On December 18, 2023, Dr. Brian King, the Director of FDA’s Center for Tobacco Products announced the Center’s new five-year strategic plan which outlines the Center’s programmatic and workforce initiatives and includes five goals, ten outcomes, and several corresponding objectives. The new strategic plan incorporates recommendations from the Reagan-Udall Foundation report published in December 2022. The Reagan-Udall Foundation report provided fifteen recommendations for CTP which included improving transparency regarding the Center’s approach to Premarket Tobacco Product Application (PMTA) r ..read more

Keller and Heckman Partner Azim Chowdhury was interviewed for the Law360 article, “Product Liability Regulation And Legislation To Watch In 2024.” The article outlines a few different regulatory and legislative developments happening in 2024, including more enforcement in the e-cigarette industry. Azim noted that the industry will most likely see enforcement against unauthorized flavored disposable e-cigarettes from the U.S. Food and Drug Administration (FDA). Additionally, the e-cigarette company Juul may finally receive decisions regarding their products from the FDA, which initial ..read more

Keller and Heckman is pleased to announce the addition of a distinguished keynote speaker for the 2024 E-Vapor and Tobacco Law Symposium. Dr. Brian King, Director of FDA’s Center for Tobacco Products (CTP), will provide expert insight into current issues facing the industry. More information regarding this valuable keynote presentation will be available soon. In the meantime, we invite you to register now to secure your seat at this can’t-miss seminar! Join us Monday, January 29 – Tuesday, January 30, 2024, in Las Vegas, NV (right before TPE). You don’t want to miss this comprehensive seminar ..read more

We are excited to announce the agenda for Keller and Heckman’s 2024 E-Vapor and Tobacco Law Symposium. Click here to view the program agenda, and don’t forget to register by this Friday for your last chance to save $200! Register now to join us Monday, January 29 – Tuesday, January 30, 2024, in Las Vegas, NV (right before TPE). You don’t want to miss this comprehensive seminar focused on legal and regulatory issues critical to the ENDS, nicotine, tobacco, CBD/hemp, and cannabis industries. This year’s program will feature new, timely topics specifically designed to help vapor and deemed tobacc ..read more

On August 29, 2023, a three-judge panel on the U.S. Court of Appeals for the District of Columbia Circuit unanimously ruled against FDA on the Agency’s review of Fontem LLC’s “unflavored” (i.e., tobacco-flavored) myblu electronic nicotine delivery system (ENDS) products, vacating FDA’s marketing denial orders (MDOs) for these products. For Fontem’s non-tobacco flavored myblu ENDS, however, the Court upheld FDA’s denial, deferring to the Agency’s general concerns surrounding “substantial risks of flavored products to youth.” Under the Tobacco Control Act (TCA), a Premarket Tobacco Product Appli ..read more

On November 2, 2023, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) released data from the 2023 National Youth Tobacco Survey (“NYTS”), a cross-sectional, school-based, self-administered, web-based survey of U.S. middle school (grades 6-8) and high school (grades 9-12) students. The NYTS has been conducted periodically during 1999–2009 and annually since 2011, and provides national data on estimates of tobacco product use among U.S. youth. In 2023, data were collected from March to June 2023 from more than 22,000 students across 179 schoo ..read more

We’re back! Keller and Heckman’s E-Vapor and Tobacco Law Symposium is returning in 2024 for our 8th annual conference. The symposium will be held Monday, January 29 – Tuesday, January 30, 2024, in Las Vegas, NV (right before TPE). Register today to join us for a two-day comprehensive seminar focused on legal and regulatory issues critical to the ENDS, nicotine, tobacco, CBD/hemp, and cannabis industries. This year’s program will feature new, timely topics specifically designed to help vapor and deemed tobacco product manufacturers stay in compliance with rapidly evolving laws and policies. Top ..read more

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 adult smokers (21+). This study, significant because it supports the role that e-cigarettes play on cigarette reduction or quitting in the real-world setting (i.e., without detailed instructions or additional cessation support), was condu ..read more

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 the Guidelines on Promoting the Construction of a Quality Assurance System for Electronic Cigarette Products for Export, which became effective immediately. The new guidelines come as U.S. public health authoriti ..read more

On August 9, 2023, Judge Amit P. Mehta of the U.S. District Court of the District of Columbia issued a final Memorandum Opinion in Cigar Association of America et al. v. United States Food and Drug Administration et al., vacating the decision of the Food and Drug Administration (FDA) to deem premium cigars subject to the agency’s regulatory authority under the Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (TCA)[1]. The decision concludes a seven-year conflict between the cigar industry and FDA. As previously reported, FDA issued a Final Rule ..read more