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
E-Cigarette
China Update: STMA Publishes Guidelines on Quality Assurance for E-Cigarettes for Export



Although e-cigarettes manufactured in China for export to overseas markets are not subject to pre-market approval in China, and are only required to comply with the regulations of the destination country, China’s State Tobacco Monopoly Administration (STMA) still attaches great importance to the quality management of e-cigarettes for export.

On July 18, 2023, STMA released…
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…
FDA Inspection Blitz Leads to Over 180 Warning Letters to Retailers for the Sale of Unauthorized E-Cigarettes

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…
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…
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 Publishes Proposed Rule on Tobacco Product Manufacturing Practices


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…

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:…