FDA Warning Letter · #715866
SemaBio: FDA Warning Letter (September 9, 2025)
SemaBio received this warning letter on September 9, 2025, 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/semabio-715866-09092025
Summary
- Company
- SemaBio
- Letter number
- #715866
- Issue date
- September 9, 2025
- Subject
- Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
What FDA cited
FDA's letter of September 9, 2025 cites SemaBio for false or misleading claims about the drugs it sells, under the subject line "Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet". The GLP-1 drugs it names: semaglutide.
As described below, your claim concerning compounded semaglutide products is false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. … Your claim implies that your products are the same as an FDA-approved product when they are not.
How this letter sits against the other 159
Our reading, from the 160 letters on this register — not part of the FDA’s document.
The FDA issued 59 of the 160 letters on this register on the same day, September 9, 2025, the largest single action in our records. This company was part of a sweep rather than singled out. That does not make the letter less serious, but it does mean the agency was acting against a practice across the market, not against one seller's conduct alone.
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.
The FDA objected to how this firm described compounded semaglutide. For what actually differs from the brand drug: Compounded semaglutide vs Ozempic and Wegovy: what is actually different.
FDA’s letter of September 9, 2025 to SimpleRx also cites its recipient for false or misleading claims about the drugs it sells.
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
Embody
A flat compounded tirzepatide or semaglutide price at every dose, from a seller that names its pharmacies
From $79/mo
Get started →Luvo Health
Moving between compounded and brand without changing seller
From $179/mo
Get started →Eden
Coverage in all 50 states, which most sellers will not confirm
From $99/mo
Get started →Other warning letters in our database
- VivioMD — June 8, 2026
- New Life Pharma LLC — April 14, 2026
- GenoGenix LLC — January 20, 2026
- Lyfe Rx — September 9, 2025
- Get.Fit.Medical — September 9, 2025
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