John O'Brien Feb. 9, 2015, 1:07pm



SAN DIEGO (Legal Newsline) – A lubricant intended for use during sex and part of the “Fifty Shades of Grey” marketing campaign should be registered as a medical device with the Food and Drug Administration, a California woman claims in a recently filed class action lawsuit.




On Feb. 5, Tania Warchol, of San Diego, filed suit in federal court against Love Honey, Inc., Adam and Eve Stores and author E.L. James regarding the Fifty Shades of Grey Come Alive Pleasure Gel. She also claims it failed to deliver on its promise to enhance her sexual experience.








Patient lubricants are defined as Class I Medical Devices intended to “lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device,” the complaint says.




When used with a condom, the lubricant should be considered a Class II Medical Device, requiring FDA clearance, the complaint says.




“Accordingly, the product is being illegally marketed and sold as ‘Latex Compatible’ lubricant despite the fact that Defendants have not sought FDA pre-market clearance,” the complaint says.




James’ erotic novel “Fifty Shades of Grey” was published in 2011, and the movie adaptation will be released on Friday.




“Defendants prominently label the product as an ‘Intimate Arousal Gel,’ expressly and impliedly conveying to consumers that the Product’s ingredients will help a user to experience heightened stimulation, pleasure and orgasm, despite that the Product fails to be effective as an aphrodisiac,” the complaint says.




“Defendant further falsely advertises and markets Fifty Shades of Grey Come Alive Pleasure Gel for Her by putting false and misleading claims on the label, stating or suggesting that the Product is a ‘Pleasure Gel for Her’ that ‘increase[s] sensual comfort and pleasure.’”




Warchol purchased the lubricant at an Adam and Eve store in August.




She is represented by the Law Offices of Ronald A. Marron in San Diego.




U.S. District Court for the Southern District of California case number 3:15-cv-00238.


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