On March 10, 2023, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule on Requirements for Tobacco Product Manufacturing Practice (TPMP),[1] which sets forth proposed requirements for the manufacture, design, packing, and storage of tobacco products[2]. The proposed requirements are essentially “good manufacturing practices” for tobacco products and are intended to minimize
PMTA
FDA Files Civil Money Penalty Complaints Against Four Small Vape Shops for Alleged Premarket Review Violations
On February 22, 2023, the U.S. Food and Drug Administration (FDA) announced the filing of civil money penalty (CMP) complaints against four domestic e-liquid manufacturers, all of which appear to be small vape shops that were producing nicotine-containing e-liquids used in open-system electronic nicotine delivery systems (ENDS) devices.[1] The four named companies are:
…Take a Look at this Year’s Lineup of Guest Speakers for Keller and Heckman’s E-Vapor and Tobacco Law Symposium
The extended early-bird discount for Keller and Heckman’s annual E-Vapor and Tobacco Law Symposium expires tomorrow, Friday, February 3. Register now in order to save $100 on your registration!
In addition to legal experts from Keller and Heckman, this year’s program will feature an impressive lineup of industry experts.
Meet this year’s guest speakers:…
Agenda Announced and Super Early-Bird Deadline Extended for Keller and Heckman’s E-Vapor and Tobacco Law Symposium
Keller and Heckman LLP is excited to announce the agenda for our upcoming E-Vapor and Tobacco Law Symposium! Please click here to register and click here to view the agenda.
In addition to the firm’s attorneys, we have several notable experts joining as guest speakers this year, including Derek Yach, the former World Health…
Partner Azim Chowdhury Authors Article on the Flaws of the Tobacco Control Act’s Premarket Authorization Requirement for New Tobacco Products in Filter
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…
Food and Chemicals Unpacked Podcast – Blowing Smoke: FDA’s Evolving Regulation of Tobacco and Nicotine Products
Food and Chemicals Unpacked, a Keller and Heckman LLP podcast, just published its fourth episode, “Blowing Smoke: FDA’s Evolving Regulation of Tobacco and Nicotine Products,” featuring Tobacco and E-Vapor Partner Azim Chowdhury. The episode illuminates the regulatory landscape for tobacco products and reports on current trends in the industry. Azim shares…
Partner Azim Chowdhury to Present at FDLI’s Tobacco and Nicotine Products Regulation and Policy Conference
Keller and Heckman Partner Azim Chowdhury will present at the Food and Drug Law Institute’s (FDLI) Tobacco and Nicotine Products Regulation and Policy Conference, taking place virtually and in Washington, DC on October 20 – 21, 2022. Azim will serve as a panelist on the panel titled, “Novel Products and Future Innovation: How Would New…
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%
…
Save the Date for Keller and Heckman’s 2023 E-Vapor and Tobacco Law Symposium
Save the date! Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium is back in person in 2023. Please join us on February 15-16, 2023, for a two-day comprehensive seminar focused on legal and regulatory issues critical to e-vapor, tobacco, and CBD industries.
This year’s program will feature new, timely topics specifically designed to help…
FDA’s Marketing Denial Order Issued to Bidi Vapor’s Non-Tobacco Flavored ENDS Products are Set Aside and Remanded by the 11th Circuit Court of Appeals for being Arbitrary and Capricious
Last year, Bidi Vapor LLC (Bidi or the Company), represented by Keller and Heckman LLP Partners Eric Gotting and Azim Chowdhury, petitioned the 11th Circuit Court of Appeals to review the Food and Drug Administration’s (FDA) order denying the Premarket Tobacco Product Applications (PMTA) for its non-tobacco flavored BIDI® Sticks, a disposable electronic nicotine…