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FDA: Zicam Can Permanently Kill Your Sense of Smell

By Jim Edwards | Jun 16, 2009

The FDA has ordered a ban on Zicam, a cold “remedy” that can permanently disable your sense of smell. The FDA moved after it received 130 reports of anosmia, long-lasting or permanent loss of smell. You’ll notice that Zicam was marketed as a cold cure without FDA approval — that’s because it’s an herbal supplement. As such it is not subject to FDA regulation.

As BNET has explained before, herbal and diet supplements fall into a ridiculous hole in federal law which allows them to be marketed without any oversight from government — unlike food or drugs. The FDA can only step in after supplements actually kill or injure people. Most recently, that happened with Hydroxycut, the diet “aid” that killed one of its customers.

The FDA told Zicam’s maker, Matrixx Initiatives, in a warning letter that

We are not aware of any data establishing that the Zicam Cold Remedy intranasal products are generally recognized as safe and effective for the uses identified in their labeling.

The FDA further added:

FDA recommends that consumers stop using these products and throw them away

(See more of FDA’s action and recommendations on Zicam here.) Although Zicam pills are not affected by the ban (only the intranasal products), the development nonetheless should be a lesson to that endless army of people who think they can cure or prevent colds with herbal products. Whether its zinc, echinacea, vitamin C or Airborne, there always seems to be someone in the office or neighborhood who thinks they have a sure thing that prevents cold or flu. They are wrong. Nothing cures or prevents colds or flu. It’s the human condition. Get used to it.

In addition to Zicam, you might want to check out that Airborne paid a $30 million fine for falsely claiming that it cures or prevents colds.

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.

BNET User Analysis

Web Buzz:
  • Matrixx Claims Victim Status in Zicam Ban; Company Sat on 800 Complaints

    BNET Pharma - 152 days 2 hours 24 minutes ago

    Matrixx Initiatives claims the FDA’s ban of Zicam cold remedy nasal swabs is political and the company is the victim — not the 130 people who lost their sense of smell. Meanwhile, the SEC has joined the FDA in investigating the company, according to the WSJ, following news that the company had been sitting on 800 consumer complaints about...

  • Matrixx slides 68% after FDA warning on Zicam

    Fierce Pharma - 160 days 20 hours 37 minutes ago

    Scottsdale, AZ-based Matrixx Initiatives suffered a 68 percent drop in share price Tuesday after federal regulators warned consumers to discontinue use of cold products manufactured by the company. In a release, the FDA said that three of the company's over-the-counter products--Zicam Cold Remedy Nasal Gel, Gel Swabs and Kids Size...

  • FDA Takes on Zicam Marketer

    Natural Products - 160 days 23 hours 53 minutes ago

    WASHINGTON—FDA is urging consumers not to use Zicam Cold Remedies, stating the agency has received 130 adverse event reports (AERs) since 1999 suggesting use of the zinc-based intranasal products could cause loss of smell (anosmia). AP reported Scottsdale, Ariz.-based Matrixx Initiatives is facing litigation over the products, but has stated...

  • FDA warning on Zicam tanks Matrixx stock

    Fierce Pharma - 160 days 5 hours 23 minutes ago

    Matrixx Initiatives suffered a 68 percent drop in share price Tuesday after federal regulators warned consumers to stop using its Zicam Cold Remedy products. In a release, the FDA said the OTC products could cause "long-lasting or permanent" loss of smell. Report More information about formatting options

  • FDA Advises Consumers Not to Use Certain Zicam Cold Remedies

    Supermarket News - 159 days 7 hours 3 minutes ago

    ROCKVILLE, Md.  The Food and Drug Administration here yesterday warned consumers to stop using three products marketed over the counter as cold remedies because they are associated with the loss of sense of smell that may be long-lasting or permanent. The products are Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold...

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