or Release: 05/01/2009
FDA, FTC Warn Public of Fraudulent 2009 H1N1 Influenza Products
Offending Web Sites and Illegal Activity Targeted for Action
The
U.S. Food and Drug Administration and the Federal Trade Commission are
alerting the public 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. The agencies are also advising operators
of offending Web sites that they must take prompt action to correct
and/or remove promotions of these fraudulent products or face
enforcement action.
“Consumers
who purchase products to treat the novel 2009 H1N1 virus that are not
approved, cleared or authorized by the FDA for the treatment or
prevention of influenza risk their health and the health of their
families,” said Michael Chappell, acting FDA Associate Commissioner for
Regulatory Affairs. “In conjunction with the Federal Trade Commission,
the FDA has developed an aggressive strategy to identify, investigate,
and take regulatory or criminal action against individuals or
businesses that wrongfully promote purported 2009 H1N1 influenza
products in an attempt to take advantage of the current flu public
health emergency.”
Products that are offered for sale to the public with claims to
diagnose, prevent, mitigate, treat, or cure infections caused by the
H1N1 influenza virus that have not been proven to be safe and effective
for these uses must be carefully evaluated. Many of these deceptive
products are being sold over the Internet via illegitimate Web sites.
The operators of these Web sites take advantage of the public’s
concerns about H1N1 influenza and their desire to protect themselves
and their families. These fraudulent products come in all varieties and
could include dietary supplements or other food products, or products
purporting to be drugs, devices or vaccines. Such fraudulent products
will not prevent the transmission of the virus or offer effective
treatments against infections caused by the H1N1 influenza virus.
“The last thing any consumer needs right now is to be conned by someone
selling fraudulent flu remedies,” said FTC Chairman Jon Leibowitz. “The
FTC will act swiftly against companies that resort to deceptive
advertising.”
Consumers are urged to contact their health
care providers or legitimate medical supply services if they have
questions or concerns about medical products or personal protective
equipment. Consumers are also urged to visit the FDA and Centers for Disease Control and Prevention
Web sites for more information about this emergency, and to determine
which products the FDA has approved, cleared or authorized for use to
diagnose, treat, prevent, mitigate or cure infections caused by H1N1
influenza virus.
Consumers should also visit FDA's Web site for tips about how to protect themselves
when buying medicines online: http://www.fda.gov/buyonlineguide/.
The two antiviral drugs approved by the FDA for treatment and
prophylaxis of the 2009 H1N1 influenza virus are 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.
For more information about FDA-approved antiviral drugs for influenza, see http://www.fda.gov/cder/drug/antivirals/influenza/default.htm.
For more information on CDC recommendations regarding use of antiviral
drugs against the current novel 2009 H1N1 influenza strain, see http://www.cdc.gov/swineflu/?s_cid=swineFlu_outbreak_001.
For more information about personal protective equipment see
http://www.fda.gov/cdrh/ppe/.
At present, there are no licensed vaccines approved for this new H1N1 influenza virus.
Consumers are urged to report any suspected fraudulent products or
criminal activity relating to FDA regulated products associated with
H1N1 Flu Virus (Swine Flu), including the names of Web sites that may
be offering these products for sale, to the FDA by visiting: http://www.fda.gov/oci/flucontact.html
Consumers who wish to file a complaint against a company that they
believe may be deceptively advertising swine flu products are urged to
call 1–877–FTC–HELP (1–877–382– 4357) or visit https://www.ftccomplaintassistant.gov/.
The Federal Trade Commission works for consumers to prevent fraudulent,
deceptive, and unfair business practices and to provide information to
help spot, stop, and avoid them. To file a complaint in English or
Spanish, visit the FTC’s online Complaint Assistant
or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into
Consumer Sentinel, a secure, online database available to more than
1,500 civil and criminal law enforcement agencies in the U.S. and
abroad. The FTC’s Web site provides free information on a variety of consumer topics.
- MEDIA CONTACT:
- Betsy Lordan
Office of Public Affairs
202-326-3707
- STAFF CONTACT:
- Rich Cleland
Bureau of Consumer Protection
202-326-3088
