FDA Clears First Pair of Underwear to Protect Against STIs During Oral Sex

For the first time, a pair of underwear has been cleared by the U.S. Food and Drug Administration to protect against sexually transmitted infections (STIs) during oral sex.

Lorals for Protection—pairs of ultra-thin, vanilla-flavored, one-time use underwear—are a new alternative to dental dams, which were approved by the FDA over 30 years ago, and have generally gone under-used.

"The FDA's authorization of this product gives people another option to protect against STIs during oral sex," Courtney Lias, director of the FDA office that led the review of the underwear, told The New York Times.

Though health experts applaud the innovation and agree that there is certainly a lack of protective measures for oral sex specifically, some worry that due to the low usage of dental dams, the new underwear will also go unused.

Here's what to know about the new underwear, what it can offer protection against, and who may benefit most from its use.

Underwear Used as Protection

According to the Lorals website, the underwear is made for use as a protective barrier while engaging in oral-vaginal or oral-anal sex. It is meant to "help reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections."

When used as directed—meaning the underwear actually stays on through sexual contact—Lorals may help reduce the risk of catching or spreading STIs like herpes, HPV, chlamydia, gonorrhea, syphilis, trichomoniasis, Hepatitis A and B, and HIV, Lorals CEO and founder Melanie Cristol told Health. "However, they cannot eliminate the risk," she added.

The ultra-thin underwear—measuring about 0.08 millimeters thick—is made from natural rubber latex, and comes in two styles: bikini and "shortie." It retails for $25 for a pack of four pairs.

The FDA did not require that Lorals do human clinical trials on its underwear, but cleared it after the company submitted documents attesting to its thickness, elasticity, and strength, among other things, according to Cristol.

"While the FDA protection aspect is incredibly important, we've also found that there's an active and engaged market of people who wouldn't have used a dental dam because they're not looking for STI protection, and who love Lorals for comfort and pleasure," Cristol said. "We have over 105,000 highly engaged followers on TikTok, which demonstrates that we're serving an unmet need."

Comparing Lorals to Dental Dams

Dental dams are barrier devices that are meant to cover the vulva and/or anus during oral sex, according to the Centers for Disease Control and Prevention (CDC). They're commonly made of latex or polyurethane.

It's hard to find exact data on how effective dental dams are, but they can help protect against STIs like herpes, HPV, and HIV when they're used correctly, Peter Leone, MD, adjunct associate professor of epidemiology for the Gillings School of Global Public Health and professor of medicine for the School of Medicine at the University of North Carolina, told Health.

However, dental dams are rarely used: Dr. Leone cites a 2010 study published in the journal Sexual Health that asked 330 Australian women who have sex with women about their dental dam use. Of those, only 9.7% said they had ever used a dental dam and 2.1% used one "often."

"I really don't know anybody who uses dental dams," Dr. Leone said. "They're hard to find and certainly not sexy to use."

Another issue: Not many people are aware dental dams exist. "A lot of people don't even know about them," Marybec Griffin, PhD, MPH, assistant professor in the Department of Health Behavior, Society, and Policy at the Rutgers School of Public Health, told Health. "They can also be tricky to use because you have to hold them in place over a person's vulva or anus."

Lorals needed to meet similar requirements for dental dams in order to be cleared by the FDA. "In order to be FDA-cleared, Lorals conducted hundreds of tests and passed all of the FDA's requirements," Cristol said. "Lorals had to meet physical requirements like dimensions, thickness, elasticity, strength, and lack of holes. In terms of elasticity, for example, dams must stretch to 650% of their resting length, and Lorals generally stretch to 750% or more. For tear-resistance tests, Lorals generally have double the required tear resistance of 5 N-mm [Newton millimeter]."

The underwear also had to be tested to make sure it was compatible with the human body. "Our packaging was also tested to ensure it doesn't make Lorals vulnerable to wear and tear," Cristol said. "We had to age Lorals using an accelerated process, and then conduct all of the tests again, in order to prove that they have a two-year shelf life."

Innovative, but Lacking Real-World Data

In general, doctors are in favor of the concept. According to Griffin, Lorals takes a "really innovative approach" that "improves upon the design of dental dams." She adds, "It creates a dental dam-like thing that's sexy and removes some of the design flaws."

But, despite giving the undies props, doctors also say that they don't really expect Lorals to catch on. "The usage of dental dams is very low and, from what I know about this product, I doubt that the usage will be any higher," Mary Jane Minkin, MD, a clinical professor of obstetrics and gynecology and reproductive sciences at Yale University Medical School, told Health.

"The problem is, people don't understand the risks around oral-genital transmission," Dr. Leone added. And, if they're not concerned about the risk of contracting an STI from oral sex, they may not be willing to spend the money on protective measures, like Lorals.

Right now, anybody with a vulva can wear Lorals, but there are a few groups who might get the most benefit, including people with active STI infections, those with multiple sexual partners, and those who just want an added layer of protection.