The FDA is enforcing the laws that protect consumers from illegal products marketed through the Internet that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 flu virus. On May 1, 2009, the FDA warned consumers regarding products related to the 2009 H1N1 flu virus offered on the Internet. The products involved are those that are promoted and marketed to diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 flu virus but are not approved, cleared, or authorized by the FDA. The agency advised operators of offending Web sites that they must take immediate action to ensure that they are not marketing products intended to diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 flu virus that have not been cleared, approved, or authorized by the FDA. Since then, the FDA has issued more than 50 warning letters to offending Web sites and as a result, more than 66 percent of these Web sites have removed the offending claims and/or products. “We are committed to aggressively pursuing those who attempt to take advantage of a public health emergency by promoting and marketing unapproved, uncleared, or unauthorized products,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “We have achieved some success and will remain vigilant in our efforts to protect consumers from these fraudulent, potentially dangerous products.” Examples of unapproved, uncleared, or unauthorized products targeted by the FDA include: –A shampoo that claimed to protect against the H1N1 flu virus; –A dietary supplement that claimed to protect infants and young children from contracting the H1N1 flu virus; –A “new” supplement that claimed to cure H1N1 flu infection within four to eight hours; –A spray that claimed to leave a layer of ionic silver on one’s hands that killed the virus; –Several tests that have not been approved to detect the H1N1 flu virus; and –An electronic instrument costing thousands of dollars that claimed to utilize “photobiotic energy” and “deeply penetrating mega-frequency life-force energy waves” to strengthen the immune system and prevent symptoms associated with H1N1 viral infection. The FDA’s warning letters are consistent with an aggressive strategy the agency put into place to protect consumers from individuals or businesses that promote fraudulent claims for products in an attempt to take advantage of the public’s concerns about the 2009 H1N1 flu virus. Unapproved, uncleared, or unauthorized products that claim to diagnose, mitigate, prevent, treat or cure the 2009 H1N1 flu are illegal and a potentially significant threat to the public health. These warning letters were the result of daily Internet surfs conducted by the FDA’s Office of Enforcement, Office of Criminal Investigations, and staff from the Center for Devices and Radiological Health, the Center for Drug Evaluation and Research, and the Center for Food Safety and Applied Nutrition. The warning letters issued by e-mail and the FDA requested a response within 48 hours. In addition, the FDA posted the offending Web sites and products on the agency’s Web site. “Taking swift action to inform unsuspecting consumers about products that could be dangerous to their health is a major priority for the FDA,” said Hamburg. The FDA will consider further civil or criminal enforcement action against those Web sites that fail to resolve the violations cited in warning letters. Actions could include seizure, injunction, and criminal prosecution.
