SILVER SPRING, Md., May 3, 2011 /PRNewswire-USNewswire/ — The
U.S. Food and Drug Administration (FDA) and the Federal Trade
Commission (FTC) today announced a joint effort to remove products
from the market that make unproven claims to treat, cure, and
prevent sexually transmitted diseases (STDs). Among the products
targeted in today’s action are Medavir, Herpaflor, Viruxo, C-Cure,
and Never An Outbreak.
The agencies issued multiple letters to companies warning that
their products violate federal law. These products, sold online and
in retail outlets, have not been evaluated by the FDA for safety
and effectiveness. The joint action is the first step in keeping
these unproven items from being sold to the public and preventing
consumers from being misled.
The companies that received the warning letters claim that their
products treat a range of STDs, including herpes, chlamydia,
genital warts, HIV, and AIDS. While some of the companies market
these products as dietary supplements, these products are all drug
products under the Federal Food, Drug, and Cosmetic Act (FD&C
Act), as they are offered for the treatment of disease. These
drug products, which are offered for the treatment of STDs, may not
be introduced into interstate commerce without an FDA-approved new
drug application (NDA).
“These products are dangerous because they are targeted to
patients with serious conditions, where treatment options proven to
be safe and effective are available,” said Deborah M. Autor,
director of the Office of Compliance in FDA’s Center for Drug
Evaluation and Research. “Consumers who buy these products may not
seek the medical attention they need and could spread infections to
Further, under the Federal Trade Commission Act it is illegal to
make such unsubstantiated treatment claims.