Substances Generally Recognized as Safe (Proposed Rule)

This proposed rule would revise the procedures by which a person introducing a human or animal food substance into interstate commerce notifies FDA of a conclusion that the use of such substance is generally recognized as safe (GRAS). Specifically, the proposed rule would require the submission of GRAS notices to FDA for certain uses of food substances. A substance that is GRAS under the conditions of its intended use is not subject to FDA premarket review and approval as a food additive for that particular use (see sections 201(s) and 409 of the FD&C Act). Under our current regulations, a person who concludes that the use of a substance is GRAS under the conditions of its intended use may, but is not required to, notify FDA of this conclusion. The submission of a GRAS notice is therefore currently voluntary. If the proposed rule is finalized, GRAS notices will be required for certain uses of substances in human and animal food.

The primary benefits of the proposed rule, if finalized, would come from increased information being made available to FDA and the public regarding substances used in human and animal foods. This information would enable us to more effectively determine if the use of a substance constitutes a food additive use that is subject to premarket review and approval under the FD&C Act. This information is also expected to provide FDA with information to help identify the use of potentially unsafe substances in food, thereby enabling FDA to take action as appropriate and regulate the safety of food substances more effectively. A mandatory GRAS notification program would allow FDA to ensure that GRAS conclusions have a scientific basis and that appropriate documentation supporting those conclusions exists. The proposed rule, if finalized, is in part intended to help strengthen public confidence in FDA’s ability to oversee the safety of the U.S. food supply. One-time costs of the proposed rule to persons who introduce a substance into interstate commerce under the GRAS provision of section 201(s) of the FD&C Act include reading the rule and revising standard operating procedures (SOPs) regarding GRAS notices. Other one-time per manufacturer costs of the proposed rule are preparing and submitting streamlined submissions related to uses of substances introduced into interstate commerce under the GRAS provision of section 201(s) of the FD&C Act before the effective date of a final rule, for firms that choose to submit this information during the window of availability for this time-limited option for such submissions. Costs associated with these activities may include translation costs for manufacturers in non-English speaking countries. Recurring costs to manufacturers would include preparing and submitting GRAS notices for new uses of substances introduced into interstate commerce under the GRAS provision of section 201(s) of the FD&C Act after the effective date of a final rule that would otherwise have been the subject of an independent conclusion of GRAS status (i.e., a GRAS conclusion has been reached without submitting a GRAS notice).

Costs to FDA would include one-time costs of reviewing streamlined submissions related to uses of substances introduced into interstate commerce under the GRAS provision of section 201(s) of the FD&C Act before the effective date of a final rule during the time-limited period for such submissions, and annual costs of evaluating ongoing submissions of GRAS notices regarding uses of substances that would otherwise have been the subject of an independent conclusion of GRAS status.

We estimate that the present value of the costs of the proposed rule would be approximately $89.6 million, with a lower bound of $34.9 million and an upper bound of $210.0 million, discounted at 3 percent at 10 years in 2024 dollars. At a 7 percent discount rate, the present value of costs would be approximately $82.3 million, with a lower bound of $31.5 million and an upper bound of $195.9 million. We estimate that the annualized costs of the proposed rule would be approximately $10.5 million, with a lower bound of $4.1 million and an upper bound of $24.6 million, discounted at 3 percent over 10 years. At a 7 percent discount rate, annualized costs would be approximately $11.7 million, with a lower bound of $4.5 million and an upper bound of $27.9 million.

Regulatory Impact Analysis

Substances Generally Recognized as Safe (Proposed Rule) -- (PDF 693 KB)

Federal Register: 91 FR 51834
Publication Date: 08/11/26
Docket: FDA-2025-N-3262