Warning letter · Center for Drug Evaluation and Research (CDER)
FDA warning letter 716501 to FitRX, LLC dba Zealthy
Issued September 9, 2025. The letter alleges that claims on getzealthy.com that compounded semaglutide is the same active ingredient as Wegovy and Ozempic are false or misleading. It asks for a written response and it did not halt the business. The ledger record for Zealthy 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 716501 |
|---|---|
| Issued | September 9, 2025 |
| Addressee | FitRX, LLC dba Zealthy |
| Address | 30 Irving Pl, New York, NY 10003 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Subject | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Website reviewed | https://www.getzealthy.com, reviewed in August 2025 |
| 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
Claims on getzealthy.com that compounded semaglutide is the same active ingredient as Wegovy and Ozempic are false or misleading.
The letter quotes 2 claims from the website it reviewed, reproduced here exactly as the letter prints them, including the agency's own elisions.
“Is Semaglutide the same as Wegovy and Ozempic? Semaglutide is the active ingredient in Wegovy and Ozempic. Semaglutide is often more cost effective...”
“Your healthcare provider will help you find the right dose of GLP-1 Medication including Semaglutide (same active ingredient as Wegovy, and Ozempic), to achieve healthy weight loss.”
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
Three anchors agree. The letter reviews getzealthy.com, prints the street address the seller prints in its own privacy policy, and its sibling letter to the same entity names the founder whose profile page this storefront publishes. 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
Zealthy is recorded against criterion S8, enforcement status as PASS. The basis reads: FDA warning letter 716501, September 2025, names FitRX, LLC doing business as Zealthy at the street address this site prints, and cites claims of the same active ingredient as an approved drug. No FDA action has halted the business, and the seller still trades. The storefront was reachable and trading when the record was last read.
The index carries no close-out letter for it. When the index was read in September 2026 it 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.
This letter belongs to a wave of 69 letters carrying one issue date on the index. That wave includes letters to Eli Lilly and Company and Novo Nordisk Inc., the manufacturers of the approved brand drugs the compounded products are compared against. A document that names the two largest manufacturers of a drug class on the same day as a telehealth seller cannot mean, on its own, that a company is disreputable.
4 other letters in this ledger carry the same issue date: 716567, to Hims & Hers Health, Inc. dba Hims, 716822, to directmeds.com, Inc. dba DirectMeds, 716825, to Hims & Hers Health, Inc. dba Hers, 716830, to Remedy Meds.
Sources
- FDA warning letter 716501 to FitRX, LLC dba Zealthy, 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 was fetched from fda.gov and read in full on the date in the meta line above, in a run where every letter this ledger discloses returned a document and a fabricated letter address returned nothing, by the same method. This page ranks nothing, recommends nothing, and carries no partner link.