United States: Food and Drugs Law

Two recent lawsuits claim supplement labels may mislead consumers by highlighting creatine content per serving on the front panel without clearly showing that a serving includes multiple gummies or tablets.

The U.S. Food and Drug Administration’s (FDA) recently released discussion paper on generative artificial intelligence (GenAI)-enabled medical devices may be as notable for what it does not say as what it does say.

The FDA has proposed a major overhaul to the Generally Recognized as Safe (GRAS) framework that would transform the voluntary notification system into a mandatory one while expanding its scope and creating new pathways for existing substances. This proposed rule could fundamentally alter how food and ingredient companies approach GRAS determinations, potentially requiring notifications for previously self-affirmed substances and introducing new post-market scrutiny mechanisms. The changes raise critical que

The USDA's Animal and Plant Health Inspection Service is reviewing a petition for genetically engineered European plum lines designed to promote early and near-continuous blooming. APHIS has prepared a draft plant pest risk assessment concluding these modified plums are unlikely to pose increased plant pest risks compared to nonmodified varieties, with public comments due by October 13, 2026.

The U.S. Department of Health and Human Services-Office of Inspector General issued a favorable advisory opinion on an independent charity patient assistance program funded by pharmaceutical manufacturers, outlining critical safeguards to minimize fraud and abuse risks while ensuring compliance with the Anti-Kickback Statute.

Earlier this month, the U.S. Food and Drug Administration (FDA) released the proposed Prescription Drug User Fee Act (PDUFA) VIII commitment letter marking a pivotal milestone on the path...

The Centers for Medicare and Medicaid Services has issued a Final Rule prohibiting federal Medicaid and CHIP reimbursement for certain gender-affirming healthcare treatments for minors, including puberty blockers, cross-sex hormone therapy, and surgical interventions. The purpose-based restriction creates exceptions for the same treatments when used for other medical purposes, while maintaining coverage for mental health counseling and medically verifiable disorders of sexual development.

The U.S. Food and Drug Administration has released its proposed eighth commitment letter for the Prescription Drug User Fee Act (PDUFA VIII), covering fiscal years 2028 through 2032, with significant changes to drug review processes, manufacturing facility oversight, and user fee structures.

The Centers for Medicare & Medicaid Services has issued a proposed rule announcing significant policy changes for Medicare payments under the physician fee schedule and other Medicare Part B issues, effective January 1, 2027. The Proposed Rule introduces new restrictions on remote patient monitoring services, restructures practice expense methodology, proposes payment reductions for same-day evaluation...