On January 15, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would set a maximum nicotine level in combusted cigarettes and certain other combusted tobacco products.

Maximum Nicotine Level

FDA proposes to “make cigarettes and certain other combusted tobacco products minimally addictive or nonaddictive by limiting the nicotine yield of these products.” Specifically, the proposed rule would set a maximum nicotine content level of 0.70 milligrams of nicotine per gram of total tobacco. This would represent a drastic reduction in nicotine content. By comparison, one recent study — which FDA cited in the proposed rule — reported that the average nicotine content in the top 100 cigarette brands of 2017 was 17.2 milligrams of nicotine per gram of total tobacco.

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.”

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.

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.

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…

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.

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.

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…