On May 4, 2022, the U.S. Food and Drug Administration (FDA) initiated a notice and comment rulemaking process to ban menthol-flavored cigarettes and all characterizing flavors in cigars and cigarillos.[1] Recently, Health and Human Secretary Xavier Becerra announced the ban on menthol-flavored cigarettes will be delayed indefinitely. This article explores the long history of
We are excited to announce the agenda for Keller and Heckman’s 2024 E-Vapor and Tobacco Law Symposium. Click here to view the program agenda, and don’t forget to register by this Friday for your last chance to save $200!
Register now to join us Monday, January 29 – Tuesday, January 30, 2024, in Las Vegas
On August 29, 2023, a three-judge panel on the U.S. Court of Appeals for the District of Columbia Circuit unanimously ruled against FDA on the Agency’s review of Fontem LLC’s “unflavored” (i.e., tobacco-flavored) myblu electronic nicotine delivery system (ENDS) products, vacating FDA’s marketing denial orders (MDOs) for these products. For Fontem’s non-tobacco flavored myblu ENDS
On August 9, 2023, Judge Amit P. Mehta of the U.S. District Court of the District of Columbia issued a final Memorandum Opinion in Cigar Association of America et al. v. United States Food and Drug Administration et al., vacating the decision of the Food and Drug Administration (FDA) to deem premium cigars subject
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
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,
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
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.
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
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
