FDA Bans Certain Uses Of Antibiotics In Food-Producing Animals

In a bid to protect an important class of antibiotics for treating humans and reduce the development of drug resistance, the US Food and Drug Administration has banned certain uses of cephalosporins in food-producing animals. The federal agency announced on Wednesday that the prohibition order comes into effect on 5 April.

The ban is intended to stop the use of "extra label" or unapproved use, of cephalosporins in what the FDA describes as the "so-called major species of food-producing animals" such as cattle, pigs (swine), chickens and turkeys.

Use of antibiotics in food-producing animals, whether for treatment, disease prevention or growth promotion, allows resistant bacteria and resistance genes to develop and spread from those animals to humans through the food-chain.

Michael R. Taylor, the FDA's Deputy Commissioner for Foods, told the press:

"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."

Cephalosporins are a class of antimicrobial drug commonly used to treat bacterial infections in various parts of the body such as throat, ears, lungs, sinuses and skin. They are increasingly seen as an effective alternative to penicillin for many patients.

Doctors prescribe them for the treatment of pneumonia and soft tissue infection, plus various other conditions such as pelvic inflammatory disease, diabetic foot infections, and urinary tract infections.

If cephalosporins are not effective in treating these conditions, then doctors have to resort to other drugs that are less effective and have worse side effects.

The FDA says the new ban takes into account the "substantial public comment" they have received on a similar order the agency issued in 2008 but then revoked prior to implementation. This new ban is less of a blanket ban, in that it appears to carefully specify certain exceptions that the agency says will not risk public health.

The reason for the ban is to "preserve the effectiveness of cephalosporin drugs for treating disease in humans", with the intention that such a move will "reduce the risk of cephalosporin resistance in certain bacterial pathogens".

Specifically, the order bans the use of cephalosporins in ways that have not been approved, such as:

• Unapproved dosage levels, frequencies, durations and ways of giving the drug,


• Using cephalosporin drugs in food producing animals that have not been approved for use in those animals (for instance, some cephalosporins are approved only for treating humans or companion animals), and


• To prevent disease in these food-producing animals,

Unlike the ban that was introduced and then revoked in 2008, the new ban does allow some exceptions to the extralabel use of cephalosporins in food-producing animals. These exceptions, which the FDA says "protect public health while considering animal health needs", are:

• The ban does not limit the use of an older drug, cephapirin, which the agency says is not thought to contribute significantly to the development of antibiotic resistance.


• Veterinarians will be allowed to administer or prescribe cephalosporins for "limited extra-label use" in the major food- producing animals, as long as they adhere to the "dose, frequency, duration, and route of administration" specified on the label.


• They will also be allowed to administer or prescribe cephalosporins for "extralabel uses" in minor species of food-producing animals such as ducks or rabbits.

There is an opportunity for the public to comment on the new order of prohibition. The window for this opportunity opens on 6 January and closes on 6 March, 2012.

To find out how to make a comment, go to http://www.regulations.gov and enter "FDA-2008-N-0326" in the keyword box.

The federal agency says it will review the comments before the order of prohibition comes into force on 5 April.

For further information, go to the FDA's own question and answer page.