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]
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:
Yesterday, Janet Woodcock, M.D., the Principle Deputy Commissioner for the Office of the FDA Commissioner, released a statement regarding the Agency’s approach towards cannabidiol (CBD) and its application in the food and drug industry.
The statement provided that FDA convened a high-level internal working group to explore potential regulatory pathways for CBD products. The working
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 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
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
Recently, California’s Office of Environmental Health Hazard Assessment (OEHHA) adopted safe harbor warning regulations for cannabis smoke and delta-9-tetrahydrocannabinol (delta-9-THC) under California Proposition 65.[1]
What is Proposition 65?
The Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65) requires the governor of California to publish, at
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
