GRAS has been a focus of attention for many years, and there have been many attempts to make changes to GRAS, especially in relation to self-affirmation.  But this time change seems to be coming.  Closing the “loophole” of self-affirmed GRAS has been on Robert F. Kennedy Jr’s regulatory chopping block since he was confirmed as HHS Secretary in early 2025. Now that aspiration is getting closer to reality with the August 10 Federal Register posting of the Proposed Rule for Substances Generally Recognized as Safe (GRAS). The proposed rule was announced in a public Food Policy Reform presentation by RFK and other officials.

In brief, the rule, if finalized, would amend GRAS regulations to:

1. Convert voluntary GRAS notification to mandatory GRAS notification.
2. Any person introducing a substance into interstate commerce under the GRAS provision must notify FDA of the basis for their conclusion that the substance is GRAS under the conditions of its intended use, unless an exception applies.
3. If the notification requirement is not met, FDA would consider the noncompliance in its prioritization of food substances for post-market review.

TAG’s TAKE: By reading into this, it can be seen that the rule does not go all the way to eliminating self-affirmation prior to a product being put on the market with a new substance. Rather, it notes that if a company fails to notify FDA, the substance would be prioritized for a post-market review. The FDA had to limit its rule to this because the FD&C Act legally excludes GRAS substances from the premarket approval process that is required for standard food additives. As Acting FDA Commissioner Kyle Diamantas stated in the presentation, mandatory review would require an act of Congress.

• Establish exceptions to the requirement to submit a GRAS notice, including a time-limited option for certain intended uses already in interstate commerce instead of an initial GRAS notice.

TAG’s TAKE: While FDA does not state that it will automatically accept currently used self-affirmed GRAS substances as approved, it is willing to provide an alternate “time-limited” option for these. This option is to submit to FDA certain information about the conditions of use of the substance, with the submission to be included on a public list maintained by FDA. It applies to a substance that was introduced into interstate commerce, based on an independent conclusion of GRAS status, before the effective date of a final GRAS rule. Thus, it would behoove anyone currently using a self-affirmed GRAS substance to take this option to help avoid post-market prioritization.

• Revise FDA procedural regulations for exemptions to reflect updated science and include uses of substances both in food and as a food contact substance.

TAG’s TAKE: This point reinforces the importance of understanding that “food substances” includes both ingredients as well as substances that are added indirectly or have the potential to migrate into food from their intended use (e.g., from packaging, conveyor belts, shipping containers, etc.).

While the proposed rule does not go all the way to removing the self-affirmed GRAS “loophole” prior to a substance being brought to market, it does increase the transparency of GRAS substances, and reduces certain issues related to voluntary notification. For example, in the current voluntary framework, a notifier may request that FDA cease to evaluate a GRAS notice, then introduce the substance to market without a final FDA evaluation or approval. The voluntary format also enables the continued use of substances that FDA has publicly noted as unapproved food additive uses, with FDA noting the use of stevia leaves and crude extracts of stevia leaves as examples of this.

Thus, making notification mandatory would help ensure that GRAS conclusions have a scientific basis and that sufficient documentation supporting those conclusions is developed and shared with FDA. With the rule also requiring that the information be accessible to the public, consumers would be able to review GRAS substances themselves and make their own conclusions on purchase of foods containing the substances.

With more than 10,000 additives being used in food, including an estimated 1,000 self-affirmed substances, gaining additional insight to these through this rule is certainly a first step in the right direction.

In summary, since early 2025, closing the “loophole” of self-affirmed GRAS has been on Robert F. Kennedy Jr’s regulatory chopping block. Now that aspiration is getting closer to reality with the August 10 Federal Register posting of the Proposed Rule for Substances Generally Recognized as Safe (GRAS). While the proposed rule does not go all the way to removing the self-affirmed GRAS “loophole” prior to a substance being brought to market, it does increase the transparency of GRAS substances, and reduces certain issues related to voluntary notification.