FDA says Zicam enforcement routine
This article was originally published in The Rose Sheet
Executive Summary
FDA says simultaneously announcing a consumer safety alert and sending a warning letter to Matrixx Initiatives about the risks of Zicam zinc-containing intranasal homeopathic products due to potential loss of smell is not an unusual action, as some industry stakeholders suggest. Center for Drug Evaluation and Research officials say "warning letters are issued to achieve voluntary compliance," as demonstrated by the agency's June 16 communication with Matrixx about Zicam. "When it is consistent with the public protection responsibilities of the agency and depending on the nature of the violation, it is FDA's practice to give firms an opportunity to take voluntary and prompt corrective actions before it initiates an enforcement action," CDER said July 13. Matrixx voluntarily recalled the products the same day it received the warning letter (1"The Rose Sheet" June 29, 2009)
You may also be interested in...
What Does FDA Deem A "Serious Adverse Event"? Matrixx Learns The Hard Way
A narrower interpretation of "serious adverse event" - compared with FDA's definition - is costing Matrixx Initiatives at least $10 million dollars with the recall of its intranasal Zicam products - assuming FDA cannot be convinced to reverse its position
Lack Of Industry Involvement In Scoping Process Exacerbates ‘Unworkable’ Timelines
Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.