FDA vows crackdown on compounded GLP-1s after Hims markets a semaglutide pill

The FDA said it would use all available compliance and enforcement tools, including restricting GLP-1 active ingredients destined for non-approved compounded drugs and acting on misleading advertising, against companies mass-marketing copies of approved GLP-1 medicines. The statement named Hims & Hers, which on February 5 had launched a compounded oral semaglutide pill as an alternative to the newly approved Wegovy pill. Hims said on February 7 that it would stop offering the product.

Sources

  1. 01FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs(opens the source in a new tab) U.S. Food and Drug Administration
  2. 02Hims & Hers' Compounded Wegovy Pill: A Swift Rise and Fall Under Regulatory Pressure(opens the source in a new tab) Frier Levitt

Peptides involved

  1. ApprovedSemaglutideGLP-1 receptor agonist31