August 30, 2011

CFI and CSI have filed three separate petitions with the Food and Drug Administration (FDA) asking that agency to address various aspects of the marketing of homeopathic drugs.

In its industry-wide petition, CFI and CSI request the FDA to initiate rulemaking that would require all 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.

It’s not clear this hands-off attitude was ever justified, but given the FDA’s many responsibilities, its free pass to homeopathic drugs would at least be understandable were use of homeopathic products rare. But that is no longer true. Homeopathic drugs used to be marketed on a relatively small scale, but their sales have been burgeoning in the last couple of decades. In 2009, consumer sales of homeopathic treatments in the United States reached $870 million.

Homeopathic remedies were first developed in the late 1700’s, 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. Essentially, homeopathy is magic posing as science.

The fact that those consuming homeopathic drugs are effectively ingesting a sugar pill or its equivalent has, undoubtedly, also influenced the FDA’s policy of non-enforcement. Some might characterize the drugs as “safe” since they usually do nothing. But the FDA has an obligation to protect the health of Americans by requiring that all drugs that are marketed be shown to be safe and effective. For sick Americans who need treatment, a useless drug is a harmful drug

The CFI/CSI petition also asks the FDA to place warning labels on homeopathic drugs until such time as they are shown to be effective. Undoubtedly, most consumers think the FDA regulates homeopathic drugs the same as real medicine. Unfortunately, that is not the case.

In separate petitions, CFI and CSI have specifically targeted homeopathic industry giant Boiron. These petitions ask the FDA to issue warning letters to Boiron regarding 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. As Ronald A. Lindsay, president & CEO for CFI/CSI has observed, “If Boiron is going to sell snake oil, the least they can do is use English on their labels.”

The other Boiron-directed petition complains that Boiron’s web ad for Oscillococcinum misleadingly implies the drug has received FDA approval.