So many products on the market have claims like "certified organic," "vegan," and "hypoallergenic," and for the most part the consumer knows what those claims mean. But what exactly does FDA clearance mean? Before answering that question, some important background information is necessary.
The FDA & Lube
The U.S. Food and Drug Administration is "responsible for protecting public health by regulating human drugs and biologics, animal drugs, medical devices..." (fda.gov) The FDA classifies devices according to risk with the highest risk devices being Class III such as mechanical heart valves, Class II devices having moderate risk such as dialysis equipment, and Class I devices having low risk such as exam gloves. In 2015, the FDA classified personal lubricants as a Class II device such that the designation of FDA clearance implies that a lubricant completed a 510(k) premarket clearance process to demonstrate that it is safe and effective based on extensive testing. Some of the required testing includes pH, microbial counts, vaginal irritation, skin sensitization, shelf life, condom compatibility, and osmolality. Osmolality (the number of particles per volume of liquid) is especially important because if a lubricant's osmolality exceeds that of the vaginal lining, water moves out of the vaginal cells causing them to shrivel and die (depressing I know). The entire 510(k) clearance process from start to finish is costly and can take anywhere from one to three years. In 2018, Dr. Michael Krychman (a former colleague and great doctor) reported on a survey of 50 women regarding their awareness of FDA clearance. Of the 50 women, 96% were not aware if their lubricant was 510(k) cleared or what that designation meant. Even more surprising is that all women were unaware if their lubricant contained additives such as caustic chemicals.
So why is it important that the lubricant you use is FDA cleared?
When you use an FDA cleared lubricant you can be reassured that it has been tested for optimal vaginal pH, conforms to a certain antimicrobial standard, does not cause significant vaginal irritation, has a minimum shelf life, and is compatible with certain condoms. Another important reason to use an FDA cleared lubricant is that it won't make your vaginal cells shrink and die (menopause alone will do that to us).
At GLISSANT we are proud that we achieved FDA clearance for our water-based lubricant. Not only do we meet FDA clearance requirements, but we went the extra steps of using natural ingredients and are free of harsh chemicals such as glycerin, parabens, silicones, and phthalates. And in case you were wondering why our CBD lubricant isn't FDA cleared, no CBD product has FDA clearance. But rest assured that we use as high quality, natural ingredients and no harsh chemicals in this lubricant as well.
Now you know why it's important that your personal lubricant is FDA cleared.
Try GLISSANT's FDA-cleared Sea-Salt & Caramel Water-Based Intimate Lubricant Spray and GLISSANT's CBD & CBG Oil-Based Intimate Lubricant Spray
Dr. Karyn Eilber MD is a physician in Beverly Hills with over 20 years of experience in female pelvic medicine and reconstructive surgery.