its website as part of the agency’s push for greater transparency. FDA did not provide a concrete timeline for any of the above plans.

Next Steps

Industry should continue to monitor FDA’s actions related to post-market safety assessments as they materialize and remain engaged throughout the process, including by participating in any stakeholder meetings and by providing feedback to the agency on its approach to these issues.

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We will continue to monitor developments in this area. Please contact us if you have any questions.

Authored by Elizabeth Fawell and Chigozie Akah.

References

1 FDA, FDA Advances Robust, Transparent Post-Market Chemical Review Program to Keep Food Supply Safe and Healthy (May 15, 2025), available at: https://www.fda.gov/news-events/press-announcements/fda-advances-robust-transparent-post-market-chemical-review-program-keep-food-supply-safe-and.

2 FDA, Discussion Paper Development of an Enhanced Systematic Process for the FDA’s Post-Market Assessment of Chemicals in Food (Aug. 2024), available at https://www.fda.gov/media/180942/download.

3 U.S. Department of Health & Human Services, HHS Secretary Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe (March 10, 2025), available at: https://www.hhs.gov/about/news/2025/03/10/hhs-secretary-kennedy-directs-fda-explore-rulemaking-eliminate-pathway-companies-self-affirm-food-ingredients-safe.html. See also HL Update, HHS Secretary Directs FDA to Explore Rulemaking to Eliminate Self-GRAS Pathway (Mar. 25, 2025), available at https://www.hoganlovells.com/en/publications/hhs-secretary-directs-fda-to-explore-rulemaking-to-eliminate-self-gras-pathway.

4 HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply (Apr. 22, 2025), available at: https://www.fda.gov/news-events/press-announcements/hhs-fda-phase-out-petroleum-based-synthetic-dyes-nations-food-supply. See also HL Update, https://www.hoganlovells.com/en/publications/hhs-and-fda-announce-plans-to-phase-out-certified-colors (Apr. 29, 2016), available at https://www.hoganlovells.com/en/publications/hhs-and-fda-announce-plans-to-phase-out-certified-colors