The FDA has delayed a major food safety rule that could reshape which ingredients make it into foods, supplements, medical foods, and natural health products. The delay gives consumers more time to demand reform that improves safety without restricting access to beneficial ingredients. Action Alert!
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THE TOPLINE
- The FDA has delayed its proposed GRAS rule until December 2026, giving consumers, advocates, and the natural products industry more time to push for reforms that improve food safety oversight without restricting access to beneficial ingredients.
- ANH-USA agrees the current system needs greater transparency, independence, and accountability, but turning GRAS notification into de facto premarket approval could burden smaller companies, limit natural-product innovation, and raise prices.
- GRAS reform should be risk-based, focusing scrutiny on novel or potentially harmful additives while preserving streamlined pathways for traditional, low-risk ingredients with long histories of safe use.
The government’s latest regulatory agenda now lists December 2026 as the expected publication date for its proposed rule on substances “generally recognized as safe,” or GRAS. The rule would require companies to submit GRAS notices for certain uses of food substances, replacing part of today’s voluntary notification system.
FDA says the change would improve transparency and oversight. But if poorly designed, it could also create regulatory bottlenecks that make it harder for safe and innovative ingredients to reach consumers.
GRAS 101
GRAS is the legal pathway that allows food ingredients to be used when qualified experts agree they are safe under their intended conditions of use.
Companies may currently reach an independent GRAS conclusion—often called “self-GRAS”—and voluntarily notify FDA.
The system clearly needs reform, as we’ve explained in our white paper. Some companies have introduced ingredients without sufficient transparency or independent scrutiny. Consumers deserve to know what is being added to their food, and unsafe additives should not be protected by secrecy, conflicts of interest, or weak oversight.
But dismantling self-GRAS would be the wrong solution.
If notification becomes a de facto premarket approval requirement, smaller companies could face significant costs and delays. Traditional, low-risk natural ingredients with long histories of safe use could be subjected to the same burdens as novel synthetic additives with limited safety data.
The result could be fewer natural products, less innovation, and higher prices—while the most dangerous chemicals remain in the food supply.
Reform Must Be Risk-Based
ANH-USA supports meaningful GRAS reform. In our April 2025 white paper, we called for a public transparency register, stronger safeguards against conflicts of interest, and greater scrutiny of substances with credible evidence of harm. We also proposed a proportionate review system that distinguishes higher-risk additives from traditional and well-established ingredients.
The real problem is not every substance that uses the GRAS pathway. It is secrecy, weak accountability, and the failure to act against genuinely unsafe ingredients.
FDA should focus its resources where the risks are greatest, make GRAS determinations publicly accessible, and preserve streamlined pathways for low-risk ingredients consumers rely on.
The delay until December gives ANH, our allies, and health-conscious consumers more time to shape the rule before it is published.
Consumers should not have to choose between safety and freedom. ANH will continue fighting for both.
Action Alert!
