SCIENCE

Zicam Reveals Holes in Drug Regulation

June 23, 2009

In the United States, there are “drugs” and there are “dietary supplements.” Each are chemicals intended to improve your health, but they are held to very different standards of regulation: Before drugs can be sold, a company must prove to the Food and Drug Administration that their product is safe and effective. Dietary supplements, meanwhile, do not need approval from the FDA before they are marketed; companies do not need to prove that these substances are safe or effective before they are sold. If a supplement proves harmful, though, the FDA can ban the substance, like it did with ephedra in 2006.

The Zicam warning issued last week by the FDA reveals a little-known third class of chemicals marketed for your health—homeopathic drugs. These are technically drugs, but they do not have to go through the long approval process; they receive automatic approval from the FDA as long as the Homeopathic Pharmacopoeia Convention of the United States adds the substance to their list. No long trials, no science needed.

On its face, this shouldn’t be too much of a problem, because homeopathic drugs shouldn’t have any active ingredients in them. Yes, you read that correctly. See, homeopathy is a type of alternative medicine in which a compound is put through a series of dilutions until little, if any, of the compound remains. It has been proposed that homeopathic drugs work by "water memory," which is a load of bunk. But at least if the “drug” doesn’t have any pharmacologically active substances left in it, then it shouldn’t have any side effects, either. The biggest risk by taking them should be that of not having taken something that would actually work.

But Zicam, which fell under the homeopathic drug label, wasn’t diluted to the point where it was indistinguishable from water. It contains biologically active levels of zinc. And it’s that zinc that is suspected to be behind reports of a decrease or loss of smell in Zicam users. The FDA has now asked Zicam’s maker to “submit a new drug application to demonstrate safety and efficacy.”

Herbal supplements and homeopathic drugs are just a couple of examples of the perils and popularity of alternative medicine. People who do not smoke, do eat organic food and drink only bottled water have no problem consuming substances that are completely unregulated, even in place of pharmaceuticals with strong trial evidence to back up their claims. Where is the sense in trying out random chemicals from unknown sources just because someone told you that it might make you feel better or lose weight or sleep more soundly?

We all want the magic cure, but it isn’t going to come from a homeopath or the herbal supplement industry or any other of the purveyors of woo. But what’s really sad is to see people, children sometimes, that modern medicine could help but who are sidetracked by this quackery.

(Hat tip: Science-Based Medicine)