On 6/17/09 the FDA issued a “warning” to the Zicam manufacturer Matrixx after receiving a number of reports through MedWatch of serious injury or illness. MedWatch is the FDA’s “new and improved” reporting mechanism, cited in the three-page letter to Matrixx they have received in excess of 130 reports of anosmia (loss of sense of smell) associated with Zicam. Prior to the New Rule (CGMP) governing dietary supplements which rolled out in 2008, Obama administration has promised that they will be taking “realtime” action against manufacturers who have a significant number of reports of serious injury or illness reported via MedWatch. Manufactures who directly receive such report are supposed to disclose those to the FDA however this honor system has drastically failed. The F.D.A. admittedly does not have the manpower to formally recall or ban a product; however, merely writing one letter that is published on the Internet is enough to stir consumers to hit the manufacturer in the pocket. Manufacturers such as Zicam have taken the offensive while issuing a message to consumers that their product is safe. Zicam issued this message “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”. The company is offering a refund to consumers that the product purchase price, unlike as we saw in Hydroxycut, they are not pulling these products off the shelves. However, the day is young The Zicam controversy is nothing new. In 2006 in Arizona they settled 340 cases for 12 million but not all “loss of smell cases”. A lot were for bottle design. Zicam stated that the nozzle was the problem and it delivered a “too forceful spray”, allegedly. One case went to trial and settled for an undisclosed amount. A recent article in the New York Times “Matrixx has received more than 800 reports of Zicam users losing their sense of smell but did not provide their reports to the F.D.A.”, said Deborah Autor, Director of Compliance in the Agency’s Drug Center. The law requires producers of approved drugs to forward to the F.D.A. all reports of product related injuries, but Ms. Autor declined to say whether this requirement applied to Matrixx.”
One thing we can be sure of the F.D.A. is on “step one “ of eight stages that are required by the government to formally ban a supplement product. As the story unfolds with Zicam, there is no doubt that this will more likely set some sort of precedent in the future with regard to how the government is handling claims for MedWatch and the dietary supplement industry under the Obama Administration.