A coalition of food safety, environmental, and consumer advocacy groups have filed a lawsuit against the US Food and Drug Administration (FDA) over the agency's refusal to limit the use of medically important antibiotics in food-producing animals.
The lawsuit, filed yesterday by the Alliance of Nurses for Healthy Environments, Food Animal Concerns Trust, Natural Resources Defense Council, and Public Citizen, claims the FDA violated the Administrative Procedure Act when it denied a 2016 petition by the groups to ban the use of medically important antibiotics for disease prevention in livestock and poultry.
The FDA denied the petition in 2021, despite, according to the lawsuit, generally agreeing that the overuse of antibiotics in food-producing animals can contribute to the development of antibiotic-resistant bacteria. The lawsuit says the agency failed to address the petition's core concern that the use of antibiotics for disease prevention in livestock and poultry poses a significant threat to human health.
"Once antibiotic resistance develops in one community, it can easily spread to other locations and establish itself in healthcare facilities," the groups argue in the lawsuit. "The threats to Plaintiffs' members can be redressed only by reducing the systemic overuse of medically important antibiotics for disease prevention in food animals."
Concerns over routine use in healthy animals
The plaintiffs are among several groups that have urged the FDA in recent years to ban the use of medically important antibiotics to prevent disease in food-producing animals. They argue that such use contributes to the increase and spread of antibiotic-resistant pathogens that can threaten human health, and that administering low levels of antibiotics through feed and water to prevent disease in healthy animals is a cover for practices that increase the risk of infection and endanger animal health.
"The FDA has allowed giant meat companies to habitually overuse antibiotics, putting everyone's health at risk," Steven Roach of the Food Animals Concerns Trust said in a press release. "This is absolutely unnecessary, as animals raised under healthy conditions do not need routine antibiotics."
The original 2016 petition from the groups asked the FDA to withdraw approval of the use of certain medically important antibiotics—those antibiotics that are used to treat human infections—for growth promotion or disease prevention in food-producing animals. The FDA didn't respond to the petition, but under Guidance for Industry No. 213, the agency did ask pharmaceutical companies to voluntarily remove growth promotion from the labels of medically important antibiotics used on farms. The agency also required all antibiotics to be administered under the supervision of a licensed veterinarian.
The FDA has allowed giant meat companies to habitually overuse antibiotics, putting everyone's health at risk
Since that guidance went into effect in 2017, the use of medically important antibiotics for growth promotion has essentially stopped. Sales data figures released by the FDA showed a significant drop in sales of medically important antibiotics for US livestock and poultry in 2016 and 2017, but sales have increased since then. The groups say that by allowing disease-prevention use, the FDA has essentially created a loophole that enables meat producers to continue using antibiotics at low levels.
'Significant, avoidable share' of antibiotics
"Disease prevention represents a significant, avoidable share of antibiotic use in livestock production," the lawsuit says. "These uses pose the same health risks as antibiotics used for the now-discontinued growth promotion purposes—both involve low doses administered to entire herds or flocks for extended periods of time."
The groups supplemented the petition in 2020 with new studies, but when the agency finally responded to the petition in 2021, it said it supported the use of medically important antibiotics, under veterinary guidance, for the "treatment, control, or prevention" of diseases, according to the lawsuit.
Advocates for more responsible use of antibiotics in food-producing animals point to Europe as an example of what greater regulation can achieve. In a report published in December 2022, David Wallinga, MD, of the Natural Resources Defense Council, found that raw sales of antibiotics for livestock and poultry fell by 42.9% in Europe from 2011 to 2020, compared with a 27.3% decline in the United States over the same period.
Wallinga attributed the greater reduction in livestock antibiotic use in Europe in part to the European Commission's region-wide commitment to better animal health. He also noted that the European Union (EU) ended the use of medically important antibiotics for growth promotion in 2006. In January 2022, EU officials adopted legislation that bans the use of antibiotics for preventing disease in groups of healthy animals.
Wallinga says the FDA has known since the 1970s that overuse of antibiotics in healthy animals compromises their effectiveness.
"It is shocking how little the FDA has done to safeguard public health from these risks in the last fifty years," he said in the press release. "The longer FDA waits to take action, the more people this crisis will harm."