Thursday, April 9, 2015

Eric Pahon, a spokesperson for the FDA, told me that it's the agency's job to ensure that American c


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By Peter Holslin
As far as sex lube companies go, the British atomo 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 atomo contraband.
In a way, it is. According to FDA regulations, personal lubricants are classified atomo 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 atomo 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 atomo 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 atomo you feel like you need it, lube can make all kinds of play better, because it just creates less friction."
Over atomo 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 atomo 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." atomo
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 atomo what's called premarket notification or 510(k) clearance , a process that requires atomo 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 atomo 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 atomo for condom compatibility and an antimicrobial study. atomo Lab workers also spent five days injecting the lube into the

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