The U.S. Food and Drug Administration’s Center for
Veterinary Medicine (CVM) took the first step toward
rescinding its approval of the use of carbadox to
treat swine because the drug may leave trace amounts
of a carcinogenic residue.

CVM’s action comes after
the center recently reexamined the safety profile of
the drug and conducted a preliminary risk
characterization that indicated there could be
potential risk to human health from ingesting pork,
especially pork liver, derived from carbadox-treated
pigs.
Pork liver is used to make liverwurst, hot dogs,
lunch meat and some types of sausage, the agency
said.
“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,” said Michael R. Taylor, FDA deputy
commissioner for foods and veterinary medicine. “As
a result, FDA’s Center for Veterinary Medicine is
taking legal action to remove this product from the
marketplace.”
Carbadox was first
approved in the early 1970s for use in swine to
control swine dysentery and bacterial swine
enteritis. It has also been used for weight gain and
feed efficiency.
In July 2014, the Codex
Alimentarius Commission determined there is no safe
level of residues of carbadox or its metabolites in
food that represents an acceptable risk to consumers.
This was based on the Food and Agriculture
Organization of the United Nations/World Health
Organization Codex Committee on Residues of
Veterinary Drugs in Foods’ conclusions on the
available scientific information.
Pork producers have
become more interested in carbadox recently because
it does not require a veterinarian's prescription,
according to John Goihl, president of Agri-Nutrition
Services Inc, a Minnesota-based firm that provides
feed formulations and consulting services to
manufacturers and livestock producers.
For more information
FDA - U.S. Food and Drug Administration
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