PMTA

AIR Global PLC (NASDAQ: AIIR), a producer of flavored shisha tobacco and next-generation nicotine products, reported an 11.1% increase in third-quarter 2026 revenue to $99.8 million and a 7.7% rise in adjusted EBITDA to $30.9 million. Revenue for the first nine months increased 6.0% to $306.7 million, but the company posted a $74.2 million net loss, affected by listing-related expenses and other costs. Its New Growth Categories (NGC) business generated $2.1 million in nine-month revenue and an adjusted EBITDA loss of $10.8 million. AIR maintained its 2026 revenue growth guidance of 4%–6%, while lowering its capital expenditure outlook and raising its year-end leverage forecast from approximately 2.1 times to 2.5 times. The company has submitted a U.S. PMTA for its Crown Switch pod vape, with future contributions from new products dependent on regulatory progress and commercialization.

AIR Global PLC (NASDAQ: AIIR) announced on November 5, 2026, that it had submitted a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA) for Crown Switch, its rechargeable pod vape platform. First launched in Germany in November 2025, the device uses Quantum Chip atomization technology developed by Canadian vaporization technology company Greentank Innovations. German retail versions feature 2mL prefilled pods containing 18mg/mL nicotine in six flavors, while AIR has separately tested two 5% nicotine formulations intended for U.S. development. AIR invested $20 million in Greentank in July and reported approximately $3.4 million in U.S. PMTA-related regulatory costs for the first nine months of 2026. The Crown Switch application has been submitted, but the FDA has not granted marketing authorization.

The U.S. FDA authorized 24 VELO nicotine pouch products from a British American Tobacco subsidiary, raising the total number of authorized products from 43 to 67, a 55.8% increase. The newly authorized 4 mg products include lime and passion fruit flavors and feature certified child-resistant packaging. VELO's first FDA marketing authorization adds BAT to a list previously limited to PMI and Altria products, while bringing the agency's nicotine pouch review pilot total to 47 authorized products.

A federal judge in Texas on Oct. 8 granted a joint request by the FDA and plaintiffs including Altria subsidiaries Helix Innovations and NJOY to stay litigation challenging the agency's 2021 PMTA rule. The court cited FDA's anticipated rulemaking concerning the regulation at issue. FDA announced on Sept. 28 that it intends to reassess the PMTA framework and could initiate new rulemaking to replace it. The parties must file a joint status report within 45 days and every 45 days thereafter. A motion by three Reynolds American companies to intervene remains pending.

At the 2026 NACS Show in Las Vegas, Philip Morris International (PMI) showcased its ZYN nicotine pouches, IQOS heated tobacco products and U.S. investments. A 2Firsts review of FDA records found that several ZYN products displayed at the booth were not on the agency's marketing authorization list, including certain nicotine strengths and flavors. A PMI booth representative also confirmed that IQOS is currently sold in three U.S. states, while the newer IQOS ILUMA system remains under FDA review.

FDA’s Center for Tobacco Products is reshaping how it approaches tobacco product review. Based on 2Firsts’ on-site reporting in New York and Washington, this report traces CTP’s emerging direction: stronger links between PMTA and tobacco harm reduction, more category-specific review, greater emphasis on decision-relevant science, more predictable timelines and expanded use of sPMTA for product modifications. CTP also acknowledged major constraints, including just nine PMTA review teams, persistent backlogs and limits on hiring capacity.

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.

The U.S. FDA has consolidated two tobacco establishment registration and product listing forms into a redesigned Form FDA 3741 covering all regulated product categories, including e-cigarettes, heated tobacco products and nicotine pouches. The current requirements remain limited to domestic establishments. Separately, the FDA has proposed extending registration and product listing requirements to foreign manufacturers, signaling greater regulatory attention to manufacturing entities and product-level information across the tobacco and nicotine supply chain.