Anal_Condom

Why It Took So Long to Get an FDA-Approved Anal Condom

The strange history of safe-sex regulation after the AIDS crisis

Some years ago, HIV activist Josh Robbins, who now serves as a spokesperson for the STI dating platform DatingPositives, was consulting for an LGBTQ publication in Nashville when a simple concern exposed a much larger issue. “I was curious about why there were no condom advertisements in the publication,” he explains.

Further investigation led Robbins to the FDA, where he was told that condoms had never been specifically approved for anal sex, and therefore, the law prevented condom manufacturers from promoting their products as such — something that undoubtedly dissuaded them from advertising in an LGBTQ publication. “I started asking questions, and I quickly found that I was touching on a subject people absolutely didn’t want me to touch,” Robbins says. “I was asking questions that people thought I’d lost my mind for asking.”

Officially, the FDA told Robbins that it couldn’t discuss product submissions — condoms or otherwise — that failed its reviews, which led him to consider the possibility that some condom manufacturers may have devised an anal-dedicated condom that never passed FDA inspection.

So Robbins asked massive condom manufacturers Trojan and LifeStyles about their plans regarding a product line for anal sex, among other related questions. LifeStyles refused comment, and the vice president of marketing for Trojan responded as you might expect: “It’s important to use a condom for every sex act including anal sex. Condoms are the best form of protection when having sex. As the most trusted brand for more than 90 years, we continue to make sex as safe and pleasurable for all those who are sexually active.”

The FDA did provide Robbins with a peculiar statement made by the Surgeon General in 1987. The declaration essentially advertised condoms as the ultimate tool to prevent the transmission of HIV — the peculiar part being that the Surgeon General used a pen to replace the phrase “sexual intercourse” with “vaginal intercourse,” indicating that he may have been uncomfortable suggesting that condoms are similarly effective for anal sex.

This, of course, convinced Robbins that the lack of FDA approval may have something to do with a lack of research concerning condoms and anal sex, which is valid. One 2015 analysis claims that several other studies suggest condoms are between 70 to 87 percent effective at reducing HIV transmission when used during anal sex. Yet, a more recent analysis proposes that those percentages are actually higher. The discrepancy might seem normal enough, but the data included in both analyses was collected more than 15 years ago, and as we all know, our anal habits have certainly increased over the ensuing years.

That said, we obviously haven’t always been so chill about anal sex, which might be the real reason for the FDA’s lack of urgency — that is, until the last decade or so, it was a sex act that wasn’t readily accepted by the mainstream. “From a taboo perspective, internationally and in the U.S., nobody was talking about or regulating condoms for anal sex,” says Melissa White, founder and CEO of Lucky Bloke, a company dedicated to better educating people about their condom options. “Truth doesn’t seem to be the precursor for how sexual health is approached.”

Which brings me to an interesting aside about how sexual education in the U.S. approaches condoms in regards to anal sex. “I was contacted by some educators in California, because they have a real problem with sex education in their schools,” Robbins explains. “They have a state law that says they can only provide sex education tools and techniques approved by the FDA. Well, they’re absolutely violating their state law by recommending condoms for anal intercourse.”

Fortunately, though, that’s no longer true, because in September, the FDA finally approved a condom designated for anal sex. Once (ironically) called the FC2 Female Condom, White tells me that it’s long been used during anal sex within gay the community, even if “it wasn’t advertised or marketed for this purpose.” Now, however, those restrictions have been lifted. As such, it’s been rebranded as the FC2 Internal Condom. (An inner ring helps with insertion of the condom, while an outer ring keeps it in place.)

But as with most change, it’s both a step forward and a half step. Or as White emphasizes, “We still need to keep pushing.”