January 21, 2018

FDA Announces Voluntary Guidance to Restrict Antibiotic Use in Farm Animals

The Food and Drug Administration (FDA) has released a guidance document listing voluntary measures to restrict the use of antibiotics in farm animals. The government is asking drug companies to change the labels on their products so they can only be used to prevent, control, or treat disease, and will only let farmers use the drugs under the supervision of a veterinarian.

Guidance documents are non-binding recommendations that are not enforceable. The FDA uses them to ask corporations and facilities to change their methods. According to the FDA, “guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word ‘should’ in Agency guidances means that something is suggested or recommended, but not required.”

If this proposal, Guidance for Industry 209 is followed, it would only prohibit the use of antibiotics to promote growth. Farmers and veterinarians would still be allowed to give animals “sub-therapeutic” doses of antibiotics to prevent disease. Scientists say that continual low level use of antibiotics create drug-resistant bacteria.

The document cites 18 scientific studies dating back to 1969 that conclude that the use of antimicrobials in food-producing animals is associated with the development of resistant bacteria.

One of those studies, a 2003 report from the Food and Agriculture Organization of the United Nations, the World Organization for Animal Health, and the World Health Organization found that “there is clear evidence of adverse human health consequences due to resistant organisms resulting form non-human usage of antimicrobials” and “the consequences of antimicrobial resistance are particularly severe when pathogens are resistant to antimicrobials critically important in humans.”

Reaction from different groups varied depending on their focus. The Animal Health Institute, which represents companies that develop and produce medicines for animals, supports the proposal and will work with the FDA through comments.

The National Pork Producers Council does not agree with this guidance document and believes that requiring veterinary oversight will make the process of raising animals for food much more difficult for some producers who in isolated areas of the country.

Tyler Smith, Senior Research and Policy Assistant at Johns Hopkins Center for a Livable Future said there are two problems with this guidance document. “The FDA has said that since antibiotics can be used for prevention, this accepts the current industry model for farming, which includes unsanitary and crowded conditions,” he said. “This will not make industry change conditions and is a step in the wrong direction. And a guidance document is just a request for the drug industry to voluntarily make changes over the next three years. If they don’t comply, the FDA may do something more forceful.”

The Union of Concerned Scientists stated it was “heartened to see the FDA finally acknowledging the connection between antibiotic overuse in animal agriculture and antibiotic-resistant human diseases, this is a very timid first step, at best, and does not live up to the agency’s earlier promsise to address this problem head on.”

If you are interested in this topic, you can submit a comment on the Federal Register. The comments period closes on July 12, 2012.

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