FDA WARNING_LETTER - Mushroom Wisdom, Inc. - January 01, 2012

The FDA issued a Warning Letter to Mushroom Wisdom, Inc. after reviewing their website (www.mushroomwisdom.com) in January 2012 and promotional materials collected on September 23, 2011, at the Natural Products ExpoEast trade show. The FDA determined that the "Maitake D-Fraction," "Maitake SX-Fraction," and "Brain-Mate" products are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321 (g)(1)(B)].

The claims on the website and in promotional materials establish these products as drugs intended for the cure, mitigation, treatment, or prevention of disease, violating the Act. Examples of claims include "Maitake D-Fraction Induces Apoptosis in Breast Cancer Cells," "Maitake SX-Fraction...including insulin resistance linked to...Type 2 diabetes," and "Hericenones...have great potential for...preventing and treating Alzheimer's disease" for Brain-Mate. Metatags like "Cancer Fighting" also contribute to these claims.

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and