As discussed in our earlier post, the U.S. Food and Drug Administration’s (FDA) new draft guidance on flavored electronic nicotine delivery system (ENDS) products represents a meaningful effort to provide additional clarity about the Agency’s evidentiary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 At the same time, the draft guidance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On March 9, 2026, the U.S. Food and Drug Administration (FDA) issued a new draft guidance for industry, Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk, clarifying how the agency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
FDA Authorizes Six on! PLUS Nicotine Pouch Products — First Decisions from the Pouch PMTA Pilot
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
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
FDA Authorizes JUUL Labs ENDS Products for U.S. Market
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
California’s E-Waste EPR Program Continues to Exclude E-Cigarettes
The California Department of Resources Recycling and Recovery (CalRecycle) is currently working on a rulemaking to implement SB 1215, which revised the state’s Covered Electronic Waste Recycling Program (E-Waste Recycling Program) to include covered battery-embedded products. These are generally products containing batteries that are “not designed to be easily removed from the product by
FDA Scores Win in Wages, but Industry Eyes Fifth Circuit Remand in Flavored Vape PMTA Denial Challenge
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
Webinar: Update on EU Regulations of E-Vapor and Nicotine Pouches
Update on EU Regulations of E-Vapor and Nicotine Pouches
Date: Thursday, 08 May 2025
Time: 4:30 PM – 5:30 PM CET | 10:30 AM – 11:30 AM EDT
Duration: 60 minutes
Cost: Complimentary
Registration: Click Here
Keller and Heckman LLP is pleased to announce a complimentary webinar, Update on EU Regulations of E-Vapor and Nicotine
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