FDA WARNING_LETTER - Greek Island Labs - September 07, 2012

The FDA issued a Warning Letter to Radcliff Consultants, LLC, agent for Greek Island Labs, on September 7, 2012, following a July 2012 review of their websites (e.g., athenaskincare.com, adoniaorganics.com). The FDA determined that products like Adonia LashAlive, Complexion Control Serum, Adonia StemuLift Serum, Athena 7 Minute Lift, Adonia LegTone Serum, and Athena Nightly Renewal Cream are promoted for conditions that classify them as drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act).

The products are marketed with claims indicating intended use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or function of the human body. Examples of such claims include "strengthen hair growth," "combat hair loss," "reduce breakouts and blemishes by 84%," "effective cell regenerator," "safe and effective alternative to Botox®," and "helps promote the development of collagen."

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 in the U.S. without prior FDA approval via an approved New Drug Application (NDA