Our healthcare and business law firm works with many providers who work with compounded medications. Recently, pharmaceutical manufacturers of weight loss drugs have brought lawsuits against compounding pharmacies and medical businesses who advertise and prescribe compounded weight loss drugs. As against the medical businesses, the manufacturers bring claims of false advertising and unfair trade practices for marketing and prescribing compounded semaglutide or compounded tirzepatide for weight loss. This blog covers two considerations that providers should account for when marketing or prescribing compounded semaglutide or tirzepatide for weight loss. If you need assistance responding to a lawsuit by a pharmaceutical manufacturer or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.
Background
Semaglutide and tirzepatide are peptides that are in popular drugs, including Ozempic®, Wegovy®, Mounjaro®, and Zepbound®. The Food and Drug Administration (“FDA”) originally approved Ozempic® and Mounjaro® for type-2 diabetes. These drugs gained enormous popularity as a weight-loss drug, so doctors started prescribing Ozempic® off label for weight-loss use. The FDA later approved Wegovy® and Zepbound® for weight loss. Because the popularity of these drugs soared, a drug shortage resulted. Because there was low supply and high demand, providers and pharmacies decided to sell compounded versions of semaglutide and tirzepatide. Compounded versions of drugs are not FDA-approved, so they are not subject to FDA scrutiny before they are sold on the market.
In October 2024, the FDA removed tirzepatide from the drug shortage list, and compound pharmacies filed a lawsuit, seeking to invalidate the decision on the grounds that it was arbitrary and capricious. On April 24, 2025, the district court judge denied the compounding pharmacies’ motion for a preliminary injunction, and the FDA announced they would not take action against providers for marketing or selling compounded versions of semaglutide until May 22, 2025.
First Consideration: Federal and State Governments Are Aware of the Risks of Compounded Semaglutide
The FDA has recently issued guidance expressing the agency’s concerns about compounded versions of semaglutide and tirzepatide as being risky for patients. Regarding compounded semaglutide, the FDA is concerned about dosing errors because compounded semaglutide may have a higher dosage of semaglutide or may recommend a higher dosage schedule than what is approved in Ozempic® or Wegovy®. As a result, the FDA has received about 1,000 adverse events associated with compounded semaglutide and tirzepatide.
Additionally, the FDA is aware of counterfeit Ozempic® being marketed, and counterfeit Ozempic® is dangerous because the counterfeit drugs may contain incorrect ingredients or other harmful ingredients, instead of semaglutide, and may cause additional harm to patients. Selling counterfeit drugs is illegal, and it is also illegal to sell drugs that are labeled as “for research purposes only” or “not for human consumption” and then market it for human use. The FDA has warned companies who have sold compounded semaglutide in this way because these products may cause unknown effects and ultimately may be harmful to humans.
State attorneys general are also aware of the dangers of counterfeit semaglutide, and the National Association of Attorneys General issued a bipartisan letter, signed by 38 state attorneys general, to the FDA requesting the federal government to take action against those involved in making counterfeit Ozempic®. State attorneys general are also involving themselves. For example, Illinois’s Attorney General issued a cease and desist to five med spas in Chicago about misleading the public about selling Ozempic® or Wegovy® when they are, in fact, selling compounded versions. Other state attorneys general, such as South Carolina, have issued public statements warning state residents about the dangers of compounded tirzepatide and semaglutide. We are continuing to monitor if state attorneys general begin prosecuting med spas and providers in this area on state law grounds for deceptive trade practices.
Second Consideration: Drug Manufacturers Are Suing Providers Who Sell Compounded Weight Loss Drugs
Novo Nordisk, the manufacturer of Ozempic® and Wegovy®, and Eli Lilly, the manufacturer of Zepbound® and Mounjaro®, have filed lawsuits against med spas and other providers who are selling compounded semaglutide and tirzepatide. Novo Nordisk has filed 111 lawsuits across 32 states, claiming entities have unlawfully marketed and sold compounded semaglutide. In these lawsuits, Novo Nordisk has accused the med spa or provider of false advertising under state and federal law and unfair or deceptive trade practices under state law.
On April 23, 2025, Eli Lilly filed four lawsuits against telehealth companies selling compounded Zepbound® and Mounjaro®. In each lawsuit, Eli Lilly accuses the telehealth companies of false advertising under state and federal law and unfair competition under state law.
If you need assistance complying with the changing weight loss landscape or responding to a lawsuit related to compounded semaglutide or tirzepatide or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.