FURTHER VINDICATION!! ->FDA gives maker of Zicam new warning
2 RapidMelts items are mislabeled homeopathic
by Ken Alltucker - Jun. 16, 2011 05:20 PM
The Arizona Republic
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Two years after a safety letter prompted a Scottsdale-based company to recall its Zicam nasal spray, federal regulators this month warned that two other Zicam products are inappropriately sold as homeopathic drugs because they include vitamin C.
The Food and Drug Administration this month warned Scottsdale-based Matrixx Initiatives that "Zicam Cold Remedy RapidMelts with Vitamin C and Echinacea" and "Zicam Cold Remedy RapidMelts with Vitamin C" are unapproved drugs with false or misleading labels.
The FDA generally allows the sale of homeopathic drugs at retail stores or over the Internet without approval as long as they contain only homeopathic ingredients.
But the federal regulators say the two Zicam RapidMelts products cannot be sold as homeopathic drugs because they include vitamin C, which is not a homeopathic ingredient.
The FDA said the products should be considered new drugs that are not approved because they are sold to reduce the severity of the common cold and common-cold symptoms.
Even though vitamin C commonly is used to treat the common cold, the FDA said existing data does not support claims that vitamin C is a safe and effective treatment for the common cold.
The FDA said in a June 3 letter that Matrixx Initiatives had 15 business days to explain how the company would address the violations.
Matrixx representatives did not return phone calls. Zicam's website, zicam.com, this week included the following message: "Site currently under construction."
It's unclear whether Matrixx will seek to change the RapidMelts labels or recall the products like it did in June 2009, when the FDA warned consumers about the safety of Zicam nasal spray, citing consumer complaints about loss of smell.
The FDA's letter earlier this month did not link the RapidMelts products to any type of consumer complaints or health issues.
Miami-based private-equity firm H.I.G. Capital closed a $75 million purchase of Matrixx in February.
Since then, the company hired a new chief executive officer, Dennis O'Donnell, and established a new office in Skillman, N.J.
O'Donnell told The Arizona Republic that the company plans to keep corporate functions such as accounting and research and development in Arizona, but he said some other corporate duties will be transferred to New Jersey.
Read more: azcentral.com |
