For 27 years food companies secretly declared their own ingredients safe, FDA now ending that

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