FDA withdraws arsenic-based drug approvals

03-10-2013 | | |
FDA withdraws arsenic-based drug approvals
FDA withdraws arsenic-based drug approvals

The Food and Drug Administration (FDA) has announced that it will withdraw approvals for three of four arsenic-based drugs currently approved for use in food animal production.

A fourth arsenic-based drug used to make turkeys and chickens grow faster, among other purposes, will remain on the market.

FDA’s move follows a study led by the Johns Hopkins Center for a Livable Future (CLF) and published in May 2013 which found clear evidence that using these drugs in chicken production increased levels of inorganic arsenic, a known carcinogen, in chicken breast meat.

Earlier this year, the Center for Food Safety (CFS) and the Institute for Agriculture and Trade Policy (IATP) sued the FDA after the agency did not respond to a 2009 petition asking it to withdraw the approvals of all four drugs. The lawsuit forced the FDA to respond.

Keeve Nachman, a member of the faculty of the Johns Hopkins Bloomberg School of Public Health and lead author of the CLF study, issued the following statement:

“Our research found clear evidence that using arsenic-based drugs in poultry production increased people’s exposure to a potent carcinogen. The findings made it clear that continuing to use these drugs would increase the risk of cancer and possibly other diseases, too.

“We are glad that FDA and drug companies have bowed to public health concerns about using arsenic to produce chickens and turkeys, but the agency still has work to do. FDA must withdraw the approvals for nitarsone so that arsenic is no longer used to make food that people eat.”

In response to the announcement, NCC Vice President of Scientific and Regulatory Affairs Ashley Peterson, 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 US broiler production.

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