The Center for Food Safety and two other public interest organizations have filed a lawsuit against the U.S. Food and Drug Administration (FDA) seeking to overturn its approval of 11 animal drugs containing ractopamine hydrochloride on the ground that the agency failed to undertake the analysis purportedly required under the National Environmental Policy Act (NEPA) before approving them. Ctr. for Food Safety v. Hamburg, No. 14-4932 (U.S. Dist. Ct., N.D. Cal., filed November 6, 2014).

The Center previously petitioned FDA to reduce the allowable levels of ractopamine, administered in animal feeds to boost growth and leanness in meat production, and to study its potential effects on human health and animal welfare. Information about the petition appears in Issue 466 of this Update.

The complaint sets forth the effects these drugs allegedly have on livestock, like pigs, and on the environment. The plaintiffs claim that the company that makes ractopamine has acknowledged the “risk of impacting the chemical composition of water bodies by ‘potential leaching into the soil and groundwater from confinement areas,” yet has “apparently never conducted a field study of ractopamine’s impact on the chemical composition of waterways.”

The complaint also states that the company “has acknowledged that ractopamine is moderately toxic to plants and slightly toxic to aquatic invertebrates” and that “at least ninety-eight species of threatened and endangered aquatic invertebrates and plants have critical habit[at] in areas where ractopamine is used.”

The plaintiffs further allege that the substance is often used in combination with other pharmaceuticals, including tylosin, monensin and melengestrol, and note that the European Union has banned the use of these pharmaceuticals for various reasons, such as the development of resistant bacteria to drugs used in human medicine, ecological risks and endocrine-disrupting activity. According to the complaint, FDA’s approvals for some of the challenged drugs rely on a single study or are based on 15-year-old documents that fail “to account for significant new circumstances and information relevant to environmental concerns raised by the use of ractopamine, particularly the current widespread use of ractopamine and other feed additives.”

Alleging that “FDA unlawfully approved Topmax in violation of NEPA and the APA [Administrative Procedure Act],” and “violated NEPA by approving applications for ractopamine-based combination drugs without any NEPA review,” the plaintiffs seek a declaration that the agency violated NEPA and the APA, an order vacating and remanding its decisions to approve ractopamine-based animal drugs, an injunction barring the use of ractopamine-based animal drugs until FDA complies with NEPA, and fees and expenses.

Announcing the litigation, plaintiff Center for Biological Diversity points to a study cited in the complaint, “[t]he drug’s primary human health study, conducted on just six healthy men, caused heart pounding in three of the men so severe that one of them had to be withdrawn from the study.” It also highlights that the European Union, China and Russia have banned the importation of U.S. pork from pigs that have been fed ractopamine. See Center for Biological Diversity News Release, November 6, 2014.