In a move hailed as a milestone for female equity in the sexual health space, FDA has cleared the first undies designed to protect against sexually transmitted infection (STI) during oral sex. The Lorals oral sex undies represent the first time FDA has cleared an underwear product as a medical device.
Los Angeles, CA-based Lorals launched its line of latex undies this week after receiving 510(k) clearance in April. The product was developed as an alternative to dental dams, which were cleared by FDA more than 30 years ago and have been largely under-utilized and considered awkward to use.
FDA cleared the Lorals latex undies for use as a barrier when engaging in oral/vaginal and oral/anal sex to help reduce the transmission of bodily fluids, harmful pathogens, and STIs. Like prophylactic dams, the Lorals latex undies are classified under FDA's MSC product code.
Lorals CEO Melanie Cristol founded the company in 2018 and says that FDA clearance for STI protection has always been part of her long-term goal for the product.
Dental dams have to be held in place during use, whereas Lorals are worn like briefs and are hands free. The company describes its oral sex undies as "stretchy, fashionable, and ultra-thin to allow for maximum sensation" while preventing skin-to-skin contact. The undies are vanilla-flavored and apparently taste like a cookie, one user told the New York Times.
Lorals currently fit waist and hip sizes 26” to 51”, which corresponds to U.S. women’s sizes 0-20. The product is designed to be used by couples of all sexual orientations. Like condoms, the Lorals oral sex undies are designed to be single-use product.
The FDA clearance comes at a time when STIs are on the rise, especially among people ages 15 to 24. It also comes on the heels of Abbott receiving FDA clearance for detecting four common STIs with the Alinity m assay.
According to the CDC, many STIs as well as other types of infections are spread through oral sex. The agency notes that getting or spreading an STI through oral sex depends on several factors, including the particular STI, type of sex, and number of sex acts performed. In general, CDC said it is possible to get some STIs in the mouth or throat after giving oral sex to a partner who has a genital or anal/rectal STI. It is also possible to get certain STIs on the genitals and genital areas after receiving oral sex from a partner with a mouth or throat infection. Also, several STIs including syphilis, gonorrhea, and intestinal infections that are transmitted by oral sex can spread in the body.