The GRAS Loophole Is Closing. Food Companies Have Until December 9 to Weigh In.

When we covered the Able Groupe felony conviction this spring, we noted that the FDA was moving toward a proposed rule that could eliminate the self-affirmation pathway for food ingredients. On August 10, 2026, that rule arrived.

The FDA is proposing to require the submission of GRAS notices for any human or animal food substance a company has concluded is Generally Recognized as Safe under the conditions of its intended use. The proposal would amend 21 CFR parts 170 and 570 and is published in the Federal Register at 91 FR 51834 under Docket No. FDA-2025-N-3262.

For 68 years, a food company could conclude on its own that an ingredient was GRAS, document that conclusion internally, and put the product on a shelf without ever telling the FDA. The agency is proposing to end that.

If your company is relying on a self-affirmed GRAS file that has been sitting untouched since 2012, the FDA is proposing to make you hand it over. The comment period closes December 9, 2026.

What the Proposed Rule Actually Does

The FDA describes three major provisions. The proposed rule, if finalized, would:

•    Convert the voluntary GRAS notification program to a mandatory one, and treat failure to meet the notification requirement as a factor in how the agency prioritizes food substances for post-market review.

•    Establish exceptions to the notification requirement, including a time-limited option to make a streamlined submission for certain intended uses of substances already in interstate commerce.

•    Revise the threshold of regulation exemption for human food to cover uses of substances in food as well as food contact substances.

One detail that catches companies off guard: the rule covers both ingredients and substances added indirectly, such as from food packaging. If you rely on a GRAS conclusion for a packaging component rather than filing a food contact notification, you are in scope.

Why the FDA Says the Voluntary System Failed

The agency's argument is a visibility argument. As of March 2025, the FDA's Human Foods Program had filed more than 1,200 GRAS notices and the Center for Veterinary Medicine had filed 75. But the agency points to estimates that, as of January 2011, roughly 1,000 human food substances were in use based on independent GRAS conclusions the FDA knows nothing about.

The proposed rule walks through what that blind spot has cost:

Substance	What the FDA Concluded	How the FDA Found Out
Caffeinated alcoholic beverages	Unsafe food additive; four Warning Letters issued	Complaints from 18 state attorneys general, years after market entry
Delta-8 THC in conventional food	Did not meet GRAS criteria; Warning Letters issued in 2024	Adverse event reports, including ingestion by children
Tara flour	Not GRAS; no food additive regulation authorizes its use	A recall following roughly 400 adverse event reports
Ashwagandha in conventional food	Unsafe food additive; added to Import Alert 99-45 in 2023	Questions raised by investigators during inspections
Stevia leaf and crude extracts	Not GRAS; import alert in place since 1991	Ongoing import screening and a 2022 Warning Letter

In every one of those cases, the FDA learned about the problem after the product was already in consumers' hands. That is the agency's argument for the rule, and it is a strong one.

In the tara flour matter, the FDA specifically noted that it requested records from the firm and received nothing demonstrating that a GRAS conclusion had ever been reached.

Notification Is Not Approval. Know the Difference.

This is the point most likely to be garbled in a headline, and the point your team needs to understand correctly.

The FDA is not proposing premarket approval. A company could still bring a GRAS substance to market and continue selling it while a notice is pending. What changes is that staying silent carries a consequence: the agency would weigh noncompliance when deciding which substances to pull in for post-market review.

Forbes covered the proposal on August 17, 2026, and framed it accurately. The rule mandates notification before marketing but stops short of premarket approval, and critics have questioned how effective it will be without stronger enforcement authority or additional FDA resources.

The FDA's own economic analysis estimates the present value of the rule's costs at approximately $89.6 million over 10 years at a 3 percent discount rate, with a range running from $34.9 million to $210.0 million.

The Legacy Ingredient Problem Is Where Most Companies Are Exposed

New ingredients are the easy case. Going forward, you file a notice.

The harder question is the portfolio you already sell. The proposed rule includes a time-limited streamlined submission pathway in proposed Subpart F for substances introduced into interstate commerce before the effective date of a final rule. For most established manufacturers, that window is the real deadline.

Ask yourself a direct question: for every ingredient in your products, can you produce the document establishing its GRAS status and the qualified expert analysis behind it? Including ingredients that came in through an acquisition? Including ingredients your co-packer selected?

Most companies cannot. That is the gap to close now, while the rule is still a proposal.

What Food Companies Should Do Now

•    Build a complete GRAS inventory. List every substance in your portfolio marketed under an independent GRAS conclusion, including ingredients inherited through acquisitions and those specified by contract manufacturers. You cannot assess exposure you cannot see.

•    Pull the files and actually read them. A safety assessment from 2009 with a short expert panel memo may not hold up to a modern FDA reviewer. Identify which conclusions are well documented and which are thin.

•    Look upstream at your suppliers and co-packers. If an ingredient is marketed under a supplier's GRAS conclusion, clarify in writing who is responsible for notifying and who owns the underlying safety data.

•    Do not overlook packaging. The rule reaches substances that migrate into food from packaging and processing equipment. If you rely on a GRAS conclusion instead of a food contact notification, that use is covered.

•    File a comment. The FDA is specifically requesting input on alternatives. Implementation feasibility, the adequacy of the proposed exceptions, and the compliance timeline are all open. Electronic comments close at 11:59 p.m. Eastern on December 9, 2026, and the FDA has stated that late comments will not be considered.

The GRAS Proposal Is Not Happening in Isolation

Federal scrutiny of food chemicals is intensifying on several tracks at once. In May 2026, the FDA finalized its post-market assessment program for chemicals in the food supply and launched reassessments of BHT and ADA. In July 2026, the agency took further steps to remove outdated authorizations for color additives in food. The GRAS proposal is the third leg of the same effort.

State legislatures are moving in parallel, with a growing number of ingredient disclosure and warning-label requirements enacted or pending across the country. A company selling nationally is now answering to multiple regulators looking at the same ingredient list on different timelines.

Ingredient documentation has quietly become the single most valuable compliance asset a food company can hold. Build it once, use it everywhere.

How Bustos Law Group Supports Food Industry Compliance

Bustos Law Group provides specialized FDA legal services for food manufacturers, importers, and distributors nationwide. The firm includes a Lead Instructor for the Food Safety Preventive Controls Alliance with over 18 years of experience in food regulatory matters.

Services include GRAS substantiation review and portfolio audits, comment drafting and regulatory advocacy, labeling audits, import compliance reviews, and Warning Letter response strategy.

The GRAS comment period closes December 9, 2026, and a final rule will follow. Companies that inventory and strengthen their GRAS files now will be filing submissions on their own schedule rather than scrambling against a compliance date. Schedule a consultation with Bustos Law Group to review your ingredient documentation before the rule is final.

Sources: U.S. Food and Drug Administration (FDA.gov) | Federal Register | U.S. Department of Health and Human Services (HHS.gov) | Forbes

This blog is for informational purposes only and does not constitute legal advice. For guidance specific to your business, contact Bustos Law Group.