Warning letter · Center for Drug Evaluation and Research (CDER)
FDA warning letter 728280 to FITISH
Issued June 8, 2026. The letter alleges that pictured labels identify FITISH as the compounder of semaglutide and tirzepatide products when it is not, and the site claims the same active ingredient as the brand medications Ozempic, Mounjaro and Zepbound. It asks for a written response and it did not halt the business. The ledger record for Fitish 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 728280 |
|---|---|
| Issued | June 8, 2026 |
| Addressee | FITISH |
| Address | 2316 Gravel Drive, Fort Worth, TX 76118 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Subject | False & Misleading Claims/Misbranded (Telehealth) |
| Website reviewed | Fitish's website, reviewed in March 2026, FDA Establishment Identifier 3044018836 |
| Sections cited | 502(a), 502(bb), 301(a) 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 FITISH as the compounder of semaglutide and tirzepatide products when it is not, and the site claims the same active ingredient as the brand medications Ozempic, Mounjaro and Zepbound.
The letter quotes 2 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 ozempic”
“Tirzepatide is the active ingredient in Mounjaro® and Zepbound®”
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). 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 the seller's own domain, Fitish's website, and its own email address; the street differs from the one the site prints, in the same Fort Worth ZIP code. 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
Fitish is recorded against criterion S8, enforcement status as PASS. The basis reads: FDA warning letter 728280, June 2026, names FITISH at Fitish's website and alleges that its claims about compounded semaglutide and tirzepatide are false or misleading, among them a pictured label naming FITISH as the compounder and the statement that semaglutide is the active ingredient in Ozempic. No FDA action has halted the business, and the storefront 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.
5 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, 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 728280 to FITISH, 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.