Homeopathic Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs Removed from the Market Due to Reports of Anosmia
The Food and Drug Administration (FDA) issued a Warning Letter to Matrixx Initiatives, Inc. (http://www.fda.gov/ICECI/EnforcementActions/
on June 15, 2009 concerning the safety of the company's homeopathic drugs Zicam Cold Remedy Nasal
Gel and Zicam Cold Remedy Swabs and reports of anosmia (loss of sense of smell). These reports
indicated that users experienced a long lasting or permanent loss of smell. The immediate safety
concern is the inability to detect gas leaks, fire, or spoiled food.
In 2006, the company
paid $12 million to settle lawsuits with 340 people who suffered anosmia after using Zicam. The FDA
notes in the Warning Letter that there is evidence in the published scientific literature that
various salts of zinc can damage olfactory function in animals and humans.
Zicam Cold Remedy
intranasal products are promoted as homeopathic drug products. Homeopathy is a 19th century
alternative medicine belief system in which the more dilute the drug the more potent the product.
Homeopathy has a cloudy history in U.S. drug law. The Homeopathic Pharmacopeia was recognized in
1938 Food, Drug, and Cosmetic largely due to the efforts of Senator Royal Copeland of New York and
The Zicam intranasal products are labeled as containing Zincum
Gluconicum 2X (zinc gluconate). The X is the Roman numeral for 10 and 2X a 1-to-10 dilution repeated
The FDA regulates homeopathic drugs in several different ways from other drug
products. Manufacturers of homeopathic drugs are deferred from submitting New Drug Applications
(NDAs) to the FDA. Homeopathic drugs are exempt from Good Manufacturing Practice (GMP) requirements
related to expiration dating and from finished product testing for identity and strength.
Homeopathic drugs in solid oral dosage form must have an imprint that identifies the manufacturer
and indicates that the drug is homeopathic. The imprint on conventional products, unless
specifically exempt, must identify the active ingredient and dosage strength as well as the
Homeopathic drugs are not exempt from the provisions of the Food, Drug, and
Cosmetic Act. Matrixx Initiatives, Inc. claims that Zicam Cold Remedy intranasal products"
reduces" the "duration of the common cold" and the "severity of cold
symptoms," including specifically "sore throat o stuffy nose osneezing o coughing o
congestion." These claims make these products drugs, as defined by the Food, Drug, and Cosmetic
Act, because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention
of disease or to affect the structure or function of the body of man or other animals.
professionals should counsel consumers on two points about Zicam and homeopathic drugs. One, Zicam
intranasal products should not be used because of the risk of anosmia. Two, the safety and efficacy
of homeopathic drugs have not been evaluated by the FDA based on high quality randomized clinical
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