For decades, food companies have been able to decide on their own that an ingredient is safe, put it into American food and never tell the Food and Drug Administration.
The Trump administration moved Monday to close that gap.
The FDA proposed requiring manufacturers to notify the agency when they conclude that a substance is “Generally Recognized as Safe,” or GRAS, and provide the scientific basis supporting that conclusion. The system is currently voluntary.
If finalized, the rule would give the FDA something it does not have today: a much fuller picture of the ingredients entering the U.S. food supply without traditional food-additive approval.
Nothing changes on grocery shelves immediately. The proposal is scheduled for publication in the Federal Register on August 11 and must go through the federal rulemaking process before it can become binding.
The distinction matters. The FDA is not proposing to eliminate GRAS, nor would every new ingredient require traditional FDA premarket approval.
Companies could still conclude that an ingredient qualifies as GRAS when qualified experts generally recognize it as safe for its intended use. What would disappear is the ability to make that determination privately and never notify the government.
“By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply,” Acting FDA Commissioner Kyle Diamantas said in announcing the proposal.
The GRAS exemption dates to 1958 and was designed to exempt substances whose safety was already generally recognized. Over time, however, manufacturers increasingly used independent GRAS conclusions for newer ingredients.
FDA currently encourages companies to submit their conclusions voluntarily. When they do, the agency reviews the supporting information and can say it has no questions, determine that the filing does not establish an adequate GRAS basis, or stop reviewing the notice at the company’s request.
But a manufacturer that does not voluntarily notify FDA can currently market an ingredient based on its own GRAS conclusion, provided it is legally supportable.
That is the part the administration wants to change.
FDA’s own economic analysis estimates that roughly 2,000 substances already entered interstate commerce based on independent GRAS conclusions, with the agency estimating the actual number could range from approximately 1,000 to 3,000.
For those already-existing ingredients, the proposal would create a temporary streamlined reporting process. Companies would submit information describing substances and their existing uses, giving FDA and the public visibility into products that may have been sold for years without a GRAS notice.
For new uses going forward, companies covered by the rule would generally have to submit a full GRAS notice rather than keeping the determination entirely inside company files.
That means more paperwork for manufacturers, ingredient suppliers and food companies — and a much larger public record.
FDA maintains a public inventory for GRAS notices it receives. Expanding mandatory reporting would make information about substantially more ingredients, their intended uses and the reasoning behind their safety determinations visible to regulators, retailers, competitors, researchers and consumers.
The proposal could also expose weak safety determinations. FDA says mandatory notification would allow it to identify cases where there is insufficient scientific support for a GRAS conclusion and determine whether an ingredient instead requires formal food-additive approval.
That does not mean FDA will approve every GRAS ingredient before it reaches stores. GRAS substances would continue to operate under a different legal framework from conventional food additives.
But manufacturers would no longer have the same ability to operate outside the agency’s view.
The compliance burden could be substantial. FDA estimates the rule would have a significant economic impact on many small businesses and projects annualized industry and government costs in the millions of dollars, with a larger one-time burden as companies inventory existing ingredients and reconstruct older safety records.
That could be particularly difficult for businesses relying on GRAS determinations made years or decades ago.
The rule also raises a larger legal and regulatory fight. Food manufacturers have long argued that GRAS is not a loophole but an exemption written into federal law by Congress. The administration is attempting to require notification without transforming GRAS into a full approval program, a distinction that could become important if industry groups challenge the final rule in court.
Separately Monday, HHS and the Agriculture Department said they submitted the federal government’s first proposed definition of “ultra-processed foods” for final review.
The definition itself has not yet been released.
The two moves point in the same direction: Washington is preparing to take a more active role in determining what ingredients are in processed foods, how those ingredients entered the market and how much information manufacturers must disclose.
For consumers, there is no immediate ban and no overnight reformulation of supermarket products.
For the food industry, however, the direction is clear: the era in which a company could make a GRAS determination entirely behind closed doors may be coming to an end.
JBizNews Desk | Washington
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