FDA Authorizes JUUL2, Cites Adult Switching Amid Efforts to Speed PMTA Reviews
FDA Authorizes JUUL2, Cites Adult Switching Amid Efforts to Speed PMTA Reviews
FDA Authorizes JUUL2, Cites Adult Switching Amid Efforts to Speed PMTA Reviews
The FDA authorized the JUUL2 device and tobacco- and menthol-flavored pods on Aug. 28, bringing the number of authorized e-cigarette products to 48. The agency highlighted complete switching among adult smokers, with six-week switching rates reaching 28.4%–49.3% for the menthol pod. The decision comes as FDA works to speed PMTA reviews, reduce application backlogs and expand authorized e-cigarette and nicotine-pouch products while maintaining enforcement priorities for unauthorized products.
Regulations
Aug.29
PMI Global R&D Chief Meets Chinese Tobacco Regulator as China Advances Heated Cigarette Standards
PMI Global R&D Chief Meets Chinese Tobacco Regulator as China Advances Heated Cigarette Standards
PMI Global R&D Chief Meets Chinese Tobacco Regulator as China Advances Heated Cigarette Standards
Philip Morris International’s global R&D chief Michele Cattoni met Liu Sanjiang, deputy director of China’s State Tobacco Monopoly Administration, in Beijing on Aug. 27. The meeting comes as China advances mandatory standards for heated cigarettes and nicotine pouches, laying groundwork for their domestic introduction. Cattoni has held senior roles in PMI’s heated tobacco development, while China’s draft standard covers multiple heating architectures, including systems similar in principle to PMI’s IQOS ILUMA technology.
Aug.27
China Tobacco Supply-Chain Leader Huabao’s Three-Way Transformation Takes Hold as Overseas Revenue Jumps 216%, Non-Flavor Businesses Reach 42.2% and the Company Expands Into Global Next-Generation Tobacco Supply Chains
China Tobacco Supply-Chain Leader Huabao’s Three-Way Transformation Takes Hold as Overseas Revenue Jumps 216%, Non-Flavor Businesses Reach 42.2% and the Company Expands Into Global Next-Generation Tobacco Supply Chains
China Tobacco Supply-Chain Leader Huabao’s Three-Way Transformation Takes Hold as Overseas Revenue Jumps 216%, Non-Flavor Businesses Reach 42.2% and the Company Expands Into Global Next-Generation Tobacco Supply Chains
Huabao’s H1 2026 results show the company advancing across three connected fronts: international expansion, entry into next-generation tobacco supply chains and diversification beyond its traditional tobacco-related base. Overseas revenue rose 216.08% to CNY 96.02 million, while non-flavor businesses reached 42.2% of total revenue. Huabao also said it had entered the supply chains of leading global tobacco customers, as its nutrition, food ingredient, fragrance and personal-care businesses gained ground in Europe, Southeast Asia, Australia and New Zealand. However, adjusted net profit increased only 2.78%, and next-generation tobacco revenue was not separately disclosed, showing that the transformation is reshaping revenue and customer exposure but has yet to translate fully into underlying earnings.
Aug.28
Earnings Analysis | CTIHK H1 2026 Revenue Falls 26.9% as Core Businesses Diverge and New Growth Drivers Remain to Be Proven
Earnings Analysis | CTIHK H1 2026 Revenue Falls 26.9% as Core Businesses Diverge and New Growth Drivers Remain to Be Proven
Earnings Analysis | CTIHK H1 2026 Revenue Falls 26.9% as Core Businesses Diverge and New Growth Drivers Remain to Be Proven
China Tobacco International (HK) reported a 26.9% revenue decline in H1 2026, while gross profit fell only 9.5%, revealing sharp divergence across its businesses. Tobacco leaf imports contracted, while leaf exports and Brazil operations expanded strongly. Cigarette exports faced China duty-free market transition, and new tobacco products remained small. Meanwhile, CTIHK continues to strengthen its role as an investment and financing platform, though major external deals have yet to emerge. 2Firsts examines what these shifts mean for its next growth drivers.
