Suit Challenging FDA on Livestock-Feed Dismissed

A federal judge dismissed a lawsuit against the U.S. Food and Drug Administration brought by advocacy groups challenging the agency's approvals of several livestock-feed products used to fatten farm animals.

The decision by U.S. District Court Judge Yvonne Gonzalez Rogers is the latest twist in a battle over a drug called ractopamine, which in recent years has become widely used on U.S. farms to promote weight gain among turkeys, cattle and pigs. Critics of ractopamine say it can have negative effects on animals, including stiffness, lameness and even death. Some other governments ban the drug, including the European Union and China.

The advocacy groups—including the Center for Food Safety, the Humane Society of the United States and United Farm Workers of America— filed two lawsuits against the FDA last November, seeking to vacate 11 approvals covering 18 new and combined animal drugs containing ractopamine. They claimed that the FDA had failed to adequately consider the drugs' effects on animal welfare, worker safety, wildlife and U.S. waterways. The judge in March consolidated the two lawsuits.

In her ruling, dated Nov. 5, Judge Gonzalez Rogers said the advocacy groups had failed to exhaust their challenges directly with the FDA and couldn't yet bring a case in federal court. The plaintiffs' challenges are subject to regulations requiring them to submit what is called a "citizen petition" to the FDA and await a response before they are entitled to file claims in federal court, she said.

Zack Marker, an attorney at the Center for Food Safety, said the citizen petition isn't an appropriate mechanism for the plaintiffs' complaints in part because it "allows drugs that may be harmful to the environment to remain on the market," pending review. According to the ruling, federal regulations require a "tentative response" to a citizen petition within 180 days, but don't set a mandatory time frame for a final agency response.

Elanco, the animal-health unit of Eli Lilly & Co., which makes ractopamine-based products for pigs, turkeys and cattle, in June filed a motion to dismiss the lawsuits.

"We are pleased with the court's decision in this case," said a spokeswoman for the company. "The FDA approved ractopamine nearly 15 years ago and we remain confident in its safety and the FDA's approval process."

Write to Jesse Newman at [e-mail]

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November 09, 2015 21:05 ET (02:05 GMT)

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