FDA Issues Warning Letters to Telehealth Companies Over Compounded GLP-1 Drugs

On March 3, 2026, the U.S. Food and Drug Administration (FDA) announced it had sent warning letters to 30 telehealth companies for making false or misleading claims regarding compounded GLP-1 products marketed on their websites. This action is part of a broader initiative aimed at addressing misleading direct-to-consumer pharmaceutical advertising that began in September 2025. The FDA has intensified its scrutiny of telehealth and pharmaceutical companies, issuing thousands of warning letters in the past six months—more than the total sent in the preceding decade.

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The FDA's warning letters highlighted several primary violations. Many companies implied that their compounded GLP-1 products were equivalent to FDA-approved medications, such as Novo Nordisk's semaglutide (Wegovy and Ozempic) and Eli Lilly's tirzepatide (Zepbound and Mounjaro). Additionally, these companies obscured the sourcing of their products by branding them with their own names, misleading consumers into believing they were the manufacturers. FDA Commissioner Marty Makary emphasized that compounded drugs are not FDA-approved, meaning they have not undergone the agency's safety, effectiveness, or quality evaluations.

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Among the telehealth companies receiving warning letters were Kin Meds, GoodGirlRx, WeightCare, PharmaZee, and Hims & Hers. The FDA has mandated that these companies respond within 15 working days, outlining how they plan to address the violations and prevent future occurrences. Failure to comply could lead to further regulatory actions, including potential legal consequences.

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Compounded GLP-1 drugs gained popularity during periods of shortage for branded medications, allowing pharmacies to create personalized formulations for patients. However, with the resumption of regular supplies for drugs like semaglutide and tirzepatide, mass marketing of compounded versions is no longer permissible. The FDA's crackdown aims to ensure that compounded drugs are used appropriately, primarily for patients with specific needs that cannot be met by standard formulations.

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The FDA's actions have drawn attention to the ongoing legal disputes surrounding compounded GLP-1 drugs. Hims & Hers, in particular, has faced scrutiny and was referred to the Department of Justice for potential criminal violations. The company initially marketed a compounded semaglutide pill but withdrew it from the market amid regulatory pressure and legal threats from Novo Nordisk.

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In his statement, FDA Commissioner Marty Makary remarked, “It’s a new era. We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action.” He reiterated that while compounded drugs can address shortages or unique patient needs, they should not circumvent the FDA's approval process.

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The FDA's recent enforcement actions signal a commitment to regulating the marketing of compounded drugs more strictly. Companies must now navigate the complexities of compliance to avoid further legal repercussions, while the FDA continues to monitor the landscape of telehealth and pharmaceutical advertising closely.

FDA warns telehealth companies about misleading GLP-1 drug claims