FDA, FTC Issue Joint Warning Letter to H1N1 Product Site

On Oct. 15, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint warning letter to a Web site allegedly marketing fraudulent supplements that claim to help prevent the spread of the 2009 H1N1 influenza virus.

The warning letter, the first to be issued jointly by the agencies, advises the owners of the site they must discontinue the fraudulent marketing of their product or face legal action. The letter further advises the owners of the site they have 48 hours to give the agencies a plan to discontinue the marketing.

The FDA and FTC are reminding consumers to be cautious of promotions or Internet sites offering products for sale that claim to diagnose, prevent, mitigate, treat, or cure the 2009 H1N1 influenza virus. Fraudulent H1N1 influenza products come in many varieties, including dietary supplements, as well as products purporting to be drugs, medical devices, or vaccines, accrdonig to FDA, which has warned more than 75 Web sites since May 2009 to stop the sale of more than 135 products with fraudulent H1N1 influenza virus claims.

"Products that are offered for sale with claims to diagnose, prevent, mitigate, treat, or cure the 2009 H1N1 influenza virus must be carefully evaluated," said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. "Unless these products are proven to be safe and effective for the claims that are made, it is not known whether they will prevent the transmission of the virus or offer effective remedies against infection. Furthermore, they can make matters worse by providing consumers with a false sense of protection."

In collaboration with FTC, FDA said it will continue to work aggressively to identify, investigate and take regulatory action against individuals or businesses that wrongfully promote purported 2009 H1N1 influenza products. This will include taking joint action, when appropriate, such as the issuance of the Oct. 15 warning letter. Additional legal action could include an injunction or issuance of an administrative order by FTC or seizure of products, an injunction or criminal prosecution by FDA.

"The FDA continues to consider the sale and promotion of fraudulent H1N1 influenza products to be a possible threat to the public health and in violation of the Federal Food Drug and Cosmetic Act," said Michael Chappell, acting associate commissioner for regulatory affairs. "The FDA has an aggressive surveillance program to detect fraudulent H1N1-related products and will take prompt action to stop the marketing of fraudulent H1N1 influenza products and will hold those who are responsible for doing so accountable."

For more H1N1 information, go to www.fda.gov/NewsEvents/PublicHealthFocus/ucm150305.htm.

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