Date: November 15, 2017

  • The U.S. Food and Drug Administration (FDA) has released two guidance documents regarding “generally recognized as safe” (GRAS) substances:  (1) Guidance for Industry: Regulatory Framework for Substances Intended for Use in Human Food or Animal Food on the Basis of the Generally Recognized as Safe (GRAS) Provision of the Federal Food, Drug, and Cosmetic Act, and (2) Draft Guidance, Best Practices for Convening a GRAS Panel: Guidance for Industry.  GRAS substances are excluded from the definition of a “food additive” under Section 201(s) of the Food, Drug, and Cosmetic Act (21 U.S.C. 321(s)) and, therefore, are not subject to mandatory premarket review by FDA under section 409 of the FD&C Act (21 U.S.C. 348).  FDA’s GRAS Final Rule (81 Fed. Reg. 54960, August 17, 2016), formally established a long-standing procedure that began April 17, 1997 (Proposed Rule, 62 Fed. Reg. 18938) for voluntarily submitting a GRAS notice for review by FDA.
  • In addition to expounding upon the required criteria for reaching a GRAS conclusion in the new guidance on the GRAS regulatory framework, FDA also “strongly encourages” the submission of a GRAS notice.  Additionally, if a GRAS notice is not submitted, FDA recommends documenting the GRAS conclusion using the regulatory framework for a GRAS notice in 21 CFR part 170, subpart E (for a substance that would be used in human food) or 21 CFR part 570, subpart E (for a substance that would be used in animal food).
  • Although not required – and, thus, not addressed in FDA’s GRAS Final Rule – FDA recognizes that convening a GRAS panel has historically been a way to provide evidence that generally available data and information are generally accepted by the expert scientific community.  In this regard, FDA’s draft guidance on convening a GRAS panel stresses that a GRAS panel is only one mechanism for demonstrating the safety of a substance under the conditions of its intended use is generally recognized by qualified experts, and also that a favorable report from a GRAS panel does not necessarily mean that the GRAS criteria have been met.  FDA’s draft guidance focuses on best practices applicable to a GRAS panel that is convened when the statutory basis for the proponent’s conclusion of GRAS status is through scientific procedures (as opposed to common use in food prior to January 1, 1958).  It provides 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 and not information that is trade secret.
  • We are working on a Client Alert which will contain more detail on FDA’s newly issued guidance on the regulatory framework for GRAS substances and draft guidance on best practices for convening a GRAS panel.