The U.S. Food and Drug Administration (FDA) on Wednesday announced that it intends to ban certain uses of cephalosporin antimicrobials in cattle, swine, chickens, and turkeys beginning April 5, 2012. The announcement appears in today’s Federal Register and stakeholders will have until March 6, 2012, to submit comments to FDA. The Federal Register notice is available here.
FDA announced that it is prohibiting the extralabel use of cephalosporin antimicrobial drugs (not including cephapirin) in cattle, swine, chickens, and turkeys: (1) for disease prevention purposes; (2) at unapproved doses, frequencies, durations, or routes of administration; and (3) if the drug is not approved for that species and production class.
The extralabel uses that are not prohibited by this order include: (1) use of approved cephapirin products in food-producing animals; (2) use to treat or control an extralabel disease indication as long as such use adheres to a labeled dosage regimen (i.e., dose, route, frequency, and duration of administration) approved for that species and production class; and (3) use in food-producing minor species.
The agency said it is prohibiting these extralabel uses in food-producing major species because they believe such uses in these animals will likely cause an adverse event in humans and, therefore, present a risk to the public health.
National Chicken Council Vice President of Communications Tom Super issued the following statement regarding the announcement:
“Antibiotics are a valuable tool in ensuring animal health and in producing wholesome food for the consuming public.
Antibiotics are used sparingly in chicken production, and only if they are approved by the FDA. A majority of the antibiotics, such as Ceftiofur, are not used in human medicine meaning the threat of creating resistance is essentially reduced to zero.
Consumers should know that chicken is safe, wholesome and that all chicken produced in the United States is inspected by the USDA. Inspectors test meat samples for chemical and antimicrobial residues–poultry must be in compliance with USDA standards. When antibiotics are used in chicken production, strict withdrawal periods must be followed before the birds are processed for food. Chicken consistently has the best record of any product tested by USDA.
We share the concerns of others that FDA’s rule on extralabel drug use will take medical decisions to treat animals out of the hands of veterinarians. We question any substantive link or scientific basis between veterinary use of cephalosporins and antibiotic resistance in humans.”
