Do All Personal Lubricants Need FDA Approval?
Most personal lubricants need to be FDA-approved before they are marketed, distributed, and sold in the United States.
The FDA “classifies personal lubricants as Class II medical devices.”
Class II medical devices are devices that carry a medium level of risk — that is, more risk than Class I devices and less than Class III devices.
Dr. Susan Milstein, a human sexuality health educator on our medical review board, researched these classifications to learn more about their meaning.
“While sometimes it’s about risk, other times it’s about how long it comes in contact with the body,” she explained. “Interestingly, a pregnancy test — which is neither high risk nor in contact with the body — is a Class II [device].”
Generally speaking, Class I, II, and III medical devices must receive 510(k) clearance under section 510(k) of the Federal Food, Drug, and Cosmetic Act before they can be marketed and sold in the United States.
Manufacturers of qualifying devices, including most lube manufacturers, must register their products to get 510(k) clearance.
Companies can market and sell their lube in the United States immediately after receiving 510(k) clearance.
One thing to note, however, is that 510(k) clearance does not guarantee that a lube is high-quality — it only pertains to safety and effectiveness.
Additionally, not all of the products we think of as being personal lubes will actually require approval from the FDA.
All of our best lube recommendations have either a registered 510(k) clearance certificate on file with the FDA or are exempt from needing one.
