By Julie Holt, Global Advisory Services Director
FoodChain ID experts in Regulatory and Scientific Consulting offer global guidance to meet the evolving demands of the food and beverage marketplace.
In a renewed push to enhance food safety and regulatory transparency, Senator Edward Markey (D-MA) has reintroduced the Ensuring Safe and Toxic-Free Foods Act of 2025, building upon a version first unveiled in December 2023. The proposed legislation aims to significantly overhaul how substances are determined to be Generally Recognized as Safe (GRAS) under the Federal Food, Drug, and Cosmetic Act (FD&C Act)—a move that could carry major implications for food manufacturers, suppliers, and regulatory professionals alike.
Key Provisions: Closing the Self-GRAS “Loophole”
At the heart of the bill is a shift away from the current framework that allows companies to independently designate food ingredients as GRAS without formal FDA review or public disclosure. Under the proposed act:
- All GRAS determinations would require prior notice to the FDA, supported by comprehensive scientific evidence.
- Supporting information would be publicly available via the FDA’s website, with a mandatory 60-day public comment period.
- Any substance identified as carcinogenic, linked to reproductive or developmental toxicity, or deemed hazardous by established regulatory bodies would be automatically disqualified from GRAS status.
- Individuals with conflicts of interest would be barred from participating in GRAS review panels.
These measures reflect growing concern among lawmakers, regulators, and advocacy groups that the current GRAS process lacks sufficient transparency and accountability.
GRAS Sunset and Submission Requirements
A significant addition in the 2025 version of the act is a proposed sunset of the GRAS notification process:
- Within two years of enactment, new self-affirmed GRAS notifications would no longer be accepted.
- Manufacturers would be required to submit notifications for all existing self-GRAS ingredients, with specific data requirements outlined in the bill.
- The FDA would be tasked with reviewing at least 50 GRAS substances annually until the backlog is cleared, and all outcomes would be made public.
Importantly, the bill does not include a “grandfathering” provision. This means that even substances currently on the market under self-GRAS designations must be re-evaluated and formally submitted for FDA review.
Regulatory Patchwork: The State vs. Federal Divide
Notably, the bill does not contain a federal preemption clause—a decision that could increase regulatory complexity for industry stakeholders. In the absence of federal preemption, states would remain free to enact and enforce their own GRAS-related regulations. This would likely expand the current patchwork of additive restrictions, further burdening food manufacturers who operate across state lines.
Political Momentum and Industry Outlook
The proposed legislation comes at a time of increased bipartisan attention to food ingredient safety, driven in part by broader public health initiatives such as the Make America Healthy Again (MAHA) campaign. Endorsements from consumer advocacy groups—including the Environmental Working Group (EWG) and the Center for Science in the Public Interest (CSPI)—underscore the mounting pressure on lawmakers to close what many call the GRAS “loophole.”
While previous efforts at GRAS reform have stalled, this version of the bill may gain traction amid evolving political and consumer priorities. Food industry professionals should prepare for potential shifts in compliance expectations, ingredient sourcing, and labeling requirements.
What Comes Next?
Whether this legislation advances or not, its introduction signals a clear message: the GRAS framework is under scrutiny, and the regulatory status quo may be poised for significant change. Stakeholders across the supply chain—R&D teams, regulatory affairs departments, quality managers, and legal advisors—should monitor this bill’s progress closely and assess its potential operational impacts.
About the Author
Julie Holt is a subject matter expert in the areas of food and beverage, additives, and regulatory strategy. She has beverage industry expertise and currently provides consulting support across multiple beverage categories. Ms. Holt has more than 25+ years of regulatory experience in the food and food ingredients industries and managed her own advisory firm, Scientific & Regulatory Solutions LLC, prior to joining FoodChain ID. As a consultant, Julie supported several food and beverage clients including a Fortune 50 company. Julie has provided global regulatory knowledge covering more than 200 countries.