[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-mile-high-compounds-llc-721600-03312026":3,"fda-latest-sync-dates":30},{"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":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":28,"updated_at":29},245,"mile-high-compounds-llc-721600-03312026","Warning Letter","Mile High Compounds LLC",null,"Center for Drug Evaluation and Research (CDER)","Unapproved New Drugs Sold Over the Internet","2026-04-07","2026-03-31","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmile-high-compounds-llc-721600-03312026","721600","Drugs","Via Email","Max Radovanic","\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 Email\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\">Max Radovanic\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>Mile High Compounds LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">490 Aspen Grove Dr.\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Clifton\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CO\u003C\u002Fspan> \u003Cspan class=\"postal-code\">81520\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:support@milehighcompounds.is\"> support@milehighcompounds.is\u003C\u002Fa>\u003C\u002Fdd>\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>Center for Drug Evaluation and Research (CDER)\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 class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>March 31, 2026\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>RE: 721600\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Max Radovanic:\u003C\u002Fp>\u003Cp>This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https:\u002F\u002Fmilehighcompounds.is, which links to your community forum www.skool.com\u002Fmilehighcompoundsofficial\u002F, from January to March 2026. The FDA has observed that your website offers “GLP-1 SM,” “GLP-2 TRZ,” “GLP-3 RT” and “BAC Water” (hereinafter Mile High Compounds products) for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\u003C\u002Fp>\u003Cp>These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.\u003C\u002Fp>\u003Cp>Despite statements on your product labeling marketing your products for “in vitro research and educational purposes only” and “not for human or veterinary consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1), because they are intended to prevent, treat, or cure disease conditions and\u002For affect the structure or function of the body.\u003C\u002Fp>\u003Cp>Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:\u003C\u002Fp>\u003Cp>\u003Cu>GLP-3 RT\u003C\u002Fu>\u003C\u002Fp>\u003Cul>\u003Cli>On the webpage https:\u002F\u002Fmilehighcompounds.is\u002Fproduct\u002Fglp-3-rt\u002F: “GLP-3 RT is a triple-receptor agonist compound targeting GLP-1, GIP, and glucagon receptors.”\u003C\u002Fli>\u003Cli>From “The Ultimate Mile High Compounds Peptide Cheat Sheet” available through www.skool.com\u002Fmilehighcompoundsofficial\u002F:\u003Cbr>o “GLP-3 RT (Retatrutide)\u003Cbr>􀂃 Uses: Weight Loss, Addiction Recovery\u003Cbr>􀂃 Dosing: Start: 1mg - 2mg weekly. Titrate up to: 12mg weekly.”\u003C\u002Fli>\u003Cli>From the “Retatrutide (GLP- 3 RT) - Peptide Cheat Sheet” available through www.skool.com\u002Fmilehighcompoundsofficial\u002F:\u003Cbr>o “2. Benefits & Effects\u003Cbr>Unprecedented Weight Loss & Metabolic Control\u003Cbr>Significant Weight Reduction. . .\u003Cbr>Improved Glycemic Control. . .\u003Cbr>Enhanced Lipid Profile. . .\u003Cbr>Liver Fat Reduction. . .\u003Cbr>Increased Energy Expenditure”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>GLP-2 TRZ\u003C\u002Fu>\u003C\u002Fp>\u003Cul>\u003Cli>On the webpage https:\u002F\u002Fmilehighcompounds.is\u002Fproduct\u002Fglp-2-trz\u002F: “GLP-2 TRZ is a research-only compound designed for scientific investigation involving GLP-1 and GIP receptor pathways.”\u003C\u002Fli>\u003Cli>From “The Ultimate Mile High Compounds Peptide Cheat Sheet” available through www.skool.com\u002Fmilehighcompoundsofficial\u002F:\u003Cbr>o “GLP-2 TRZ (Tirzepatide)\u003Cbr>􀂃 Uses: Weight Loss, Addiction Recovery\u003Cbr>􀂃 Dosing: Start: 2.5mg weekly. Titrate up to: 15mg weekly.”