FDA Agrees to Deadline for Issuance of GRAS Final Rule

By Ricardo Carvajal – 

FDA and the Center for Food Safety (CFS) entered into a consent decree that calls for FDA “to submit a final rule regarding ‘Substances Generally Recognized as Safe’ to the Federal Register for publication no later than August 31, 2016.”  As we reported in a prior posting, CFS sued FDA over the agency’s administration of a GRAS notification program consistent with a proposed rule issued in 1997.  The consent decree does not address CFS’s substantive concerns.  Rather, it commits FDA to issue a final rule by the agreed-upon deadline.  CFS reserves the right to “challenge the merits of the final rule, including but not limited to claims relating to whether FDA’s final action complies with the APA and other applicable laws.”  FDA can seek an extension of the agreed-upon deadline for good cause and/or exceptional circumstances.

Notwithstanding the limited relief obtained through the consent decree, CFS trumpeted a victory on its website.  The CFS announcement propagates a number of mischaracterizations of the GRAS exception (e.g., that it was intended only for common food ingredients like sugar and gelatin, and that manufacturers could once “formally petition FDA to approve a food additive as GRAS”).  Further, CFS claims that finalization of the GRAS rule “gives the public the right to challenge FDA on its GRAS system.”  CFS’s posture suggests that FDA’s issuance of a final rule could beget additional litigation – and a corresponding delay in the rule’s implementation.