Hims & Hers Swallows Tough Regulatory Pill Following FDA Crackdown

Hims & Hers has abruptly halted sales of its discounted version of Novo Nordisk’s weight-loss drug Wegovy, a decision made under significant pressure from both the drugmaker and federal regulators. This retreat was triggered less than a day after the U.S. Food and Drug Administration (FDA) announced it would investigate the telehealth company and others for offering compounded versions of popular weight-loss medications.

Novo Nordisk’s Legal Prescription for Competition

The move caps a rapid series of events that began when Hims & Hers unveiled its $49-a-month product, which contained the same active ingredient, semaglutide, as Novo’s FDA-approved Wegovy. The Danish pharmaceutical giant Novo Nordisk, which began selling its own approved pill last month for $149, immediately threatened legal action, arguing its product is under patent protection.

Wall Street analysts noted the obvious litigation risk, a concern that was reflected in Hims & Hers’ share price, which sank approximately 15 percent after the market closed Friday following the FDA’s enforcement threat. The company’s stock is now trading at its lowest level since late 2024, a period during which it has sought to diversify beyond selling cheaper alternatives to branded drugs from Novo and rival Eli Lilly.

When the FDA Draws the Line on Compounding

At the heart of the dispute is the practice of drug compounding, where pharmacies mix ingredients to create specialized medicines, sometimes to copy a drug at different dosages. The compounded drug offered by Hims & Hers was not approved by the FDA and had not undergone the agency’s rigorous clinical trials to prove its safety and efficacy.

In a public statement, the FDA commissioner emphasized that the agency cannot verify the quality of non-approved drugs and would act against companies mass-marketing “illegal copycat drugs.” This stance from the FDA represents a significant escalation in scrutiny over the burgeoning market for compounded weight-loss treatments.

FDA Declares War on Illegal Copycat Drugs

Novo Nordisk has been fiercely critical, calling Hims & Hers’ mass-compounding operation illegal and a waste of patients’ money, while vowing to protect its intellectual property. The company asserted it is collaborating with regulators and law enforcement to ensure patient access to affordable, safe, and FDA-approved medications.

This conflict is not new; the two companies have been tussling since 2023, when a shortage of injectable weight-loss drugs led to an FDA policy that allowed compounded versions to be sold. Hims & Hers had previously been warned by the FDA about misleading marketing claims for its compounded semaglutide, which were said to imply equivalence to branded products.

The regulatory landscape is clearly tightening. Last year, the FDA sent warning letters about advertising claims to several drug companies, actions that were partly prompted by a Super Bowl commercial from Hims & Hers. With another Super Bowl ad scheduled, the company now faces a markedly different environment.

Telehealth’s Drug Frontier Gets a Fence

The recent, forceful statement from the FDA has made it clear that the agency’s tolerance for the mass marketing of these unapproved compounds is wearing thin, creating substantial business and legal risk for telehealth providers in this space. Hims & Hers’ decision to withdraw its product is viewed as a direct victory for Novo Nordisk. It also serves as a stark warning to the broader industry about the boundaries of compounding practices.

The FDA’s intensified focus suggests that similar enforcement could be anticipated, especially as more weight-loss drugs enter the market. For consumers, the episode underscores the complex trade-off between lower cost and the guarantees provided by the FDA’s approval process. The agency’s position reinforces that the only way to verify a drug’s safety and effectiveness is through its own rigorous review pathway. Moving forward, companies will likely need to navigate these regulations with far greater caution.