FDA Would Require GRAS Notices. Ask Suppliers Who Decided.

FDA proposed making GRAS notification mandatory on August 10. Comments close December 9. The filing obligation falls on whoever introduces the substance into interstate commerce under the GRAS provision. The finished product is a separate question, and FDA has long answered that one the same way: the manufacturer of a food is responsible for its ingredients complying with all applicable authorizations.

What FDA actually proposed

The voluntary GRAS notification program becomes mandatory, with seven exceptions.

The proposed rule (91 FR 51834, Docket No. FDA-2025-N-3262) would amend 21 CFR parts 170 and 570 so that any person introducing a substance into interstate commerce under the GRAS provision of section 201(s) of the FD&C Act has to notify FDA of the basis for that conclusion, unless one of the exceptions in proposed 170.205(b) applies. It reaches ingredients and substances that get into food indirectly, including from packaging. For a qualifying food-contact substance, a supplier can file a food contact notification (FCN) instead.

Three dates matter. A final rule would take effect 60 days after it publishes. Proposed sections 170.205 and 570.205 would carry a compliance date 18 months after that. And for substances already in interstate commerce before the effective date, proposed subpart F opens a one-year window to file a short-form submission instead of a full GRAS notice. After that, the subpart closes.

Comments are due December 9, 2026.

This is not a premarket approval program

The proposal wouldn't halt marketing while FDA decides whether to file a notice, and it wouldn't make an otherwise unlawful food lawful either.

FDA is direct about the first half: a company may keep marketing a purported GRAS substance before it submits a notice, and after it submits one while FDA decides whether to file it. What changes is what FDA does with a missing filing. Noncompliance would be "a factor in its prioritization of food substances for post-market review."

The older consequence doesn't move. If a use isn't GRAS and lacks another applicable authorization, such as a food additive regulation or an effective FCN, it can be an unapproved food additive use. Food bearing an unsafe food additive is adulterated under section 402(a)(2)(C) of the FD&C Act. That's the hook behind warning letters, seizures, and import alerts.

FDA puts the ingredient question on the manufacturer

FDA's position is that the manufacturer of any food is responsible for all ingredients used complying "with specifications and limitations in all applicable authorizations." This rule doesn't invent that.

In 2022, a firm used tara flour as an ingredient in a human food product. The product drew roughly 400 adverse event reports covering gastrointestinal distress, hepatotoxicity, and hospitalization. The firm recalled it and ran a root cause analysis that pointed at tara flour. FDA asked for records showing a GRAS conclusion on that ingredient. The firm didn't produce any. Tara flour had never been the subject of a GRAS notice or a pre-submission meeting, and FDA determined there weren't enough data to consider it GRAS.

Recalls are usually initiated by a manufacturer or a distributor, and FDA's recall guidance puts obligations on everyone in the chain once one starts. The assessment sits upstream of that. Whether the ingredient was cleared for that use was the food company's call before anything shipped.

Many supplier approval programs check allergen status, micro specs, and a COA. Fewer ask what authorizes the ingredient's use, or who decided it.

How to find out which of your ingredients are self-affirmed

Ask the supplier what authorizes the ingredient's use, per ingredient, in writing.

Under the proposal, a use needs a GRAS notice unless one of the seven exceptions in proposed 170.205(b) applies:

1. A "no questions" letter from FDA covers the substance under those conditions of use.

2. It's listed or affirmed as GRAS in 21 CFR parts 182, 184, or 186.

3. It's GRAS under 170.30(d) or (i)(1).

4. FDA already considered the use through an established process for evaluating potential unapproved food additives, and the public documentation doesn't call for a notice.

5. It holds a threshold of regulation exemption under 170.39.

6. An effective food contact notification covers it, and the material comes from the manufacturer or supplier named in that FCN.

7. Information about it went in under proposed 170.305 and sits on FDA's public list, unless FDA later determines a notice or a petition is required.

A substance authorized by a food additive regulation isn't under the GRAS provision at all, so it sits outside the list.

If none of that fits, the supplier is relying on an independent GRAS conclusion. That's what people mean by self-affirmed, and it's what the rulemaking is aimed at. There may be no GRN with a no-questions letter behind it, and FDA may never have evaluated it, so ask whether any earlier notice drew a cease-to-evaluate letter. FDA estimates roughly 2,000 independent GRAS conclusions in use across about 1,028 firms, 1,885 in human food.

Two traps sit inside exception one.

A "no questions" letter covers the substance under the conditions of its intended use. A GRN issued for a beverage at one use level isn't coverage for a bakery application at a different one. Get the GRN number, then read what the conditions of use say.

The second trap is procedural. Under proposed 170.265, the notification requirement is met when FDA files the submission, not when the supplier sends it. If FDA declines to file, or FDA grants the notifier's request to cease evaluating the notice, the requirement is not met. Ask whether FDA filed it.

What goes on the specification

One field: the authorization, plus the GRN number or CFR citation behind it.

That's the change that survives turnover. A questionnaire answer sits in a folder somebody has to find two years later. A field on the specification travels with the material every time it's ordered, received, and reviewed.

If you import any of these ingredients, this sits on top of work you already owe. FSVP warning letters keep landing on manufacturers who didn't realize they were the importer. A May 26, 2026 letter cites 21 CFR 1.502(a) against an importer with no FSVP on file for anything it brought in.

Beacon's supplier file keeps the COA, the allergen declaration, and the document requests you've sent in one place, so the answer lands in the file instead of in an email thread.

What to watch before December 9

Watch whether your suppliers are getting ready to file.

FDA estimates about 32 hours of work per short-form subpart F submission. An ingredient distributor sitting on forty independent GRAS conclusions is looking at real labor against a hard cutoff. A supplier that misses the window can't use that path, and has to work out which authorization or exception covers the ingredient.

Two provisions deserve a close read if you're commenting. Proposed 170.305(d)(1) says FDA will post these submissions publicly and that posting doesn't mean FDA reviewed the substance's GRAS status. Proposed 170.305(d)(3) lets FDA later require a full GRAS notice or a food additive petition anyway. Listing is disclosure. FDA can still pull a listed ingredient into full review.

New York's legislature has moved on the same question. The Food Safety and Chemical Disclosure Act passed both chambers in April and would require manufacturers to report self-designated GRAS substances and their safety basis to the state, which would publish them. We covered what that does to ingredient intake when it passed.

Three questions for the supplier approval questionnaire

Add these for every ingredient. Start with flavors, colors, enzymes, processing aids, and anything you buy as a blend.

1. What authorizes this ingredient's use in food? Name the specific path from the list above.

2. If there's a GRN, does the no-questions letter cover our food category, our use level, and our purpose? Send the GRN number with the answer.

3. If it's an independent conclusion, do you hold the supporting dossier, and which path will you file under if the rule is finalized?

Send them now, while the answer is a routine request rather than a deadline. FDA estimates 1,740 GRAS conclusions reached by association expert panels rather than by the agency, including substances evaluated by the Flavor and Extract Manufacturers Association. Check whether any of them are in your formulas.

Book a call and we'll walk through what a supplier file looks like when the authorization lives on the record. See how it works.