Highlights
- The U.S. Food and Drug Administration (FDA) has announced a new initiative to systematically review the safety of chemicals already in the nation's food supply.
- This effort marks one of the most significant changes in food chemical regulation in decades and signals a shift toward proactive scrutiny of chemicals by the FDA.
In an attempt to revamp food safety oversight in the U.S., the U.S. Food and Drug Administration (FDA) has announced a new initiative to systematically review the safety of chemicals already in the nation's food supply. This effort marks one of the most significant changes in food chemical regulation in decades and signals a shift toward proactive scrutiny of chemicals by the FDA.
A New Era of Accountability in Food Safety
Historically, the FDA's post-market chemical reviews have largely been reactive – triggered by citizen petitions, new studies or public outcry.
The new framework, announced May 15, 2025, under the leadership of U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin Makary, initiates a proactive, comprehensive review process with an eye toward public health – under the intent of improving consumer confidence in the nation's food supply.
"We're taking decisive action and using every authority we have to clean up the food supply and protect American families, " said Secretary Kennedy.
Key Components of the New Framework
The FDA plans to implement several cornerstone actions in the coming months:
- Modernized Prioritization Scheme. A draft framework outlining how the FDA will identify and prioritize chemicals for review will soon be released for public comment.
- Systematic Post-Market Review Process. For the first time, the FDA will adopt a standardized methodology for reviewing chemicals, incorporating stakeholder feedback to promote a transparent and inclusive approach.
- Updated Chemical Review List. High-profile additives such as butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA) and azodicarbonamide (ADA) will be among the first to undergo expedited review. The agency will also fast-track its evaluation of phthalates, propylparaben and titanium dioxide.
This initiative is part of a broader FDA campaign to modernize food chemical oversight. In recent months, the agency has moved to phase out petroleum-based synthetic dyes and has initiated preliminary steps to reform the Generally Recognized As Safe (GRAS) designation process, which currently allows companies to self-affirm ingredient safety without FDA approval.
Intersection with EPA Oversight: Navigating Federal, State and Global Chemical Regulation
As the FDA intensifies its post-market review of food additives and food-contact substances, businesses must navigate a growing web of overlapping chemical regulations. The U.S. Environmental Protection Agency (EPA) plays a key role under the Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), with increasing alignment through a formal Memorandum of Understanding with the FDA – particularly around substances such as phthalates, per- and polyfluoroalkyl substances (PFAS), bisphenols and titanium dioxide.
Key Regulatory Layers
- The FDA (under the Food, Drug, and Cosmetic Act) and EPA (via TSCA and FIFRA) now share responsibilities and data in assessing chemical risks, requiring businesses to track evolving standards and enforcement.
- States such as California (Prop 65), Maine, New York and Washington are enacting chemical disclosure laws, bans and priority lists – sometimes ahead of federal rules.
- The European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Food Contact Materials frameworks, along with new rules in Canada and Japan, increasingly impact U.S. exporters, especially those using substances of very high concern.
Strategic Legal and Regulatory Implications
From a regulatory standpoint, the FDA's actions signal increased scrutiny and potentially greater compliance burdens for food manufacturers and chemical suppliers. Companies should anticipate:
- more rigorous safety assessments for food ingredients previously considered low-risk
- greater public visibility into regulatory decisions, including new avenues for public comment
- a possible reevaluation of GRAS notifications, particularly those made without robust scientific substantiation
For stakeholders in the food, chemical and regulatory compliance sectors, this evolving landscape presents both risk and opportunity. Early engagement with the FDA's proposed frameworks and active participation in public comment periods will be critical.
Compliance now demands a cross-jurisdictional approach. Companies need legal support to:
- align products with both FDA and EPA expectations
- manage state-level bans and chemical lists
- anticipate EU and global compliance needs
- engage in risk communication and regulatory advocacy
The developments in recent months mark a pivotal time for food regulation in the U.S. The proposed new frameworks could influence everything from ingredient labeling to product liability exposure and class-action risk.
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