CSPI Statement on FDA Proposed GRAS Pathway Rule

ALBANY, NY (08/10/2026) (readMedia)-- Today, the U.S. Food and Drug Administration officially announced plans to address the decades-old "generally recognized as safe" (GRAS) pathway, which currently allows food and beverage companies to independently self-certify the safety of the chemicals they add to food without even notifying the FDA. The proposed rule, not yet finalized, would require mandatory GRAS notification to FDA for new substances and uses moving forward, but lacks clear enforcement mechanisms and leaves a major gap for the thousands of chemicals already used in food.

According to data from The Pew Charitable Trusts, more than 70% of American adults are concerned about dangerous chemicals in the nation's food supply and 5 in 6 want government and businesses to do more on chemical safety and transparency. Albany lawmakers have already passed nation-leading legislation that would strengthen industry transparency standards and help clean up New York's food supply: the Food Safety and Chemical Disclosure Act (S1239F/A1556G). It is currently awaiting final signature from Governor Hochul.

CSPI Director of Regulatory Affairs Sarah Sorscher issued the following statement in response:

"The Center for Science in the Public Interest recognizes the FDA's proposed rule to reform the long-exploited GRAS loophole as an important step forward. However, it leaves a major gap: FDA still won't have the full picture of the safety of chemicals currently in our food supply. That makes New York's Food Safety and Chemical Disclosure Act even more important. The bill would give New York regulators and the public access to the safety evidence behind GRAS substances already in our food supply. Now isn't the time for state leaders to stop their work to improve the food system. We urge Governor Hochul to lead the way in protecting New Yorkers by signing this bill into law immediately."

Sponsored by Senator Brian Kavanagh and Assemblymember Dr. Anna Kelles, the Food Safety and Chemical Disclosure Act would require manufacturers to disclose safety data for chemicals that have bypassed the FDA's formal safety review, and ban harmful additives Red No. 3, potassium bromate, and propylparaben in foods sold statewide.

Even with FDA's new GRAS proposal, this legislation is critical. The agency's proposal may never be finalized, particularly with an administration hostile to new safety regulations and a powerful food industry poised to oppose it. If finalized, the proposed rule will still allow companies to sell products before or during the process of submitting a GRAS notice to FDA. There's no requirement for companies to get FDA approval before marketing new chemicals, which is one of the fundamental flaws in the existing system. For chemicals already in use, the proposal would not require companies to submit the underlying safety data supporting GRAS determinations.

New York's Food Safety and Chemical Disclosure Act would provide real transparency for GRAS substances already on the market by requiring safety evidence supporting GRAS determinations to be submitted to the state and published publicly. This would give regulators and the public meaningful information to evaluate the safety of chemicals already in our food supply - something FDA's proposed process would not guarantee. Until a strong federal policy is finalized and implemented, states must continue to lead the way on ensuring transparency and safety in the food supply. Signing the Food Safety and Chemical Disclosure Act will keep pressure on the FDA to deliver meaningful safety reforms.

BACKGROUND

The Food Safety and Chemical Disclosure Act (S1239F/A1556G): Ends the secrecy of a federal loophole that allows companies to self-designate their ingredients as "generally recognized as safe" or GRAS without adequate FDA oversight. The bill requires companies to disclose evidence confirming the safety of food chemicals that bypass the FDA's safety review. It also prohibits the use of three harmful additives in foods sold statewide. By implementing commonsense transparency requirements for chemical use in foods and eliminating unsafe additives, the bill aims to improve health outcomes and protect New York consumers from health harms like cancer and developmental delays.

Why Food Safety Regulation Is Urgent:

• Dangers in the Nation's Food Supply: Americans are regularly exposed to food chemicals with known health concerns, some of which have been banned throughout the European Union, Canada, China, and other countries. Additives like Red No. 3, potassium bromate, and propylparaben have been linked to cancer, hormone disruption, and other serious conditions – yet they remain legal in the U.S.
• Federal Inaction: According to a 2024 American Journal of Public Health analysis, the FDA rarely re-evaluates or revokes GRAS status, even as new research raises concerns about the safety of long-used chemicals. Simultaneously, the FDA's food safety program has been severely weakened by ongoing layoffs, structural reforms, and workforce instability, limiting its ability to inspect, regulate, or enforce food safety standards.