FDA WARNING_LETTER - Skin Authority LLC - March 31, 2015

The FDA issued a Warning Letter to Skin Authority, LLC. on March 25, 2015, following a review of their website in March 2015. The FDA determined that six products—"Wrinkle Reversing Serum," "Moisturizing Lift Cream," "VitaD Fortified Topical Elixir," "Reviving Eye Brightener," "Coffee Almond Scrub," and "Bamboo Ginseng Scrub"—are promoted for uses that classify them as drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act).

The violations stem from claims on the company's website indicating the 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 claims cited include stimulating collagen, activating wound healing, reducing scar tissue, counteracting infection (e.g., acne), reducing inflammation (e.g., Rosacea), inhibiting cellular breakdown, stimulating blood flow, and decreasing cellulite.

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their claimed uses. Introducing new drugs into interstate commerce without prior FDA approval violates sections 505(a) and 301(d) of the Act. Additionally, the "Wrinkle Reversing Serum" is deemed misbranded under section 5