You may not realize it, but lubricant is one of the only sexual wellness products regulated by the FDA, requiring pre-approval of the formulation before it can be sold to consumers and retailers. The FDA classifies lubricants as a Class II medical device, its middle-risk tier, sitting between low-risk Class I products like bandages and high-risk Class III products like pacemakers.

Over 40% of medical devices fall into Class II, making it the largest of the FDA's three device categories. Most lubricant formulas reach market through the 510(k) premarket notification pathway, where the manufacturer proves the formula is "substantially equivalent" to an already-approved product rather than running a full clinical trial for an entirely new formulation. The clinical trial route starts at around $1,000,000 and can run as high as $25,000,000, with a timeline measured in years.

Even the shorter 510(k) pathway isn't cheap! It's estimated to cost between $100,000 and $500,000, depending on the size of the business and whether that business is already registered with the FDA. That price tag creates an unusually high barrier for most startups and small businesses. 

As the sexual wellness market has grown, plenty of new "lubricants" have entered the villa. Unfortunately, many of these brands market their product as an "intimate balm" or "intimate moisturizer" specifically to avoid FDA oversight.

But make no mistake: if you're inserting a liquid into your body to decrease friction during sex, it's a lubricant, and it should carry FDA approval.

Balms and moisturizers aren't overseen by the FDA as a medical device, so they aren't held to any product safety standard. If you're ever unsure, you can always ask a brand directly whether their formula is FDA-approved. If they do not know the answer, do not buy it.

When we set out to make our own silicone lubricant, we wanted the formula to have FDA approval and be deemed body-safe by the regulatory agency. We also knew we didn't have $100,000 to $500,000 sitting around to get a new formula approved ourselves.

So, we did what we always do: rolled up our sleeves and got to work. We scoured the FDA website, which truly looks like it has not been redesigned since 1998, and combed through the entire 510k PreMarket Notification database to find every lubricant formulation the FDA has ever approved.

The result: as of 2026, only 142 personal lubricant formulas have received FDA 510(k) clearance under the agency's product classification code, "NUC." That's a strikingly small number, given how many people use personal lubricant.

From there, we exported every approved formula into a spreadsheet and began the long process of contacting each manufacturer to ask two things: whether they had approval for a silicone-based formula, and whether they'd license that formula to another brand.

Of the 142 manufacturers, many had gone out of business and were no longer active. Others didn't want to license their formula to a potential competitor. Some manufacturers only had approval for water-based, hybrid, or suppository formulas. By the end of our search, we'd narrowed the list to five FDA-approved silicone formulas from manufacturers open to a potential partnership.

From there, we began a rigorous testing process to determine which formula was strongest. We evaluated each one against a range of criteria: ingredient quality, skin irritation, duration of use, absorption rate, viscosity, texture, scent, cost, and its tendency to stain fabric. You can see a glimpse of our scorecard below:

Luckily, we had a clear winner. One formula stood out for its rich, thick texture, quality ingredients, and long-lasting performance. Once we convinced that manufacturer to partner with us, we turned our focus to packaging.

We knew we wanted Unbound's silicone product to stand out from other lubricants through its packaging and design. Making sexual wellness more accessible, through both design and price, has always been our goal as a company. We went through many rounds of packaging design and hit more roadblocks than we'd like to admit, but eventually landed on the perfect name and look: BUFF!

From the day we opened that spreadsheet of 142 manufacturers (April 25, 2025) to the day BUFF  shipped its first bottle, the process took 16 months of development and iterations. We couldn't be more excited to see the final product and how it turned out.

BUFF is now available to purchase, starting at only $24!

If you've ever wondered whether the lubricant in your nightstand is actually regulated, well, now you know! And if you want a formula that's FDA-cleared, silicone-based, and made without cutting corners on safety, you know where to find us. 🤓