FDA bans extra-label use of cephalosporin drugs
The Center for Food Safety (CFS) applauds FDA for pre-releasing its long-awaited prohibition on the extra-label use of cephalosporin drugs in food-producing animals. Cephalosporin drugs are an essential tool in both human and animal medicine, but mounting evidence has linked extra-label use of these drugs to the development and spread of cephalosporin-resistant organisms.
“This is a critical win for consumers, food safety advocates and the medical community,” says Andrew Kimbrell, executive director for CFS. “But it’s high time that FDA wakes up to the dangers that non-therapeutic uses of all antibiotics pose to our health and the safety of our food supply.”
Cephalosporins are a vitally important class of antibiotics used most often in the treatment of serious Salmonella infections; it is also used to treat many other serious infections. FDA’s announcement comes more than three years after it first published an order prohibiting extra-label uses of these drugs in food-producing animals. FDA then withdrew the order before it could go into effect, citing the need for additional review of the public comments it received.
In its current notice, FDA plans to publish the Final Rule in the Federal Register announcing the prohibition of the extra-label use of cephalosporin drugs in food-producing animals. The Final Rule will go into effect 90 days from being published in the Federal Register; FDA will accept public comments for 60 days following the Federal Register notice. FDA’s Final Rule will continue to allow approved label uses of these drugs for food-producing animals as long as they are done in a safe and effective manner.
“The extra-label ban is just the first of many actions that FDA must make in order to better protect the public from the dangers of antibiotic resistance,” says Paige Tomaselli, CFS staff attorney. “Losing the effectiveness of critically important antibiotics as a result of our own misuse would be a catastrophic loss for modern medicine.”
A recent recall of ground beef involving product contaminated with an antibiotic-resistant (ABR) form of Salmonella demonstrates the danger of the weakened efficacy of antibiotics. “The outbreak strain, Typhimurium, has shown resistance to multiple, commonly prescribed antibiotics, making the illnesses difficult to treat,” says Sarah Klein, Center for Science in the Public Interest (CSPI) staff attorney. This strain is one of four ABR Salmonella strains that CSPI urged USDA to declare as adulterants, which would trigger enhanced testing for these dangerous pathogens.