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
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%
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
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,
FDA Denies Authorization to Market JUUL ENDS Products; Company Intends to Seek Stay of the Marketing Denial Orders
On June 23, 2022, the U.S. Food and Drug Administration (FDA) issued marketing denial orders (MDOs)[1] to Juul Labs Inc. for all of the company’s JUUL electronic nicotine delivery system (ENDS) products currently marketed in the United States. After review, FDA determined that Juul’s Premarket Tobacco Product Applications (PMTAs), submitted more than two years
FDA Issues Delta-8 THC Warning Letters
Reposted from Keller and Heckman’s Blog, The Daily Intake
- On May 4, 2022, FDA announced that it had issued warning letters to five companies selling products (including gummies, capsules, tinctures, lotions, vaping products, pet products, and hand sanitizers) labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC), as well as cannabidiol (CBD), in violation of the Federal
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