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The Day FDA Warned 58 Telehealth Sellers — and Both Drugmakers

One day in September 2025, FDA warned 58 telehealth sellers of compounded GLP-1s. The same day it warned Eli Lilly and Novo Nordisk. What that tells you.

By Marla Whitfield, Pricing Editor

A warning letter from the Food and Drug Administration is written in the language of violation. It names statutes, it says a product is misbranded, it warns of seizure and injunction, and it lands in a public database that anyone can search by company name for the rest of that company's life. Read cold, it looks like a verdict.

It is not one, and the clearest proof we have found is a single day.

Letters that day

69

To telehealth

58

To Lilly & Novo

4

In September 2025, FDA sent warning letters to 58 telehealth companies over how they marketed compounded GLP-1 drugs. On the same day, it sent four more: three to Eli Lilly and Company, one to Novo Nordisk Inc. Those are the two companies that make the drugs all 58 of the other letters are about.

We read all four, plus two of the telehealth letters, in full. This is what they say, what they have in common, where they genuinely differ, and why a letter in this database is a disclosure rather than a disqualification.

Sixty-nine letters in one day

We did not take the count on trust. FDA publishes a searchable index of every warning letter it has issued; we paginated the whole thing and filtered on the issue date rather than on any company name.8

Sixty-nine letters carry that date. Fifty-eight of them carry the subject line "Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)". Seven carry "False & Misleading Claims/Misbranded" — and four of those seven went to the manufacturers. The remaining three went to two other pharmaceutical companies. We did not read those three bodies, so this article says nothing about what they allege.

The letter numbers interleave

FDA gives each letter a MARCS-CMS number, and the four manufacturer letters do not sit in a block of their own. They fall between the telehealth letters, in the same run:

  • 716458 — a telehealth seller
  • 716462 — Eli Lilly and Company
  • 716475 — Eli Lilly and Company
  • 716484 — a telehealth seller
  • 716485 — Eli Lilly and Company
  • 716487, 716488 — telehealth sellers
  • 716495 — Novo Nordisk Inc.
  • 716501 — a telehealth seller

We make no claim about how FDA assigns those numbers. The observable fact is only that the manufacturers' letters are threaded through the same sequence as the sellers' letters, not filed apart from them.

The subject line is not the allegation

Before quoting anything, a warning about the database itself, because it is the trap this article was nearly written into.

The subject line FDA's index prints against a letter is not a summary of that letter. For the September 2025 telehealth wave it is actively misleading — and it is what a journalist, a competitor or a nervous customer sees first, because it is the only text on the search results page.

What the index says, and what the letter says

The index prints this against 58 letters:

"Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)"

That reads as illegal-sales enforcement. Here is what the body of one of those 58 actually alleges, in full — this is the entire cited violation:

"The following claim concerning compounded semaglutide and tirzepatide products appears on your website: 'GLP-1 medications are FDA-approved and backed by extensive clinical research….'"

"Compounded drug products are not FDA-approved. Your claim implies that your products are the same as an FDA-approved product when they are not. As a result, this claim is false or misleading and your products are therefore misbranded."

One sentence on a marketing page.5 Not a sale, not a shipment, not a product defect. The letter is an advertising letter with a sales letter's subject line.

The four manufacturer letters do not have that problem. All four are filed under "False & Misleading Claims/Misbranded", and that is a fair description of what their bodies allege. The asymmetry is worth naming plainly: on this particular day, FDA's index described the drug companies' letters accurately and the telehealth companies' letters more harshly than their contents support.

What FDA told Eli Lilly

Three letters, all naming Zepbound, one also naming Mounjaro. Two of the three are near-twins.

716462 and 716475 — two sponsored local-television segments

Both concern a sponsored interview segment featuring the same two Lilly executives, published on a local news website. FDA's core finding in the first, verbatim:

"The video, which features a reporter introducing Dr. Lee and Ms. Pacheco as representatives from Eli Lilly, contains claims and representations about obesity and the benefits of Zepbound but fails to communicate any risk information."

"The video, however, entirely omits risk information. By omitting the risks associated with Zepbound, the video fails to provide material information about the consequences that may result from the use of Zepbound and creates a misleading impression about the drug's safety."

The second letter makes the same finding about a second segment.2 Both also cite a filing failure — the videos were not submitted to FDA on Form FDA-2253 at the time of publication, as the advertising regulations require.1

There is a detail inside those two letters that is easy to sensationalise and should not be.

What the executives were saying when FDA objected

The segments FDA cited were, in substance, warnings to consumers about unapproved weight-loss drugs. FDA quotes a Lilly medical executive telling viewers that adults with obesity should:

"look out for FDA-approved safe and authentic medicines if they are already on treatment for obesity and to avoid those unapproved ones. . . ."

And in the second segment:

"if pharmacotherapy is indicated, . . . make sure they have access to the FDA-approved, authentic and safe medicines . . . ."

