Masterclass – FDA Demystified: A Practical Path to the U.S. Market for Nicotine Products

Roxana Weil, Chief Regulatory Science Officer McKinney Speciality Labs

Willie McKinney, Chief Executive Officer McKinney Speciality Labs

Navigating the U.S. FDA Premarket Tobacco Product Application (PMTA) process can be complex. This session provides manufacturers with a clear, high-level overview of the PMTA requirements and what they mean for bringing nicotine and tobacco products to the U.S. market. Attendees will gain practical insight into key regulatory requirements, and common challenges manufacturers face. This session also offers practical guidance on preparing submissions that align with FDA expectations and support successful product authorization.