FDA Escalates Enforcement Against Compounded GLP-1 Marketing

By Rebecca Zadaka

The U.S. Food and Drug Administration (FDA) has recently issued 30 warning letters to telehealth companies regarding the illegal marketing of compounded Glucagon-Like Peptide-1 Receptor Agonist (GLP-1) medications. This signals a significant escalation in the FDA’s oversight of the rapidly expanding weight-loss drug market and marks a second wave of enforcement following the Agency’s broader crackdown on pharmaceutical direct-to-consumer (DTC) advertising.

For companies operating in the telehealth, pharmacy compounding, and digital health sectors, FDA is sending a clear message: Compounding cannot be used as a way to mass-market GLP-1 drugs or to bypass FDA approval requirements. Drug compounding is intended to address patient-specific medical needs, such as allergies, a need for a different dosage form, or when the FDA-approved drug is not medically appropriate to treat a particular patient. Compounded drugs are not FDA-approved, so the FDA does not review the drugs’ safety, effectiveness, or quality before they are marketed. 

FDA’s Concerns with Compounded GLP-1 Marketing

FDA’s warning letters state that telehealth companies are making false or misleading claims about compounded GLP-1 drugs. Many of the letters cite claims implying that compounded GLP-1 drugs have been FDA approved, evaluated for safety and effectiveness, or are the same as FDA-approved reference products. Examples cited by FDA include the following statements: 

• “[A] proven medication” 
• “Clinically studied and shown to deliver powerful results when combined with healthy habits”
• "from the same family as GLP-1 treatments like Mounjaro® and Zepbound®” and
• “It contains the same active ingredient as FDA-approved medications”

Per FDA, claims such as the above examples imply that these compounded drugs have been reviewed and approved by the Agency, or that they have been shown to be safe and effective, when they have not. As a result, the FDA concluded that these products were misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. 

Compliance Considerations for Telehealth and Life Sciences Companies

FDA’s enforcement activity highlights several compliance risks for companies operating in the telehealth, compounding, and digital health sectors.

Marketing and Advertising

Companies should review marketing materials to ensure they do not:

• Imply that compounded drugs are equivalent to FDA-approved products;
• Imply that compounded drugs are safe or effective; or
• Imply FDA approval, clearance, or clinical evaluation or otherwise misrepresent the source or regulatory status of the product

Compounding Practices

Organizations involved in dispensing or coordinating compounded medications should evaluate whether compounding is performed pursuant to patient-specific prescriptions and the activity aligns with federal compounding requirements.

Telehealth Platforms

Telehealth providers should review:

• Website disclosures about compounded medications;
• Relationships with compounding pharmacies; and
• Patient communications regarding regulatory status and safety

“Companies that prescribe, compound, distribute, or market GLP-1 products should expect continued scrutiny of marketing claims, pharmacy relationships, and patient communications. Proactive compliance reviews of promotional materials may help reduce regulatory risk as FDA continues to monitor this evolving market.” 
Rebecca Zadaka, Associate Attorney, Gardner Law

How Gardner Law Can Help

FDA’s recent warning letters underscore the regulatory risk associated with compounded GLP-1 marketing, particularly where promotional claims overstate product status, safety, effectiveness, or comparability to approved drugs. 

Gardner Law advises companies on FDA promotional compliance, product communications, and regulatory risk management. Our team can assist with reviewing marketing materials, evaluating relationships with telehealth and compounding partners, assessing patient-facing disclosures, and strengthening compliance processes to reduce enforcement exposure in this evolving area.