Matrixx Receives SEC Inquiry Post Zicam Warning
Matrixx Initiatives

Matrixx Initiatives Inc., said Tuesday it received an informal inquiry from the Securities and Exchange Commission, asking for documents and information related to a warning letter it received from the Food and Drug Administration last week.

The FDA had warned consumers that Matrixx Initiatives popular nasal cold and allergy remedy Zicam that included Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs and the discontinued Zicam Cold Remedy Swabs, Kids Size, could cause a permanent loss of smell.

The popular zinc-based nasal remedies accounted for about 40% of Matrixx's $112 million sales in its fiscal year ended March 31. The company said it has sold more than a billion doses of the products since the nasal gel first went on sale in 1999.

The Scottsdale, Ariz., based company said it received the "informal inquiry" from the SEC June 19; three days after the Food and Drug Administration issued a warning to consumers. Bill Barba, Matrixx's treasurer and head of investor relations, said Tuesday the company would cooperate fully though they didn't know what the SEC was looking into.

The SEC declined to comment.

The FDA made its public warning before Matrixx had agreed to withdraw the over-the-counter products. The company announced the withdrawal later the same day and Matrixx has said the recall could cost as much as $10 million while Matrixx stock lost 70% of its value the day of the FDA warning.

According to the FDA the products have "not been shown to be effective in the reduction of the duration and severity of cold symptoms."

They also added that in a May inspection they found that the company hadn't reported several hundred cases of serious side effects, mostly involving loss of sense of smell.

Matrixx however insists reports of smell loss aren't attributable to its products and says it didn't need to report the side effects. The company said it is preparing a response to the FDA's warning and wants to meet with the agency to address its concerns.

The FDA action didn't affect other Zicam products, such as tablets, "rapid melts" and liquid forms.

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