In a groundbreaking move, FDA has kicked off the year with its very first marketing authorization for an oral nicotine pouch product. On January 16, 2025, FDA authorized twenty ZYN nicotine pouch products, marketed by Swedish Match (a subsidiary of Philip Morris International), in two nicotine strengths, 3 mg and 6 mg. The newly authorized
CTP Advances Proposal to Set Maximum Nicotine Level in Cigarettes



On December 10, 2024, the U.S. Food and Drug Administration (FDA or the Agency) Center for Tobacco Products (CTP) advanced a proposal to set a maximum nicotine level in cigarettes and certain other combusted tobacco products. The Agency requested the White House Office of Management and Budget (OMB) expedite a proposed tobacco product standard in…
Keller and Heckman Co-Authored Upcoming FDLI Publication on Nicotine Delivery Products

Keller and Heckman Tobacco and E-Vapor attorneys, led by Partner Azim Chowdhury, co-authored with Latham & Watkins the upcoming Food and Drug Law Institute (FDLI) publication, “Nicotine Delivery Products: Navigating FDA’s Policies and Regulations in a Dynamic Environment.” The following Keller and Heckman attorneys also contributed: Kathryn Skaggs, Neelam Gill, LieAnn Van-Tull, Thomas Smith, Kelsey…
Agenda and Keynote Speaker Announced – Keller and Heckman’s 9th Annual E-Vapor and Tobacco Law Symposium

We are excited to announce the agenda for Keller and Heckman’s 2025 E-Vapor and Tobacco Law Symposium, featuring Keynote Speaker, Dr. Brian King, Director of FDA’s Center for Tobacco Products (CTP). Click here to view the full program agenda.
Register now to join us Monday, January 27 – Tuesday, January 28, 2025, in Las…
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.