FDA Cracks Down: GRAS Food Safety Notices Now Required?
Published Date: 8/11/2026
Proposed Rule
Summary
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Analyzed Economic Effects
4 provisions identified: 1 benefits, 2 costs, 1 mixed.
GRAS Notices Become Mandatory
FDA proposes to require anyone who introduces a substance into interstate commerce under the GRAS provision of section 201(s) of the FD&C Act to submit a GRAS notice for human or animal food uses (including indirect additives such as from packaging). FDA estimates the present value of the rule's industry costs at about $89.6 million (3% discount, 10 years) and annualized costs of about $10.5 million (3% discount).
Time-Limited Streamlined Submission Option
The proposal includes a time-limited option allowing firms to submit a streamlined submission for certain uses of substances already in interstate commerce before the final rule's effective date; doing so would incur one-time per-manufacturer costs (including possible translation costs for non-English-speaking manufacturers).
Not Notifying May Trigger FDA Review Priority
FDA states that if the mandatory notification requirement is not met for a substance's intended use, FDA would consider that noncompliance when prioritizing substances for post-market review, potentially increasing the chance of FDA scrutiny or action for non-notified uses.
Greater Public Disclosure of GRAS Uses
The rule would increase public disclosure and transparency about substances claimed to be GRAS for human and animal foods, giving consumers, state regulators, and advocacy groups more information about what is being added to the food supply.
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Key Dates
Department and Agencies
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