[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-leaf-life-llc-619191-08042022":3,"fda-latest-sync-dates":31},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":13,"case_status":14,"letter_url":15,"reference_number":8,"marcs_cms_no":16,"product_type":17,"delivery_method":18,"recipient_name":19,"recipient_title":8,"body_html":20,"body_text":21,"body_fetched_at":22,"medical_device_id":8,"raw":23,"created_at":29,"updated_at":30},2467,"leaf-life-llc-619191-08042022","Warning Letter","Leaf of Life LLC",null,"Office of Human and Animal Food- West Division II","Unapproved New Drugs\u002FMisbranded","2022-09-06","2022-08-04","2023-01-23","Closed Out","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fleaf-life-llc-619191-08042022","619191","Drugs","VIA UPS","Michael Alexander Bolin","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">VIA UPS\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Drugs                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Michael Alexander Bolin\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">CEO\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Leaf of Life LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">4419 S. Kingshighway Blvd.\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">St. Louis\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">MO\u003C\u002Fspan> \u003Cspan class=\"postal-code\">63109\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Office of Human and Animal Food- West Division II\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>August 4, 2022\u003C\u002Fp>\n\n\u003Cp>FEI: 3015401107\u003Cbr>\nReference CMS # 619191\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Bolin:\u003C\u002Fp>\n\n\u003Cp>This letter is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fwww.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\u002FBag 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 \u003Ca href=\"\u002F\u002Fwww.fda.gov.\">www.fda.gov.\u003C\u002Fa>\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Unapproved New Drugs\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:\u003C\u002Fp>\n\n\u003Cp>The following statements were found under the benefits tab of your website:\u003C\u002Fp>\n\n\u003Cp>Coca [an ingredient in the products Kokatonic 50 grams Coca Leaf Powder, HOJA DE COCA NATURAL EN POLVO Delisse (Fresh New) 250g\u002FBag 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:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>Reduces Eating Anxiety Issues\u003C\u002Fli>\n\t\u003Cli>Regulates Blood Glucose\u003C\u002Fli>\n\t\u003Cli>Lower Risks of Cardiovascular Disease\u003C\u002Fli>\n\t\u003Cli>Regulates Blood Pressure\u003C\u002Fli>\n\t\u003Cli>Extraordinarily Combats Anemia\u003C\u002Fli>\n\t\u003Cli>Arthritis and Osteoporosis Relief\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>On your YouTube Channel at https:\u002F\u002Fwww.youtube.com\u002Fwatch?v=_ulGmMXVi8s, the video titled Kokatonic Coca Leaf Song Instrumental Official Video posted on Sep 25, 2019, states the following:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>“COCA LEAF REDUCES EATING ANXIETY ISSUES” at approximately 0:43sec in the video\u003C\u002Fli>\n\t\u003Cli>“COCA LEAF LOWERS RISKS OF CARDIVASCULAR DISEASE” at approximately 1m:28sec in the video\u003C\u002Fli>\n\t\u003Cli>“COCA LEAF REGULATES BLOOD PRESSURE & BLOOD GLUCOSE” at approximately 1m:45sec in the video\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>Your Kokatonic 50 grams Coca Leaf Powder, HOJA DE COCA NATURAL EN POLVO (Fresh New) 250g\u002FBag 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.\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Misbranded Drugs\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>Your Kokatonic 50 grams Coca Leaf Powder, HOJA DE COCA NATURAL EN POLVO Delisse (Fresh New) 250g\u002FBag 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\u002FBag 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)].\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>LaTonya M. Mitchell, Ph.D.\u003Cbr>\nDistrict Director | FDA Kansas City District\u003Cbr>\nProgram Division Director\u003Cbr>\nOffice of Human and Animal Foods – West Division 2\u003C\u002Fp>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVIA UPS\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nMichael Alexander Bolin\n\nRecipient Title\n\nCEO\n\nLeaf of Life LLC\n\n4419 S. Kingshighway Blvd.\n\nSt. Louis, MO 63109\n\nUnited States\n\nIssuing Office:\n\nOffice of Human and Animal Food- West Division II\n\nUnited States\n\nAugust 4, 2022\n\nFEI: 3015401107\n\nReference CMS # 619191\n\nWARNING LETTER\n\nDear Mr. Bolin:\n\nThis letter is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fwww.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\u002FBag 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.\n\nUnapproved New Drugs\n\nExamples of some of the website claims that provide evidence that your products are intended for use as drugs include:\n\nThe following statements were found under the benefits tab of your website:\n\nCoca [an ingredient in the products Kokatonic 50 grams Coca Leaf Powder, HOJA DE COCA NATURAL EN POLVO Delisse (Fresh New) 250g\u002FBag 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:\n\nReduces Eating Anxiety Issues\n\nRegulates Blood Glucose\n\nLower Risks of Cardiovascular Disease\n\nRegulates Blood Pressure\n\nExtraordinarily Combats Anemia\n\nArthritis and Osteoporosis Relief\n\nOn your YouTube Channel at https:\u002F\u002Fwww.youtube.com\u002Fwatch?v=_ulGmMXVi8s, the video titled Kokatonic Coca Leaf Song Instrumental Official Video posted on Sep 25, 2019, states the following:\n\n“COCA LEAF REDUCES EATING ANXIETY ISSUES” at approximately 0:43sec in the video\n\n“COCA LEAF LOWERS RISKS OF CARDIVASCULAR DISEASE” at approximately 1m:28sec in the video\n\n“COCA LEAF REGULATES BLOOD PRESSURE & BLOOD GLUCOSE” at approximately 1m:45sec in the video\n\nYour Kokatonic 50 grams Coca Leaf Powder, HOJA DE COCA NATURAL EN POLVO (Fresh New) 250g\u002FBag 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.\n\nMisbranded Drugs\n\nA 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.\n\nYour Kokatonic 50 grams Coca Leaf Powder, HOJA DE COCA NATURAL EN POLVO Delisse (Fresh New) 250g\u002FBag 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\u002FBag 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)].\n\nThis 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.\n\nThis 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.\n\nWithin 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.\n\nYour 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.\n\nSincerely,\n\n\u002FS\u002F\n\nLaTonya M. Mitchell, Ph.D.\n\nDistrict Director | FDA Kansas City District\n\nProgram Division Director\n\nOffice of Human and Animal Foods – West Division 2","2026-08-20T01:36:41.739+00:00",[24,25,26,9,10,27,28,27],"\u003Ctime datetime=\"2022-09-06T13:20:00Z\">09\u002F06\u002F2022\u003C\u002Ftime>\n","\u003Ctime datetime=\"2022-08-04T04:00:00Z\">08\u002F04\u002F2022\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fleaf-life-llc-619191-08042022\">Leaf of Life LLC\u003C\u002Fa>","","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fleaf-life-llc-619191-01182023\">\u003Ctime datetime=\"2023-01-23T05:00:00Z\">01\u002F23\u002F2023\u003C\u002Ftime>\n\u003C\u002Fa>","2026-08-18T06:42:29.145918+00:00","2026-08-20T02:24:56.344395+00:00",{"510k":32,"classification":33,"enforcement":34,"event":35,"pma":36,"warning_letter":37},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]