FDA WARNING_LETTER - Cosmetic Dermatology

The FDA issued a Warning Letter to Drbrandtskincare.com Cosmetic Dermatology, Inc. in December 2015, following a November 2015 review of their website. The FDA determined that numerous products, marketed as cosmetics, are promoted for uses that classify them as unapproved new drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act. These products are intended for the cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or function of the human body. Specific drug claims cited include boosting collagen production, addressing seborrheic dermatitis, acting as "botox alternatives," breaking down fat deposits, repairing damaged skin, protecting from inflammation, inhibiting bacterial reactions, serving as an emergency solution post-laser/peeling/injections, fading dark circles, reducing puffiness, and providing antibacterial action. As these products are not generally recognized as safe and effective for these uses, they are considered "new drugs" under Section 201(p)(1) of the Act and require prior FDA approval per Section 505(a). The company was instructed to promptly correct all violations, review all product labeling, and respond within 15 working days detailing corrective actions. Failure to comply could lead to enforcement actions, including injunctions and product seizure.