With the U.S. Food and Drug Administration’s (FDA) guidance on antibiotic use in food-animal production, some confustion and many questions have surfaced. The new guidance calls for voluntary suspension of antimicrobial use for growth promotion purposes and more veterinary oversight in the form of Veterinary Feed Directives (VFD). FDA is giving companies three years to work through the process.
To address some of the questions and provide media with clarifications, representatives from the American Veterinary Medical Association (AVMA), National Pork Producers Council (NPPC) and the Animal Health Institute (AHI) spoke with reporters this week.
“Antibiotic used in food-animals are regulated by FDA under the same laws as products for humans are regulated under,” said Ron Phillips, AHI’s vice president of public affairs. He pointed out that companies have to provide the same kind of proof of safety and efficacy before products are approved. FDA allows four efficacy label claims for antimicrobials:
- Disease treatment
- Disease control-- such as during a disease outbreak.
- Disease prevention-- when a veterinarian determines an outbreak is likely.
- Growth promotion—which increases an animal’s weight gain or feed efficiency
The first three are considers to be therapeutic uses, while growth promotion is a sub-therapeutic use. “Regardless of the antibiotic, producers and veterinarians must follow the label when administering the product,” Phillips said. “They are very tightly bound to what they can and can’t do.”
Christine Hoang, DVM, AVMA’s assistant director of scientific activities, said the association supports the collaborative approach FDA has taken in developing the new guidance. “AVMA is a strong proponent of having antimicrobials available to ensure animal health and wellbeing,” she said. “But at the same time, we are also concerned about public health and food safety.” AVMA has formed a steering committee to work with FDA in specifying veterinary oversight provisions in the guidance.
Representing the pork industry, Liz Wagstrom, DVM, chief veterinarian for NPPC, said that the loss of subtherapeutic antimicrobials, is expected to result in more sick animals and higher cost of production without any real public-health benefits.
“We’ve always been supportive of veterinary oversight and judicious use of antibiotics,” she added. “A veterinarian should always be involved in the decision-making process.” But FDA’s guidance also raises concerns that the requirements could cause hardships for producers running smaller operations and those in remote areas that cannot afford or do not have access to veterinary support to obtain the required VFDs.