News & Views
Zicam is Not
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
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.
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
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.
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.