By Himiyer.com — March 23, 2026
What Is Self-Affirmed GRAS?
"Generally Recognized as Safe" (GRAS) is a legal designation under U.S. food law that allows certain substances to be used in food and supplements without premarket FDA approval. In its current form, companies can determine GRAS status for their own ingredients through an internal review — with no obligation to notify the FDA. The agency has a voluntary GRAS notification program, but thousands of substances have entered the market without any submission whatsoever.
Why Reformers Target It
Critics of self-affirmed GRAS — including Robert F. Kennedy Jr. — argue the pathway is a transparency gap that allows potentially harmful or inadequately tested substances to reach consumers. Kennedy raised the issue directly during his Senate confirmation hearings as HHS Secretary and directed the FDA commissioner to pursue rulemaking shortly after taking office. Mandatory notification, reformers contend, would give regulators the visibility needed to identify safety issues before products reach store shelves.
What the Proposed Rule Would Do
The anticipated rule would require companies to submit a formal GRAS notice to the FDA for any new substance before it can be marketed. The FDA would then review the submission — a process that typically takes 6 to 12 months — before the ingredient could be used commercially. Proprietary formulations would not be made public, but the FDA would have a record of every substance entering the market.
Timeline
The proposed rule was originally expected to be published in the Federal Register in October 2025. A government shutdown postponed that deadline. As of early 2026, the rule had not yet appeared, but FDA officials and legal observers expect it to be released during the year. Once published, it would open a formal notice-and-comment period before any final rule could take effect.
Impact on the Supplement Industry
The change would lengthen ingredient onboarding timelines significantly, particularly for smaller companies and growth-stage brands that currently rely on self-affirmed GRAS to move quickly. Established players with larger compliance teams may be better positioned to absorb the added burden. Industry associations have expressed concern that mandatory GRAS notification could stifle innovation in botanical and novel ingredient categories.
