On May 8, 2026, the U.S. Food and Drug Administration (FDA) issued final guidance describing how the Agency intends to prioritize enforcement for certain unauthorized electronic nicotine delivery systems (ENDS) and oral nicotine pouch products marketed without premarket authorization. The guidance is effective immediately and replaces FDA’s prior April 2020 ENDS enforcement-priorities guidance.
Critically
On May 5, 2026, the U.S. Food and Drug Administration (FDA) issued marketing granted orders (MGOs) for four Glas closed-pod electronic nicotine delivery system (ENDS) products: Classic Menthol, Fresh Menthol, Gold (mango), and Sapphire (blueberry). The authorization is a significant development for the ENDS industry because the Gold and Sapphire are FDA’s first authorized non-tobacco
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
As discussed in our earlier post, the U.S. Food and Drug Administration’s (FDA) new draft guidance on flavored electronic nicotine delivery system (ENDS) products represents a meaningful effort to provide additional clarity about the Agency’s evidentiary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 At the same time, the draft guidance
On March 9, 2026, the U.S. Food and Drug Administration (FDA) issued a new draft guidance for industry, Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk, clarifying how the agency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
We are pleased to announce the agenda for Keller and Heckman’s 10th Annual E-Vapor, Nicotine, and Tobacco Law Symposium, being held Monday, May 4 – Tuesday, May 5, 2026, in Las Vegas, Nevada, right before the CHAMPS Trade Show! Click here to view the full program agenda.
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On January 9, 2026, China’s top tobacco regulator, the State Tobacco Monopoly Administration (STMA), published Announcement No. 1 of 20261, officially incorporating nicotine pouches and other “smokeless tobacco products” into its regulatory framework. According to the Announcement, “smokeless tobacco products” refer to tobacco products containing nicotine that are used orally, nasally, or externally
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
Save the date for Keller and Heckman’s 10th Annual E-Vapor, Nicotine, and Tobacco Law Symposium, taking place on May 4 – 5, 2026, in Las Vegas, NV, at the Paris Las Vegas hotel (right before the CHAMPS Trade Show)!
This two-day seminar is designed to provide in-depth knowledge on legal, regulatory, and scientific
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
