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FDA Warns against Unapproved Products

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As the H1N1 vaccination program gets underway, the FDA has continued to warn people against purchasing unknown products especially from Websites. The Food and Drug Administration are concerned about the number of fraudulent products being offered and remind consumers only to purchase FDA approved products from licensed pharmacies in the US.

Commissioner of Food and Drugs Margaret A. Hamburg, M.D. says that “Products that are offered for sale with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated,” She warns that unless these products can be proven safe and effective they will not help in preventing the transmission of the virus and that “Furthermore, they can make matters worse by providing consumers with a false sense of protection.”

The FDA has sent out letters to around 75 Websites regarding their sale of 135 products that they believe to be at the very least unhelpful, and at the worst, possibly harmful. On October 15 the Federal Trade Commission sent a joint letter with the FDA warning the owners of one website that they must stop the fraudulent marketing of their product or they would be facing legal action.

Some of the fraudulent products that claim to protect against, prevent, or cure H1N1 are shampoos, and dietary supplements. Some are supposedly designed for children, another claims to cure the H1N1 flu within 8 hours. Among some of the more interesting ‘cures and preventions’ noted were; a ‘photo-bionic’ instrument to strengthen the immune system, and an ionic silver spray to protect against the virus.

The FDA have purchased and tested a number of drug products offered over the internet too. One such product from a website claiming to be providing the equivalent of Tamiflu was delivered unmarked and unsealed. Testing showed that the pills contained no trace of oseltamivir, which is the active ingredient in Tamiflu. Others contained varying levels of oseltamivir, but were not approved for USA sale. Most of these didn’t require a prescription.

The FDA is working to keep these kinds of fraudulent products off the market, as well as keep people informed. They have produced a portable application that can be copied onto any website or blog. It can be found embedded in an agency web page www.fda.gov/NewsEvents/PublicHealthFocus/ucm186340.htm. FDA’s website also has a ‘fraudulent products’ page www.accessdata.fda.gov/scripts/h1n1flu/.

The only two FDA approved antiviral products for treatment of the H1N1 virus are Tamiflu (oseltamivir phosphate) and Relenza (zanamivir). They come with approved labelling, and have been issued Emergency Use Authorizations by FDA that describes specific authorized uses during the H1N1 public health emergency. Seeing a health professional is the best way to ensure that you are using an approved and safe product.

Both the FDA and the FTC will continue working together to combat fraudulent products and websites. Those found offering these products could face legal action such as seizure of products, injunction, or criminal prosecution.

Individuals are reminded that using non-approved products to combat H1N1 could prove to be harmful and urge caution.