On February 23, the United States Food and Drug Administration (FDA) authorized ONE condoms to be used for protection against STIs during anal sex, marking the first time that the FDA granted condom approval specifically for “anal pentration.” The condoms, marketed as ONE male condom and manufactured by Global Protection Corp., had a failure rate (breakage and/or slippage) of less than one percent (0.7) in a clinical study of “252 men who have sex with men and 252 men who have sex with women,” said the FDA in a statement.
Lead author of the National Institutes of Health-funded study (which classified people with penises as men and people with vaginas as women), Aaron Siegler, PhD, associate professor of epidemiology and assistant director of the Prevention Core in the Emory Center for AIDS Research at Emory University, said in a statement on the One condoms website: “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.”
The FDA noted that “unprotected anal intercourse carries the greatest sexual exposure risk of HIV transmission.” In fact, the risk of HIV through unprotected “receptive” anal sex is as much 18 times greater than unprotected “receptive” vaginal sex, according to Stanford Healthcare. The FDA said that other companies can apply for approval by demonstrating that their condoms have “substantial equivalence” to One Male Condom products.
Courtney Lias, PhD, director of the GastroRenal, ObGyn, General Hospital, and Urology Devices, said in an FDA statement that the FDA’s authorization of a condom specifically for anal sex could make it more likely that people will use condoms during anal sex overall. Kenneth Mayer, MD, medical research director for Fenway Health, similarly said in an interview with The New York Times that this will open doors to increase marketing and “normalize the conversation” around anal sex.
In a statement published on the ONE Condoms website, Davin Wedel, the company’s president and founder wrote:
We’ve seen some media report that we designed a condom specifically for anal sex. This is not accurate, so let’s clear it up. Our existing ONE Condoms and myONE fitted condoms became the first brands ever approved by the FDA for anal. Our condoms are also still approved for vaginal sex.
Condoms have previously only been approved for vaginal sex – 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, our 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. This was a 10 year project in the making, and we’re super excited what this means for public health outreach.
The FDA clearance provides another layer of confidence for consumers to know their health is a priority. It also empowers us to have deeper conversations about sexual health education on a larger scale and influence key stakeholders to follow our lead. ONE Condoms are the first condom brand ever to be labeled for safe and effective use for anal sex. This is a massive moment in public health and one of our most significant company accomplishments.
And another quick note: Our brand is ONE Condoms, not “One Male Condom.” FDA still uses “male condom” as a term, and used that in their press release. So then articles described us as “One Male Condom.” That’s not our name – it’s ONE Condoms. As a brand, we use the term “external condom” instead to be inclusive. Our mission is to be a brand for everyONE.
The FDA stated that people should apply lube compatible with condoms when using the ONE condom for anal sex. You can purchase ONEcondoms at onecondoms.com; via Amazon.com, in Walmart, CVS, and Walgreens stores and other retail outlets.
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