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
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 Administrat
ion (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.
2022 National Youth Tobacco Survey Indicates Modest Increase in Youth Vaping Rates
- On October 6, 2022, FDA and CDC released data from the 2022 National Youth Tobacco Survey, a school-based, cross-sectional, self-administered survey of U.S. middle school (grades 6–8) and high school (grades 9–12) students. The study was conducted from January to May 2022. According to the survey, 14.1% of U.S. high school students and 3.3%
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
Counsel Daniel McGee to Present at Next Generation Nicotine Delivery USA 2022 Conference
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
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
FDA Authorizes NJOY ACE Tobacco-Flavored Electronic Nicotine Delivery System (ENDS) Products for Marketing
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
Tobacco Industry Leader Joins Keller and Heckman’s Expanding Tobacco and E-Vapor Practice
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,
FDA Authorizes Tobacco-Flavored Logic Technology Electronic Nicotine Delivery System (ENDS) for Marketing & Issues Marketing Denial Orders for Fontem’s myblu ENDS Products
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