Capital Markets
Aug.24
2Firsts Data | China’s Vape-Related Exports Rise 16.5% in July 2026 as U.S.-Bound Shipments Jump 53.5%
2Firsts Data | China’s Vape-Related Exports Rise 16.5% in July 2026 as U.S.-Bound Shipments Jump 53.5%
2Firsts Data | China’s Vape-Related Exports Rise 16.5% in July 2026 as U.S.-Bound Shipments Jump 53.5%
China’s vape-related exports reached $1.047 billion in July 2026, up 16.5% year on year and the highest monthly total of the year. Growth was heavily concentrated in the U.S., where exports jumped 53.5% to $404 million and accounted for 94.9% of the overall increase. Exports to all other markets rose just 1.2%. By category, nicotine-containing non-combustible products—primarily vapes—under HS24041200 rose 24.7% and generated 95.5% of the total increase. Vape-device exports under HS85434000 fell 0.4%, while other nicotine-substitute products under HS24041990 grew 88.9% but remained comparatively small.
DATA
Aug.24
FDA Authorizes JUUL2, Cites Adult Switching Amid Efforts to Speed PMTA Reviews
FDA Authorizes JUUL2, Cites Adult Switching Amid Efforts to Speed PMTA Reviews
FDA Authorizes JUUL2, Cites Adult Switching Amid Efforts to Speed PMTA Reviews
The FDA authorized the JUUL2 device and tobacco- and menthol-flavored pods on Aug. 28, bringing the number of authorized e-cigarette products to 48. The agency highlighted complete switching among adult smokers, with six-week switching rates reaching 28.4%–49.3% for the menthol pod. The decision comes as FDA works to speed PMTA reviews, reduce application backlogs and expand authorized e-cigarette and nicotine-pouch products while maintaining enforcement priorities for unauthorized products.
Regulations
Aug.29
PMI Global R&D Chief Meets Chinese Tobacco Regulator as China Advances Heated Cigarette Standards
PMI Global R&D Chief Meets Chinese Tobacco Regulator as China Advances Heated Cigarette Standards
PMI Global R&D Chief Meets Chinese Tobacco Regulator as China Advances Heated Cigarette Standards
Philip Morris International’s global R&D chief Michele Cattoni met Liu Sanjiang, deputy director of China’s State Tobacco Monopoly Administration, in Beijing on Aug. 27. The meeting comes as China advances mandatory standards for heated cigarettes and nicotine pouches, laying groundwork for their domestic introduction. Cattoni has held senior roles in PMI’s heated tobacco development, while China’s draft standard covers multiple heating architectures, including systems similar in principle to PMI’s IQOS ILUMA technology.
Aug.27
China Tobacco Supply-Chain Leader Huabao’s Three-Way Transformation Takes Hold as Overseas Revenue Jumps 216%, Non-Flavor Businesses Reach 42.2% and the Company Expands Into Global Next-Generation Tobacco Supply Chains
China Tobacco Supply-Chain Leader Huabao’s Three-Way Transformation Takes Hold as Overseas Revenue Jumps 216%, Non-Flavor Businesses Reach 42.2% and the Company Expands Into Global Next-Generation Tobacco Supply Chains
China Tobacco Supply-Chain Leader Huabao’s Three-Way Transformation Takes Hold as Overseas Revenue Jumps 216%, Non-Flavor Businesses Reach 42.2% and the Company Expands Into Global Next-Generation Tobacco Supply Chains
Huabao’s H1 2026 results show the company advancing across three connected fronts: international expansion, entry into next-generation tobacco supply chains and diversification beyond its traditional tobacco-related base. Overseas revenue rose 216.08% to CNY 96.02 million, while non-flavor businesses reached 42.2% of total revenue. Huabao also said it had entered the supply chains of leading global tobacco customers, as its nutrition, food ingredient, fragrance and personal-care businesses gained ground in Europe, Southeast Asia, Australia and New Zealand. However, adjusted net profit increased only 2.78%, and next-generation tobacco revenue was not separately disclosed, showing that the transformation is reshaping revenue and customer exposure but has yet to translate fully into underlying earnings.
