2Firsts Perspectives
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FDA Revises Import Alert 98-07 Rules, Bringing May Enforcement Priorities Into Unauthorized ENDS Detentions
The U.S. Food and Drug Administration has revised the rules under Import Alert 98-07 to incorporate its May 2026 enforcement-priority policy for certain electronic nicotine delivery systems marketed without premarket authorization. The alert continues to allow detention without physical examination, or DWPE, for ENDS lacking required marketing authorization, while directing field divisions to apply the May risk-based framework. When necessary, detention or refusal decisions must also undergo review by the FDA's Center for Tobacco Products. Products including PACHA and Vuse Pro have already emerged as industry examples of the May policy, although enforcement discretion does not constitute FDA marketing authorization.
News
Sep.28 · 2Firsts Perspectives

U.S. Expands Illicit Vape Enforcement as ATF Brings PACT Act Powers Into Trade Fraud Task Force
The U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives said on September 23 that it has joined the interagency Trade Fraud Task Force to strengthen enforcement against illegal, misdeclared and smuggled vape and tobacco products. ATF will bring its authority under the Prevent All Cigarette Trafficking Act into the task force, including registration, reporting, shipping and record-inspection requirements covering interstate sales of electronic nicotine delivery systems. ATF said the move will strengthen its ability to trace illicit products from U.S. points of entry through domestic trafficking and distribution networks.
News
Sep.28 · 2Firsts Perspectives

India Steps Up Nicotine Pouch Enforcement as ZYN, White Fox Circulate and Drug Panel Urges Halt to New Nicotine Formulations
India's Ministry of Health and Family Welfare has directed states to step up enforcement against nicotine pouch sales, citing increased availability through online and offline channels and concern about nicotine exposure among children. Reuters reported that international brands including ZYN and White Fox are being sold in India. A study led by ICMR-NICPR found pouches in seven of 10 surveyed locations and identified 68 brands and 445 flavors online. Separately, India's Drugs Technical Advisory Board recommended in August that no new nicotine formulation be approved.
Regulations
Sep.28 · 2Firsts Perspectives

2Firsts Data|China’s Vape-Related Exports Rose 3.3% in August 2026 as UK Shipments Jumped 51.4% and U.S. Exports Fell 12.4%
China exported $979 million of vape-related products in August 2026, up 3.3% from a year earlier but down 6.4% from July. The UK replaced the U.S. as the main source of growth: UK-bound shipments jumped 51.4% to a 2026 high of $177 million, while exports to the U.S. fell 12.4% to $339 million. Shipments to markets outside the U.S. increased 14.2%, broadening growth beyond the market that had driven July’s rebound.
News
Sep.23 · 2Firsts Perspectives

FRE and ALP Push Modern Oral to 48% of Q2 Sales as Turning Point Brands Changes CEO and Lowers Profit-Guidance Ceiling
Turning Point Brands said Executive Chairman David E. Glazek will become CEO on October 1, replacing Graham Purdy, who is stepping down for personal reasons. The company narrowed its 2026 adjusted EBITDA outlook to $70 million-$80 million from $70 million-$90 million while maintaining Modern Oral gross sales guidance of $330 million-$350 million and net sales guidance of $260 million-$270 million. In the second quarter, Modern Oral net sales rose 128% to $68.4 million and accounted for 48% of company-wide net sales. Adjusted EBITDA fell 50% year over year. TPB shares closed about 10% lower on September 21.
Market
Sep.22 · 2Firsts Perspectives

JTI Proposes 25-Cent Irish Cigarette Tax Increase, Says It Could Raise €45 Million
Japan Tobacco International's Irish business has proposed a €0.25 tax increase on a pack of 20 cigarettes in its pre-Budget 2027 submission, below the €0.50-or-more increases typically imposed in recent Irish budgets. JTI says the proposal could generate around €45 million in additional Exchequer revenue while limiting further movement toward illicit and non-Irish-tax-paid tobacco. Revenue's existing estimate for a comparable €0.25 increase, including pro-rata rises on other tobacco products, is about €18 million for a full year.
JTI
Sep.18 · 2Firsts Perspectives

Philip Morris Malaysia Again Meets Religious Authority Over Cigarette Alternatives as Perlis Mufti Responds on Halal Criteria
Philip Morris Malaysia Managing Director Naeem Shahab Khan met Perlis Mufti Mohd Asri Zainul Abidin on September 17 and presented the company's shift from conventional cigarettes toward alternative products. The mufti said a product could be considered halal if it is clean, its side effects are not harmful or can be controlled, and it does not involve excessive waste. His remarks did not mention IQOS or any other specific PMI product and did not amount to a new product-specific religious ruling. It was at least the second publicly reported engagement between Philip Morris Malaysia and a Malaysian religious institution over cigarette alternatives within six months.
Regulations
Sep.18 · 2Firsts Perspectives

IVG Parent Secures HMRC Excise Warehouse and Duty Stamp Approvals Ahead of UK Vape Tax
Acme Vape Ltd, the company behind UK vaping brand IVG, has received HM Revenue & Customs approval to operate an excise warehouse for vaping products and participate in the Vaping Duty Stamps Scheme. The UK's Vaping Products Duty will take effect on October 1, 2026, at a flat rate of £2.20 per 10ml of vaping liquid. Acme Vape Ltd says its approved warehouse in Preston will become operational under the new regime on the same date.
Regulations
Sep.18 · 2Firsts Perspectives

EU Tobacco Tax Reform Targets November Push as Sweden Holds Nicotine-Pouch Minimum at €20 per Kilogram
The Irish presidency of the Council of the European Union is using bilateral talks to push the bloc’s Tobacco Taxation Directive toward a political agreement in November. According to Law360, citing an EU official, Sweden is unwilling to accept a minimum excise threshold above €20 per kilogram for nicotine pouches. Council negotiations have already lowered the European Commission’s original proposal, but a May 2026 presidency compromise still set the minimum at 10% of the tax-inclusive retail price or €30 per kilogram in 2028-29, with higher levels later.
Market
Sep.17 · 2Firsts Perspectives

Kumulus Vape2026 H1 Revenue Falls 8.3% but Profit Rises 24% as B2B Weakens and Consumer Channels Grow
French vaping company Kumulus Vape reported first-half 2026 revenue of €25.5 million, down 8.3% year over year, as its core B2B distribution business fell 11% to €21.6 million. B2C and store-network revenue rose 5.6% and 17.8%, respectively. Commercial margin increased to 26.3% from 21.7%, while net profit rose 24.1% to €0.8 million. The company attributed the profitability improvement to catalog optimization, logistics restructuring and the ramp-up of Labster, its in-house production unit for proprietary brands.
Market
Sep.17 · 2Firsts Perspectives
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