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  5. Leaf of Life LLC - 619191 - 08/04/2022
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WARNING LETTER

Leaf of Life LLC MARCS-CMS 619191 —

Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Michael Alexander Bolin
Recipient Title
CEO
Leaf of Life LLC

4419 S. Kingshighway Blvd.
St. Louis, MO 63109
United States

Issuing Office:
Office of Human and Animal Food- West Division II

United States

August 4, 2022

FEI: 3015401107
Reference CMS # 619191

WARNING LETTER

Dear Mr. Bolin:

This letter is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.kokatonic.com in July 2022 and has determined that you take orders there for the products 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 claims on your website establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing, or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Unapproved New Drugs

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

The following statements were found under the benefits tab of your website:

Coca [an ingredient in the products 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] “is a plant with a complex array of mineral nutrients, essential oils, and varied compounds with greater or lesser effects. It can:

  • Reduces Eating Anxiety Issues
  • Regulates Blood Glucose
  • Lower Risks of Cardiovascular Disease
  • Regulates Blood Pressure
  • Extraordinarily Combats Anemia
  • Arthritis and Osteoporosis Relief

On your YouTube Channel at https://www.youtube.com/watch?v=_ulGmMXVi8s, the video titled Kokatonic Coca Leaf Song Instrumental Official Video posted on Sep 25, 2019, states the following:

  • “COCA LEAF REDUCES EATING ANXIETY ISSUES” at approximately 0:43sec in the video
  • “COCA LEAF LOWERS RISKS OF CARDIVASCULAR DISEASE” at approximately 1m:28sec in the video
  • “COCA LEAF REGULATES BLOOD PRESSURE & BLOOD GLUCOSE” at approximately 1m:45sec in the video

Your Kokatonic 50 grams Coca Leaf Powder, HOJA DE COCA NATURAL EN POLVO (Fresh New) 250g/Bag Coca Powder Delisse, and Delisse HOJA DE COCA MICROPULVERIZADO Del CUSCO al MUNDO Harina de LOS Inkas 100% Natural 500 grams Coca Leaf Powder Bulk products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the FD&C Act [ 21 U.S.C. 331(d) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

Misbranded Drugs

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your 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” products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, 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 fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Within fifteen working days of receipt of this letter, please notify FDA in writing of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Your written response should be sent to the following address: U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, Kansas 66214, to the attention of Bruce E. Taylor, Compliance Officer. If you need additional information or have questions concerning any products distributed through your website, please contact CO Taylor at 913-495-5114 or at the above address or via email at: bruce.taylor@fda.hhs.gov.

Sincerely,
/S/

LaTonya M. Mitchell, Ph.D.
District Director | FDA Kansas City District
Program Division Director
Office of Human and Animal Foods – West Division 2

 
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