Aug.28
Earnings Analysis | CTIHK H1 2026 Revenue Falls 26.9% as Core Businesses Diverge and New Growth Drivers Remain to Be Proven
Earnings Analysis | CTIHK H1 2026 Revenue Falls 26.9% as Core Businesses Diverge and New Growth Drivers Remain to Be Proven
Earnings Analysis | CTIHK H1 2026 Revenue Falls 26.9% as Core Businesses Diverge and New Growth Drivers Remain to Be Proven
China Tobacco International (HK) reported a 26.9% revenue decline in H1 2026, while gross profit fell only 9.5%, revealing sharp divergence across its businesses. Tobacco leaf imports contracted, while leaf exports and Brazil operations expanded strongly. Cigarette exports faced China duty-free market transition, and new tobacco products remained small. Meanwhile, CTIHK continues to strengthen its role as an investment and financing platform, though major external deals have yet to emerge. 2Firsts examines what these shifts mean for its next growth drivers.
Capital Markets
Aug.24
2Firsts Data | China’s Vape-Related Exports Rise 16.5% in July 2026 as U.S.-Bound Shipments Jump 53.5%
2Firsts Data | China’s Vape-Related Exports Rise 16.5% in July 2026 as U.S.-Bound Shipments Jump 53.5%
2Firsts Data | China’s Vape-Related Exports Rise 16.5% in July 2026 as U.S.-Bound Shipments Jump 53.5%
China’s vape-related exports reached $1.047 billion in July 2026, up 16.5% year on year and the highest monthly total of the year. Growth was heavily concentrated in the U.S., where exports jumped 53.5% to $404 million and accounted for 94.9% of the overall increase. Exports to all other markets rose just 1.2%. By category, nicotine-containing non-combustible products—primarily vapes—under HS24041200 rose 24.7% and generated 95.5% of the total increase. Vape-device exports under HS85434000 fell 0.4%, while other nicotine-substitute products under HS24041990 grew 88.9% but remained comparatively small.
DATA
Aug.24
U.S. Fifth Circuit Vacates NicQuid Vape MDO, Says FDA Comparative-Efficacy Standard Violated APA Procedures
U.S. Fifth Circuit Vacates NicQuid Vape MDO, Says FDA Comparative-Efficacy Standard Violated APA Procedures
U.S. Fifth Circuit Vacates NicQuid Vape MDO, Says FDA Comparative-Efficacy Standard Violated APA Procedures
According to VitalLaw on August 27, 2026, the U.S. Court of Appeals for the Fifth Circuit vacated an FDA marketing denial order (MDO) against NicQuid LLC, ruling that the agency’s comparative-efficacy standard for electronic nicotine delivery system (ENDS) applications had become a substantive rule requiring notice-and-comment rulemaking under the Administrative Procedure Act (APA). The court did not reject FDA’s authority to compare the public health benefits and risks of flavored vapes, but held that the agency could not establish a broadly binding standard through informal adjudications. The case was remanded to FDA for further proceedings.
Aug.28
Retail Case Study | Wisconsin Vape Market One Year After New Regulations: Johnny Vapes Reports 80% Sales Decline as Consumers Shift Online and Across State Lines
Retail Case Study | Wisconsin Vape Market One Year After New Regulations: Johnny Vapes Reports 80% Sales Decline as Consumers Shift Online and Across State Lines
Retail Case Study | Wisconsin Vape Market One Year After New Regulations: Johnny Vapes Reports 80% Sales Decline as Consumers Shift Online and Across State Lines
According to WNCY on August 24, 2026, some independent vape retailers in Wisconsin say they have faced significant business pressure one year after new vape regulations took effect. Johnny Vapes, a retailer operating in northeast Wisconsin, said its store count fell from seven locations to four, sales declined by about 80%, and roughly 90% of its inventory was affected. Retailers said some consumers have shifted to online purchases or traveled to neighboring Michigan to buy vape products. The case highlights how local regulations can reshape retail operations, inventory management and consumer purchasing patterns.
Aug.28
California Lawmakers Pass Disposable Nicotine Vape Ban, With Sales Prohibition Set for 2028
California Lawmakers Pass Disposable Nicotine Vape Ban, With Sales Prohibition Set for 2028
California Lawmakers Pass Disposable Nicotine Vape Ban, With Sales Prohibition Set for 2028
According to CBS Los Angeles on August 27, 2026, California lawmakers have passed Assembly Bill 762, which would phase out disposable, battery-embedded nicotine vapes in the state. If signed by Governor Gavin Newsom, manufacturing and importation of the covered products would be prohibited beginning January 1, 2027, followed by a sales ban on January 1, 2028. Driven primarily by concerns over electronic waste, lithium-battery fires and environmental pollution, the legislation would further shift California’s legal vape market toward rechargeable, refillable or replaceable-pod devices.
