HAVE YOU HEARD THE GROUNDBREAKING NEWS?
ONE® and myONE® Custom Fit™ are the first & only condoms cleared by FDA for anal sex!
For the first time ever, the U.S. FDA has officially authorized a condom to be used for anal sex, not just vaginal sex. We're ecstatic about this achievement and what it means for public health outreach – a project 10 years in the making!
A Little History
Condoms have only previously been approved by the FDA for vaginal use. This is because no company had brought data from a clinical trial to the FDA showing condoms are safe and effective for anal sex. Until now!
"I think most people would be surprised to know that condoms were not approved for anal sex. With this new designation from the FDA, people will have more confidence using condoms for anal sex,” said Davin Wedel, CEO of Global Protection Corp., maker of ONE® condoms and lubricants and the myONE® Custom Fit™ condom brand.
Clinically Tested, Butt Stuff Approved™
The FDA authorization was granted based on aclinical trial conducted by the Rollins School of Public Health at Emory University.The study found ONE® and myONE® Custom Fit™ condoms used during anal sex failed less than 1% of the time.This far exceeded the FDA’s previously stated less than a 5% condom failure rate for vaginal sex. This was the largest clinical trial of effectiveness of condoms for anal sex ever conducted, with participants split evenly between men who have sex with men (MSM) and men who have sex with women (MSW). The clinical trial also highlighted the importance of using additional lubricant with condoms to prevent condom failure.
Which Condom Styles?
The condom styles that were tested in the clinical trial and that have the new anal use indication are our Vanish®, Super Sensitive™, Classic Select™, and myONE® Custom Fit™ styles. As of February 2022, the FDA approved these condoms as the first brands ever to be labeled safe and effective for anal sex. We’ll be researching how we can expand the new anal use indication to additional condom styles in the future.
Important for Public Health
The FDA anal use indication allows educators to have conversations about safer sex practices in a new way, and provides people confidence on the effectiveness of condoms for anal sex. A previous study led by faculty at Emory University found 69% of MSM reported they would be more likely to use condoms more frequently if the condoms were FDA label-indicated for anal sex.
The New York Times wrote that the “decision has long been sought by sexual health experts, who said it could encourage more people who engage in anal sex to use condoms to protect themselves against HIV and other sexually transmitted infections.”
Correcting Media Misreporting
Here at Global Protection, we’re all about correct info. So let’s clear some things up. The FDA press release referred to us (and some articles listed us) as “One Male Condom,” but that is not our brand name. Our brand is ONE® Condoms, and we use the term external condom to be inclusive. Also we did not create a new product that is specifically designed for anal use. All ONE® and myONE® Custom Fit™ products tested in the clinical trial and that now have the new FDA anal use indication are existing products.
Download our FAQ, read our press release, or check out news clips such as New York Times, VeryWell Health, Boston Globe, BuzzFeed, and Cosmopolitan.
Dr. Aaron Siegler, an Associate Professor of Epidemiology at the Rollins School of Public Health, Emory University, who lead the clinical trial
“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. This is despite two-thirds of HIV transmission in the United States being linked to anal sex. Having condoms tested and approved for anal sex will allow users to have confidence in using condoms to prevent HIV transmission.”
Davin Wedel, president and founder of Global Protection Corp, owner of the ONE® and myONE® Condom brands.
"We want people to have lots of sex – but we also want them to be empowered and informed. This recognition from the FDA highlights the substantial protection ONE Condoms provide for anal sex, which we hope enhances trust, leads to increased use, and lessens the new cases of sexually transmitted infections."