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Food safety, environmental and animal rights groups last week sued the U.S. Food and Drug Administration (FDA) in federal court in a bid to force the agency to ban or reduce the allowable levels of a widely used livestock growth drug that the groups said causes harm to humans, animals and the environment.

Ractopamine — banned or restricted in about 160 countries — is used by U.S. industrial livestock producers to rapidly grow muscle in cows, pigs and turkeys.

According to the complaint, the drug has been shown to cause a host of adverse effects in animals. It also can cause heart and respiratory issues in meat consumers and farmworkers and pollutes ground and surface waters.

The groups — including the Center for Food Safety, the Animal Legal Defense Fund, the Center for Biological Diversity and the Food Animal Concerns Trust — allege the FDA violated the Administrative Procedure Act by failing to respond in a “reasonable” time to their 2012 and 2020 petitions asking that the agency ban or severely limit ractopamine use in livestock.

Hannah Connor, environmental health deputy director at the Center for Biological Diversity, said in a press release the FDA “has dragged its feet for years while factory farms have continued using this dangerous animal drug.”

“Until the FDA can prove ractopamine is completely safe,” she said, “the best solution is to act urgently to better protect human health, animals and the environment by granting these petitions.”

The lawsuit — filed in the U.S. District Court for the District of Columbia — demands the FDA provide “substantive responses” to the petitions, which in turn could result in stricter regulations or an all-out ban of the drug.

FDA’s own files show evidence of harm

Ractopamine is a beta-agonist drug created and marketed by Elanco Animal Health to boost muscle growth in meat-producing animals.

It’s usually administered in the animal’s final weeks of life and may increase an animal’s risk of “painful injury, inhumane treatment and extreme stress,” according to the complaint.

Livestock producers and researchers issued more reports to the FDA of pigs sickened or killed by ractopamine than reports related to any other drug given to pigs.

The FDA’s data show that more pigs have experienced adverse effects from ractopamine than from any other veterinary drug, the groups said in the complaint:

“The reports of adverse effects to pigs include, but are not limited to, leg stiffness, paralysis, immobility, rapid breathing, severe redness of the skin, muscle tremors, walking with difficulty, frequent vomiting, decreased motor apathy, lacrimation, vasodilation affecting ears and abdomen, fever, bloody diarrhea, enlarged lymph nodes, cracked hooves, coughing, lung congestion, infections on the body, cannibalism, heart attack, aortic rupture, increased fighting, hyperactivity, high body temperature, pneumonia, aggressive sexual behavior, and death by frothy bloat and other means.”

Scientific studies and other evidence — including studies contained in the FDA’s own files — also link ractopamine to human heart and respiratory issues in those who eat the meat and in farmworkers, the groups said.

The plaintiffs also are concerned about the drug’s impact on the environment since the animals excrete about 95% of it into manure within the first couple of days after eating feed containing ractopamine.

Run-off from the manure contaminates nearby waterways.

Plus, uneaten feed containing the drug may also be buried, which further increases the amount of the drug in the environment.

“The environmental impacts of the release of ractopamine into the environment have not been fully studied and could threaten water quality and wildlife,” the complaint said.

Ractopamine also can negatively affect meat taste and tenderness, according to a Center for Food Safety factsheet.

About 160 countries ban or restrict ractopamine

The FDA first approved ractopamine for use in American farm animals in 1999 — an approval based primarily on safety studies conducted by the drugmaker, the groups said.

The European Union in 2009 banned ractopamine after finding in part that data could not support a conclusion that the drug is safe. China, Japan, South Korea and Russia also have prohibited or restricted ractopamine use.

In 2012, the Animal Legal Defense Fund and the Center for Food Safety filed a citizen petition with the FDA calling for the immediate reduction in the allowable levels of ractopamine. The groups urged the agency to conduct comprehensive studies on the long-term effects of human consumption, immediate health impact on animals and a thorough review of international standards.

In 2020, three of the groups petitioned the FDA for emergency rulemaking to immediately suspend ractopamine’s approval for use in pig and cow feed.

Like the 2012 petition, the 2020 petition documented ractopamine’s harmful effects on humans, animals and the environment.

Despite receiving the two petitions, the FDA continues to approve of ractopamine. The complaint said, “around 60–80% of pigs raised for food in the United States receive ractopamine, amounting to, at minimum, tens of millions of pigs each year.”

The “FDA has ignored the health risks of ractopamine for far too long,” said Food Safety’s Co-Executive Director Sylvia Wu in the press release. “Our farmworkers, animals, and environment cannot and should not have to wait for a lawsuit to be filed for the agency to do its job.”

The FDA did not immediately respond to The Defender’s request for comment.