Save the date for Keller and Heckman’s 11th Annual E-Vapor, Nicotine, and Tobacco Law Symposium, taking place on February 22 – 23, 2027, in Las Vegas, NV, at the MGM Grand Las Vegas (right before Total Products Expo (TPE) 2027)!
The 2027 E-Vapor, Nicotine, and Tobacco Law Symposium is a two-day program designed
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 electronic nicotine delivery system (ENDS) products, and remanding the PMTAs back to the agency for
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 Procedure Act when it imposed its comparative-efficacy standard without notice-and-comment rulemaking.
To watch the full
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
