FDA WARNING_LETTER - Janson-Beckett - July 31, 2012

The FDA reviewed Janson Beckett, Inc.'s website (janson-beckett.com) in July 2012 and determined that several products, including DermaExcel 7, AlphaDerma CE, OkuSil Intensive Eye Rejuvenating Serum, 10% Argireline & Trace Mineral Enriched Facial Skin Prep, Vitamin C&C Facial Serum, Alpha Lipoic Acid Vitamin C Ester & DMAE Moisturizing Day Cream, Alpha Lipoic Acid Vitamin C Ester & DMAE Night Cream, and BeautiFull Lips? Lip Plumper, 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 FDA cited numerous claims on the website indicating these products are intended to affect the structure or function of the human body, such as reducing wrinkle depth, moderating acetylcholine release, blocking nerve signals, stimulating circulation to reduce dark circles, promoting collagen synthesis, and stimulating blood flow for lip plumping.

Because these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under section 201(p) of the Act. Marketing new drugs without prior FDA approval, specifically an approved New Drug Application (NDA) under section 505(a) of the Act, is a violation.

Janson Beckett, Inc. is required to take prompt action to correct