In historic change, ONE® brand condoms are the first to receive FDA “safe and effective use” label approval for anal sex
Condoms are a Class II medical device according to 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 US FDA has never allowed condom manufacturers to include anal sex in the indication for use – allowing condoms to be labeled “safe and effective” for vaginal use only. Indeed, no data on the safety of condoms for anal sex has been provided to the FDA.
A study led by Dr. Aaron Siegler at the Rollins School of Public Health in Emory University provides this data and paved the way for Global Protection to submit a De Novo application to the FDA to extend the intended use claim of its ONE® and myONE® Condom brands include anal sex.
The study of Emory University – the largest clinical trial of the 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%). At August 26, 2021, Global Protection Corp. cited the study as the basis of its De Novo request to the FDA to expand its intended use approvals to include anal sex. At February 23, 2022FDA officials announced that it had granted the request, allowing ONE® and myONE® to become the first condom brands with the new anal use designation.
“This historic change demonstrates that when researchers, advocates and businesses come together, we can create lasting impact in public health efforts,” said David Wedelchairman and founder of Global Protection Corp, owner of ONE® and myONE® Condom brands. “I think most people would be surprised to know that condoms aren’t approved for anal sex. With this new designation from the FDA, people will have more confidence in using condoms for anal sex.”
This study1 was led by Dr. Aaron Sieglerassociate 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 teachers of EmoryDr. Siegler began seeking funding for the study a decade ago, in 2012, and partnered with Global Protection Corp. to provide ONE participants® and myONE® Condoms.
Study participants were evenly split 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 (fitting, thin, and standard) and were asked to track their sexual activity in an electronic daily diary. The results were published in Lancet’s ECMedicineClinical 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,” Dr. Siegler said. “This despite two-thirds of HIV transmission in United States be related 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 shown that condoms had a 6% to 7% failure rate for anal sex. However, this research had significant limitations, such as not requiring the use of a condom-compatible lubricant for anal sex. For vaginal intercourse, condoms have already been cleared by the FDA based on a clinical failure threshold of
“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 that ONE condoms provide for anal sex, which we believe ‘hopefully builds trust, leads to increased use and decreases new cases of sexually transmitted infections,’ Wedel said.
In fact, an earlier study by professors of Emory University found that 69% of MSM said they would be more likely to use condoms more frequently if condoms were listed on the FDA label for anal sex.2
“The clinical trial also confirmed something we believed but without clinical proof – using lubricant makes condoms even more effective than they already are,” Wedel added. “We’re excited to bring this information to our health educator partners and continue to educate people on the importance of lube.” Lubricant use for anal sex is part of the FDA’s new label indication.
In the clinical study, condom failure was lower for anal intercourse than for vaginal intercourse. The researchers hypothesized that this difference was due to the much higher use of condom-compatible lubricant for anal sex acts (98.3%) compared to vaginal sex acts (41.6%) due to of the study design. When the researchers controlled for lube use, they found no difference in condom failure for anal sex compared to vaginal sex.
“A critical finding of the study was that failure was low when condom-compatible lubricant was used, and lubricant use is part of the FDA’s new label indication. Programs providing condoms should also provide lubricant,” Dr. Siegler said.
About ONE® & Global Protection Corp.
Launched in 2004, ONE® is a socially responsible company committed to raising awareness of sexual health. As a leader in premium condoms and lubricants, ONE® brings a new perspective to sexual health through a fusion of advanced product design, manufacturing technology and customer involvement. A® is fond of developing new technologies to improve its condoms, such as the exclusive Sensatex® Softer latex, MicroRoll® Comfort base and TotalGlide® Complete lubrication technologies. A® The condoms are vegan, non-GMO and made from natural rubber latex. The brand’s round packaging features hundreds of designs to spark conversations. A® and myONE® are part of the Global Protection Corp family of sexual health products. founded by David Wedel with a mission to make condoms as socially acceptable as toothpaste. A® 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 condom clinical failure for anal sex: a randomized crossover trial. ECClinical Medicine. 2019;17:100199. Published October 31, 2019. doi:10.1016/j.eclinm.2019.10.012
2(Siegler AJ, Ahlschlager L, Rosenthal EM, Cecil MP, Kelley CF, Rosenberg ES, et al. Usefulness of a US Food and Drug Administration (FDA) label indication for condoms for anal sex .Sex Health 2019.)
SOURCE Global Protection Corp.