News & Trends
The third wave: FDA sent another round of telehealth warning letters in June — with no press release we could find
Since September 2025, the FDA has run three rounds of enforcement against telehealth companies marketing compounded GLP-1 drugs. It announced the second round with a press release on March 3, 2026. For the third round — letters posted the week of June 15, 2026 — we could locate no announcement at all. That absence is why almost no consumer coverage of the June round exists, and why a woman comparing weight-loss programs this summer has no easy way to learn that, by the count in the one trade analysis we found, the agency wrote to roughly two dozen more companies eight weeks ago. What the FDA did publish in June may be more useful than a press release: a plain-language page, updated June 15, 2026, listing the five marketing practices it considers improper. Below is that list turned into something you can hold against any ad you see — plus the narrow meaning of a warning letter, which alleges a problem with marketing, not a recall and not a finding about any patient's medication.
Three waves in nine months
The campaign began on September 9, 2025, when the FDA announced a broad crackdown on deceptive drug advertising. The framing was about scale: FDA said it was "sending thousands of letters warning pharmaceutical companies to remove misleading ads and issuing approximately 100 cease-and-desist letters," having let warning letters to drug companies fall "to one in 2023 and zero in 2024." It did not break out telehealth firms as a category. The compounded-GLP-1 subset is visible instead in the individually posted letters — a September 9, 2025 letter to a seller trading as GLP-1 Solution, for instance, told the company its "claims imply that your products are the same as an FDA-approved product when they are not."
The second wave was the loud one. On March 3, 2026, the FDA announced warning letters to 30 telehealth companies, calling them "the second group of warning letters sent to telehealth firms since the agency launched in September a crackdown on misleading direct-to-consumer pharmaceutical advertisements." In the FDA's own characterization, the "[p]rimary violations identified in the letters included making claims implying sameness with FDA-approved products and obscuring product sourcing by advertising drug products branded with the telehealth firm's name or trademark without qualification, implying they are the compounder."
The third wave has no equivalent announcement that we were able to locate. It surfaced through the FDA's routine weekly posting of warning letters and through trade analysis: a National Law Review article published June 18, 2026 reported 25 warning letters issued during the week of June 15. That analysis, not the FDA, is the source of the count; we could not locate an FDA document stating a total for the June round, so readers should treat "25" as a reported figure rather than an agency figure. The same analysis supplied the only public comment we found from the agency side: a post on X from CDER Acting Director Michael Davis stating that "Protecting consumers from false and misleading claims about compounded drugs is a priority for CDER."
| Wave | Letter dates | Number of letters | FDA press release? | Stated violations |
|---|---|---|---|---|
| First | September 9, 2025 | Per the National Law Review analysis, the wider advertising crackdown involved roughly 80 warning letters and 40 untitled letters, of which 58 addressed claims about compounded GLP-1s and other compounded products. These are the analysis's figures, not FDA's; FDA's own press release gave only campaign-wide counts ("thousands of letters," about 100 cease-and-desist letters) | Yes — but framed as a general crackdown on drug advertising, not a telehealth action | Per the posted GLP-1 Solution letter: sameness claims, unapproved new drug, misbranding |
| Second | Announced March 3, 2026 | 30 warning letters, stated by FDA in its press release | Yes — a dedicated press release | FDA: "claims implying sameness with FDA-approved products and obscuring product sourcing" |
| Third | Posted the week of June 15, 2026; the one letter we examined is dated June 8, 2026 | 25 warning letters, per the National Law Review analysis. This is the analysis's count, not FDA's — we found no FDA document stating a total | No press release located | Per the Altru letter: sameness claims, cost comparisons, and pharmacies described as "FDA approved" |
Read the counts carefully: the first- and third-wave numbers come from the National Law Review analysis of June 18, 2026, not from the FDA, and the first-wave 80/40 figures describe the broader direct-to-consumer advertising push rather than a telehealth-only tally. Only the second-wave count of 30 is a figure the FDA itself published, in its March 3, 2026 press release. Letter dates and violation language come from the letters as posted by the FDA.
