Skin Devices, ‘Hair-ceuticals’ Are Opportunities For Firms That Avoid Pitfalls
This article was originally published in The Rose Sheet
Growth opportunities exist for firms marketing home-use skin-care devices and cosmeceuticals in new categories such as hair care, but such products also can invite regulatory scrutiny for exceeding FDA’s definition of a cosmetic. Consulting with FDA on a premarket basis and crafting claims with attention to regulatory parameters can help firms stay in the agency’s good graces.
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With FDA scrutinizing the marketplace for cosmetics promoted as drugs, and a clear cautionary statement from the agency about topical products marketed as hair growers or hair-loss preventers, beauty firms have little choice but to incorporate approved OTC drug ingredients in such products. P&G’s professional hair-care brand NIOXIN has done just that with its new Advanced Thinning range featuring minoxidil.
FDA cites Strivectin’s Potent Wrinkle Reducing Treatment and TL Advanced Tightening Neck Cream as unapproved drugs based on claims touting elastin-stimulating effects, skin-firming action and other structure/function benefits. Widely credited as a pioneer that helped create the cosmeceutical category, Strivectin has been warning-free since 2005 when FDA came down on its “Better than Botox?” positioning.
Identifying its luxury and makeup artistry brands as second-quarter growth drivers, the Estee Lauder Companies says it will put more resources behind its core Estee Lauder and Clinique brands in the second half of fiscal 2015. The firm’s sales for the quarter inched up 1% on a reported basis to $3.04 billion.