What FDA’s record states
| Field | What FDA’s record states | Source |
|---|---|---|
| Recipient | Royal Peptides LLC | FDA letter ↗ |
| Location | Boynton Beach, FL | 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 | 734884 | 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 ↗ |
“Based on our review, “Tirzepatide,” “Semaglutide,” “Retatrutide,” “SS-31 (Elamipretide),” “PT-141,” “Tesamorelin,” and “BIMORELIN” 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).”FDA warning letter to Royal 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