CSPI Sues FDA for Delay in Response to Mercury-Labeling Petition

The Center for Science in the Public Interest (CSPI) and Mercury Policy Project have sued the U.S. Food and Drug Administration (FDA), seeking a declaration that the agency’s delay in responding to their citizen petition on labeling fish with high levels of mercury is unreasonable and violates the Administrative Procedure Act and Federal Food, Drug, and Cosmetic Act. CSPI v. FDA, No. 14-0375 (D.D.C., filed March 10, 2014). Further details about the petition, which seeks labeling on seafood packaging and point-of-purchase signage, appear in Issue 401 of this Update. The plaintiffs also seek an order compelling the agency to issue a final response by a court-imposed deadline.

According to the complaint, the plaintiffs submitted the petition to FDA in July 2011 and received a tentative response from the agency beyond the 180-day limit required by FDA regulations. The plaintiffs claim that they have not received any communication from FDA since then either granting or denying the petition, providing additional reasons for its failure to issue a decision, or “any information on when it intends to take final action on the Petition.” The plaintiffs claim that seafood contaminated with mercury “presents serious health risks to hundreds of thousands of children in the United States,” and that research shows consumers are unaware of the risks of mercury exposure from eating seafood.

Issue 517