WASHINGTON D.C. — (02-27-22) — The U.S. Food and Drug Administration made history last week with ONE Male Condom was approved to be the first ever condom specifically indicated for anal intercourse.
While the One Male Condom is not markedly different from the hundreds of other condoms on the market, it is the first that will be authorized to use the “safe and effective use” label for reducing sexually transmitted infections during anal sex.
It is also approved for use as a contraceptive and as a means to reduce STIs during vaginal intercourse!
According to the FDA, a clinical trial of 252 men who have sex with men and 252 men who have sex with women found the One Male Condom has a failure rate of 0.68 percent for anal sex and 1.89 percent for vaginal sex, according to the FDA, which defined condom failure as condom slippage or breakage.
“This landmark shift demonstrates that when researchers, advocates, and companies come together, we can create a lasting impact in public health efforts,” Davin Wedel, president and founder of Boston-based Global Protection Corp, maker of the One Male Condom, said in a statement. “There have been over 300 condoms approved for use with vaginal sex data, and never before has a condom been approved based on anal sex data.”
Courtney Lias, director of the FDA’s Office of GastroRenal, ObGyn, General Hospital and Urology Devices, added that the risk of STI transmission during anal intercourse is “significantly higher” than during vaginal intercourse.
“The FDA’s authorization of a condom that is specifically indicated, evaluated and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse,” Lias said in a statement. “Furthermore, this authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations.”
ONE Male Condom posted the following on its official website:
“A historic change occurred in the condom industry this week after a 10-year process, when the FDA approved a request from Global Protection Corp. to expand the “intended use” claim of its ONE® Condoms to include anal sex. The approval applies to three different types of ONE® Condoms — standard, thin and myONE® custom-fit condoms which come in 54 different sizes. ONE® will become the first condom brand ever to be labeled for safe and effective use for anal sex.
Condoms are a class II medical device under the FDA, and therefore must meet strict regulatory and product labeling guidelines. Although many people use condoms for anal sex (and the CDC recommends it), the U.S. FDA has never allowed condom companies to include anal sex in the Indication for Use – allowing condoms to be labeled “safe and effective” only for vaginal use. This is because no data on condom safety for anal sex has been previously provided to the FDA.
A study led by Dr. Aaron Siegler at the Rollins School of Public Health at Emory University provides that data, and paved the way for Global Protection to submit a De Novo request to the FDA to expand the intended use claim of its ONE® and myONE® Condom brands to include anal sex.
The study from Emory University – the largest clinical trial of effectiveness of condoms for anal sex ever conducted – found that ONE® and myONE® Condoms used during anal sex failed less than 1% of the time (0.7%). On August 26th, 2021, Global Protection Corp. cited the study as the basis for its De Novo Request to the FDA to expand its intended use approvals to include anal sex. On February 23, 2022, officials from the FDA announced that it has accepted the request, enabling ONE® and myONE® to become the first condom brands with the new anal use designation.
“This landmark shift demonstrates that when researchers, advocates, and companies come together, we can create a lasting impact in public health efforts,” said Davin Wedel, president and founder of Global Protection Corp, owner of the ONE® and myONE® Condom brands. “I think most people would be surprised to know that condoms are not approved for anal sex. With this new designation from the FDA, people will have more confidence using condoms for anal sex.”
One Male Condoms are available in standard, thin and fitted versions, and the fitted version is available in 54 different sizes.
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Retailers can review ONE Male Condoms on the Official Paradise Marketing B2B Website.
For immediate ordering information, contact your preferred account representative at Paradise Marketing Services toll free at 1+800-993-3664 | International Calls: 1+760-597-0800 | Fax: 1+888-810-3888 | EMAIL | Official B2B Site.
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Article by: Andy Powell, Staff Writer
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