Users are instructed to dissolve one lozenge in the mouth as soon as they notice cold symptoms, then take another lozenge every three hours until the symptoms disappear. According to the label, Zicam RapidMelts are recommended for adults and children ages 3 or older. Matrixx Initiatives, the company behind Zicam, voluntarily recalled these products in after the FDA warned that more than users had lost their sense of smell.
Homeopaths generally believe that dilution makes the active ingredients more effective — the greater the dilution, the greater the relief. According to the label, all of the active ingredients have a dilution of at least 6X, which means one part ingredient per million parts water. Some of the ingredients, including sulphur, have a dilution of 12X, which is a million times less concentrated than the 6X dilution. Children ages 2 to 5 can take a teaspoon every four hours.
Children ages 6 to 12 can take two teaspoons every four hours, and children and adults over 12 can take 3 teaspoons every four hours.
A 4-oz. The claims. Food and Drug Administration issued a warning about some Zicam products based on having received over 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 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! In an accompanying warning letter to Matrixx, the FDA said that they had received "more than reports of anosmia. The FDA has requested that Matrixx immediately submit all such reports to the agency. In addition, the FDA warned Matrixx that it was selling its products illegally because they are actually "drugs" according to the regulatory definition of a drug, which is a product "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
On receipt of the warning letter, Matrixx voluntarily recalled its products although they said in a press release that "Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its Zicam Cold Remedy intranasal gel products and anosmia.
You might wonder how Matrixx was allowed to market its product in the first place as well as all the other homeopathic remedies clogging the shelves? In fact, even when the FDA determines there's a safety problem, as it did with Zicam, it doesn't use the enforcement discretion set forth in the guideline.
Instead, it declares that the product is actually a "drug" and forces the company to withdraw it from the market and then either prove it's safe and effective, with a new drug application, or else never market it again. This is one of the reasons both homeopathic remedies and nutritional supplements, like herbs, vitamins and minerals, can be quite dangerous: They have not undergone any safety or efficacy testing.
With all such products, you are at the mercy of the manufacturers and particularly the marketers who concoct these formulations and then sell them to an unsuspecting public. You basically have no idea what you are buying, whether it is either safe or effective, or bears any relationship whatsoever to the claims made on the label or in advertising. Anyone can throw together whatever mixture of herbs, vitamins and minerals they want and sell it essentially for whatever they want.
That's exactly how Airborne tablets, as one example, which I've railed about extensively in these pages, came into being. And they're still proud of the fact that Airborne was developed by a second grade teacher with no medical or pharmacy background. She just believed that her particular formulation of herbs, vitamins and minerals would be effective of course, it isn't, but that doesn't stop millions of people from falling for their scam.
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