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Petition Seeks FDA Review of Homeopathic Drugs

August 30, 2011

The Center for Inquiry (CFI) and its affiliate, the Committee for Skeptical Inquiry (CSI), both nonprofit educational organizations, have filed a petition with the Food and Drug Administration (FDA) requesting that the FDA initiate rulemaking that would require over-the-counter homeopathic drugs to meet the same standards of effectiveness as non-homeopathic drugs. Although the FDA has the authority to require homeopathic drugs to undergo testing for effectiveness, it has to date declined to do so.

Homeopathic drugs were previously marketed on a relatively small scale, but their sales have been burgeoning in the last couple decades. In 2009, consumer sales of homeopathic treatments in the United States reached $870 million.

Homeopathic drugs are controversial because most scientists and physicians maintain there is no reliable scientific evidence to support the therapeutic claims made for these drugs. Homeopathic remedies were first developed in the late 1700s, before the advent of modern medicine. Homeopathic drugs are produced by taking a substance that is believed to cause disease symptoms and then diluting the substance repeatedly until, according to accepted laws of chemistry, there are no molecules left of the original substance. But homeopaths insist that by virtue of some scientifically inexplicable process, their drugs possess therapeutic value.

“In 1800 it might have been excusable to allow homeopathic drugs to be marketed without proof that they work, but not in 2011,” observed Ronald A. Lindsay, president and CEO of CFI and CSI. “The FDA has an obligation to protect the health of Americans by requiring that all drugs that are marketed be shown to be effective. For Americans who need treatment, a useless drug is a harmful drug.”

The petition also asks the FDA to place warning labels on homeopathic drugs until such time as they are shown to be effective.

In separate petitions, CFI and CSI have asked the FDA to issue warning letters to Boiron, a leading homeopathic manufacturer, over its marketing of Oscillococcinum, an alleged flu treatment. One petition complains that Boiron’s packaging for Oscillococcinum lists the alleged active ingredient—duck liver and heart—in Latin only. Another petition complains that Boiron’s web ad for this product implies that it has received FDA approval. “If Boiron is going to sell snake oil, the least they can do is use English on their labels,” observed Lindsay.

The Center for Inquiry is a nonprofit educational, advocacy, and research organization based in Amherst, New York; CFI is home to both the Committee for Skeptical Inquiry and the Council for Secular Humanism. The mission of CFI is to foster a secular society based on science, reason, freedom of inquiry, and humanist values. Our web address is www.centerforinquiry.net.

The Committee for Skeptical Inquiry is a nonprofit organization dedicated to promoting scientific inquiry and critical investigation, including critical investigation of claims relating to unconventional healthcare practices, such as acupuncture, therapeutic touch, and homeopathic medicine. CSI’s advisors include a number of leading scientists, some of whom are medical specialists. A list of CSI’s fellows, advisors, and staff is available on CSI’s website at www.csicop.org/about/csi_fellows_and_staff/.