The Food and Drug Administration (FDA) has issued draft guidance that urges the “judicious” use of antibiotics in food-producing animals to minimize drug resistance in humans.

The guidance recommends limiting “medically important” antimicrobial drugs to uses deemed necessary for animal health on the basis of veterinary oversight or consultation. It supports the theory that “nontheraputic” or “subtherapeutic” antibiotic use for production or growth enhancing purposes “is not in the interest of protecting and promoting the public health.” FDA has requested written comments by August 30, 2010. See FDA News Release, June 28, 2010; Federal Register, June 29, 2010.

FDA Principal Deputy Commissioner Joshua Sharfstein has called the matter an urgent public health issue, telling news sources that the agency would issue new regulations if farmers do not voluntarily adhere to them. “We’re not handcuffed to the steering wheel of a particular strategy, but I’m not ruling out anything that we can do to establish these important public-health goals,” he was quoted as saying. See The New York Times, June 28, 2010; The Washington Post, June 29, 2010.

Meanwhile, farming interests such as the National Pork Producers Council have reportedly requested more evidence before calling for changes to long-standing practices. “Top scientists with the Centers for Disease Control and Prevention and the National Institutes of Health recently told a U.S. House committee that there is no scientific study linking antibiotic use in food animal production with antibiotic resistance,” stated a June 29, 2010, council press release.

Public health groups, however, have expressed concern that the agency’s actions were timid. “The FDA should define and regulate what constitutes judicious use,” opined Laura Rogers, project director of the Pew Campaign on Human Health and Industrial Farming, in a June 29, 2010, statement. “The authorization for the therapeutic use of antibiotics should be limited to treatment of sick animals, in cases that have been diagnosed and documented by a veterinarian. As it currently stands, the agency’s attempt to define appropriate therapeutic uses of antibiotics in food animal production may actually create a loophole, jeopardizing effectiveness of the drugs in humans and animals.”

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For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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