On August 10, the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) proposed major changes to the regulation of food ingredients. This Legal Development provides key background on the proposed rule.
GRAS background
Under current law, food additives must receive premarket approval from FDA, unless the substance falls under a specific exclusion, such as when a food additive is “generally recognized as safe,” or GRAS, for its intended use.
In August 2016, FDA finalized its voluntary GRAS notification procedures, which detailed the criteria for concluding that the use of a substance in human or animal food is GRAS. The 2016 final rule strongly encouraged, but did not require, companies to use the voluntary GRAS notification procedures to inform the agency of GRAS conclusions.
The 2016 final rule noted that FDA would respond to a voluntary GRAS notice. Generally, the agency’s responses are in the form of (1) a “no questions letter,” meaning FDA had no questions about the notifier’s conclusion the subject substance is GRAS under its intended conditions of use; (2) an “insufficient basis letter,” reasoning that the notification lacked sufficient basis to conclude the noticed substance was GRAS under its intended conditions of use; or (3) a “cease to evaluate letter,” where the agency acknowledged that a notifier had asked the agency to cease its evaluation of the subject substance’s GRAS status. Substances Generally Recognized as Safe, 81 Fed. Reg. 54960, 55015 (Aug. 17, 2016).
Among other things, the agency’s rulemaking noted that FDA lacked “express statutory authority to require companies to submit GRAS notices.” Id. at 54982. In 2021, the U.S. District Court for the Southern District of New York upheld this final rule, concluding—under the then-controlling Chevron Doctrine—that the agency’s interpretation that it lacked statutory authority to mandate GRAS notifications was reasonable.
What’s the new proposal?
Now, HHS and FDA have proposed considerable expansion of FDA’s oversight of GRAS substances.
- First, FDA proposes to eliminate the current voluntary GRAS notification process, in favor of a mandatory notification procedure.
- Second, the agency would create a repository to make certain information related to GRAS notices available online.
- Third, FDA proposes the ability to update or rescind prior analysis, including the ability to update or rescind prior agency-issued “no questions” letters.
The proposal includes several exceptions to the mandatory notification requirement, including for certain substances that have already been reviewed by FDA, are already recognized as GRAS under existing regulations, or qualify for a Threshold of Regulation (TOR) exemption.
For substances already on the market based on existing self-affirmed GRAS determinations, the proposal would establish a time-limited submission pathway allowing manufacturers to provide FDA with basic information regarding the substance, intended uses, use levels, and evidence of commercial marketing. FDA would maintain these submissions on a public list and could later require a full GRAS notice or food additive petition if warranted.
What’s next?
FDA’s proposal was formally published in the Federal Register on August 11, 2026. Public comments will be open for 120 days, with comments expected to be due in early December 2026. Following the comment period, the agency will address comments received and finalize the rule. If finalized, FDA proposes that the rule become effective 60 days after publication of the final rule, with compliance required within 18 months.
Members of Ashurst Perkins Coie’s food regulatory team are available to assist clients navigating the array of food regulations at the state and federal levels.
