Warning letter · Center for Drug Evaluation and Research (CDER)
FDA warning letter 728293 to Roen Health, Inc. dba RoenRx
Issued June 8, 2026. The letter alleges that pictured labels identify RoenRx as the compounder of semaglutide products when it is not, and claims that semaglutide is the active ingredient in Wegovy and Ozempic represent the compounded products as FDA-approved when they are not. It asks for a written response and it did not halt the business. The ledger record for RoenRx passes S8.
The letter, as filed
Every line below is copied from the letter itself. The addressee and the address are the ones the agency prints in the header, which is the pair an attribution rests on.
| Number | MARCS-CMS 728293 |
|---|---|
| Issued | June 8, 2026 |
| Addressee | Roen Health, Inc. dba RoenRx |
| Address | 30 Irving Pl, New York, NY 10003 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Subject | False & Misleading Claims/Misbranded (Telehealth) |
| Website reviewed | RoenRx's website, reviewed in March 2026 |
| Sections cited | 502(a), 502(bb), 301(a), 301(c) of the Federal Food, Drug, and Cosmetic Act |
| Close-out letter | None on the index when the close-out column was last read. |
What it alleges
Pictured labels identify RoenRx as the compounder of semaglutide products when it is not, and claims that semaglutide is the active ingredient in Wegovy and Ozempic represent the compounded products as FDA-approved when they are not.
The letter quotes 3 claims from the website it reviewed, reproduced here exactly as the letter prints them, including the agency's own elisions.
“Semaglutide is the active ingredient in FDA-approved medications like Wegovy and Ozempic….”
“RoenRx also offers semaglutide, the active ingredient in Wegovy® and Ozempic®….”
“Get affordable semaglutide (main ingredient in Ozempic® & Wegovy®) at an affordable price.”
A quoted claim is evidence of what a page said when the agency read it. It is not evidence of what the page says today, and this site records the seller's current pages separately, on the seller record, with their own date.
The sections cited are 502(a), 502(bb), 301(a), 301(c). Section 502(a) makes a drug misbranded where its labeling is false or misleading, and section 502(bb) extends that to the advertising or promotion of a compounded drug. Both are labeling and advertising provisions.
How it was attributed
The letter names RoenRx's website as the website it reviewed and writes to the support address that site prints, and its entity, Roen Health, Inc., is the one the seller's own terms name. A letter is filed under an operating entity, and a company may trade under names that appear nowhere in it, so the screen is run against the entity and the address rather than against the brand on the storefront. A name resemblance is never the test, because attaching one company's enforcement record to another is a worse error than missing a disclosure.
What the ledger records since
RoenRx is recorded against criterion S8, enforcement status as PASS. The basis reads: FDA warning letter 728293, June 2026, names Roen Health, Inc. doing business as RoenRx, reviews this website and writes to the support address it prints. It says the labels pictured name RoenRx as the compounder and that claims such as semaglutide being the active ingredient in Wegovy and Ozempic present the compounded products as FDA-approved. No FDA action has halted the business, and the seller still trades. The storefront was trading as of the date on its record.
The index carries no close-out letter for it. As of September 2026 the index held 3,677 letters and 417 of them carried a close-out letter, so the column is populated and an empty cell is a reading rather than a gap. A letter that has been neither closed out nor followed by an action is the ordinary state of a warning letter.
Why this is not a disqualification
A warning letter identifies a concern, requests a response, and states that failure to address the violations may result in legal action, including seizure and injunction. Those actions are what criterion S8 fails on. The letter is the notice that precedes them and it is not one of them, so this ledger records it in full, dates it, links it, and leaves the seller listed and linked exactly as a seller with no letter.
11 other letters in this ledger carry the same issue date: 728236, to Trinity HealthCare Supply, LLC dba altRx, 728275, to FitRX, LLC dba AM RX, 728279, to Eden Health International Inc. dba Eden, 728280, to FITISH, 728281, to Nexus Health Solutions LLC dba Harper Meds, 728283, to Joi and Blokes dba Joi + Blokes, 728287, to NativeMed LLC dba NativeMed, 728291, to OrderlyMeds LLC dba OrderlyMeds, 730095, to Maximus Health, Inc. dba Maximus, 730096, to Nexlife Inc. dba Nexlife, 730390, to Glow Medispa, LLC dba Mint Med.
Sources
- FDA warning letter 728293 to Roen Health, Inc. dba RoenRx, read in full
- FDA, About Warning and Close-Out Letters
- FDA warning letter index, and its close-out column
- The seller record this letter is disclosed on
The letter is quoted from its own page on fda.gov, as it stood on the date in the meta line above. This page ranks nothing, recommends nothing, and carries no partner link.