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CFS Files Suit to Vacate FDA's GRAS Notification Program

March 7, 2014

The Center for Food Safety (CFS) filed a lawsuit in the U.S. District Court for the District of Columbia against the U.S. Food and Drug Administration (FDA) over its Generally Recognized as Safe (GRAS) program. CFS claims that FDA is operating the GRAS Notification program under a proposed rule that was never subject to notice and comment rulemaking, essentially making the program illegal under the Administrative Procedure Act (APA).

By way of background, under the 1958 Food Additives Amendment, a substance can be considered GRAS by qualified experts based on scientific procedures and thereby exempt from the definition of a "food additive" and the formal preclearance requirements that apply to food additives. FDA has recognized GRAS substances in the Code of Federal Regulations (see 21 C.F.R. Parts 182, 184, and 186) but has acknowledged that: 1) the regulations do not capture all GRAS substances and 2) companies are legally entitled to reach self-determined GRAS positions. Once a GRAS determination is reached for a substance, there is no requirement that FDA approval of the GRAS status be sought before the substance can be marketed. Between 1958 and 1970, FDA would issue informal opinion on the GRAS status of a substance at the request of a manufacturer. These letters were often only available to the requestor and were not binding on the Agency.

In 1970, FDA conducted a rulemaking to provide a voluntary GRAS affirmation petition process. Under the process, FDA would: publish a notice of a filing in the Federal Register, request comments, conduct a comprehensive review, and then publish a final rule in the Federal Register. Although, once the GRAS petition was "accepted for filing," petitioners were able to market their products.

In 1997, FDA proposed the GRAS Notification procedure in a proposed rule. While the rule was never finalized, the Agency started accepting GRAS Notifications in 1998. To date, there have been almost 500 GRAS Notifications submitted to FDA. After evaluating a GRAS notice, FDA responds to the notifier by written correspondence. Generally, FDA either: 1) does not question the basis for the notifier's GRAS determination; 2) determines that the notice does not provide a sufficient basis for a GRAS determination; or 3) ceases to evaluate the GRAS notice at the notifier's request. FDA requested further comments on the proposed 1997 GRAS Notification procedure in December 2010.

In the lawsuit, CFS claims FDA's GRAS practice under the "interim" rule, which was never subject to the formal review process mandated under APA, has allowed potentially harmful substances—including Volatile Oil of Mustard, Olestra, and mycoprotein—to be declared safe. The Center is petitioning the Court to vacate the 1997 proposed rule, effectively reinstating the petition process until FDA promulgates a final GRAS rule. The case is Center for Food Additive Safety v. Sebelius et al (case number 1:14-cv-00267).