FDA Approves First Condom Meant Specifically for Anal Sex

The US Food and Drug Administration (FDA) has approved the first-ever condoms specifically intended for anal sex in hopes of reducing the spread of sexually transmitted infections (STIs)

Unprotected anal intercourse carries the greatest sexual exposure risk of HIV transmission, FDA officials said in a news release earlier this week. Anal sex is also considered to be much riskier compared to vaginal sex when it comes to the spread of infections such as human immunodeficiency virus (HIV) and human papillomavirus (HPV).

The Centers for Disease Control (CDC) and other health authorities have long encouraged use of condoms during anal intercourse even though the FDA has not deemed the practice safe until now.

According to the FDA, the approved latex brand is called ONE Male Condom and is manufactured by Boston, Massachusetts-based Global Protection Corp. The condom has already been available for vaginal sex, but FDA action now allows the company to market the product for anal 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," Courtney Lias, director of the FDA's Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a press release. "Furthermore, this authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations."

The FDA relied on an Emory University clinical study, which focused on the condom safety of more than 500 men. Participants were evenly divided between men who have sex with men and men who have sex with women.

Researchers found that the ONE Male Condom failure rate (a condom that either broke or slipped) was less than 1% (0.68%) during anal sex, and it was 3% times higher (1.89%) during vaginal intercourse. The study also highlighted that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people.

Here's everything you need to know about the recent FDA approval.

How is a condom approved for anal sex different from other condoms?

Before this FDA authorization, health care providers and educators often recommended the use of typical condoms during anal sex "off-label"—simply because any kind of unprotected sex increases your risk of contracting an STI or HIV, "Liz Klinger, an Everyone Deserves Sex Education (ESDE) certified sex educator, told Health in an email.

The difference between the ONE Male Condom and other condoms boils down to the FDA authorization now. Though it still uses latex (a natural rubber) and is similar to condoms that are used during vaginal sex, the One Male Condom has been specifically tested and authorized, and is now allowed to be marketed for anal sex.

Alexis May Kimble, DO, a board-certified urogynecologist at the Kimble Center, told Health that the FDA requires a condom to have a 5% or less failure rate during anal intercourse. The ONE Male Condom has a failure rate of less than 1% during anal intercourse, which demonstrates the effectiveness, safety, and trust users can have in the product.

"When we compare it to other condoms for perfect use, we're talking about a less than 2% failure rate," she said. "Other condoms aren't tested for this specific indication of anal sex making this approval very significant. It's important to have a health product that's been tested before wide use."

Why is FDA approval significant?

The new authorization from the FDA may encourage condom use among people who engage in anal intercourse, helping to reduce the risk of spread for certain sexually transmissible infections, said Dr. Kimble. She adds the approval paves the way and makes it slightly easier for other organizations and companies to step up and make their products available for use as well.

"I hope this not only encourages marketing but opens up the conversation to making anal sex normal and encourage use among people who engage in it, which we know has been very low and that's a problem," Kimble said. "This comes at the perfect time where there's more awareness, recognition, and there's more of a movement to be inclusive of everybody."

The FDA approval also opens up more opportunities for marketing and education from condom companies to reach those who identify within the LGBTQ community and to anyone who has and is interested in having anal intercourse, according to Liz Klinger, an Everyone Deserves Sex Education (ESDE) certified sex educator.

"Without this approval, companies could not market their own condoms as safe for anal sex because they did not have official FDA approval to market them that way and would be heavily penalized if they did so," said Klinger. "With this pathway, companies that get approval will finally be able to spread the message far and wide about condoms you can use during anal sex as well as education about safe anal sex."

What companies will produce this condom?

Global Protection Corp. will manufacture and produce the condom, as they are the only ones with authorization to market the condom for anal sex. The ONE Male Condoms is the only brand that has received approval for anal intercourse.

ONE Male Condoms sell for about $3.48 for a three-pack and $14.48 for a 24-pack, according to the company's website.

The FDA said the condom is a natural rubber latex sheath that covers the penis. It is offered in three different versions: standard, thin, and fitted. The fitted condoms are available in 54 different sizes and incorporate a paper template to aid in finding the best condom size for each user. The ONE Male Condom should also be used with a condom-compatible lubricant during anal intercourse.

Other condom companies—especially ones that already produce condoms that are FDA approved for vaginal sex—are also now be able to apply for similar approval by submitting claims and evidence showing their product's demonstrated "substantial equivalence" in their effectiveness, according to the FDA.

"Other companies, educators and other health care professionals can have specific products they can recommend to people as products that are safe for use during anal sex," said Klinger. "Over time, these actions will help further destigmatize anal sex since we will have more data, products, and data-backed education to provide to people."

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