Condoms approved for anal sex for the first time by FDA

A surprising detail about condom use has been revealed after the FDA made a historical decision about the contraceptive method.

The US Food and Drug Administration has for the first time approved a condom specifically for anal intercourse.

Marketing materials for condoms in the US are regulated by the FDA, under its broad mandate to regulate the sale of medical devices.

Although condoms are commonly used for anal sex, Global Protection Corp’s ‘One Male Condom’ is the first range of products for which the FDA has explicitly authorised the manufacturer to indicate in marketing material that it is safe and effective for anal sex.

The US FDA has for the first time approved a condom specifically for anal intercourse. Picture: Olivier Douliery/AFP

Previously, condoms could only be marketed as being “safe and effective” for vaginal use.

The manufacturer of the condom says that this is the first time that “data on condom safety for anal sex” has been provided to the FDA.

The FDA stressed that using other condoms only approved for vaginal sex was still safer than unprotected anal intercourse.

“Unprotected anal intercourse carries the greatest sexual exposure risk of HIV transmission,” a FDA press release said.

“Consistent and correct condom use has the potential to significantly help decrease the risk of STIs. While today’s authorisation underscores the public health importance of condoms tested and labelled specifically for anal intercourse, all other FDA-cleared condoms can continue to be used for contraception and STI prevention.

“The safety and efficacy of the One Male Condom was studied in a clinical trial comprised of 252 men who have sex with men and 252 men who have sex with women. All participants were between 18 through 54 years old.”

Dr Courtney Lias, the director of the FDA office that issued the approval, added, “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.

She implied the authorisation was a win for parts of the LGBTI+ community, saying the decision “helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations”.

One condoms can also be used in vaginal sex to reduce the risk of pregnancy and transmission of STIs.

“I think most people would be surprised to know that condoms are not approved for anal sex. With this new designation from the FDA, people will have more confidence using condoms for anal sex,” said Davin Wedel, the founder of Global Protection Corp.