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

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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

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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

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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,

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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

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As we have previously reported, on December 27, 2020, Congress amended the Prevent All Cigarette Trafficking (PACT) Act to apply to e-cigarettes and all vaping products (referred to in the legislation collectively as “Electronic Nicotine Delivery Systems” or “ENDS”).  Under the amended PACT Act, these products are subject to the same federal and state

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Background on the PACT Act

As part of the “Consolidated Appropriations Act, 2021,” in the most recent COVID-19 relief bill signed into law on December 27, 2020, Congress amended the Prevent All Cigarette Trafficking (“PACT”) Act to apply to e-cigarettes and all vaping products. Originally passed in 2009, the PACT Act amended the

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Keller and Heckman’s 4th annual E-Vapor and Tobacco Law Symposium is just around the corner. Take advantage of the early bird discount and register today for the most comprehensive 2-day seminar focused on legal and regulatory issues critical to e-vapor, tobacco and CBD industries. Topics that will be covered include:

  • Status of the Industry: What

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In March of this year, the Consumer Product Safety Commission (CPSC) announced that it would interpret the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA) as mandating specific flow-restrictor requirements for liquid nicotine containers that are sold, offered for sale, manufactured for sale, or distributed in commerce. CPSC soon began aggressive enforcement of its new

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Small businesses are facing serious compliance burdens as a result of the Consumer Product Safety Commission (CPSC)’s recent interpretation of the Child Nicotine Poisoning Prevention Act (CNPPA). Keller and Heckman partner Sheila Millar testified on behalf of the E-Vapor Coalition about the adverse impact at the Small Business Administration’s (SBA) regulatory fairness hearing held on