Technology and Science10 August, 20263 min read
Trump Administration FDA Proposes Rule Requiring Manufacturers To Notify GRAS Additives
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FDA proposes manufacturers notify FDA when using GRAS ingredients in foods. Rule does not create new premarket review; adds required information on GRAS determinations.
GRAS notification proposal
The Trump administration, via the U.S. Food and Drug Administration, proposed a rule that would require food manufacturers to notify the FDA when they deem additives as “generally recognized as safe,” or GRAS, and to provide information on existing additives.
NBC News reported that under the proposal manufacturers would have to notify the FDA, but critics said it would not prevent companies from self-affirming new ingredients and would not remove “the many thousands of additives already in foods.”
Acting FDA Commissioner Kyle Diamantas said the FDA lacks “a complete inventory of substances in the domestic food supply” because manufacturers can self-affirm GRAS status without informing the agency.
The FDA’s plan would also require a pre-filing decision within 45 days and a more substantive review within 180 days, with the FDA able to ask for more information or determine the application hasn’t met GRAS criteria.
CNN added that the rule is still only a proposal and will be subject to industry and public comment over the months to come, even as acting FDA Commissioner Kyle Diamantas said it “lays a blueprint designed to work effectively for FDA oversight, responsible industry, and consumer safety advocates alike.”
Critics, advocates, and limits
Public health experts and food scientists criticized the proposal as a first step that still leaves companies able to self-affirm safety, with Alyssa Moran saying, “It does require mandatory notification, but my understanding is that there’s not even a timeline for notification.”
Jennifer Pomeranz, speaking to NBC News, said the rule was “an incredibly important first step” but pressed on what data would be required for ingredients already in the food supply.
STAT reported that Peter Lurie, president of the Center for Science in the Public Interest, said, “Mandatory without enforcement is not mandatory at all,” in a statement.
CNN quoted Robert F. Kennedy Jr. saying, “Industry hijacked the loophole and drove a convoy of chemical trucks through it, straight into the American food supply,” and added that the FDA was left with a “major blindspot.”
Vani Hari, popularly known as the FoodBabe, told STAT that the biggest benefit would be “transparency, so we can know what we are eating,” while also describing the current scheme as allowing thousands of chemical additives to enter the U.S. food supply “without any vetting of their health effects.”
What changes next
The FDA proposal would shift GRAS from a voluntary framework toward mandatory notification, with Food Dive describing that all manufacturers introducing a new ingredient under the newly proposed GRAS pathway would need to notify the FDA and provide why the company believes the product is safe. Food Dive said safety information provided by companies would be housed in public online inventories to “ensure greater transparency” for consumers, while also giving the FDA more visibility to make post-market safety determinations. CNN reported that Kennedy also announced a federally recognized definition for ultraprocessed foods is under “final review,” though the text was not provided and a spokesperson for the Department of Health and Human Services did not give a timeline for when it would be made public.
Spectrum News 13 said Kennedy stated the FDA does not know exactly how many ingredients are in the U.S. food supply, saying it could be anywhere between 4,000 and 12,000, and he tied the GRAS loophole to that “major blind spot.” In a statement carried by Spectrum News 13, Consumer Brands Association Executive Vice President Rhonda Bentz said, “America’s packaged food supply is safe and has been a staple in American households for decades,” while also warning that any so-called definition that captures “80% of the nation’s food supply” would be “fundamentally flawed.”