FDA acts to protect public from fraudulent avian flu therapies
(1 January 2006: VIDYYA MEDICAL NEWS SERVICE) -- The U.S. Food and Drug Administration (FDA) issued warning letters recently to nine companies marketing bogus flu products behind claims that their products could be effective against preventing the avian flu or other forms of influenza. FDA is not aware of any scientific evidence that demonstrates the safety or effectiveness of these products for treating or preventing avian flu and the agency is concerned that the use of these products could harm consumers or
interfere with conventional treatments.
"There are initiatives in place
to deter counterfeiters and those who sell fraudulent or phony products to
prevent or treat avian flu," said
Andrew von Eschenbach, MD, Acting FDA Commissioner. "The use of unproven
flu cures and treatments increases the risk of catching and spreading the
flu rather than lessening it because people assume they are protected and
safe and they aren't. I consider it a public health hazard when people
are lured into using bogus treatments based on deceptive or fraudulent medical
FDA issued Warning Letters to nine firms marketing products
making unproven claims that they treat or prevent avian flu or other forms
of influenza. Eight of the products purported to be dietary supplements.
Examples of the unproven claims cited in the Warning Letters include: "prevents
avian flu," "a
natural virus shield," "kills the virus," and "treats
the avian flu." These alternative therapies are promoted as "natural" or "safer" treatments
that can be used in place of an approved treatment or preventative medical
In the Warning Letters, FDA advises the firms that it considers their
products to be drugs because they claim to treat or prevent disease. The Warning
Letters further state that FDA considers these products to be "new drugs" that
require FDA approval before marketing. The letters also note that the claims
regarding avian flu are false and misleading because there is no scientific
basis for concluding that the products are effective to treat or prevent avian
flu. The companies have 15 days to respond to FDA.
Consumers who believe that they have seen a fraudulent product can report
it to the FDA at http://www.fda.gov/oc/buyonline/buyonlineform.htm.
For information on helping prevent flu, see the Centers for Disease Control
and Prevention http://www.cdc.gov/flu/protect/preventing.htm.
FDA Warning Letters:
Sacred Mountain Management Inc.
Iceland Health Inc.
PolyCil Health Inc.
PRB Pharmaceuticals Inc.
Return to Vidyya Medical News Service for 1 January 2006