Warning letter · Center for Drug Evaluation and Research (CDER)
FDA warning letter 728287 to NativeMed LLC dba NativeMed
Issued June 8, 2026. The letter alleges that pictured labels identify NativeMed as the compounder of tirzepatide products when it is not, and a claim of the same active ingredient as Ozempic and Wegovy represents compounded semaglutide as FDA-approved or evaluated for safety and effectiveness. It asks for a written response and it did not halt the business. The ledger record for NativeMed 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 728287 |
|---|---|
| Issued | June 8, 2026 |
| Addressee | NativeMed LLC dba NativeMed |
| Address | 66 W. Flagler Street, Miami, FL 33130 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Subject | False & Misleading Claims/Misbranded (Telehealth) |
| Website reviewed | NativeMed's website, reviewed in March 2026, FDA Establishment Identifier 3044024130 |
| 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 NativeMed as the compounder of tirzepatide products when it is not, and a claim of the same active ingredient as Ozempic and Wegovy represents compounded semaglutide as FDA-approved or evaluated for safety and effectiveness.
The letter quotes 1 claim from the website it reviewed, reproduced here exactly as the letter prints it, including the agency's own elisions.
“The same active ingredient in Ozempic® and Wegovy®”
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 entity, the street and the reviewed domain in the letter match the legal name, the Miami street address the seller prints in its terms and privacy policy and the domain it trades from; the letter's email is a NativeMed email address, the address the seller's contact page prints. 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
NativeMed is recorded against criterion S8, enforcement status as PASS. The basis reads: FDA warning letter 728287, June 2026, names NativeMed LLC dba NativeMed at the Miami street address the site prints, alleging that pictured labels presented NativeMed as the compounder of its tirzepatide and that a claim of the same active ingredient as Ozempic and Wegovy implied FDA approval. 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.
6 other letters in this ledger carry the same issue date: 728236, to Trinity HealthCare Supply, LLC dba altRx, 728279, to Eden Health International Inc. dba Eden, 728280, to FITISH, 728283, to Joi and Blokes dba Joi + Blokes, 728291, to OrderlyMeds LLC dba OrderlyMeds, 730095, to Maximus Health, Inc. dba Maximus.
Sources
- FDA warning letter 728287 to NativeMed LLC dba NativeMed, 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.