The FDA has issued Matrixx Initiatives, maker of these Zicam
products, a warning letter telling it that these
products cannot be marketed without FDA approval.
“Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of CDER’s Office of Compliance.