Monday, September 25, 2023

FDA Approves First Condom Marketed Specifically For Anal Sex

For the first time ever, U.S. regulators have authorized a condom specifically designed for anal sex.

Though health experts have encouraged condom use for all varieties of sexual intercourse, the U.S. Food and Drug Administration previously prohibited companies from marketing their products as an effective tool for safe anal sex. But that all changed on Wednesday, when the FDA announced it will allow Global Protection Corp. to market its One Male Condom as a product that helps “reduce transmission of sexually transmitted infections” during both vaginal and anal intercourse.

As reported by the New York Times, experts believe the authorization will encourage more people to use condoms during anal sex, which “carries the greatest sexual exposure risk of HIV transmission.”

“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse,” said Courtney Lias, Ph.D., director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health. “The FDA’s authorization of a condom that is specifically indicated, evaluated and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse. Furthermore, this authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations.”

According to the Times, Global Protection Corp. asked the FDA last year to approve an update to its labeling—specifically adding anal sex to the list of intended uses for the condom. The company filed the request after a study found that the One Male Condom had a 1.89 percent failure rate for vaginal sex and less than 1 percent failure rate for anal sex. More than 500 men, ages 18-54, participated in the clinical trial; 252 of the subjects have sex with other men, and 252 have sex with women.

The FDA says the move will allow other companies to apply for similar approval.

“I think most people would be surprised to know that condoms are not approved for anal sex,” said Davin Wedel, president and founder of Global Protection Corp. “With this new designation from the FDA, consumers will have important information about the safety and effectiveness of condoms for anal sex.”

Source: Complex.Com

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