FDA warning letter: Nomida.biz

What the FDA told Nomida.biz in September 2024 about semaglutide and tirzepatide — and whether it has been resolved.

By Sam Reed · Founder and data lead

FDA warning letter, issued to Nomida.biz · Sep 12, 2024

The FDA has published no closeout letter for it yet, so it stands on the public record as issued. What that does and does not mean is explained below.

What this letter is about

Selling a drug the FDA has not approved

The FDA says the company sold a drug that it has never approved for sale in the United States. Compounded semaglutide is the usual example: a compounded drug is legal to prescribe in specific circumstances, but it has not been through FDA approval, and selling it like an approved product is what the agency objects to.

“As discussed below, FDA has observed that www.nomida.biz introduces into interstate commerce unapproved and misbranded semaglutide and tirzepatide drug products. There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs.”

FDA warning letter to Nomida.biz, MARCS-CMS 687590. Read it on fda.gov

Context

What an FDA warning letter is

It is a letter. The FDA writes to a company to say which of its practices the agency believes break the law, and asks it to fix them. That is the whole mechanism: a written notice, published so anyone can read it.

It is the FDA’s position, not a court’s finding. The company can reply, and can disagree. The agency states in these letters that failing to address the problems may lead to further action such as seizure or an injunction — which tells you the letter itself is not yet either of those things.

A warning letter does not recall a product, suspend a licence or close a business. It does not mean that medicine already dispensed was unsafe. When the FDA is satisfied the problems are fixed, it publishes a closeout letter.

What it does tell you is that a regulator looked at this company and wanted something changed. The useful question is what — and the quoted passage above answers it more precisely than any summary can.

The record

What the letter says

Field	What the letter states	Source
Recipient	Nomida.biz	FDA warning letter
Issued	Sep 12, 2024	FDA warning letter
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA warning letter
FDA reference	MARCS-CMS 687590	FDA warning letter
Location	United States	FDA warning letter
Subject	Unapproved New Drugs/Misbranded	FDA warning letter
What it concerns	Selling a drug the FDA has not approved	Read from the subject line
Medication named	Semaglutide and Tirzepatide	Letter text
Status	Open — no closeout letter published	FDA warning letter list

Data sources · cited with retrieval dates

FDA warning lettersPublished compliance actions, updated weekly
FDA registered outsourcing facilities503B register, with inspection and enforcement status
FDA National Drug Code directoryLabeler, product and package listings

NADAC figures are pharmacy acquisition costs, not retail prices and not what you will pay. This content is educational and is not medical advice.