Photo of Azim Chowdhury

As we previously reported, the Reagan-Udall Report evaluated FDA’s Center for Tobacco Products (CTP) and reported that stakeholders were concerned over, among other things, a lack of clear guidance and transparency regarding regulations, the premarket review process, and enforcement priorities. On February 24, 2023, CTP responded to the report and committed to addressing all

On June 7, Partner Kathryn (Katie) Skaggs will present at the Food and Drug Law Institute’s (FDLI) Legal and Practical Issues in Cannabis Regulation virtual event, to be held June 7 – 8, 2023. Katie will participate on the panel, “Packaging and Labeling: Product Safety and Youth Use Prevention,” which will focus on the role

Photo of Azim ChowdhuryPhoto of Ian Murray

I.      Reagan-Udall Report

In July 2022, the Food and Drug Administration (FDA) Commissioner, Dr. Robert Califf, released a public statement saying the agency “has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations.” As such, Commissioner Califf was “prompt[ed] . . . to take a closer look at

Photo of Azim ChowdhuryPhoto of Ales BartlPhoto of David J. Ettinger
Banner to advertise Keller and Heckman's series of articles on tobacco regulation in the European Union, with imagery of an e-vapor device, cigarettes, and a European Union flag.

On February 21, 2023, the European Commission opened a public consultation[1] seeking feedback on the performance of the current legislative framework for tobacco products, and ways that the legislation could be improved. All interested stakeholders can submit comments until May 16, 2023.

I. Background

In May 2008, the European Commission issued a report[2]

Photo of Azim ChowdhuryPhoto of Ian Murray

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:

From December 5-7, 2022, Keller and Heckman hosted a private conference with the China State Tobacco Monopoly Administration (STMA) on the topic of U.S. and global e-cigarette and tobacco product regulation. The event was approved by China’s Ministry of Science and Technology (MOST) and was attended by over 700 officials from STMA and its local

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