Cancer Risk from Pork Leads FDA to Withdraw Approval for Drug Used to Treat Pigs

Following concerns that humans may face a risk of cancer from residue in pork, federal regulators have withdrawn approval for the swine drug carbadox, which has been on the market since 1972. 

The FDA’s Center for Veterinary Medicine (CVM) announced that it was withdrawing approval for carbadox, a drug for pigs, after determining that cancerous residue could be left in certain pork products, especially pork liver, which is derived from animals treated with the drug. However, the agency is not suggesting people change their pork-eating habits.

According to the agency, it recently reexamined the safety profile of carbadox, which is manufactured by Phibro Animal Health, based in Teaneck, New Jersey, and is used to prevent dysentery and bacterial enteritis in pigs. It is also often used to help pigs gain weight.

“The manufacturer of carbadox has failed to provide sufficient data to demonstrate the safety of this drug given evidence that carbadox may result in carcinogenic residues,” Michael R. Taylor, FDA deputy commissioner of food and veterinary medicine, said in the press release. “As a result, FDA’s Center for Veterinary Medicine is taking legal action to remove this product from the marketplace.”

The move concludes a safety review initiated by the agency after a July 2014 study conducted by the United Nations and World Health Organization committee, which determined that there were no safe levels of residue of carbadox (PDF) that constituted an acceptable risk to consumers. The FDA says it sees a potential risk to human health, particularly in products made from pork liver, like hot dogs, liverwurst, and some lunch meat and sausages.

The FDA says that eating pork from pigs given carbadox is not likely to affect a person’s lifetime risk of cancer significantly, but that removing it from the market will lower the overall lifetime risk to consumers.

The agency notes that there are other FDA-approved antibiotics available to treat swine and that the CVM will work with pork producers to minimize the impacts on the industry.