FDA WARNING_LETTER - Mile High Compounds LLC - March 01, 2026

On March 31, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Mile High Compounds LLC following a review of the company’s website and community forums conducted between January and March 2026. The investigation revealed that the firm is marketing and selling several injectable peptide products—including “GLP-1 SM,” “GLP-2 TRZ,” “GLP-3 RT,” and “BAC Water”—as unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic (FD&C) Act.

Although Mile High Compounds labeled these products for “research and educational purposes only,” the FDA determined their intended use was for human treatment based on marketing claims regarding weight loss, addiction recovery, and metabolic control. The agency expressed significant public health concerns, noting that these injectable drugs bypass the body’s natural defenses and can cause life-threatening conditions if they contain toxins or microorganisms. Under the FD&C Act, these products are considered “new drugs” because they are not generally recognized as safe and effective for their promoted uses and lack the required FDA-approved applications for distribution in interstate commerce.

The FDA has mandated that Mile High Compounds LLC take immediate action to address these violations. The company must submit a written response within 15 working days outlining the specific steps taken to correct the issues and prevent their recurrence. Failure to comply with these requirements may lead to further legal action, including product seizure or an injunction.