FDA WARNING_LETTER - Chaga Mountain, Inc. - October 01, 2014

On January 20, 2015, the FDA issued a Warning Letter to Chaga Mountain, Inc. following an inspection from September 23 to October 1, 2014, and a review of their website. The FDA found serious violations of the Federal Food, Drug and Cosmetic Act.

The company's products, including Chaga Mushroom Tincture/Extract – Alcohol Free, Chaga Mushroom Tea Bags, Chaga Mushroom Powdered Loose Teas, Chaga Skin Cream, and Lip Balm, were deemed unapproved new drugs. This determination was based on therapeutic claims on their website, such as "anti-cancer," "fighting HIV," "antiviral," "anti-inflammatory," and claims related to treating conditions like arthritis, influenza, Crohn's disease, and erectile dysfunction. These products are not generally recognized as safe and effective for these uses and lack FDA approval, making their interstate commerce illegal. Furthermore, they are misbranded because they lack adequate directions for layperson use for conditions not amenable to self-diagnosis.

Additionally, the dietary supplement products (Chaga Mushroom Tincture/Extract – Alcohol Free, Chaga Mushroom Tea Bags, and Chaga Mushroom Powdered Loose Teas) were found to be adulterated due to non-compliance with Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). Specific violations included: 1. Failure to establish and verify identity specifications for