Compounded drug claims FDA has flagged in telehealth ads

Current as of October 21, 2026.

The short version

Since September 2025, FDA has sent dozens of warning letters to telehealth companies over how they market compounded drugs. These include 30 announced in March 2026.
The recurring problems FDA cites include saying or implying a compounded drug is the same as, or a generic of, an approved drug. FDA also cites implying FDA approval, and branding that hides who compounds the drug.
Warning letters state FDA’s allegations. They are not findings of a violation.

Paul’s take

The rules here keep moving, so you have to stay on top of them. You don’t want to be the company that gets the letter, but you can learn from the ones that do. These letters quote the websites, which makes them the cheapest compliance review you’ll ever get.

The bigger problem I see is companies treating compliance as an aside to selling. It needs to be part of how the business runs. Build an ad review process where counsel, the business team and the marketers agree on how claims go up before they go live. Over time you’ll acquire customers more efficiently, and your costs will be lower because nobody shut you down.

— Paul Albarrán

What has FDA said about telehealth marketing of compounded drugs?

FDA has told telehealth companies that some common claims about compounded drugs are false or misleading. Its main targets are claims that a compounded drug is the same as an approved drug, or is FDA approved. Since September 2025, FDA has sent public warning letters to telehealth companies in groups.

FDA describes compounding as generally combining, mixing or altering a drug’s ingredients to create a medication tailored to an individual patient. Compounded drugs are not FDA approved. FDA does not verify their safety, effectiveness or quality before they are marketed. FDA also notes that compounded drugs are not generic drugs, which are FDA approved.

Which claims has FDA told telehealth companies to avoid?

FDA keeps a page for telehealth companies on promoting compounded drugs. As updated on June 15, 2026, it lists these claims as false or misleading:

branding that falsely or misleadingly implies the telehealth company is the compounder;
describing a compounded drug as a generic version of an FDA-approved drug, or the same as one;
claiming a compounded drug is FDA approved, or has been evaluated for safety and effectiveness;
describing a compounded drug as clinically proven to produce the same result as the approved drug;
claiming a compounded drug comes from an FDA-approved or FDA-licensed pharmacy or outsourcing facility.

FDA says it does not approve or license any facility. In one 2026 letter, FDA added that registering as a 503B outsourcing facility is not FDA approval or licensure.

What did FDA’s warning letters allege?

FDA posts its warning letters publicly. Each letter states FDA’s concerns and asks the company to respond in writing within 15 working days. The letters say the claims they list are not a complete list of FDA’s concerns.

The letters describe a consistent set of allegations:

FDA’s September 9, 2025 letter to Hims & Hers Health, Inc., dba Hims, quoted two website claims. One was “Same active ingredient as Ozempic and Wegovy”. FDA alleged that the claims implied the products were the same as an FDA-approved product.
Another letter from that date quoted website claims that labeled compounded drugs as generic versions of brand-name drugs, such as “SEMAGLUTIDE (GENERIC OZEMPIC/WEGOVY)”.
A letter dated February 20, 2026 alleged that a product label showed the telehealth brand’s name. FDA said this suggested the brand was the compounder when it was not.
A letter dated June 8, 2026 quoted a claim that a compounded drug offered the same results at a lower cost. It also cited a claim that the company’s compounding pharmacies were FDA approved.

What law do the letters cite?

The letters rely mainly on these provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 502(a) treats a drug as misbranded if its labeling is false or misleading in any particular. Section 502(bb) treats a compounded drug as misbranded if its advertising or promotion is false or misleading in any particular. Section 301(a) prohibits introducing a misbranded drug into interstate commerce. Section 301(c) prohibits receiving a misbranded drug in interstate commerce, and delivering or offering to deliver it. Several letters also cite sections 201(g) and 201(p), which define a drug and a new drug.

A February 20, 2026 letter also cited an FDA labeling rule, 21 C.F.R. § 201.1(h)(2). Under that rule, a person’s name on a drug label without qualification represents that the person is the sole manufacturer.

When did FDA send the letters?

FDA’s warning-letter index shows three groups of letters to telehealth companies about compounded drugs:

September 9, 2025. Dozens of letters, on the unlawful sale of unapproved and misbranded drugs over the internet. On September 9, 2025, HHS and FDA also announced a broader crackdown on misleading drug advertising.
February 20, 2026. About 30 letters on false and misleading claims. FDA announced them on March 3, 2026, as its second group of letters to telehealth firms.
June 8, 2026. About 25 letters on false and misleading claims.

These counts come from a search of FDA’s index on October 20, 2026. A search of that kind may not capture every letter.

In its March 2026 announcement, FDA named two main problems. One was claims implying sameness with FDA-approved products. The other was branding that implied the telehealth firm was the compounder.

Why does “essentially a copy” matter here?

Federal law limits compounding of drugs that copy approved products. Section 503A bars a pharmacy from compounding, regularly or in inordinate amounts, drugs that are essentially copies of commercially available products. Under FDA’s 2018 guidance, a 503A drug is generally a copy if it meets three tests. It has the same active ingredient as the commercial product, and a same, similar or easily substitutable strength. The commercial product can also be used by the same route of administration. It is not a copy if the prescriber determines that a change produces a significant difference for an identified individual patient. FDA’s guidance says that determination should be documented on the prescription, and that a lower price is not sufficient.

Section 503B bars an outsourcing facility from compounding drugs that are essentially copies of approved drugs. A drug identical or nearly identical to an approved drug is a copy, unless the approved drug is on FDA’s drug shortage list. The approved drug must be on that list at the time of compounding, distribution and dispensing. A drug made with an approved drug’s bulk ingredient is a copy unless a change produces a clinical difference for an individual patient. That difference is determined by the prescribing practitioner.

The companion article on 503A and 503B relationships covers the shortage history and supply contracts.

How do telehealth companies review their marketing?

A marketing review usually starts with the claims themselves. It can compare each page, ad and label with FDA’s published list. It can also check where the brand’s name appears on product images and labels. Statements about a pharmacy can be checked against its actual status, such as state licensure or 503B registration.

Contracts with pharmacy partners can assign who reviews marketing and how quickly changes are made. They can also require each side to share any FDA letter that concerns the products.

FDA’s published list and its letters show the agency’s current concerns. They do not settle every question about a particular claim, and FDA’s positions can change.

The information on this site is general information, not legal advice.