The Food and Drug Administration (FDA) has just approved a condom for use during anal intercourse for the first time. Now, this doesn’t mean that a new prophylactic has been created specifically for this use; rather, an existing condom can be marketed as reducing one’s risk for sexually transmitted infections (STIs) during anal sex.
Late last month, the FDA green-lighted three types of ONE brand male condoms (standard, thin, and myONE custom-fit; available in 54 different sizes), according to a press release from ONE Condoms, part of Global Protection Corp. Launched in 2004, ONE Condoms also can be used during vaginal intercourse and as contraception.
According to the FDA in its press release, “Before today’s authorization, the FDA had not cleared or approved condoms specifically indicated for anal intercourse. Unprotected anal intercourse carries the greatest sexual exposure risk of HIV transmission. Consistent and correct condom use has the potential to significantly help decrease the risk of STIs.… It’s important to continue to use condoms consistently and correctly to reduce the risk of STI transmission, including HIV, and to prevent pregnancy.”
According to Poz.com, “Previously, condoms could only be labeled as ‘safe and effective’ when used for vaginal sex. That’s because, according to ONE Condoms, no data specific to anal sex had been provided to the FDA.
“But a study led by Aaron Siegler, PhD, MHS, at the Rollins School of Public Health at Emory University, finally provided that data. Siegler’s study found that ONE Condoms failed only 0.7% of the time during anal sex.”
According to The New York Times, to receive approval from the FDA, condom makers had to show that the prophylactic had less than a 5% failure rate during anal sex— a threshold no brand had previously reached. Then, in August 2021, Global Protection Corp cited that data in an FDA request to expand its approved marketing to include anal sex.
Siegler stated, “A critical finding of the study was that failure was low when condom-compatible lubricant was used, and the use of lubricant is part of the new FDA label indication.” He emphasized that “programs providing condoms should also be providing lubricant.”
“I think most people would be surprised to know that condoms are not approved for anal sex,” stated Davin Wedel, president and founder of Global Protection Corp. “With this new designation from the FDA, people will have more confidence using condoms for anal sex.”
FDA Director Courtney Lias, PhD, weighed in. “The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse. 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.”
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