\u003C\u002Fli>\u003Cli>From the “Tirzepatide - Peptide Cheat Sheet” available through www.skool.com\u002Fmilehighcompoundsofficial\u002F:\u003Cbr>o “2 Studied Research Areas\u003Cbr>Visceral Fat & Appetite Regulation. . .\u003Cbr>Lean Muscle Maintenance Research. . .\u003Cbr>Liver Health & Lipid Metabolism . . .\u003Cbr>Cognitive Function & Neuroprotection”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>GLP-1 SM\u003C\u002Fu>\u003C\u002Fp>\u003Cul>\u003Cli>On the webpage https:\u002F\u002Fmilehighcompounds.is\u002Fproduct\u002Fglp-1-sm\u002F: “GLP-1 SM is a research-only compound designed for scientific investigation involving GLP-1 receptor pathways.”\u003C\u002Fli>\u003Cli>From “The Ultimate Mile High Compounds Peptide Cheat Sheet” available through www.skool.com\u002Fmilehighcompoundsofficial\u002F:\u003Cbr>o “GLP-1 SM (Semaglutide)\u003Cbr>􀂃 Uses: Weight Loss\u003Cbr>􀂃 Dosing: Start: 0.25mg weekly. Titrate up to: 2.5mg weekly.”\u003C\u002Fli>\u003Cli>From the “Semaglutide - Peptide Cheat Sheet” available through www.skool.com\u002Fmilehighcompoundsofficial\u002F:\u003Cbr>o “2 Studied Research Areas\u003Cbr>Visceral Fat & Appetite Regulation . . .\u003Cbr>Lean Muscle Maintenance Research. . .\u003Cbr>Liver Health & Metabolism . . .\u003Cbr>Cognitive Function & Neuroprotection”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>BAC Water\u003C\u002Fu>\u003Cbr>Your firm offers “BAC Water” for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the above-mentioned products. The sale of these products together demonstrates that you intend for your “BAC Water” to be used in combination for injection. Therefore, your “BAC Water” is a drug.\u003C\u002Fp>\u003Cp>Your Mile High Compounds products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>The violations cited in this letter are 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>\u003Cp>This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.\u003C\u002Fp>\u003Cp>Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct 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 believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.\u003C\u002Fp>\u003Cp>Your response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “721600” in the subject line of the email.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Tina Smith, M.S.\u003Cbr>Captain, U.S. Public Health Service\u003Cbr>Director\u003Cbr>Office of Unapproved Drugs and Labeling Compliance\u003Cbr>Office of Compliance\u003Cbr>Center for Drug Evaluation and Research\u003Cbr>Food and Drug Administration\u003C\u002Fp>\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 Email\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nMax Radovanic\n\nMile High Compounds LLC\n\n490 Aspen Grove Dr.\n\nClifton, CO 81520\n\nUnited States\n\nsupport@milehighcompounds.is\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nWARNING LETTER\nMarch 31, 2026\nRE: 721600\nMax Radovanic:\nThis letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https:\u002F\u002Fmilehighcompounds.is, which links to your community forum www.skool.com\u002Fmilehighcompoundsofficial\u002F, from January to March 2026. The FDA has observed that your website offers “GLP-1 SM,” “GLP-2 TRZ,” “GLP-3 RT” and “BAC Water” (hereinafter Mile High Compounds products) for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\nThese products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.\nDespite statements on your product labeling marketing your products for “in vitro research and educational purposes only” and “not for human or veterinary consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1), because they are intended to prevent, treat, or cure disease conditions and\u002For affect the structure or function of the body.