Kyle A. Diamantas

Jones Day


Results 1 to 5 of 10

Food, Drugs, Cosmetics, and Devices: Federal Regulatory Focus Areas in 2023

USA - January 23 2023 With the calendar officially turned to a New Year several significant changes and regulatory initiatives are on the horizon at…

Claire E. Castles, Sarah A. Geers, Colleen M. Heisey, Robert Luther III, Anthony M. Insogna

The FTC Overhauls and Expands 25-Year-Old Health Products Advertising Compliance Guide

USA - January 8 2023 The Federal Trade Commission ("FTC")'s revised Health Products Compliance Guidance expands its reach to explicitly cover all health-related products…

Colleen M. Heisey, Michael J. Mcferran, Courtney Lyons Snyder, Esther Vinarov, Meredith M. Wilkes

FDA Proposes IND Exemptions for Drug Studies of Foods, Supplements, or Cosmetics

USA - January 8 2023 Under the proposed regulation, sponsors and sponsor-investigators whose planned study falls within an exemption will not be required to submit an…

Maureen Bennett, Andrew G. Jack, Dana Molt, Jessica Tierney

FDA Proposes Updated Definition of "Healthy" Claim for Food; Seeks Comment

USA - November 22 2022 To conform with current nutrition science and federal dietary guidance, the U.S. Food and Drug Administration ("FDA") has proposed updated criteria…

Jonathan Berman, Colleen M. Heisey, Philip M. Oliss, Sharyl A. Reisman

FDA Submits Final Food Traceability Rule in Effort to Mitigate Foodborne Illness Outbreaks

USA - November 22 2022 On November 7, 2022, the U.S. Food and Drug Administration ("FDA") sent the Food Safety Modernization Act ("FSMA") Final Rule on Requirements for…

Claire E. Castles, Darren K. Cottriel, Colleen M. Heisey, Philip M. Oliss