FDA sent warning letters to telehealth companies in September 2025, March 2026 and June 2026 under the misbranding provisions, sections 502(a) and 502(bb). It objected to implied FDA approval, implied equivalence to brand-name drugs, company names on labels of products they did not compound, and calling pharmacies FDA-licensed. Describe compounded products plainly and name the compounder.
Market a compounded GLP-1 program by describing exactly what the patient gets: a compounded drug, made by a named pharmacy, that FDA has not approved or reviewed for safety, effectiveness or quality, prescribed only if a licensed clinician decides it is appropriate. FDA's warning letters in September 2025, March 2026 and June 2026 objected to the opposite: websites that implied FDA approval, implied equivalence to brand-name approved drugs, and put the telehealth company's name on the product as if it made it.
This is a description of FDA's stated positions for operators and their marketing teams. Legal review of your claims belongs with counsel.
When did FDA act?
- September 9, 2025. FDA and HHS announced a crackdown on misleading direct-to-consumer drug advertising, with thousands of letters and about 100 cease-and-desist letters. Warning letters went to telehealth companies selling compounded semaglutide and tirzepatide; Holland & Knight described it as the first time regulators specifically targeted telehealth companies over advertising for compounded products.
- Early March 2026. About 30 more warning letters to telehealth firms over compounded GLP-1 marketing, as reported by Drug Topics and others.
- June 2026. 25 more warning letters, summarized by McDermott Will & Emery on June 30, 2026.
What was the legal basis?
Misbranding. The June letters cited sections 502(a) and 502(bb) of the Food, Drug, and Cosmetic Act. Section 502(bb) (21 U.S.C. 352(bb)) deems a compounded drug misbranded "if the advertising or promotion of a compounded drug is false or misleading in any particular." Section 502(a) covers false or misleading labeling. A misbranded drug may not lawfully be introduced into interstate commerce. Companies were given 15 business days to respond.
Which claims did FDA object to?
McDermott's summary of the June 2026 letters groups them into three categories:
- Misidentifying the compounder. Product images on the site showed the telehealth company's name on the label, though the company did not compound the product.
- Implied approval or safety review. Statements representing that the compounded products had been approved by FDA or otherwise evaluated for safety.
- Claims about the pharmacy. Describing the compounding pharmacy as "FDA-approved" or "FDA-licensed," which FDA does not grant to pharmacies.
Earlier letters, as summarized by Holland & Knight and others, also cited claims of sameness between compounded products and brand-name approved drugs, and claims that obscured where the product came from.
How should you review the website?
Product pages
- Name the drug as compounded semaglutide or compounded tirzepatide, not by a brand name and not as a version of a brand.
- State that compounded drugs are not approved by FDA and FDA does not review them for safety, effectiveness or quality.
- Name the pharmacy that compounds the product, and whether it is a 503A pharmacy or a 503B outsourcing facility.
- Show product images only with the pharmacy's actual label, or no product image.
- Remove clinical outcome figures drawn from brand-name drug trials. Those trials studied the approved drugs, not your compounded product.
Ads and social
- No brand names of approved drugs in ads for compounded products.
- No before-and-after claims without substantiation for the typical patient.
- No promise of a prescription. A clinician decides, and some patients will not qualify. See the advertising claims checklist.
- Influencer and affiliate content is your advertising too. Give them approved language and monitor it.
Intake and checkout
- Price displayed is the real price, including any membership, with the renewal and cancellation terms stated before payment. The FTC's 2024 Cerebral order included refunds for deceptive cancellation practices.
- Intake that routes to a clinician who can decline, with no automatic approval language.
Privacy
- Weight-loss intake answers are health information. Check what your pixels send. See tracking pixels on telehealth sites.
Is compounding itself the problem?
FDA's letters focused on false or misleading promotion, not on the existence of compounding. Whether a pharmacy may lawfully compound a particular GLP-1 product for a particular patient is a separate question under sections 503A and 503B, and it changed when FDA declared the tirzepatide and semaglutide shortages resolved. See compounded GLP-1s after the shortages ended.
If you receive a letter
- Call counsel the same day; the response window is short.
- Preserve the site and ads as they were when the letter issued.
- Fix the cited claims everywhere, not only on the cited page: ads, emails, affiliate content, app store listings.
- Expect follow-up. FDA posts warning letters publicly, and plaintiffs' firms read them.
Our Service-Line Pivot Package ($3,950) reviews a weight-loss program's claims, pharmacy relationship and clinical protocols together for counsel's review. See running a compliant telehealth weight-loss program and pricing.
Common questions
- Why did FDA send warning letters to GLP-1 telehealth companies?
- For false or misleading promotion of compounded semaglutide and tirzepatide, which makes a compounded drug misbranded under section 502(bb) of the Food, Drug, and Cosmetic Act. Letters cited implied FDA approval, implied equivalence to brand-name drugs, and labels naming the telehealth company instead of the compounder.
- Can a telehealth company use Ozempic or Wegovy in ads for compounded semaglutide?
- FDA's letters objected to claims that implied a compounded product was equivalent to brand-name approved drugs. Using brand names to sell a compounded product invites exactly that reading. Name the compounded drug and the pharmacy instead, and have counsel review the copy.
- What disclosures should a compounded GLP-1 page include?
- That the product is compounded, that compounded drugs are not approved by FDA or reviewed for safety, effectiveness or quality, the name of the compounding pharmacy, and that a licensed clinician decides whether a prescription is appropriate.
- How long do companies have to respond to an FDA warning letter?
- The June 2026 letters asked for a response within 15 business days. Counsel should be involved immediately, the cited claims fixed everywhere they appear, and the site preserved as it was when the letter issued.
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