A Guide to the First FDA-Approved Condom for Anal Sex

In the past, the CDC recommended the use of condoms when having anal sex, but an FDA-approved condom for anal sex did not exist. February 2022 saw a change to that when the FDA granted approval for Global Protection Corp.’s ONE Male Condom, the first condom deemed safe for anal sex.  

Here at Rapid STD Testing, we are very excited about this development. In this article, we discuss the new ONE Male Condom and its implications related to preventing STDs. 

If you need an STD screening, call us at 866-872-1888. We offer fast results and answers with same-day STD testing.

Introducing Anal Condoms: the ONE Male Condom

Developed by Global Protection Corp., the ONE Male Condom is a natural rubber-latex product that comes in 54 fitted sizes so every man can find his ideal fit for maximum comfort. The manufacturer also offers standard and thin varieties. A three-pack sells for $3.48 and a 24-pack for $14.48 (at the time of writing). 

The ONE Condoms brand provides reliable external condoms for everyone. The manufacturers offer a variety of sizes because they believe condoms shouldn’t have to be uncomfortable, and men should be able to protect themselves with a condom that doesn’t bunch, slip, squeeze, or pinch. They provide recommendations, kits, and other resources to help you find your ideal condom size.  

So, what makes the ONE Male Condom so unique? This product marks the first instance of FDA approval for a condom deemed safe for anal sex. Before the ONE Male Condom, the FDA had only designated condoms as safe for vaginal sex and only allowed companies to market them for that purpose.   

The ONE Male Condom underwent testing in a study by Emory University that included both men who have sex with men and men who have sex with women for comprehensive results that were groundbreaking. The study found this product to be a reliable and safe form of barrier protection against both pregnancy and sexually transmitted diseases (STDs). 

The ONE Male Condom proved quite effective during clinical trials, with a condom failure rate of only 0.68% for anal sex. In fact, the failure rate for vaginal intercourse was higher at 1.89%, possibly due to less consistent lubrication use. The FDA recommends always using condom-compatible lubricant when using the ONE Male Condom for anal sex.

Do You Need Condoms for Anal Sex?

Some people incorrectly consider condoms unnecessary during anal sex due to the lack of pregnancy risk, but this is not true. In fact, barrier protection methods like condoms are the best options for preventing sexually transmitted infections like HIV and HPV. 

In fact, infection transmission presents more of a risk during anal sex than during vaginal sex, according to a statment made by Courtney Lias, Ph.D., in a press release. Lias works for the FDA as the director of the Office of GastroRenal, ObGyn, General Hospital and Urology Devices. 

This fact is a bit shocking, considering that the FDA allowed none of the hundreds of condoms deemed safe for vaginal use in the past to be marketed as safe for anal use. With the ONE Male Condom, men can feel confident about using condoms for anal sex, knowing that industry professionals specifically tested the condom for anal intercourse.  

You may still be wondering how effective condoms really are at preventing STDs. Click here to learn whether you can still get an STD with a condom. This linked blog article also includes helpful information on the transmission of specific STDs, including HPV, genital herpes, and syphilis—and how to use and store condoms properly.

Significance of FDA Approval

Another Emory University study, conducted in 2019, illustrates the significance of FDA approval for using the ONE Male Condom for anal sex. That study gathered information by surveying a sample of men who have sex with men. 

The study found that 69% of survey participants would use condoms more often if the condom had an FDA-approved label for anal sex. Consumers of all types may hesitate to use products for purposes other than those described on the label. With this new approval, however, men can be confident in using condoms for anal sex, knowing that industry professionals have tested and approved the condoms. 

The ONE Male Condom’s low failure rate of 0.68% for anal sex makes it an even more attractive option for preventing STD transmission during anal intercourse. Anal sex accounts for two-thirds of U.S. HIV transmission. Anyone can have confidence in a condom with a failure rate below 1%.  

This official FDA approval of a condom for anal sex, many believe, should have happened a long time ago. Many professionals, such as Dr. Will DeWitt, Callen-Lorde Community Health Center’s clinical director of anal health, are frustrated that it has taken this long for an official endorsement. 

Hopefully, the FDA’s endorsement of the ONE Male Condom for anal sex will serve as a regulatory model for the approval of future products of the same intended use.

Is There a Female Condom for Anal Sex?

Female-worn condoms, more appropriately called internal condoms, also offer barrier protection against STDs. Although no testing has occurred regarding the prevention of STDs while using internal condoms for anal sex, research has proven their effectiveness in stopping viral infections like HIV. Some people prefer them over external (male-worn) condoms. 

An internal condom is a sheath made from nitrile, a synthetic rubber material. While an external condom covers the penis before intercourse, a woman inserts an internal condom gets into her vagina or anus beforehand. It functions much the same way as an external condom, providing a protective barrier that catches semen and prevents skin-to-skin contact. 

The nitrile material offers an alternative to latex condoms for people with latex allergies. Some consider nitrile superior to latex in many ways, including softness, puncture resistance, and heat transfer, creating a more pleasurable sexual experience with a penis or a toy. 

When using an internal condom, ensure that the outer ring remains on the outside to help prevent tearing and breakage. The couple should also use a generous amount of lubricant, including oil-based lubricants, on the outside and inside of the condom. Internal condoms are meant for single use only, so avoid re-use to get optimal protection against STDs.

Implications of Anal Condoms on STD Prevention

This FDA approval of the ONE Male Condom marks the beginning of a long-overdue conversation about keeping men who have sex with men safe from STDs. Before now, professionals recommended condoms for all types of intercourse in blanket statements that never referred explicitly to anal sex. 

We need to start having honest conversations about preventing STDs no matter what kind of sex you’re having. As Dr. Courtney Lias mentioned in the press release linked above, having this FDA approval will guide future conversations on health equality and help the healthcare industry better provide for the diverse needs of every individual. Men no longer have to ask themselves, “Can I use a condom for anal sex?” because the FDA has now endorsed the ONE Male Condom. 

The effectiveness of the ONE Male Condom for anal sex is truly impressive. Even condoms with higher failure rates of 9% are very effective at preventing STDs, so a 0.68% failure rate means even better protection.

Get a Rapid STD Test Today 

We hope you stay safe in all sexual encounters by using condoms and other protective methods. All it takes is one unsafe encounter to become exposed to an STD. Click here to learn about the odds of getting an STD from one-night stands. 

Have you had a sexual exposure risk to STDs? Find answers with a 10-panel STD test from Rapid STD Testing.