On May 12, 2026, FDA finalized the process it will use to re-examine chemicals that are already lawfully in the food supply, and it started with two familiar ingredients: BHT, a preservative, and azodicarbonamide (ADA), a dough conditioner. Together with BHA, which FDA opened for review earlier in the year, they make up the agency's work plan for fiscal year 2026. This program can end with an authorization being revoked, so companies that use these ingredients should treat it as more than a comment exercise.
What FDA finalized
FDA issued two documents. The first describes the process. FDA collects signals about a chemical from published studies, other regulators, adverse event reports and its own AI screening tool, then triages and prioritizes them and announces a work plan each year. For each chemical it takes up, FDA intends to publish a data call in the Federal Register, then a preliminary assessment for public comment, each open for 60 days, and then a final assessment even when it decides to take no action. The second document is a scoring tool built on four equally weighted public health criteria: toxicity, changes in exposure, use in foods eaten by susceptible groups, and new scientific information. FDA is clear that a high score is a reason to look, not a finding that a chemical is unsafe.
If FDA does find a problem, its options include amending or revoking an authorization, negotiating a voluntary phase-out, refusing imports and issuing alerts. FDA's own explainer says the program has no fixed overall timeline, so treat any target dates you hear as goals rather than deadlines.
Where BHT, ADA and phthalates stand
FDA published its requests for information on BHT and ADA on May 13, 2026. The ADA comment period closed July 13. FDA reopened the BHT docket for another 30 days, and it closed August 31. As of FDA's late-October update to its list of chemicals under review, both are still at the review-of-information stage, with no preliminary assessment posted. BHA, whose request for information came out in February, is listed at the scientific assessment stage.
Phthalates are on their own track. In 2022 FDA withdrew authorization for 23 phthalates in food contact uses and asked for information on the eight that remain authorized as plasticizers. In May 2026 it released a scientific evaluation of whether phthalates should be treated as related substances for a future cumulative risk assessment. A grouped assessment could reach packaging and processing materials that look low risk one chemical at a time.
What to do now
Find out where these chemicals sit in your products and your supply chain, including packaging, gaskets, tubing and other food contact materials, not just the ingredient statement. Ask suppliers for use levels and migration data while there is time to get it. FDA has said it does not need individual recipes and encourages aggregated submissions through trade groups, which is often the practical route for confidential information. When a preliminary assessment comes out, the 60-day comment window will be the main chance to put your data in the record, and FDA has said it does not plan to extend those windows. That alone is a good reason not to wait. We would also start quiet reformulation planning for BHT and ADA, since customers and retailers may ask about them well before FDA decides anything.
How MDRXLaw can help
We help food manufacturers, importers and packaging suppliers assess their exposure to FDA chemical reviews, prepare data submissions and comments, and plan formula and labeling changes. To talk through your products, contact us at info@mdrxlaw.com or 212-668-0200.
Sources: FDA, FDA Finalizes Food Chemical Safety Post-Market Assessment Program, Launches Reassessment of BHT, ADA; FDA, List of Select Chemicals in the Food Supply Under FDA Review; FDA, FDA Reopens Public Comment Period on Request for Information on Butylated Hydroxytoluene; Federal Register, Azodicarbonamide (ADA); Request for Information. This alert is for general information and is not legal advice.
