FDA WARNING_LETTER - Almased USA, Inc. - January 31, 2012

On January 18, 2012, the FDA issued a Warning Letter to Almased USA, Inc. after reviewing their website (www.almased.com) and "The Weight Loss Program" booklet in January 2012. The FDA determined that the "Almased?" product, labeled as a dietary supplement, was promoted for conditions that classify it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The therapeutic claims on the website and in the booklet establish the product as a drug intended for the cure, mitigation, treatment, or prevention of disease, violating the Act. Examples of claims include "beneficial effects of Almased? on ... obese individuals," "Almased? can be extremely helpful for people with diabetes," "significantly lowers insulin level as well as the HbA1c level," "reduce blood pressure and cholesterol levels," and "actively fights ... high blood pressure and insulin resistance." Testimonials also claimed the product helped normalize glucose, cholesterol, and triglycerides, and allowed a user to stop diabetes medication. Metatags like "blood sugar level control" further supported these claims.

The FDA stated that Almased? is a "new drug" under section 201(p) of the Act because it is not generally recognized as safe and effective for these uses and lacks prior FDA approval. Furthermore, the product is mis