Warning letter · Center for Drug Evaluation and Research (CDER)
FDA warning letter 717991 to Kare Solutions, LLC dba Zappy
Issued February 20, 2026. The letter alleges that claims on zappyhealth.com naming compounded products as the same active ingredient as approved brand drugs are false or misleading. It asks for a written response and it did not halt the business. The ledger record for Zappy Health 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 717991 |
|---|---|
| Issued | February 20, 2026 |
| Addressee | Kare Solutions, LLC dba Zappy |
| Address | 7660H Fay Ave, Suite 504, La Jolla, CA 92037 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Subject | False & Misleading Claims/Misbranded (Telehealth) |
| Website reviewed | https://zappyhealth.com, 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
Claims on zappyhealth.com naming compounded products as the same active ingredient as approved brand drugs 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.
“Semaglutide (Active Pharmaceutical Ingredient in Wegovy®)See Wegovy FDA Information”
“Liraglutide (Active Pharmaceutical Ingredient in Saxenda®)See Saxenda FDA Information”
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), 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 zappyhealth.com and prints customer@zappyhealth.com. It names a different company from the one the site prints, and it prints a street address the site does not publish at all. 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
Zappy Health is recorded against criterion S8, enforcement status as PASS. The basis reads: FDA warning letter 717991, February 2026, names Kare Solutions, LLC doing business as Zappy and cites claims naming the compounded product as the same active ingredient as an approved brand. 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.
4 other letters in this ledger carry the same issue date: 717989, to Lean Rx, Inc. dba SkinnyRx, 721448, to Strut Health, LLC dba Strut, 721478, to Weightless Medical LLC dba WeightCare, 721816, to Ivim Services LLC dba Ivim.
Sources
- FDA warning letter 717991 to Kare Solutions, LLC dba Zappy, 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.