July 15, 2004
FDA Withdraws Guidance On Use Of Unapproved Hormone Implants In Veal Calves
The Food and Drug Administration (FDA) is withdrawing a Guidance For Industry (GFI #172) entitled “Use of Unapproved Hormone Implants in Veal Calves.” This guidance, which was issued April 2, 2004, is being withdrawn because the policy contained within it only applied to veal calves presented for slaughter prior to June 6, 2004.
Additional information about the withdrawal of this guidance document is contained in the July 15, 2004 Federal Register. Questions may be directed to Gloria J. Dunnavan, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7500 Standish Place., Rockville, MD 20855, 301-827-1168, e-mail: gloria.dunnavan@fda.gov.
GFI #172 outlined special measures to ensure the safety of veal in response to the identified illegal use of unapproved hormone implants in veal calves. The policy outlined in this guidance only applied to veal calves presented for slaughter prior to June 6, 2004. Therefore, the guidance is no longer relevant and is being withdrawn.
Growth-promoting hormones are approved for use in ruminating cattle, but 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.
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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