In June the U.S. Food and Drug Administration issued a warning about some Zicam products based on having received over 130 reports of a decreased sense of smell, often after single use of one of these products. The FDA's action against a homeopathic drug presents a bizarre situation. Homeopathic drugs, according to the tenets of this curious practice, derive their effect (an illusionary one if we abide by the laws of science) from extreme dilution. Indeed, homeopathic medications are so dilute that there may not contain a single molecule of the substance that is supposed to have a therapeutic effect. Somehow the sequential dilutions and ritual banging into a leather pillow between dilutions is supposed to leave some sort of curative imprint on the solution. Such a notion is pretty hard to stomach. But here is another problem. How can a product that contains nothing, damage the sense of smell? It can鈥檛.
As it turns out, Zicam isn鈥檛 really a homeopathic medication. It contains a measurable amount of zinc gluconate which is there because of some soft evidence that zinc can reduce the severity of the common cold if taken at the first signs of an infection. So Zicam may actually have some mild effect. But if it contains a biologically active ingredient, how can it be called a homeopathic medication? A curiosity! Well it becomes a homeopathic medication by simply declaring itself to be one! Sounds odd doesn鈥檛 it? Well it is odd. Everything about homeopathy is odd. When the original Food and Drug Act was passed in the U.S. in 1938, the FDA was charged with regulating drug marketing. Safety and efficacy had to be demonstrated before either a prescription or a non-prescription drug was put on the market. But there was an exception. Homeopathic drugs were given a free ride. Any substance that was listed in the Homeopathic Pharmacopeia of the United States was allowed be freely marketed without any need to prove safety and efficacy. The thinking was that these substances, since they contained no active ingredient, were innocuous and did not require government scrutiny. But the question of the concentration at which a substance ceases to be homeopathic was not addressed. So a product can become homeopathic just by its manufacturer declaring it to be such, and it can be happily sold unless some problem that attracts FDA attention comes up. That is just what happened in the case of Zicam. When FDA officials followed up on consumer complaints, they discovered that the manufacturer itself had received over 800 complaints that it had never forwarded to FDA, as required by a 2007 law. As illustrated by this case, it is time to stop giving homeopathic drugs a free pass. If their intent is to treat a medical condition, as it obviously is, homeopathic formulations should be regulated just like any other drug. If they can鈥檛 be proven to be safe and effective, they should not be sold. And if phantom molecules are proven to be an effective therapy, well, then we will have to rewrite all the chemistry, biology, physics and physiology texts that exist.聽
