What FDA’s record states
| Field | What FDA’s record states | Source |
|---|---|---|
| Recipient | EA WORKS Limited Liability Company dba Trust Labs | FDA letter ↗ |
| Location | Sheridan, WY | FDA letter ↗ |
| Letter date | Sep 9, 2025 | FDA letter ↗ |
| Posted by FDA | Sep 16, 2025 | FDA index ↗ |
| Issuing office | Center for Drug Evaluation and Research (CDER) | FDA letter ↗ |
| Subject | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) | FDA letter ↗ |
| MARCS-CMS number | 715798 | 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 ↗ |
“As described below, your retatrutide drug products are unapproved new drugs and misbranded drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a), 502(f)(1), 301(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 355(a), 352(f)(1), 331(a) and 331(d)].”FDA warning letter to EA WORKS Limited Liability Company dba Trust Labs, Sep 9, 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.
Other GLP-1 letters FDA issued that week
Chengdu Brilliant Biopharmaceutical Co., Ltd.Sep 11, 2025motionpharmacy.comSep 10, 2025All American WellnessSep 9, 2025Amazing MedsSep 9, 2025ASN-LABSSep 9, 2025Bioverse, Inc. dba BioverseSep 9, 2025Body Good StudioSep 9, 2025Canada Med StopSep 9, 2025Cosmo Medical Spa dba Cosmo Med SpaSep 9, 2025CurexSep 9, 2025directmeds.com, Inc. dba DirectMedsSep 9, 2025Dr. Gater’s Weight Loss & WellnessSep 9, 2025
And 48 more in the full list.
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