Yes, unfortunately, you did read the title of this article correctly. For over forty (40) years we have been preached to about the dire need to use condoms EACH and EVERY time we have sex, or be permanently branded as someone who is suicidal, wants to force “death sex” on others, a TRUVADA WHORE and or a Barebacker. But, what we were never told was that latex had not ever been tested for usage on gay males during anal sex, and no country in the world, including the United States has ever approved one for this act.
“…there’s never been a cleared or approved condom specifically for anal intercourse—the condoms on the market are more or less recommended for “off-label” use during anal or oral intercourse by the Center for Disease Control.”
If you have read any of our other articles about condoms, this is not news to you. But, as you know, far too many in our community are convinced that condoms are 99.99% effective in preventing HIV, that they are the BEST and ONLY way to prevent sexually transmitted diseases and that ANY dissent is heresy.
This community wide belief system hinders our ability to promote and practice any alternatives to condoms such as PrEP, PEP and #Uequalsu, without rejection and or condemnation. These are very EFFECTIVE ways to prevent HIV infection, without the usage of condoms, especially for those who hate using them.
So, we are going to take a look at why no condom has ever been approved in the past, what qualities and metrics a condom must have to be considered and who is the winner of the first ever FDA anal sex condom approval award.
The approval process
Repeat after us. “Condoms were created for the goal of birth control and pregnancy prevention. Gay males and our anal sex practices have NEVER been considered or tested for usage in STD, specifically HIV prevention in large and or significant studies.”
Once you accept the truth of the above sentences, it should make a lot of other things about condoms make more sense. For example, why you have never read on a box of condoms their effectiveness during anal sex and their ability to prevent STD & HIV infection in gay males. Why you never see large condom manufacturing companies marketing their products to our community based on peer reviewed research and data. And finally, why no non-profit or government agency has said explicitly that condoms are PROVEN to prevent STD and HIV infection in gay males. Many LGBT organizations hint at it, but are careful never to say it is a fact.
“Before today’s authorization, the FDA had not cleared or approved condoms specifically indicated for anal intercourse,” noted the FDA in its own press release. “Unprotected anal intercourse carries the greatest sexual exposure risk of HIV transmission. Consistent and correct condom use has the potential to significantly help decrease the risk of STIs.… It’s important to continue to use condoms consistently and correctly to reduce the risk of STI transmission, including HIV, and to prevent pregnancy.”
Previously, condoms could only be labeled as “safe and effective” when used for vaginal sex.
How it’s done
Condoms are approved through a De Novo premarket review pathway for new low to moderate risk health devices.
Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for devices of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.
Aaron Siegler, an associate professor of Epidemiology at the Rollins School of Public Health at Emory University who led the study, said “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,” Siegler said in a statement. “Having condoms tested and approved for anal sex will allow users to have confidence in using condoms to prevent HIV transmission.”
The FDA said it relied on an Emory University clinical study of condom safety of more than 500 men. Those who took part in the study were evenly divided between men who have sex with men and men who have sex with women.
Despite representing a fraction of most populations, men who have sex with men comprise a majority of new HIV transmissions in many countries. Male condoms are the most accessible and widely used prophylactic to prevent transmission, yet regulatory agencies have not label indicated condoms for anal sex.
“We searched for English-language publications using the PubMed database, on May 22, 2019, for trials assessing condom failure for anal sex with terms “condom,” “trial,” “anal,” and “failure” in any field and any year. Among 8 articles identified, 1 was a trial with anal sex failure as a primary outcome.”
This study found clinical failure to be 6.5% using a paper diary method, a level higher than the 5% threshold regulatory agencies have used to approve condoms for vaginal sex.
- Estimates of the performance of condoms for anal sex vary widely depending on study design. In two secondary analyses, the estimated range for the reduction in HIV transmission that results from condom use for anal sex was 63–91% . Both studies relied on lengthy recall periods to determine condom use or nonuse. Studies assessing per-act total clinical failure (breakage or slippage) found condom failure for anal sex ranging from 1.8% to 8.0%, with median 3•4%. The median recall period for these studies was 6 months. Two studies with diary-based assessments of per-act clinical failure, recorded with pen and paper at the event-level, found total clinical failure for anal sex of 6.5% and 6.9%
- Due in part to inconsistent estimates and lack of data with minimal recall bias, condoms are not currently label indicated for anal sex by regulatory agencies, including the US Food and Drug Administration (FDA). ISO guidance, which is used by many countries to inform their clearance of condoms, notes that testing of condoms should include only vaginal sex use, explicitly excluding anal sex. This may be because of a perception, as noted by FDA, that, “condoms may be more likely to break during anal intercourse than during other types of sex.”
