United States: Food, Drugs, Healthcare, Life Sciences

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.

Eli Lilly has filed five lawsuits targeting companies selling products containing retatrutide, an unapproved investigational peptide. The cases challenge online retailers using "research use only" disclaimers, weight loss clinics, and med spas, alleging their marketing practices and business operations demonstrate intent to sell for human use despite FDA warnings. These complaints reveal how manufacturers can leverage a company's own advertising, affiliate relationships, and operational details to build leg

FDA has submitted an interim access policy for peptide compounding to the Office of Management and Budget for review, marking a potential shift in federal enforcement. While the submission signals regulatory progress, the policy's scope, covered substances, and operational requirements remain undisclosed, leaving compounding pharmacies to navigate uncertainty about which peptides will qualify and under what conditions they may be prepared.