What to Know About the First Condom Authorized for Anal Intercourse
Key takeaways:
For the first time ever, the FDA has authorized a male (external) condom as a “safe and effective” option for anal sex. It’s made by a company called ONE.
ONE condoms are the first external condoms that can be marketed specifically for use during anal sex.
There are a number of precautions to consider before using any type of external condom. If you or your partner have any concerns, remember to always read the package directions and to ask a pharmacist or healthcare provider any questions.
Table of contents
Everybody who wants to have sex deserves the opportunity to have safe sex. This is true regardless of your partner, sexual interests, and background. Your preferred way to have sex also doesn’t make a difference.
Anal sex is one common way to have sex. However, it’s known to be the riskiest way of spreading and developing certain sexually transmitted infections (STIs), like HIV. Because of this, wearing a condom is one of the best ways to have a safe and confident sex life.
The CDC already recommends using a condom during anal sex. But in late February 2022, the FDA took a big step to improve sexual safety. For the first time ever, they authorized a certain brand of condoms to be marketed for use during anal sex, made by a company called ONE. This means that ONE condoms can now advertise their male (external) condoms for anal sex.
This might not sound like a big deal, especially since many people already use external condoms during anal sex. But the FDA hopes that this new authorization will encourage more people to use condoms during anal sex — especially those who might have been skeptical about how well they work.
Here, we’ll talk more about the ONE brand external condom — what it is, how to use it, and things to keep in mind.
What is the ONE condom?
The ONE external condom is an external condom that covers your penis. It’s made of natural rubber latex, and it’s reported to be available in about 60 sizes. It also comes in different styles, such as thin or standard.
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The ONE condom is the first condom to be authorized specifically for anal intercourse. Before this new FDA authorization, it was already being sold and used — though the company could only market it for use during vaginal sex. The condom itself hasn’t changed, but ONE is now the first condom brand that can also be marketed as “safe and effective for anal sex” on its labeling.
And just like all external condoms, ONE condoms can also be used during vaginal sex to lower the risk of spreading STIs or starting a pregnancy. They can also be used during oral sex.
How does it compare to other condoms?
The FDA plays a key role in saying how condoms can be marketed. Up until now, no condoms could be officially labeled as safe and effective options for anal sex. This is because ONE is the first company to provide the FDA with solid evidence that spoke to their products’ safety and effectiveness for anal sex.
Other than this new authorization, ONE condoms are the same as other male latex condoms.
Will other condoms be authorized for anal sex in the future?
Most likely.
Even though ONE condoms are the first — and only — condoms to be authorized for anal sex, that doesn’t mean they’ll be the only one for too long. That’s because this authorization was through a special FDA pathway called the “De Novo” pathway.
Since no other anal condoms are currently authorized, ONE was able to make a “De Novo” request for their product. With this request, the FDA made a risk-based evaluation of the condom and determined that the public can use their product safely for this use. This pathway also set a precedent for other condoms to follow in its footsteps so they can have an easier time obtaining authorization for anal sex.
How do you put on a ONE external condom?
All condoms are effective tools to prevent STIs and unintended pregnancy — especially when they’re used correctly. Here’s a few pointers for getting started with external condoms, including the ONE brand condom:
Purchase a pack of condoms that’s the right size for you or your partner.
Grab an unopened condom and carefully open the side of the packaging. Be careful not to rip the condom while you open the packaging.
Place the opened, unused condom on the head of you or your partner’s erect penis. If there’s foreskin, pull it back before putting it on.
Pinch any air out of the condom’s tip.
Roll the condom down the shaft (base) of the penis.
If you notice any holes or damage in the condom after putting it on, take it off and put on a new one.
Once the condom is on, apply a water- or silicone-based lubricant that’s compatible with latex. This is necessary for anal sex, but optional for vaginal sex.
How effective is the ONE external condom?
No condoms are 100% effective — including ONE brand condoms.
Nonetheless, when it comes to anal sex, what we currently know about the ONE external condom comes from a clinical trial. This study included about 500 people. Half of the people in the study were men who have sex with men, and the other half were men who have sex with women.
