FDA Retrospective: The Comprehensive Plan for Tobacco and Nicotine Regulation at One Year

From: The National Law Review

ARTICLE BY 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]

National Association of Tobacco Outlets Comments to FDA on Flavored Tobacco Products

From: Convenience Store Decisions

NATO outlines key concerns in response to the ANPRM on flavored tobacco.

The National Association of Tobacco Outlets (NATO) announced that it submitted comments to the U.S. Food and Drug Administration (FDA) in response to the agency’s Advanced Notice of Proposed Rulemaking (ANPRM) regarding the role of flavors in tobacco products.


In its comments, NATO focuses on many different issues and concerns raised by this ANPRM which include the following:


4.  The likelihood of a significant illicit market for menthol cigarettes and flavored tobacco if the FDA mandates the elimination of flavors.

New York Attorney General Underwood – Leading Bipartisan Coalition Of 9 AGs – Urges FDA To Ban Flavored Tobacco

From: New York Attorney General

Research Repeatedly Shows Flavored Tobacco Leads Middle and High School Students to Begin Tobacco Use at Young Age

NEW YORK – New York Attorney General Barbara D. Underwood—leading a bipartisan coalition of 9 Attorneys General—filed comments urging the Food and Drug Administration (FDA) to ban flavored tobacco products, which have been repeatedly shown to lead middle and high school students to begin tobacco use at a young age.

A Quarter Million Fake Anti-Vaping Comments Flood FDA, Group Asserts

From: Vape News


Regulator Watch released this video announcing over 255,000 fake anti-vaping comments have flooded the Regulations.Gov website. The target is specifically directed at the Regulation of Flavors in Tobacco Products. The Canadian News source states the spammed comments nearly brought down federal servers and bogged down the internal network, making it nearly impossible to process any submissions.

The bot attack began on June 8th and ran until June 11th. During this time frame, 255,000 fake comments were made before staff could isolate the incident from offending IP addresses and cease the flow. The comments are under investigation by the FDA. A decision is pending on whether or not to accept or reject the comments.

The FDA Wrongly Blames E-Cig Companies for Teen Vaping

From: Vaping Post

A renowned tobacco harm reduction expert, pointed out that while the FDA is blaming vaping businesses for an alleged rise in teen vaping, the agency is failing to take into account research indicating that most teens obtain their devices from social sources.