New FDA regulations bring lubricant introductions


Sales of personal lubricants were down 5.2% to $207.5 million in sales for the 52 weeks ended Oct. 6, according to IRI across total U.S. multi-outlets. A big part of that decrease is due to new Food and Drug Administration regulations that require lubricant manufacturers to submit a 501k medical device application for approval.

(For the full category review, including sales data, click here.)

“Everybody needed to become approved as a medical device,” Jim Beghtol, Lil’ Drug Store Products director North American sales consumer products, told DSN. “It definitely hurt the category.”

That may explain the spate of recent lubricant introductions and suggest that the category is primed to recover.

The FDA just last month approved Conceive Plus from Sasmar, which joins Li’l Drug Products’ PreSeed as one of the only fertility-friendly personal lubricants that helps increase a woman’s chances of getting pregnant naturally.

One, a specialty brand of premium condoms in North America, this summer sought to extend its non-traditional line into the personal lubricant space with One Move — a silicone-based lubricant — and One Oasis — a water-based lubricant that is paraben-free.

And Sylk USA this summer launched a personal lubricant marketed as gentle and pH balanced. According to the company, the new personal lubricant not only meets the needs of the young woman, but also the menopausal woman and seniors as the product is touted as adding comfort to those suffering from vaginal dryness associated with certain medications and treatments, including chemotherapy and radiation.

Lil’ Drug Store Products is planning a personal lubricant launch in the spring under its Replens banner. “We’re getting ready to launch our own silicone-based item that will appeal to the older crowd,” Beghtol said. “We’ve got thousands of women who are on our [Replens] mailing list,” he said. “And 76% of Replens users use lubricants. So there’s a real opportunity to help our retail partners capture more of the silicone users and help bring this category back to where it needs to be.”