Save the date for Keller and Heckman’s 9th Annual E-Vapor and Tobacco Law Symposium, taking place on January 27 – 28, 2025, in Las Vegas, NV, right before the Total Product Expo (TPE)! This two-day seminar is designed to provide in-depth knowledge on legal, regulatory and scientific issues that are essential for tobacco, nicotine and ..read more

Keller and Heckman Partner Azim Chowdhury will present at the 2024 New Approaches Summit: Saving Lives in the 21st Century. The summit will be held in New York, New York on September 23, 2024. The overall focus of the summit this year is on how policy, innovation, and technological advancements can collectively prevent one billion ..read more

On June 21, 2024, FDA issued marketing granted orders (MGOs) to NJOY LLC for two non-tobacco flavored electronic nicotine delivery system (ENDS) products, the DAILY 4.5% and DAILY EXTRA 6% disposable devices, along with two ACE 2.4% and 5% pre-filled pods. All four of these NJOY ENDS products are menthol flavored. This FDA action, the first of its kind since the Tobacco Control Act (TCA) was enacted in 2009, marks the only instance in which FDA, which has rejected over 26 million premarket tobacco product applications (PMTAs) to date, has concluded that a non-tobacco flavored ENDS product meet ..read more

On May 4, 2022, the U.S. Food and Drug Administration (FDA) initiated a notice and comment rulemaking process to ban menthol-flavored cigarettes and all characterizing flavors in cigars and cigarillos.[1] Recently, Health and Human Secretary Xavier Becerra announced the ban on menthol-flavored cigarettes will be delayed indefinitely. This article explores the long history of the proposed ban on menthol-flavored cigarettes.   A. Cigarette Characterizing Flavor Ban in Tobacco Control Act The availability of menthol combustible cigarettes has long been a subject of controversy due to t ..read more

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