United States: Food and Drugs Law

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.

The federal government is reportedly considering a temporary pathway that could allow compounding pharmacies to dispense certain unapproved peptides while the Food and Drug Administration (FDA) evaluates permanent rules. The contemplated policy has encountered opposition from FDA career staff concerned about patient safety and the implications for the drug approval process.

California continues to lead the way in regulating foods and dietary supplements sold within its borders. Two recent developments are worth highlighting: the nation’s first statewide “Non-Ultraprocessed” food certification program, and a second-of-its-kind law restricting sales of certain dietary supplements and over-the-counter products to individuals under 18. Below, we break down both measures and what they may mean for food and supplement companies doing business in the state.

The FDA has proposed a significant overhaul to the Generally Recognized as Safe (GRAS) notification system, making notifications mandatory for the first time since the system's inception. With only a two-month comment period ending December 9, 2026, food manufacturers and suppliers face critical decisions about compliance strategies and risk management. The proposed rule maintains existing GRAS criteria but introduces new notification requirements, streamlined submission options, and extended review timelin

The Trump administration's most-favored-nation pricing initiative has expanded to include nine additional mid-sized pharmaceutical manufacturers, bringing the total coverage to 89% of the brand drug market. These new agreements focus on Medicaid pricing discounts aligned with international rates, while manufacturers commit billions to U.S. manufacturing and research in exchange for exemptions from future pricing mandates and potential tariffs.

The U.S. Court of Appeals for the Second Circuit has entered the contentious debate over how rigorously district courts should scrutinize expert testimony under Rule 702 and Daubert standards. In a precedential opinion addressing expert admissibility in acetaminophen litigation, the appellate court sought to define the boundaries between a judge's gatekeeping role and improperly deciding scientific disputes that belong before a jury.

Thirteen Blue Cross and Blue Shield (BCBS) carriers are suing CVS Health over the prices it charges for some generic drugs in its $4 drug program. The insurance carriers claim that CVS improperly manipulated the “usual and customary prices” of those drugs.