FDA Sends Warning Letter to Makers of Zicam Cold Remedies

On Tuesday the U.S. Food and Drug Administration sent a letter of warning to Matrixx Initiatives, Inc., the makers of the popular Zicam homeopathic cold remedies. The letter referenced two Zicam products in particular: Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs (including the kids’ size swabs). The FDA says it has received more than 130 reports since 1999 from consumers reporting a loss of smell, both temporarily and permanently (anosmia).  The following is an excerpt from a news release issued by Matrixx Initiatives, Inc., dated June 16, 2009:

Matrixx Initiatives, Inc. has confirmed that it received a warning letter today from the U.S. Food and Drug Administration about two of its 19 existing Zicam products, specifically Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The warning letter cited consumer reports that the use of these products could cause a temporary or permanent loss of smell, known as anosmia. Zicam Cold Remedy oral products and other products in the Zicam cold, allergy and sinus lines were not included in the letter. The company has announced it will comply with the FDA’s requirements, but will seek a meeting with the FDA to vigorously defend its scientific data, developed during more than 10 years of experience with the products, demonstrating their safety.
 

Consumer safety is and has always been the company’s top priority. While Matrixx Initiatives believes that the FDA action today was unwarranted, it is voluntarily withdrawing Zicam Cold Remedy Swabs and Zicam Cold Remedy Gel from the market. Based on the FDA’s recommendation, consumers should discard any unused product or contact Zicam at 1-877-942-2626 or visit www.zicam.com to request a refund.
 

You can read the entire release here.
 

So what does this mean for consumers? Well, I can’t really say, because I don’t have all the information pertaining to this case. Most natural health consumers are savvy enough to investigate and educate themselves on the products they take or are thinking of trying. This is the true power of natural health, giving you the power over your own health.
 

Many people and organizations have long questioned the judgment, ethics, politics, etc of the FDA, but for fear of becoming completely jaded and cynical, I think we must continue to trust, at the very least, that the FDA does have the best interest of the American consumers at heart. But that in no way detracts from your individual responsibility to educate yourself. After all, it’s ultimately your health we’re talking about, and you still have the power.
 

What are your thoughts about the Zicam warning? The FDA? Should we be worried? Or is this another swine flu media over-kill?

 

Posted by Ben