Aug.28
Malaysia’s Vape Rules Face Review as Health Minister Dzulkefly Ahmad Addresses Dropped Nicotine Appeal
Malaysia’s Vape Rules Face Review as Health Minister Dzulkefly Ahmad Addresses Dropped Nicotine Appeal
Malaysia’s Vape Rules Face Review as Health Minister Dzulkefly Ahmad Addresses Dropped Nicotine Appeal
According to Free Malaysia Today on August 26, 2026, Malaysia’s Health Minister Dzulkefly Ahmad said the Health Ministry would explain the government’s decision to withdraw its appeal against a High Court ruling involving the exemption of liquid nicotine used in vape products from the Poisons List. The High Court previously ruled that the exemption decision was irrational. Dzulkefly said withdrawing the appeal did not mean the government would stop regulating vaping, and that future regulatory approaches would continue under existing legal frameworks.
Aug.28
Australian Coalition Taskforce Calls for 80% Tobacco Tax Cut to Combat Illicit Market
Australian Coalition Taskforce Calls for 80% Tobacco Tax Cut to Combat Illicit Market
Australian Coalition Taskforce Calls for 80% Tobacco Tax Cut to Combat Illicit Market
According to SGST on August 26, 2026, Australia’s Coalition Illegal Tobacco Taskforce released a report recommending an up to 80% cut in tobacco excise to reduce the appeal of the illicit tobacco market. The report claimed organised crime groups now control about 80% of Australia’s tobacco market and argued that high excise rates have widened the price gap between legal and illegal products. The recommendation remains a policy proposal and has not been adopted by the Australian government, which said its focus remains on enforcement, compliance and additional resources.
Aug.27
PMI Opens Generative AI Center in Portugal to Support Global Operations
 PMI Opens Generative AI Center in Portugal to Support Global Operations
PMI Opens Generative AI Center in Portugal to Support Global Operations
According to information released by Portugal’s Trade & Investment Agency (AICEP) in July 2026, Philip Morris International (PMI) has established a global Generative Artificial Intelligence Factory (GenAI Factory) at its Portuguese subsidiary Tabaqueira. The center will support PMI’s global operations by developing and deploying AI solutions focused on industrial process optimization, data analytics, operational automation and AI application development. The initiative strengthens Portugal’s role in PMI’s global technology and innovation network.
Aug.27
U.S. Ninth Circuit Upholds FDA Denial of MH Global’s Flavored Vape PMTA Applications
U.S. Ninth Circuit Upholds FDA Denial of MH Global’s Flavored Vape PMTA Applications
U.S. Ninth Circuit Upholds FDA Denial of MH Global’s Flavored Vape PMTA Applications
The U.S. Court of Appeals for the Ninth Circuit upheld the FDA’s denial of MH Global LLC’s applications to market flavored electronic nicotine delivery systems (ENDS). The court ruled that FDA’s comparative-efficacy framework, which requires applicants to show that flavored products provide greater cessation or switching benefits than tobacco-flavored alternatives, is consistent with the Tobacco Control Act’s “appropriate for the protection of the public health” standard. The court also found that FDA was not required to establish the framework through notice-and-comment rulemaking.
Aug.26
Kantar Study Finds More Than 93% of Vape Products in Ukraine Fail Regulatory Requirements
Kantar Study Finds More Than 93% of Vape Products in Ukraine Fail Regulatory Requirements
Kantar Study Finds More Than 93% of Vape Products in Ukraine Fail Regulatory Requirements
According to Interfax-Ukraine, a study conducted by market research firm Kantar Ukraine at the request of major tobacco companies found that more than 93% of vape products in Ukraine did not fully comply with regulatory requirements. The research examined product categories, brand distribution and consumer purchasing channels, showing that pod systems and disposable vapes represent major segments of the market, while offline retail remains the dominant purchasing channel. The findings highlight ongoing compliance challenges in Ukraine’s vape market.
Aug.26
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