On August 11, 2026, the U.S. Food and Drug Administration (FDA) published a proposed rule in the Federal Register (91 Fed. Reg. 51834) that would fundamentally transform the existing voluntary Generally Recognized as Safe (GRAS) notification program into a mandatory one. If finalized, the rule would require any person who introduces a food substance into interstate commerce under the GRAS provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to notify FDA of the scientific basis for its GRAS conclusion. This proposed rule represents the most significant change to the GRAS regulatory framework in decades and will have substantial compliance implications for food manufacturers, ingredient suppliers, and other stakeholders across the food industry.

 

Background

Since 2016, FDA has maintained a voluntary GRAS notification program under which companies may, but are not required to, notify the agency of their independent determinations that a substance is GRAS for its intended use. Under this voluntary framework, a company could conduct its own safety evaluation, conclude that a substance is GRAS, and introduce it into the food supply without ever informing FDA.

 

As of March 2025, FDA’s Human Foods Program had filed over 1,200 GRAS notices. However, FDA estimates that an additional 1,000 or more human food substances were the subject of independent GRAS conclusions without any notification to the agency. This lack of visibility has concerned regulators, particularly considering recent food safety incidents.

 

On March 10, 2025, HHS Secretary Robert F. Kennedy Jr. directed FDA to explore rulemaking to eliminate the pathway for firms to introduce purported GRAS substances into the market without notifying FDA. This initiative aligns with the Administration’s Make America Healthy Again priorities. FDA cited several examples where mandatory notification would have improved its ability to protect public health, including tara flour (linked to approximately 400 adverse event reports in 2022), caffeinated alcoholic beverages, Delta-8 THC products, and stevia leaves and crude extracts.

 

Key Provisions of the Proposed Rule
1. Mandatory GRAS Notifications

The proposed rule would amend 21 CFR Parts 170 and 570 to require mandatory submission of GRAS notices for both human and animal food substances purported to be GRAS under section 201(s) of the FD&C Act. The conversion from voluntary to mandatory notification is the central feature of this proposal.

 

2. Exceptions to the Mandatory Notification Requirement

The proposed rule (at proposed § 170.205[b]) provides several important exceptions under which a mandatory GRAS notification would not be required:

  • Existing “No Questions” Letter: The substance is already covered by a “no questions” letter from FDA for the specific intended use.
  • Listed or Affirmed GRAS: The substance is listed or affirmed as GRAS in 21 CFR Parts 182, 184, or 186.
  • Pre-1958 Natural Substances: The substance qualifies as GRAS under § 170.30(d) (i.e., it is of natural biological origin and was in use prior to 1958) or under § 170.30(i)(1).
  • Established FDA Review Process: The substance was reviewed through an established FDA process, such as biotechnology consultations.
  • Threshold of Regulation (TOR) Exemption: The substance is covered by a threshold of regulation exemption.
  • Effective Food Contact Notification (FCN): The substance is covered by an effective premarket notification for a food contact substance from the same manufacturer or supplier.
  • Streamlined Submission: The substance was submitted under the proposed time-limited streamlined submission option (Subpart F) and is included on FDA’s public list.

 

3. Time-Limited Streamlined Submission Option for Pre-Rule Substances

Recognizing that many substances are already in the marketplace without FDA notification, the proposed rule includes a time-limited streamlined submission pathway (proposed Subpart F, § 170.305) designed to bring these substances within FDA’s awareness without imposing the full burden of a standard GRAS notice.

  • The streamlined submission option is available only for substances that were already in interstate commerce before the effective date of the final rule.
  • It is not available for:
    • Substances that previously received an “insufficient basis” letter from FDA
    • Substances that received a “not GRAS” determination from FDA
  • Streamlined submissions must be filed within one year of the effective date of the final rule.

 

What Food Companies Should Do Now

In light of this proposed rule, food companies should consider the following actions:

  • Conduct a GRAS Inventory: Identify all substances in your product portfolio that rely on a GRAS determination, distinguishing between those with existing FDA notifications (“no questions” letters) and those based on independent GRAS conclusions without FDA notification.
  • Assess Exception Eligibility: For each GRAS substance, determine whether any of the proposed exceptions would apply, potentially eliminating the need for a new submission.
  • Prepare for Streamlined Submissions: For substances currently in interstate commerce without FDA notification, begin gathering evidence of presence in commerce to support a streamlined submission within the one-year window.
  • Evaluate Safety Dossiers: Review the adequacy of existing safety data for substances that may require a full GRAS notice and identify any gaps that will need to be addressed.
  • Update SOPs and Compliance Programs: Begin planning updates to internal standard operating procedures to incorporate mandatory notification requirements into new product development workflows.
  • Consider Submitting Comments: The comment period closes December 9, 2026. Companies should consider submitting comments addressing the proposed rule’s impact on their operations, particularly regarding costs, the streamlined submission pathway, and the 18-month compliance timeline.
  • Monitor Developments: Track FDA’s progress toward finalizing the rule, including any changes made in response to public comments.

 

Timeline and Key Dates
  • Published: August 11, 2026 (91 Fed. Reg. 51834)
  • Comment Deadline: December 9, 2026
  • Effective Date (if finalized): 60 days after publication of the final rule in the Federal Register
  • Compliance Date: 18 months after the effective date (for §§ 170.205 and 570.205)
  • Streamlined Submission Window: Within 1 year of the effective date

 

We will continue to monitor this development as well as other FDA regulatory developments related to drugs, medical devices, biologics, foods, and dietary supplements. Please contact us if we can be of assistance with this or similar FDA regulatory issues.

 

Kirton McConkie provided this article as a service to clients and friends of the firm. It is for informational purposes only and should not be construed as legal advice. If you have questions about how these developments may affect your organization, please contact Seth Olson.