US Appeals Court Orders FDA to Re-examine E-cigarette Regulations

Sep.16.2022
US Appeals Court Orders FDA to Re-examine E-cigarette Regulations
US court approves appeal of 4 e-cigarette companies, requiring the FDA to reconsider their tobacco product applications.

Recently, the United States Court of Appeals for the Eleventh Circuit approved the appeals of four electronic cigarette companies, demanding that the U.S. Food and Drug Administration (FDA) reconsider the pre-market tobacco product applications submitted by these four companies. The court stated that the FDA did not conduct a thorough and reasonable evaluation of these four companies, and that the FDA's decision was too arbitrary. The court ruled that before the FDA issues a ban, it must consider all legal regulations and relevant factors. In the future, the FDA must have sufficient legal basis and corresponding evidence before making decisions, rather than relying solely on the results of a vote.


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Product | BAT Launches VELO WRKS Nicotine Pouches in Sweden, Introducing Dual-Compartment Cans With Two Flavours
Product | BAT Launches VELO WRKS Nicotine Pouches in Sweden, Introducing Dual-Compartment Cans With Two Flavours
British American Tobacco (BAT)'s VELO brand launched the VELO WRKS nicotine pouch range in Sweden on November 2, 2026. The initial release features three Dual Can variants, each containing two separate flavours in a dual-compartment container. Each can holds 20 slim pouches with 8mg of nicotine per pouch and retails for SEK 52.99. According to VELO, the first release, Drop 1, is limited to 75,000 cans and will remain available until February 2027 or while stocks last. VELO positions WRKS as a platform for testing new product concepts and has introduced an online consumer feedback survey. EU trademark records show BAT applied to register VELO WRKS in March 2026 under Class 34, covering nicotine pouches, e-cigarettes, heated tobacco products and other tobacco-related goods.
product
Nov.03
India Steps Up Nicotine Pouch Enforcement as ZYN, White Fox Circulate and Drug Panel Urges Halt to New Nicotine Formulations
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
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Malaysia's Poisons Board Backs New Vape Nicotine Exemption After Unanimously Opposing 2023 Proposal
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Malaysia's Poisons Board has endorsed Health Minister Dzulkefly Ahmad's proposal to exempt liquid nicotine used in vaping products from the Poisons List, according to a November 2, 2026, report by CodeBlue. The Board unanimously opposed a similar proposal in 2023, but the government proceeded with the exemption. The Kuala Lumpur High Court invalidated the 2023 decision in May 2026, and the government withdrew its appeal in August. No new ministerial order has been published. The development raises questions about the interaction between Malaysia's two regulatory frameworks and the treatment of RM354.51 million in excise duties collected on e-cigarette and vape products between May 2023 and June 11, 2026.
Regulations
Nov.03
On-Site Report | CTP Details PMTA Backlog, 180-Day Review Goal and sPMTA Process
On-Site Report | CTP Details PMTA Backlog, 180-Day Review Goal and sPMTA Process
FDA’s Center for Tobacco Products detailed new PMTA review data and process changes at the 2026 FDLI conference. Pending PMTAs fell from about 450,000 at the start of 2025 to 135,000 by September 2026. CTP also discussed its 180-day review goal, current sPMTA pilot, alternate-supplier planning, more than 50,300 pending SE reports, and lessons from the nicotine pouch pilot already being applied to ENDS review.
Regulations
Oct.07
South Korea Imports 12,126 Kg of Nicotine Analogues From April to August After Bringing Synthetic Nicotine Under Tobacco Law
South Korea Imports 12,126 Kg of Nicotine Analogues From April to August After Bringing Synthetic Nicotine Under Tobacco Law
South Korea's liquid-vape market is showing changes across raw-material imports, product types and sales channels after synthetic nicotine came under the Tobacco Business Act on April 24. Customs data show nicotine-analogue imports totaled 12,126 kilograms from April through August, while synthetic-nicotine imports over the same five months totaled 231,663 kilograms, just 39.3% of the amount imported in March alone. Physical liquid-vape stores tracked in Seoul and Gyeonggi Province fell 9.9%, unmanned outlets edged higher and online sales listings increased from 27,774 to 42,437. Government testing of 105 liquid inhalation products promoted as nicotine-free separately found nicotine in 13 and 6-methylnicotine in 12.
Sep.22
As Regulators Focus on Nicotine Pouch Child Safety, Safeguard Pursues an External Packaging Route
As Regulators Focus on Nicotine Pouch Child Safety, Safeguard Pursues an External Packaging Route
As regulators pay closer attention to child safety in nicotine pouches, manufacturers face a practical challenge: how to strengthen child-resistant packaging without unnecessarily reworking products, production lines and regulatory submissions already in place. In a written interview with 2Firsts, Chemular detailed Safeguard’s external packaging approach, its customer-specific testing requirements and possible PMTA pathways. The model remains early-stage, but it offers a new way to think about an increasingly important regulatory and manufacturing issue.
Industry Insight
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