What FDA’s record states
| Field | What FDA’s record states | Source |
|---|---|---|
| Recipient | Prime Sciences | FDA letter ↗ |
| Location | Scottsdale, AZ | FDA letter ↗ |
| Letter date | Mar 31, 2026 | FDA letter ↗ |
| Posted by FDA | Apr 7, 2026 | FDA index ↗ |
| Issuing office | Center for Drug Evaluation and Research (CDER) | FDA letter ↗ |
| Subject | Unapproved New Drugs Sold Over the Internet | FDA letter ↗ |
| MARCS-CMS number | 721805 | 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 ↗ |
“Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following: Cagrilintide On the webpage https://prime-sciences.com/product/cagrilintide: “In one study, weight loss of 25% or more was achieved in 40.4% of patients receiving Cagri compared to 16.2% with semaglutide alone.” “Mechanism of action: Cagrilintide promotes weight loss through various mechanisms: Slowing gastric emptying.”FDA warning letter to Prime Sciences, Mar 31, 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