FDA to limit GLP-1 substances utilized in non‑authorized compounded medication – Imperial Wire

The U.S. Meals and Drug Administration stated on Friday it plans to limit GLP-1 substances utilized in non-approved compounded medication that corporations reminiscent of Hims & Hers and different compounding pharmacies have been advertising as alternate options to licensed therapies, citing issues over high quality, security and potential violations of federal legislation.

Shares of on-line telehealth firm Hims and Hers Well being fell practically 12% in after-hours commerce.

The FDA stated it is usually taking steps to fight deceptive direct-to-consumer promoting and advertising following warning letters that have been despatched within the fall of 2025.

The U.S. Division of Well being and Human Companies’ Basic Counsel, Mike Stuart, additionally stated on Friday he has referred Hims & Hers to the Division of Justice for investigation over potential violations, following a evaluate of the relevant information.

Hims and Hers didn’t instantly reply to a Reuters request for remark.

The corporate had stated earlier on Thursday that it will start providing copies of Novo Nordisk‘s new Wegovy capsule at an introductory value of $49 monthly, about $100 lower than the model title.

Novo Nordisk later stated it will take authorized motion in opposition to the telehealth firm over its plan to promote compounded copies of the drug.

The well being regulator stated that, in promotional supplies, corporations can’t declare that non-FDA-approved compounded merchandise are generic variations or the identical as medication authorized by FDA.

It added that “additionally they can’t state compounded medication use the identical energetic ingredient because the FDA-approved medication or that compounded medication are clinically confirmed to supply outcomes for the affected person.”