FDA record · warning letter

FDA warning letter: Roen Health, Inc. dba RoenRx (Jun 8, 2026)

On Jun 8, 2026, FDA issued a warning letter to Roen Health, Inc. dba RoenRx of New York, NY under the subject "False & Misleading Claims/Misbranded (Telehealth)". It names semaglutide. 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 Roen Health, Inc. dba RoenRx
Field	What FDA’s record states	Source
Recipient	Roen Health, Inc. dba RoenRx	FDA letter
Location	New York, NY	FDA letter
Letter date	Jun 8, 2026	FDA letter
Posted by FDA	Jun 16, 2026	FDA index
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA letter
Subject	False & Misleading Claims/Misbranded (Telehealth)	FDA letter
MARCS-CMS number	728293	FDA letter
GLP-1 drugs named	Semaglutide	FDA letter
Response letter	Not published by FDA	FDA letter
Closeout letter	Not published by FDA	FDA letter

“FDA observed that your website offers compounded drug products, including semaglutide products.”FDA warning letter to Roen Health, Inc. dba RoenRx, Jun 8, 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

And 12 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