On August 17, 2016, the U.S. Food and Drug Administration (FDA) issued a Final Rule regarding Substances Generally Recognized as Safe (GRAS), which will become effective October 17, 2016.
Currently, the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as long as the substance is generally recognized as safe under the conditions of its intended use. A food manufacturer can intentionally add a GRAS substance to food without FDA premarket review or approval. In addition, any person can voluntarily submit a petition requesting the FDA to affirm the GRAS status of a substance for its intended use. The Final Rule amends and clarifies the criteria in FDA regulations for when a substance may obtain the GRAS status. It also replaces the previous voluntary GRAS affirmation petition process with a voluntary notification procedure, under which any person may notify the FDA of a conclusion that a substance is GRAS.
Criteria for eligibility for classification as GRAS
The Final Rule provides that:
- 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 experience based on common use of a substance in food prior to January 1, 1958.
- 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are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.
Procedure for Voluntary GRAS Notification
The Final Rule outlines the procedure and requirements for submitting a GRAS notice, including:
- Definitions for certain terms, including amendment, GRAS notice, notified substance, notifier, qualified expert, supplement, etc.
- 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 required in a GRAS notice, including, for example:
- Signed statements and certification
- Identity, method of manufacture, and specification of the notified substance
- History of consumption of the substance for food use by a significant number of consumers
- A narrative providing the basis for the submitter’s conclusion of GRAS status as supported by scientific data, information, methods, and principles
- Process for submitting an amendment to GRAS notice
The Final Rule also specifies the requirement for FDA when administrating the GRAS notice, including:
- Information regarding how the 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 (extendible by another 90 days)
- FDA’s procedure if the notified substance will be used in a product subject to regulation by the Food Safety and Inspection Service of the U.S. Department of Agriculture
- Provisions governing the public disclosure of a GRAS notice, including FDA actions to make some information readily accessible to the public
FDA hopes the clarified criteria for GRAS status will help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the FD&C Act. According to FDA, the new notification procedure enables stakeholders to be aware of whether FDA has questioned the basis of a conclusion of GRAS status. As expected, certain consumer advocacy groups have called the Final Rule “unacceptable” and a failure to consumers because it allows the GRAS process to continue. There have already been reports of a legislative effort to require mandatory reporting of GRAS substances.
Michael Best’s FDA attorneys and Life Sciences Team have experience preparing and prosecuting all types of FDA regulatory submissions, establishing intellectual property protections, and counseling and negotiating a broad variety of collaborative research, development, licensing and marketing arrangements, and technology transfers.