Blog: The Daily Intake
FDA Announces Proposed Mandatory GRAS Notification Rule
- On August 10, 2026, HHS Secretary Robert F. Kennedy Jr., announced that FDA’s long-anticipated proposed GRAS rule has been released. The proposed rule seeks to fundamentally reform FDA’s oversight of food ingredients by converting the current voluntary GRAS notification program into a mandatory system.
- Key Takeaways from the Proposed Rule:
- Mandatory GRAS notifications: FDA would replace the existing voluntary notification framework with a mandatory notification requirement for most substances introduced into commerce under the GRAS exemption.
- New transparency measures: FDA would continue publicly posting filed GRAS notices and agency response letters and would also establish a public inventory for certain existing substances submitted through a new transitional process.
- Expanded FDA oversight: FDA would expressly reserve the ability to revisit prior GRAS conclusions, ask follow-up questions concerning previously submitted notices, and update or rescind prior “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, among others.
- Rather than immediately requiring full GRAS notices for all existing substances, FDA proposes allowing companies to submit a streamlined filing containing 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.
- The proposal also contains several provisions affecting food-contact substances and packaging materials. FDA would expand the TOR process beyond traditional food-contact articles and would continue to allow manufacturers of food-contact substances to utilize the FCN pathway as an alternative to GRAS notification in certain circumstances.
- If finalized, FDA proposes that the rule become effective 60 days after publication of the final rule, with a compliance date 18 months later.
- FDA is accepting comments on the proposal for 120 days following publication in the Federal Register. With publication currently scheduled for August 11, 2026, comments are expected to be due in early December 2026. Comments may be submitted electronically through Regulations.gov under Docket No. FDA-2025-N-3262.
- Keller & Heckman is continuing to review the proposal, including FDA’s legal authority to require mandatory GRAS notifications under the existing statutory framework. Notably, Secretary Kennedy stated during the August 10 announcement that Congress may need to provide FDA with additional tools and authorities.