PERSONAL LUBRICANTS: CLASS II MEDICAL DEVICES

BY STACI CRUSE, CERTIFIED SEXUAL EDUCATOR

So, did you know that personal lubricants are classified as Class II Medical Devices? If you didn't, you do now! So let's talk a little more about why this is so important and what the Food and Drug Administration requires to acquire this certification. 

The FDA requires anyone who wants to market a class I medical device, class II medical device, or class III medical device intended for human use to submit a 510(k) to them. Class II devices are considered to be moderate to high risk to the user and include devices such as powered wheelchairs, some pregnancy test kits, dialysis equipment and, yep again, lube. 

A 510(k) is a premarket submission made to the US Food and Drug Administration to demonstrate that the device to be marketed is safe and effective for the human body, that is, substantially equivalent to a legally marketed device. Until the submitter receives an order declaring a device substantially equivalent, the submittee may not proceed to market the device. The process for getting a 510(k) certification can be expensive and time consuming. Sometimes taking as long as 3 years to have a product approved.

Why this is so important for personal lubricants? One, they come in prolonged contact with users either topically, internally, or orally. Two, they check for biocompatibility and overall safety. This means that they test for vaginal irritation and penile irritation, product stability testing, condom compatibility, and conform to a certain antimicrobial standard. A 510(k) establishes which condom materials the lubricant is compatible with, ensuring safe use with various condom materials, for example, polyurethane condoms. This is so important for your sexual health because the last thing you want when trying to practice safer sex, reduce your risk of STI's (sexually transmitted infections), or keep from having an unintended pregnancy is to use a low quality lube that will break down the materials in external or internal condoms. 

Warning - Sometimes people like to use products they have readily available such as olive oil or petroleum jelly. This is obviously not their intended use. You should know that olive oil will break down latex condoms and petroleum jelly will break down both polyisoprene and latex condoms and has been linked to the growth of yeast (and we already know yeast infections are no fun!!!)

The FDA also test for osmolality. If you don't know what this is, maybe it's a topic for another post. But, for now just know that if personal lubricant has a higher osmolality than the cells of the body it's called hyper-osmotic. This may cause vaginal dryness to occur in vulva owners by causing the body's cells to push out water in an effort to dilute the lubricant, sometimes leading to cell death via dehydration. This can also make you more susceptible to bacterial infections and STI contraction. 

The most upsetting part about this is that even though the FDA requires these certifications, the facts show that most personal lubricants in the United States are sold unregulated by the FDA. So, like we discussed in the last blog, whether you are a vulva or penis owner, whether you are having anal sex, vaginal sex, or solo play, know your types of lubricants and their ingredients. Do your research, make sure the lubricants you are purchasing have this certification. All you have to do is go to the FDA website(www.fda.gov) to find out which lubes have made an effort to make sure their ingredients are safe for internal, oral, or topical use. 

I'll give you a little fun fact in case you don't want to search the FDA's database. System JO currently holds nineteen 510(k) certifications, is ISO certified (International Organization for Standardization), holds an FDA over the counter license, and holds one of the very few lube formulations that is USDA Certified Organic on the market.

System JO has an extensive line of personal lubricants so there is something for everyone! Silicone, water-based, hybrids(including one with coconut oil), warming/cooling, anal, organic, different viscosities, with and without glycerin's(ours is pure plant based and sustainably sourced). Most are compatible with sex toys but always check the sex toy manufacturers suggestions!

Well, that was a lot of information on 510(k) certification. There is a ton more information out there and the best place to start research is www.fda.gov if you want to learn even more. We have just touched on the basics here. 

Disclaimer - I am an account manager for System JO, their product specialist, and a certified sex educator. I say this because I want you to be fully aware that I have this association.