Food Safety News - 4/12/16

Phibro Animal Health Corp. will “vigorously defend” the pork antibiotic known as carbadox and sold under its Mecadox brand, which the U.S Food and Drug Administration now wants remove from the market after 40 years of use.

FDA’s Center for Veterinary Medicine (CVM) began the process for removing carbadox from the market with the publication on April 8 of a Notice of Opportunity for a Hearing. The Teaneck, NJ-based drug company responded already, requesting the hearing.

Michael R. Taylor, FDA deputy commissioner, said the decision to remove carbadox from the marketplace is intended to reduce life-long human carcinogenic risks associated with consuming carbadox residues over time in pork liver or other pork products.

Pork liver is used to make liverwurst, hot dogs, lunchmeats and certain types of sausages. Carbadox is used to treat swine dysentery and enteritis. There are other approved medications to treat those conditions in swine, according to FDA.

“The manufacturer of carbadox has failed to provide sufficient scientific data to demonstrate the safety of this drug given evidence that carbadox may result in carcinogenic residues,” Taylor said when FDA announced its intent to join other countries in banning carbadox.

However, Taylor said, FDA is not recommending people make any changes in their near-term food choices because of the agency’s actions regarding carbadox.

Phibro Animal Health officials say carbadox is “highly effective treatment for controlling bacterial diseases and swine dysentery.”  The antibiotic is not for human use and the Mecadox label requires a 42-day withdrawal period before pigs that have received the drug can be taken to market.

The company says hazardous residues of carbadox have not been detected in pork and the drug has a four-decade safety record. Further, the company charges FDA’s move to ban the substance came before studies the agency recently demanded could be completed.

“Phibro has complete confidence in the safety of Mecadox,” a company statement says. “We are disappointed that the FDA would take this action, when definitive studies are so close to being completed.”

In defense of the FDA acton, Taylor pointed to the international Codex Almentarius Commission, which in July 2014 found there is no safe level of carbadox residues.

While the process goes forward, Phibro is free to sell its Mercadox branded carbadox in the U.S.