Environmental Groups Challenge FDA Ractopamine Approvals

Environmental Groups Challenge FDA Ractopamine Approvals

Several interest groups say FDA impact assessments of ractopamine-based drugs are incomplete

An assortment of non-profit interest groups this week challenged the U.S. Food and Drug Administration's environmental review of ractopamine-based drugs in two separate lawsuits, claiming the FDA did not adequately examine how the drugs may affect people, animals and the environment.

Ractopamine is commonly used as a feed additive to improve animals' feed efficiency and production of lean muscle rather than fat. The FDA approved the first Ractopamine product for swine, in 1999; two others for cattle and turkeys came in 2003 and 2008.

Several interest groups say FDA impact assessments of ractopamine-based drugs are incomplete

In a first lawsuit, groups the Center for Food Safety, the Center for Biological Diversity and Sierra Club say 11 ractopamine-based drugs were approved on "incomplete and inadequate environmental analyses" and could impact welfare of the environment, farm workers, consumers.

The group says FDA also has failed to review ractopamine's effects when used with steroids or antibiotics. It asks the court to shelf the approval of the 11 ractopamine-based drugs until more thorough analyses can be completed.

Related: Veterinary Drug Ractopamine Standards Approved

In a second lawsuit brought by the Humane Society of the United States, the United Farm Workers and the Animal Legal Defense Fund, groups allege also that FDA analyses on ractopamine-based drugs' cumulative effects on animal behavior, worker safety, wildlife and waterways are incomplete.

"The drugs include new combinations of ractopamine with controversial antibiotics and steroids. These drugs remain active in animal waste," HSUS claims.

The second suit also asks FDA to set aside the drug approvals pending additional environmental review.

FDA has listed on its website the environmental assessments and findings of no significant impact for the three initial ractopamine HCI drugs.

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