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U.S. FDA to Review Regulations, or Lack of, on Homeopathic Remedies

Alternative MedicineThe U.S. Food and Drug Administration (FDA) began two days of hearings yesterday to review safety claims of homeopathic treatments.

Homeopathic remedies are made from diluted forms of herbs and minerals and claim to trigger an immune response in the body. They can primarily be found over-the-counter at pharmacies and health stores; they usually promise to treat conditions such as allergies, headaches, and the common cold.

This is first time in almost 30 years that the government is looking at whether to regulate these natural remedies the way it does over-the-counter drugs. Currently, they can be manufactured and marketed without prior approval from regulators.

The FDA is concerned about the quality and safety of these remedies. In 1988, they had originally decided not to require homeopathic remedies to go through the same drug-approval process as standard medical treatments. Since then, the industry has skyrocketed from a million dollars a year revenue to 2.9 billions dollars profits in 2009.

According to Justice Cynthia Schnedar, the director of the FDA’s Center for Drug Evaluation and Research Office of Compliance, the policy may not be keeping up with the growth and popularity of these alternative treatments. The agency has issued 40 warnings to individual homeopathic products in recent years, including one that involved tablets being sold to alleviate teething pain in babies that contained toxic levels of the plant belladonna.

“So we thought it was time to take another look at our policy,” Schnedar says to Bloomberg News.

A report published in March from the National Health and Medical Research Council (NHMRC) in Australia reviewed hundreds of published studies testing the effectiveness of homeopathic treatments, and found no reliable evidence that they are effective. The report also found that studies on homeopathic remedies tended to be poorly designed and scientifically flawed.

S.C. Rhyne is a blogger and novelist in New York City. Follow the author on Twitter @ReporterandGirl, and visit her website at

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