Media Inquiries: Christopher Kelly, 301-796-4676,
christopher.kelly@fda.hhs.gov Consumer Inquiries:
888-INFO-FDA
FDA Warns Web Sites against Marketing Fraudulent H1N1 Flu Virus Claims
The U.S. Food and Drug Administration 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.
