FDA Approves First Condom for Anal Sex

Health experts say FDA authorization may increase condom usage during anal intercourse and reduce sexually transmitted infections

ONE condoms
ONE Condoms become the first condoms approved for anal sex by the FDA.  ONE Condoms

The United States Food and Drug Administration has authorized the use of ONE Condoms during anal intercourse to reduce sexually transmitted infections. This is the first time the agency has approved a condom specifically for use during anal sex. 

“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse,” says Courtney Lias, director of the FDA’s office of GastroRenal, ObGyn, General Hospital, and Urology Devices in a statement. “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.”

Condoms need to have less than a five percent failure rate for authorization, and earlier studies have shown higher failure rates, writes the New York Times’ Pam Belluck. 

A clinical trial in 2019 tested the effectiveness of ONE condoms, manufactured by Global Protection Corporation, in 252 men who have sex with men and 252 men who have sex with women. ONE condoms have previously been approved for use during vaginal sex. Condom failure was defined as slippage or breakage, per the study, which found a 0.68 percent total failure rate for anal intercourse and 1.89 percent failure rate for vaginal intercourse. 

The gap in effectiveness may have been because of differences in lubricant use. Lubricant was used for 98 percent of anal sex during the study, while it was only used for about 42 percent of vaginal sex acts. The study instructed men having sex with men to always use lubricant, while men having sex with women were instructed to use lubricant as needed or preferred. A secondary analysis using data only from participants that used lubricant showed similar failure rates for both anal and vaginal sex, per the study.

Canada-themed condom labels
ONE Condoms has previously partnered with artists to create condom labels, including holding a Canada-themed label design contest. ONE Condoms

“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,” says Dr. Aaron Siegler, lead author of the clinical trial, in a statement. “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.”

A previous study led by Siegler found that 69 percent of men who have sex with other men were likely to use a condom more often if it indicated FDA approval on the label. 

Despite a lack of authorization, people have long used condoms for anal sex; the Centers for Disease Control and Prevention even recommends it, per the Agence France Presse. However, condom companies were only allowed to market their products as safe and effective for vaginal sex. 

“It’s a great thing if the package inserts could indicate anal sex because it might create an incentive for the companies to do more marketing,” Dr. Kenneth Mayer, the medical research director for Fenway Health, who was not involved in the study, tells the Times. “You don’t see condom ads on gay social media, for example, so this would incentivize that as part of the conversation.”

Dr. Will DeWitt, clinical director of anal health at the Callen-Lorde Community Health Center in New York City, tells NBC News the FDA approval is long overdue. 

“Here we are in 2022, and we are only now getting condoms approved for anal sex,” DeWitt tells the outlet. “It’s a little frustrating that it’s taken this long to have this kind of official endorsement.”