FDA's Naughty List This Holiday Season Includes Doctor Skin-Care Brands
This article was originally published in The Rose Sheet
December warning letters to firms behind the doctor-founded dr. brandt and epionce skin-care lines cite claims positioning products as treatments for acne, eczema, psoriasis and other skin diseases, as well as collagen-boosting statements and other structure/function claims. FDA issued warning letters to cosmetic companies in at least seven months of 2015.
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FDA issued close to 30 warning letters to cosmetics firms in 2016 for unapproved drug claims as part of “a project for reviewing product labels and websites for drug claims related to anti-aging.” That initiative may be winding down, if it hasn’t already, but the agency is playing its cards close to its vest going into the new year.
A key component of FDA’s enforcement strategy in the cosmetics space is monitoring companies’ websites for overreaching product claims and issuing warning letters accordingly. Examination of past offenders’ current sites and updated claims offers potential visibility into language the agency will and will not tolerate when it comes to promoting skin-care benefits.
Ronald Moy, a cosmetic surgeon practicing in Los Angeles and former president of the American Academy of Dermatology, receives an FDA warning letter for unapproved drug claims on his DNA Eye Renewal product, part of the doctor’s DNAEGF Renewal line marketed online. The warning, newly posted to FDA’s website, was one of three that went out to cosmetics players Feb. 12.