\nExamples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:\nGLP-3 RT\nOn the webpage https:\u002F\u002Fmilehighcompounds.is\u002Fproduct\u002Fglp-3-rt\u002F: “GLP-3 RT is a triple-receptor agonist compound targeting GLP-1, GIP, and glucagon receptors.”\nFrom “The Ultimate Mile High Compounds Peptide Cheat Sheet” available through www.skool.com\u002Fmilehighcompoundsofficial\u002F:\no “GLP-3 RT (Retatrutide)\n􀂃 Uses: Weight Loss, Addiction Recovery\n􀂃 Dosing: Start: 1mg - 2mg weekly. Titrate up to: 12mg weekly.”\nFrom the “Retatrutide (GLP- 3 RT) - Peptide Cheat Sheet” available through www.skool.com\u002Fmilehighcompoundsofficial\u002F:\no “2. Benefits & Effects\nUnprecedented Weight Loss & Metabolic Control\nSignificant Weight Reduction. . .\nImproved Glycemic Control. . .\nEnhanced Lipid Profile. . .\nLiver Fat Reduction. . .\nIncreased Energy Expenditure”\nGLP-2 TRZ\nOn the webpage https:\u002F\u002Fmilehighcompounds.is\u002Fproduct\u002Fglp-2-trz\u002F: “GLP-2 TRZ is a research-only compound designed for scientific investigation involving GLP-1 and GIP receptor pathways.”\nFrom “The Ultimate Mile High Compounds Peptide Cheat Sheet” available through www.skool.com\u002Fmilehighcompoundsofficial\u002F:\no “GLP-2 TRZ (Tirzepatide)\n􀂃 Uses: Weight Loss, Addiction Recovery\n􀂃 Dosing: Start: 2.5mg weekly. Titrate up to: 15mg weekly.”\nFrom the “Tirzepatide - Peptide Cheat Sheet” available through www.skool.com\u002Fmilehighcompoundsofficial\u002F:\no “2 Studied Research Areas\nVisceral Fat & Appetite Regulation. . .\nLean Muscle Maintenance Research. . .\nLiver Health & Lipid Metabolism . . .\nCognitive Function & Neuroprotection”\nGLP-1 SM\nOn the webpage https:\u002F\u002Fmilehighcompounds.is\u002Fproduct\u002Fglp-1-sm\u002F: “GLP-1 SM is a research-only compound designed for scientific investigation involving GLP-1 receptor pathways.”\nFrom “The Ultimate Mile High Compounds Peptide Cheat Sheet” available through www.skool.com\u002Fmilehighcompoundsofficial\u002F:\no “GLP-1 SM (Semaglutide)\n􀂃 Uses: Weight Loss\n􀂃 Dosing: Start: 0.25mg weekly. Titrate up to: 2.5mg weekly.”\nFrom the “Semaglutide - Peptide Cheat Sheet” available through www.skool.com\u002Fmilehighcompoundsofficial\u002F:\no “2 Studied Research Areas\nVisceral Fat & Appetite Regulation . . .\nLean Muscle Maintenance Research. . .\nLiver Health & Metabolism . . .\nCognitive Function & Neuroprotection”\nBAC Water\nYour firm offers “BAC Water” for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the above-mentioned products. The sale of these products together demonstrates that you intend for your “BAC Water” to be used in combination for injection. Therefore, your “BAC Water” is a drug.\nYour Mile High Compounds products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\nConclusion\nThe violations cited in this letter are 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.\nThis letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.\nPlease notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct 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 believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.\nYour response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “721600” in the subject line of the email.\nSincerely,\n\u002FS\u002F\nTina Smith, M.S.\nCaptain, U.S. Public Health Service\nDirector\nOffice of Unapproved Drugs and Labeling Compliance\nOffice of Compliance\nCenter for Drug Evaluation and Research\nFood and Drug Administration","2026-08-19T04:49:18.911+00:00",[23,24,25,9,26,27,27,27],"\u003Ctime datetime=\"2026-04-07T04:00:00Z\">04\u002F07\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-03-31T04:00:00Z\">03\u002F31\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmile-high-compounds-llc-721600-03312026\">Mile High Compounds LLC\u003C\u002Fa>","Unapproved New Drugs Sold Over the Internet\u003Cbr \u002F>\r\n","","2026-08-18T06:42:28.498414+00:00","2026-08-20T02:24:55.726997+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"pma":35,"warning_letter":36},"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"]