FDA Proposes Mandatory GRAS Notification Framework for Human and Animal Food Substances

On August 10, 2026, the U.S. Food and Drug Administration (“FDA” or “Agency”) proposed a new rule to require human and animal food manufacturers to notify the Agency of food substances purported to be generally recognized as safe (“GRAS”) under the conditions of their permitted use pursuant to section 321(s) of the Food, Drug and Cosmetic Act (“FD&C Act”) (21 U.S.C. § 321(s))). Since Congress established the GRAS exception process in 1958, FDA has operated a voluntary GRAS notification program that permits manufacturers to review and conclude on their own whether their products meet the GRAS determination without mandatory Agency review. A substance that is considered “GRAS” is excluded from the statutory definition of a food additive and does not require a food additive petition or FDA approval before marketing.

Under the proposed rule if enacted, manufacturers introducing human or animal food substances into interstate commerce must now notify FDA of the basis for their conclusion that the food substance is GRAS unless an exemption applies. This requirement would include food substances already on the market. Exemptions include:

• “When an existing no questions letter covers the food substance under the condition of its intended use;”
• “Where FDA has previously conducted rulemaking to list or affirm a substance as GRAS under the conditions of its intended use in [21 C.F.R.] Parts 182, 184, or 186;”
• “A food ingredient of natural biological origin that has been widely consumed for its nutrient properties in the U.S. prior to January 1, 1958 without known detrimental effects, which is subject only to conventional processing as practiced before January 1, 1958 and for which no known safety hazard exists;”
• Where FDA has “considered the intended use of the substance through an established FDA process to evaluate the potential presence of unapproved food additives;”
• “Where the intended use of a substance is the subject of an exemption under the [threshold of regulation] process in [21 C.F.R.] § 170.39;”
• “Where there is an effective premarket notification for a [food contact substance] which covers the substance under the conditions of its intended use and the substance in interstate commerce originates from the manufacturer or supplier listed in the effective [food contact notification];” and,
• When information required under [21 C.F.R.] § 170.305 is submitted to FDA for food substances introduced into interstate commerce before the effective date of the proposed rule.

FDA believes this rule will help increase transparency in the food supply while allowing the Agency a more efficient way to determine whether substances constitute food additives subject to review under the FD&C Act.

Food manufacturers should be aware of the obligations in the proposed rule and consider the following:

• Whether there are GRAS food additives in products currently on the market that were not previously voluntarily submitted to FDA for review;
• Whether any food substances in development may be GRAS;
• Whether any food substances in development t meet the exemptions for GRAS notification to FDA; and.
• Whether it is advisable provide public comments to FDA regarding any aspect of the proposed rule.

The proposed rule was published in the federal Register on August 11, 2026 and FDA is accepting comments on the proposed rule until December 9, 2026. Please consult the Michael Best team if you would like assistance in evaluating how this proposed rule may impact your business.