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FDA Warning Letter · #696885

Usapeptidecom — FDA Warning Letter (February 26, 2025)

Issued February 26, 2025Status: activeCenter for Drug Evaluation and Research (CDER)

Primary Source

View the original FDA letter on fda.gov →

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usapeptidecom-696885-02262025

Summary

Company
Usapeptidecom
Letter number
#696885
Issue date
February 26, 2025
Subject
Compounded GLP-1 marketing and labeling concerns

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 185

Our reading, from the 186 letters on this register — not part of the FDA’s document.

No other letter on this register carries the date February 26, 2025. 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.

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

7.5

Synergy Rx

Knowing which pharmacy fills the vial — it names Belmar Pharmacy

8.5

Strut Health

Semaglutide at $99/month, 48% under the register median

6.8

Care Bare Rx

Knowing which pharmacy fills the vial — it names Belmar Pharmacy

Other warning letters in our database

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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.