On June 30, 2026, FDA issued modified risk granted orders to Swedish Match USA, Inc., a wholly owned subsidiary of Philip Morris International Inc., for 20 ZYN nicotine pouch products, authorizing the company to market those products with the claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart
On June 26, 2026, the U.S. Food and Drug Administration (FDA), Center for Tobacco Products (CTP), announced a proposed rule titled “Establishment Registration and Product Listing for Tobacco Products” that, if finalized, would require foreign tobacco product manufacturing establishments to register with FDA and list tobacco products manufactured for import into the United
On April 23, 2026, Maine enacted Public Law Chapter 769, An Act to Create a Stewardship Program for Electronic Smoking Devices and Related Products, codified at 38 M.R.S.A. § 1618. The law appears to make Maine the first U.S. state to enact an extended producer responsibility (EPR) law specifically targeting “electronic smoking devices.” Once the
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
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Among other things, the episode discusses the U.S. Supreme Court’s decision in FDA vs. Wages and FDA’s newly released draft guidance for flavored electronic nicotine delivery system (ENDS)
On March 9, 2026, the U.S. Food and Drug Administration (FDA) issued a new draft guidance for industry, Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk, clarifying how the agency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 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
Save the date for Keller and Heckman’s 9th Annual E-Vapor and Tobacco Law Symposium, taking place on January 27 – 28, 2025, in Las Vegas, NV, right before the Total Product Expo (TPE)! This two-day seminar is designed to provide in-depth knowledge on legal, regulatory and scientific issues that are essential for tobacco
On May 4, 2022, the U.S. Food and Drug Administration (FDA) initiated a notice and comment rulemaking process to ban menthol-flavored cigarettes and all characterizing flavors in cigars and cigarillos.[1] Recently, Health and Human Secretary Xavier Becerra announced the ban on menthol-flavored cigarettes will be delayed indefinitely. This article explores the long history of
