Hims & Hers Withdraws Low-Cost Semaglutide Pill After Legal Threats

New York — Telehealth company Hims & Hers Health Inc. said Saturday that it will discontinue access to a compounded semaglutide pill that aimed to undercut Novo Nordisk’s prescription weight-loss drug Wegovy, following warnings from both Novo Nordisk and U.S. regulators.

The withdrawal comes less than a week after the San Francisco-based platform announced plans to provide the medication for as little as $49 during the first month of treatment, roughly $100 below the price of Novo Nordisk’s branded oral formulation. In a statement posted on social media, the firm said that conversations with “stakeholders across the industry” led to the decision to halt the program. It emphasized a continued commitment to “safe, affordable, and personalized care” for its customer base.

Hims & Hers had presented the product as a more affordable alternative to Wegovy by compounding semaglutide, the same active ingredient found in Novo Nordisk’s injectable and forthcoming oral weight-management therapies. Compounding involves mixing or altering ingredients to create a custom medication, a practice permitted under specific circumstances but subject to strict federal and state oversight.

On Thursday, Novo Nordisk accused Hims & Hers of engaging in “illegal mass compounding” and threatened legal and regulatory action. The Danish pharmaceutical company argued that the telehealth provider was misleading consumers with “knock-off GLP-1 products,” referencing the class of glucagon-like peptide-1 agonists that includes semaglutide. Novo Nordisk also noted that the U.S. Food and Drug Administration (FDA) had previously warned Hims & Hers about marketing practices related to similar compounded medications.

The situation escalated on Friday when the FDA announced plans to pursue enforcement steps against Hims & Hers. According to the agency, those steps include restricting access to semaglutide ingredients and referring the matter to the Department of Justice for potential litigation. The FDA’s move underscores its authority to intervene when compounded drugs are produced on a scale or under conditions that regulators deem inconsistent with public safety requirements. A summary of the agency’s enforcement powers is available on the FDA’s official website (www.fda.gov).

In the wake of the FDA’s notice, Hims & Hers maintained that it operates “with a deep commitment to the safety and best interests of consumers” and that it complies with applicable laws. Nevertheless, the company opted to terminate the semaglutide pill offering, avoiding a protracted dispute with both a global pharmaceutical manufacturer and federal regulators.

The now-shelved pill was introduced amid widespread enthusiasm for GLP-1–based weight-loss treatments, which have attracted significant consumer interest because of notable clinical results reported by drug makers. Hims & Hers positioned the compounded version as a cost-effective solution for patients unable to afford branded products. By Saturday’s announcement, the initiative had been active on the company’s online marketplace for only a short time before being removed.

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The timing of the decision is notable: Hims & Hers plans to air a commercial during Sunday’s Super Bowl 60 broadcast. The advertisement, voiced by rapper Common, will highlight a message that “America’s wealth gap has turned into a health gap.” Ahead of game day, the company said it anticipated that the spot could “ruffle some feathers,” though it did not specify whether the ad would reference GLP-1 medications or the recent controversy.

The dispute highlights heightened scrutiny over compounded versions of brand-name weight-loss drugs and the aggressive marketing strategies used by digital health companies. While compounding can offer patients customized solutions, regulators have repeatedly cautioned that large-scale production of compounded drugs, especially when lower-priced copies of patented therapies are involved, may violate federal law.

For now, Hims & Hers has stepped back from distributing its compounded semaglutide pill, avoiding an immediate courtroom battle but leaving unresolved questions about how telehealth providers will navigate the demand for lower-cost weight-management therapies. The company indicated no timeline for revisiting the product and said it will focus on other services aimed at broadening access to care.

Crédito da imagem: Piotr Swat | LightRocket | Getty Images