Novo Nordisk Warns Of Legal Action Over Hims & Hers’ Mass Compounding Semaglutide Pill, Mentions Safety Risks Of Compounded GLP-1 Drugs

Novo Nordisk released a statement criticising Hims & Hers for announcing plans to mass-market what it described as an unapproved and unsafe semaglutide pill. The company said such activity constitutes illegal drug compounding and creates serious patient-safety risks, adding that it intends to pursue legal and regulatory action to defend patients, its intellectual property, and the U.S. drug-approval system.

Novo Nordisk further argued that Hims & Hers has a history of promoting unauthorized GLP-1 products and noted that the FDA has previously cautioned the company about misleading advertising. It also pointed to newly updated standards of care from the American Diabetes Association and the Obesity Association, which discourage the use of compounded GLP-1 medicines due to concerns about quality, safety, and effectiveness.

According to Novo Nordisk, it is the sole manufacturer of an FDA-approved oral semaglutide formulation, Wegovy tablets made with SNAC technology to enhance absorption, and the product is currently available nationwide in the U.S. in all doses. The company warned that compounded versions are not FDA-approved and could include impurities, unnecessary ingredients, or untested strengths.

Novo Nordisk highlighted its long history as a global healthcare company focused on diabetes and other chronic diseases, noting its worldwide workforce and broad international commercial footprint.