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You are viewing: News & Views - Aug 09 - Level 2

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Aug 09
News & Views

Zicam is Not Homeopathic
nor is it Homeopathy!

On June 16th the Federal Drug Administartion (FDA) of the US issued a Warning Letter to Matrixx International Inc., the company that manufactures an over-the-counter nasal spray for colds called Zicam. Observers say the FDA move is indicative of the new Obama Administration whose commissioner, Margaret Hamburg, sworn in last month, has promised to pursue enforcement more swiftly and aggressively.

The Warning Letter was issued after a number of consumers complained of problems with loss of smell from using the product. Doctor and consumer reports to the FDA and Zicams maker showed that Zicam nasal sprays and swabs may have caused more than 900 people to lose their sense of smell, The FDA first began receiving reports of patients losing their sense of smell in 1999. Zicam's maker, Matrixx, paid $12 million in 2006 to settle hundreds of lawsuits brought by Zicam users who also claimed to have lost their sense of smell.

Zicam became a household name helped by television, radio and print advertising campaigns, with Matrixx spending $24.4 million last year, according to data from The Nielsen Company in New York. Major retailers such as Wal- Mart Stores Inc., Target Corp., Rite Aid Corp., and CVS Caremark Corp. sold Zicam.

However although Zicam is marketed as a homeopathic preparation in reality it is not The manufacturers have simply adopted homeopathic nomenclature as a way to market a product in accordance with the particular legislative position that exists in the United States. The FDA does not regulate homeopathic, non-drug products like Zicam, nor does it have the authority to enforce a product recall, and Matrixx continues to sell its products in stores.

The following is a summary of the present position:-
1. For a remedy to be considered homeopathic, it must be listed in the Homeopathic Pharmacopeia , which is compiled by the Homeopathic Pharmacopeia Congress of the United States The group sets guidelines for testing and verifying clinical effectiveness, though it has no enforcement capabilities. The notion that homeopathic remedies can be produced on a whim is unsupportable a spokesperson said. Moreover the nasal route of administration has not yet been approved under Pharmacopia rules.
2. Zicam claims to be a 1X potency of zinc gluconate whereas in fact it is only a 10% dilution as no succussion is used in its preparation.
3. Zicam contains, as well as zinc gluconate, many other ingredients including benzalkonium chloride, sodium hydroxide, hydroxycellulose, glycerol, and a couple of other "solvents," preservatives, and suspending agents.
4. Zinc gluconate has long been known (since the 1930s) when used intranasally to cause permanent loss of smell in the quantities found in Zicam.
5. Zicam became a household name helped by television, radio and print advertising campaigns, with Matrixx spending $24.4 million last year. It was promoted as a blanket remedy for use with all colds and in this respect it is not even homeopathic being contrary to the homeopathic principle of individuality.
6. There have been lawsuits for several years against Zicam. The FDA estimate from doctor and consumer reports which date back 10 years to 1999 that more than 900 people could have been so affected. In 2006 Matrixx International paid $12 million to settle hundreds of lawsuits brought by Zicam users who claimed to have lost their sense of smell.

Vigourous Response to false (AP) Report
The FDAs action produced a story distributed by Associated Press (AP) that is full of fabrications and falsely called into question the safety of homeopathic remedies. The American Association of Homeopathic Pharmacists (AAHP) has been vigorously responding to the AP story published under Jeff Donn and has listed 7 false claims with respective rebuttals.

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