US FDA sends 25 letters to telehealth companies over claims on compounded weight-loss drugs

Live updates

1. 6d ago

   FDA increases warning letters to telehealth firms over compounded GLP-1 claims

   The FDA issued 30 warning letters to telehealth companies for using false or misleading claims about compounded GLP-1 products on their websites. This regulatory pressure coincides with a separate legal battle for Hims & Hers. The FTC and the states of California and Utah sued the company for allegedly sharing patient health data with advertisers and deceiving customers regarding billing, subscriptions, and cancellations. Hims & Hers has described these specific allegations as baseless.

   Why it matters

   The FDA targets these firms to prevent patient safety risks caused by inappropriate promotions of weight-loss drugs. These actions occur as federal and state regulators increase scrutiny of telehealth business practices.

   What is confirmed

   • The FDA issued 30 warning letters to telehealth companies for false or misleading claims regarding compounded GLP-1 products.
   • The FTC and the states of Utah and California sued Hims & Hers over alleged privacy violations and deceptive billing practices.
   • Regulators allege Hims & Hers shared consumer health information with advertisers.

   Still unconfirmed

   • Hims & Hers charged patients without consent and used a cumbersome cancellation policy.
   • Hims & Hers claims the FTC allegations are baseless.

   What to watch next

   • Court rulings in the FTC and state lawsuits against Hims & Hers
   • Further FDA enforcement actions against the 30 warned telehealth companies
   Sources used for this update (5)

   1. www.fda.gov — FDA Warns 30 Telehealth Companies Against Illegal Marketing of ...
   2. www.healthline.com — Thyroid Medication Recalled Nationwide: What to Do If Yours Is Affected
   3. www.forbes.com — FTC Claims Hims & Hers Charged Patients Without Consent And Shared Health Data With Big Tech
   4. medcitynews.com — Why Hims & Hers Is Embroiled in Yet Another Controversy, This Time with the FTC
   5. www.healthcaredive.com — FTC sues Hims & Hers over alleged privacy violations, deceptive billing practices
   confidence 100%
2. 41d ago

   FDA Targets Telehealth Firms Over Compounded GLP-1 Marketing

   The FDA issued 25 warning letters to telehealth companies for misleading claims about compounded GLP-1 receptor agonists. The agency is concerned that false promotions may compromise patient safety. This action targets five specific categories of inappropriate behavior.

   What's confirmed:

   • The FDA issued 25 warning letters to telehealth companies for misleading marketing of compounded GLP-1 receptor agonists.
   • The agency identified five categories of inappropriate promotional behavior.
   • The FDA is concerned about telehealth companies using false or misleading claims to promote compounded drugs including GLP-1s.

   Still unconfirmed:

   • FDA enforcement activity seemed to slow in mid-2026 before this new wave of letters.
   Sources used for this update (4)

   1. FDA's Focus Returns To Compounding And Telehealth: Another ... - Mondaq
   2. Telehealth Regulatory Compliance for GLP-1 Receptor Agonists
   3. FDA Enforcement Action GLP-1: Clinical Evidence & Safety
   4. What to Know When Promoting Compounded Drugs - FDA
   confidence 90%
3. 44d ago

   FDA Issues 25 Warning Letters to Telehealth Firms Over Compounded Drug Claims

   The FDA issued 25 warning letters to telehealth companies for misleading marketing of compounded GLP-1 receptor agonists. The agency identified five categories of inappropriate promotional behavior that may compromise patient safety. These include false claims regarding FDA approval and the interchangeability of compounded drugs with approved therapies.

   What's confirmed:

   • The FDA issued 25 warning letters to telehealth companies regarding misleading marketing of compounded medications.
   • The agency targeted the promotion of compounded glucagon-like peptide-1 receptor agonists.
   • The FDA identified five categories of inappropriate promotional behavior.
   • Prohibited claims include suggesting compounded products are interchangeable with approved therapies or have undergone FDA safety evaluation.
   • The FDA stated that designations such as FDA-approved or FDA-licensed facilities do not exist in the context of compounding.

