Photo of Azim ChowdhuryPhoto of LieAnn T. Van-TullPhoto of Josephine Hsu

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

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

Photo of Azim ChowdhuryPhoto of David J. EttingerPhoto of Eric Gu

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

Photo of Azim ChowdhuryPhoto of David J. EttingerPhoto of Eric Gu

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

Photo of Azim ChowdhuryPhoto of Josephine Hsu

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

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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,

Photo of Azim ChowdhuryPhoto of Josephine HsuPhoto of LieAnn T. Van-Tull

FDA Premarket Tobacco Product Application (PMTA) Pathway

Under FDA’s premarket tobacco product application (PMTA) pathway, manufacturers or importers of tobacco products must demonstrate to the U.S. Food and Drug Administration (FDA) that the marketing of a new tobacco product would be appropriate for the protection of the public health (APPH). See Section 910(c)(2)(A) of the

Photo of Azim ChowdhuryPhoto of Neelam Gill

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

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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

Photo of Azim ChowdhuryPhoto of Kathryn C. Skaggs

Ahead of the Food and Drug Law Institute’s (FDLI) annual Tobacco and Nicotine Products Regulation and Policy Conference in Washington, DC, on October 23, 2019, Keller and Heckman attorneys Ben Wolf and Kathryn Skaggs presented on FDA’s “Pathways to Market” for new tobacco products during the pre-conference seminar, Introduction to Tobacco and Nicotine Law and