A proposed Food and Drug Administration rule meant to close a decades-old loophole that let companies add new chemicals to food without telling the agency would also quietly expand a separate exemption allowing some chemicals into food without pre-market safety review, according to analyses published October 4 through 10.
The backdrop is the “generally recognized as safe,” or GRAS, system. For nearly 70 years the FDA has relied on voluntary disclosure, letting manufacturers effectively self-certify new ingredients as safe without notifying the agency. More than a thousand chemical additives are present in the American food supply that have never undergone rigorous safety testing or received FDA approval, according to consumer advocates cited by The Center Square. On August 11, 2026, the FDA proposed a rule requiring companies to notify the agency when claiming a new additive is safe. Acting FDA Commissioner Kyle Diamantas called the shift a move to close “a decades-old information gap,” and the proposal is open for public comment.
But consumer groups say the proposal has no teeth. Brian Ronholm, director of food policy at Consumer Reports, told The Center Square the effort amounts to a “regulatory mirage”: a company that fails to notify the FDA would face no real penalty beyond being flagged as a higher risk for audit. Crucially, the rule would not apply retroactively to additives already on the market, including substances banned in other countries such as titanium dioxide, potassium bromate and propyl paraben.
The newest wrinkle, detailed in an October 10 analysis of the Federal Register filing, is that the same proposed rule would expand the agency’s “Threshold of Regulation” exemption — currently limited to trace levels of non-carcinogenic substances in food-contact materials — so that such chemicals could be added directly to food as flavorings, preservatives or emulsifiers if deemed to pose “no appreciable risk to human health.” Advocates noted the expansion was not mentioned in the administration’s public materials touting the rule as closing the GRAS loophole, and some accused officials of deception. The FDA did not respond to a request for comment, according to the report.
The rule is not final, and comments are due December 9. Susan Mayne, the FDA’s former food-program director and now a public health expert at Yale University, told the AP the proposal is “a reasonable first step towards a more complete inventory” — but cautioned that most self-affirmed GRAS ingredients will still never be reviewed for safety by the FDA.
