Warning letter · Center for Drug Evaluation and Research (CDER)
FDA warning letter 721478 to Weightless Medical LLC dba WeightCare
Issued February 20, 2026. The letter alleges that the pictured label on WeightCare's website names WeightCare as the compounder of its semaglutide and tirzepatide when it is not. It asks for a written response and it did not halt the business. The ledger record for WeightCare 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 721478 |
|---|---|
| Issued | February 20, 2026 |
| Addressee | Weightless Medical LLC dba WeightCare |
| Address | United States |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Subject | False & Misleading Claims/Misbranded (Telehealth) |
| Website reviewed | WeightCare's website, reviewed in December 2025 |
| Sections cited | 502(a), 502(bb), 301(a), 301(c), 503(b)(1), 503(b)(2) 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
The pictured label on WeightCare's website names WeightCare as the compounder of its semaglutide and tirzepatide when it is not.
The sections cited are 502(a), 502(bb), 301(a), 301(c), 503(b)(1), 503(b)(2). 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 reviews WeightCare's website and prints a WeightCare email address. Its recipient block gives no street address, so the attribution rests on the domain and the support address the seller 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
WeightCare is recorded against criterion S8, enforcement status as PASS. The basis reads: FDA warning letter 721478, February 2026, names Weightless Medical LLC doing business as WeightCare and alleges the pictured label presents WeightCare as the compounder when it is not. 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.
19 other letters in this ledger carry the same issue date: 717985, to Zeuss LLC dba Zeuss, 717987, to FitRX, LLC dba FitRx, 717989, to Lean Rx, Inc. dba SkinnyRx, 717991, to Kare Solutions, LLC dba Zappy, 721448, to Strut Health, LLC dba Strut, 721449, to Good Girl LLC dba GoodGirlRX, 721450, to Kin Meds, 721451, to Genesis Health International Inc. dba Genesis, 721453, to MaxLife Technologies Inc. dba Maxlife, 721454, to Better Health Labs, Inc. dba Measured, 721455, to MEDVi, LLC dba MEDVi, 721472, to NewSelf Limited dba NewSelf, 721474, to Premium Health Management Inc. dba Premium Health, 721475, to Refills Health, LLC dba Refills Health, 721479, to Bliv Wellness LLC dba Bliv, 721481, to Aspen Aesthetics dba Fifty 410, 721795, to Belle Health LLC dba Belle, 721814, to Alan Health Technologies Inc. dba Alan, 721816, to Ivim Services LLC dba Ivim.
Sources
- FDA warning letter 721478 to Weightless Medical LLC dba WeightCare, 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.