What FDA’s record states
| Field | What FDA’s record states | Source |
|---|---|---|
| Recipient | NuScience Peptides LLC | FDA letter ↗ |
| Location | Cornelius, NC | FDA letter ↗ |
| Letter date | Aug 24, 2026 | FDA letter ↗ |
| Posted by FDA | Sep 1, 2026 | FDA index ↗ |
| Issuing office | Center for Drug Evaluation and Research (CDER) | FDA letter ↗ |
| Subject | Unapproved New Drugs/Misbranded | FDA letter ↗ |
| MARCS-CMS number | 733652 | FDA letter ↗ |
| GLP-1 drugs named | Semaglutide, Retatrutide | FDA letter ↗ |
| Response letter | Not published by FDA | FDA letter ↗ |
| Closeout letter | Not published by FDA | FDA letter ↗ |
“Based on our review, “GLP-2 Tirz Peptide,” “GLP-1 Sema Research Peptide,” “GLP-3 RT (Retatrutide) Research Peptide,” “Survodutide,” “Mazdutide,” “PT-141 Peptide (Bremelanotide),” “Tesamorelin Research Peptide,” “Tesamorelin Ipamorelin Blend,” and “Bacteriostatic water for Peptides (BAC Water)” 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 NuScience Peptides LLC, Aug 24, 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