FDA WARNING_LETTER - Alistrol Health - June 26, 2012

The FDA issued a Warning Letter to Alistrol Health, Inc. on June 26, 2012, following a review of their websites (www.alistrol.com, www.alistrol.net, www.drophighbloodpressure.com, www.highbloodpressure-treatment.net, www.naavudi.com, www.depressionfighters.com) and promotional materials in June 2012.

The FDA determined that Alistrol Health's "Alistrol," "Naavudi," "CLE Vitamin D3," and "Depression Fighters" products are promoted with therapeutic claims that cause them to be unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (the Act). Examples of claims cited include "Alistrol ... is the number one choice for my patients suffering from high blood pressure," "Naavudi ... has helped many to manage their diabetes," and "Depression Fighters ... will provide relief to your depression and anxiety disorders." These claims, found on websites, in testimonials, promotional materials, and metatags, establish the products' intent for use in the cure, mitigation, treatment, or prevention of disease.

Since these products are not generally recognized as safe and effective for their claimed conditions, they are considered "new drugs" requiring prior FDA approval, which they lack. Furthermore, the products are deemed misbranded because they are offered for conditions not amenable to self-diagnosis and