FDA Posts Proposed Rule on GRAS: What We Know So Far

The FDA has posted an outline of a proposed rule to require the mandatory submission of Generally Recognized as Safe (GRAS) notices. If finalized, the rule would effectively eliminate self-affirmed GRAS without notification—long criticized for its lack of transparency—by requiring companies to notify the FDA and be listed in a public-facing register. Substances already listed as GRAS by regulation or that have received a “no questions” letter would be exempt.

At first glance, this sounds like the kind of transparency reform ANH has long advocated: bringing GRAS determinations into the light rather than shutting them down entirely. But we need to see the details. The rule has not yet been officially published, and many key questions remain unanswered.

ANH General Counsel Jonathan Emord said:

“It will be critical for ANH to participate in the FDA rulemaking to ensure that foods, dietary ingredients, and dietary supplements long used safely are not encumbered with new regulatory strictures that rob consumers of freedom of choice. We are all for FDA reliance on the peer reviewed scientific literature to identify specific food additives that are provably unsafe (and, thus, adulterated) for removal from the market. But we are dead set against any federal effort to impose a pre-market FDA authorization system on foods, dietary ingredients, and dietary supplements. The overwhelming majority of manufacturers and distributors that have lawfully and safely sold their products for decades ought not be treated like criminals and shackled by a paternalistic FDA nanny state.  Public access to truthful information is essential. Individual freedom of choice must be preferred over regulator preference, overreach, and prior restraint.”

If this rule mirrors recent legislative proposals, like the Markey-Booker Ensuring Safe and Toxic-Free Foods Act of 2025, it could be devastating. That bill would not only force over 10,000 self-affirmed GRAS substances through new submissions but also shut down the pathway entirely after a two-year transition, effectively replacing GRAS with a burdensome, European-style pre-market approval system.

The GRAS system is in dire need of reform—but the solution is transparency, not destruction. ANH has outlined a better way forward in our white paper Reforming GRAS: Food Safety Without Sacrifice. We’ll continue to analyze this proposed rule as details emerge and will keep our members informed.

Stay tuned—and be ready to take action once the full proposal is published.

Adblock test (Why?)