FDA did not object to that message. Nothing in either letter criticises the advice or the anti-counterfeit framing. What FDA objected to is narrower and entirely procedural in character: a promotional communication about a prescription drug has to present that drug's risks, and these presented none.1

It is still worth registering. On one day, the agency told 58 sellers that calling a compounded drug FDA-approved was misleading — and told the manufacturer that a broadcast urging consumers toward FDA-approved drugs was also misleading, for a different reason.

One broadcast, two companies, two letters

The remaining Lilly letter and the Novo Nordisk letter concern the same thing: a 42-minute prime-time television special about weight-loss drugs, later carried on a streaming service. Lilly got one letter about it. Novo Nordisk got another. Both letters quote the same on-air exchanges.

The finding both letters share

On the balance of the programme:

"Of the 42-minute video, only four minutes in total are devoted to the important shared risks associated with GLP-1s"

On what was said in those four minutes, quoted identically in both letters:

"There's been a lot of hype around like pancreatitis, gallbladder complications, concerns for thyroid cancer. This has really not been shown in human studies that this is a downstream complication, and that really the risk is less than 1%."

"I think that they've gotten overhyped. Medicines have side effects, but the important part is that they're mild to moderate in the research studies."

And FDA's own characterisation of those statements:

"the statements that 'there's been a lot of hype' about the risks and they are 'rare, but…there' are especially egregious, given the nature of the risks to patients from GLP-1 treatment"

Both letters also record that the two clinicians who made the statements were paid consultants of the company being written to, with the payment records cited to a federal database.3

Both letters also carry a section headed "Prior Communications", and that section is the part of this story least likely to appear anywhere else. FDA lists the advisory comments it had already sent each company about the same category of problem before it escalated to a warning letter. For Novo Nordisk the list runs to seven sets of comments across Victoza, Ozempic and Wegovy, the earliest dated 2010, then 2011, 2013, 2016, 2018 and 2021.4 For Lilly it runs to comments on Mounjaro in 2022 and on Zepbound in 2024.3

Which is to say: a warning letter to a company this size is usually the visible end of a long, invisible correspondence, not a bolt from a clear sky.

Same statute, different hook

This is where the two kinds of letter genuinely part company, and flattening the difference would be the easy mistake.

Section 502(a)
A drug is misbranded if its labeling is false or misleading in any particular. Cited in the telehealth letters AND in all four manufacturer letters. This is the shared spine.
Section 502(bb)
Misbranding specific to compounded drugs — false or misleading advertising or promotion. Cited in the telehealth letters. It has no application to an approved product, and appears in none of the manufacturer letters.
Section 502(n) and 21 CFR 202.1
The prescription-drug advertising rules, including risk presentation. Cited in all four manufacturer letters. They govern advertising of approved drugs, and appear in none of the telehealth letters.
21 CFR 314.81(b)(3)(i)
The requirement to file promotional material with FDA on Form FDA-2253 when it is first published. Cited in all four manufacturer letters; not applicable to the telehealth letters.
Section 301(a)
Introducing a misbranded drug into interstate commerce is a prohibited act. Cited in both kinds of letter.

The offices differ too. A telehealth company is told to respond to the Office of Compounding Quality and Compliance; Lilly and Novo Nordisk are told to respond to the Office of Prescription Drug Promotion. Two different desks, one centre, one day.

So these are not identical letters, and anyone claiming they are has not read them. What they are is two sweeps run by two offices of the same FDA centre on the same day, each alleging that a promotional communication was false or misleading, each landing on misbranding under section 502(a), and each signed by the same official — the Director of the Center for Drug Evaluation and Research.

The sentence that appears in every one of them

Word for word, in the letters to the telehealth sellers and in the letters to Eli Lilly and Novo Nordisk alike:

"Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction."

That sentence is not a description of something that has happened. It is a description of something that might happen if a company does not fix what FDA has pointed at. It is boilerplate — which is exactly the point, because it is the same boilerplate for a two-person telehealth startup and for a company with a market capitalisation in the hundreds of billions.

What a warning letter is, in FDA's own words

FDA publishes a manual describing what these letters are for. It is unusually blunt, and it settles the question better than any commentary could.7

"A Warning Letter is informal and advisory. It communicates the agency's position on a matter, but it does not commit FDA to taking enforcement action. For these reasons, FDA does not consider Warning Letters to be final agency action on which it can be sued."

"A Warning Letter constitutes official but not final agency action."

"Warning Letters are issued to achieve voluntary compliance and to establish prior notice."

  1. 1

    Letter issued

    FDA states its position and asks for correction.

  2. 2

    15 working days

    The company must respond in writing.

  3. 3

    Close-out, if issued

    FDA may post one once satisfied the cited issues were corrected.

The exception that proves the rule

One caveat, because a rule with no exception is usually a rule that has not been tested.

Of the 58 telehealth letters from that day, one does allege what its subject line says. Its body opens by alleging that the company's retatrutide products are "unapproved new drugs and misbranded drugs introduced or delivered for introduction into interstate commerce", citing the drug-approval and adequate-directions provisions of the Act — not only the advertising ones.6 That is a materially heavier allegation than a single misleading sentence on a marketing page.

