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Matrixx Failed to Give FDA 800 Zicam Complaints

Company claims it thought it was exempt from reporting requirement

By Mark Huffman
ConsumerAffairs.com

June 19, 2009

The product is one of three listed in the FDA warning and withdrawn from the market June 16.

The FDA warned consumers they should stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell, a condition known as anosmia. Anosmia may be long-lasting or permanent.

The products are:

• Zicam Cold Remedy Nasal Gel

• Zicam Cold Remedy Nasal Swabs

• Zicam Cold Remedy Swabs, Kids Size, a discontinued product

The FDA said it has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.

William Hemelt, acting president of Matrixx, announced the company would recall the products but insisted they were safe and said he was surprised by the FDA action. However, in a conference call with reporters, he revealed that the FDA had uncovered 800 consumer complaints during a routine inspection in May. Hemelt said Matrix didn’t report the complaints because company lawyers told him he didn’t have to.

“We have complaints but we weren’t required to send them,” Hemelt said. “At least we didn’t believe we were required to send them and we based that on an opinion of counsel who looked at the FDA regulation and said no, it doesn’t fit.”

The FDA, meanwhile, says Matrixx was not exempt from the requirement to forward complaints to the FDA.

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