FDA WARNING_LETTER - Mushroom Revival, Inc. - December 08, 2020

The FDA issued a Warning Letter to Mushroom Revival, Inc. after reviewing their website in November 2020. The FDA determined that the company's products, Cordyceps Militaris, Reishi, and Mush-10, are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The violations stem from claims made on the company's website, including product pages and a "Know Your Mushrooms" section, which establish the products' intended use in the cure, mitigation, treatment, or prevention of disease. Examples of such claims include: Cordyceps Militaris for anti-viral properties and alleviating respiratory diseases; Reishi for anti-inflammatory response, preventing allergic reactions, treating cancer, and as an adaptogen; and Mush-10 (containing Maitake, Shiitake, Turkey Tail, Poria Cocos, Chaga, and Meshima) for being "naturally anti-inflammatory," preventing diabetes, supporting cancer treatment, fighting infections, treating high cholesterol, anxiety, and stomach problems.

These claims classify the products as drugs under section 201(g)(1)(B) of the FD&C Act. Since they are not generally recognized as safe and effective for these uses, they are considered "new drugs" under section 201(p) and require prior FDA approval, which they lack, violating sections 301(d) and 505