   Still unconfirmed:

   • The FDA is rethinking its block on compounding pharmacies producing Eli Lilly's tirzepatide due to a lawsuit.
   Sources used for this update (4)

   1. US FDA sends 25 warning letters to telehealth firms over compounded ...
   2. FDA Clarifies Marketing Limits for Compounded GLP-1 Drugs Amid Ongoing ...
   3. US FDA Issues 25 Warning Letters to Telehealth Firms Over False Weight ...
   4. FDA rethinking block on compounding of Lilly's obesity drug
   confidence 90%
4. 48d ago

   FDA issues 25 warning letters to telehealth firms over compounded weight-loss drugs

   The US FDA sent 25 warning letters to telehealth companies making misleading claims about compounded versions of diabetes and weight loss drugs. These products target versions of medications from Novo Nordisk and Eli Lilly. A primary-source database now tracks these letters.

   What's confirmed:

   • The US FDA issued 25 warning letters to telehealth companies for marketing false and misleading claims about compounded versions of Eli Lilly and Novo Nordisk weight loss and diabetes drugs.
   • An independently maintained database links to the original fda.gov letters issued to compounded GLP-1 telehealth providers.
   Sources used for this update (2)

   1. US FDA sends 25 letters to telehealth companies over claims on ...
   2. FDA Warning Letters: Compounded GLP-1 Telehealth Providers
   confidence 100%
5. 49d ago

   FDA Issues 25 Warning Letters to Telehealth Firms Over GLP-1 Marketing

   The FDA is targeting telehealth companies that market compounded GLP-1 products like semaglutide and tirzepatide. Regulators are focused on false or misleading claims that suggest these compounded versions are equivalent to FDA-approved drugs. This effort is part of a broader initiative to curb misleading direct-to-consumer pharmaceutical ads.

   What's confirmed:

   • The FDA issued 25 warning letters to companies marketing compounded GLP-1 products.
   • Targeted medications include semaglutide and tirzepatide.
   • The agency is challenging marketing claims that lead consumers to believe compounded products are equivalent to FDA-approved drugs.
   • The FDA is working to rein in misleading direct-to-consumer pharmaceutical advertisements.
   Sources used for this update (3)

   1. FDA Targets Telehealth GLP-1 Marketing Claims in Sweeping Enforcement ...
   2. FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
   3. FDA, HHS Taking Action Against Telehealth's Compounded Drug Advertising
   confidence 100%
6. 49d ago

   FDA Issues 25 Warning Letters to Telehealth Firms Over Compounded GLP-1 Claims

   The US FDA sent 25 warning letters to telehealth companies for making false and misleading claims about compounded weight-loss and diabetes drugs. These copycat versions of medications from Eli Lilly and Novo Nordisk are not proven to be safe, effective, or of consistent quality. The agency is cracking down on the unauthorized marketing of these GLP-1 receptor agonist drugs.

   What's confirmed:

   • The FDA issued 25 warning letters to telehealth companies for marketing false and misleading claims about compounded versions of weight loss and diabetes drugs.
   • The warning letters targeted compounded versions of drugs from Eli Lilly and Novo Nordisk.
   • The FDA stated that these compounded products have not been proven to be safe, effective, or of consistent quality, unlike FDA-approved drugs.
   • The FDA cited more than two dozen telehealth companies for marketing compounded glucagon-like peptide-1 receptor agonist drugs without authorization.

   Still unconfirmed:

   • Life-threatening GLP-1 overdoses are increasing.
   • Some consumers have been scammed while buying GLP-1s online.
   Sources used for this update (13)

   1. Life-threatening GLP-1 overdoses are on the rise — what’s behind the scary increase
   2. US FDA sends 25 letters to telehealth companies over claims on compounded weight-loss drugs
   3. I Was Scammed Buying GLP-1s Online. I’m Not Alone
   4. POLL: What's causing the spike in weight-loss drug mistakes?
   5. FDA cites companies for CGMP violations, telehealth firms for illegally marketing GLP-1 drugs
   6. US FDA sends 25 letters to telehealth companies over claims on compounded...
   7. Federal Trade Commission sues leading transgender health group
   8. US FDA sends 25 letters to telehealth companies over claims on ...
   9. FDA Warns Companies Over Misleading Claims of GLP-1 Copycats
   10. FDA cites companies for CGMP violations, telehealth firms for illegally ...
   11. FDA Warns Telehealth Companies Against Misleading Claims on Compounded ...
   12. Novo joins Lilly in asking FDA for ban on GLP-1 compounding
   confidence 100%