On June 22, 2023, FDA announced it had issued warning letters to 189 retailers for selling unauthorized flavored tobacco products manufactured by Elf Bar and Esco Bar brands. This enforcement action comes on the heels of earlier aggressive action by FDA in its issuance of more than 570 warning letters to firms for the manufacture
Regulatory
Experts Recommend FDA Adopt an Enhanced Regulatory Strategy for Nicotine and Tobacco Products to Help Reach Cancer Moonshot Goals


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…
Keller and Heckman Tobacco and E-Vapor Attorneys to Speak at Upcoming Industry Events


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…
The Reagan Udall Foundation – A Critical Evaluation of FDA’s Center for Tobacco Products



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…
News Alert: Public Consultation on the EU’s Tobacco Products Legislation: Comment Period Open Until May 16, 2023




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]…
The EU’s Tobacco Products Directive: Revisiting the Requirements and Updates on Heated Tobacco Products

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…

Take a Look at this Year’s Lineup of Guest Speakers for Keller and Heckman’s E-Vapor and Tobacco Law Symposium
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:…
FDA Concludes that New Regulatory Frameworks for Foods and Supplements Containing Cannabidiol are Needed, Will Work with Congress
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…
Keller and Heckman Hosts E-Cigarette Regulatory Conference with China STMA
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…
Agenda Announced and Super Early-Bird Deadline Extended for Keller and Heckman’s E-Vapor and Tobacco Law Symposium
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…