Homeopathic Drugs – Not Tested For Safety By The FDA?

This month the popular cold remedy drug Zicam was in the spotlight after 130 different consumers reported that the cold remedy swabs and cold remedy nasal spray damaged, impaired, or completely destroyed their sense of smell. The Food & Drug Administration issued a warning to consumers to stop using the product immediately, while also asking the drug manufacturer to stop marketing their defective swabs and sprays.

How did this dangerous drug get on the market in the first place? The answer is that it is considered a homeopathic drug - and is therefore not regulated by the FDA in any meaningful way. Zicam not only can market their drug without ever having to prove that it is effective - it can also market its drug without ever having to prove that it is safe for consumers. While the FDA can intervene after a problem has been found with a homeopathic drug, as it has done in the case of Zicam, it does not intervene in the manufacture or marketing of homeopathic drugs beforehand.

What makes a drug homeopathic? Any over-the-counter remedies that use plant, mineral or animal derivatives. The FDA assumes, in this case, that even if homeopathic drugs may not have been proven to work, their "natural" ingredients mean that they are harmless to consumers. Of course, this is simply not the case. In the case of Zicam, the zinc ingredient in the swab may be harmful to some people's sense of smell and sense of taste. Perhaps it is just one more reason not to assume that anything you buy at your local pharmacy is safe.
James R. Keller
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Partner at Keller & Keller