FDA has published a final rule (81 Fed. Reg. 54,959 (Aug. 17, 2016)), based on its 1997 proposed rule (62 Fed. Reg. 18,937 (Apr. 17, 1997); see also 75 Fed. Reg. 81,536 (Dec. 28, 2010) (reopening comment period)), which:
- Clarifies the criteria for when the use of a substance in a food for humans or animals is not subject to the premarket approval requirements of sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. §§321(s), 348) because the substance is generally recognized as safe (GRAS) for its intended use; and
- Replaces the voluntary GRAS affirmation petition process (21 C.F.R. § 35(c)) with a voluntary notification procedure under which any person may notify FDA of a determination that a substance is GRAS under the conditions of its intended use.
Both the agency and the food industry had been operating under the proposed rule (which substituted a GRAS notification procedure for the traditional petitioning process) for nearly two decades. FDA’s publication of the final rule fulfills a settlement agreement reached in October 2014 with the Center for Food Safety (CFS), which sued the agency in February 2014, seeking to vacate FDA’s 1997 proposed rule on GRAS.
With respect to clarification of the criteria for GRAS status, the final rule provides:
- A substance cannot be classified as GRAS under the conditions of its intended use if the available data and information do not satisfy the safety standard for a food additive under the FD&C Act;
- General recognition of safety requires common knowledge, throughout the expert scientific community knowledgeable about the safety of substances directly or indirectly added to food, that there is a reasonable certainty that the substance is not harmful under the conditions of its intended use;
- “Common knowledge” can be based on either “scientific procedures” or on experience based on common use of a substance in food prior to January 1, 1958; and
- General recognition of safety through scientific procedures must be based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.
With respect to the notification procedure, the final rule includes:
- Definitions for certain terms, including “amendment,” “GRAS notice,” “notified substance,” “notifier,” “qualified expert,” and “ supplement”;
- A clear statement of the opportunity for any person to submit a GRAS notice;
- Information on available formats (electronic and paper) and where to send a GRAS notice;
- What data and other information may be incorporated into a GRAS notice;
- General provisions applicable to a GRAS notice;
- Specific information that must be provided in a GRAS notice;
- The process to submit an amendment to a GRAS notice; and
- The process to request that FDA cease to evaluate aGRAS notice.
Finally, with respect to FDA’s administration of a GRAS notice, the final rule specifies:
- Information about how FDA will file a GRAS notice, respond to it, and send subsequent correspondence about it;
- FDA’s commitment to respond within 180 days of filing of a GRAS notice, with a potential
- to extend its response timeframe by another 90 days;
- The procedures in the event that the intended conditions of use of the notified substance include use in a product subject to regulation by the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA); and
- Provisions governing the public disclosure of a GRAS notice, including the actions FDA will take to make some information regarding a GRAS notice readily accessible to the public.
The final rule becomes effective on October 17, 2016. As of the effective date of the final rule, FDA will close the docket for any pending GRAS affirmation petition. The petitioner may incorporate the applicable petition into a new GRAS notice.
Some speculate that the final rule will be challenged in court by CFS and/or others. However, the ultimate success of such an action seems doubtful. It likely would be better for FDA to enforce the final rule, once effective, to demonstrate its practicality in safeguarding consumer food consumption.