Keller and Heckman Tobacco and E-Vapor attorneys, led by Partner Azim Chowdhury, co-authored with Latham & Watkins the Food and Drug Law Institute (FDLI) 2026 publication, “Nicotine Delivery Products: Navigating FDA’s Policies and Regulations in a Dynamic Environment.” Counsel Neelam Gill and LieAnn Van-Tull also served as co-authors, while the following Keller and Heckman attorneys
Pennsylvania has joined the growing group of states that condition ENDS sales on federal PMTA status. Enacted as Act 57 of 2025, House Bill 1425 adds Section 206-I to The Fiscal Code and directs the Pennsylvania Attorney General to maintain a directory of electronic cigarettes that may be sold in the Commonwealth. The law ties
Keller and Heckman Partner Azim Chowdhury was interviewed on the recent episode of Regulator Watch (RegWatch), “Flawed Baseline | FDA Formalizes De Facto Flavor Ban.” Among other things, the episode discusses the U.S. Supreme Court’s decision in FDA vs. Wages and FDA’s newly released draft guidance for flavored electronic nicotine delivery system (ENDS)
As discussed in our earlier post, the U.S. Food and Drug Administration’s (FDA) new draft guidance on flavored electronic nicotine delivery system (ENDS) products represents a meaningful effort to provide additional clarity about the Agency’s evidentiary expectations for premarket tobacco product applications (PMTAs). That clarity is welcome. At the same time, the draft guidance
On March 9, 2026, the U.S. Food and Drug Administration (FDA) issued a new draft guidance for industry, Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk, clarifying how the agency evaluates whether a non-tobacco-flavored electronic nicotine delivery system (ENDS) product is appropriate for the protection of the public
On December 19, 2025, FDA issued Marketing Granted Orders authorizing six on! PLUS oral nicotine pouches from Helix Innovations (Altria): Mint, Tobacco, and Wintergreen, each in 6 mg and 9 mg nicotine strengths. FDA framed these as the first decisions to come out of its nicotine-pouch PMTA pilot, designed to speed reviews without lowering
On July 17, 2025, the U.S. Food and Drug Administration (FDA) issued Marketing Granted Orders (MGOs) to JUUL Labs Inc. (JUUL), authorizing for sale JUUL’s tobacco- and menthol-flavored pod-based electronic nicotine delivery system (ENDS) products in the United States, reversing its previous position and marking a major regulatory milestone in the years-long evaluation of JUUL’s
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
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
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
