Entia Biosciences, Inc – FDA Warning Letter, Feb 2, 2021

On January 6, 2021, the FDA issued a Warning Letter to Total Nutraceutical, following website reviews in September and December 2020. The FDA determined that products sold on www.totalnutraceutical.com, including Lion's Mane - All Natural Supplement, Antrodia Mushroom Powder, Maitake Mushroom Powder, Reishi Mushroom Powder, Cordyceps Mushroom Powder, and Cordyceps - All Natural Mushroom Dietary Supplement, are unapproved new drugs and misbranded.

The products are deemed 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)] due to claims on the website indicating their intended use in the cure, mitigation, treatment, or prevention of disease. Examples of such claims include "Helps to lower cholesterol," "Anti-inflammatory," "Promotes balanced blood sugar," "cancer fighting properties," "Relief of viral infections," and "Faster recovery from bronchitis and respiratory diseases."

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 effective for their claimed uses. Introducing or delivering new drugs into interstate commerce without prior FDA approval violates sections 301(d)