Tobacco Asia

18 tobaccoasia FRONT PAGE NEWS 卷首新闻 FDA Fast-Track for Nicotine Pouches Slows A US regulatory push to fast-track approvals for nicotine pouches has lost momentum as regulators' concerns over youth uptake and new addiction risks complicate decision- making, reports Reuters. The US Food and Drug Administration (FDA) had planned to expedite reviews of several nicotine pouch applica- tions under a pilot program, targeting decisions by the end of 2025. However, multiple applications remain under review as agency scientists evaluate whether current data meet authoriza- tion standards. Nicotine pouches have become the fastest-growing nicotine category in the US, a market valued at about US$22 billion. Millions of consumers use the products, with Philip Morris International alone reporting sales of roughly 794 million cans of its Zyn brand in 2025, more than double its 2023 volume. Despite strong commercial momentum, regulators continue to weigh potential public health benefits against risks to non-users. FDA must determine whether new products help adult smokers switch to less harmful alternatives without increasing nicotine initiation among youth or non-smokers. Sources familiar with the review process say uncertainty around scientific evidence has slowed approvals. Regulators have raised specific concerns about potential uptake among adolescents and the possibility of creating new adult nicotine users who did not previously smoke. Six products under Altria's on! PLUS brand secured authorization in December, but applications tied to other leading products—including newer versions of Zyn and British American Tobacco's Velo—remain pending. The delays have frustrated manufacturers, who view the pilot program as a pathway to modernize product portfolios and compete more effectively in the US market. At the same time, anti-tobacco groups say rising popularity and marketing could drive increased youth use. FDA data show pouch use among middle- and high-school students remains relatively low but has increased in recent years. While evidence suggests pouches may reduce harm for smokers who switch completely, regulators have not reached a clear conclusion on whether the benefits of all pending products outweigh the risks. As a result, several applications remain in what one source described as a "holding pattern," casting uncertainty over the pace of category expansion in the world's largest reduced-risk market. Japan Raises Tobacco Tax for Defense Japan raised tobacco and corporate taxes to help fund a major increase in defense spending, with an income tax hike sched- uled to follow in 2027. The government expects the combined measures to generate about ¥1.3 trillion (US$8 billion) in annual revenue as it expands military capabilities amid a worsening security environment. Defense spending has already climbed to a record ¥9 trillion (US$55 billion) per year, increasing pressure to secure stable funding sources. Starting April 1, 2026, authorities introduced a 4% surtax on corporate tax liabilities after deducting ¥5 million (US$31,000). The measure is projected to bring in ¥869 billion (US$5.3 billion) and will not apply to small and midsize enterprises with lower earnings. Japan has also begun raising taxes on heated tobacco products in two phases—one starting this April and another in October—to align their tax burden with that of conventional cigarettes, which currently face higher rates. From April 2027, the government will increase taxes on both heated and combustible cigarettes in three steps, adding ¥0.5 (US$0.003)per stick. These increases are expected to generate an additional ¥212 billion (US$1.3 billion) in revenue. In addition, officials plan to introduce a 1% income tax surcharge from January 2027, which they estimate will raise ¥256 billion (US$1.6 billion). FDA Reinstates Tobacco Staff The US Food and Drug Administration (FDA) reinstated hundreds of staff within its Center for Tobacco Products (CTP) after reversing earlier layoffs, even as recent job cuts continue to disrupt key enforcement functions. In a recent court filing, the agency said it brought back 229 employees and withdrew prior layoff notices affecting CTP. The restored roles cover premarket application reviews, enforcement, and public education. The move followed a lawsuit by state attorneys general that resulted in a preliminary injunction blocking broader workforce reductions across the Department of Health and Human Services. Despite the reversal, disruptions have continued. In early April, FDA dismissed dozens of employees responsible for pursuing penalties against retailers that sell cigarettes and vaping products to minors. According to Politico, senior officials have since asked some of those workers to return temporarily, according to four federal health officials familiar with the matter. The layoffs stem from health and human services secretary Robert F. Kennedy Jr.'s decision to cut roughly 10,000 positions across the department, including the office that handles civil monetary penalties for repeat violations of the federal minimum age law. Before the cuts, FDA filed more than 100 enforcement complaints each week. That activity stopped after the April 1 layoffs, removing what officials described as the agency's primary enforcement tool. Remaining staff worked to extend active cases scheduled for review while raising concerns about maintaining oversight of retail tobacco sales. Federal survey data show tobacco use among middle and high school students reached its lowest level in 25 years in 2024. Officials warned that reduced enforcement could weaken compliance among retailers and affect efforts to limit youth access. The penalties program also served as a tool in address- ing illicit vape sales. FDA has not outlined a long-term plan to stabilize enforcement operations. In the interim, it has asked affected employees to return temporarily until their terminations take effect on June 2, with more than two dozen agreeing so far.

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