FDA Denies Citizen Petition on Arsenic-based Animal Drugs

October 1, 2013

The U.S. Food and Drug Administration (FDA) today denied a petition from the Center for Food Safety and the Institute for Agriculture and Trade Policy that asked the agency to take steps to revoke the approvals of four arsenic-based animal drugs. The petitioners’ requests with respect to three of the four drugs at issue became moot after the sponsors of those drugs requested that FDA withdraw the approvals for those products.

In response to the announcement, NCC Vice President of Scientific and Regulatory Affairs Ashley Peterson, Ph.D., released the following statement:

“The only arsenical used as a feed additive in broiler production in the last ten years, Roxarsone, was suspended in 2011 and the product is no longer manufactured or used.  No other feed additives containing arsenic are currently used in broiler meat production in the United States.”

With respect to the only remaining approved arsenic-based animal drug, FDA said it denied the petitioner’s request because the agency is in the process of completing several scientific studies and reviewing and evaluating information to help the agency more fully evaluate any potential concerns related to the safety of arsenic-based animal drugs.  This drug, nitarsone, is not used in U.S. broiler production.

FDA’s response can be read in its entirety by clicking here.


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