Zicam Products With Vitamin C Mislabeled

Zicam, in various formulations, has been marketed for years in retail stores and on the Internet as a homeopathic remedy for the common cold. Yet Zicam has repeatedly been the target of regulatory scrutiny. For instance, in 2009 the FDA advised consumers to discontinue use of several Zicam non-prescription nasal sprays because of the risk that it was causing anosmia, a loss of the sense of smell that was potentially permanent. Matrixx Initiatives, Zicam’s Scottsdale-based maker, recalled the products and reportedly settled over 300 cases by consumers who were injured.

Earlier this summer, Matrixx again became the subject of regulatory action when the FDA issued a warning letter advising that the formulations Zicam Cold Remedy RapidMelts with Vitamin C and Echinacea and its Zicam Cold Remedy RapidMelts with Vitamin C, were being inappropriately sold without approval as homeopathic remedies when they contained Vitamin C, which is not a homeopathic ingredient. FDA said that these Zicam tablets were not approved because under the regulations the inclusion of Vitamin C made the products new drugs, and that those new drugs were being sold to reduce the severity of the common cold, when existing data does not support the claim that Vitamin C is safe and effective for the treatment of colds or cold symptoms.

Since the issuance of the FDA warning letter, Zicam’s website is still "under construction." It is not known whether Zicam is going to recall the tablets or reissue them with a new label.

If you purchased either of the Zicam RapidMelt products containing with Vitamin C based on the advertising promises that they were a homeopathic remedy for the common cold, you may have been a victim of consumer fraud. Please contact us to discuss your legal options.

FDA Warns Consumers To Stop Using Intranasal Zicam Products

In past posts, this blog warned consumers of potentially dangerous ingredients that may be harmful to you or your child’s health.  Recent events have shown the warnings to be justified.

The Food and Drug Administration (“FDA”) has warned consumers to stop using zinc-based intranasal Zicam cold products and discard them or return them to stores because they have been associated with anosmia -- long lasting or permanent loss of smell.  The loss of smell can be "life-threatening," said Deborah M. Autor, director of the office of compliance for the FDA's Center for Drug Evaluation and Research, because people with impaired smell cannot detect leaking gas or smoke and cannot tell if food has spoiled before they eat it.  Indeed, the FDA has received more than 130 reports of anosmia associated with use of Zicam products from doctors and consumers.  The loss of sense of smell may be long-lasting or even permanent in some people.

The affected Zicam branded products, manufactured by Matrixx Initiatives, are Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size (a discontinued product that consumers may still have in their homes).

Moreover, Zicam products are marketed as cold remedies used purportedly to reduce the duration and severity of cold symptoms.  According to the FDA, however, these products have not seen to be effective in the reduction of the duration and severity of cold symptoms.  As such, consumers may have been deceived into purchasing a useless product.

If you have purchased a Zicam product, or have been injured as a result of using a Zicam product, please contact us to discuss your legal options.