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:
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:
Keller and Heckman Partner Azim Chowdhury, Counsel Neelam Gill, and Associate Josephine Hsu received the 2022 “Go-To Thought Leader” award from the National Law Review under the “Biotech, Food and Drug” category.
Azim, Neelam, and Josephine received this distinction for their March 16, 2022 article, FDA Receives Authorization to Regulate Synthetic Nicotine
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
Keller and Heckman Counsel Daniel McGee will present at the Alternative Products Expo, taking place in Tampa, Florida on November 10 – 12, 2022. Daniel’s presentation is titled, “Overview of Current Regulatory Status of Nicotine Vape and Alternative Products.”
For more information on this event, including registration, please click here.
Be sure to register
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
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
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
With the implementation of the Management Rules of E-cigarettes and the forthcoming effective date for the GB Standard on E-cigarettes (October 1, 2022), China has been regularly updating its e-cigarette regulations. Following up on our recent articles on China’s GB Standard and manufacturer license requirements, below we summarize various e-cigarette regulations recently promulgated by the
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
