On December 17, 2024, Iowans for Alternatives to Smoking & Tobacco, Inc., Global Source Distribution, LLC, and others filed a complaint[1] and motion for a preliminary injunction[2] in federal district court against the Iowa Department of Revenue (the Department) challenging Iowa House File 2677 (HF 2677), a law imposing certification and directory requirements on vapor products sold in Iowa. A hearing on the plaintiffs’ motion for a preliminary injunction is scheduled for March 5. If the court rules in the plaintiffs’ favor, it could stay enforcement of the new law until the case is ultimately resolved. While the Department was previously scheduled to publish the vapor products directory on January 2 and begin enforcement on February 3, the Department has not published the directory, and its website indicates that it will not be enforcing the directory. The Department’s website states: “Publication and enforcement of Iowa’s vapor products directory is delayed until further notice. The Department will make an additional announcement before publication and enforcement of the vapor products directory begins. During the delay, manufacturers should continue to submit certification applications.”
Opportunities for the Trump Administration to Step Up Enforcement Against Unauthorized ENDS
Throughout 2024, the U.S. Food and Drug Administration (FDA) endeavored to curb sales of unauthorized electronic nicotine delivery systems (ENDS) in the U.S. In light of persistent demand for flavored ENDS — nearly all of which are unauthorized — there is little evidence that these enforcement efforts have reduced illicit sales. Indeed, some observers estimate that flavored ENDS account for more than 80% of all ENDS sales. With a new administration on the horizon, our team highlights two opportunities for FDA to step up its enforcement efforts: (1) focusing enforcement on imports and (2) authorizing premarket tobacco product applications (PMTAs) for flavored products.
12 Days of Regulatory Insights: Day 9 – Trends in the Tobacco Industry
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.
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
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.
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.
Agustin Rodriguez to Speak at the Third Annual New Approaches Summit
Agustin Rodriguez is attending the Third Annual New Approaches Summit on September 23 during UN week in New York City, which will focus on how policy, innovation, and technological advancements can collectively prevent 1 billion tobacco-related deaths this century.
Agustin will be participating on a panel discussion titled “Chevron, Triton
Tobacco Team to Attend the Tobacco Science Research Conference
Agustin Rodriguez and Bryan Haynes will be attending the upcoming Tobacco Science Research Conference in Atlanta, GA, from September 8 to 11.
This year’s conference is focused on “Tobacco Harm Reduction: What Have We Learned and How Do We Move Forward?”
Agustin will be participating in a panel discussion on