Navigation Links
FDA, FTC Act To Remove Fraudulent STD Products From The Market
Date:5/3/2011

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.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

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 sexual partners."

Further, under the Federal Trade Commission Act it is illegal to make such unsubstantiated treatment claims.

"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. "They also should know that health scams that endanger public health will not be tolerated."  

Consumers should be aware that there are no over-the-counter or online drugs or dietary supplements available to treat or prevent STDs. Appropriate treatment of STDs can only occur under the supervision of a health care professional. There are many FDA-approved medications available for treating these conditions, but they do require a prescription.

"Our Warning Letters give these firms time to voluntarily comply with the law," said Dara Corrigan, the FDA's associate commissioner for regulatory affairs. "The FDA will continue to take aggressive enforcement action against firms that market false treatments or cures that may lead to significant public health consequences."

The Warning Letters inform the companies that they have 15 days to notify the FDA of the steps they have taken to correct the violations cited. Failure to do so may result in legal action, including seizure and injunction, or criminal prosecution.  

Consumers and health care professionals should notify the FDA to file a complaint or report a problem with these products. Reports may be made to MedWatch, the FDA's voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm .

For more information:

www.fda.gov/STDfraud

Warning Letters

Consumer Update

Video: "STD Treatments That Don't Work"

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Shelly Burgess 301-796-4651
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. New Deep Vein Thrombosis (DVT) Registry Data Show Clot Quickly Removed, Blood Flow Restored in Large Patient Registry
2. New Localized Cancer Treatment for Advanced Retinoblastoma Saves Children From Having Eyes Removed, Restores Vision in Some Cases
3. Trellis(R) Catheter Removes Blood Clots Quickly, Restoring Blood Flow in 771 Deep Vein Thrombosis (DVT) Patients
4. Trellis(R) Peripheral Infusion System Removes Blood Clots in Largest Reported Prospective Endovascular DVT (Deep Vein Thrombosis) Patient Series
5. FDA Begins Process To Remove Breast Cancer Indication From Avastin Label
6. NASDAQ Removes TLCR From Biotechnology Index Pending FTC Decision on Grifols Acquisition
7. FDA CONSUMER HEALTH INFORMATION - FDA Intends to Remove Unapproved Drugs From Market
8. Los Angeles Business Owner Pleads Guilty to Submitting Nearly $1 Million in False and Fraudulent Claims to Medicare
9. FDA Warns About Fraudulent Tamiflu
10. OTC Anti-Aging Products: Hype or Hope?
11. Keeping the Data Center Clean: ATEN Launches Industry-First KVM Switches with Antimicrobial Nanocoating to Protect Products from Bacteria Surviving on Surfaces
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... Amarantus BioScience Holdings, Inc. (OTCQX: AMBS), ... and Orphan Diseases, today announced that President & CEO Gerald ... SeeThru Equity MicroCap Conference   Where: ... , NY When: Tuesday, May 31 st , ... Where: Grand Hyatt Hotel, 109 East 42 nd St, ...
(Date:5/26/2016)... 2016   Change Healthcare , a ... solutions and technology-enabled services designed to enable ... a strategic channel partnership with SourceMed, the ... and revenue cycle management services that empower ... clinics to optimize revenue, operational efficiency and ...
(Date:5/25/2016)... and GERMANTOWN, Maryland , May ... QGEN ; Frankfurt Prime Standard: QIA) today announced that ... with Therawis Diagnostics GmbH to develop and commercialize predictive assays ... market PITX2 as a marker to predict effectiveness of anthracycline ... "We are pleased to partner with Therawis, which ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... 2016 , ... W.S. Badger Co. Inc ., the maker of certified ... as one of the best small businesses for new dads by Fatherly, the digital ... businesses providing progressive benefits to new parents on the organization’s 2016 Best Places ...
(Date:5/27/2016)... ... ... This campaign aims to provide a path to improved education and awareness ... change. , As nearly 795,000 Americans suffering from a new or recurrent stoke each ... an estimated 129,000 of these people dying from stroke, it’s become our nation’s fifth-leading ...
(Date:5/27/2016)... Texas (PRWEB) , ... May 27, 2016 , ... ... satisfying Army body fat composition regulations. This is the first time that Coolsculpting ... normally screened at least every six months to ensure they meet the prescribed body-fat ...
(Date:5/27/2016)... ... 2016 , ... Each year Standard Process Inc. ... this year’s Life University winner of a $2,500 scholarship from Standard ... Awards ceremony. , Outerbridge is approaching her last quarter at Life University in ...
(Date:5/26/2016)... ... 26, 2016 , ... There are many ways to cook a hot dog, ... that Americans prefer their dogs straight off the grill. Of the 90 percent of ... way to cook a hot dog, far outpacing other cooking methods such as steaming ...
Breaking Medicine News(10 mins):