FDA’s New Antibiotics Policy Fails to Protect Health

NRDC: FDA Gives Industry a Free Pass on Antibiotic Misuse

WASHINGTON (December 11, 2013) – The U.S. Food & Drug Administration today released a long pending policy that lays out a voluntary approach to reducing the use of antibiotics in animals that are not sick. The policy, known as Guidance 213, was widely criticized by NRDC and other public interest organizations when it was released in draft form in April 2012, because it fails to require any changes in the use of antibiotics.

About 80 percent of the antibiotics sold in the U.S. are for use in cows, chickens and pigs – mostly on animals that are not sick. That practice has been widely recognized by scientists to breed antibiotic resistant bacteria and threaten human health.

Natural Resources Defense Council health attorney Avinash Kar made the following statement:

“FDA’s policy is an early holiday gift to industry. It is a hollow gesture that does little to tackle a widely recognized threat to human health. FDA has essentially followed a voluntary approach for more than 35 years, but use of these drugs to raise animals has increased. There’s no reason why voluntary recommendations will make a difference now, especially when FDA’s policy covers only some of the many uses of antibiotics on animals that are not sick. FDA is failing the American people.”

For more information, see Avinash Kar’s blog here:



When antibiotics are used day after day at low doses to speed up animal growth or compensate for crowded, stressful, unsanitary feedlot conditions, some bacteria become resistant, multiply, and escape the feedlot to threaten human health. FDA’s policy would address only uses of antibiotics to speed up animal growth even though preventive uses to avoid diseases associated with poor conditions pose the same risks, are similar in nature, and have significant overlap with uses for growth promotion.

Leading health groups, medical doctors and other scientists such as the American Academy of Pediatrics and the Infectious Disease Society have sounded the alarm, stating that “overuse and misuse of important antibiotics in food animals must end, in order to protect human health.” The World Health Organization and the Institute of Medicine of the National Academy of Sciences have reached similar conclusions.

A new U.S. Centers for Disease Control and Prevention (CDC) Antibiotic Resistance Threats report recently estimated that at least 23,000 Americans die each year from drug resistant infections and that antibiotic resistance is implicated in at least 2 million infections annually. Both human and animal uses of antibiotics contribute to the problem. CDC has confirmed the link between antibiotic use on industrial farms and the rise of antibiotic resistance, saying that there is “strong scientific evidence of a link between antibiotic use in food animals and antibiotic resistance in humans” and warns of “potentially catastrophic consequences” if resistance is not slowed. The report also states: “Up to half of antibiotic use in humans and much of antibiotic use in animals is unnecessary and inappropriate and makes everyone less safe.”

In 1977, FDA itself concluded that feeding animals low doses of certain antibiotics used in human medicine, namely, penicillin and tetracyclines, could promote antibiotic-resistant bacteria capable of infecting people, and posed a risk to human health. Despite this, FDA has failed to take meaningful action to curb the misuse of antibiotics on animals that are not sick for over 35 years. NRDC and its partners brought a lawsuit to force the FDA to act and won two landmark decisions in federal district court in 2012. FDA has appealed the decisions and a decision is pending on appeal. NRDC’s partners in the litigation are the Center for Science in the Public Interest, the Food Animal Concerns Trust, Public Citizen, and the Union of Concerned Scientists.