FDA Advances Post-Market Safety Reviews for Food-Contact Substances

The U.S. Food and Drug Administration (FDA) has finalized a more systematic post-market assessment process for chemicals in food and has launched reassessments of butylated hydroxytoluene (BHT) and azodicarbonamide (ADA). The FDA is also proposing to group four authorized food-contact phthalates as chemically or pharmacologically related substances for future cumulative risk assessment.

These developments signal a stronger FDA focus on lifecycle oversight of food additives and food-contact substances already permitted in the U.S. market.

FDA Finalizes a More Systematic Post-Market Assessment Process

FDA's enhanced post-market assessment process applies to "chemicals in food" including food additives, color additives, GRAS substances, food-contact substances, and contaminants.

The purpose of the process is to ensure that chemicals already used or present in food and food-contact materials remain safe when new scientific information, exposure data, or use patterns emerge.

New toxicological findings, migration or exposure information, regulatory actions in other jurisdictions, or changes in consumer intake patterns may all bring a substance back into FDA’s review process.

The process mainly includes:

• Signal identification: FDA monitors information that may indicate a change in risk, including reports, scientific literature, industry input, and international regulatory developments.

• Initial screening and triage: FDA determines whether a signal is suitable for the post-market assessment process.

• Prioritization: Substances are prioritized based on toxicity, exposure, affected populations, and other relevant factors.

• Annual work planning: FDA publishes an annual post-market assessment work plan, listing selected food chemicals for scientific review and updating assessment progress.

• Scientific assessment and public engagement: Before a scientific assessment, FDA may request information from stakeholders. After a preliminary assessment, FDA may also publish its findings for public comment.

• Risk management: Once an assessment is completed, FDA decides whether risk management measures are needed. Possible measures may include revising or revoking certain authorized uses, working with industry on voluntary market withdrawal, recalls, or refusal of admission at import.

BHT and ADA Reassessments Are Now Underway

FDA has issued Requests for Information (RFIs) for BHT and ADA, with the public comment period closing on July 13, 2026. FDA is seeking relevant data from manufacturers, researchers, and other stakeholders.

FDA Proposes Grouping Four Food-Contact Phthalates

On May 27, 2026, FDA released a scientific evaluation proposing to group four ortho-phthalates currently authorized for selected food-contact applications as chemically or pharmacologically related substances:

The proposed grouping would support a future cumulative risk assessment approach, meaning FDA could evaluate combined dietary exposure to related compounds rather than assessing each substance only in isolation. FDA's evaluation focused on male reproductive toxicity endpoints associated with anti-androgenic activity. Public comments on the proposal are due by June 26, 2026.

Four other authorized food-contact ortho-phthalates were not classified as chemically or pharmacologically related under the proposal due to insufficient evidence of comparable effects based on current data: DIDP, DEP, BPBG, and EPEG.

Impact on Industry Businesses and Compliance Advice

FDA's strengthened post-market assessment mechanism shows that existing compliance conclusions may be revisited as toxicological research develops, exposure levels and use patterns change, and international regulatory trends evolve.

FDA encourages manufacturers to submit relevant data through industry associations or other collaborative channels. This is particularly important because, when actual use levels, migration data, and exposure information are unavailable, regulators may rely on conservative assumptions. Such assumptions can lead to overestimation of dietary exposure and may influence future authorization decisions.

Companies do not need to overreact at this stage. However, they should closely follow FDA's latest substance assessment activities and review whether their product lines or packaging materials contain chemicals that have been placed under priority review. For substances that may be affected, companies should consider early research into alternatives so they are better prepared for possible future regulatory restrictions.

How REACH24H Can Help

REACH24H provides professional regulatory compliance support for companies navigating U.S. FDA requirements for food ingredients, GRAS substances, food additives, and food-contact materials. In response to FDA's enhanced post-market review activities, companies may need to reassess existing compliance documentation and prepare scientific or exposure-related data more proactively.

• Substance applicability review: Identify whether food ingredients, additives, packaging materials, or processing aids may be affected by FDA review activities.

• Data gap analysis: Review available toxicology, migration, exposure, use-level, and market information against FDA data expectations.

• Regulatory strategy support: Assess possible compliance pathways, including GRAS, food additive, and food-contact substance considerations.

• Post-market monitoring: Track FDA reassessments, RFIs, dockets, and international regulatory trends that may affect existing U.S. market access.

Official References

• FDA Food Chemical Safety

• FDA Systematic Process for Post-Market Safety of Chemicals in Food

• FDA List of Select Chemicals in the Food Supply Under Review

• FDA Packaging & Food Contact Substances (FCS)

• FDA Generally Recognized as Safe (GRAS)