On March 10, 2025, Robert F. Kennedy, Jr., Secretary of the U.S. Department of Health and Human Services (“HHS”), in a seismic shift, announced that the U.S. Food and Drug Administration (“FDA”) would “explore potential rulemaking” to eliminate the pathway allowing companies to self-affirm that food ingredients are Generally Recognized as Safe (“GRAS”).
This means that companies seeking to introduce new food ingredients would be required to publicly notify the FDA of the ingredients’ intended use and underlying safety data. Presently, the FDA strongly encourages but does not require the submission of a GRAS notice. Given the importance of the issue, the food industry should closely monitor any change to the FDA’s regulation of GRAS ingredients.
Defining GRAS
Under the Federal Food, Drug, and Cosmetic Act, unless a substance is generally recognized among qualified experts as safe under the conditions of its intended use, food additives are subject to premarket review and approval by the FDA. The implementing regulations, 21 C.F.R. §§ 170.3 and 170.30, provide that the use of a food substance can be GRAS through scientific procedures or experience based on common use in food before 1958. Salt, pepper, vinegar, baking powder, and monosodium glutamate are some examples.
GRAS Pathways and FDA Procedures
Currently, manufacturers may determine a food ingredient is GRAS through one of two pathways: self-affirmation, or notification to the FDA by submission of a GRAS notice. But if the voluntary FDA notification pathway becomes mandatory through legislation or rulemaking, companies using the self-affirmation process would be well-served to familiarize themselves with current FDA GRAS procedures.
- As mentioned above, 21 C.F.R. § 170.30 sets forth the eligibility for classification of a substance as GRAS.
- Under 21 C.F.R. § 170.35, the Commissioner may affirm that a substance that directly or indirectly becomes a component of food is GRAS under the conditions of its intended use. If so, the Commissioner will publish a notice in the Federal Register and evaluate comments received following a 60-day comment period.
- If there is convincing evidence that the substance is GRAS, the Commissioner will publish a notice listing the GRAS conditions of use.
- If there is a lack of convincing evidence and the substance should instead be considered a food additive, the Commissioner shall publish a notice in accordance with 21 C.F.R. § 170.38.
- In 2016, the FDA issued the final rule at issue, 81 Fed. Reg. 54960 (Aug. 17, 2016), that formalized the voluntary GRAS notification program. 21 C.F.R. Part 170, Subpart E provides the process for submission of a GRAS notice, including how to send a GRAS notice to the FDA, general requirements of a GRAS notice, the seven required parts of a GRAS notice, the FDA’s evaluation and response, and public disclosure of a GRAS notice. According to the HHS, the FDA evaluates 75 GRAS notices per year and has published over 1,000 notices, which are available in a public inventory.
Takeaways
In the HHS release, Secretary Kennedy commented, “For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public.” His proposal for addressing the “loophole” may involve more than rulemaking—the release also states that the HHS “is committed to working with Congress to explore ways legislation can completely close the GRAS loophole.” In the meantime, companies should familiarize themselves with FDA GRAS procedures.