On November 2, 2023, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) released data from the 2023 National Youth Tobacco Survey (“NYTS”), a cross-sectional, school-based, self-administered, web-based survey of U.S. middle school (grades 6-8) and high school (grades 9-12) students. The NYTS has been conducted periodically during
E-Liquid
Keller and Heckman Files Supreme Court Amicus Brief on Behalf of ENDS Industry in Support of Request to Overturn or Limit the Chevron Doctrine


On July 24, 2023, Keller and Heckman Partners Eric Gotting and Azim Chowdhury, along with co-counsel, on behalf of members of the Electronic Nicotine Delivery Systems (ENDS) industry[i], filed an amicus brief with the Supreme Court of the United States (SCOTUS) in support of petitioners in Loper Bright Enterprises v. Raimondo[ii]…
Keller and Heckman Files Supreme Court Amicus Brief on Behalf of Public Health Experts in Support of Avail Vapor’s Cert Petition Challenging FDA’s Marketing Denial Order



On June 14, 2023, Keller and Heckman Partners Eric Gotting and Azim Chowdhury, on behalf of a group of public health experts, filed an amicus brief with the Supreme Court of the United States (SCOTUS) in support of Avail Vapor’s writ of certiorari petitioning SCOTUS to review the Fourth Circuit’s decision to uphold the Food…
News Alert: Public Consultation on the EU’s Tobacco Products Legislation: Comment Period Open Until May 16, 2023





On February 21, 2023, the European Commission opened a public consultation[1] seeking feedback on the performance of the current legislative framework for tobacco products, and ways that the legislation could be improved. All interested stakeholders can submit comments until May 16, 2023.
I. Background
In May 2008, the European Commission issued a report[2]…

FDA Publishes Proposed Rule on Tobacco Product Manufacturing Practices


On March 10, 2023, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule on Requirements for Tobacco Product Manufacturing Practice (TPMP),[1] which sets forth proposed requirements for the manufacture, design, packing, and storage of tobacco products[2]. The proposed requirements are essentially “good manufacturing practices” for tobacco products and are intended to minimize…

FDA Files Civil Money Penalty Complaints Against Four Small Vape Shops for Alleged Premarket Review Violations


On February 22, 2023, the U.S. Food and Drug Administration (FDA) announced the filing of civil money penalty (CMP) complaints against four domestic e-liquid manufacturers, all of which appear to be small vape shops that were producing nicotine-containing e-liquids used in open-system electronic nicotine delivery systems (ENDS) devices.[1] The four named companies are:
…Keller and Heckman Hosts E-Cigarette Regulatory Conference with China STMA
From December 5-7, 2022, Keller and Heckman hosted a private conference with the China State Tobacco Monopoly Administration (STMA) on the topic of U.S. and global e-cigarette and tobacco product regulation. The event was approved by China’s Ministry of Science and Technology (MOST) and was attended by over 700 officials from STMA and its local…
FDA Files Permanent Injunctions Against Six Small Vape Shops for Alleged Premarket Review Violations


On October 18, 2022, the U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug Administration (FDA), filed complaints for permanent injunctions against six domestic e-liquid manufacturers across different federal district courts, all of which appear to be small vape shops that were producing nicotine-containing e-liquids used in open-system e-cigarette devices.…
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…

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…