What FDA’s record states
| Field | What FDA’s record states | Source |
|---|---|---|
| Recipient | USApeptide.com | FDA letter ↗ |
| Location | Not published by FDA | n/a |
| Letter date | Feb 26, 2025 | FDA letter ↗ |
| Posted by FDA | Mar 11, 2025 | FDA index ↗ |
| Issuing office | Center for Drug Evaluation and Research (CDER) | FDA letter ↗ |
| Subject | Unapproved New Drugs/Misbranded | FDA letter ↗ |
| MARCS-CMS number | 696885 | FDA letter ↗ |
| GLP-1 drugs named | Semaglutide, Tirzepatide | FDA letter ↗ |
| Response letter | Not published by FDA | FDA letter ↗ |
| Closeout letter | Not published by FDA | FDA letter ↗ |
“As discussed below, FDA has observed that www.usapeptide.com introduces into interstate commerce unapproved and misbranded semaglutide and tirzepatide drug products. There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs.”FDA warning letter to USApeptide.com, Feb 26, 2025 · 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.
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