FDA WARNING_LETTER - Mushroom Wisdom, Inc. - April 30, 2012

The FDA conducted an inspection of Mushroom Wisdom, Inc.'s dietary supplement manufacturing facility from April 2 to April 30, 2012. The inspection revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

Several products, including Amyloban 3399 From Lion’s Mane and Super Shiitake, are deemed unapproved new drugs due to therapeutic claims on their labels, such as supporting nerve cell survival and displaying hepato-protective activity, which classify them as intended for disease treatment or prevention. These products are not generally recognized as safe and effective for these uses and lack FDA approval.

Additionally, the firm's dietary supplements are adulterated under 21 CFR Part 111 (CGMP for Dietary Supplements). Mushroom Wisdom, Inc. is responsible for ensuring compliance even when using contract manufacturers, as they supply raw materials and labels, and approve finished products for distribution.

Specific CGMP violations include: - Failure to verify finished product specifications for identity, purity, strength, and composition (e.g., Breast Mate, Heart Mate, Prost Mate). - Failure to conduct identity testing for dietary ingredient components prior to use, relying instead on unverified Certificates of Analysis (e.g., Maitake PSX-Fraction). - Failure to investigate product complaints involving potential specification failures or risk of illness/injury (e.g., allergic reactions, increased blood pressure, burned tongue). - Lack of written procedures for