FDA Faces Lawsuits Over Animal Feed Additive Approval

Several environmental and worker activist groups are suing the government over its approval of a controversial animal feed additive, which they claim is unsafe. 

Two separate lawsuits were filed against the FDA last month in the U.S. District Court for the Northern District of California, by the Center for Food Safety, Center for Biological Diversity, the Humane Society, the United Farm Workers of America, and the Sierra Club.

The complaints challenge the FDA’s 2008 and 2014 approvals of 11 drugs using ractopamine as the active ingredient in animal feed. The groups say the drug approvals were issued without adequate testing, research or a full examination of ractopamine side effects on people, animals, and the environment. In addition, the lawsuits indicate the approval does not comply with the National Environmental Policy Act (NEPA).

The plaintiffs allege the FDA did not conduct an environmental analysis, relying solely on cursory environmental assessments developed by the pharmaceutical industry. The groups that filed the lawsuits maintain that the agency never conducted a broad look at how the drug affected public health and the environment, including the effects of the drug on threatened and endangered species.

Ractopamine is an animal feed additive approved in 1999. It is fed to pigs, cattle and turkeys to cause rapid weight gain.

The drug mimics stress hormones, causing the animals to convert feed to muscle rapidly in preparation for slaughter. Estimates indicate that between 60% to 80% of the pork sold in the U.S. comes from pigs treated with ractopamine.

The chemical has been linked to muscle tremors, heart problems and increased aggressive behavior in animals.

According to the lawsuits, the FDA began allowing the drug in food production animals without fully examining the health effects. It has never been proven to be fully safe for human consumption or for animals, the lawsuits claim.

“FDA is basing controversial drug approvals on incomplete and inadequate environmental analyses,” said Paige Tomaselli, senior attorney for Center for Food Safety, in a press release concerning one of the complaints.

The effect of ractopamine on humans has not been well studied. One of the few studies used only six test subjects. During the study, three of the six healthy males enrolled in the study began to experience rapid heart beats. In one instance, the heart pounding was so severe a participant had to be withdrawn from the study.

The lawsuits call on the court to set aside the “unlawful approval” issued by the FDA. They also urge the FDA to issue more thorough environmental analyses for these drugs.

Another concern regarding ractopamine is the use of the drug in combination with antibiotics and hormones, all drugs heavily used in livestock and poultry production. Widespread antibiotic use in animals is linked to increasing bacteria resistance to antibiotics and decreasing the effectiveness of antibiotics in people.

Ractopamine has been used widely for more than 10 years, but in recent years many countries have begun banning the additive. The European Union, China and Russia all banned U.S. pork from pigs that have been fed the drug. About 20% of pork products tested in the U.S. have traces of the ractopamine.

“These drugs in our food supply impact the environment, thousands of farm workers, millions of consumers, and billions of animals,” said Tomaselli. “FDA cannot continue to abdicate its responsibility to do its job.”