FDA Takes Action Against Telehealth Companies Over Misleading Drug Advertisements

The U.S. Food and Drug Administration (FDA) has initiated a series of enforcement actions targeting telehealth platforms and drug manufacturers for promoting unapproved and potentially misleading prescription medications online. On September 17, 2025, the FDA issued over 100 warning letters to various entities, including well-known platforms like Hims & Hers. These companies have been accused of making false claims about their products, specifically regarding medications for weight management.

Hims, a prominent telehealth service, has come under scrutiny for asserting that their compounded products contain the same active ingredients as approved drugs such as Ozempic and Wegovy. However, the FDA clarifies that these compounded medicines are prepared by pharmacies without FDA review or approval, and thus, their safety and efficacy cannot be guaranteed. The warning letter highlights that such claims mislead consumers into believing they are purchasing equivalent, FDA-approved treatments.

Hims responded by acknowledging that their communications specify that compounded medications are not FDA-approved and expressed willingness to engage with the FDA to address the concerns. The process of compounding involves customizing medications by mixing or altering ingredients to meet individual patient needs, but recent regulations indicate that many of these drugs are no longer in shortage and should not be marketed as such.

This crackdown marks the first direct action by the FDA against online telehealth companies for deceptive advertising, reflecting increased regulatory focus following directives from the federal government, including orders from President Donald Trump to ensure truthful drug advertising across media. The FDA’s actions also extended to companies like Eli Lilly and Novo Nordisk, criticizing advertisements that provided misleading impressions about weight loss injections such as Wegovy and Zepbound.

While compounding can be appropriate in specific situations, the recent enforcement indicates a shift toward tighter regulation. The FDA emphasizes that consumers should be cautious, and healthcare providers are urged to rely on approved medications to ensure safety and efficacy.

For more information on the FDA’s efforts to regulate drug advertising, visit the official FDA announcement.