It is also, of the 50 warning letters this site publishes, the only company we have found that has since stopped operating.

That is the distinction worth carrying away. It is not the existence of a letter that separates the two, and it is not the subject line. It is what the body alleges, and what happened afterwards.

How we read the 50 letters on this site

Every letter page we publish carries the same line: a warning letter discloses, it does not disqualify. Until now that was our assertion. It is now a citation.

  • A letter alone tells you almost nothing about a company's size, legitimacy or safety. On one day in September 2025 it was sent to 58 telehealth sellers and to the two largest manufacturers in the category.
  • Marketing letters are the common case. The overwhelming majority of what we publish concerns claims made in advertising — the same category of problem that produced four letters to Lilly and Novo Nordisk.
  • Read the body, never the subject line. On this evidence the index can describe a small company's letter more harshly than its contents warrant.
  • What actually changes our reading is a body alleging unapproved drugs or a product-quality failure, a pattern of repeat letters, or a company that stops operating.

Novo Nordisk received a further letter in March 2026 on an entirely different subject — post-marketing adverse-event reporting.8 We have not read that body and make no claim about what it alleges. We note it only because it is the ordinary condition of a large pharmaceutical company to have letters in this database, which is the whole argument of this piece.

You can read every letter we cover, with its body quoted and its status checked, on our FDA warning letters index. Twenty-two of those 50 letters were issued on the day this article is about, including the two quoted above: letter 715879 and letter 715883.

Frequently asked questions

Does an FDA warning letter mean a company broke the law?

No. FDA's own Regulatory Procedures Manual states that a warning letter 'is informal and advisory', that 'it does not commit FDA to taking enforcement action', and that FDA 'does not consider Warning Letters to be final agency action'. It sets out the agency's position and asks for correction; a finding that the law was broken would come from a court.

Did Eli Lilly and Novo Nordisk really get warning letters about GLP-1 drugs?

Yes. In September 2025, FDA issued three warning letters to Eli Lilly and Company (MARCS-CMS 716462, 716475 and 716485) and one to Novo Nordisk Inc. (716495), all concerning direct-to-consumer promotional videos for Zepbound, Mounjaro, Wegovy, Ozempic and Victoza. All four allege that the videos omitted or minimised risk information. They were issued on the same day as 58 letters to telehealth companies selling compounded GLP-1s.

Are the letters to the manufacturers the same as the letters to telehealth companies?

Not quite, and the difference matters. Both allege misbranding under section 502(a) of the Food, Drug, and Cosmetic Act and a prohibited act under section 301(a), and both are signed by the same FDA official. But the telehealth letters also cite section 502(bb), which applies only to compounded drugs, while the manufacturer letters cite the prescription-drug advertising rules and the Form FDA-2253 filing requirement, which apply only to approved drugs. Responses go to two different FDA offices.

Should I avoid a telehealth provider that received a warning letter?

A letter on its own is not a reason to. What matters is what the body alleges, whether the issue was corrected, and whether the company is still operating. Of the 50 letters covered on this site, the only company we have found to have stopped operating is also the one whose letter alleges unapproved new drugs rather than a misleading marketing claim.

References

  1. U.S. Food and Drug Administration (2025). Warning Letter to Eli Lilly and Company (MARCS-CMS 716462). FDA Center for Drug Evaluation and Research. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eli-lilly-and-company-716462-09092025
  2. U.S. Food and Drug Administration (2025). Warning Letter to Eli Lilly and Company (MARCS-CMS 716475). FDA Center for Drug Evaluation and Research. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eli-lilly-and-company-716475-09092025
  3. U.S. Food and Drug Administration (2025). Warning Letter to Eli Lilly and Company (MARCS-CMS 716485). FDA Center for Drug Evaluation and Research. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eli-lilly-and-company-716485-09092025
  4. U.S. Food and Drug Administration (2025). Warning Letter to Novo Nordisk Inc. (MARCS-CMS 716495). FDA Center for Drug Evaluation and Research. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novo-nordisk-inc-716495-09092025
  5. U.S. Food and Drug Administration (2025). Warning Letter to Sprout Health Partners LLC dba Sprout Health (MARCS-CMS 715879). FDA Center for Drug Evaluation and Research. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sprout-health-partners-llc-dba-sprout-health-715879-09092025
  6. U.S. Food and Drug Administration (2025). Warning Letter to GLP-1 Solution (MARCS-CMS 715883). FDA Center for Drug Evaluation and Research. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glp-1-solution-715883-09092025
  7. U.S. Food and Drug Administration (2024). Regulatory Procedures Manual, Chapter 4: Advisory Actions (MAN-000007, Revision 12). FDA Office of Regulatory Affairs. https://www.fda.gov/media/71878/download
  8. U.S. Food and Drug Administration (2026). Warning Letters (searchable index of issued warning letters). FDA Inspections, Compliance, Enforcement, and Criminal Investigations. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters

Medical disclaimer: This content is for general educational purposes only and is not medical advice, diagnosis, or treatment. Always consult a licensed healthcare professional before starting, stopping, or changing any treatment.

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