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FDA issues warnings to companies claiming to cure H1N1 virus


ROCKVILLE, Md. The Food and Drug Administration last month issued 35 warning letters to companies promoting a product for the treatment or prevention of the novel H1N1 influenza virus, suggesting that the agency is paying close attention to Internet marketers who may be hoping to capitalize on consumer fears of the “swine flu.”

Marketers were given 48 hours to respond to the warning letters.

“Firms that fail to take corrective action may also be referred to FDA's Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws,” the agency warned.

For those companies located outside the United States, the agency promised to intercept and refuse entry of their products at the border.

“This is to advise you that the United States Food and Drug Administration reviewed your web site at the Internet address on May 15, 2009,” the agency stated in its most recent letter emailed to Fitura. “The FDA has determined that your web site offers a product for sale [Power Immune] that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people. This product has not been approved, cleared, or otherwise authorized by FDA.”

The agency noted it is paying close attention to the marketing and sale of unapproved H1N1-related products partly on the request of the Centers for Disease Control and Prevention. However, the agency also noted that these products are “a potentially significant threat to the public health.”

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