Why didn’t Zicam give the FDA the information they asked for?
Matrixx has always cooperated fully with the FDA, willingly shared all information requested by the FDA, and fully complied with its understanding of the FDA’s regulations. As required by FDA regulations, Matrixx has always maintained detailed records of all consumer complaints. In the past four years the FDA has conducted two audits of the company, most recently in May 2009. During each audit, Matrixx made available to the FDA all adverse event complaints received by the Company, along with complaint trends. These included all consumer complaints alleging loss or diminishment of the sense of smell. During the May 2009 audit, the FDA suggested – for the first time – that the FDA’s interpretation of new regulations required the Company to report to the FDA all complaints of diminishment of smell, rather than having those complaints available for FDA inspection. The FDA’s position is directly contrary to the written advice received from the Company’s FDA counsel shortly after the new reg
