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
Federal Court Rules That FDA Was Arbitrary and Capricious in Deeming Premium Cigars Subject to the Tobacco Control Act
Since it became effective in 2016, the cigar industry has mounted several challenges to the U.S. Food and Drug Administration’s (FDA) “Deeming Rule,” which extended the Agency’s tobacco product authority beyond cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco, to all products that meet the “tobacco product” definition in the Food, Drug and Cosmetic Act,
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
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
FDA Holds Public Hearing on Strategies to Address Youth E-Cigarette Use
Sam Jockel has been published in the Food and Drug Law Institute’s Update Extra, an electronic-only feature of Update Magazine. The article “FDA Holds Public Hearing on Strategies to Address Youth E-Cigarette Use” is available online here. This article is republished with the permission of FDLI.
What Will “Heightened” Online Age-Verification Look Like? FDA Forthcoming Online Age Verification Requirements for Vapor Products May Mirror California Rules
As previously reported on this blog, on November 15, 2018, citing new data from the 2018 National Youth Tobacco Survey (NYTS) that showed a surge in e-cigarette use among youth, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. announced new steps aimed at curtailing illegal underage use of e-cigarettes by limiting where
Staying in Compliance and Staying in Business in the Face of Regulatory Uncertainty: Agenda Announced for Keller and Heckman’s E-Vapor and Tobacco Law Symposium
Keller and Heckman is pleased to announce the agenda for this year’s E-Vapor and Tobacco Law Symposium. This comprehensive 2-day course will provide you with guidance on how to stay in compliance with FDA’s recent announcements and much more. Click here to view the agenda.
Topics that will be covered include: FDA and State law
Stay in Compliance: Register Today for Keller and Heckman’s E-Vapor and Tobacco Law Symposium
Learn how to stay in compliance with FDA’s recent announcements and much more at Keller and Heckman’s upcoming E-Vapor and Tobacco Law Symposium on January 29 – 30, 2019, in Miami, Florida. Below is a sampling of topics that will be covered at the event. Sign up now and take advantage of our early bird
FDA Announces Additional Steps to Protect Youth: Limiting Access to Flavored ENDS, Enhancing Online Age-Verification and Banning Menthol in Cigarettes and Flavored Cigars
Following a series of actions over the last several months, on November 15, 2018, the U.S. Food and Drug Administration (“FDA”) announced new steps aimed at protecting youth from tobacco, including, among other things, preventing access to flavored electronic nicotine delivery system (“ENDS”) sold in certain retail locations, and potentially banning menthol in combustible tobacco
Register Now for Keller and Heckman’s 3rd Annual E-Vapor and Tobacco Law Symposium
Registration is open for Keller and Heckman’s 3rd Annual E-Vapor and Tobacco Law Symposium being held January 29-30, 2019 in Miami, Florida. Click here to register.
This comprehensive 2-day course will address regulatory and business issues relevant to e-vapor, e-liquid and tobacco product manufacturers, distributors and retailers including, among other things:
- FDA enforcement and inspections