Does Lube Require FDA Approval? (And Ones That Are)

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.

Why Some Lubes Do Not Need FDA Approval

Some personal lubricants are exempt from needing 510(k) clearance from the FDA.

For example, lubes that are branded as massage oils or vaginal moisturizers may not need 510(k) clearance because the FDA does not consider them to be medical devices.

A vaginal moisturizer that doubles as a lube, for instance, may not have (or need) FDA approval because it’s considered to be a vaginal moisturizer — not a personal lubricant by definition.

In such cases, the FDA grants an exemption and the company then has permission to market and sell its product without having a 510(k) clearance established.

A lube that lacks 510(k) clearance is not inherently bad; it simply means it didn’t require this type of approval from the FDA.

It’s worth noting that any product of this nature must first be deemed exempt by the FDA.

This means that regardless of a 510(k) clearance being in place, if a personal lubricant is available for sale, the product was considered by the FDA for either approval or exemption.

How To Know If A Lube Is FDA-Approved

If you want to know whether a product you’re considering is an FDA-approved lube, the organization provides a public, searchable database.

You can look for records by company or product name, or by using any other details you may have on hand.