ONE® Condoms is the First Brand Ever FDA Approved for Anal! - ONE®

ONE® Condoms is the First Brand Ever FDA Approved for Anal!

We at ONE® are very excited to share an update about our unique, innovative and comfortable condoms. While we’ve always been proud of the products we make and share with the world, on February 23rd, 2022, we were honored to become the first and only condom brand to date to receive FDA approval for anal sex. This is a real game-changer, and we’ve been working towards this for 10 years! It’s definitely been a prolonged courtship, but as of this week it’s official.

The condom styles that the new anal use indication currently applies to are: Vanish HyperthinSuper Sensitive, and myONE Custom Fit condoms.

What does this mean for us, for you and for future great sexual experiences? Let us explain, and by the end of this post we think you’ll be just as excited as we are. Who knows, you might even want to celebrate by slipping ONE® on and doing your own in-depth study. *wink*

ONE Condoms and myONE Custom Fit condoms are now approved for anal sex!

Why the FDA?

You may be wondering what the Food and Drug Administration (FDA) has to do with condoms, and it’s a fair question. After all, they are a federal agency generally responsible for regulating the safety of everything from pharmaceuticals to cosmetics to pet food. But trust us, their involvement will make complete sense in a moment.

It may surprise you to know that condoms are classified as a class II medical device by the FDA, which is why they’re so closely regulated. This regulation includes determining what the approved “intended use” is for products under their purview, such as medical devices like condoms.

Until this week, condom companies like ONE® were not allowed to list condoms are “safe and effective” for sexual practices beyond vaginal sex. This new approval means that ONE® Condoms and myONE® Custom Fit Condoms are labeled as safe and effective for vaginal sex – and now they also have FDA authorization for anal sex.

The reason no condom brands could not market their condoms as intended for anal intercourse is because no one had ever done a study to test and confirm condoms are safe for anal sex. Emory University did a study that found ONE Condoms and myONE Custom Fit Condoms have a less than 1% failure rate during anal sex. This data made it possible for us to send a request to the FDA to allow us to market our condoms as safe for anal – and the FDA approved!

The condoms that were tested in the clinical trial were our thin, classic and custom fit styles. So these are our Vanish HyperthinSuper Sensitive, Classic Select (distributed through our public health channel), and myONE Custom Fit condoms. MyONE is hyperthin, has 60 sizes, and we offer sample kits to test out before you buy.

We should make one very important clarification: FDA listed us in their press release as “One Male Condom.” An unintentional faux pas, certainly – our brand is, always has been and will continue to be ONE® Condoms, because we truly believe that the sexual health needs of our community extend across all genders, expressions and identities. And besides, we know lots of people enjoy anal sex who don’t necessarily identify as men! That’s why we like the terms external condoms vs internal condoms – instead of male vs female condoms.

On another note, some press unfortunately mis-reported the story that we “designed a condom specifically for anal sex.” This is not true – so help us correct it if you hear that. The story is: We took our existing ONE and myONE Condom brands, Emory University conducted a clinical trial to confirm our condoms are safe and effective for anal, and now the FDA approved for us to market our condoms as safe for anal.

And even bigger news, we’re the only condom company to receive this stamp of approval! We see this as yet another example of our commitment to always innovating and expanding access to critical, premium and reliable sexual health supplies and education. It’s a big win for public health, and we hope this continues to generate important conversations around safer sex practices.

ONE Condom wrappers with cute butts, ONE Condoms are now approved for anal sex

Tell Me More About This Study and Its Findings

If the FDA has the power to grant this type of approval, what took so long? There’s a bit more to the approval process than a review by the FDA. Despite the rigorous testing and safety procedures during the manufacturing process for our condoms, FDA approval for a new intended use requires a peer-reviewed, medically sound and applicable study to be conducted for the products under review.

This opportunity presented itself to ONE® following the completion of a study by researchers at the Rollins School of Public Health at Emory University (and some stellar results, if we don’t say ourselves).

This study was the largest clinical trial to date for the effectiveness of condoms for anal sex, and it set out to determine the success and failure rate of ONE® and myONE® Custom Fit Condoms. As a refresher, you may remember from some previous blog posts on our site, condom failure is typically defined as the condom breaking, slipping off or otherwise failing to provide the greater protection you should be able to rely on.

So just how did they study condom success/failure? It’s almost as simple as it sounds. With funding from the National Institutes of Health (NIH), the research team provided ONE® (both standard and thin) and myONE® (custom sized) condoms to participants to test out and digitally record their results after each sexual encounter. Participants were categorized as either men who have sex with men (MSM) or men who have sex with women (MSW) and the data was analyzed.

We were thrilled when the research team found that ONE® and myONE® condoms failed less than 1% of the time (0.7%) during anal sex. That means that over 99% of the time, partners were able to complete their sexual experience with successful condom use.

Given that over three hundred condom brands have been approved for use with vaginal sex based on a threshold of less than 5% failure, this was outstanding to see. Can’t argue with those numbers! Beyond the effectiveness of ONE® and myONE® condoms, lube was a surprise standout! The study confirmed how important it is to use lubricant for vaginal and anal sex to help prevent condom failure (and we love lube).

Taking a step back, the results of the study gave an optimistic look into what more widespread condom use could mean for those practicing anal sex. In a previous Emory University study, more than two-thirds of MSM participants said they would be even more likely to use condoms more frequently with anal sex based on the FDA approval.

As a relatively small community which is disproportionately impacted by STIs like HIV, this could have widespread and lasting positive impacts for sexual health across the country. It certainly provides a whole new way to talk about safer sex practices during anal!

Curious to learn more? Don’t worry, there’s been a ton of great buzz around this announcement, including this great piece in the The New York Times, BuzzFeed, Homoculture, VeryWell, and even Saturday Night Live!

ONE Condoms and myONE Condoms now approved for anal. Photo of a butt with a condom wrapper in the pocket.

Get Your Hands on ONE® Today

Excited to try out some of our premium condoms? Whether you’re a returning customer or a first-timer with ONE®, we have a broad and ever-evolving collection of condoms on our site, from our Vanish Hyperthin to Super Sensitive. Customize your condom fit with myONE Custom Fit.

And you know what pairs well with condoms? Lube! We’ve got you covered when it comes to silky, smooth lube, too – don’t just take our word for it. Shipping is always free, convenient, and discreet (plus you can even get samples if you’re not sure right away). See you there!

ONE Condoms and myONE Condoms packaging

More Reading:

ONE® Condoms Press Release


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