January 19, 2005
Labels Changed on Hormone Implants to Indicate That They Are Not Permitted for Use in Veal Calves
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. While growth-promoting hormones are approved for use in ruminating cattle, they have never been approved for use in non-ruminating veal calves. FDA's Center for Veterinary Medicine believes that there are differences in the way ruminating and non-ruminating cattle process and eliminate such hormones.
Because there is no approved animal drug application providing for the use of these implants in veal calves, such use is illegal. Under section 512 of the Federal Food, Drug, and Cosmetic Act (the Act), use of an unapproved new animal drug results in the drug being unsafe, and, therefore, the drugs are adulterated. In addition, food that bears or contains these drugs is adulterated under the Act, and a person or firm that uses these implants illegally is also subject to regulatory action.
Sponsors of 16 New Animal Drug Applications (NADAs) and Abbreviated New Animal Drug Applications (ANADAs) for growth-promoting hormones have voluntarily filed supplemental NADAs or ANADAs with the FDA to update the labels on their approved products to indicate that effectiveness, animal safety, and human food safety have not been demonstrated in veal calves. The 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 pre-ruminating calves. Do not use in calves to be processed for veal.”
Any questions on these changes may be directed to Dr. Daniel Benz, FDA/Center for Veterinary Medicine, 7500 Standish Place, HFV -126, Rockville, MD 20855, 301-827-0223, daniel.benz@fda.hhs.gov.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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