In the ninth episode of our 12 Days of Regulatory Insights podcast series, Michael Jordan, a member of the firm’s Tobacco + Nicotine practice, is joined by colleagues Bryan Haynes and Agustin Rodriguez to delve into the regulatory landscape of the tobacco industry in 2024 and what to expect in 2025. Bryan, head of the firm’s Tobacco + Nicotine practice, and Agustin, also a member of the Tobacco + Nicotine practice, discuss the increased state-level actions against illicit flavored e-cigarettes due to FDA’s inaction. They highlight efforts by state AGs to combat these products, including issuing letters to retailers and establishing product registries. The conversation also touches on the anticipated regulatory changes under the new administration, the potential impact on nicotine pouches, and the implications of the Tobacco Master Settlement Agreement (MSA) and the upcoming escrow refunds for nonparticipating manufacturers. Bryan and Agustin provide insights into the evolving regulatory environment and the implications for the tobacco industry in the coming year.
Troutman Pepper Tobacco + Nicotine Team to Attend FDLI Enforcement Conference
Agustin Rodriguez of the Troutman Pepper Tobacco + Nicotine team will attend the Food and Drug Law Institute 2024 Enforcement Conference on Wednesday, December 10-11, in Washington D.C. Members of our team will also attend the FDLI Holiday Party on December 10th.
Agustin will speak on a panel…
Oregon Appeals Court Rules E-Cigarette Packaging Restrictions Unconstitutional
In October, the Oregon Court of Appeals ruled that a law restricting the packaging of e-cigarettes violates the state constitution’s free speech protections. The decision illustrates the utility of free speech arguments against packaging requirements and the importance of state constitutions in regulatory challenges generally.
California AG Provides Update on State Tobacco Enforcement Efforts
Last month, California Attorney General (AG) Rob Bonta announced the awardees for the 2024-2025 Tobacco Grant Program, a program spearheaded by the California Department of Justice (DOJ) that aims to support local law enforcement agencies in their efforts to reduce illegal tobacco sales and usage, particularly among minors. Bonta also provided an update on “Operation Up in Smoke,” a comprehensive law enforcement operation targeting illegal tobacco sales. These updates illustrate that California continues to prioritize coordinated law enforcement efforts against businesses that make illegal tobacco sales, particularly to minors.
Please join the Troutman Pepper Tobacco + Nicotine team at the 2024 Food and Drug Law Institute Tobacco and Nicotine Products Regulation and Policy Conference on October 24-25, 2024
Bryan Haynes, Agustin Rodriguez, Michael Jordan and Zie Alere will be in attendance.
Bryan will be speaking during the “Recent State Regulatory and Enforcement Activity: Filling Gaps or Impeding Progress” panel. The panel will discuss recent measures enacted by state and local legislators and regulators to combat the illegal e-cigarette…
Class Action Lawsuit Alleges Puff Bar Violated State Consumer Protection Laws
A consumer class action lawsuit has been filed in the U.S. District Court for the Southern District of New York against EVO Brands, LLC and PVG2, LLC, both doing business as Puff Bar. The lawsuit alleges that Puff Bar violated state consumer protection laws by engaging in deceptive marketing practices aimed at youth, and by misleading consumers about the legality and safety of their synthetic nicotine e-cigarettes.
$11M Cigarette Drawback Dispute Could Have Significant Consequences for FTZ Importers
In August, N.C.-based cigarette importer, King Maker Marketing Inc., challenged a decision by U.S. Customs and Border Protection (Customs) that rejected its claims for more than $11 million in drawback duties as untimely.
FDA Says Agency Will Enforce the Cigarette Graphic Warning Rule in December 2025, But Pending Litigation Could Still Derail Those Plans
In September, the U.S. Food and Drug Administration (FDA) told industry that it would begin enforcing the agency’s cigarette graphic warning rule in December 2025 in an enforcement policy outlined in a short guidance document. Although a federal district court previously found the rule unconstitutional, an appeals court reversed that decision and the final rule is now in effect. In its guidance, FDA says that it will not begin enforcing until December 2025 at the earliest, but we believe it likely that the rule might yet again be postponed or vacated, as it remains the subject of ongoing litigation.
State AGs File Amicus Curae Brief in US Supreme Court Case Involving Flavored E-Cigarettes
Earlier this month, 20 Democratic state attorneys general (AG) filed an amicus brief supporting the U.S. Food and Drug Administration’s (FDA) marketing denial orders (MDOs) of premarket tobacco applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS or e-cigarettes) currently under review by the U.S. Supreme Court. The brief not only demonstrates which side these states support, but also identifies specific enforcement priorities for these states.
FDA Proposes Submission Tracking Number Requirement for ENDS Imports
In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN) to U.S. Customs and Border Protection (CBP) for imports of such products. This rule could result in the denial of entry for ENDS imports for which the manufacturer has not submitted a premarket tobacco product application (PMTA) to FDA.