FDA Closing the GRAS Loophole? What Food and Beverage Companies Need to Know

On August 11, 2026, the Department of Health and Human Services published a proposed rule that would require companies to notify the Food and Drug Administration (FDA) when they conclude that an ingredient used in human or animal food is “generally recognized as safe” (GRAS), and to submit the scientific basis for that conclusion. The prosed rule would replace the current GRAS voluntary submission process. Comments are due by December 9, 2026.

The GRAS Pathway Today

Federal law exempts ingredients that are GRAS from premarket approval required of food additives. Since Congress established the GRAS exemption in 1958, companies have been permitted to self-determine that an ingredient’s use is safe. While FDA has a notification program in place, participation has always been voluntary. The FDA has received more than 1,200 GRAS notices under the voluntary program, but it estimates that at least 1,000 substances used in human food are based on company safety conclusions that were never submitted to the FDA. The agency maintains that pathway was only supposed to apply to basic foods that were already on shelves, but instead it has become the primary mechanism for new ingredients to enter Americans’ diets.

What the Proposed Rule Would Change

Notification would become mandatory. A company introducing an ingredient in reliance on its own GRAS conclusion would be required to submit a GRAS notice to FDA, with the information supporting its safety conclusion. The requirement would cover both human and animal food, and it would reach substances added indirectly, such as those that migrate from packaging or manufacture. Ingredients FDA has already listed as GRAS by regulation, or addressed with a “no questions” letter, would be exempt.

For ingredients already on the market under a self-affirmed GRAS conclusion the proposal offers a streamlined submission: for one year after the final rule takes effect companies will be able to file basic information, including the substance’s identity, its intended uses, and use levels, instead of a full notice. The FDA will publish those submissions in an expanded public inventory. Publication would not signify agency agreement, and FDA could later require a full GRAS notice or a food additive petition for any listed substance that is currently in use.

The proposal also sets review clocks: 45 days for FDA to decide whether to file a submission as a GRAS notice, and 180 days to respond once filed, subject to extensions. It is unclear at this stage how the FDA would police and enforce failure to make these submissions.

The agency would also expressly reserve the ability to revisit prior GRAS conclusions and to update or rescind earlier “no questions” letters.

What It Would Not Change

The rule would not create a premarket approval system, such as those in use in other countries. Companies would still make the initial determination that an ingredient is safe, and marketing would not wait on an FDA sign-off.

For many in the Make America Healthy Again movement, that is the proposed rule’s shortcoming. Movement advocates and allied consumer groups argue that leaving companies free to self-affirm safety does not truly close the loophole. Some call for premarket review of all new food chemicals, question how the mandate would be enforced, and say they will keep pressing for more. From the other direction, industry lawyers question whether FDA can mandate notification without new legislation, and legal challenges to a final rule are widely expected.

If the rule is finalized as proposed, it would take effect 60 days after the final rule is published, and compliance with the mandatory notification requirement would be due 18 months after that.

Key Takeaways

• The rule is about notification, not pre-market approval. Companies would still make the initial GRAS determination for new ingredients, but FDA would have to be told, and the safety basis documented.
• Companies relying on self-affirmed GRAS designation for ingredients they currently use should inventory them now. The streamlined pathway for existing ingredients is proposed to stay open for only one year after the final rule takes effect, and FDA could later require full notices.
• The 120-day comment period, running through December 9, 2026, is the opportunity to shape the final rule.

This alert is provided for informational purposes only and does not constitute legal advice.