Health Canada Is Issuing An Order To Stop The Sale Of Carbadox



Health Canada Press Release
August 10, 2001

OTTAWA - Health Canada announced today it is issuing an order to stop the sale of the veterinary drug carbadox. The decision to stop sale followed a scientific review of recent information on the drug, which is used in the rearing of pigs intended for human food. Departmental scientists concluded that continued sale of carbadox cannot be justified in light of the potential for misuse and unintentional contamination of other products.

Carbadox is an antibiotic approved in the 1970s for use in swine to prevent and treat disease as well as to maintain weight gain during periods of stress, such as weaning. It has been shown that the drug, and the by-products of the drug that occur when the drug is metabolized in the body, can cause cancer in rats. However, when an appropriate withdrawal period (i.e stopping the administration of the drug before slaughter) is observed, the drug and its breakdown products are not found in the food derived from the treated animal.

Carbadox was approved on the basis that this specified 35-day withdrawal period be strictly observed. However, reports of misuse and accidental contamination, combined with a better scientific capacity to detect breakdown products of carbadox, resulted in serious concerns about the safety of the product. The first reported incident occurred in the fall of 2000 when pigs at a farm in Quebec were accidentally fed carbadox and slaughtered without respecting the withdrawal period. All affected product was recalled and removed from store shelves and an investigation into the incident was launched. The investigation was then broadened to review the use of carbadox throughout the Canadian pork industry.

In February 2001, responding to the European Union Fall 2000 audit of the Canadian Program for the Control of Residues, Canada made a public commitment to reassess the use of carbadox in pigs. Based on the reassessment, Health Canada proposed to amend the Food and Drug Regulations to ban the sale of any drug containing carbadox for administration to food-producing animals. As part of this regulatory process, Health Canada advised manufacturers of its human safety concerns and asked them to provide evidence to respond to these concerns. The manufacturers provided information, which was reviewed carefully by experts in health risk assessment.

Health Canada concluded that this information does not satisfy its concerns for safety and is proceeding immediately with a stop sale order. The stop sale order protects consumers until the completion of the regulatory process that might lead to a permanent ban. As part of this process, Health Canada will continue its review of carbadox.

Swine producers, feed mill manufacturers, veterinarians and other affected groups are being informed of the decision. Health Canada will monitor compliance with the order. The Canadian Food Inspection Agency is continuing to monitor for the presence of residues in food and animal feed.


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