The Troutman Sanders Tobacco Team will attend the FDLI Tobacco and Nicotine Products Regulation and Policy Conference on October 24-26, 2018. The conference will feature a diverse group of stakeholders – manufacturers, governmental agencies, researchers, public health advocates and attorneys – discussing the effective regulation of tobacco and nicotine products in the U.S. and globally. The FDA’s Center for Tobacco Products Director Mitch Zeller will speak about the latest updates on regulations, guidance and other initiatives.
For the third year in a row, Bryan Haynes will teach the “Deeming Regulations” segment of FDLI’s Introduction to Tobacco Products Law and Regulation, an intensive one-day seminar exploring the essentials of tobacco law and regulation. Participants will gain a comprehensive understanding of the various administrative agencies that impact this industry, and learn about the FDA’s Deeming Rule, Premarket Tobacco Applications and Modified Risk Tobacco Applications, advertising and promotion, compliance, enforcement and related issues.
In addition, Bryan Haynes will moderate a panel discussion, “Premarket Applications and the Element of Uncertainty,” on October 25. The panelists will address how manufacturers and the FDA have been making decisions in the complex and changing regulatory environment surrounding premarket review submissions, including Premarket Tobacco Applications and Substantial Equivalence Reports, and what they think should be included in foundational rules to be issued by the FDA.