The telehealth company Hims & Hers Health is facing increased scrutiny regarding its business model centered around compounded versions of glucagon-like peptide-1 (GLP-1) medications, originally intended for diabetes treatment but increasingly used for weight loss. The company addressed these concerns during its recent earnings call, as regulatory risks and potential legal challenges mount. This comes after a period of rapid growth fueled, in part, by the demand for these compounded drugs.
Hims & Hers CEO Andrew Dudum emphasized the company’s broader portfolio of medications during the earnings call, including those for weight management, signaling a strategy to diversify beyond GLP-1s. “We believe there’s a really durable weight business,” Dudum stated, “even if you think you’re kind of in a draconian scenario of compounding GLP-1s not being there.” However, investor sentiment remains closely tied to the availability and success of these weight-loss drugs, which the company began offering in May 2024.
Despite the regulatory headwinds, Hims & Hers reported positive financial results for the end of 2025. The company now has 2.5 million subscribers, a 282,000 increase from the same period in 2024. Full-year revenue reached $2.35 billion, up from $1.5 billion in 2024, although net income remained relatively flat at $128 million. Looking ahead, Hims & Hers projects revenue between $2.7 billion and $2.9 billion for 2026, according to a company statement.
The increased scrutiny stems from the practice of compounding pharmacies creating customized versions of drugs like Wegovy, a GLP-1 medication manufactured by Novo Nordisk. Compounding pharmacies traditionally address specific patient needs, such as allergies or the inability to swallow pills, or to alleviate shortages. However, the surge in demand for GLP-1s for weight loss led telehealth companies like Hims & Hers to partner with compounding pharmacies to offer these medications more widely, raising questions about safety and regulatory compliance. Novo Nordisk has even filed a lawsuit against Hims & Hers, alleging patent infringement related to the compounded Wegovy, as reported by Rollins School of Public Health.
The Food and Drug Administration (FDA) is also taking a firmer stance on compounded GLP-1 products. On February 6, 2026, the FDA announced plans to restrict access to ingredients used in these non-approved drugs, signaling heightened enforcement for both pharmacies and telehealth platforms. Simultaneously, the Department of Health and Human Services (HHS) General Counsel referred Hims & Hers to the Department of Justice (DOJ) for investigation of potential federal law violations, as detailed in a Wall Street Journal report.
This increased regulatory pressure follows concerns raised about the safety and efficacy of compounded GLP-1s, as well as questions surrounding Hims & Hers’ marketing of an unapproved cancer detection test. The FDA’s actions suggest a broader crackdown on drug compounders, particularly those operating in the rapidly growing weight-loss market. Polsinelli PC notes that the intense reaction from the FDA likely stems from Novo Nordisk receiving a Commissioner’s National Priority Voucher for the Wegovy pill.
The situation highlights the complex interplay between telehealth innovation, patient demand, and regulatory oversight in the pharmaceutical industry. As the FDA tightens its control over compounded GLP-1s, the future of Hims & Hers’ weight-loss business, and the broader market for these drugs, remains uncertain. The company’s ability to navigate these challenges and demonstrate compliance with evolving regulations will be crucial for its continued success.
Looking ahead, the DOJ investigation and FDA enforcement actions will likely shape the future of compounded GLP-1 medications and the telehealth companies that offer them. The outcome of these legal and regulatory battles will have significant implications for patient access to weight-loss treatments and the broader pharmaceutical landscape.
Disclaimer: The information provided in this article is for general informational purposes only and does not constitute medical or legal advice. Consult with a qualified healthcare professional or legal expert for personalized guidance.
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