Key Takeaways
- What Happened: The U.S. Food and Drug Administration (FDA) announced plans to update its food safety post-market chemical review program over the next few months to increase transparency and accelerate its evaluation of chemicals already in the U.S. food supply.
- Who’s Impacted: Food and chemical manufacturers, including suppliers of food additives and ingredients, color additives, and substances used in food‑contact materials.
- What Should You Do: Track the forthcoming draft prioritization framework and other public comment opportunities, and be prepared to engage with FDA.
On May 15, 2025, FDA announced plans to transform post-market oversight of food chemicals. FDA says it will take several key steps over the next few months. Those steps include:
- Publishing a draft prioritization framework for ranking existing chemicals (those already in the U.S. food supply) according to risk, followed by a public comment period.
- Finalizing a systematic post-market review process to apply when reassessing food chemicals already on the market.
- Updating the public list of existing food chemicals under review—adding at least butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), and azodicarbonamide (ADA)—and accelerating reviews already underway for phthalates, propylparaben, and titanium dioxide.
FDA describes the initiative as a “proactive, science‑based” program intended to give consumers greater confidence in the safety of the food supply while providing the industry with clearer expectations and timelines.
What is FDA’s Post-Market Chemical Review Program?
FDA regulates chemicals in food through both pre-market and post-market mechanisms. Pre-market, manufacturers generally must obtain FDA authorization or acquiescence—via food additive petitions, color additive petitions, Generally Recognized as Safe (GRAS) notifications or self-affirmations, or food-contact notifications—before introducing new substances. Post-market, FDA evaluates emerging safety data, conducts targeted research, monitors contaminants, and, where justified, can amend or revoke prior approvals. To find out more about how FDA may revoke existing approvals, read B&D’s article.
How Does FDA’s Plan Build on Earlier Work?
Historically, FDA has reassessed food chemical authorizations ad hoc after receiving a petition for re-review or if the agency discovers new information about the safety of a chemical. However, FDA has been working for some time to develop a more systematic review of chemicals already in the U.S. food supply, and the May 2025 announcement represents a continuation of this work.
FDA held a public meeting on September 25, 2024, to present a draft systematic post‑market review model and solicit comments, signaling a move toward a more predictable and risk-prioritized process. Following the meeting, FDA accepted public comments on the topic until January 21, 2025.
With its latest announcement, FDA now indicates that its updated systematic post-market review process will be “shaped by stakeholder input,” indicating that the final process will consider public input received by the agency through the previous meeting and an additional public comment period.
Expressly Prioritized and Accelerated Reviews
As a first step, FDA announced that it will update its list of existing chemicals under review in the next few months and that the expanded list will include BHT, BHA, and ADA, each of which is now partially or entirely banned in several states.
- Butylated Hydroxytoluene (BHT) is currently authorized by FDA as a food additive for use as an antioxidant to extend shelf life in cereals, certain potato products, and other foods. Louisiana recently passed legislation restricting public schools from serving foods that contain BHT, and bills are pending in Florida, Texas, and Indiana that would ban BHT in all foods made and sold throughout those states.
- Butylated Hydroxyanisole (BHA) is currently authorized as a food additive for use as an antioxidant to preserve cereals and various other dry foods. B&D recently discussed a petition to prohibit the use of BHA as an antioxidant that has been pending with FDA for nearly 35 years. Louisiana and Texas recently passed legislation that restricts food containing BHA in public schools. Legislators in Texas, Indiana, and New Jersey have proposed banning BHA in food throughout those states.
- Azodicarbonamide (ADA) is currently approved as a food additive used in cereal flour and dough as both a bleaching agent, and to fluff up bread. However, concerns have been raised that ADA breaks down into carcinogenic byproducts. Texas legislators recently banned ADA-containing foods from schools, and New Jersey, Texas, and Wisconsin have pending legislation that would ban ADA in those states.
FDA also announced that it will speed up review of some existing chemicals or chemical groups already under evaluation, including phthalates, propylparaben, and titanium dioxide.
- Phthalates: While FDA does not currently authorize phthalates for use as direct food additives or ingredients, the agency does authorize nine phthalates for use as plasticizers in food contact applications (e.g., food packaging). FDA’s review of phthalates in food contact applications has been ongoing for many years. In 2018, FDA received a petition requesting revocation of the authorization of 23 phthalates approved for food contact applications because industry had abandoned use of those substances. In May 2022, in response to that petition, FDA revoked its authorization of food contact use for those 23 phthalates. Also in May 2022, FDA requested information from the public about the safety of the remaining phthalates that are still authorized for food contact use—FDA’s review of those nine phthalates has been pending since then.
- Propylparaben: FDA approved a GRAS petition for propylparaben for use as a preservative in baked goods and processed meats in 1977. However, concerns have since arisen that propylparaben may affect human hormone development. The European Union (EU) banned propylparaben from use as a food additive in 2006. Arizona, Texas, and Louisiana each recently passed legislation prohibiting foods containing propylparaben from school lunches. Additionally, North Carolina, South Carolina, Oregon, and Wisconsin have proposed similar legislation. Meanwhile, California and Arkansas recently enacted complete bans of propylparaben in food throughout the state, and similar bans are pending in Connecticut, New York, Oklahoma, Missouri, Texas, Vermont, and New Jersey.
- Titanium Dioxide: FDA currently authorizes the use of titanium dioxide as a color additive to make food white. However, in 2022, the EU banned the use of titanium dioxide as a food additive due to concern that it could damage DNA, and FDA received a petition in 2023 requesting that it revoke the color additive authorization. Arizona and Texas recently passed legislation restricting titanium dioxide in food served in schools, and North Carolina and South Carolina have proposed similar legislation. Oklahoma, Indiana, and New Jersey have proposed legislation that would ban the use of titanium dioxide in food throughout those states.
Next Steps
FDA is expected to roll out its new post-market chemical review program over the next few months. Food and chemical manufacturers should watch these developments closely to stay informed of changes and provide comments on the draft framework when given the opportunity. B&D will continue to track these issues and is available to assist in preparing comments for submission.
Heather Olson contributed to this article