The approved condom has a less than 1% slippage or breakage rate.
In a move long called for by sexual health experts, the United States Food and Drug Administration authorized the marketing of condoms specifically intended to reduce transmission of sexually transmitted infections (STIs) during anal sex.
The approved brand, ONE male condoms manufactured by Global Protection Corp was made after a yearlong process at the request of the company asking the F.D.A. to allow it to add anal sex to the intended use on the product label.
Until now, condom companies in the United States have not been legally able to market their products as being approved for usage during anal sex.
The request was made after the company produced a which showed the ONE condom’s failure rate, defined as slippage or breakage, to be less than 1% during anal sex, a lower rate than other condoms.
While condoms have long been at the forefront of sexual health campaigns to reduce the risk of STIs associated with anal sex, particularly amongst gay males, the move from the FDA is likely to further increase their usage.
The F.D.A.’s authorization of a condom that is specifically indicated, evaluated and labelled for anal intercourse may improve the likelihood of condom use during anal intercourse,” Courtney Lias, director of the F.D.A. office that issued the approval, said in a statement.
The F.D.A. said in the statement that other condom companies would now be able to apply for similar approval by submitting claims that their condoms demonstrated “substantial equivalence” to the evidence shown for ONE condom.
