Fraud, Counterfeits, and Unsafe Doses: NCL Sounds Alarm on Compounded GLP-1 Market
Media Contact: Lisa McDonald, Vice President of Communications, 202-207-2829
Washington, DC – On behalf of the millions of consumers who have been lulled into believing that compounded GLP-1s are safe and effective for weight loss, the National Consumers League (NCL) appreciates the Food and Drug Administration’s updated policy statement warning that these drugs can carry significant health risks and should only be taken by patients who cannot tolerate the widely available FDA-approved GLP-1 medicines.
Specifically, the FDA’s statement makes clear that:
Compounded GLP-1s are unapproved products that do not undergo the FDA’s review for safety, effectiveness, and quality before they are marketed.
Compounded GLP-1s carry significant safety risks and may cause serious adverse events, hospitalizations, and in some cases death. These adverse events are directly linked to dosing errors when patients measure and self-administer incorrect doses of the drug, and in some cases, when health care professionals miscalculate doses of the drug.
The FDA has received 1,150 reports of adverse events related to compounded versions of semaglutide and tirzepatide as of July 31, 2025. Because federal law does not require all compounders to submit adverse reaction reports, these numbers are the tip of the iceberg in terms of harm to consumers.
The FDA is aware of fraudulent compounded semaglutide and tirzepatide marketed in the U.S. that contain false information on the product label.
The FDA is also aware that counterfeit GLP-1s are widely available online and may contain the wrong ingredients, contain too little, too much, or no active ingredient at all, or other harmful ingredients, and are illegal.
Similarly, the agency is warning the public that bad actors are illegally selling directly to consumers unapproved ingredients falsely labeled “for research purposes” or “not for human consumption,” which are extremely dangerous.
Making these concerns known is necessary to protect the public, but the National Consumers League calls on the FDA to take the next step by issuing regulations that will actually solve these problems and keep Americans safe.
Unless the FDA acts forcefully, the tide of misleading online marketing of compounded GLP-1 drugs will continue, and the public will be faced with a “caveat emptor” approach that requires patients to fend for themselves. As a consequence, consumers will continue to choose treatments that may increase their health risks or opt for fraudulent and counterfeit drugs, including dangerous products that are falsely labeled “for research purposes” or “not for human consumption.”
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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
