WASHINGTON, D.C. — Today, the Animal Legal Defense Fund, Center for Biological Diversity, Center for Food Safety, and Food Animal Concerns Trust filed a lawsuit to require the U.S. Food and Drug Administration (FDA) provide a substantive response to their 2012 and 2020 rulemaking petitions, urging for the immediate reduction or elimination of the allowable levels of ractopamine in farmed animals. Ractopamine is a drug used to rapidly grow muscle in cows, pigs and turkeys that also causes animals' bodies to suffer tremors, lesions, and deterioration, elevates consumers' heart rates, and harms the environment.  

Ractopamine is a nontherapeutic, beta-agonist drug created and marketed by Elanco Animal Health to boost growth rates in farmed animals. In the U.S., it is widely used in the industrial raising of pigs, cows, and turkeys on factory farms. It is generally administered during the animal's final weeks of life. Animals given beta-agonists such as ractopamine face increased likelihood of experiencing painful injury, inhumane treatment, and extreme stress. Evidence, including that within the FDA's own files, also links ractopamine to human heart and respiratory issues in meat consumers and farm workers, increased risk of pathogen contagion, and intensified environmental pollution through seepage and runoff to ground and surface waters. Still, ractopamine usage has been estimated in 60-80 percent of all pigs raised for food in the U.S.   

"For years the FDA has had evidence of the dire effects ractopamine has on animals physically and mentally but has refused to take action — risking the safety of public health and the environment," says Animal Legal Defense Fund Managing Attorney Daniel Waltz. "The Animal Legal Defense Fund urges the FDA to reduce allowable ractopamine levels — or withdraw the drug's approval all together — instead of allowing the industrial animal agriculture industry to dictate what is safe."

"FDA has ignored the health risks for ractopamine for far too long," said Sylvia Wu, Co-Executive Director for the Center for Food Safety. "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."

"We're suing the FDA because the agency has dragged its feet for years while factory farms have continued using this dangerous animal drug," says Hannah Connor, environmental health deputy director at the Center for Biological Diversity. "Until the FDA can prove ractopamine is completely safe, the best solution is to act urgently to better protect human health, animals and the environment by granting these petitions." 

Ractopamine is banned or restricted in meat production in at least 160 countries, including China and all countries in the European Union. Nonetheless, the FDA has approved ractopamine for use in cows, pigs and turkeys raised for meat in the U.S. and continues to allow ractopamine residue levels in meat that exceed those adopted by the international United Nations' food standards body, the Codex Alimentarius Commission.  

The Administrative Procedure Act (APA) requires federal agencies to decide on all rulemaking petitions within a "reasonable" period of time. The FDA has violated this mandate by failing to provide final decisions on the 2012 and 2020 petitions.