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Zicam Maker violated FDA Regulations

Matrixx Initiatives, Inc., the company that makes Zicam, received a Warning Letter from the Food and Drug Administration (the "FDA"). The FDA stated that the Company is in violation of its regulations by failing to file a new drug application for its Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs and that those products are misbranded under their regulations for failing to adequately warn of risks. The FDA referred to numerous complaints it has received of anosmia associated with the use of these products.

 

The Company believes these products are safe and do not cause anosmia. The Company’s position is supported by the cumulative science and has been confirmed by a multi-disciplinary panel of scientists. (See the Company’s Report on Form 10-K under the heading "Legal Proceedings - Product Liability Matters" for additional information.)

 

The Company believes the FDA action is unwarranted and is in the process of determining its response, which may include removing these products from the marketplace. These products constituted approximately 40% of the Company’s net sales in 2009.