The U.S. Food and Drug Administration (FDA) just released another warning about bogus flu products that are targeting consumers via Websites. The agency stated it 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 (swine flu), but which are not approved, cleared, or authorized by the FDA.
On May, 1, the FDA
and the Federal Trade Commission (FTC) issued an alert to consumers to be wary of Internet sites and other promotions for products that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus. Both agencies advised operators of such Websites to take prompt action to correct and/or remove promotions of these fraudulent products or face enforcement action.
Deception ipod The FDA has issued more than 50 warning letters to offending Websites, with more than 66 percent having been removed of 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.”
Chasing Amy hd Examples of such 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.
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 were issued by email and the FDA requested a response within 48 hours. The FDA posted the offending Web sites and products at: FDA’s Fraudulent H1N1 Flu Virus Product List
The FDA has approved two antiviral drugs for treatment and prophylaxis of the 2009 H1N1 influenza virus: Tamiflu (oseltamivir phosphate) and Relenza (zanamivir). Tamiflu and Relenza, in addition to their approved labeling, have Emergency Use Authorizations that describe specific authorized uses during this public health emergency.
The Wild Geese divx In late 2006, the FDA alerted doctors and parents to watch for signs of bizarre behavior in children treated with Tamiflu after federal health officials noticed an increasing number of such cases overseas. There have been reports of 596 neuropsychiatric events, including 16 neuropsychiatric-related deaths, among children and adults taking Tamiflu, according to documents posted online at the FDA’s Website. Japan was also the origin of 81 Relenza reports and, according to Health Canada’s adverse reaction database, 27 people reported adverse reactions to Relenza, including one adult who died. One 14-year-old reported nightmares and another six-year-old temporarily lost consciousness. Another 96 people reported adverse reactions to Tamiflu, including 11 adults who died and nine who reported psychiatric problems.
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