FDA Publishes Two Guidance Documents on GRASDecember 14, 2017
FDA recently published a guidance document reminding proponents of GRAS status of their obligations under the FFDCA and its implementing regulations (which we refer to as the “Reminder Guidance,” available here). FDA also published a draft guidance document setting out best practices for convening a GRAS expert panel (which we refer to as the “GRAS Panel Guidance,” available here).
The Reminder Guidance provides a useful summary of FDA’s interpretation and application of the GRAS exception to the statutory definition of “food additive.” It is based primarily on FDA’s regulations and guidance, but also includes in an appendix certain comments and responses drawn from the preamble to the GRAS final rule. The Reminder Guidance “strongly” encourages submission of GRAS notices to the agency. For those who decide not to notify FDA of their independent GRAS conclusion, it recommends using the GRAS notification procedure in FDA regulations as guidance, organizing supporting information in the format of a GRAS notice, referring to FDA’s FAQ on GRAS (see here), and making the basis for an independent GRAS conclusion publicly available. The latter recommendation appears not to recognize the significant investment of resources that a GRAS evaluation can demand. Comments on the Reminder Guidance, which was issued in final form, can be submitted at any time.
The issuance of the draft GRAS Panel Guidance comes as no surprise; as we discussed in a prior blog posting, the stage was set by external critiques of FDA’s administration of the GRAS exception. The GRAS Panel Guidance includes a lengthy discussion of the potential for bias in scientific panels that draws on policies and guidance deemed relevant by FDA. It also provides recommendations on how to select experts to ensure appropriate and balanced expertise, procedural considerations in organizing and managing the deliberations of a panel, assessing and managing conflicts of interest and appearance issues, providing information to a panel, and documenting a panel’s deliberations and conclusions.
Those with an interest in the continued use of GRAS panels in the conduct of GRAS evaluations would be well advised to read the draft GRAS Panel Guidance and consider its potential impacts if finalized in its current form. As noted in the guidance, the use of a GRAS panel is not required. To the extent that any final guidance significantly increases the burdens associated with convening a GRAS panel, such guidance could have the unintended effect of discouraging the use of GRAS panels as a mechanism for demonstrating that the safety of the use of a substance is generally recognized by qualified experts. In that regard, an estimate of burdens associated with adhering to the draft guidance is included in the accompanying Federal Register notice (available here). Comments on the draft guidance are due by May 15, 2018.