Is Your Lube Safe & Cleared by the FDA?

The lube you're using may not be cleared by the US Food and Drug Administration (FDA). That should concern you. It may have been sold to you illegally, without your knowledge. That should infuriate you because it may not be safe.

For your safety and the health of your lovely lady parts, we recommend only using lube that has gone through the rigorous testing and clearance required by the FDA. 

We believe women should only use lube that’s cleared by the FDA.

Beloved is cleared.

Click to Shop.

If a personal lubricant isn’t cleared, it could cause irritation, inflammation and infection—or worse—to you and your partner's body. Your private parts are made up of some of the most sensitive skin on the body and you are putting lube on and in it where it can get absorbed.

As women’s bodies age and we have a drop in estrogen, the vaginal skin becomes thinner and even more sensitive. Also, your vaginal environment is healthy when it's perfectly balanced, but it can be easily be disrupted by certain ingredients.

What is FDA Clearance? 

Lube is regulated by the Food and Drug Administration (FDA) as a Class II medical device. Class II devices are considered moderate-risk medical devices and are required to have FDA 510(k) clearance before being manufactured and sold. 

There’s a lot that goes into getting and keeping that clearance. That’s an excellent thing for you, the consumer, and quite a process for the company.

The FDA is very rigorous about lube ingredients, how they interact together and the manufacturing process. It also has tight requirements on the type of packaging that is used and specific content on the packaging including consumer warnings, ingredient listings, expiration dates and boundaries on medical claims. 

Be warned that there are lubes out there that contain some pretty questionable ingredients. Many of the bestselling lubes out there contain some of the same ingredients that are also in brake fluid, antifreeze and oven cleaner. Some contain ingredients like parabens and glycerine (which can cause yeast infections). Click here to read more about lube ingredients. 

There is a significant investment in the process of getting cleared and keeping the clearance including intensive testing, record keeping and compliance. Testing includes biocompatibility studies, vaginal irritation, pH sensitization, cytotoxicity, condom compatibility, shelf life testing, yeast and mold count, absence of pathogens and more. 

The FDA also has the authority to inspect regulated facilities to verify that they comply with applicable good manufacturing practice regulations.

It's a significant investment of money and time (sometimes years) to get a lube approved by the FDA. We don’t share this sentiment, but perhaps that's why some brands ignore the law and sell their lube without approval.

While this whole process is intense for brands, this is all for your safety. It was never a question if Beloved would make the investment to be FDA cleared. Investing in your safety by obtaining the FDA clearance was an absolute must-do for Beloved. Click here to shop Beloved’s lube.

Why Does FDA Clearance Matter? 

You wouldn't get Botox if it wasn't approved by the FDA, right? It's the same thing here. You want these things to have been tested to be safe before you put them on and in your body.

This is all about taking care of some of the most sensitive skin and systems in your body. The last thing you want is to get an infection or irritation (or worse) down there.

How Can Companies Even Sell Illegal Lube? 

They just haven't been caught yet. The FDA polices illegal selling of lube, but uncleared and illegal lube is being sold right now.

These companies are taking a big chance (and risking your health) by selling lubes that aren’t approved. Maybe they're willing to take the risk (and gamble with your health) that they can get away with this for a bit of time.

Some of the companies are quite brazen about it. Others skirt around the issue by not calling their products "lubrication" or not marketing it for sex lubrication. They may carefully-worded marketing language such as the product can be used to "prep for sex." 

How Do I Know if My Lube is Cleared or Not? 

Here's the FDA database where you can search for specific class II medical devices.

Although this may or may not give you the answer you're seeking. These government filings can be under a different name than the actual product brand. Also, filings can be confidential and the details aren’t made available to the public. That's the case with Beloved. 

So look for it on the packaging and ask the company if they have clearance. They will be able to provide you with the actual FDA letter if they have it. 

Bottom Line: Use FDA-Cleared Lube

The possible harm just isn’t worth the risk.

If you're interested in more of the nitty-gritty details, click here to read the FDA website.

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