Matrixx Initiatives has confirmed that it has received a warning letter from FDA about two of its 19 existing Zicam products – Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs.
The warning letter mentioned consumer reports that the use of these products could cause a temporary or permanent loss of smell, known as anosmia. Zicam cold remedy oral products and other products in the Zicam cold, allergy and sinus lines, were not included in the letter.
The company has announced that it will comply with the FDA’s requirements, but will seek a meeting with FDA to vigorously defend its scientific data, developed during more than 10 years of experience with the products.
While Matrixx believes that the FDA action today was unwarranted, it is voluntarily withdrawing Zicam Cold Remedy Swabs and Zicam Cold Remedy Gel from the market.
William Hemelt, Acting President, Matrixx Initiatives, said: We were surprised that the FDA decided to take this action without notifying us first, given our cooperative relationship with the FDA since we launched our first product in 1999. Had we had the opportunity to sit down with the FDA beforehand, we are confident that the FDA would have agreed that the scientific data clearly demonstrated the safety of our products.