Week of January 19 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

Federal Regulatory Updates

• FDA Reviews Zyn Modified Risk Claims: The Food and Drug Administration (FDA) and the Tobacco Products Scientific Advisory Committee (TPSAC) convened to review Philip Morris International’s (PMI) request to market Zyn nicotine pouches with a modified risk claim. The proposed claim states that using Zyn puts users at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis compared to cigarettes. While independent experts on the panel conceded the risk statement is likely accurate given the high relative harm of combustible cigarettes, they raised concerns regarding the company’s research on youth appeal and whether the marketing would effectively convert current smokers. (See analysis below)

• Trump Administration Abandons ATF Merger: The Trump administration has reportedly dropped its proposal to merge the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) into the Drug Enforcement Administration (DEA). The plan faced significant opposition from both gun-rights and gun-control advocacy groups. This reversal comes as the White House seeks Senate confirmation for Robert Cekada as the permanent director of the ATF.

• NIDA Reports Rise in Flavored Marijuana Vaping: The National Institute on Drug Abuse (NIDA) released findings from the annual Monitoring the Future survey indicating that flavored marijuana vaping has become the most common method of cannabis consumption among teenagers. The survey noted a sharp increase in use among eighth graders, jumping from 47% in 2021 to 63% in 2024.

State Regulatory & Legislative Updates

• New York (Taxation & Enforcement): Governor Kathy Hochul’s proposed $260 billion budget includes measures to tax "alternative nicotine products," such as Zyn pouches, bringing them under the state's existing 75% wholesale tax on tobacco products. Additionally, the Governor announced plans to crack down on the sale of colorful, flavored vaping devices, estimating that up to 99% of products currently sold in the state are unauthorized. The proposal includes creating a registry of legal products to assist law enforcement and mandating the confiscation of illegal devices.

• Virginia (Litigation): The Commonwealth of Virginia has asked the U.S. Court of Appeals for the Fourth Circuit to stay a district court order that is currently blocking the enforcement of its new law restricting the sale of unauthorized vaping products. The district court had previously ruled that the state law was preempted by the Federal Food, Drug, and Cosmetic Act (FDCA).

• Michigan (Product Trends): Observations from the state's adult-use cannabis market indicate that dispensaries are now selling THC pouches that closely mimic the appearance and function of Zyn nicotine pouches, signaling a cross-category product trend.

• Georgia (Legislation): Lawmakers at the Georgia Capitol introduced new education and school safety bills that target vaping, along with phone usage and gun safety, aimed at changing safety protocols within schools.

• Colorado (Public Health Data): A report from Mesa County Public Health indicates a significant decline in local youth tobacco use, dropping more than 70% since 2019. The current high school tobacco use rate is reported at 8%, down from 33% four years prior.

Trade Press & Industry Updates

• Retraction of Vaping Study: The publisher MDPI retracted a 2022 study published in Neurology International that claimed e-cigarette users faced a higher risk of early stroke than smokers. The retraction followed complaints from researchers affiliated with Juul Labs, who identified significant errors in the study's sample size and data analysis.

• "Big Nicotine" Shift: Industry analysts note a strategic pivot by major tobacco companies, such as BAT and PMI, transitioning from "Big Tobacco" to "Big Nicotine." The focus has shifted toward growth in non-combustible categories like vapes and oral pouches, marketed as less harmful alternatives, though they remain addictive.

• Rise of Nootropic Pouches: A new category of "wellness" pouches is emerging, marketed as "nootropic" or energy pouches. Brands like Ultra are raising capital and using athletes to market nicotine-free pouches containing caffeine and other supplements, positioning them as cognitive performance tools rather than cessation aids.

• PMI White Paper on Cognition: Philip Morris International released a white paper discussing human cognition in the age of AI. The paper argues that as AI automates routine tasks, protecting and nurturing human cognitive capacity, critical thinking and creativity, will become essential for organizational resilience. (See review below)