There Are Finally Condoms Authorized for Anal Sex


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Key Takeaways

  • The FDA green-lit a condom to be used for anal sex, the first authorization of its kind.
  • When coupled with a condom-compatible lubricant, the condoms have a 1% failure rate when used for anal sex.
  • The move could help protect against HIV and other STIs among people who have anal sex.

For the first time, regulators permitted a company to label its condoms for use during anal sex. Advocates said the move could encourage condom use and help prevent the spread of sexually transmitted infections (STIs).

Last week, the Food and Drug Administration (FDA) authorized the ONE condoms by Global Protection Corp to be marketed for use during anal sex. The condom was also authorized for vaginal sex.

The decision came after the FDA reviewed data submitted by researchers from Emory University on the condom’s high effectiveness. Based on the study, the condoms had a failure rate of less than 1% when used for anal sex.

While health authorities have long recommended the use of condoms for anal sex, the FDA has only allowed condom manufacturers to label their products as safe and effective for use during vaginal sex, until now.

“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, PhD, director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a statement. “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.” 

Aaron Siegler, PhD, MHS, associate professor of epidemiology at Emory University and lead author on the study, said the FDA decision could have significant public health implications.

“There have been over 300 condoms approved with vaginal sex data, and there’s never been a condom approved for anal sex by FDA,” Siegler told Verywell. “We know that two-thirds of HIV transmission in the United States is linked to anal sex. So, it’s critical to have condoms tested and approved for this use.”

Building the Case for Condom Use

Siegler said that condoms have long been used for anal sex. Establishing data on how well they hold up during anal sex could increase confidence and encourage people to use them more often.

“This is a long-established intervention, but I don’t think there was a general understanding that condoms would have such a low failure level for anal sex,” Siegler said.

The study followed 252 men who have sex with men and 252 men who have sex with women for a year. The research team sought to understand if different kinds of condoms performed differently during anal sex. They tested three kinds—thin, regular, and fitted. The fitted version used in the research was produced in 56 sizes. The version now available for sale is available in 60 sizes.

They found that the condoms failed in 0.7% cases of anal sex. Failure during vaginal sex was higher, at 1.9%.

There was no significant difference in how condoms of different types held up during sex.

The research was funded by the NIH through a small business research grant to test the effectiveness of a condom by a company later acquired by Global Protection Corp. The Emory team and Global Protection Corp together sought the FDA label.

“People put their health and trust in our hands, and deserve to know the products we provide are safe and effective. It’s a responsibility we take very seriously,” Davin Wedel, president and founder of Global Protection Corp, parent company of ONE Condoms, told Verywell in an email. “We hope the FDA clearance enhances trust, leads to increased condom and lubricant use, and reduces the number of new cases of sexually transmitted infections.”

Smaller studies have found the clinical failure rate to be higher than the 5% threshold needed for FDA authorization. Siegler said his team designed their study to minimize biases, through steps like decoupling incentives to participants from condom use and using electronic reporting system to minimize mistakes and lags in reporting outcomes.

The researchers analyzed failure rates by a variety of demographic factors. Failure rates stayed low, at about 1% for all groups.

Siegler said he hopes other condom manufacturers will undertake similar studies and seek FDA authorization for their products.

Lubricant Is Key to Successful Condom Use

Risk of failure may be lower among men who had sex with men due to the common use of lubricant in this group. More than 98% of anal sex acts involved condom-compatible lubricant, while less than 42% of vaginal sex acts did. When researchers compared only sex acts that used lubricant, the risk of failure dropped by more than half and they found there was no risk difference between the groups.

Water- and silicone-based lubricants help reduce friction during sex, minimizing the risk of the condom breaking during use. 

Oil-based lubricant, on the other hand, can degrade the latex used to make most condoms, making them more susceptible to breakage. In the study, condoms failed in 2 out of 16 cases when non-condom compatible lubricant was used.

“Condoms and condom compatible lubricants should be going hand in hand and should be provided together to optimize condom performance,” Siegler said. “It really is kind of an essential part of condom use for anal sex.”

Improving Sexual Health

Pre-exposure prophylaxis (PrEP) is a preventative medicine for people at high risk of getting HIV. PrEP use has more than doubled in the U.S. in the last five years.

Condoms have the additional benefit of reducing the chances of sexually transmitted infections, including syphilis, gonorrhea, and chlamydia. Unlike PrEP, condoms can also greatly reduce the chance of pregnancy after vaginal sex.

Condoms and condom-compatible lubricant, Siegler said, are low-cost public health tools that could have important public health implications. A 2015 survey found that 69% of surveyed men who have sex with men would be more likely to use a condom for anal sex if the FDA labelled it as safe and effective for that use.

Broadening access to tools like condoms and PrEP could increase sexual health across the board.

“The FDA clearance provides another layer of confidence for people to know their health is a priority,” Wedel said, “This is a massive moment in public health and one of our most significant company accomplishments.”

What This Means For You

The ONE condom is the only product currently labeled for use during anal sex. The CDC and WHO say condoms by other manufacturers may be used off-label. The move may pave the way for other companies to test their products for use during anal sex and seek FDA approval. 

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

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

By Claire Bugos
Claire Bugos is a health and science reporter and writer and a 2020 National Association of Science Writers travel fellow.