FDA Scrutinizes Telehealth Firms Like Hims for GLP-1 Drug Advertising Practices

In early 2025, the FDA was prompted to review advertising by telehealth companies like Hims & Hers after lawmakers and advocacy groups raised concerns about their GLP-1 weight-loss drug commercials2 4 6.

A Super Bowl ad by Hims & Hers promoted prescription access to GLP-1 receptor agonist medications (including compounded semaglutide) without providing required disclosures on safety, risks, or side effects typical for pharmaceutical advertising1 2 4.

Senators sent a letter to the FDA, arguing the Hims ad omitted critical risk information and alleging it may mislead patients by suggesting compounded drugs are equivalent to FDA-approved medications2 4 6.

Novo Nordisk, an original manufacturer of approved GLP-1 drugs, publicly criticized the telehealth model and compounded GLP-1 products, warning that such compounded versions may not be proven safe or effective and are not subject to the same regulatory scrutiny as approved products1.

Current regulations permit pharmacies to compound copies of certain drugs while they’re on the FDA’s shortage list, but these compounded formulations are not FDA-approved and do not require the same clinical or labeling standards6.

There is ongoing debate between pharmaceutical manufacturers, compounding pharmacies, lawmakers, and regulators about whether telehealth marketing of compounding drugs for weight loss adheres to or circumvents consumer protection and pharmaceutical advertising laws1 6.

The FDA has the authority to take enforcement action (such as warning letters or civil penalties) if advertisements are found to mislead patients regarding drug safety, efficacy, or regulatory status4 6.