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The Word is Out on Unapproved H1N1 Products

The Food and Drug Administration (FDA) is informing consumers of—and protecting them against—potential harm associated with unapproved products claiming to diagnose, prevent, or otherwise act against the 2009 H1N1 influenza virus.

Within the past two weeks, FDA has

  • urged caution regarding promotions and Internet sites offering products for sale that claim to diagnose, prevent, mitigate, treat or cure the H1N1 flu virus
  • enhanced efforts to warn about potentially deceptive H1N1 products, and encourage reporting of suspected criminal activity, with the release of an H1N1 flu fraud widget. This portable application is embedded in an agency Web page (www.fda.gov/NewsEvents/PublicHealthFocus/ucm186340.htm) and can be copied onto any other Web site or blog.
  • with the Federal Trade Commission (FTC), issued a warning letter to a Web site marketing fraudulent supplements that claim to help prevent the spread of the H1N1 virus. The letter advises the site’s owners to discontinue marketing the products or face legal action

Previous Actions

These new measures follow FDA actions earlier this year to protect consumers against Web sites offering unapproved products. These actions included enforcing laws that protect consumers against these sites, and warnings posted through media outreach and a “Fraudulent Products List” posted on FDA’s Web site at www.accessdata.fda.gov/scripts/h1n1flu/.

Since May 2009, FDA has warned more than 75 Web sites 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,” says Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “Unless these products and the claims they make are proven to be safe and effective, they will not 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.”

Buy Only FDA-Approved Products

Consumers are urged to only purchase FDA-approved products from licensed pharmacies located in the United States, and should contact their health professional if they have any questions or concerns about medical products or personal protective equipment.

Tamiflu (oseltamivir phosphate) and Relenza (zanamivir) are the only two FDA-approved antiviral drugs for treatment and prophylaxis of the 2009 H1N1 influenza virus. In addition to their approved labeling, these drugs have been issued Emergency Use Authorizations by FDA that describe specific authorized uses during the H1N1 public health emergency.

Patients who buy prescription drugs from Web sites operating outside the law are at increased risk of suffering life-threatening adverse events such as side effects from inappropriately using prescription medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs.

An Assortment of Targeted Products