In December 2013, manufacturers of 293 products were warned by the FDA that they would have to revise the labels of their animal antibiotics as part of a multifaceted plan to combat the rise of antibiotic-resistant super bugs. The agency set a deadline of the end of this year. But if a progress report released by the FDA on June 30 is any indication, those companies have a long way to go before they’re fully in compliance with the new rules.
The regulations require that the labels of antibiotics marketed for treatment of animals as medicated feed or water products be revised so they no longer suggest the products can be used for growth promotion. What’s more, all therapeutic uses of antibiotics will have to be supervised by veterinarians. According to a statement from the FDA, however, only one label has been revised to eliminate mentions of growth promotion, and four have been converted from over-the-counter status to prescription status. An additional 41 products have been withdrawn from the market.
That leaves hundreds of drugs that presumably are being marketed just as they were before--and that worries the FDA. On June 20, the agency sent a letter to stores that sell animal drugs reminding them that the marketing status of all antibiotics used in food or water will change at the end of the year and that those products will no longer be able to be sold over the counter. Recognizing the need for continued education, the FDA “has made presentations to dozens of stakeholders groups and responded to hundreds of individual questions over the past six months,” it said in the release.
Stopping the routine use of antibiotics for non-medical purposes is proving to be a challenge for the FDA and other stakeholders in the anti-antibiotics movement. Last year, the FDA took random samples of dairy products from 2,000 U.S. farms and found several containing residues of the antibiotic florfenicol, as well as 11 other drugs--none of which are approved for use in lactating dairy cows. And an FDA report released last December found that overall sales of antibiotics for use in food animals rose 4% between 2013 and 2014, even though the impending new regulations limiting use of the drugs were already well established.
In February of this year, Stephen Ostroff stepped in as the FDA’s new deputy commissioner for foods and veterinary medicine, after which he vowed to clarify the proper role of antibiotics in the care of farm animals. Part of that effort includes collecting sales data from makers of the products. Those companies are also required to estimate their percentage of sales by species.
“I would hope that every American understands what it is that we do and why we do it to protect the food supply,” Ostroff said in a Q&A posted online by the FDA earlier this month.
- here’s the FDA’s antibiotics progress report
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