In a far too infrequent moment of proaction (or is that proactivity?), the FDA announced that they have
issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval.What’s the problem? Oh, nothing much… it just seems that using their product even once can permanently remove your sense of smell. And while we’re not canines, and rely mostly on our visual sense, losing your sense of smell is a great way to increase your risk of death through fire, food contamination, or the over-consumption of durian.
Matrixx’s response is what you’d expect:
Had we had the opportunity to sit down with the FDA beforehand, we are confident that the FDA would have agreed that the scientific data clearly demonstrated the safety of our products.
I wonder how convincing the non-scientific data is. That's the stuff that seems to be on the outside of the box.
Randi has covered Zicam a couple of times, here and here. And while skeptics are right to revile Zicam, which claims to be homeopathic but actually isn’t (it contains actual active ingredients, like zinc), this proclamation isn’t something we can celebrate too heartily.
We rely on the FDA to keep our food and drug supply safe, and this case, though they’ve finally reacted to public outcry, they failed to stop a dangerous product from going to market and being widely sold for a decade. This could be an example of science correcting itself, or it could be an example of a homeopathic loophole, where drugs labeled “homeopathic” are governed under a different set of rules than actual medicine. From the about.com article:
although conventional prescription drugs and new OTC drugs must undergo thorough testing and review by the FDA for safety and effectiveness before they can be sold, this requirement does not apply to homeopathic remedies.
Remember the terms “safe and effective”? How do they apply to Zicam? Consumer Reports was on to them in 2006, reporting:
More important, studies with animals and case reports suggest that nasal zinc may cause loss of smell, possibly permanent. Last year we unearthed more than 200 complaints to the Food and Drug Administration about an impaired sense of smell, taste, or both after using zinc nasal products. And about 340 consumers have sued Matrixx Initiatives, the maker of Zicam, claiming loss of smell. Last January the company agreed to settle almost all outstanding lawsuits without admitting fault. Matrixx’s promotion of Zicam is being investigated by the Federal Trade Commission, which regulates product advertising.
Gee, where does Matrixx mention that in its "scientific data"? And it seems like Matrixx was aware of the FDA's interest three years ago... and yet they mention "surprise" at the FDA's "sudden" action.
So kudos to the FDA for recalling a dangerous product, but wow, it would have been nice to have caught this dangerous “alternative” medicine before it was released to the public. Maybe a lesson can be learned.
By the way, if any of you have some Zicam gel or nasal swabs at home, here's how you can get a refund:
Contact Zicam at 1-877-942-2626 or visit www.zicam.com to request a refund.
Try to avoid the propaganda on the site though.