FDA Warning Letter · #684435
Ozempencom: FDA Warning Letter (June 24, 2024)
Ozempencom received this warning letter on June 24, 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/ozempencom-684435-06242024
Summary
- Company
- Ozempencom
- Letter number
- #684435
- Issue date
- June 24, 2024
- Subject
- Not listed by FDA for this letter
What FDA cited
FDA's letter of June 24, 2024 cites Ozempencom for selling products FDA calls unapproved new drugs. The GLP-1 drugs it names: semaglutide.
For example, www.ozempen.com offers semaglutide drug products marketed as “4mg Semaglutide Pen” and “8mg Semaglutide Pen.” … While there are FDA‐approved versions of semaglutide, on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “4mg Semaglutide Pen” and “8mg Semaglutide Pen” offered by www.ozempen.com.
How this letter sits against the other 159
Our reading, from the 160 letters on this register — not part of the FDA’s document.
No other letter on this register carries the date June 24, 2024. The agency acted against this company on its own that day, which is uncommon here — most of the letters we hold arrived in sweeps.
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.
For checking a pharmacy website before you order: How to verify an online GLP-1 pharmacy: six public checks.
FDA’s letter of August 20, 2024 to AnuMed International, LLC also cites its recipient for selling products FDA calls unapproved new drugs.
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
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 →YourEra
Semaglutide at $99/month, well below the typical price
From $99/mo
Get started →Other warning letters in our database
- Medica Weight Loss — June 8, 2026
- HydraMed — June 8, 2026
- FitRx — February 20, 2026
- Elevated — September 9, 2025
- cheaptrustedpharmacy.com — July 29, 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