In a landmark move, the U.S. Food and Drug Administration (FDA) has granted authorization for a condom marketed specifically for anal sex.
While all condoms currently on the market are recommended by health officials for all forms of sexual intercourse, the FDA previously banned the specific marketing of condoms for being effective for use with anal sex.
On Wednesday, however, the FDA announced via their website that they would allow Global Protection Corp. to market its One Male Condom as a product to help “reduce transmission of sexually transmitted infections (STIs) during anal intercourse.” The condom is already marketed as a pregnancy contraceptive and protection against STIs in vaginal intercourse.
According to the New York Times, this 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 H.I.V. and other sexually transmitted infections.”
This is especially important, the FDA says, because “the risk of sexually transmitted diseases is ‘significantly higher’ during anal sex than vaginal sex.”
“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,” said Courtney Lias, Ph.D., director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health.
“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.
“This De Novo authorization will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster.”
According to the NYT article, Global Protection Corp. had asked the FDA in 2021 to approve the labeling update to explicitly add anal sex to the list of its intended uses.
This updated labeling request was submitted after a study done on the One Male Condom showed a 1.9% failure rate for vaginal sex, and a 0.7% failure rate for anal sex. This failure rate (which is defined by the study as slippage and/or breakage) decreased for both sex acts with the use of lubricant.
The study was done with 252 men who had sex with male partners and 252 men who had sex with female partners, ages 18-54. Participants in the study reported 4,884 anal or vaginal sex acts using study-provided condoms, according to the published paper.
With this milestone decision made, the FDA says that it will now allow other companies to apply for similar marketing approvals.
The president and founder of Global Protection Corp., Davin Wedel, said of the approval, “I think most people would be surprised to know that condoms are not approved for anal sex.
“With this new designation from the FDA, consumers will have important information about the safety and effectiveness of condoms for anal sex.”