FDA Launches Major Post-Market Review of Food Chemicals Approved Decades Ago
The chemical preservative in your breakfast cereal was approved when Dwight D. Eisenhower was president—and it hasn't been formally reviewed since.
On May 15, 2025, the FDA announced its most significant expansion of food chemical oversight in decades: a comprehensive post-market review program targeting legacy chemicals that have remained in the U.S. food supply for 60+ years without modern safety reassessment. The program directly challenges the GRAS (Generally Recognized As Safe) loophole that has allowed substances like BHA, BHT, and titanium dioxide to persist indefinitely after their initial approval in the 1950s and 1960s.
For consumers, this represents a potential turning point. For decades, Americans have been exposed to food additives approved when safety testing standards were far less rigorous than they are today. The FDA's new program signals the end of the "approve and forget" era—and the beginning of systematic, science-based reassessment.
The Chemicals Under Review: A Troubling Legacy
The FDA's review list includes several high-profile additives that have drawn increasing scrutiny from scientists and regulators worldwide:
BHA (Butylated Hydroxyanisole)
Originally classified as GRAS in 1958 and approved as a food additive in 1961, BHA is a synthetic antioxidant used to prevent oils and fats from going rancid. It's found in everything from breakfast cereals to snack foods to preserved meats.
The concern: In 2011—fourteen years ago—the National Toxicology Program listed BHA as "reasonably anticipated to be a human carcinogen" based on animal studies showing tumor formation. Despite this classification, BHA has remained in widespread use while the FDA took no formal action—until now.
BHT (Butylated Hydroxytoluene)
BHT, a companion preservative to BHA, received its original approval in the 1960s. While less studied than BHA, it has been linked to endocrine disruption concerns and potential developmental effects in animal research.
Titanium Dioxide
Perhaps the most striking example of regulatory divergence, titanium dioxide (used as a whitening agent in products like chewing gum, candies, and sauces) was banned in the European Union in 2022 after the European Food Safety Authority concluded it could no longer be considered safe. The ban followed concerns about nanoparticle accumulation and potential DNA damage.
It remains legal in the United States.
Azodicarbonamide (ADA)
Known infamously as the "yoga mat chemical," ADA has been used as a dough conditioner and whitening agent since the 1960s. It breaks down during baking into compounds that have raised respiratory and toxicity concerns.
Phthalates
These chemicals, used in food packaging and processing equipment, have been linked to hormone disruption and developmental effects. Unlike direct food additives, they migrate into food from contact materials—making them harder for consumers to identify and avoid.
How the GRAS Loophole Enabled Decades of Inaction
To understand why these chemicals persisted so long without review, you need to understand the GRAS system.
When Congress passed the Food Additives Amendment of 1958, it created two pathways for substances to enter the food supply:
The FDA approval pathway: Manufacturers petition the FDA for approval, and the agency conducts a safety review.
The GRAS pathway: Substances "generally recognized as safe" by qualified experts could bypass formal FDA review. This was intended for obviously safe ingredients like salt and vinegar.
Over time, the GRAS pathway expanded dramatically. The FDA allowed companies to self-affirm GRAS status without even notifying the agency—a practice that consumer advocates have long criticized as a major loophole.
The result: Thousands of chemicals entered the food supply with minimal oversight, and many have never been revisited despite dramatic advances in toxicology and safety science.
What the New Program Changes
The FDA's Post-Market Chemical Review Program, announced May 15, 2025, introduces several significant changes:
- A modernized prioritization process that weighs new scientific evidence, exposure levels, and vulnerable populations
- An updated public list of chemicals under active review, creating transparency around what the agency is evaluating
- Accelerated reviews for high-profile substances with clear safety signals
- Regular public updates on evaluation progress, including anticipated timelines
The program specifically targets chemicals now flagged by modern toxicology research—those where the weight of evidence has shifted since their original approval.
The EU vs. US Divide: A Case Study in Regulatory Divergence
The titanium dioxide case illustrates a growing gap between American and European food safety regulation.
In 2022, the European Commission banned E171 (titanium dioxide) as a food additive after EFSA concluded that genotoxicity concerns could not be ruled out. The ban followed a comprehensive reassessment that found nanoparticles of titanium dioxide could accumulate in the body and potentially damage DNA.
Three years later, American consumers can still find titanium dioxide in chewing gum, salad dressings, and candy coatings.
This regulatory divergence isn't unique to titanium dioxide. The EU has banned or restricted numerous food dyes, preservatives, and other additives that remain legal in the U.S. The FDA's new review program may begin closing this gap—but only if it leads to meaningful action.
Important Context: What This Review Means—and Doesn't Mean
Review is not the same as a ban. The FDA has emphasized that placing a chemical under review does not automatically mean it will be prohibited. The process involves:
- Comprehensive evaluation of all available safety data
- Assessment of actual exposure levels in the food supply
- Consultation with external scientific experts
- Public comment periods
Timelines remain unclear. The FDA has not specified how long individual reviews will take or when decisions on specific chemicals will be announced. The process could take months—or years.
Industry resistance is expected. Food manufacturers have legitimate concerns about reformulation costs, supply chain disruption, and shelf-life impacts. Some may proactively reformulate before any regulatory requirement; others may resist changes that affect product profitability.
Key Takeaways
| What changed? | The FDA launched its first systematic post-market review program for legacy food chemicals on May 15, 2025. |
| What's being reviewed? | BHA, BHT, titanium dioxide, azodicarbonamide, phthalates, and other chemicals approved 60+ years ago. |
| Why now? | Modern toxicology has flagged safety concerns that weren't evident when these chemicals were originally approved. |
| Is this a ban? | No—review does not mean automatic prohibition. The process will take time and involve public input. |
| What's different in Europe? | The EU banned titanium dioxide in 2022; it remains legal in the U.S. despite similar safety concerns. |
| What should consumers do? | Stay informed, read labels, and understand that the review process signals change—but not immediate change. |
Sources
FDA Official - Chemicals Under Review
https://www.fda.gov/food/food-chemical-safety/list-select-chemicals-under-fda-reviewFDA Press Release - Program Launch (May 15, 2025)
https://www.fda.gov/news-events/press-announcements/fda-advances-robust-transparent-post-market-chemical-review-program-keep-food-supply-safe-andMichael Best Food & Beverage Regulatory Update
https://www.michaelbest.com/insights/food-beverage-regulatory-update-may-2025/Food Safety News - BHA Review
https://www.foodsafetynews.com/2026/02/fda-announces-review-of-bha/US News & World Report - Health
https://www.usnews.com/news/health-news/articles/2026-02-11/fda-reviews-safety-of-food-preservative-bha-over-cancer-concernsNational Toxicology Program - BHA Classification
https://ntp.niehs.nih.gov/go/roc14