FDA Draft Guidance #213 proposes voluntary guidelines to reduce the use of antibiotics in farm animals raised for food. It specifically recommends that drug companies remove indications (instructions) for using antibiotics for growth promotion. Manufacturers have 3 months to notify FDA of their intent to comply with the guidelines and 3 years to modify their labels and indications, after which FDA will evaluate the success of this voluntary approach.
These guidelines were developed as part of an effort to reduce resistance to antibiotics currently approved for use in animals raised for food. Cattle, swine and poultry are typically raised in very large, confined animal feeding operations (CAFOs). Antibiotics are mixed into the healthy animals’ feed or water to promote faster growth and to compensate for unsanitary living conditions. This practice accounts for approximately 70% of all antibiotics used in the United States.
Yet because the levels used are too low to treat disease, this practice also creates resistant bacteria, which can be found on the animals’ skin and in their manure. These resistant bacteria in feedlot animals contribute to the emergence of antimicrobial resistance in human pathogens.
Draft guidance #213 follows lawsuits against FDA, brought by public interest groups attempting to prevent the widespread use of antibiotics in farm animals. In 2011, a federal court ruled that FDA must withdraw approval for non-therapeutic uses of penicillin in animal feed, after the Natural Resources Defense Council (NRDC) and several other environmental groups sued FDA for failing to ban the use of penicillin in animal growth promotion despite having formally recognized its potential human health risk over thirty-five years ago. FDA subsequently addressed efforts to prohibit the use of antibiotics in animals to preserve efficacy in treating life-threatening human diseases, including pneumonia, septicemia, and meningitis.
Critics question the effectiveness of the guidelines. Drug manufacturers are for-profit entities and have little incentive to voluntarily follow guidelines limiting the use and sales of antibiotics. Furthermore, the measure limits the use of antibiotics rather than addressing the underlying reasons for their use. A more salient issue is how to change practices on large scale farming operations to reduce the need for prophylactic antibiotics in the first place. The ultimate criticism is whether or not these guidelines can actually result in a substantial reduction in the overall quantities of antibiotics used in animal agriculture.