A new study published this month in The Lancet’s eClinical Medicine – the largest electronic cigarette (e-cigarette) clinical trial in the U.S. to date – confirms the role of e-cigarettes in smoking cessation. Specifically, the new research supports that e-cigarettes can be a viable means of quitting or reducing more harmful combustible cigarette use for
Nicotine
Azim Chowdhury Quoted in Law360 Article on Legislation to Watch at Midyear

Keller and Heckman Partner Azim Chowdhury was quoted in the Law360 article, “Product Liability Regulation & Legislation To Watch At Midyear.” The article discusses e-cigarette company Juul’s decision to file an application with the U.S. Food and Drug Administration (FDA) for a new device that has been on the market in the U.K. for several…
Keller and Heckman Files Supreme Court Amicus Brief on Behalf of ENDS Industry in Support of Request to Overturn or Limit the Chevron Doctrine


On July 24, 2023, Keller and Heckman Partners Eric Gotting and Azim Chowdhury, along with co-counsel, on behalf of members of the Electronic Nicotine Delivery Systems (ENDS) industry[i], filed an amicus brief with the Supreme Court of the United States (SCOTUS) in support of petitioners in Loper Bright Enterprises v. Raimondo[ii]…
Azim Chowdhury Quoted in a CSP Magazine Article on 2023 Tobacco Regulations

Keller and Heckman Partner Azim Chowdhury was interviewed for the CSP Magazine article, “Regulations 2023: One Thing After Another.” The article discusses the many regulatory updates coming for tobacco products in 2023, including a likely ban on menthol cigarettes, an effective ban on non-tobacco flavored vapor products, new retail signage requirements, and even the likelihood…
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]…

FDA Files Civil Money Penalty Complaints Against Four Small Vape Shops for Alleged Premarket Review Violations


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:
…
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:…