JANESVILLE, Wis. — Simply Slick Personal Lubricant has received Section 510(k) medical device approval from the U.S. Food and Drug Administration, the company reports.
This allows this organic, oil-based and condom safe product to be marketed in interstate commerce in a fashion similar to other legally marketed predicate products.
The FDA clearance means that Simply Slick has passed all laboratory tests to ensure the product and ingredients are safe and meet the appropriate provisions of the Federal Food, Drug and Cosmetics Act for good manufacturing practice, labeling and prohibitions against misbranding and adulteration.
"Since our company was founded, we have advocated safe and healthy sex practices while applying real science to organic compounds,” said John Goepfert, CEO of Simply Solutions LLC., makers of Simply Slick. “This new FDA clearance of our 510(k) submission will enable us to expand our national marketing, while assuring retailers and consumers that Simply Slick, like all of our products, will continue to meet the clinical standards that have cleared it for sale by the FDA.”
Recent research on lubricant use by the World Health Organization and other international entities have triggered a new round of FDA reviews for personal lubricants sold in the U.S. to evaluate their safety and quality.
Simply Slick is cleared under the new test protocols and procedures set forth by the FDA, Goepfert said.
Simply Slick is an oil-based lubricant that provides long-lasting lubricity while remaining compatible with latex and non-latex condoms. Because the oil-based formula breaks down with water, it does not not stain sheets or clothing.
For more info, visit SimplySlick.com.
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