# FDA WARNING_LETTER - Leaf of Life LLC - September 06, 2022

Source: https://www.keypedia.com/records/warning_letter/leaf-of-life-llc/f0d770b8-6e3f-40d6-b601-8d5d1c9f53ce

> FDA WARNING_LETTER for Leaf of Life LLC on September 06, 2022. Product: Food. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Leaf of Life LLC
- Inspection Date: 2022-09-06
- Product Type: Food
- Office Name: Office of Human and Animal Food West Division II
- Summary: 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

## Related Officers

- [District Director](https://www.keypedia.com/people/latonya-mitchell/433fa355-5a9b-4723-876c-782d1ca5737d)

Company: https://www.keypedia.com/companies/leaf-of-life-llc/4e2fcb1a-a93c-4499-92cc-62dfe7f29e9b

Office: https://www.keypedia.com/offices/office-of-human-and-animal-food-west-division-ii/5966c263-9d27-4d22-8c31-6c72f83e0767