FDA Approves ONE and MyONE Condoms for Anal Sex

Emory University study clears path for FDA clearance for ONE Condoms and myONE fitted condoms to become the first brands approved by the FDA for anal sex.

Health Sexual Health Triston Brewer

This article was published on February 28th, 2022

A dramatic, history-making change has recently occurred in the condom history that is over 10 years in the making with the announcement that the FDA has approved a request to expand ONE® Condoms use to include anal sex. The approval is for three different types of their condoms – the standard, thin and custom-fit condoms that are available in 54 different sizes. The brand will be the first one ever to be labeled as effective and safe for anal sex. The hope is that the condoms will significantly decrease the risk of sexually transmitted infections as well as reduce the transmission of STIs for both vaginal and anal intercourse. 

ONE® and myONE® condoms are the first condom brand ever to be labeled for safe and effective use during anal sex.

Condoms have previously only been approved for vaginal sex by the FDA – because no one had ever brought data to the FDA showing condoms are also safe for anal sex. In a clinical trial published in 2019, conducted by Emory University, myONE custom fit condoms and ONE Condoms used during anal sex failed less than 1% of the time. This clinical trial provided the data we needed to submit a De Novo Request to the FDA to expand the intended use claim of ONE and myONE Condoms to include anal sex. On February 23rd, 2022, FDA accepted this request.

The FDA Responds

The FDA released a statement on the news, saying:

“While today’s authorization underscores the public health importance of condoms tested and labeled specifically for anal intercourse, all other FDA-cleared condoms can continue to be used for contraception and STI prevention.”

The study was led by Dr. Aaron Siegler of Emory University, which was the largest of its kind to test the effectiveness of condoms for anal sex. They found that ONE® and myONE® Condoms used during anal sex failed less than 1% of the time and on the 23rd of February, FDA officials accepted the request that enabled ONE® and myONE® to become the first brand with the new anal use designation. 

Unbeknownst to many, condoms are a class II medical device under FDA classifications and therefore meet strict regulatory guidelines for the general public. Many people use condoms for anal sex, but the FDA has never before allowed companies to include anal sex as an indication for use – only for vaginal use. This is because previously there was no data to support the claims. ONE Condoms are available in standard, thin, and myONE custom fit, with a failure rate for anal intercourse at just 0.68 percent.

ONE and myONE Condom President Responds

The President of the brand responded to the news, adding: “This landmark shift demonstrates that when researchers, advocates, and companies come together, we can create a lasting impact in public health efforts. I think most people would be surprised to know that condoms are not approved for anal sex. “With this new designation from the FDA, people will have more confidence using condoms for anal sex.”

Emory University’s leader of the research, Dr. Siegler, added: “There have been over 300 condoms approved for use with vaginal sex data, and never before has a condom been approved based on anal sex data. This is despite two-thirds of HIV transmission in the United States being linked to anal sex. Having condoms tested and approved for anal sex will allow users to have confidence in using condoms to prevent HIV transmission.”


Now that these condoms have paved the way for anal sex to be recognized through conventional condoms, what are the implications for the future? As the story develops, HomoCulture will continue to provide the latest updates on this research that affects the LGBTQ+ community. 

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