Nov 06 2018

WASHINGTON, DC—Womble Bond Dickinson attorney Mark Vaders moderated a panel discussion on “The Future of Nicotine Products and FDA’s Nicotine Steering Committee” at the annual Food and Drug Law Institute (FDLI) Tobacco and Nicotine Products Regulation and Policy Conference .

The FDA established the Nicotine Steering Committee to analyze opportunities for nicotine-containing tobacco products, like e-vapor products, to be approved as drug products. In August, the FDA issued draft guidance with the promise of additional guidance to be issued this fall. Panelists in this session discussed this guidance, the latest developments with the Nicotine Steering Committee, and what it could all mean for pathways for orally inhaled nicotine-containing products at CTP and CDER.

Vaders was joined in the panel discussion by Philip Morris International President for External Affairs and General Counsel Marc S. Firestone, Pinney Associates, Inc. President Joseph Gitchell, University of Minnesota Professor Dorothy Hatsukami, and FDA CDER Deputy Center Director for Regulatory Policy Grail Sipes.

The FDLI Tobacco and Nicotine Products Regulation and Policy Conference was held at the National Press Club in Washington, DC on Oct 25-26.

Mark Vaders provides cost-effective scientific and legal solutions to clients whose branded products are regulated by the FDA and state agencies. He has assisted in drafting many submissions to FDA’s Center for Tobacco Products, and serves as an in-house resource on vapor product science. His practice also focuses on developing legal- and science-based defenses to product liability lawsuits. Before his law practice, Vaders worked in the genomics services industry supporting global clinical trials.

Vaders