During anal sex, ONE condoms failed (slipped or broke) less than 1% of the time. This means the condoms held up for over 99% of people who used them for anal sex. For vaginal sex, the condoms failed less than 2% of the time. This means the condoms held up for over 98% of people who used them for vaginal sex.
In other words, this means the results were good enough for ONE condoms to be considered a good option for anal sex. The FDA generally allows condoms to be marketed for a certain purpose if the failure rate is less than 5%.
However, since we’re all just humans, it’s hard to use a condom perfectly every time. A condom’s effectiveness is generally a bit lower in real life (outside of a clinical trial).
What are the known risks or side effects of the ONE external condom?
Condoms are officially Class II medical devices. This means they have a moderate risk of complications for most people.
In other words, they’re generally safe to use. But they can lead to unintended consequences, such as STIs or unintended pregnancy, if they’re not used properly or if they don’t work as expected.
However, condoms don’t usually have many direct side effects. If they do cause side effects, they’re usually related to condom discomfort, lubricant discomfort, or allergic reactions to latex.
Are there any precautions I should take while using ONE brand condoms?
In general, there are a few things you and your partner should keep in mind before using, and while using, a ONE brand condom:
Always use a lubricant if you’re having anal sex. But it’s important that you don’t use oil-based lubricants — these can damage latex condoms. Water- or silicone-based lubricants are better.
All condoms are single-use, so make sure you use a new one every time you have sex.
Read the expiration date before use. If it’s expired, try to find a non-expired one.
If you or your partner have a latex allergy, don’t use this condom. Use a different one.
For condoms, size matters. Consider experimenting with different sizes to find the size that’s best for you or your partner — not too big or not too tight.
A condom is always better than no condom. Even though ONE condoms are currently the only brand of condom that’s officially authorized for anal sex, other condoms can still be used instead.
One of the other most important precautions to take is to recognize any uncertainty you have. If you or your partner have any questions about condoms, it’s recommended to talk to a pharmacist or healthcare provider. They can help you find a condom that’s safe and empowering for you and your partner's needs.
When will ONE external condoms be available?
This condom is already available in the U.S. Remember: The condoms themselves haven’t changed, only their FDA authorization status has.
If you’re interested in trying ONE brand condoms, they can be ordered from the company’s website, and free sample kits are currently being offered, too. ONE condoms are also available at various retailers throughout the country.
And in general, many different brands of condoms are widely available at no cost throughout the U.S. It’s a possibility that ONE brand condoms will be available at certain clinics, but this will vary by location.
The bottom line
The ONE brand external condom is the first condom to be officially FDA-authorized for anal sex. It’s a latex condom that comes in many sizes and styles, and it can be also used during vaginal and oral sex. Just like other external condoms, ONE condoms are a great way to lower your risks for STIs and unintended pregnancy.
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References
Belluck, P. (2022). F.D.A. grants the first condom approval for anal sex. The New York Times.
Centers for Disease Control and Prevention. (2021). Condom fact sheet in brief.
Centers for Disease Control and Prevention. (2021). Ways HIV can be transmitted.
Centers for Disease Control and Prevention. (2022). Male (external) condom use.
Food and Drug Administration. (2022). De Novo classification request.
Food and Drug Administration. (2022). FDA permits marketing of first condom specifically indicated for anal intercourse.
Food and Drug Administration. (2022). Product classification.
Hey, It’s Free. (2022). Free condoms by mail or in-person.
HIV.gov. (2022). Sexually transmitted infections.
ONE Condoms. (n.d.). Where to buy.
ONE Condoms. (2022). ONE Condoms are first to receive FDA approval for anal sex!
Phillips, H. (2020). Condom testing for anal sex finds very low failure rates. Avert.
Planned Parenthood. (2021). How do you use lube with condoms?
Siegler, A. J., et al. (2019). Levels of clinical condom failure for anal sex: A randomized cross-over trial. EClinicalMedicine.
