On April 2, 2025, the U.S. Supreme Court issued its decision in the Wages and White Lion Investments d/b/a Triton Distribution (hereafter “Triton”) Premarket Tobacco Product Application (PMTA) Marketing Denial Order (MDO) challenge. In a 9-0 unanimous ruling, the Supreme Court held that FDA did not act arbitrarily and capriciously when it denied the
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Webinar: Update on EU Regulations of E-Vapor and Nicotine Pouches
By Ales Bartl & Azim Chowdhury
Update on EU Regulations of E-Vapor and Nicotine Pouches
Date: Thursday, 08 May 2025Time: 4:30 PM – 5:30 PM CET | 10:30 AM – 11:30 AM EDTDuration: 60 minutesCost: ComplimentaryRegistration: Click Here
Keller and Heckman LLP is pleased to announce a complimentary webinar, Update on EU Regulations of E-Vapor and Nicotine Pouches, hosted by the Tobacco & E-Vapor…
FDA Issues First Marketing Authorization for Oral Nicotine Pouches
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…
New Extended Producer Responsibility Requirements for Companies Selling Tobacco and Nicotine Products in Single-Use Packaging
A wave of new “Extended Producer Responsibility” or “EPR” programs is beginning to impact companies placing packaged products, including tobacco products, on the market in U.S. states, including California, Colorado, Maine, Minnesota, and Oregon.
The five EPR programs for packaging enacted thus far have different facets. However, at their core,…
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 Vegas,…
California Bans Online Sales of Flavored Tobacco Products Effective January 1, 2025
On August 28, 2024, the California legislature passed two laws – Assembly Bill 3218 (“AB 3218”) and Senate Bill 1230 (“SB 1230”) – that expand the scope of the state’s enforcement powers against flavored tobacco products. These laws, which have been signed by the Governor and are set to go into effect on January 1,…
Oregon Court Strikes Down Vape Packaging Law as Unconstitutional Violation of Free Speech
On October 16, 2024, the Oregon Court of Appeals in Bates v. Oregon Health Authority made a significant ruling by overturning a law restricting the packaging of e-cigarette and cannabis products on the grounds that the law is an unconstitutional restriction on free speech.
The law in question, ORS. 431A.175(2)(f), prohibited an “inhalant…
U.S. Youth Vaping Rates Continue to Show Dramatic Decline
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…