FDA record · warning letter

FDA warning letter: Mile High Compounds LLC (Mar 31, 2026)

On Mar 31, 2026, FDA issued a warning letter to Mile High Compounds LLC of Clifton, CO under the subject "Unapproved New Drugs Sold Over the Internet". It names semaglutide, tirzepatide, retatrutide. Open: no closeout letter published as of Oct 3, 2026.

Julian CaraulaniFounder, PriceTracker GLP-1FDA record read Oct 3

Status: Open: no closeout letter published as of Oct 3, 2026.

What FDA’s record states

FDA record for the warning letter to Mile High Compounds LLC
Field	What FDA’s record states	Source
Recipient	Mile High Compounds LLC	FDA letter
Location	Clifton, CO	FDA letter
Letter date	Mar 31, 2026	FDA letter
Posted by FDA	Apr 7, 2026	FDA index
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA letter
Subject	Unapproved New Drugs Sold Over the Internet	FDA letter
MARCS-CMS number	721600	FDA letter
GLP-1 drugs named	Semaglutide, Tirzepatide, Retatrutide	FDA letter
Response letter	Not published by FDA	FDA letter
Closeout letter	Not published by FDA	FDA letter

“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).”FDA warning letter to Mile High Compounds LLC, Mar 31, 2026 · read the full letter on fda.gov ↗

What this is and is not.A warning letter is FDA’s statement of what it considers significant violations. It is an allegation, not a court finding, and the firm can respond. A closeout letter is posted when FDA confirms the violations were corrected.

Other GLP-1 letters FDA issued that week

Source

Every field above is copied from FDA’s page for this letter, read Oct 3, 2026. The letter on fda.gov ↗ · All 161 GLP-1 warning letters