Antibiotics that are “medically important” to humans should not longer be used in animal feed for non-therapeutic purposes, such as growth promotion, the U.S. Food and Drug Administration (FDA) announced on Wednesday.
The agency did state that antibiotics used for disease prevention, control and treatment are therapeutic applications and essential to protect animal health, as such those label claims will not be affected by this new policy—the final version of Guidance 209. Subtherapeutic antibiotics in food-producing animals should only be use for treatment and control, and targeted to specific disease issues, according to FDA.
The agency will work with drug companies to voluntarily phase out the use of antibiotics for non-medical (growth promotion) purposes and to apply a veterinary feed directive or VFD standard to the drugs. This policy means veterinarian oversight will be required to direct product usage for all antibiotics classified for use in human medicine.
“A veterinarian will have to write an order to incorporate any antimicrobial product into animal feed, Liz Wagstrom, chief veterinarian for the National Pork Producers Council told Pork Network. This will further insure a veterinary-client-patient relationship.
Several FDA officials stated at Wednesday’s conference that there has been a “sea change” in the drug companies’ attitude toward the issue since FDA issued a draft Guidance 209 report in June 2010, suggesting that antibiotics be used judiciously and only when necessary to keep animals healthy.
Since June 2010, there has been “a very productive engagement” of the animal health community and the animal production community and “broad buy-in that the time has come to make this shift,” Michael Taylor, FDA deputy commissioner for foods, told reporters attending a teleconference.
The guidance does not have the force of law but may be treated as such by FDA. “A public health imperative drives our actions today,” Taylor said. That imperative involves bacterial resistance to antibiotics used in human medicine.
While the overuse of antibiotic drugs in human medicine is part of the “resistance” problem, Taylor acknowledged, that the use in animal feed for production purposes also has been a “contributing factor.”
Asked why they are taking the voluntary approach rather than an outright ban, FDA officials explained that proceeding with a formal ban would require evidentiary hearings in front of a judge for the numerous drug compounds. It would be a “lawyer-driven process” that could take decades to complete, they explained.
"It looks like they are heading in the right direction," said Steve Kopperud, government affairs counsel for the American Feed Industry Association. "It is critical this remains collaborative rather than a formal rule-making process."
A statement from the Animal Health Institute (AHI), which represents animal-health companies, agreed with the collaborative approach that FDA is taking with the various stakeholders.
"Implementation of this policy means all medically important antibiotics used in animal agriculture will be used only for therapeutic purposes – disease treatment, control and prevention -- under the supervision of a licensed veterinarian. This policy will assure these medically important medicines are used in animal health in much the same way they are used in human health -- under the supervision of a licensed professional and only to address disease challenges at various stages," AHI said.
There is no specified timeline for companies to comply with this voluntary shift, but FDA indicated that it could take three years.
“The take-home message for producers is that these changes are in the works,” Wagstrom said, “voluntary is kind of a relative term.”
"The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective," FDA Commissioner Margaret Hamburg said in a statement.
But not everyone agrees with that position. NPPC contends that FDA’s new policy “likely will disproportionately affect small producers, have a negative effect on animal health and increase the cost of producing food while not improving public health.”
“The guidance could eliminate antibiotics uses that are extremely important to the health of animals,” said NPPC President R.C. Hunt, a pork producer from Wilson, N.C. “And the requirement for VFDs could be problematic, particularly for smaller producers or producers in remote areas who may not have regular access to veterinary services.”
FDA said it will work with USDA to understand the implications of the VFD on underserved areas.
Environmental advocacy groups have long argued that using common antibiotics like tetracyclines and penicillin in animal feed or in animals has contributed to the rise of antibiotic-resistant bacteria.
Last month, a federal judge in New York ordered FDA to start proceedings for a mandatory withdrawal for the non-therapeutic use of common antibiotics in animal feed, based on a lawsuit filed by environmental groups. (See, Judge’s ruling requires action on food-animal antibiotics use.)