Warning letter · Center for Drug Evaluation and Research (CDER)
FDA warning letter 695663 to Swisschems
Issued December 10, 2024. The letter alleges that the semaglutide and retatrutide products offered from swisschems.is are unapproved new drugs intended for human use, despite research-chemical labeling. It asks for a written response and it did not halt the business. The ledger record for Swiss Chems 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 695663 |
|---|---|
| Issued | December 10, 2024 |
| Addressee | Swisschems |
| Address | 42 Broadway FL 12th, New York, NY 10004 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Subject | Unapproved New Drugs/Misbranded |
| Website reviewed | https://swisschems.is/, reviewed in October 2024 |
| Sections cited | 505(a), 301(d) 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 semaglutide and retatrutide products offered from swisschems.is are unapproved new drugs intended for human use, despite research-chemical 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.
“Peer-Reviewed Studies . . . Once-weekly semaglutide in adults with overweight or obesity. . .. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes.”
“Ready to elevate your research? Semaglutide, a key player in metabolic and weight regulation is now available! Don’t miss this chance to explore its role in glucose regulation, energy balance, and more. . .. Special Offer: Buy 3 or more and get 10% OFF your order! Stock up now for your next breakthrough. #Semaglutide #MetabolicStudies . . . #GlucoseRegulation”
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 505(a), 301(d). 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 names the storefront domain, swisschems.is, and quotes its product pages. 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
Swiss Chems is recorded against criterion S8, enforcement status as PASS. The basis reads: FDA warning letter 695663, December 2024, names Swisschems over unapproved semaglutide and retatrutide offered from this domain. No close-out letter appears in the index. No FDA action has halted the business, and the store 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.
Sources
- FDA warning letter 695663 to Swisschems, 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.