We reported in December 2021 that China’s State Tobacco Monopoly Administration (STMA) published on its website the draft Management Rules for E-cigarettes and the updated national standard (GB) on e-cigarettes for public comment. Working with important industry members, including industry associations and manufacturers, Keller and Heckman filed comments to STMA to address and seek clarification

On March 15, President Joe Biden signed a $1.5 trillion omnibus spending bill to fund the federal government through September. The bill, as passed, includes a provision amending the definition of “tobacco product” in Section 201(rr) of the Federal Food, Drug, and Cosmetic Act (“FDCA”) as “any product made or derived from tobacco, or containing

In case you couldn’t attend our recently held “E-Vapor and Tobacco Law Symposium” we recorded it—so you can view it at your leisure. Register today and receive full access to the recorded sessions, along with seminar presentations and other materials.

Keller and Heckman is pleased to provide on-demand access to our two-day comprehensive seminar focused

Keller and Heckman Associate Neelam Gill will be a panelist at the Food and Drug Law Institute’s (FDLI) Enforcement, Litigation, and Compliance Conference, to be held virtually on December 9 – 10, 2021. Neelam will be participating in the panel on “Preparing for Tobacco Product Standards and cGMPs,” which will focus on pending Tobacco Product

The tobacco industry in China, which is home to more than 300 million cigarette smokers, is controlled by the largest tobacco company in the world – the China National Tobacco Corporation (CNTC). The CNTC’s dominant global market share is almost entirely the result of its monopoly of the domestic Chinese tobacco industry. When fulfilling its

Two months after the September 9, 2021 PMTA enforcement discretion deadline, the US Food and Drug Administration (FDA) has taken action on well over 90% of timely submitted Premarket Tobacco Product Applications (PMTAs), and has issued over 323 marketing denial orders (MDOs) for more than
1.2 million non-tobacco and non-menthol flavored Electronic Nicotine Delivery Systems

Please be sure to join us for a two-day comprehensive seminar focused on legal and regulatory issues critical to e-vapor, tobacco, and CBD industries following the aftermath of FDA’s decisions on millions of premarket applications. Topics that will be covered include PMTA marketing denial order (MDO) challenges, new requirements for PMTAs and Substantial Equivalence reports,

Keller and Heckman Partner Azim Chowdhury and Associate Neelam Gill published an article for the Food and Drug Law Institute (FDLI) titled, “Will FDA Extend Its Proposed Ban on Menthol Cigarettes and Characterizing Flavors in Cigars to Flavored ENDS Products?” The article discusses FDA’s recent announcement to initiate a rulemaking to ban menthol cigarettes, as

A new paper co-authored by fifteen past presidents of the Society for Research on Nicotine and Tobacco (SRNT) and published in the American Journal of Public Health encourages the media, legislators, and the general public to re-evaluate negative attitudes toward vaping. Kenneth Warner, lead author and dean emeritus and the Avedis Donabedian Distinguished University Professor