Lawsuits Filed Against FDA’s Approval of Controversial Animal Drugs

Two different lawsuits have been filed by groups that include the Center for Food Safety and the Humane Society of the United States against the U.S. FDA for approving several controversial drugs used in food production without fully examining how they affect people, animals, and the environment. The products targeted in the lawsuits are based on ractopamine, which is fed to farm animals to cause rapid weight gain.

Critics of ractopamine say it can have detrimental effects on animals, resulting in extreme stiffness, cardiovascular dysfunction, and even death. According to the groups named in the lawsuit, these drugs can also remain active in animal waste, and when sprayed on fields or spilled from manure lagoons, they have potential to damage habitat, wildlife, and endangered species. Additionally, the groups say that ractopamine exposure has been linked to adverse health events in humans.

“FDA is basing controversial drug approvals on incomplete and inadequate environmental analyses,” says Paige Tomaselli, senior attorney for Center for Food Safety. “These drugs in our food supply impact the environment, thousands of farm workers, millions of consumers, and billions of animals. FDA cannot continue to abdicate its responsibility to do its job.”

It’s estimated 60 percent to 80 percent of pork sold in U.S. supermarkets comes from pigs treated with the drug. However, the European Union, China, and Russia have been known to ban U.S. pork from pigs that were fed ractopamine.

The lawsuits allege that the approvals made by FDA on ractopamine-based animal drugs since 2008 did not adequately assess the impact of ractopamine on farm workers, food safety, animal welfare, and the environment—failing to fully follow the federal National Environmental Policy Act (NEPA). The agency also failed to analyze the impacts of ractopamine used in combination with antibiotics and hormones. The FDA and USDA have recently been feeling pressure to eliminate the use of antibiotics for growth promotion purposes in food-producing animals.

The complaints are asking the court to set aside FDA’s approvals of ractopamine-based animal drugs and comply with NEPA before approving ractopamine-based products in the future.