FDA issues warnings on avian flu 'remedies'

Dec 13, 2005 (CIDRAP News) – The US Food and Drug Administration (FDA) today announced it has warned nine companies to stop selling unlicensed products advertised as remedies for avian influenza and other kinds of flu.

The nine firms have been marketing products with unproved claims that they treat or prevent avian or other types of flu, the FDA said in a news release. Eight products are termed "dietary supplements" and claim to prevent or treat the flu or kill the virus.

The FDA warned the companies that their products are considered to be drugs because of the claims made about them, the news release said. As drugs, the products need FDA approval before marketing. The letters also say the claims about avian flu are "false and misleading because there is no scientific basis for concluding that the products are effective to treat or prevent avian flu," according to the agency.

The nine companies are BODeSTORE.com; Chozyn, LLC; Healthworks 2000; Iceland Health Inc.; Melvin Williams; PolyCil Health Inc.; PRB Pharmaceuticals, Inc.; Sacred Mountain Management, Inc.; and Vitacost.com. They have 15 days to respond to the FDA.

"FDA is not aware of any scientific evidence that demonstrates the safety or effectiveness of these products for treating or preventing avian flu, and the agency is concerned that the use of these products could harm consumers or interfere with conventional treatments," the agency said.

"I consider it a public health hazard when people are lured into using bogus treatments based on deceptive or fraudulent medical claims," said Andrew von Eschenbach, MD, acting FDA commissioner.

See also:

FDA news release with links to the individual warning letters
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108531.htm

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