I linked to this in a discussion forum: http://science.slashdot.org/story/09/06/17/2225246/FDA-Says-Homeopathic-Cure-Can-Cause-Loss-of-Smell And got this reply back: Yes, interesting. That would be back-door proof that homeopathics are in fact effective, if it's actually homeopathic. And so I wrote back: It's only "2X", so only 1/100 dilution, which in the case of zinc is actually allopathically potent. Normally a "2X" dilution is a very "weak" solution according to the rules of homeopathy, 10X to 20X being more common and supposedly more "potent". 10X and 20X means it's diluted to 10 or 20 zeros, extremely diluted such that there's only a few or no molecules of the active ingredient left. It's the lack of "dilution" in this particular product that causes the "efficacy" at damaging the nasal membranes. In this case, the manufacturer was trying to use the homeopathic exemption "understanding" to avoid having it cleared for marketing by the FDA. The FDA is disagreeing and saying they can regulate so-called homeopathic products if they exhibit real negative dangers, especially since it makes a medical claim on the box. I think the main thing the FDA wants is 1) a warning and 2) an application to market the product as a new drug as it and its use are not on the currently approved list. Because of part of the FDA's assertions of its powers, it could open a floodgate of the FDA's regulating most homeopathic claims in my mind. I don't know why the FDA hadn't asserted its power over this kind of snake oil in the past, but it would be refreshing to see people have to go to a doctor (naturopathic even) and get a prescription for homeopathic products instead of trying to self-manage their homeopathic treatments, leading to not just problems like this, but people's underlying problems continuing due to their use of what is effectively a placebo. While placebos are effective, I believe their use must be done under the direction of a competent physician who can ensure that the symptoms can be managed psychosomatically without an underlying condition that if left untreated would lead to more danger and thus rising health-care costs for all of us.