What FDA’s record states
| Field | What FDA’s record states | Source |
|---|---|---|
| Recipient | Synthetix Inc. DBA Helix Chemical Supply | FDA letter ↗ |
| Location | Bronx, NY | FDA letter ↗ |
| Letter date | Feb 7, 2024 | FDA letter ↗ |
| Posted by FDA | Feb 13, 2024 | FDA index ↗ |
| Issuing office | Center for Drug Evaluation and Research | CDER | FDA letter ↗ |
| Subject | Unapproved New Drugs/Misbranded | FDA letter ↗ |
| MARCS-CMS number | 668918 | 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 ↗ |
“This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.helixchem.com in October 2023 and has observed that your website offers “Semaglutide” and “Tirzepatide” products for sale in the United States.”FDA warning letter to Synthetix Inc. DBA Helix Chemical Supply, Feb 7, 2024 · 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