Hims & Hers Faces Scrutiny as FDA Cracks Down on Compounded GLP-1 Drugs
Direct-to-consumer telehealth company Hims & Hers Health is navigating increased regulatory scrutiny surrounding its compounded glucagon-like peptide-1 (GLP-1) weight loss medications. The company’s business model, which gained traction in 2024, is now under pressure as the U.S. Food and Drug Administration (FDA) intensifies its efforts to restrict access to ingredients used in these non-approved compounded drugs.
Increased Regulatory Pressure
The FDA announced plans to restrict GLP-1 ingredients used in compounded drugs, citing concerns over quality, safety, and potential violations of federal law as reported by CNBC. This action includes a referral of Hims & Hers to the Department of Justice for investigation according to CNBC. The agency’s move follows a surge in the availability of lower-cost, compounded versions of popular weight-loss drugs like Wegovy and Zepbound, often marketed without a prescription.
Hims & Hers Response and Financial Performance
During an earnings call on February 23, 2026, Hims & Hers CEO Andrew Dudum addressed the scrutiny, emphasizing the company’s broader medication offerings and potential for branded partnerships as detailed in STAT News. Dudum expressed confidence in the durability of the company’s weight loss business, even in a scenario where compounded GLP-1s become unavailable.
Despite the regulatory challenges, Hims & Hers reported 2.5 million subscribers at the end of 2025, a 28.2% increase from the previous year. Full-year revenue reached $2.35 billion, up from $1.5 billion in 2024, though net income remained relatively flat at $128 million. The company projects revenue between $2.7 billion and $2.9 billion for 2026 according to STAT News.
Broader Implications for Compounded Drugs
The FDA’s crackdown extends beyond Hims & Hers, impacting compounding pharmacies nationwide. The agency’s concerns center on the safety and effectiveness of compounded medications, particularly given the rapid proliferation of retailers offering these drugs as reported by Scientific American. The move is expected to benefit established pharmaceutical companies like Novo Nordisk and Eli Lilly, who have been losing market share to telehealth firms and compounding pharmacies.
Novo Nordisk has already announced its intention to take legal action against Hims & Hers over its plan to sell compounded copies of Wegovy according to CNBC.
Looking Ahead
The future of compounded GLP-1 drugs remains uncertain as the FDA continues to enforce stricter regulations. Hims & Hers, along with other companies operating in this space, will need to adapt to the changing landscape and prioritize patient safety and compliance with federal law. The FDA’s actions signal a broader effort to ensure the quality and safety of compounded medications, potentially reshaping the market for weight-loss treatments.