Regulatory Watch
FDA Proposes Rule to Make GRAS Notification Mandatory
The FDA says converting GRAS notification from voluntary to mandatory would ‘lead to increased transparency about substances that are added to food.
The U.S. Food and Drug Administration has proposed a rule to convert the voluntary generally recognized as safe (GRAS) notification program to mandatory, requiring anyone introducing a food substance into interstate commerce to present the basis for their conclusion that it is GRAS for its intended use.
The FDA says the change would “lead to increased transparency about substances that are added to food, enabling FDA to regulate the safety of food substances more effectively and efficiently.” Both substances already in the food supply and those being marketed for food use for the first time would be subject to mandatory notification.
Under the proposed rule, failing to outline a substance’s conditions of intended use would factor into the FDA’s prioritization of food substances for post-market review. Additionally, the agency specified that simply submitting materials for a GRAS notice wouldn’t be enough — the FDA also would have to submit a GRAS notice, with the initial evaluation to take 45 days.
The FDA outlined several exceptions to the potential mandatory GRAS notification process, which include substances that:
- Have already received a “no questions” letter
- Are listed or affirmed as GRAS under the conditions of its intended use
- Have already undergone an established FDA process
- Are exempt under a “threshold of regulation” process
- Are of “natural biological origin” and have been widely consumed for their nutrient properties in the U.S. before Jan. 1, 1958 with no known safety hazards
Pesticides, color additives, animal drugs and dietary supplements are not eligible for GRAS classification and are therefore excluded from the GRAS mandatory notification process.
The FDA would also establish electronic submission for GRAS notification to “ensure submissions are transmitted in a timely fashion, thus making our administration of the GRAS notification procedure more efficient.”
The agency will accept public comments on the proposed rule until Dec. 9.
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