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The Food and Drug Administration has signaled it wants to take action to plug a major loophole in the rules governing antibiotic use in livestock to try to slow drug resistance.

The agency published a request for comments on a plan to establish treatment time limits for a number of antibiotics that currently do not come with any instructions on how long they can be used.

The FDA’s action relates to medically important antibiotics, a term used to describe drugs that are used both by people and in animal production. Overuse of the drugs is fueling the development of superbugs — bacteria that have figured out how to evade many of the drugs that used to quell them, and making treatment of infections difficult and expensive.


That lack of guidance leads some analysts to fear producers may be dosing their animals for substantially longer than they need to. The FDA document notes some of the labels say “feed continuously” or “feed continuously as the sole ration.”

“Producers could just go to their feed stores and pick up antibiotics and use them however they wanted. If they didn’t have a duration of use they could use them for however long they felt was appropriate,” explained Karin Hoelzer, who works on antibiotic resistance and food safety issues at the Pew Charitable Trusts. “They can be used indefinitely. … It’s a big problem.”


World leaders will discuss the dangers of antibiotic resistance and attempt to chart a path towards curbing the risks next week in a special meeting at the United Nationals General Assembly in New York. The fear is that the world is moving to a time when some infections will be untreatable, rendering many of the miracles of modern medicine — hip replacements, heart surgery, cancer chemotherapy — much more dangerous.

Use of medically important antibiotics is rising in the US; from 2009 to 2014, sales increased 23 percent, data from manufacturers revealed. It’s estimated that 70 percent of drugs sold are used in agriculture.

But Hoelzer said there is little available information on how the drugs are used in that sector and what percentage of the use is actually appropriate.

For decades, the drugs were used in food animal production as growth promoters. But as of Jan. 1, 2017, that practice is supposed to stop in the US. Drug manufacturers have signed on to a voluntary policy that will bar this use of medically important antibiotics.

But the lack of label information setting out maximum usage periods for a number of drugs raises concerns that food animal producers could still use the drugs for growth promotion under the guise of treating animals for infections.

Newer antibiotics all specify how long they should be used on their labels; the FDA has been requiring that information for a number of years.

But antibiotics brought to market before the rule changed may not carry those instructions on their labels. The FDA is signaling it wants to change that, and is asking for input from interested parties.

Hoelzer welcomed the request for comments, but said closing this loophole needs to be done.

“FDA has been talking about taking action on these labels for a while,” she said. “Time is really running out and it’s important to take action.”

People wishing to weigh in on the issue have 90 days in which to comment.

  • BCG is an old anti-tuberculosis vaccine that was first used in 1921. Hundreds of millions of people have received it, and it is on WHO’s list of essential medicines. In France, where I grew up, it is mandatory for attending public schools. I got it decades ago, and never experienced adverse effects. In the late 1970s, it was found useful against bladder cancer, and has since been used for that purpose as well. The reason for its activity against bladder cancer is not well understood beyond being mediated by the immune system. BCG is very well known since it has been extensively used for almost a century. Bladder cancer is a much bigger threat to a patient’s health than BCG.

  • I am treated repeatedly with an agent called BCG for bladder cancer. BCG is a weakened form of “bovine” (read cow) tuberculosis. I have begun to question what this agent really does to my body and what treatment vaccines, etc. these animals receive to make their TB healthy enough to be given to me. BCG is the recommended treatment of choice. I can’t help wondering if I (and other BCG recipients) could eventually end up with other health issues.

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