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
Azim Chowdhury, Neelam Gill, and Josephine Hsu Awarded 2022 “Go-To Thought Leader” Distinction by The National Law Review
Keller and Heckman Partner Azim Chowdhury, Counsel Neelam Gill, and Associate Josephine Hsu received the 2022 “Go-To Thought Leader” award from the National Law Review under the “Biotech, Food and Drug” category.
Azim, Neelam, and Josephine received this distinction for their March 16, 2022 article, FDA Receives Authorization to Regulate Synthetic Nicotine
Partner Azim Chowdhury Authors Article on the Flaws of the Tobacco Control Act’s Premarket Authorization Requirement for New Tobacco Products in Filter
Keller and Heckman Partner Azim Chowdhury authored the Filter article, “Fundamental Flaws of Tobacco Control Act—and FDA’s Implementation,” published on November 14, 2022. The article discusses the Tobacco Control Act, passed by Congress in 2009, which gave the U.S. Food and Drug Administration (FDA) authority over tobacco and nicotine products. Azim describes some of the
Food and Chemicals Unpacked Podcast – Blowing Smoke: FDA’s Evolving Regulation of Tobacco and Nicotine Products
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
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
FDA’s Marketing Denial Order Issued to Bidi Vapor’s Non-Tobacco Flavored ENDS Products are Set Aside and Remanded by the 11th Circuit Court of Appeals for being Arbitrary and Capricious
Last year, Bidi Vapor LLC (Bidi or the Company), represented by Keller and Heckman LLP Partners Eric Gotting and Azim Chowdhury, petitioned the 11th Circuit Court of Appeals to review the Food and Drug Administration’s (FDA) order denying the Premarket Tobacco Product Applications (PMTA) for its non-tobacco flavored BIDI® Sticks, a disposable electronic nicotine
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
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
China Publishes Final GB Standard on E-Cigarettes: The Basis for Product Compliance
Since we reported in December 2021 on some significant developments in China’s regulation of e-cigarettes (including the draft national standard on e-cigarettes) as well as in March 2022 on the finalized Management Rules for E-Cigarettes, China’s State Tobacco Monopoly Administration (STMA), also referred to as China National Tobacco Corporation (CNTC), has not only released the