FDA Warning Letter · #669074
US Chem Labs: FDA Warning Letter (February 7, 2024)
US Chem Labs received this warning letter on February 7, 2024, from FDA’s Center for Drug Evaluation and Research | CDER. What it cites, and FDA’s own words where we matched them against the letter, are summarized below.
Primary Source
View the original FDA letter on fda.gov →
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-chem-labs-669074-02072024
Summary
- Company
- US Chem Labs
- Letter number
- #669074
- Issue date
- February 7, 2024
- Subject
- CGMP/Finished Pharmaceuticals/Adulterated
What FDA cited
FDA's letter of February 7, 2024 cites US Chem Labs for selling products FDA calls unapproved new drugs, under the subject line "CGMP/Finished Pharmaceuticals/Adulterated". The GLP-1 drugs it names: semaglutide and tirzepatide.
As described below, your “Semaglutide,” “Tirzepatide” and “Thymalin” 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 301(d).
How this letter sits against the other 159
Our reading, from the 160 letters on this register — not part of the FDA’s document.
2 letters on this register carry the date February 7, 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.
This letter is one of a run to online sellers of research-use peptides: FDA warning letters to peptide sellers, 2023 to 2026.
FDA’s letter of April 24, 2024 to Wwwdashpctcom also cites its recipient for selling products FDA calls unapproved new drugs.
From the letter
Read full letter on FDA.gov →Word for word, from the letter of February 7, 2024
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.uschemlabs.com in October 2023 and has observed that your website offers “Semaglutide,” “Tirzepatide” and “Thymalin” products for sale in the United States. As described below, your “Semaglutide,” “Tirzepatide” and “Thymalin” 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 301(d). Furthermore, your “Semaglutide,” “Tirzepatide” and “Thymalin” products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352, introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Despite statements on your product labeling marketing your products as “research chemicals only” and “not for human consumption,” 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:
“It's a carefully researched medication with approval from the U.S. Food and Drug Administration (FDA) that was discovered to be a ‘missing link’ for weight loss by accident.
Semaglutide first gained FDA approval as a treatment for type 2 diabetes. When used as part of a lifestyle update, semaglutide injections have been shown to help control blood sugar levels in people living with type 2 diabetes. Additionally, semaglutide is used to help reduce the risk of stroke, heart attack, and heart disease in people with type 2 diabetes. However, this medication has received heavy attention for other reasons recently.
Semaglutide injections are quickly becoming famous for weight loss. When used as part of an individualized plan that includes calorie adjustments and exercise, semaglutide can help overweight adults to lose significant amounts of weight. The treatment is especially promising for people seeking to shed pounds quickly due to obesity-related health risks tied to high blood pressure, high cholesterol, and diabetes. The best part is that nobody has to feel hungry when losing weight with semaglutide.
Injections mimic the body's own natural hunger-suppressing hormones that are triggered when the stomach is full. Is semaglutide the ultimate hack for losing weight without feeling deprived? Take a look at what everyone struggling with weight loss needs to know about what is shaping up to be the most promising injectable medication for weight loss ever.”
“What is Tirzepatide? Tirzepatide is a GLP-1 receptor agonist, it can promote feelings of fullness and reduce food intake, which may lead to weight loss as a secondary effect.”
“Benefits of Tirzepatide • Improved glucose control: Tirzepatide to US Chem Labs’ tirzepatide product page has been shown to be effective in early clinical trials in improving blood glucose control in people with type 2 diabetes. • Weight loss: In clinical trials, people with type 2 diabetes treated with Tirzepatide have reported modest reductions in body weight compared to those treated with placebo. • Once-daily dosing: Tirzepatide can be taken as a once-daily injection, which is more convenient than multiple injections or doses per day required by some other medications for type 2 diabetes. • Low risk of side effects: Tirzepatide has been shown to be well-tolerated with a low risk of side effects in clinical trials. • Delayed or prevented need for insulin injections: Tirzepatide has the potential to delay or prevent the need for insulin injections in people with type 2 diabetes. • Improved quality of life: By controlling blood glucose levels and reducing the need for multiple injections or doses of medication, Tirzepatide has the potential to improve the quality of life for people with type 2 diabetes.”
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/us-chem-labs-669074-02072024
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
Oak
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Get started →Other warning letters in our database
- Pink Pony Peptides — March 31, 2026
- Refills Health — February 20, 2026
- NewSelf — February 20, 2026
- Lumimeds — September 9, 2025
- Xcel Research LLC — December 10, 2024
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