- To clarify the performance of condoms for anal sex and to provide data to inform consideration of indication of condoms for anal sex, we conducted a study that differed in three ways from its predecessors. First, measures were obtained on a daily basis rather than requiring accurate memory of condom use over longer time periods; memory for specific experiences becomes increasingly inaccurate with the passage of time. Another difference was that this was the first study to pursue a label indication for anal sex for condoms. A third difference was that the study was larger than previous clinical trials of condoms for anal and vaginal sex. The study had two a priori hypotheses regarding clinical failure (NCT02753842): (1) the rate of clinical failure for anal sex among MSM would be lower than a threshold to be determined by FDA for fitted, thin, and standard condoms and (2) fitted condoms would improve anal sex clinical failure performance relative to standard condoms.
- From May 19, 2016 to May 2, 2017, we enrolled 504 participants in the crossover trial: 252 MSM and 252 men who have sex with women (MSW). A crossover design is recommended by FDA for condom clinical failure trials, likely due to the limited potential for carryover effects across different types of condoms. The study was conducted in Atlanta, GA, USA at several sites of the Rollins School of Public Health at Emory University. The study was approved by the Emory University Institutional Review Board, IRB00083754 and adheres to CONSORT reporting guidance.
- The full eligibility assessment with 27 criteria includes male sex at birth, recent insertive sex, age 18–54, being HIV-negative at a baseline test, not using condoms for contraception, and willing to complete all study procedures, including using condoms and lubricant. Recruitment was conducted through a variety of sources including flyers, posters, website banner ads, app-based ads, and social media. To maximize the separation of study arms, MSM that reported recent vaginal sex or MSW that reported recent anal sex were ineligible. Individuals testing HIV positive were provided linkage to care services. The eligibility assessment also included home measurement of fitted condom size, accomplished with a paper template to indicate condom size. All study participants completed an informed consent procedure.
- The condom failure rate, meaning that a condom either broke or slipped, was less than 1% during anal sex.
And the winner is…..
According to The New York Times, in order to receive approval from the FDA, condom makers had to show the prophylaxis had less than a 5% failure rate during anal sex, a threshold no brand had previously reached.
In August 2021, Global Protection Corp (the makers of ONE BRAND Condoms) cited the above research data in a request to the FDA to expand its approved marketing to include anal sex. ONE Condoms failed only 0.7% of the time during anal sex.
On February 22, 2022 The FDA approved three types of ONE brand male condoms—standard, thin and myONE custom-fit condoms, which are available in 54 different sizes, according to a press release from ONE Condoms, part of Global Protection Corp.
Who is ONE Brand?
We first wrote about this company for our article on custom condoms. But, now they are branching out and doing much more. Launched in 2004 “ONE® strives to give you better feeling protected sex. Our mad scientists created a softer and silkier latex than anything on the market called Sensatex®. And if you’re struggling with condoms that squeeze, slip, or feel uncomfortable, myONE® Condoms fit you perfectly with 60 unique sizes. On top of all that – we are committed to sustainability as a company and as co-habitants of this beautiful planet. Our condoms are non-GMO & vegan-friendly, our packaging tube is made from 100% recycled cardboard, and our factory is more energy efficient than ever.”
ONE Male Condoms sell for between $3.48 for a three-pack and $14.48 for a 24-pack, according to Milla Impola, Global Protection’s director of marketing and communications.
Although not a huge brand like some older condom manufacturers, ONE brand makes up for this by having multiple outlets for purchase of their products. They may be bought within the United States, but are also available internationally in the UK, Malaysia, Thailand, Portugal, Indonesia, Singapore, UAE, and Vietnam. You may also purchase their products on their website, as well as find a seller near you.
Before you go…
We should not need to tell you this but the FDA has approved THIS SPECIFIC COMPANY’S CONDOMS for marketing and sale for anal sex. NOT ANY OTHER COMPANY.
This does not mean another company’s product is not effective or you should not use it. Rather, that ONE Brand is the ONLY one that you should say has the approval of the FDA for anal sex. NOT, that “condoms are approved for anal sex by the FDA.”
This difference is very important because the Emory researchers also found that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people..
A final thing we should not need to tell you, but we will because almost all government agencies and LGBT/HIV orgs addressing HIV within our community and promoting the usage of condoms for anal sex, ALWAYS leave out the importance of PROPER LUBRICATION while using condoms. SPIT IS NOT LUBE! Buy and use condom SAFE lubrication. And use it LIBERALLY!
Every gay male that has ever had anal sex knows this, but it took a team of straight researchers to study it, before anyone would believe it. This is why gay male centric organizations, like ours, created by and for gay males, and run by gay males are so important.
“A critical finding of the study was that failure was low when condom-compatible lubricant was used, and the use of lubricant is part of the new FDA label indication,” noted Siegler, adding that “programs providing condoms should also be providing lubricant.”