FDA WARNING_LETTER - Crown Wellness, Inc - March 31, 2021

The FDA issued a Warning Letter to Crown Wellness, Inc. on April 29, 2021, following a review of their website (www.crownwellness.com) in February and March 2021. The FDA determined that Crown Wellness, Inc. sells products, including Clinic’s Choice CLO2, E3 Renew Me/B.G. Blue Green Algae, Diatomaceous Earth Powder (DE), E3 Digestive Enzymes Supreme, Karma Cleanse, and Iodine Detoxified, with claims establishing them as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act.

The violations stem from claims on the company's website and product labels indicating the products are intended for the cure, mitigation, treatment, or prevention of disease, or to affect the body's structure/function. Specifically, Clinic’s Choice CLO2 was marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19, as well as for arthritis/inflammation, autism, bacterial/fungal infections, yeast, parasites, and Morgellon's. Diatomaceous Earth Powder (DE) was marketed for killing worms/parasites, lowering cholesterol, sweeping bacteria, maintaining lung tissue elasticity, reducing inflammation, and addressing various other conditions including diabetes and Alzheimer's. E3 Renew Me/B.G. Blue Green Algae was linked to fungal issues and claims of reversing cancer and stimulating healthy white blood cells. E