August 11, 2026
Substances Generally Recognized as Safe
Summary:
The Food and Drug Administration (FDA) 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).
Dates:
Either electronic or written comments on the proposed rule must be submitted by December 9, 2026. Submit comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by December 9, 2026.
Addresses:
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 9, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
Please click here for more information on FDA’s proposed rule.
August 10, 2026
FDA is Proposing a Significant Change to the GRAS Framework
Under a proposed rule scheduled for publication in the Federal Register on August 11, 2026, FDA would move from the current voluntary GRAS notification process to a mandatory notification program for certain substances used in human and animal food.
If finalized, the rule would significantly change how companies document and notify FDA of GRAS conclusions, with important implications for ingredient manufacturers, suppliers and finished product companies.
NPA is reviewing the proposal and its potential impact on the natural products industry and will continue engaging with FDA throughout the rulemaking process.
Click here to read the proposed rule.
