How the FDA’s Voluntary Guidance Fails to Curb Antibiotic Misuse in Livestock

Last December, FDA released voluntary guidance to industry (GFI #213) that would limit certain nontherapeutic uses of what the agency deems “medically important” antibiotics in livestock and put those drugs under the guidance of a veterinarian. Currently, many antibiotics are available for livestock producers to use for nontherapeutic reasons and without veterinary oversight. FDA’s action to curb these uses is long overdue.

But that guidance comes with a catch. It only limits the use of medically important antibiotics for promoting faster growth in livestock. Giving livestock low doses of antibiotics necessary to treat human illnesses to make the animals grow faster – all the while creating antibiotic-resistant bacteria in those livestock – is a pretty terrible use of an important resource. However, the FDA guidance still permits low doses of antibiotics to be given to healthy animals as disease prevention. Whether for growth promotion or disease prevention, the result is the same: this practice is creating more bacteria resistant to antibiotics that we need to protect human health.

Food &Water Watch analyzed FDA’s list of over 400 antibiotic drug products affected by GFI #213 to find out just how much overlap exists between growth promotion uses, which are being limited, and prevention uses, which remain unchecked. Each drug has a list of “label indications,” or reasons the drug can be used in certain conditions. Using FDA’s search function and also reading each label, we identified overlapping indications that demonstrate significant loopholes in GFI #213.

FDA’s list includes 217 antibiotic drug products with growth promotion indications. Of those drugs, 63 percent also have disease prevention indications, meaning the drugs can continue to be used nontherapeutically, which will continue to promote the development of antibiotic resistance. Of the remaining medically important antibiotic drugs used for growth promotion, 59 can still be used for “disease control” in healthy animals. That leaves only 23 drugs – 11 percent – with no approved nontherapeutic uses under full implementation of GFI #213. To put it another way, 89 percent of the drugs losing growth promotion uses can still be given to healthy animals for other reasons, leading to the spread of antibiotic resistance.

It’s frustrating. Advocates have fought for years to push FDA to do even this much. Yet the substantial overlap of allowable uses raises serious questions about how much GFI #213 will change antibiotic use and whether it will slow the development of antibiotic resistance.

According to Tyler Smith, program officer at the Johns Hopkins Center for a Livable Future who has written about the voluntary guidelines, “The overlap between growth promotion and disease prevention makes the voluntary guidelines a shell game. FDA should use its regulatory authority to ban feeding low doses of antibiotics to food animals, including for disease prevention.”

To save antibiotics and protect human health, we need a complete ban on nontherapeutic uses of antibiotic use in livestock. Take a moment to tell Congress to step in and pass a ban.