In landmark shift, ONE® brand condoms are first to receive FDA approval for "safe and effective use" label for anal sex

BOSTON, Feb. 23, 2022 /PRNewswire/ -- 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."

This study¹ was led by Dr. Aaron Siegler, an Associate Professor of Epidemiology at the Rollins School of Public Health, Emory University. Dr. Siegler is also Associate Director of the Emory Center for AIDS Research (CFAR) Prevention Sciences Core. The study was funded by the National Institutes of Health (NIH). In collaboration with other faculty at Emory, Dr. Siegler began pursuing funding for the study ten years ago, in 2012, and partnered with Global Protection Corp. to provide the participants with ONE^® and myONE^® Condoms.

Participants in the study were split evenly between men who have sex with men (MSM) and men who have sex with women (MSW). All participants received ONE^® latex condoms in three different styles (fitted, thin and standard) and were asked to track their sexual activity in an electronic daily diary. The results were published in Lancet's EClinicalMedicine in 2019.

"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," said Dr. Siegler. "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."

In the clinical trial, condoms used during anal sex failed less than 1% of the time (0.7%). Previous studies with a similar outcome measure had found condoms to have a 6% to 7% failure rate for anal sex. However, that research had substantial limitations, such as not requiring condom-compatible lubricant be used for anal sex. For vaginal sex, condoms have been previously cleared by the FDA based on a clinical failure threshold of <5.0%.

"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," said Wedel.

In fact, 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.²

"The clinical trial also confirmed something that we have believed but had no clinical proof - the use of lubricant makes condoms even more effective than they already are," Wedel added. "We're ecstatic to bring this information to our health educator partners, and continue to educate people about the importance of lubricant." The use of lubricant for anal sex is part of the new FDA label indication.

In the clinical study, condom failure was lower for anal sex than for vaginal sex. The researchers hypothesized this difference was driven by the much higher use of condom-compatible lubricant for acts of anal sex (98.3%) compared with vaginal sex acts (41.6%) due to study design. When the researchers controlled for the use of lubricant, they found no difference in condom failure for anal sex versus vaginal sex.

"A critical finding of the study was that failure was low when condom-compatible lubricant was used, and the use of lubricant is part of the new FDA label indication. Programs providing condoms should also be providing lubricant," said Dr. Siegler.

About ONE^® & Global Protection Corp.
Launched in 2004, ONE^® is a socially responsible business committed to raising sexual health awareness. As a leader in premium condoms and lubricants, ONE^® brings a fresh perspective to sexual health through a fusion of advanced product design, manufacturing technology and customer participation. ONE^® is fanatic about developing new technologies to upgrade its condoms, such as the proprietary Sensatex^® Softer Latex, MicroRoll^® Comfort Base, and TotalGlide^® Full Lubrication technologies. ONE^® Condoms are vegan-friendly, non-GMO, and made from natural rubber latex. The trademark round wrappers feature hundreds of designs to spark conversations. ONE^® and myONE^® are part of the Global Protection Corp. family of sexual health products founded by Davin Wedel with a mission to make condoms as socially acceptable as toothpaste. ONE^® products are available for purchase at onecondoms.com, and select retailers such as Walmart, CVS, and Walgreens. The myONE^® fitted condoms are available at myonecondoms.com.

¹Siegler AJ, Rosenthal EM, Sullivan PS, et al. Levels of clinical condom failure for anal sex: A randomized cross-over trial. EClinicalMedicine. 2019;17:100199. Published 2019 Oct 31. doi:10.1016/j.eclinm.2019.10.012

²(Siegler AJ, Ahlschlager L, Rosenthal EM, Cecil MP, Kelley CF, Rosenberg ES, et al. Utility of a US Food and Drug Administration (FDA) label indication for condoms for anal sex. Sex Health 2019.)

SOURCE Global Protection Corp.