Zicam maker discusses FDA warning letter with analysts

SCOTTSDALE, Ariz. The Food and Drug Administration’s warning letter issued Tuesday to Matrixx Initiatives was “quite honestly unprecedented,” commented Bill Hemelt, acting president of Matrixx Initiatives, during a conference call with analysts Tuesday morning.

“The letter we received Tuesday morning came as a complete surprise to us,” Hemelt said. There was no indication that the FDA was reviewing the matter, he said, and it was “surprising particularly because those reports [complaints around Zicam use and anosmia, or the loss of smell] have been declining in recent years.”

And while Matrixx plans to sit down with the agency and present its evidence that the products are safe in the next 15 days, Hemelt emphasized that “public safety is and will continue to be our No. 1 priority” during that conference call.

The FDA’s action is unprecedented across several fronts. The agency issued a warning letter without any prior indication to a company that’s been on the market with legally marketed and merchandised products for more than 10 years, and the agency had conducted a routine audit of Matrixx in the past three weeks, Hemelt said.

The agency based that warning letter on some 130 adverse events that it had compiled across those 10 years. Even if you add the 800 consumer complaints fielded by Matrixx in that time, and assumed every one of those complaints suggested a link between anosmia and Zicam use, that’s still less than 1,000 complaints over a 10-year period, as compared with the more than 35 million units sold in that time frame -- less than 0.003% of complaints versus use.

The three most common causes of anosmia, according to epidemiological studies on the matter, are the common cold, sinusitis and nasal injury. Consumer complaints around anosmia and Zicam use are no more than would be expected in the number of anosmia incidences that you would find in the general public, Hemelt said.

Further, the peer-reviewed, published research on the subject would indicate that there is no causality link between Zicam swab or gel intranasal use and anosmia, Hemelt said, and since that research has been published, no additional research has suggested anything to the contrary. “The cumulative evidence does not support the allegation” that Zicam use is a root cause of anosmia, Hemelt said.

And there is legal precedent supporting that research — no fewer than 10 federal judges dismissed plaintiff experts attempting to establish such a link. “The FDA position does not introduce any new science in that situation,” Hemelt responded, when asked if the FDA warning letter would influence future court decisions.

The FDA action is expected to significantly impact Matrixx’ business. Preliminary cost estimates directly related to the recall are expected to run north of $10 million, but there also is the damage to the brand name and the necessity to defend the company against future lawsuits. Law firms that actively pursue product liability litigants already have been advertising around the issue, Hemelt noted.