What a June letter actually alleges
With no announcement to read, the June round is best understood through a single letter. The FDA's June 8, 2026 warning letter to Altru Telehealth, LLC of Oakland, Maryland quotes the company's own website back to it. Among the flagged statements: "Compounded semaglutide & tirzepatide offers the same results but at a fraction of the cost of brand names such as Ozempic, Mounjaro & Wegovy," and "[a]n FDA approved, regulated & sterile compounding pharmacy mixes the formula based on the medical providers prescription," alongside "[o]ur compounding pharmacies are all FDA approved."
The FDA cited sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act — misbranding through false or misleading labeling, and false or misleading advertising of compounded drugs — and section 301(a), which bars introducing a misbranded drug into interstate commerce. The problem with that second set of quotes is factual, not rhetorical: FDA does not approve pharmacies. There is no such thing as an FDA-approved compounding pharmacy, so the phrase cannot be true of anyone.
What that letter is not is equally important. It is an allegation about the words on a website, which the company has the opportunity to answer; it is not a court judgment, and the FDA has not said it found anything wrong with the medicine Altru's patients received. The letter reports no testing of any product, no recall and no adverse-event finding. As of this writing we are not aware of a public response from the company, and none of the June letters we discuss here should be read as a safety determination about a named product.
The five marketing practices FDA says are improper: a checklist you can use
The most useful document from June is not a letter. It is the FDA's consumer page, "FDA to Telehealth Companies: What to Know When Promoting Compounded Drugs," updated June 15, 2026, which enumerates five marketing practices the agency considers improper. Under all five sits one sentence from that page: "Compounded drugs are not reviewed by the agency for safety, effectiveness or quality prior to marketing."
| What the ad says | FDA's wording | Why it misleads |
|---|---|---|
| The telehealth brand's name and logo on the vial or box, no other pharmacy named | Branding "that falsely or misleadingly implies the telehealth company is the compounder" | You cannot tell who made the drug or look up that facility's record. The seller and the pharmacy mixing it are usually different businesses |
| "The generic version of Ozempic" / "the same as Wegovy" | Describing a compounded drug as "a generic version of an FDA-approved drug or the same as a drug approved by FDA" | Generics are FDA-approved before marketing, after demonstrating equivalence. A compounded drug is not. "Generic" is a regulatory status, not a synonym for cheaper |
| "FDA-approved semaglutide" | Claiming a compounded drug "has been FDA-approved or has otherwise been evaluated for safety and effectiveness" | The active ingredient may be one FDA approved in someone else's product. That says nothing about the compounded formulation in your box |
| "Clinically proven to work just like the brand" | Describing a compounded drug as "clinically proven to produce the same result as the FDA-approved drug" | The trials were run on the branded products. No compounded version was in them. Borrowing another product's results is the sameness claim in a lab coat |
| "From an FDA-approved" or "FDA-licensed pharmacy" | Claiming drugs are "sourced from an FDA-approved or FDA-licensed pharmacy or outsourcing facility," when, in FDA's words, "FDA does not approve or license any facility" | The category does not exist. Facilities register with FDA and can be inspected; none is approved or licensed by it |
One caveat. Spotting these phrases tells you a company's marketing is out of step with what FDA says is acceptable. It does not tell you the medicine in the box is contaminated, underdosed or dangerous — a different question requiring different evidence. Our explainer on compounded versus branded GLP-1s covers product quality, and how GLP-1 telehealth works explains the split between the company you pay and the pharmacy that fills the prescription.
If you are on a compounded program right now
Precision matters here, legally and factually. A warning letter is FDA's statement that it believes a company has violated the law — an allegation, addressed to a company, ordinarily requiring a written response within 15 working days. It is not a recall. It is not a finding that a batch was tested and failed. It is not a determination about the medication in your refrigerator. It is also not a ruling: a company that receives one has not been found by any court to have broken the law, and describing a recipient as having "violated" the rules gets ahead of the record. The June letter reproduced above concerns what a company said in its advertising, and the National Law Review analysis describes the rest of the June round the same way — as letters "over alleged false or misleading promotional claims."
Practically: do not stop a prescribed medication because a headline mentions enforcement — dosing decisions belong with a clinician who knows your history. What is worth doing is establishing facts you may not have: which pharmacy compounds your medication, whether it is a 503A pharmacy or a 503B outsourcing facility, and the program's plan if supply changes. That last question carries weight beyond marketing, because FDA has separately proposed excluding semaglutide, tirzepatide and liraglutide from large-scale compounding — a rulemaking whose comment period closed July 30, 2026 with no final rule yet issued.
