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      The FDA's Crusade Against Lube

      March 4, 2015

      Koko, an employee at the Pleasure Chest in Los Angeles, shows off some lube. All photos by Peter Holslin

      As far as sex lube companies go, the British manufacturer Yes looks fairly tame. Its packaging is sleek and elegant, almost like a chic cosmetics line; its products are filled with luxurious and organic ingredients, like shea butter and almond oil. But based on the US Food and Drug Administration's treatment of Yes, you'd think the lube was illegal contraband.

      In a way, it is. According to FDA regulations, personal lubricants are classified as medical devices and require agency approval before going on the market. Right now, Yes is waiting to get official clearance, and lately one retailer says the company's been barred from attempting to sell product in the States.

      "The FDA actually started seizing our shipments of their lubricant, so we can't even get it in the store anymore," said Sarah Mueller, senior sex educator and resident lube expert at the Smitten Kitten, a sex boutique in Minneapolis. "If we continued to sell that product here, it would be technically illegal."

      The crackdown highlights one of the more frustrating aspects of FDA policy regarding sex lube. The agency's rules are designed to keep consumers safe from potentially toxic products, but critics say its approval process leads to major bureaucratic hurdles for lube companies, especially smaller ones that cater to a niche audience. And in the end, a lot of lube products that end up on the store shelves aren't always that good for you anyway.

      "I think it's bullshit," Mueller told me. "There are lubes that have FDA approval as medical devices that have been proven to increase STI transmission rates, kill skin cells, dehydrate mucus, and a few that even increase viral activity."

      While supermarkets tend to hawk mass-market products like K-Y Jelly—the iconic lube formerly owned by American multinational Johnson & Johnson and now run by the UK maker of Durex condoms—the Smitten Kitten has long boasted a specialty lube section that focuses on lesser-known brands, like Überlube and Sliquid, whose lubes are made with natural ingredients like purified water, plant cellulose, and guar gum. Having high-quality lube is kind of like putting high-quality gas in your car: Everything runs a lot better.

      "The first sex toy that anyone should buy is lube," said Sarah Tomchesson, director of Business Development and Strategy at the Pleasure Chest, a sex toy retailer with locations in Chicago, New York, and Los Angeles. "Regardless of whether you feel like you need it, lube can make all kinds of play better, because it just creates less friction."

      Over the years a number of brands have turned their attention toward healthier, organic lubricants—some of which have added health benefits. For example, lubes like Divine 9 contain a seaweed extract that is supposed to prevent the growth of HPV cells. Yes's Yes Baby kit features two sets of lubes with different pH balances, along with ovulation tests and instructions designed to aid couples in the adventure of conception. (A spokesperson for Yes declined to be interviewed for this article because the company's clearance with the FDA is still pending.)

      Lube specialists say it's paramount to be mindful of what you're using the lube for, and also what's inside. "Vaginas and butts are mucous membranes, as susceptible to harmful ingredients as mouths," said Epiphora, a sex toy writer who runs the website Hey Epiphora!, in an email interview. "They'll absorb whatever we put in them and react accordingly."

      Eric Pahon, a spokesperson for the FDA, told me that it's the agency's job to ensure that American consumers have "both safe and effective products." If there weren't regulatory protocols in effect, he said, "people could put out a lot of stuff out there that could have hidden ingredients in them that could possibly be dangerous."

      According to Pahon, personal lubricants are classified as Class II medical devices, putting them in the same category as items like condoms, acupuncture needles, and powered wheelchairs. In order for their products to be sold on store shelves, lube companies must obtain what's called premarket notification or 510(k) clearance, a process that requires a comprehensive round of safety testing.

      John Goepfert, CEO of the lube maker Simply Slick, says the process to get 510(k) for his company took about two years and cost over $200,000. Simply Slick's lube is based on a novel formula that includes glycerin and castor oil—which, Goepfert notes proudly, is also the stuff used to slicken NASCAR V8 engines. According to lab documents Goepfert showed me, tests included examinations for condom compatibility and an antimicrobial study. Lab workers also spent five days injecting the lube into the vaginas of New Zealand white rabbits in order to check for possible discharge, irritation, and infection.

      That latter part is what concerns Dean Elliott. The founder and CEO of Sliquid, he's long championed ethical, environmentally friendly business practices, and he considers himself a great animal lover too—indeed, the company regularly makes charitable donations to animal sanctuaries in Georgia, Utah, and Texas.

      He's currently in the process of obtaining 510(k) certification, and he's gathering up data to present to the FDA to show that they won't need animal testing for their products. (Pahon, the agency spokesperson, says animal testing isn't required if a company can provide a suitable alternative.)

      "For me, it's led to hundreds of sleepless nights," Elliott says, thoughts of defenseless bunnies being probed with Sliquid lube running through his head. "There's a better way to do this than put us all through the animal testing."

      What's strange is that, for all of the FDA's strict regulations, many lubes currently being sold don't actually have 510(k) clearance. Partly it stems from confusion over how the FDA categorizes different products. While the agency counts lubricants as medical devices, it also has a category for "moisturizers," which are considered cosmetics and held to lower standards. However, some moisturizers can also be classified as drugs if they have certain ingredients or make claims about affecting the structure or function of the human body.

      For years, Elliott was under the impression that Sliquid lubes were considered cosmetics—that is, until the FDA contacted him in the fall of 2013 and told him otherwise.

      More recently, the confusion came to the fore in February, when a California woman filed a class-action lawsuit against a British toy maker and Fifty Shades of Grey author E.L. James. According to the Hollywood Reporter, she accused them of flouting FDA rules by marketing a Fifty Shades–branded "Pleasure Gel" as having "aphrodisiac"-like qualities without registering it as a drug.

      Mueller, the lube expert at Smitten Kitten, thinks the FDA's regulations are beneficial in some ways. In recent years, she says, demand has increased for lubricants, especially among baby boomers who are opening their minds to new sex toys and eager to find products that will help them find pleasure as their bodies change through old age and other health issues.

      Still, as Yes awaits the official thumbs up from the FDA, she can't help but feel bummed that she can't sell their products in the store.

      "It's the most popular lubricant that we sell to post-menopausal women, and we can't get it in," she says. "Almost every day, we get somebody coming in being like, 'Hey, do you have this in stock?' And we're like, 'No, we can't get it for the foreseeable future.'"

      Follow Peter Holslin on Twitter.

      Topics: sex, lube, FDA-approved, lubricant

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