A coalition of state and national vapor trade associations[1] has moved to intervene in and appeal the District Court for the District of Maryland’s decision in American Academy of Pediatrics, et al. v. FDA, Case No. 8:18-cv-00883, which drastically accelerated the Premarket Tobacco Product Application (PMTA) deadline for vapor products to May 11,
Azim Chowdhury was interviewed by “Regulator Watch” regarding the recent court case, American Academy of Pediatrics v. FDA, 2019 U.S. Dist. LEXIS 81652 (D. Md. May 15, 2019).
To watch the full interview, click here.
As previously reported on this blog, earlier this year, the U.S. Consumer Product Safety Commission (CPSC) announced that it was now reading the Child Nicotine Poisoning Prevention Act (CNPPA) to require nicotine e-liquid bottles to meet the “restricted flow requirement” in 16 C.F.R. § 1700.15(d), in addition to having child-resistant closures. A wave of enforcement
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 Scientific Workshop on Youth E-Cigarette Cessation Treatment Strategies” is available online here. This article is republished with the permission of FDLI.
Since the Child Nicotine Poison Prevention Act (CNPPA) became law in 2015, liquid nicotine in containers “from which nicotine is accessible through normal and foreseeable use by a consumer” (such as e-liquid bottles) have been required to utilize child-resistant packaging pursuant to the Poison Packaging Prevention Act (PPPA) and its implementing regulations. The Consumer
Section 904(a)(3) of the Food, Drug and Cosmetic Act, as amended by the Tobacco Control Act, (FDCA) requires manufacturers and importers to report the quantities of Harmful and Potentially Harmful Constituents (HPHCs) found in their tobacco products, or in the smoke produced by their products, by brand and sub-brand. 21 U.S.C. § 387d(a)(3). This
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
As a reminder, the registration requirement for domestic U.S. tobacco product manufacturing establishments, including manufacturers of deemed products such as e-liquids and cigars, is a biannual obligation that requires each such establishment to “update” their Registration and Product Listing information with FDA by December 31 every year (product listing information must also be updated by
