Mile High Compounds LLC
FDA issued a warning letter to Mile High Compounds LLC (Clifton, CO) on March 31, 2026, after reviewing the company's website and affiliated community forum from January to March 2026. The company was found to be selling unapproved new drugs — including products containing semaglutide ('GLP-1 SM'), tirzepatide ('GLP-2 TRZ'), retatrutide ('GLP-3 RT'), and bacteriostatic water ('BAC Water') — marketed under research-only labels but with clear human-use dosing and therapeutic claims. FDA determined these products are intended for human use to treat obesity and metabolic conditions, making them unapproved new drugs in violation of sections 301(d) and 505(a) of the FD&C Act. The company was directed to respond within 15 working days, with failure to comply potentially resulting in seizure and injunction.
Flagged claims (9)
GLP-3 RT is a triple-receptor agonist compound targeting GLP-1, GIP, and glucagon receptors.
GLP-3 RT (Retatrutide) Uses: Weight Loss, Addiction Recovery Dosing: Start: 1mg - 2mg weekly. Titrate up to: 12mg weekly.
2. Benefits & Effects Unprecedented Weight Loss & Metabolic Control Significant Weight Reduction. . . Improved Glycemic Control. . . Enhanced Lipid Profile. . . Liver Fat Reduction. . . Increased Energy Expenditure
GLP-1 SM (Semaglutide) Uses: Weight Loss Dosing: Start: 0.25mg weekly. Titrate up to: 2.5mg weekly.
2 Studied Research Areas Visceral Fat & Appetite Regulation . . . Lean Muscle Maintenance Research. . . Liver Health & Metabolism . . . Cognitive Function & Neuroprotection
2 Studied Research Areas Visceral Fat & Appetite Regulation. . . Lean Muscle Maintenance Research. . . Liver Health & Lipid Metabolism . . . Cognitive Function & Neuroprotection
GLP-2 TRZ is a research-only compound designed for scientific investigation involving GLP-1 and GIP receptor pathways.
GLP-2 TRZ (Tirzepatide) Uses: Weight Loss, Addiction Recovery Dosing: Start: 2.5mg weekly. Titrate up to: 15mg weekly.
GLP-1 SM is a research-only compound designed for scientific investigation involving GLP-1 receptor pathways.
Required actions (3)
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 cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.
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