FDA record · warning letter

FDA warning letter: Gram Peptides (Mar 31, 2026)

On Mar 31, 2026, FDA issued a warning letter to Gram Peptides of Rancho Santa Fe, CA under the subject "Unapproved New Drugs Sold Over the Internet". It names tirzepatide, retatrutide. Open: no closeout letter published as of Oct 3, 2026.

Julian CaraulaniFounder, PriceTracker GLP-1FDA record read Oct 3

Status: Open: no closeout letter published as of Oct 3, 2026.

What FDA’s record states

FDA record for the warning letter to Gram Peptides
Field	What FDA’s record states	Source
Recipient	Gram Peptides	FDA letter
Location	Rancho Santa Fe, CA	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	721806	FDA letter
GLP-1 drugs named	Tirzepatide, Retatrutide	FDA letter
Response letter	Not published by FDA	FDA letter
Closeout letter	Not published by FDA	FDA letter

“The FDA has observed that your website offers “Retatrutide” (also referred to by your firm as “GLP-1-R peptide”) and “Tirzepatide” (also referred to by your firm as “GLP-2 peptide”) and “Bacteriostatic Water for Injection” (hereinafter Gram Peptides products) for sale in the United States.”FDA warning letter to Gram Peptides, 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