FDA has proposed making companies notify the agency before selling ingredients they deem “generally recognized as safe,” but the proposal would not require FDA approval and would let existing ingredients through without safety data. Comments are due December 9.
A company that has already put an ingredient into the food supply on its own judgment would not have to hand the Food and Drug Administration the safety data behind that judgment. It would have to say what the substance is, how it is used, and show it was already being sold. That is the transition clause in the proposed rule FDA published in the Federal Register on August 11, and it tells you the shape of what the agency is offering.
The proposal would end the voluntary system under which manufacturers can decide an ingredient is “generally recognized as safe,” or GRAS, and sell it without ever telling FDA. Notification would become mandatory. What would not change is who makes the safety call in the first place. The company still concludes its own substance is safe; FDA gets a copy. Comments are due December 9, and RIPIRG published an explainer today arguing the rule is a first step that stops well short of putting the agency in front of the ingredient before it reaches a shelf.
I read the proposed regulatory text, FDA’s current GRAS guidance, and the 2010 Government Accountability Office audit that first laid this gap out. The advocates are right about what the proposal does and does not do. The industry groups are right that GRAS is a statutory pathway with a real safety standard, not an absence of one. Both can be true, and the distance between them is the story.
A 1958 exception that became a pathway
Congress created the food-additive approval system in the Food Additives Amendment of 1958. Any substance intentionally added to food has to clear FDA premarket review, unless its use is generally recognized as safe by qualified experts. That exception was meant for the vinegar-and-salt category of ingredients with long histories in the kitchen. FDA still recognizes two routes to GRAS status: scientific procedures, or common use in food before January 1, 1958.
The standard is the same either way. FDA’s guidance says a GRAS use must meet the same “reasonable certainty of no harm” test as an approved food additive, and a scientific-procedures determination needs the same quantity and quality of evidence. The difference is who does the reviewing. For a food additive, FDA does. For a GRAS substance, the company does, relying on experts and information that are generally available and generally accepted.
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Since 1998, when FDA received its first GRAS notice, a company has been able to send the agency its conclusion voluntarily. FDA finalized that framework on August 17, 2016. The agency answers a filed notice in one of three ways: it has no questions, it finds the notice does not provide a sufficient basis, or it stops evaluating at the company’s request. A “no questions” letter, in FDA’s own words, is not an approval and not an FDA affirmation that the substance is GRAS. The guidance also says a company that correctly concludes its substance is GRAS does not have to wait for any response before marketing it.
And a company that never sends a notice? It can sell anyway. That is the pathway HHS Secretary Robert F. Kennedy Jr. directed FDA to explore eliminating on March 10, 2025.
What FDA says it does not know
GAO documented the problem sixteen years ago. Its February 2010 report found that FDA generally lacked information about GRAS determinations companies did not submit, had not systematically reconsidered the safety of GRAS substances since the 1980s, and did not randomly audit companies’ determinations. The last comprehensive review, by the Select Committee on GRAS Substances, produced 151 reports covering more than 400 substances between roughly 1972 and 1982. GAO’s recommendation that FDA obtain basic information about all GRAS determinations remains open on the agency’s tracking page.
The number that follows this issue everywhere, roughly 1,000 substances, comes from that era too. FDA’s proposal cites an estimate, as of January 2011, that more than 10,000 additives were used in food, including about 1,000 human-food substances for which companies had reached independent GRAS conclusions without notifying the agency. Pew Charitable Trusts published a similar estimate in 2013. FDA says the current number of substances entering the market under GRAS is unknown.
The regulator of the American food supply does not know how many ingredients are in it. That is FDA’s own description of the problem it now proposes to fix.
What the proposal would require
Under the proposed text, any person introducing a substance into interstate commerce under the GRAS provision would have to notify FDA of the basis for that conclusion. Submissions would go through FDA’s Centralized Online Submission Module unless a waiver is granted, with English translations of any foreign-language material. FDA would make an initial filing decision within 45 days. Once the agency files the submission as a GRAS notice, the notification requirement is met. FDA would then generally respond within 180 days, with the ability to extend that window by 90 days up to two times.
Notice the sequence. The obligation is satisfied at filing, before FDA has said a word about the science. Nothing in the proposed text converts GRAS into a premarket approval system, and FDA does not describe it as one. The agency’s stated purpose is to close information gaps, give itself and the public more to look at, and improve its ability to identify uses that may actually require food-additive approval.
The proposal also carves out a set of exceptions. No notice would be required for a use already covered by an FDA “no questions” letter, for substances listed or affirmed as GRAS in specified regulations, for certain uses previously considered through FDA processes, for threshold-of-regulation exemptions, for certain food-contact notifications, or for qualifying submissions under the transition program.
The transition program is the soft spot
That transition program is where RIPIRG’s criticism bites hardest, and the proposal supports it. For substances already in interstate commerce before a final rule takes effect, a company could file a time-limited streamlined submission instead of a full GRAS notice: identifying information, conditions of use, and evidence the substance was already on the market. FDA states expressly that this submission would not need to include the underlying safety data.
FDA would post qualifying information from those submissions on a public list. It also states, just as expressly, that posting would not mean FDA had reviewed the substance’s GRAS status. The result, if finalized as written, is a more complete inventory of what is in the food supply paired with an incomplete set of safety reviews. A longer list. Not a longer list of things FDA checked.
Dina Akhmetshina, a federal legislative advocate for U.S. PIRG, and Stephanie Seferian, deputy editor for the Public Interest Network, make three points in the RIPIRG explainer: mandatory notice does not eliminate what they call self-certification, it does not require FDA to evaluate a substance before it is marketed, and it does not address the backlog of substances already sold under independent GRAS conclusions. Akhmetshina made the same case in a U.S. PIRG statement on August 10, the day FDA announced the proposal, calling mandatory notification a first step.
The industry’s answer, and its limit
The strongest response comes from the companies themselves. The Consumer Brands Association says the consumer-packaged-goods industry supports greater transparency and mandatory notification for new GRAS ingredients, while rejecting the word “loophole” for a science-based statutory pathway. The Meat Institute called the proposal a “good first step” and said reforms should preserve a science-based, risk-based system along with innovation and affordable food.
On the standard, the industry has a point: GRAS is not lawlessness, and FDA holds GRAS uses to the same safety bar as approved additives. On the oversight, the answer is in FDA’s own filing. A safety bar no one outside the company is required to see cleared is a promise, not a check. GAO said as much in 2010, and its recommendation is still open.
RIPIRG’s explainer also promotes a citizen petition filed August 6, 2025, by former FDA Commissioner David Kessler, asking the agency to reconsider the GRAS status of specified refined carbohydrates used in industrial food processing. The petition argues those ingredients drive metabolic harm. That is the petitioner’s argument, and it is a separate matter from the notification rule, which does not decide the status of any particular ingredient.
Where Rhode Island sits
This is a federal question. Rhode Island’s Food Code, effective January 8, 2025, governs retail food establishments licensed by the Department of Health and adopts the 2022 FDA Food Code. RIDOH’s food-safety program inspects establishments, reviews facility plans, and regulates retail food safety. The upstream question of whether a manufacturer’s ingredient belongs in the national supply chain at all belongs to FDA. Products on Rhode Island shelves arrive through that interstate market, so what FDA does about GRAS reaches every checkout line in the state.
The proposal is docket FDA-2025-N-3262. Anyone can file a comment, electronically or in writing, through December 9. Whether the final rule requires companies to show their safety work on existing ingredients, or only to say those ingredients exist, is the question the agency is asking the public to weigh in on right now.
