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
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
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]
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
To be placed on the European Union market, tobacco and related products must comply with specific requirements and procedures, harmonized at the European level by Directive 2014/40/EU concerning the manufacture, presentation, and sale of tobacco and related products (hereinafter the “Tobacco Products Directive” or the “Directive”). This article provides a general overview of the requirements
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
On November 8, 2022, California voters approved[1] the Referendum on 2020 Law That Would Prohibit the Retail Sale of Certain Flavored Tobacco Products (Proposition 31). The referendum, submitted in accordance with the provisions of Section 9 of Article II of the California Constitution, asked California citizens to vote on whether to uphold a 2020
