FDA regulatory designation allowing food additives to bypass full safety testing if manufacturers determine they are 'generally recognized as safe' by qualified experts, based on long history of use or scientific evidence.
GRAS (Generally Recognized as Safe) is a regulatory classification established by the FDA under the 1958 Food Additives Amendment that permits certain food additives to be used without formal FDA approval or pre-market testing. Under GRAS designation, manufacturers can self-certify that substances are safe based on either extensive history of safe use in food or established scientific evidence reviewed by qualified experts. This process was intended to streamline regulation of substances with long-standing safety records, such as salt and vinegar.
However, GRAS determinations have become controversial due to minimal FDA oversight and industry influence on the determination process. In 2010, the FDA acknowledged that companies frequently submit GRAS determinations to the agency for procedural review without independent scientific validation. Notable examples include trans fats (partially hydrogenated oils), which received GRAS status and remained in food supplies until 2018, and high-fructose corn syrup, approved as GRAS in 1983. An investigative review by the Government Accountability Office documented instances where GRAS designations relied on undisclosed studies or experts with conflicts of interest, raising questions about the adequacy of the self-certification model for protecting consumer health.
