Anal Condoms: What You Should Know Before Sex

In 2022, the Food and Drug Administration approved one of the first condoms designed explicitly for anal sex.

For years, people who wanted to have anal sex using a condom only had one option: Conventional condoms, which are not explicitly approved for anal penetration. While sex is safer with a condom than without, conventional condoms fail during anal sex more often than vaginal sex.  

But in February 2022, the Food and Drug Administration approved marketing one of the first condoms proven effective for anal sex, hoping to reduce the spread of sexually transmitted infections (STIs).

Here's what you need to know about the anal condom, where to find it, and what research suggests about its efficacy.

FDA approves first condom for anal sex
Alex Sandoval

How Are Anal Condoms Different Than Other Condoms?

The Centers for Disease Control and Prevention (CDC) and other health authorities have long encouraged using condoms during anal sex. Still, there weren't any sold explicitly for that purpose until the Food and Drug Administration approved one brand.

Boston-based Global Protection Corp began marketing its natural rubber latex condoms for anal sex under a brand called ONE in 2022. ONE condoms aren't that different than conventional condoms. However, they are some of the only ones that research suggests are effective for anal sex. They come in a variety of styles and sizes.

In 2017, clinical trials found that the failure rate of ONE condoms, meaning the condom broke or slipped during sex, was significantly less than the failure threshold needed for the Food and Drug Administration's approval.

The published study findings also highlighted that almost 70% of men, based on an online survey of 10,000 people, who have sex with men reported being more likely to use condoms explicitly designed for anal sex.

The Food and Drug Administration's approval of ONE condoms intended to advance health equity by encouraging diverse populations to use condoms made for their needs.

"The [Food and Drug Administration'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 division of chemistry and toxicology devices at the Food and Drug Administration, explained in a news release.

Why Do You Need Condoms?

Unprotected anal sex carries one of the most significant sexual exposure risks of various STIs.Anal sex, in general, is riskier than vaginal sex regarding the spread of human immunodeficiency virus (HIV) and human papillomavirus (HPV). For instance, men who have sex with men are 28 times more likely to contract HIV than men who have sex with women.

Additionally, anal sex between men and women is becoming more common, leading to a greater need for adequate protection. Some evidence suggests that 36% of women and 44% of men aged 25 to 44 in the United States reported having heterosexual anal sex at least once in their life.

Condoms are the most widely available way of preventing the spread of STIs through anal sex. If used correctly, they are 98% effective in preventing pregnancy. However, in practice, that number is closer to 87%.

Why Are ONE Condoms Unique?

Before 2022, healthcare providers and educators often recommended using standard condoms during anal sex. That's because any unprotected sex increases your risk of contracting an STI or HIV, Liz Klinger, a sex educator, told Health in an email.

The difference between the ONE condom and other condoms boils down to authorization. Though it uses latex (a natural rubber) and is similar to condoms used during vaginal sex, the ONE condom has been tested and explicitly authorized for anal sex. 

Alexis May Kimble, DO, a board-certified urogynecologist at the Kimble Center, told Health that the Food and Drug Administration requires a condom to have a 5% or less failure rate during anal intercourse.

And clinical trials demonstrated that ONE condoms had a failure rate of less than 1% during anal sex. Kimble said that explains 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," explained Kimble. "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 Does Approval Matter?

The new Food and Drug Administration authorization may encourage condom use among people who engage in anal sex. It also makes it slightly easier for other companies to step up and prove their products effective for anal sex or to develop new ones.

It also makes it easy to talk about practicing safety during anal sex.

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

According to Klinger, the approval also opens up more opportunities for marketing and education from condom companies to reach the LGBTQ+ community and anyone interested in having anal sex.

"Without this approval, companies could not market their own condoms as safe for anal sex because they did not have official [Food and Drug Administration] approval to market them that way and would be heavily penalized if they did so," added 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."

How Do You Use an Anal Condom?

ONE condoms are natural rubber latex sheaths designed to cover the penis. The brand offers 60 sizes and supplies a guide to help you choose the right one.

Planned Parenthood also has step-by-step directions and a video guide on using condoms. You use them like any other condom, although ONE highly suggests using their condoms with condom-compatible lubricant during anal sex. Some of the best types are water- or silicon-based, so they don't interfere with effectiveness.

A Quick Review

Before 2022, the Food and Drug Administration appoved ONE condoms specifically for use during anal sex. Before that date, no other anal condom had approval. That's significant because unprotected anal sex is significantly riskier than vaginal sex regarding STI transmission.

The approval of ONE condoms may encourage more people to talk about safety during anal sex and use anal condoms. Additionally, it may inspire more companies to begin developing and offering their own anal condoms.

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8 Sources
Health.com uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Centers for Disease Control and Prevention. Condom fact sheet in brief.

  2. Siegler AJ, Rosenthal EM, Sullivan PS, et al. Levels of clinical condom failure for anal sex: A randomized cross-over trialEClinicalMedicine. 2019;17:100199. doi:10.1016/j.eclinm.2019.10.012

  3. Siegler AJ, Ahlschlager L, Rosenthal EM, et al. Utility of a US Food and Drug Administration (FDA) label indication for condoms for anal sexSex Health. 2020;17(1):91-95. doi:10.1071/SH18152

  4. Food and Drug Administration. Food and Drug Administration permits marketing of first condom specifically indicated for anal intercourse.

  5. Hernandez AL, Efird JT, Holly EA, Berry JM, Jay N, Palefsky JM. Incidence of and risk factors for type-specific anal human papillomavirus infection among HIV-positive MSMAIDS. 2014;28(9):1341-1349. doi:10.1097/QAD.0000000000000254

  6. Joint United Nations Programme on HIV and AIDS. Global HIV & AIDS statistics - fact sheet.

  7. Hess KL, DiNenno E, Sionean C, Ivy W, Paz-Bailey G; NHBS Study Group. Prevalence and Correlates of Heterosexual Anal Intercourse Among Men and Women, 20 U.S. CitiesAIDS Behav. 2016;20(12):2966-2975. doi:10.1007/s10461-016-1295-z

  8. Planned Parenthood. How effective are condoms?

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