Brilliant Enterprises LLC – FDA Warning Letter, Jul 20, 2021

The FDA issued a Warning Letter to Adam and Angela Schultz of 621 Main Street, Unit 182, Gaylord, MI 49735, regarding products sold on their website, https://levelupmushrooms.com, and social media. The FDA reviewed their websites in June and July 2021 and determined that their products Lion’s Mane, BoomChaga, CordaCex, and LVL:MAX are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act (the Act).

The products are deemed drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] due to claims on their websites and social media indicating intended use in the cure, mitigation, treatment, or prevention of disease. Examples of such claims include "Protects Against Ulcers," "Relieves Depression and Anxiety," "Combating Dementia/Alzheimer’s Disease," "Lowers Cholesterol," "cancer fighters," "Anti-diabetic Effects," and "reduces inflammation."

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 and lack prior FDA approval, violating sections 301(