Unapproved New Drugs - GLP-1/GIP/Glucagon Peptide Compounds
Summary
FDA issued a Warning Letter to Mile High Compounds LLC for marketing unapproved new drugs, including GLP-1 SM, GLP-2 TRZ, and GLP-3 RT peptide compounds, via their website. The agency determined these products are drugs under section 201(g)(1) of the FD&C Act because labeling and marketing materials make therapeutic claims for weight loss, addiction recovery, and metabolic control despite labeling disclaimers. The FDA cites violations of sections 301(d) and 505(a) of the FD&C Act for introducing unapproved drugs into interstate commerce.
What changed
The FDA reviewed Mile High Compounds' website and associated marketing materials from January to March 2026 and determined that the company is marketing peptide compounds—GLP-1 SM (Semaglutide research compound), GLP-2 TRZ (Tirzepatide research compound), GLP-3 RT (Retatrutide research compound), and BAC Water—as unapproved new drugs in violation of the FD&C Act. Despite labeling these products as 'research use only' and 'not for human consumption,' the FDA found evidence of intended human drug use, including dosage instructions, therapeutic benefit claims (weight loss, addiction recovery, glycemic control), and marketing through a community forum with detailed clinical benefit descriptions. Injectable drug products bypass natural body defenses, creating heightened public health risk from unapproved formulations.
Pharmaceutical manufacturers and distributors of compounded or research-grade peptide products must ensure their products are either FDA-approved drugs or properly compounded under applicable regulations. Marketing materials—even those distributed through external platforms like community forums—can be used as evidence of intended use under 21 CFR 201.128. Companies relying on 'research use only' disclaimers must ensure all promotional materials, third-party forums, and product labeling are consistent and do not contradict the disclaimer with therapeutic benefit claims. The FDA has requested a response within 15 business days, and continued violation may result in further enforcement action including seizure, injunction, or criminal prosecution.
What to do next
- Cease manufacturing and distribution of all unapproved drug products immediately
- Provide a written response to FDA within 15 business days detailing corrective actions and steps to address violations
- Destroy all existing inventory of unapproved products or bring them into compliance with FDA requirements
Source document (simplified)
Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Max Radovanic Mile High Compounds LLC 490 Aspen Grove Dr.
Clifton, CO 81520
United States
support@milehighcompounds.is Issuing Office: Center for Drug Evaluation and Research (CDER) United States
WARNING LETTER
March 31, 2026
RE: 721600
Max Radovanic:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://milehighcompounds.is, which links to your community forum www.skool.com/milehighcompoundsofficial/, 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).
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.
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/or affect the structure or function of the body.
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:
GLP-3 RT
- On the webpage https://milehighcompounds.is/product/glp-3-rt/: “GLP-3 RT is a triple-receptor agonist compound targeting GLP-1, GIP, and glucagon receptors.”
- From “The Ultimate Mile High Compounds Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/: o “GLP-3 RT (Retatrutide) Uses: Weight Loss, Addiction Recovery Dosing: Start: 1mg - 2mg weekly. Titrate up to: 12mg weekly.”
From the “Retatrutide (GLP- 3 RT) - Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/:
o “2. Benefits & Effects
Unprecedented Weight Loss & Metabolic Control
Significant Weight Reduction. . .
Improved Glycemic Control. . .
Enhanced Lipid Profile. . .
Liver Fat Reduction. . .
Increased Energy Expenditure”
GLP-2 TRZOn the webpage https://milehighcompounds.is/product/glp-2-trz/: “GLP-2 TRZ is a research-only compound designed for scientific investigation involving GLP-1 and GIP receptor pathways.”
From “The Ultimate Mile High Compounds Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/:
o “GLP-2 TRZ (Tirzepatide)
Uses: Weight Loss, Addiction Recovery
Dosing: Start: 2.5mg weekly. Titrate up to: 15mg weekly.”From the “Tirzepatide - Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/:
o “2 Studied Research Areas
Visceral Fat & Appetite Regulation. . .
Lean Muscle Maintenance Research. . .
Liver Health & Lipid Metabolism . . .
Cognitive Function & Neuroprotection”
GLP-1 SMOn the webpage https://milehighcompounds.is/product/glp-1-sm/: “GLP-1 SM is a research-only compound designed for scientific investigation involving GLP-1 receptor pathways.”
From “The Ultimate Mile High Compounds Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/:
o “GLP-1 SM (Semaglutide)
Uses: Weight Loss
Dosing: Start: 0.25mg weekly. Titrate up to: 2.5mg weekly.”From the “Semaglutide - Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/:
o “2 Studied Research Areas
Visceral Fat & Appetite Regulation . . .
Lean Muscle Maintenance Research. . .
Liver Health & Metabolism . . .
Cognitive Function & Neuroprotection”
BAC Water
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.
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).
Conclusion
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.
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.
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.
Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office 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.
Sincerely,
/S/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
- ## Content current as of:
04/07/2026
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