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Biotech / Medical : GUMM - Eliminate the Common Cold

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To: DanZ who wrote (2440)3/31/2000 6:55:00 AM
From: Hank   of 5582
 
Here's a VERY informative paragraph from GUMM's 424B1 filing on 3/13/00:

"The marketing of certain of our chewing gum and nasal gel products, including Zicam, involves claims that such products assist in weight loss, promote dental hygiene, and reduce the duration of the common cold, among others. Under FDA and FTC rules, we are required to obtain scientific data to
support any health claims we make concerning our products. Although we have not provided nor been requested to provide any scientific data to the FDA in support of claims regarding our products, we have obtained such scientific data for all
of our products. There can be no assurance that the scientific data we have obtained in support of such claims will be deemed acceptable to the FDA or FTC, should either agency request any such data in the future. If the FDA or the FTC requests any supporting information, and we are unable to provide support that is acceptable to the FDA or the FTC, either agency could force us to stop making the claims in question or restrict us from selling the affected products."

Don't be surprised if a request for documentation is made very soon. They can't hide behind the absense of published data forever.
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