Questions to ask a telehealth provider before you pay
- Who compounds this, by name? Ask for the pharmacy or outsourcing facility, not the brand on the packaging. A company that will not name it has answered you.
- Is it a 503A pharmacy or a 503B outsourcing facility? That determines which rules apply and how a final compounding rule would affect your supply.
- Is this product FDA-approved? For a compounded GLP-1 the correct answer is no. Any other answer is the claim in row three above.
- Which trial results are you citing, and were they run on this product? STEP 1 and SURMOUNT-1 studied the branded products, not compounded versions.
- What happens if your pharmacy stops supplying? Ask for the transition protocol in writing, including how a dose would translate to an approved product.
- Have you received an FDA warning letter? Posted letters are searchable by company name in the FDA's public database.
For readers weighing specific services, we compare programs in our 2026 guide to GLP-1 telehealth for women, and one compounded-GLP-1 program is reviewed in detail in our RxFemale review. General questions about the medications themselves are covered in our GLP-1 FAQ for women.
What to watch
Three rounds in nine months describes a campaign settling into routine rather than winding down. The counts are less comparable than they look: the September figure is a law firm's tally of a much broader advertising push, the March figure of 30 is the FDA's own and telehealth-specific, and the June figure of about 25 is again the law firm's. What is documented is the sequence, not a trend line — the agency sent letters in three rounds, gave the second a dedicated press release, framed the first as a general advertising crackdown, and in June updated a consumer page spelling out the five improper marketing practices. Why it announced March and not June is not something the record explains, and we will not guess; nor can we prove a negative — we can only report that we searched and found no June announcement. Where the effect lands is clearer: enforcement that is not announced is enforcement most people never hear about.
The nearer-term signal is the rulemaking, not the letters. Letters change what companies write on their websites; a final rule would change what they may sell. We will update this article if FDA publishes a total for the June round or announces a fourth.
Sources
- US Food and Drug Administration. FDA to Telehealth Companies: What to Know When Promoting Compounded Drugs. Last updated June 15, 2026 — the five improper marketing practices and the statement that compounded drugs are not reviewed for safety, effectiveness or quality prior to marketing. fda.gov/drugs/human-drug-compounding/fda-telehealth-companies-what-know-when-promoting-compounded-drugs
- US Food and Drug Administration. Warning letter to Altru Telehealth, LLC dba Altru Telehealth, MARCS-CMS 728274, dated June 8, 2026 — the quoted marketing claims and the FD&C Act sections cited. fda.gov/…/warning-letters/altru-telehealth-llc-dba-altru-telehealth-728274-06082026
- US Food and Drug Administration. FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s. March 3, 2026 — the second-wave count and the "second group of warning letters" framing. fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s
- US Food and Drug Administration. FDA Launches Crackdown on Deceptive Drug Advertising. September 9, 2025 — the campaign-wide figures and the 2023/2024 comparison. fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising
- US Food and Drug Administration. Warning letter to GLP-1 Solution, MARCS-CMS 715883, dated September 9, 2025 — a first-wave example and the "same as an FDA-approved product when they are not" language. fda.gov/…/warning-letters/glp-1-solution-715883-09092025
- National Law Review. FDA's Focus Returns to Compounding and Telehealth: Another Wave of Warning Letters. June 18, 2026 — the sole source for the count of 25 June letters; for the roughly 80 warning letters and 40 untitled letters attributed to the broader September 2025 advertising push, of which the analysis says 58 addressed compounded GLP-1 and other compounded-product claims; and for the quoted Michael Davis statement, which the analysis reports was posted on X. None of these figures or that quotation appears in an FDA document we were able to locate. natlawreview.com/article/fdas-focus-returns-compounding-and-telehealth-another-wave-warning-letters
- US Food and Drug Administration. Warning Letters database — searchable by company name. fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
- Wilding JPH, et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP 1). NEJM 2021 — cited only as an example of a trial run on a branded product. pubmed.ncbi.nlm.nih.gov/33567185
- Jastreboff AM, et al. Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1). NEJM 2022 — cited only as an example of a trial run on a branded product. pubmed.ncbi.nlm.nih.gov/35658024
This article is general information, not medical or legal advice; discuss any weight-loss medication decision with a licensed clinician who knows your health history.