FDA Warning Letter · #695663
Swisschems — FDA Warning Letter (December 10, 2024)
Primary Source
View the original FDA letter on fda.gov →
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024
Summary
- Company
- Swisschems
- Letter number
- #695663
- Issue date
- December 10, 2024
- Subject
- Unapproved New Drugs/Misbranded
What FDA cited
FDA cited the company in connection with the marketing and distribution of compounded GLP-1 products. See the linked FDA warning letter for the full text of the agency's concerns and the specific provisions of the Federal Food, Drug, and Cosmetic Act referenced.
How this letter sits against the other 156
Our reading, from the 157 letters on this register — not part of the FDA’s document.
4 letters on this register carry the date December 10, 2024, so this was a small group action rather than a mass sweep.
A warning letter is the agency putting a company on notice, not a court finding and not a ban. What it is worth to you is in what it alleges, so read the original on fda.gov rather than the fact that one exists.
From the letter
Read full letter on FDA.gov →Word for word, from the letter of December 10, 2024
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://swisschems.is/ in October 2024 and has observed that your website offers “Semaglutide” and “Retatrutide” products for sale in the United States. We have also reviewed your Facebook social media website at https://www.facebook.com/swisschems.is/ and your Instagram social media website at https://www.instagram.com/swisschemsupgraded where you direct consumers to your websites at https://swisschems.is/ to purchase your products. As described below, your “Semaglutide” and “Retatrutide” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).
Despite statements on your product labeling marketing your products as “research chemicals only,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because they are intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body. Examples of claims observed on your website that establish the intended use of your products as drugs intended for human use include, but may not be limited to, the following:
• “Peer-Reviewed Studies . . . Once-weekly semaglutide in adults with overweight or obesity. . .. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes.”
On a September 18, 2024, post from your Facebook social media website, https://www.facebook.com/swisschems.is/ and your Instagram social media website, https://www.instagram.com/swisschemsupgraded:
• “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”
• “Retatrutide (LY-3437943) is a promising anti-obesity agent. It is designed to be a triple hormone receptor agonist, meaning it activates three important receptors in the body: GLP-1 (glucagon-like peptide-1), GIP (glucose-dependent insulinotropic polypeptide), and GCGR (glucagon receptor). These receptors play crucial roles in regulating glucose levels and metabolic functions in the body.”
• “Peer-Reviewed Studies . . . Triple-Hormone-Receptor Agonist Retatrutide for Obesity – A Phase 2 Trial . . . Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA”
Your “Semaglutide” and “Retatrutide” products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Quoted word for word from the U.S. Food and Drug Administration. We assert nothing beyond what the agency published, and the full letter is at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024
What FDA warning letters mean
It is the agency writing to a company to say it believes something that company is doing breaks the Federal Food, Drug, and Cosmetic Act — usually a claim on a website, a labeling choice, or how a drug is being made. The company has about fifteen working days to write back.
Read carefully what it is not. It is not a recall, not a criminal charge, and not a court deciding anyone broke the law. It is the regulator opening a file. Companies frequently answer a letter, fix what was cited, and carry on trading, and when FDA accepts that it can issue a close-out letter. We do not track close-outs, so the presence of a letter on this page tells you what FDA said on one date — not where the matter stands today. Ask the company; they will usually tell you, and how they answer is informative in itself.
Across this market the same three citations recur: claiming a compounded product is equivalent to an approved one, labeling that misleads, and compounding from bulk substances FDA has not cleared under sections 503A and 503B. If you are reading a letter here, it is probably one of those.
Where to get GLP-1 online, safely: sellers our editors have checked
These are telehealth sellers our editors have checked. For each one we hold a price, the form the drug comes in, and the states it reaches.
No insurance needed · vetted by our editors
Some of the links on this page earn us money. If you sign up with a provider after following one, that provider may pay GLP Watchdog a commission. Learn more
CoreAge Rx
Semaglutide at $99/month, 48% below the typical price
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Get started →Trimi Health
Knowing which pharmacy fills the vial: it names VialsRx
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Get started →ShedRx
Oral orforglipron alongside the injectables
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Editorial Disclaimer
This is a public communication from a regulator, and by itself it settles nothing about whether the company broke any law. Corrective action is a common response, and a fair number of letters end in a close-out. Read the whole thing on fda.gov through the link above rather than taking our excerpt as the full picture.
Glossary
The words sellers use, defined. Tap any term.
- Compounded GLP-1 · Pharmacy and drug forms
- 503A pharmacy · Pharmacy and drug forms
- 503B outsourcing facility · Pharmacy and drug forms
- PCAB accreditation · Pharmacy and drug forms
- FDA Warning Letter · Insurance and regulatory
- Off-label use · Insurance and regulatory
- FDA Drug Shortage List · Insurance and regulatory