Which telehealth companies has the FDA warned over compounded GLP-1 marketing?

What is an FDA warning letter about compounded GLP‑1s?

An FDA warning letter is a formal notice that the agency believes a company's marketing violates federal law. In this series the finding is almost always about claims: describing a compounded drug as FDA-approved, equating it with Ozempic, Wegovy, Mounjaro or Zepbound, or asserting safety and efficacy the compounded product has never been reviewed for.

Compounded semaglutide and tirzepatide are prepared by compounding pharmacies. They are not FDA-approved products, they have not been reviewed by the FDA for safety, effectiveness or quality, and no compounded drug may be marketed as though it had been. That distinction is what almost every letter below turns on, and it is the same distinction a LegitScript reviewer applies when reading your website.

How many letters has the FDA sent, and when?

The FDA has issued these letters in batches rather than continuously. Each batch is dated on the day the letters were signed and published about a week later, which is why a round reported in the press on one date carries an earlier date on the letters themselves.

What do the letters actually object to?

Claims, not compounding. The letters do not say a company may not offer compounded drugs; they say the way the drugs were advertised misrepresented what they are. A single letter usually cites several of these at once, which is why the counts below add up to more than the letter total.

The full list

Every letter in the series, newest first. The reference number is the FDA's own MARCS-CMS identifier where the letter carries one. A few do not, and the FDA has issued two letters under the same number, so the link is the reliable identifier.

What does this mean for LegitScript certification?

LegitScript reviews the claims your website makes. The wording that drew these letters (calling a compounded product FDA-approved, comparing it directly to Ozempic or Zepbound, or promising results) is the same wording that causes a certification application to come back with questions or a denial.

The practical read is that marketing copy is a compliance surface, not a marketing surface. A site can be operationally sound (licensed prescribers, a registered pharmacy partner, real clinical oversight) and still fail on the sentence under the product photograph. Fixing that language before submission is cheaper than answering for it afterwards, whether the question comes from LegitScript or from the FDA.

How this list was built

Each letter was located through the FDA's own warning letter database and then retrieved individually from fda.gov, where the company name, reference number and date were read from the letter's own page. No row is taken from a news report or a law-firm summary. Violation categories are our coding of what each letter states, and the link on every row is there so you can disagree with our coding and check the original.

If you believe a row is wrong or out of date, tell us and we will correct it. This page is not legal advice.