FDA Retrospective: The Comprehensive Plan for Tobacco and Nicotine Regulation at One Year
From: The National Law Review
Azim Chowdhury Adam M. Susser | Keller and Heckman LLP
On August 2, 2018, just over one year since FDA announced its “Comprehensive Plan for Tobacco and Nicotine Regulation”[1] (hereinafter, the “Comprehensive Plan”), FDA Commissioner, Scott Gottlieb, M.D., and Center for Tobacco Products (CTP) Director, Mitch Zeller, J.D., authored a post on the Agency’s FDA Voice blog, which reviewed the progress made to date and outlined several new initiatives related to the Comprehensive Plan.[2] Among other things, these initiatives included a potential e-cigarette product standard and also proposed foundational rules on various topics related to premarket applications. The authors note that the Comprehensive Plan is a multi-year roadmap for the future of tobacco regulation and “provides a framework for regulating nicotine and tobacco.”[3]
Recent Actions Implementing FDA’s Comprehensive Plan
The FDA Voice blog post recounts the FDA’s actions over the first year of the Comprehensive Plan. For instance, the authors note that FDA recently issued three advanced notices of proposed rulemaking(ANPRMs) that have the “potential to reframe the tobacco landscape.”[4] These ANRPMs focus on: (i) the potential development of a product standard to lower nicotine in cigarettes to minimally or no-addictive levels; (ii) the role that flavors – including menthol – play in initiation, use and cessation of tobacco products; (iii) the patterns of use and resulting public health impacts from “premium” cigars. While the comment period for each of these ANPRMs has closed, FDA is currently in the process of reviewing the comments that the Agency has received. In addition, the authors note the Agency’s efforts to re-evaluate and modernize its approach to the development of nicotine replacement therapy products, including, among other things, by establishing a Nicotine Steering Committee and issuing a draft guidance related to the nonclinical testing of orally inhaled nicotine-containing drug products.[5]
