The Dental Dam Gets Competition As Lorals’ Latex “Undies” Receive FDA Clearance As An Oral Sex Barrier

Finally some good news in the realm of women’s sexual wellness equality: Lorals’ Lorals for Protection latex “undies” have secured clearance from the United States Food and Drug Administration as a barrier to protect against sexually transmitted diseases from oral vaginal and anal sex. 

The FDA clearance represents a significant milestone for female equality in the sexual health arena. While there are thousands of condom options on the market spanning every size, color and shape imaginable, the only FDA-cleared option for vaginal oral sex up until now has been the much-maligned dental dam. A version of the thin latex sheet made by condom company Glyde is FDA-approved to protect against the spread of infections. 

“STI protection has always been part of my plan for the company,” says Lorals CEO and founder Melanie Cristol, a former attorney at O’Melveny & Myers who hatched the idea for Lorals on her honeymoon. She explains, “I had an STI, and I didn’t want to pass it to my then wife. I was so frustrated that there was only the dental dam available. There wasn’t a product that would help me feel sexy and confident and great about myself during oral sex. I’m so happy that we’ve been able to provide more oral to all of our customers in the meantime, but this really has always been so important to me.”

Lorals founder Melanie Cristol BarneyCrowPhoto

Lorals sells Lorals for Protection as well as Lorals for Comfort & Pleasure, an offering that’s not attained FDA clearance and isn’t intended for protection against STDs. Both varieties are available on Lorals’ website priced at $25 for a pack of four. The research and development process for Lorals for Comfort & Pleasure lasted three years. After launching the brand in 2018, Cristol spent the next few years refining the product based on user feedback and to align with the FDA’s stringent restrictions. 

Lorals began the FDA clearance process last year. It involved conducting tests on the product and teaming up with scientists to prepare the application, a document that ended up hundreds of pages long when it was submitted in September. Achieving approval from the agency, which was issued on April 22, required Lorals to accomplish several difficult tasks. A major one was enabling wearers of Lorals for Protection to feel sensation through the undies as they ensure protection from STDs. The undies have uniform thickness across their surface area. 

“Suffice it to say it was a very large expense for a small business,” says Cristol. “We spent more than six figures on lawyers and consultants to guide us through FDA clearance as well as R&D and equipment. Of course, this figure does not take into account my and our team’s time working on the product. It was a substantial expense, and we’re proud to have been successful in achieving FDA clearance for our Lorals for Protection product.”

Lorals for Pleasure & Comfort undies are available on the brand’s website for $25 for a pack of 4.

Many startups aiming for FDA clearance and patents—Lorals has four—raise millions of dollars in funding, but Cristol has chosen not to go that route for Lorals. She’s personally invested in the brand, and it raised a $250,000 pre-seed round with participation from Backstage Capital and angel investors. Currently, Lorals has customers in over 60 countries, including South Africa, Iceland and Australia.

In the U.S., Lorals is sold at a mix of lifestyle and sex retailers such as Urban Outfitters and Babeland. However, direct-to-consumer distribution is its primary focus. Cristol shares that 90% of Lorals’ current sales come from its DTC channel. That percentage could change as a result of an entrance into big-big stores. Now that the brand has gained FDA clearance, large retailers have been reaching out to it, and Cristol welcomes conversations with them. 

In addition to preventing STDs, Cristol is proud of Lorals playing a role in facilitating more people with vaginas giving and getting oral sex. Via its thriving TikTok community—Lorals has amassed over 106,000 followers and nearly 4 million likes on the platform—the brand has learned it’s allowed consumers who found receiving oral sex too intense of a sensation to be able to enjoy the act.

“I had no idea that other people felt this way, but with our videos talking about it, they are so excited that there is a solution out there,” says Cristol. “They’re able to receive oral sex with this tiny little barrier that, of the 8,000 nerve endings of the clitoris, maybe blocks 50. For a person who doesn’t have sensitivity issues, they’re still going to feel normal sensation, but for the person who does have sensitivity issues, it’s just enough to take a little bit of the edge off, and they’re able to enjoy oral sex when they wouldn’t otherwise.”