On August 19, 2026, the U.S. Court of Appeals for the Fifth Circuit issued a published opinion granting petitions for review in seven consolidated cases, vacating FDA’s Premarket Tobacco Product Application (PMTA) marketing denial orders (MDOs) for each manufacturer petitioner’s
Latest from The Continuum of Risk
Eric Gotting Discusses Major Fifth Circuit PMTA Decision on RegWatch
Keller and Heckman Partner Eric Gotting was interviewed on the recent episode of Regulator Watch (RegWatch), “Major Win | Court Ruling Could Dismantle FDA’s Flavored Vape Ban.” The episode discusses the recent Fifth Circuit ruling that FDA violated the Administrative
FDA Authorizes Modified Risk Claims for ZYN Nicotine Pouches: A Landmark Step for Tobacco Harm Reduction
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:
FDA Proposes Long-Awaited Rule to Require Foreign Tobacco Manufacturers to Register Establishments and List Products
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
Maine Enacts First-in-the-Nation EPR Law for Electronic Smoking Devices
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
Call for Data Launched to Revise EU Tobacco Products Directive
On 18 May 2026, the European Commission launched a call for evidence related to the upcoming revision of EU Tobacco Products Directive 2014/40/EU (TPD). Feedback is open until 15 June 2026 and is open to everybody. In the meantime, public
Keller and Heckman Featured in RegWatch Briefs Series
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
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
Kyle Diamantas to Serve as Acting FDA Commissioner as Dr. Marty Makary Resigns
Reposted from Keller and Heckman’s Blog, The Daily Intake
- 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
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