For almost thirty years, a food company could decide on its own that an ingredient was generally recognized as safe, keep the paperwork in a file, and start selling. FDA never had to hear about it. That is about to change. On August 11, 2026, FDA published a proposed rule that would require a GRAS notice for these ingredients, and the comment period closes on December 9, 2026.
What the proposal would change
Anyone who adds a substance to food based on a GRAS conclusion would have to file a GRAS notice with FDA. The rule covers human and animal food, and it reaches ingredients that are already on the market, not only new ones.
Some uses are carved out. An ingredient that already has a "no questions" letter from FDA, or is listed or affirmed as GRAS in FDA's regulations, would not need a new notice. The same goes for a food contact substance covered by an effective notification (for the company named in it) and for uses exempt under FDA's threshold-of-regulation process.
The proposed timeline
If FDA finalizes the rule as written, it would take effect 60 days after publication, and companies would have 18 months after that to comply. For ingredients already being sold on a self-affirmed basis, FDA proposes a shorter streamlined submission, open for one year after the effective date. Those ingredients would go on a public list, although FDA could still ask for a full notice or a food additive petition later.
Nothing is final yet, and the details may shift after comments. But FDA has already said it will treat a missing notice as a reason to put an ingredient higher on its list for post-market review. That alone is a good reason not to wait.
What to do now
Start with an inventory. Which of your ingredients rely on a GRAS conclusion that your company or a supplier reached without going to FDA? Then find the file behind each one. This is where problems tend to surface: the dossier is old, thin, or sitting with a supplier that won't share it. It is far easier to deal with that now than inside a one-year window.
Ingredient suppliers should expect customers to start asking for GRAS documentation and should decide early whether they will file, and who pays for it. And if the scope of the exceptions or the length of the transition matters to your business, the comment period is the time to say so.
How MDRXLaw can help
We work with food manufacturers, ingredient suppliers and importers on GRAS positions: reviewing the existing record, preparing comments to FDA, and planning notices and streamlined submissions. If self-affirmed GRAS ingredients are part of your formulas, contact us at info@mdrxlaw.com or 212-668-0222.
Source: Federal Register, Substances Generally Recognized as Safe (proposed rule, Aug. 11, 2026). This alert is for general information and is not legal advice.
