Big news in the realm of agricultural antibiotics: For the first time in almost 37 years of trying, the US Food and Drug Administration has achieved some control over the meat-industry practice of routinely giving antibiotics to livestock. The drawback: The control comes in the form of a voluntary commitment by veterinary drug manufacturers — and while the FDA maintains the voluntary program will work, there is widespread skepticism that the agency may be optimistic.
Here is what has happened; it takes a few steps to lay out. The FDA has been putting this voluntary program together for several years now, via two “Guidances” (numbered 209 and 213), which are nonbinding agency recommendations without the legal force of regulations, plus a Directive, which fills in the details. The three documents set forth what the agency wants to see happen: for meat production to stop using the routine micro-doses (“growth promoters” or “subtherapeutic antibiotics”) that fatten animals, but create antibiotic resistance; for farmers to stop administering antibiotics to entire herds or flocks via their feed and water; and for antibiotics to be used on farms only with the oversight of a licensed veterinarian. They accomplish that by asking veterinary antibiotics manufacturers to change the labeling on the drugs, so that they can no longer legally be sold over-the-counter to be used for growth promotion. The first Guidance, 209, was made final a year ago, and sets out the rationale for making this change. The second, 213, was made final last December; at that time, the FDA gave veterinary drug manufacturers three months to say whether they were going to comply.
Which brings us to the new news: On Wednesday afternoon, the FDA’s Center for Veterinary Medicine published the list of veterinary drug manufacturers who have agreed to comply with the voluntary label change. Out of 26 manufacturers in that market, 25 agreed to cooperate. The FDA says this represents “99.6 percent of the applications,” that is, drugs and the ways they are administered.
So: Is the long battle over growth-promoter antibiotics, banned in Europe for 8 years now, over just like that? Or is there more to do?