Revisiting GRAS: Getting FDA’s Post-Market Review Right

Many food additives are classified as generally recognized as safe (GRAS) by the U.S. Food and Drug Administration (FDA), from familiar household items like vinegar and vitamin C to widely used commercial ingredients such as xanthan gum. A focus of the FDA under the current administration has been to revisit the GRAS approval (pdf) of many food chemicals currently on the market to reevaluate their safety on human health. This “post-market assessment” may include preservatives such as BHA (butylated hydroxyanisole) and BHT (butylated hydroxytoluene), as well as whitening agents like ADA (azodicarbonamide). It will also examine ingredients facing increased scrutiny at the state level and expedited federal review, including phthalates, propylparaben, and titanium dioxide.

Strengthening the post-market assessment process is a constructive step toward improving food safety and maintaining public trust. As FDA formalizes a more structured review framework—moving beyond its current case-by-case approach—it is essential that the process be rooted in sound scientific evidence and informed by the expertise of the food science community. Earlier this year, IFT submitted comments on FDA’s enhanced post-market assessment process (pdf) and the proposed prioritization tool (pdf), supporting the agency’s effort while recommending greater transparency, clearer evaluation criteria, and a framework that ensures scientific considerations appropriately drive decision-making.

To strengthen FDA’s post-market assessment framework, five priorities should guide its implementation:

1. Anchor prioritization in scientific evidence.
   Public health criteria should drive decisions about which food chemicals warrant review. Scientific considerations must be appropriately weighted to ensure substances with credible safety concerns are prioritized.
2. Increase transparency in signal monitoring and horizon scanning.
   FDA should clearly define the evidence thresholds, evaluation criteria, and data sources that trigger review. Public visibility into how ingredients are identified and prioritized will build trust and reduce ambiguity.
3. Establish a defined pathway for public input.
   Consumers and stakeholders should have a clear mechanism to submit concerns during the signal monitoring phase. Transparent engagement strengthens confidence in the review process.
4. Clarify prioritization criteria, timelines, and resource allocation.
   Providing insight into how chemicals are prioritized for review, how FDA staff and lab capacity constraints are managed, and how long reviews are expected to take will help set realistic expectations and improve accountability.
5. Engage the food science community through structured consultation.
   Ongoing dialogue with scientific experts—potentially through advisory mechanisms—can support prioritization decisions, inform appropriate review frequency, and provide technical guidance on complex or controversial topics. Sustained engagement helps ensure the framework remains scientifically rigorous over time.

Strengthening post-market review requires more than new tools—it requires sustained scientific engagement. For all of FDA’s review processes, pre- or post-market, the expertise of the food science community must remain central.

These issues will continue to shape conversations across the food system in the months ahead. At this year’s IFT FIRST Annual Event and Expo, scientific sessions will explore the impact of evolving regulatory actions on food safety and product development, including a keynote on food safety in a changing regulatory landscape and expert panels on building scientific consensus and science communication in an era of misinformation.

There has never been a more important time for the scientific community across the food, health, and wellness sectors to come together and make its voice heard. I hope you will join us in July in Chicago at IFT FIRST, where these critical conversations will continue. Registration opens in March.

Key Resources

• IFT Resources on Key Topics
• GRAS Overview (pdf)
• Food Additives Overview
• Food Additives Toolkit
• Rethinking GRAS Requires More Resources (Food Technology magazine)
• IFT Comments to FDA on Post-Market Assessment (pdf)
• IFT Top Food Trends for 2026 (Brain Food blog)
• 21 CFR Part 184: Direct Food Substances Affirmed as Generally Recognized as Safe