Does Lube Require FDA Approval? (And Ones That Are)
Most lubes on the market are 510(k) certified (FDA-approved Class II Medical devices) and in the absence of approval, are deemed exempt from needing it.

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Updated:May 2023
When it comes to personal lubricants, the U.S. Food and Drug Administration (FDA) is responsible for setting labeling standards, approving products for sale, and issuing mandatory product recalls.
Here’s what you need to know about the FDA approval of personal lube:
- FDA regulations classify personal lubricants as Class II medical devices.
- As a result of this classification, the FDA requires 510(k) clearance for such products before they can be marketed, distributed, or sold within the United States.
- The 510(k) clearance issued by the FDA means that a product has been examined and deemed to be safe and effective — although that doesn’t necessarily mean that it’s high quality.
- Some lubes are exempt from 510(k) requirements because they are considered to be massage oils or vaginal moisturizers, rather than “personal lubricants” that would fall under the medical device classification.
- Products that are exempt from 510(k) clearance can be marketed, distributed, and sold within the US upon the exemption.
- You can easily find out whether any personal lubricant has been approved by the FDA by using its searchable database.
- We’ve also put together a list of FDA-approved lubes we’ve personally vetted and tested.
When you purchase any product designed to be used on some of the most sensitive areas of your body, you want to know that what you have chosen is safe and if applicable, FDA-approved.
We’ll cover everything you need to know about the FDA, how it determines whether a lube requires approval, why some products are exempt from it, and how to find out if your favorite lube is FDA-approved.

Medically Reviewed By: Susan Milstein, PhD, Human Sexuality
About The Author 

I believe sex, sexuality, and relationships are important subjects that uniquely reflect our individual experiences and societal values at the same time. I...