The FDA Approves Anal Condoms

For the first time in its history, the U.S. Food and Drug Administration (FDA) has authorized the marketing of condoms especially intended for anal sex. Before the authorization for the ONE brand, levied on February 23, the agency had never cleared nor approved condoms specifically geared toward anal sex.

"The risk of STI transmission during anal intercourse is significantly higher than during vaginal 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, via a press release. "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."

Though condoms are recommended for anal sex by both the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), this will be the first time condoms engineered for anal sex will be marketed to customers in the United States.

"I think most people would be surprised to know that condoms are not approved for anal sex," said Davin Wedel to the New York Times. Wedel is the president and founder of Global Protection Corp., the manufacturer of ONE's condoms. "With this new designation from the FDA, consumers will have important information about the safety and effectiveness of condoms for anal 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.'

Not unlike other condoms available for purchase, the ONE's condoms are a rubber-latex sheath for a penis, and the brand sells different varieties, such as standard, thin and myONE custom-fit condoms, which come in 54 different sizes. The FDA also noted in its press release that the condom should be used with a compatible lubricant during anal sex. The condoms are safe for vaginal sex, too, according to the FDA.

The efficacy of the condoms was studied in a clinical trial composed of 252 men who have sex with men and another 252 who have sex with women, with participants between ages 18 and 54. The total failure rate for anal intercourse was 0.68 percent and 1.89 percent for vaginal intercourse, with the failure rate defined as the condom slipping off or breaking during sex. The combined rate for adverse events was 1.92 percent, which includes recent STI or STD diagnosis, lubricant-related discomfort, partner discomfort and a partner UTI.

"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," Lias said in the press release.

The ONE condoms were reviewed through the FDA's De Novo premarket review pathway, which allows for low-risk devices to achieve regulation. With these condoms paving the way, the FDA said other condom companies that demonstrated "substantial equivalence" could also apply for similar approval.

"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," Lias explained.