September 1, 2025
An estimated 1,000+ substances entered the food supply through the self-affirmed GRAS loophole without FDA review
Congress created the GRAS (Generally Recognized as Safe) designation in the Food Additives Amendment of 1958 to exempt common substances like salt and vinegar from formal approval
In 1997, FDA replaced the resource-intensive GRAS affirmation petition process with a voluntary notification program, allowing companies to self-affirm GRAS status without any FDA notification
FDA codified the voluntary notification system in a 2016 final rule, making self-affirmation official policy
An estimated 1,000+ GRAS determinations were made by food companies without FDA ever being notified, according to a 2010 GAO report
EWG found that since 2000, industry has greenlighted nearly 99% of new food chemicals without federal safety review through self-affirmed GRAS
On March 10, 2025, HHS Secretary RFK Jr. directed FDA to explore rulemaking to eliminate the self-affirmation pathway
In September 2025, FDA announced a Notice of Proposed Rulemaking (NPRM) to require mandatory GRAS notifications
On December 1, 2025, FDA sent its proposed GRAS rule to the White House OIRA for review
Senator Roger Marshall introduced S. 3122, the Better Food Disclosure Act, on November 6, 2025
Under the proposed rule, companies would have a two-year grace period to file GRAS notices for ingredients already in the food supply
HHS Secretary who directed FDA to eliminate self-affirmed GRAS on March 10, 2025
Agency division responsible for drafting the proposed GRAS mandatory notification rule
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White House office that reviews proposed rules before publication in the Federal Register