On September 5, 2024, the U.S Food and Drug Administration (“FDA”) and Centers for Diseases Control and Prevention (“CDC”) released data from the 2024 National Youth Tobacco Survey (“NYTS”), which shows the most remarkable decline in youth vaping to date. Specifically, the most recent NYTS, an annual, cross-sectional, web-based survey of U.S. middle school (grades
Save the Date: Keller and Heckman’s 9th Annual E-Vapor and Tobacco Law Symposium
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
Partner Azim Chowdhury to Present at the 2024 New Approaches Summit
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
FDA Authorizes First Menthol-Flavored Vapor Products
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
The Menthol Cigarette Ban Saga: Biden Administration Delays Long-Anticipated Ban Indefinitely
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
CTP Releases New 5-year Strategic Plan
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.
5th Circuit Issues Blistering Critique of FDA’s Handling of PMTAs for E-Cigarettes
In a long-anticipated decision, the U.S. Court of Appeals for the Fifth Circuit ruled against FDA on January 3, 2024, criticizing the Agency for its handling of Wages and White Lion Investments, LLC, d/b/a Triton Distribution and Vapetasia LLC (“Vapetasia”) (collectively, “Triton”) premarket tobacco product applications (“PMTAs”) for its non-tobacco flavored, open-system e-liquid products.
Azim Chowdhury Quoted in Law360 Article on Legislation to Watch in 2024
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
FDA Guest Speaker Announced – Keller and Heckman’s E-Vapor and Tobacco Law Symposium
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.
Agenda Announced – Keller and Heckman’s E-Vapor and Tobacco Law Symposium
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
DC Circuit Vacates MDO for Tobacco-Flavored myblu ENDS Products; Potential Impact on Pending Juul PMTA
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