FDA in 2026: telehealth GLP-1 letters and a line on retatrutide

Two FDA communications from 2026 set out how the agency is treating compounded and unapproved incretin products: a March 2026 batch of warning letters to telehealth companies, and an updated FDA page that now names retatrutide and cagrilintide as substances that cannot be used in compounding ^1,2. This article summarizes both. It is information about regulatory actions, not legal advice; Amiravo's legality guide covers the wider framework.

March 2026: 30 letters to telehealth firms

On 3 March 2026, FDA announced 30 warning letters to telehealth companies for what it described as false or misleading claims about compounded GLP-1 products on their websites ¹. FDA said the main violations were claims implying sameness with FDA-approved products, and advertising drug products under the telehealth firm's own name or trademark without qualification, in a way that implied the firm was the compounder ¹. FDA described this as the second group of letters to telehealth firms since it began a campaign against misleading direct-to-consumer drug advertising in September 2025 ¹.

The announcement repeats a point FDA makes in most of its compounding communications: compounded drugs are not FDA-approved, FDA does not review them before marketing, and they are not the same as generic drugs, which are FDA-approved ¹.

Retatrutide and cagrilintide named on FDA's GLP-1 page

FDA's page "FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", current as of 1 October 2026, now contains a section headed "Retatrutide and cagrilintide cannot be used in compounding" ². It states that both cannot be used in compounding under federal law, and that neither is a component of an FDA-approved drug or has been found by FDA to meet its standards for any condition ². Retatrutide is Eli Lilly's investigational triple agonist; cagrilintide is the amylin analogue in Novo Nordisk's investigational CagriSema combination ³.

The page lists three groups that FDA says it has warned ²:

• telehealth companies, for marketing unapproved drugs such as retatrutide, including direct marketing to consumers;
• active pharmaceutical ingredient distributors, for selling retatrutide and other GLP-1 drugs to compounders;
• outsourcing facilities, for repackaging retatrutide.

A separate section says FDA has warned companies selling unapproved drugs containing semaglutide, tirzepatide, retatrutide, survodutide or mazdutide that were labelled "for research purposes" or "not for human consumption", and that these were sold directly to consumers with dosing instructions ².

Adverse event reports

The same page reports that, as of 31 May 2026, FDA had received 990 adverse event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide ². FDA notes that it is not always possible to determine whether an event resulted from the drug or from other factors, and that events are likely underreported because compounders are not required to report them in all cases ².

What this means for readers

• FDA's 2026 actions target marketing and supply chains (telehealth claims, ingredient distributors, outsourcing facilities) as well as end sellers ^1,2.
• For investigational molecules such as retatrutide and cagrilintide, FDA's position is that there is no lawful compounding route, independent of the separate 503A bulks-list process covered in FDA's 2025-2026 review of peptides for compounding ².
• Adverse event counts are spontaneous reports, not incidence rates; they cannot be used to compare products ².
• Earlier letters to research-chemical sellers are summarized in What FDA warning letters to peptide sellers say.