Judge OKs FDA Decision To Approve Additive Banned In 150 Countries

By Derrick Broze

Last Thursday, a federal judge in California dismissed two lawsuits claiming the Food and Drug Administration illegally approved a dangerous drug for use in animal feed.

The lawsuits were filed by the Center for Food Safety, the Sierra Club, the Center for Biological Diversity, United Farmworkers of America, the Animal Legal Defense Fund, and the Humane Society of the United States. The Center for Food Safety originally filed the suit against the FDA in November 2014, stating the agency violated the National Environmental Policy Act and Administrative Procedure Act when it approved an animal feed additive that contained the controversial drug ractopamine hydrochloride.

Ractopamine is part of a class of drugs known as beta-agonists, which are intended to add muscle weight to animals before they are led to slaughter. Ideally, the drug helps animals gain weight while eating less, resulting in reduced costs. However, imports of beef, pork, and turkey with ractopamine are banned in 150 countries, including China, Russia, and member states of the European Union. Japan, the United States, Canada, South Korea, and 27 other countries still assert meat containing ractopamine is safe for human consumption.

The plaintiffs argued the FDA approved drugs manufactured by Elanco, a division of Eli Lilly, without properly testing ractopamine. An investigation by the Food and Environment Reporting Network (FERN) found that ractopamine is fed to “an estimated 60 to 80 percent of pigs in the United States” and has “resulted in more reports of sickened or dead pigs than any other livestock drug on the market.”

FERN examined records from the FDA’s Center for Veterinary Medicine showing Elanco studied the drug Paylean and initially found “no adverse effects were observed for any treatments.” However, within a few years, the company received hundreds of reports from farmers and veterinarians of sickened pigs. FERN also found that as of March 2011, 160,000 pigs administered the drug were reported to have suffered adverse effects. FDA records released under a Freedom of Information Act request also detail pigs suffering from hyperactivity, trembling, broken limbs, an inability to walk, and death.

Elanco Companion Animal Health, a division of Elanco, had previously filed a motion to dismiss the suits, claiming the defendants lacked standing because of their failure to “exhaust administrative remedies.” U.S. District Judge Yvonne Gonzalez Rogers agreed and dismissed the lawsuit. “The FDA citizen petition process is the appropriate procedural mechanism for plaintiffs to raise its contentions in the first instance, before seeking judicial review,” Rogers wrote in her 16-page ruling. The judge made no mention of the adverse health effects witnessed in animals.

The plaintiffs said the “failure-to-exhaust condition” did not apply because the FDA’s approval process is secretive and denies the public a meaningful opportunity to participate in the process. The judge disagreed, ordering both parties to file statements detailing why the judge should not suspend the case by November 19th.

Anti-Media will continue to monitor this developing situation and keep you posted on future developments with this lawsuit and studies on the effects of ractopamine.

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