Warning letter · Center for Drug Evaluation and Research (CDER)

FDA warning letter 721795 to Belle Health LLC dba Belle

Issued February 20, 2026. The letter alleges that pictured labels identify Belle as the compounder of semaglutide and tirzepatide products when it is not, which the letter calls false or misleading. It asks for a written response and it did not halt the business. The ledger record for Belle 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.

What it alleges

Pictured labels identify Belle as the compounder of semaglutide and tirzepatide products when it is not, which the letter calls false or misleading.

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 and the reviewed domain in the letter match the entity the seller prints in its terms and the domain it trades from; the letter's email is a Belle email address. The street address in the letter differs from the Draper address the site prints now. 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

Belle is recorded against criterion S8, enforcement status as PASS. The basis reads: FDA warning letter 721795, February 2026, names Belle Health LLC dba Belle and Belle's website, alleging that pictured labels presented Belle as the compounder of its semaglutide and tirzepatide 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.

8 other letters in this ledger carry the same issue date: 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, 721478, to Weightless Medical LLC dba WeightCare, 721814, to Alan Health Technologies Inc. dba Alan, 721816, to Ivim Services LLC dba Ivim.

Every letter in this ledger →

Sources

• FDA warning letter 721795 to Belle Health LLC dba Belle, 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.