Warning letter · Center for Drug Evaluation and Research (CDER)
FDA warning letter 719811 to Elevate Your Wellness LLC, dba Elevated
Issued September 9, 2025. The letter alleges that claims that compounded semaglutide and tirzepatide contain the same active ingredient as the branded medications imply the products are the same as an FDA-approved product, which the letter calls false or misleading. It asks for a written response and it did not halt the business. The ledger record for Elevated 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 719811 |
|---|---|
| Issued | September 9, 2025 |
| Addressee | Elevate Your Wellness LLC, dba Elevated |
| Address | United States |
| 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 | Elevated Health's website, 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 that compounded semaglutide and tirzepatide contain the same active ingredient as the branded medications imply the products are the same as an FDA-approved product, which the letter calls 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.
“They contain the same active ingredient as the branded medications, but are compounded to offer a more personalized and often more accessible option.”
“Semaglutide ODT is a custom-formulated, dissolvable tablet that delivers the same active ingredient found in the leading GLP-1 weight loss medications – without the need for injections.”
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
The entity and the reviewed domain in the letter match the entity the seller prints in its terms and privacy policy and the domain it trades from. 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
Elevated Health is recorded against criterion S8, enforcement status as PASS. The basis reads: FDA warning letter 719811, September 2025, names Elevate Your Wellness LLC, dba Elevated and Elevated Health's website, alleging that claims presenting its compounded semaglutide and tirzepatide as containing the same active ingredient as the branded medications imply sameness with an FDA-approved product. 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.
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.
7 other letters in this ledger carry the same issue date: 715879, to Sprout Health Partners LLC dba Sprout Health, 716501, to FitRX, LLC dba Zealthy, 716567, to Hims & Hers Health, Inc. dba Hims, 716822, to the operating company of Direct Meds dba DirectMeds, 716825, to Hims & Hers Health, Inc. dba Hers, 716830, to Remedy Meds, 719809, to Healthon Inc. dba Healthon.
Sources
- FDA warning letter 719811 to Elevate Your Wellness LLC, dba Elevated, 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.