Global healthcare giant Novo Nordisk has accused telehealth company Hims & Hers of illegally mass-marketing an unapproved semaglutide pill, warning that the move poses serious safety risks and violates US drug regulations.

 

In a sharply worded statement, the pharmaceutical giant said it would pursue legal and regulatory action following Hims & Hers’ announcement that it plans to offer a compounded oral version of semaglutide—a drug used to treat obesity and diabetes.

 

“The action by Hims & Hers is illegal mass compounding that poses a significant risk to patient safety. Novo Nordisk will take legal and regulatory action to protect patients, our intellectual property and the integrity of the US gold-standard drug approval framework. This is another example of Hims & Hers' historic behaviour of duping the American public with knock-off GLP-1 products, and the FDA has previously warned them about their deceptive advertising of GLP-1 knock-offs.”

 

Novo Nordisk said the move runs counter to recently updated medical guidance. The American Diabetes Association’s Obesity Association™ has issued new standards of care discouraging the use of compounded GLP-1 medications, citing concerns over safety, quality, and effectiveness.

 

The company emphasized that it is the only manufacturer of an FDA-approved oral semaglutide product. “Only Novo Nordisk manufactures an FDA-approved Wegovy pill formulated with SNAC technology, which facilitates semaglutide absorption when administered orally,” the statement said. “The Wegovy® pill is available in all doses, in full supply, nationwide in the US.”

 

By contrast, Novo Nordisk warned that compounded versions of semaglutide lack regulatory approval and may present unknown risks. “Compounded semaglutide is not approved by the FDA and may contain impurities, unnecessary additives, and untested doses.”