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
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Among other things, the episode discusses the U.S. Supreme Court’s decision in FDA vs. Wages and FDA’s newly released draft guidance for flavored electronic nicotine delivery system (ENDS)
As discussed in our earlier post, the U.S. Food and Drug Administration’s (FDA) new draft guidance on flavored electronic nicotine delivery system (ENDS) products represents a meaningful effort to provide additional clarity about the Agency’s evidentiary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 At the same time, the draft guidance
On March 9, 2026, the U.S. Food and Drug Administration (FDA) issued a new draft guidance for industry, Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk, clarifying how the agency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 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
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
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
In a long-anticipated decision, the U.S. Court of Appeals for the Fifth Circuit ruled against FDA on January 3, 2024, criticizing the Agency for its handling of Wages and White Lion Investments, LLC, d/b/a Triton Distribution and Vapetasia LLC (“Vapetasia”) (collectively, “Triton”) premarket tobacco product applications (“PMTAs”) for its non-tobacco flavored, open-system e-liquid products.
