Food and Chemicals Unpacked, a Keller and Heckman LLP podcast, just published its fourth episode, “Blowing Smoke: FDA’s Evolving Regulation of Tobacco and Nicotine Products,” featuring Tobacco and E-Vapor Partner Azim Chowdhury. The episode illuminates the regulatory landscape for tobacco products and reports on current trends in the industry. Azim shares
Tobacco
Partner Azim Chowdhury to Present at FDLI’s Tobacco and Nicotine Products Regulation and Policy Conference
Keller and Heckman Partner Azim Chowdhury will present at the Food and Drug Law Institute’s (FDLI) Tobacco and Nicotine Products Regulation and Policy Conference, taking place virtually and in Washington, DC on October 20 – 21, 2022. Azim will serve as a panelist on the panel titled, “Novel Products and Future Innovation: How Would New…

Save the Date for Keller and Heckman’s 2023 E-Vapor and Tobacco Law Symposium

Save the date! Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium is back in person in 2023. Please join us on February 15-16, 2023, for a two-day comprehensive seminar focused on legal and regulatory issues critical to e-vapor, tobacco, and CBD industries.
This year’s program will feature new, timely topics specifically designed to help…
A Closer Look at China’s New E-Cigarette Regulations



With the implementation of the Management Rules of E-cigarettes and the forthcoming effective date for the GB Standard on E-cigarettes (October 1, 2022), China has been regularly updating its e-cigarette regulations. Following up on our recent articles on China’s GB Standard and manufacturer license requirements, below we summarize various e-cigarette regulations recently promulgated by the…

Federal Court Rules That FDA Was Arbitrary and Capricious in Deeming Premium Cigars Subject to the Tobacco Control Act



Since it became effective in 2016, the cigar industry has mounted several challenges to the U.S. Food and Drug Administration’s (FDA) “Deeming Rule,” which extended the Agency’s tobacco product authority beyond cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco, to all products that meet the “tobacco product” definition in the Food, Drug and Cosmetic Act,…

FDA Denies Authorization to Market JUUL ENDS Products; Company Intends to Seek Stay of the Marketing Denial Orders



On June 23, 2022, the U.S. Food and Drug Administration (FDA) issued marketing denial orders (MDOs)[1] to Juul Labs Inc. for all of the company’s JUUL electronic nicotine delivery system (ENDS) products currently marketed in the United States. After review, FDA determined that Juul’s Premarket Tobacco Product Applications (PMTAs), submitted more than two years…

Counsel Daniel McGee to Present at Next Generation Nicotine Delivery USA 2022 Conference
Keller and Heckman Counsel Daniel McGee will present, “Navigating Evolving Vaping Laws Around the Country – State Law Update,” at the Next Generation Nicotine Delivery USA 2022 event, June 22-23, 2022, in Miami, Florida. This event will bring together business leaders from the ENDS and tobacco industry together with other experts in the field for…

Manufacturing E-Cigarettes in China: How to Obtain the Manufacturer License



Following China’s new GB standard on e-cigarettes that we summarized in early May 2022, the State Tobacco Monopoly Administration (STMA) has now published a rule outlining the process for Chinese e-cigarette manufacturers to obtain the required manufacturer license. This rule applies not only to manufacturers producing e-cigarettes for the domestic Chinese market, but also to…

FDA Authorizes NJOY ACE Tobacco-Flavored Electronic Nicotine Delivery System (ENDS) Products for Marketing


On April 26, 2022, the U.S. Food and Drug Administration (FDA) authorized an additional four tobacco-flavored electronic nicotine delivery system (ENDS) products for marketing under the Premarket Tobacco Product Application (PMTA) pathway. Marketing granted orders (MGOs)[1] were issued for the following NJOY tobacco-flavored ENDS products:
- NJOY Ace Device: Closed e-cigarette device
- NJOY Ace Pod
…
Tobacco Industry Leader Joins Keller and Heckman’s Expanding Tobacco and E-Vapor Practice

FOR IMMEDIATE RELEASE
April 12, 2022
Media Contact: Caryn Wick
wick@khlaw.com
+1 202.434.4318
—Washington, D.C.— International regulatory law firm Keller and Heckman LLP welcomes the addition of Counsel, Daniel P. McGee, to the firm’s expanding Tobacco and E-Vapor practice.
Prior to joining Keller and Heckman, Daniel worked as in-house counsel for several multinational tobacco,…