FDA WARNING_LETTER - Emu Products and Management, Inc. (EPMI) - November 19, 2012

The FDA issued a Warning Letter to Emu Products and Management, Inc. (EPMI) on November 19, 2012, following a July 2012 review of their website, www.EPMI.net. The FDA determined that several EPMI products, including Multi-Omega Gel Caps, Recovery Gel Caps, ARP Gel Caps, Extreme Cryo Gel, F.A.C.E. Doctor, Skin Doctor, and Pure Emu Oil, are promoted with claims that cause them to be unapproved new drugs and/or misbranded drugs under the Federal Food, Drug, and Cosmetic Act (the Act).

The claims on EPMI's website indicate that these products are intended for the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the human body, thus classifying them as drugs. Examples of such claims include "lower cholesterol," "alleviate aches and pains due to the anti-inflammatory properties," and "alternative treatment to acne."

These products are considered "new drugs" because they are not generally recognized as safe and effective for their stated uses and lack FDA approval via a New Drug Application (NDA), violating Section 505(a) of the Act. Furthermore, Multi-Omega Gel Caps, Recovery Gel Caps, and Skin Doctor are deemed misbranded under Section 502(f)(1) of the Act because they are intended for conditions