-- HealthDay staff
TUESDAY, May 3 (HealthDay News) -- The U.S. Food and Drug
Administration and the U.S. Federal Trade Commission are cracking
down on manufacturers of over-the-counter products that claim to
treat, cure or prevent sexually transmitted diseases.
The agencies jointly sent letters to companies including
Medavir, Herpaflor, Viruxo, C-Cure and Never An Outbreak, warning
that their products are unproven and violate federal law, the FDA
said in a news release issued Tuesday.
"These products are dangerous because they are targeted to patients with serious conditions, where treatment options proven to be safe and effective are available," Deborah M. Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said in the release.
Chlamydia, genital warts, herpes, HIV and AIDS are among the
diseases that the products -- sold online and through retail
outlets -- claim to treat. However, the only FDA-approved
medications available to treat these conditions require a
prescription and supervision of a health-care professional, the
Because the products have not been evaluated for safety and
effectiveness, people who buy them may not get needed treatment and
could then infect their sexual partners, Autor said.
The items are considered drug products under the Federal Food,
Drug, and Cosmetic Act because they are sold to treat disease, and
they violate interstate commerce law if they lack an FDA-approved
new drug application, the FDA explained. Further, under the Federal
Trade Commission Act it is illegal to make unsubstantiated
treatment claims, regulators said.
"These companies are on notice that advertising health benefits that are not supported by rigorous scientific evidence violates the FTC Act," said David Vladeck, director of the FTC's Bureau of Consumer Protection. Health scams that endanger public health will not be tolerated, he added.
The letters are the first step in removing the unproven products
from the market. The companies have 15 days to inform the FDA of
measures they're taking to correct the alleged violations or face
possible legal action.
The U.S. National Library of Medicine has more about
sexually transmitted diseases.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
Copyright © EBSCO Publishing. All rights reserved.