FDA Won’t Rescind Zicam Warning Letter

In spite of their best efforts, Matrixx Initiatives, Inc. has failed to persuade the FDA to withdraw its warning letter concerning the homeopathic cold remedy Zicam. Last June, the FDA issued a warning letter to Zicam’s manufacturer’s after certain Zicam products were linked to a loss of the sense of smell (anosmia). As a result of the warning letter, Matrixx Initiatives pulled the Zicam products in question off the market.
The FDA has refused to rescind the warning letter because no new evidence has demonstrated that the Zicam nasal swabs and gels are not associated with the loss of the sense of smell. According to the FDA, the federal agency has received 130 reports of issues with the nasal products. These Zicam products contain zinc gluconate a compound that has been linked to nasal cavity damage.
“Loss of sense of smell is a serious risk for people who use these products,” the FDA said in its letter.