FDA approves HIV-safe condom for anal sex

The FDA has approved the first-ever condom specifically for anal sex that will help prevent the transmission of HIV.

Up until 2022, the US Food and Drug Administration failed to approve a condom specifically for safe anal sex. People speculated that conservatives mightn’t appreciate the endorsement of a “taboo” sex act from a government agency, but hey! It’s not 1950 anymore and we’re all adults who can handle the fact that anal sex happens, so ipso facto, let’s make it safe?

In 2022, the FDA has approved the commercial availability of the ONE Male Condom, which has been designed to prevent the transmission of the human immunodeficiency virus (HIV) and other sexually transmitted infections (STI) specifically during anal sex.

Credit: Romi Yusardi

“The approval applies to three different types of ONE Condoms: standard, thin and myONE custom-fit, which comes in 54 different sizes,” the company stated in a press release.

“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse,” Doctor Courtney Lias – director of the FDA’s Office of GastroRenal ObGyn, General Hospital, and Urology Devices in the Centre for Devices and Radiological Health – said in an official statement.

As a Class II medical device, the FDA require condoms to meet strict product guidelines. Due to an absence of data on anal sex, there was no precedent for approving condoms for safe use for anal sex.

The clinical trial that featured participants between 18 – 54 included 252 men who have sex with men and 252 men who have sex with women.

“The FDA’s authorisation of a condom that is specifically indicated, evaluated and labelled for anal intercourse may improve the likelihood of condom use during anal intercourse.”

“There have been over 300 condoms approved [by the FDA] for use with vaginal sex… and never before has a condom been approved based on anal sex data”, said Dr Aaron Siegler, who led the study.

This historic change in condom production comes after a 10-year process, which was the result of researchers, advocates and businesses working together to “create a lasting impacting in public health efforts,” said Davin Wedel, president and founder of Global Protection Corp, the owner of the ONE Male Condom.

“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.”

Safe sex is the best kind of sex, so thanks FDA and ONE Male Condom.