Leaf of Life LLC – FDA Warning Letter, Sep 6, 2022

The FDA issued a Warning Letter to Mr. Bolin regarding products sold on kokatonic.com, specifically "Kokatonic 50 grams Coca Leaf Powder," "HOJA DE COCA NATURAL EN POLVO Delisse (Fresh New) 250g/Bag Coca Powder," and "Delisse HOJA DE COCA MICROPULVERIZADO Del CUSCO al MUNDO Harina del LOS Inkas 100% Natural 500 grams Coca Leaf Powder Bulk."

The FDA determined these products are unapproved new drugs under section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)] because website claims, including those under a "benefits" tab and in a YouTube video, indicate intended use for cure, mitigation, treatment, or prevention of disease. These products are not generally recognized as safe and effective for their claimed uses, making them "new drugs" under section 201(p) of the FD&C Act [21 U.S.C. 321(p)], requiring prior FDA approval.

Additionally, the products are deemed misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] because they lack adequate directions for use by a layperson. As they are