A company can decide on its own that a new food ingredient is safe, put it into products sold nationwide, and never tell the Food and Drug Administration it exists. That is not a violation of the rules. It is the rules.
The mechanism is called self-affirmed GRAS, short for generally recognized as safe. Under current regulations, a company can convene a panel of experts, conclude an ingredient meets the safety standard, and market it without notifying the agency. There is no requirement to submit anything and no public database of self-affirmed ingredients.
That may change, though not soon. FDA has a proposed rule tracked under RIN 0910-AJ02 in the federal regulatory agenda that would require notification for certain uses of food substances.
Pathway That Requires No Federal Sign-Off
The framework dates to the 1958 Food Additives Amendment, which requires premarket approval of anything intentionally added to food unless the substance is generally recognized as safe. The exemption was intended for ingredients with long histories of safe use, things like vinegar, salt, and spices.
The self-affirmation route emerged from regulations in the 1970s. Two pathways exist today. A company can voluntarily submit a GRAS notice to the FDA, which reviews it and may issue a letter stating it has no questions. Those notices and responses are public. Or a company can self-affirm, which requires a safety assessment by a scientific panel that may include the company's own employees, with no filing and no disclosure.
Self-affirmation is faster, cheaper, and protects proprietary information. A company facing a formal review timeline and a competitor who skips it entirely faces an obvious incentive.
Over time, the exemption became a primary route for introducing novel, highly processed substances rather than the narrow carve-out for familiar ingredients it was designed to be.
Scale of What Regulators Cannot See
The honest answer to how many self-affirmed ingredients are in the food supply is that nobody knows, including the FDA. That is the structural problem.
Estimates of substances added to food under the GRAS umbrella run into the thousands. Because there is no registry, the agency cannot produce a list, which becomes visible during safety events when regulators cannot quickly identify which products contain an ingredient of concern.
FDA's oversight of these substances is postmarket. If evidence emerges that an ingredient is unsafe, the agency can act against products containing it, but that action comes after the ingredient is already in circulation and often after people have consumed it for years.
States have moved into the gap. Legislation in New York, Pennsylvania, California and New Jersey would require companies to report ingredient information at the state level, with several bills covering substances already on the market, according to a review of state activity. A patchwork of state disclosure rules is now a realistic near-term outcome regardless of what happens federally.
Proposed Rule, Its Delays and Its Legal Vulnerability
The federal proposal has slipped repeatedly and narrowed along the way, and its details matter.
The effort began in March 2025, when HHS Secretary Robert F. Kennedy Jr. directed FDA to explore eliminating the self-affirmed pathway. The rule was submitted to the Office of Management and Budget for interagency review in December 2025 and was originally targeted for October 2025, then the spring 2026 agenda. It is now pushed back to December, a delay the Environmental Working Group criticized as leaving consumers waiting on a broken system.
Readers should be clear on what December would actually be. It is when the comment period opens, not a compliance deadline, with a final rule estimated two to three years out.
The most consequential element is a presumption. Under the agenda entry, uses of food substances would be presumed not to be GRAS unless the mandatory notification requirement has been met. That reverses decades of practice, under which the burden sat with the agency to demonstrate a problem.
The scope remains genuinely unsettled. The agenda refers to "certain uses," while FDA said in February 2026 that the rule would require notices for all new substances claimed to be GRAS. Attorneys have flagged that the proposed rule itself will be needed to reconcile the two. The agenda also suggests a possible transition mechanism for existing determinations, including streamlined submissions available for a limited window rather than forcing every existing self-affirmed conclusion through full notification.
The rule faces a real legal question. In the preamble to its 2016 GRAS final rule, FDA stated that it lacks express statutory authority to require companies to submit GRAS notices. Industry attorneys have flagged that admission, and courts no longer defer to agency interpretations of ambiguous statutes, which raises the likelihood of litigation.
Readers should treat this as proposed rather than settled. It has not been published, has not gone through comment, and has not taken effect.
Where Shoppers Can Actually Look
Consumers have fewer tools than they should, but the ones that exist are worth knowing.
The FDA GRAS Notice Inventory on the agency's website lists every ingredient a company voluntarily submitted for review, along with the agency's response. It is searchable by substance. Its limitation is fundamental: it contains only what companies chose to submit, so an ingredient's absence proves nothing.
The ingredient list on a package remains the most direct tool. Every intentionally added substance must be declared, though names are often unfamiliar. Searching an unfamiliar ingredient name alongside the term GRAS notice will show whether FDA has reviewed it.
Practical framing helps more than ingredient-by-ingredient investigation. Products with short ingredient lists made from recognizable whole foods contain fewer novel additives by definition. That is a reasonable heuristic, not a safety guarantee, and it is not an argument that every additive is dangerous. Most have been used for decades without evidence of harm.
Anyone who believes a food caused a reaction can report it to FDA through the MedWatch program or a district consumer complaint coordinator. Those reports feed the postmarket signal system the agency currently relies on.
People with food allergies, celiac disease, or other dietary medical needs should continue working from allergen declarations and clinician guidance rather than from GRAS status, which addresses general population safety rather than individual sensitivity.
The bottom line: companies can currently introduce food ingredients without notifying FDA, no complete public list exists, a proposed rule expected in December would require notification but opens a comment period rather than a deadline, its scope and legal authority remain contested, and the most useful consumer tools remain the ingredient list and the GRAS Notice Inventory.
Key Questions Answered
What does GRAS mean? Generally recognized as safe. It is an exemption from FDA premarket approval for substances added to food, created by the 1958 Food Additives Amendment.
What is self-affirmed GRAS? A company convenes an expert panel, concludes its ingredient is safe, and markets it without notifying FDA. There is no filing requirement and no public disclosure.
How many self-affirmed ingredients are in the food supply? Nobody knows, including FDA, because no registry exists. Estimates run into the thousands.
Does GRAS mean an ingredient is unsafe? No. GRAS substances must meet the same safety standard as approved additives. The concern is about who verifies that determination and whether the public can see it.
What would the proposed rule do? Require notification for certain uses of food substances and presume those uses are not GRAS unless notification is made. It has slipped from an original 2025 target and is now expected in December.
When would it take effect? Not soon. Publication would open a comment period, with a final rule estimated two to three years afterward. The scope and FDA's statutory authority are both contested.
Where can consumers look up an ingredient? The FDA GRAS Notice Inventory lists voluntarily submitted ingredients and the agency's responses. It does not include self-affirmed ingredients.
