According to an article published February 24, 2014 on the webportal of the industry news agency Food Business News, the non-profit organization The Center for Food Safety filed a lawsuit against the U.S. Food and Drug Administration (FDA) on February 20, 2014. The Center for Food Safety accuses the FDA of never issuing a final rule formally adopting the currently used notification process for generally recognized as safe (GRAS) substances. In 1997, the FDA published a proposed rule (pdf), but failed to review public comments and to issue a final rule. Nevertheless, the GRAS notification process replaced the previously used GRAS petition process. Under the notification process manufacturers may notify the FDA of a GRAS claim, in response to which the FDA can pose questions or issue a ‘no objections’ letter. In contrast to the petition process, the notification does not require the FDA to affirm GRAS status. However, both processes are voluntary providing manufacturers with a mechanism for official recognition. In the case of success of the lawsuit, the FDA would have to revert back to the GRAS petition process in place before 1997. The FDA did not comment on the pending litigation.
Jeff Gelski (February 24, 2014). “F.D.A. faces lawsuit over GRAS program.” Food Business News.