At Keller and Heckman’s recent 10th Annual E-Vapor, Nicotine, and Tobacco Law Symposium in Las Vegas, Nevada, Partners Azim Chowdhury, David Ettinger, and Katie Skaggs—along with several guest speakers—were featured in RegWatch Briefs, a series hosted by Brent Stafford. The series spotlights concise discussions on key issues in the nicotine and tobacco space, including
FDA’s New ENDS and Nicotine Pouch Enforcement Guidance: Lower Priority for Post-November 2021 Reviewable Applications, Higher Scrutiny for Illicit Products
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
Kyle Diamantas to Serve as Acting FDA Commissioner as Dr. Marty Makary Resigns
- FDA Commissioner Dr. Marty Makary is widely reported to have resigned yesterday, with President Trump thanking Dr. Makary and stating that Kyle Diamantas, the FDA Deputy Commissioner for Food, will serve as the acting FDA Commissioner in a Truth Social post yesterday afternoon. There has, however,
FDA Authorizes Glas Flavored ENDS Products, Opening an Age-Gating Pathway for Flavors
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
Keller and Heckman Co-Authors FDLI’s 2026 Publication on Nicotine Delivery Products
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’s New ENDS Directory Law Raises the Bar for Market Access
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
Azim Chowdhury Featured in RegWatch Episode on FDA’s New Draft Guidance on Flavored ENDS
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)
How FDA Can Better Align Its Draft Guidance on Flavored ENDS with the Tobacco Control Act’s APPH Mandate
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
FDA Formalizes a Flavor-Specific PMTA Framework as Youth Vaping Continues to Decline
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
Agenda Announced – Keller and Heckman’s 10th Annual E-Vapor, Nicotine, and Tobacco Law Symposium
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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China State Tobacco Monopoly Administration Expands Oversight to Nicotine Pouches and Smokeless Products
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