Warning letter · Center for Drug Evaluation and Research (CDER)
FDA warning letter 694608 to Xcel Research LLC
Issued December 10, 2024. The letter alleges that the peptide products offered from xcelpeptides.com are unapproved new drugs intended for human use, despite research-only labeling. It asks for a written response and it did not halt the business. The ledger record for Xcel Peptides 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 694608 |
|---|---|
| Issued | December 10, 2024 |
| Addressee | Xcel Research LLC |
| Address | 1309 Coffeen Ave., Suite 12238, Sheridan, WY 82801 |
| Recipient | Andrew Pierce, Named recipient |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Subject | Unapproved New Drugs/Misbranded |
| Website reviewed | https://www.xcelpeptides.com, reviewed in October 2024 |
| Sections cited | 201(g)(1), 201(p), 301(d), 505(a) 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 peptide products offered from xcelpeptides.com are unapproved new drugs intended for human use, despite research-only labeling.
The letter quotes 2 claims from the website it reviewed, reproduced here exactly as the letter prints them, including the agency's own elisions.
“FOR RESEARCH USE ONLY”
“NOT INTENDED FOR HUMAN USE,”
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 201(g)(1), 201(p), 301(d), 505(a). Section 505(a) prohibits introducing an unapproved new drug into interstate commerce and section 301(d) makes doing so a prohibited act. That is an unapproved-drug allegation rather than a labeling one.
How it was attributed
The letter reviews xcelpeptides.com by name and prints a support address at that domain. The storefront itself is behind a login, so nothing on it could be compared. 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
Xcel Peptides is recorded against criterion S8, enforcement status as PASS. The basis reads: FDA warning letter 694608, December 2024, names Xcel Research LLC over the peptide products offered from this domain and alleges they are unapproved new drugs. 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.
2 other letters in this ledger carry the same issue date: 695156, to Prime Vitality, Inc. dba Prime Peptides, 695663, to Swisschems.
Sources
- FDA warning letter 694608 to Xcel Research LLC, 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.