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This rule, if finalized, would amend FDA’s regulations at 21 CFR parts 170 and 570 to require the submission of a generally recognized as safe (GRAS) notice for the use of a human or animal food substance that is purported to be GRAS under the conditions of its intended use under section 201(s) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The rule would clarify that FDA maintain and update the public-facing GRAS notice inventory for all substances that are the subject of mandatory GRAS notice for the conditions of their intended use. The rule would also clarify the process under which FDA would determine that the use of a substance is not GRAS. This change would provide greater transparency about substances that are added to food, so that FDA can more efficiently determine if the use of a substance constitutes a food additive use that is subject to the premarket review and approval requirements under the FD&C Act.

Statement of Need:

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.  Uses of food substances that are subject to the mandatory notification requirement will be presumed by FDA not to be GRAS unless the notification requirement has been met regarding the use of the substance.

Summary of the Legal Basis:

We are issuing this proposed rule consistent with our authority in sections 201, 402, 409, and 701 of the FD&C Act (21 U.S.C. 321, 342, 348, 371).

Alternatives:

TBD

Anticipated Costs and Benefits:

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 help FDA identify and prevent the use of unsafe food additives in food, thereby enabling FDA to regulate the safety of food substances more effectively. 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 affected manufacturers would include preparing and submitting GRAS notices for the 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).

Risks:

TBD