March 01, 2005

 

 Label changed on hormone implants - March 1, 2005

 

posted February 15, 2005

A new warning statement has been added to the labels of all growth-promoting hormones reminding producers and veterinarians that their use in veal calves is illegal. Although growth-promoting hormones are approved for use in ruminating cattle, they have never been approved for use in nonruminating veal calves. The Food and Drug Administration's Center for Veterinary Medicine believes that there are differences in the way ruminating and nonruminating cattle process and eliminate such hormones.

This past year, the FDA issued a guidance on the use of unapproved hormone implants in veal calves, after the Department of Agriculture's Food Safety and Inspection Service discovered hormone implants in veal calves that arrived at slaughter plants in Wisconsin.

The new labels include the following statements: "Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established." These statements appear in the "Indications" section and are in addition to the following statements that are also included in the "Warning" section: "A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal."

Sponsors of 16 new animal drug applications and abbreviated new animal drug applications for growth-promoting hormones have voluntarily filed supplemental NADAs or ANADAs with the FDA to update their labels.

Individuals who have questions about the label changes can contact Dr. Daniel Benz, FDA's Center for Veterinary Medicine, 7500 Standish Place, HFV-126, Rockville, MD 20855, (301) 827-0223, daniel.benz@fda.hhs.gov.