Does Lube Require FDA Approval? (And Ones That Are)
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.
- 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.
FDA Approval Of Lube: Everything You Need To Know
Personal lubricants generally need approval from the Food And Drug Administration (FDA) before they can be marketed, distributed, or sold within the United States.
This FDA requirement applies to all types of lubricants, including water-, silicone-, and oil-based lubes.
FDA approval is required for most personal lubricants because they are classified as medical devices and, as such, must be certified as safe and effective before they can be sold.
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.
FDA-Approved Lube — Tested By Our Team
Before you buy any lube, it’s important to make sure it’s safe and performs well.
Below, we’ve shared a selection of FDA-approved lubricants that have been tested by our own team at Women’s Health Interactive — so you can purchase (and use them) with confidence.
|
Best Overall Lube
|
Top Pick: Water-Based
|
Top Pick: Silicone-Based
|
Top Pick: Oil-Based
|
|
|
|
|
|
|
$11.95 (2.5 oz)
|
$12.99 (4 oz)
|
$21.95 (8.5 oz)
|
$21.99 (4.7 oz)
|
|
|
|||
|
Description: Bottom Line: The best personal lubricants offer a completely natural texture that mimics your body’s own lubrication while being compatible with all condom types, sex toys, and sexual activities. Aloe Cadabra is our best overall lube because it is easy to use, lightweight, highly versatile, and made with 95% food-grade NSF Certified organic aloe — a soothing ingredient that is perfect for those with sensitive skin — plus it’s available in 12+ flavors to sweeten oral sex safely. [Full Review + Video] |
Description: Bottom Line: Water-based personal lubricants are the go-to choice for many people because they are compatible with every sex toy material and condom type, making them incredibly popular among lube enthusiasts. Almost Naked is our top lube in this category because it is made with 95% organic ingredients while offering a long-lasting, gel-like formula that mimics your body's natural lubrication with a delicious vanilla scent and no sweet flavor during oral sex. [Full Review + Video] |
Description: Bottom Line: This is our team's favorite silicone-based lubricant because a little goes a very long way and it feels incredibly silky and smooth to the touch. The need for reapplication is minimal and like most lubes of this nature, holds up well when used in the water. One thing we really loved about Valm is the smart bottle design, which not only features a sleek pump, but a smart locking mechanism that prevents accidental spills or leakage — and it can be activated with just one hand. [Full Review + Video] |
Description: Bottom Line: While often overlooked, oil-based lubricants are as long-lasting as those made from silicone while being equally waterproof, moisturizing, and suited to anal sex. They are not compatible with latex or polyisoprene condoms and shouldn't be used with latex or rubber sex toys. Made with the best ingredients, AH! YES OB is a certified 99% organic lubricant that doubles as a sensual massage oil. Formulated to soothe and condition skin, it doesn’t need to be washed off. [Read Full Review] |
Bottom Line: The best personal lubricants offer a completely natural texture that mimics your body’s own lubrication while being compatible with all condom types, sex toys, and sexual activities. Aloe Cadabra is our best overall lube because it is easy to use, lightweight, highly versatile, and made with 95% food-grade NSF Certified organic aloe — a soothing ingredient that is perfect for those with sensitive skin — plus it’s available in 12+ flavors to sweeten oral sex safely. [Full Review + Video]
Bottom Line: Water-based personal lubricants are the go-to choice for many people because they are compatible with every sex toy material and condom type, making them incredibly popular among lube enthusiasts. Almost Naked is our top lube in this category because it is made with 95% organic ingredients while offering a long-lasting, gel-like formula that mimics your body's natural lubrication with a delicious vanilla scent and no sweet flavor during oral sex. [Full Review + Video]
Bottom Line: This is our team's favorite silicone-based lubricant because a little goes a very long way and it feels incredibly silky and smooth to the touch. The need for reapplication is minimal and like most lubes of this nature, holds up well when used in the water. One thing we really loved about Valm is the smart bottle design, which not only features a sleek pump, but a smart locking mechanism that prevents accidental spills or leakage — and it can be activated with just one hand. [Full Review + Video]
Bottom Line: While often overlooked, oil-based lubricants are as long-lasting as those made from silicone while being equally waterproof, moisturizing, and suited to anal sex. They are not compatible with latex or polyisoprene condoms and shouldn't be used with latex or rubber sex toys. Made with the best ingredients, AH! YES OB is a certified 99% organic lubricant that doubles as a sensual massage oil. Formulated to soothe and condition skin, it doesn’t need to be washed off. [Read Full Review]
Editor's Note: When you purchase a product via an affiliate link (*) on our site, we earn a small commission at no extra cost to you. On behalf of our entire team, thank you in advance for your support!
→ For more, read: The Best Lube For Any Type Of Sex: Tested & Reviewed
FAQs About FDA Lube Approval
People have lots of questions regarding the FDA approval of lubes, and we’ll cover some of the most frequently asked.
Is Lube Considered A Medical Device?
Yes, personal lubricants are considered “Class II medical devices.”
Class II medical devices carry what is designated as a medium level of risk.
Class I carries the least amount of risk while Class III has the most amount of risk associated with their use.
The FDA offers a classification database and device panel that allows product manufacturers to understand which type of approval they may need for their products before they apply for 510(k) clearance.
Personal lubricant manufacturers must apply for 510(k) approval using the Class II designation.
Is Aloe Cadabra FDA Approved?
Yes, Aloe Cadabra is an all-natural water-based lube that has received FDA approval (#K124044).
Is Lube TSA Approved?
Speaking of federal regulations, the answer is yes, you can fly with lube.
You can travel with any amount of personal lubricant in your checked bag or containers of 3.4 ounces/100 milliliters or less in your carry-on.
Is Lube A Cosmetic?
No, lubes are not classified as cosmetics.
They are classified as obstetrical and gynecological medical devices.
If You’re Worried
An important part of practicing safe sex is ensuring that the products you use on your body have been tested and FDA-approved, if applicable.
When shopping for personal lubricants, you can take comfort in the fact that most of the products you see on the market are 510(k) certified and in the absence of FDA approval, were deemed exempt from needing it.
For products that you’re unsure about, a quick search using the FDA’s database should clear up any confusion — and quickly — or reference our vetted list above.
Editor’s Note: This article is part of our Everything Lube hub, an in-depth and evolving resource that comprehensively explores all aspects of personal lubricants from the different types and how to use them, to ingredients and safety — created to help you achieve the sexual pleasure you deserve.
About The Author 
Other Articles From This Author:
