A Consumer Group Files Suit to Vacate FDA’s GRAS Notification Program

By Mark L. Itzkoff

In a formal challenge to FDA’s GRAS Notification Program, a consumer group called the Center for Food Safety (CFS) filed a lawsuit on Thursday alleging that FDA’s operation of the program under a proposed rule since 1997 and its failure to promulgate a final rule governing the program is a violation of the Administrative Procedures Act (APA).  The suit asks the court to vacate the proposed rule creating the GRAS Notification Program and “reinstat[e] the GRAS rule previously in force” (i.e., the GRAS affirmation rule) until FDA properly promulgates a GRAS notification final rule.

The lawsuit is the latest in a number of attacks on the GRAS Notification System over the past year.  As we noted in earlier posts (see here, here, and here), the GRAS notification system has been the subject of recent criticism by The Pew Charitable Trusts and the Natural Resources Defense Council (NRDC).  While the earlier criticisms questioned the validity of GRAS determinations in general or raised issues regarding the adequacy of specific GRAS notifications, the CFS suit is the first attempt to invalidate the GRAS Notification Program entirely.  Also, while this may seem to be a coordinated attack on the GRAS system by consumer groups, it is just as likely a case of different consumer groups jockeying for position (and for public attention and funding) on a hot issue.

In the lawsuit, CFS notes that the current GRAS Notification Program was proposed by FDA over 15 years ago.   Substances Generally Recognized as Safe, 62 Fed. Reg. 18938 (April 17, 1997)(GRAS Proposal).  The agency continues to operate the program under that proposed rule, and no final rule has been issued.  CFS had filed comments on the proposed rule under its previous name, International Center for Technology Assessment (ICTA), and claims that its procedural due process rights were violated “by FDA’s decision to implement a rule without following the notice-and-comment rulemaking procedures mandated by the APA.”  However, while FDA continues to operate under the proposed rule, the agency did reopen the comment period and discuss possible changes in the program in 2010.

The lawsuit also claims that under the current system, “several substances … have achieved GRAS status” that may pose serious risks to consumers, including Volatile Oil of Mustard, Olestra and mycoprotein (“Quorn”).  CFS claims that FDA’s alleged failure to comply with the APA has exposed the public, including CFS, to “risky products” without proper FDA oversight.

On the surface, the new lawsuit appears to be similar to the lawsuit filed by CFS in 2012, Center for Food Safety v. Hamburg, No. C 12-4529 PJH, 2013 WL 1741816 (N.D. Cal. Apr. 22, 2013), asking the federal courts to compel FDA to issue regulations implementing the Food Safety Modernization Act (FSMA).  In response to that suit, the federal court ordered FDA to comply with a specific timeline and issue the regulations by the dates specified in that timeline.

However, the new lawsuit is based on a significantly different statutory requirement that may result in a different decision.  FSMA required that FDA issue implementing regulations by certain statutory deadlines.  In essence, CFS simply asked the court to enforce those statutory deadlines.  By contrast, federal law does not require that FDA establish a GRAS Notification Program, much less establish any deadline for promulgating the regulations governing that program.

Finally, we note that CFS claims that FDA is unlawfully “exempting substances that are [GRAS] from regulation as food additives …” This is a mischaracterization of the agency’s response to GRAS Notices.  GRAS substances are exempt from FDA premarket scrutiny under the provisions of the Federal Food, Drug and Cosmetic Act because they meet certain statutory criteria, see 21 USC §321(s) and §342(a)(2)(C)(1).  Unlike food additive approval, GRAS status does not require FDA action.

For this reason, FDA does not issue exemptions under the GRAS Notification Program.  Rather, the agency “evaluate[s] whether the submitted notice provides a sufficient basis for a GRAS determination and whether information in the notice or otherwise available to FDA raises issues that lead the agency to question whether use of the substance is GRAS”  GRAS Proposal, 62 Fed. Reg. at 18938.

Regardless of the outcome of this case, GRAS status and some sort of FDA program for recognizing GRAS status are not going away.  That is because, as noted above, the GRAS exemption from the definition of “food additive” is written into FDA’s governing statute.  It would require legislation to change that.