This new order takes into consideration the substantial public comment FDA received on a similar order that it issued in 2008, but revoked prior to implementation.

Preserve the effectiveness
FDA is taking this action to preserve the effectiveness of cephalosporin drugs for treating disease in humans. Prohibiting these uses is intended to reduce the risk of cephalosporin resistance in certain bacterial pathogens.

Cephalosporins are commonly used in humans to treat pneumonia as well as to treat skin and soft tissue infections. If cephalosporins are not effective in treating these diseases, doctors may have to use drugs that are not as effective or that have greater side effects.  

In its order, FDA is prohibiting what are called “extralabel” or unapproved uses of cephalosporins in cattle, swine, chickens and turkeys, the so-called major species of food-producing animals. Specifically, the prohibited uses include:

• using cephalosporin drugs at unapproved dose levels, frequencies, durations, or routes of administration;
• using cephalosporin drugs in cattle, swine, chickens or turkeys that are not approved for use in that species (e.g., cephalosporin drugs intended for humans or companion animals);
•  using cephalosporin drugs for disease prevention.

"We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account the need to protect the health of both humans and animals," said Michael R. Taylor, Deputy Commissioner for Foods.

National Chicken Council statement
“Antibiotics are a valuable tool in ensuring animal health and in producing wholesome food for the consuming public," said National Chicken Council Vice President of Communications Tom Super in a statement.

“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.”

The new order of prohibition has a comment period that will begin on Jan. 6, 2012 and close on March 6, 2012. To comment on the order of prohibition, visit www.regulations.gov and enter FDA-2008-N-0326 in the keyword box.