FDA WARNING_LETTER - Skin Biology, Inc. - October 31, 2012

The FDA issued a Warning Letter to Skin Biology, Inc. following a review of their website, www.reverseskinaging.com, in October 2012. The FDA determined that ten of the company's products, including "Copper Sun Tanning & Firming Body Lotion," "CP Serum," "BioHeal Cream," and "Squalane," are unapproved new drugs. This classification stems from website claims indicating the products are intended for the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the human body, thereby rendering them drugs under 21 U.S.C. § 321(g)(1)(B) and/or (C). Examples of such claims included healing cysts, shingles, burns, eczema, psoriasis, stimulating hair growth, reducing warts, and possessing anti-cancer/anti-fungal properties. As these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under 21 U.S.C. § 321(p) and are illegally marketed without an approved New Drug Application (NDA) under 21 U.S.C. § 355. Furthermore, "BioHeal Cream," "CP Serum," "Emu Oil S for Skin," and "Squalane" are misbranded under 21 U.S.C. § 352(f)(1) because they are offered for conditions not amenable to self-diagnosis and treatment, lacking adequate directions for use. Skin Biology, Inc. is required to take prompt corrective action, review all promotional materials, and respond within fifteen working days, or face potential regulatory actions like product seizure and injunctions.