GRAS Loophole Allows Thousands of Untested Food Additives in US

The 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act created two pathways: one requiring FDA safety review for new additives, and a 'generally recognized as safe' (GRAS) exemption for common ingredients like vinegar. However, the GRAS pathway has been exploited by food companies to introduce thousands of industrially produced chemicals without FDA notification or public disclosure. Companies self-determine GRAS status using unpublished studies and industry-paid expert panels. The Trump administration, via Health Secretary Robert F. Kennedy Jr., directed the FDA in March to explore closing this loophole. NYU professor Jennifer Pomeranz notes that the FDA has been historically slow to act, citing the 30-year struggle to remove partially hydrogenated vegetable oil (trans fat), which was not fully banned until 2023. The Consumer Brands Association defends industry practices, claiming strict safety protocols. Pomeranz emphasizes that even if new rules require pre-market notification, ingredients already in the supply chain remain unaddressed, and FDA funding for review is uncertain. User fees, similar to those paid by pharmaceutical companies, have been proposed to fund the process.