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January 29, 2013
WASHINGTON Federal agencies in Washington have teamed up to warn Flu and Cold Defense LLC that its GermBullet product is making unlawful disease-based claims and statements that the botanical formula is intended "to affect the structure or function of the body."
In a letter dated Jan. 24, officials with FDA and FTC cited a press release and marketing information on websites, including the following statement, as evidence that GermBullet is making claims that only an approved drug can make. "[GermBullet] has been laboratory tested and shown to reduce illness-causing bacteria, cold and flu viruses and fungi."
Florida-based Flu and Cold Defense was accused of violating federal law by making claims that render GermBullet an unapproved drug. Regulators also declared GermBullet is "misbranded" because it fails to include adequate directions for its intended uses.
"In addition, it is unlawful under the FTC Act to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made," regulators warned in the letter that was addressed to Todd Whidden of Flu and Cold Defense. "More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, consumer testimonials, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act."
Flu and Cold Defense was given 15 days to inform FDA and FTC of how it is addressing their concerns. The company did not immediately respond Tuesday to an emailed request for comment on the warning letter.
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