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FDA Issues Guidance Documents on GRAS Panels and Regulatory Framework

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The U.S. Food and Drug Administration (FDA) has released two guidance documents regarding “generally recognized as safe” (GRAS) substances: 

GRAS substances are not subject to the premarket approval requirements applicable to food additives under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and manufacturers are entitled to make their own determination as to whether a substance is GRAS for its intended use in food or in contact with food. FDA’s GRAS Final Rule (81 Fed. Reg. 54960, August 17, 2016), formally established a long-standing procedure for voluntarily submitting a GRAS notice for review by FDA. (For background information on the final rule, see the article, FDA Issues Final GRAS Rule; Formally Adopts Voluntary Notification Process.)

The regulatory framework guidance expounds upon the required criteria for reaching a GRAS conclusion and discusses the GRAS notification procedure. Although not legally required, FDA indicates that the Agency strongly encourages the submission of a GRAS notice for food substances intended to be marketed on the basis of a GRAS exemption. For companies making a self-determined GRAS conclusion, FDA recommends documenting the GRAS conclusion by  following the framework for a GRAS notice set out in Title 21 Code of Federal Regulations (C.F.R.) part 170, subpart E (for a substance that would be used in human food) or 21 C.F.R. part 570, subpart E (for a substance that would be used in animal food).

FDA’s draft guidance on GRAS panels describes best practices for convening a GRAS panel, including FDA’s recommendations on: (1) identifying GRAS panel members who have appropriate and balanced expertise; (2) taking steps to reduce the risk that bias (or the appearance of bias) will affect the credibility of the “GRAS panel report,” including the assessment of potential GRAS panel members for conflict of interest and the appearance of conflict of interest; and (3) providing only public information to the GRAS panel.  

Although GRAS panels are not required, FDA recognizes that convening a GRAS panel has historically been a way to provide evidence that the safety of a substance when used as intended is “generally recognized” by qualified experts within the scientific community. FDA’s draft guidance on convening a GRAS panel stresses that a GRAS panel is only one mechanism for demonstrating that the safety of a substance under the conditions of its intended use is generally recognized by qualified experts. The guidance also points out that a favorable report from a GRAS panel does not necessarily mean that the GRAS criteria have been met.