Challenging FDA’s Unreasonable Delay in Responding to Petition to Limit Use or Withdraw Approval of Ractopamine

On March 26, 2024, 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 its 2012 rulemaking petition, urging for the immediate reduction in 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. The complaint also seeks a response to its related 2020 emergency petition, filed with the Food Animal Concerns Trust and the Center for Biological Diversity to suspend the FDA’s approval of ractopamine as processing plants faced shutdowns and delays due to the COVID-19 pandemic. 

Animal Legal Defense Fund, et al. v. FDA, et al. Complaint

Animal Legal Defense Fund, et al. v. FDA, et al.

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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.    

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. 

Who is being sued, why, and under what law? 

The FDA is being sued under the Administrative Procedure Act (APA) which 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 plaintiffs with final decisions on the petitions. Since the FDA has unreasonably delayed responding to the petitions, plaintiffs seek a declaration that the FDA has violated the APA and an order compelling the agency to provide plaintiffs with substantive responses to the petitions. 

What court is the lawsuit filed in?

The U.S. District Court for the District of Columbia.

Why this action is important: The FDA itself has reports from consumers and producers about the adverse effects of ractopamine, including increased numbers of lameness and deaths in producers’ herds. Given the known effects that risk the health of animals, humans and the environment, as well as the requirements set forth by the Animal Welfare Act, a response is necessary to address the immediate threat that comes from the use of Ractopamine.