FDA Moves to Restrict Mass-Marketed Compounded GLP-1 Weight Loss Products

The FDA announced plans to take action to restrict the use of glucagon-like peptide-1 (GLP-1) active pharmaceutical ingredients in non-FDA-approved compounded drugs that are being mass-marketed as alternatives to approved products, including those by companies such as Hims & Hers and certain compounding pharmacies. The agency said the move is intended to protect consumers from medications whose quality, safety, and efficacy it cannot verify and emphasized that it takes potential violations of the Federal Food, Drug, and Cosmetic Act seriously.

The FDA stated that it is acting to address misleading direct-to-consumer advertising after issuing warning letters in the fall of 2025. Companies marketing non-FDA-approved compounded products cannot claim they are generic versions of, equivalent to, or the same as FDA-approved drugs. Additionally, companies may not assert that compounded drugs contain the same active ingredients as approved products or that they are clinically proven to deliver results.

Compounded drugs are not FDA-approved, which means that the FDA does not review their safety, effectiveness, or quality before they are marketed. Compounded drugs could lead to serious injury or death if the drug does not meet appropriate quality standards, including contamination or containing too much active ingredient. The FDA noted that compounded drug labels may lack essential information, such as adequate directions for safe use.

High demand for GLP-1 medications for weight loss, including semaglutide (Wegovy) and tirzepatide (Zepbound), led to shortages soon after their approval. Combined with limited insurance coverage and high out-of-pocket costs, these shortages have prompted some patients to turn to compounded versions as alternatives.

Injectable GLP-1 receptor agonists require refrigeration, but the FDA has received complaints that some compounded versions arrived warm or improperly cooled, potentially affecting quality. The agency has also identified fraudulent compounded semaglutide and tirzepatide products with false or misleading labels, including listings of nonexistent or uninvolved pharmacies.

The FDA has received reports of adverse events, some requiring hospitalization, which were linked to dosing errors and the use of compounded products at doses exceeding those in FDA-approved labeling. Reported symptoms include nausea, vomiting, diarrhea, abdominal pain, and constipation. The FDA noted that although some adverse events are consistent with those seen in approved GLP-1 drugs, it is likely some are underreported because most state-licensed compounding pharmacists are not required to submit event reports to the FDA.

The FDA emphasized that compounded drugs should be used only when a patient's medical needs cannot be met by an FDA-approved product. Patients are advised to obtain a prescription from their physician and fill it at a state-licensed pharmacy.

The FDA said it will use all available compliance and enforcement authorities to address unsubstantiated claims and related public health concerns. They warned that manufacturers, distributors, and marketers of unapproved compounded GLP-1 products who fail to correct violations may face legal action without further notice, including seizure or injunction.

Because compounded drugs can also serve important medical needs for patients, the FDA aims to balance preserving access to legally marketed compounded medications for patients with legitimate medical needs while protecting the public from risks associated with compounded drugs that are not produced in compliance with federal law.