I find it interesting FDA is quick to ban a product on the basis of a side-effect like smell sensory loss, but approves hundreds of products having far worse s-e’s (mental impairment, high BP, vomiting, cancerous, &c). In this instance, the reason given was sense of smell is important to hazard detection (e.g., natural gas leak in your house, industrial strength ammonia or chlorine). Not vital, mind you, not crucial, not compensatible; just ‘important’. Consider the risks from operating a car (which we all do) while on drugs bearing warnings against driving. Many of us drive every day while ‘under the influence’ of drugs that make us better functioning overall yet impairing response and judgement in some degree. The frequency this occurs approaches 100% for some of us. The frequency of situations in which smell-loss matters pales by comparison, while the benefits of breathing normally are huge. Most houses built since the mid-1970s are all-electric, and only those people who work in hazardous environments need be especially worried by this impairment. Yet, FDA, spurred by a handful of people who have lost this sense (none of whom claimed to have died or suffered significantly), is causing FDA conniption fits and to denying those of us who suffer chronically to forgo Zicam’s obvious benefit. It is good knowing this side-effect is out there and I will certainly use the product less; but it ought to left up to us (and not FDA) when and how much.

That’s kind of frightening that this stuff supposedly did not work well if at all in the first place and folks are also losing their sense of smell – permanently. We really need to be careful when approving these kinds of remedies for public consumption.

We noticed that you recently wrote about the FDA warning issued to Zicam about two of its 19 products (Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs). Since there has been much misinformation in the news over the past week, we invite your readers to click here to get the facts. They also can find out how to get a refund or product exchange for one of our other products not affected by the FDA warning.

Marla Bradbury
Zicam

Everyone is ignoring that FDA does not have the authority to regulate products labelled “homeopathic” until they receive data that the product is harmful. Actual drugs must submit clinical trial evidence of safety and effectiveness – Congress, in its infinite wisdom, exempted homeopathic products from any premarket safety or efficacy studies. (Good lobbying, homeopaths!)

The Code of Federal Regulations, the rulebook constructed by Congress, spells out the rules for FDA. The CFR exempts homeopathic products – the FDA doesn’t decide which products to regulate how (e.g. cigarettes are now being added to the list of products they regulate – but this is being required by Congress).

Of course companies call their products homeopathic whenever they can. It can save them a billion $$ (literally) and a decade+ in upfront prep, and the FDA can do nothing until the product is on the market and demonstrates harm.

Anecdotal evidence of Zicam actually working does not represent a controlled clinical trial that rigorously tests the product. Even then, products that are harmful are approved because the incidence of adverse events are only statistically apparent when taken by a huge population. I think throwing a homeopathic drug the market and then casually receiving reports of a serious adverse effect after enough people have tried it is considerably less effective than the admittedly imperfect drug system already in place.

I have been using Zicam Cold Gel Swaps for a couple of years now. I have seven kids so any and all colds they get exposed to are brought home. I use the Zicam at my first symptoms or as soon as one of the kids has symptoms and I have not had a Cold in over two years. I never use it more than twice though in a row and it works well enough that I don’t get the cold. My sense of smell is still as good as ever. Usually I have to start my numerous prescription allergy and asthmas medications in May…tomorrow is July and I haven’t had to use anything except my Patanol (eye drops).

This stuff does work. It works almost instantly for me. I think it is an amazing product. I have suffered with sinus problems my entire life (33 yrs), and was shocked at how effective Zicam Extreme is. I will be very upset if this product is discontinued because a handful of the millions of users lost their sense of smell. I would gladly give up my sense of smell today if it meant that I could breath freely for the rest of my life.