IQOS Smoking Room at Manila International Airport

Following recent FDA authorizations for JUUL2 and ZYN ULTRA, 2Firsts Compliance Solutions held an online PMTA briefing on Sept. 4 to examine what the decisions may signal about review efficiency, scientific evidence and U.S. market access. Nearly 30 participants from brands, manufacturers, compliance service providers and investment firms joined the discussion.

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.

At the 2026 New Approaches Summit in New York, former FDA Center for Tobacco Products Director Mitch Zeller called for the tobacco harm reduction debate to shift from the traditional “end game” toward defining a desired “end state.” He also highlighted unresolved concerns around dual use, argued that biomarkers of exposure may be more meaningful than cigarettes-per-day in assessing risk reduction, and said nicotine misperceptions remain a major barrier to public health progress.

At InterTabac 2026 in Dortmund, China Tobacco International (HK) Company Limited (CTIHK) is exhibiting across two separate booths in Hall 5 and Hall 4. Products observed by 2Firsts include heated tobacco products, nicotine pouches, Chinese cigars and tobacco leaf. Nicotine pouch products on display include TOOP, Shuangxi and Ashima.

Philip Morris International (PMI) introduced TEREA Bold Red and Bold Black heated tobacco sticks in Germany in October 2026, both carrying a brand-rated tobacco-flavor intensity of 10, the highest level in the country's TEREA portfolio. Bold Red features leather and warm woody notes, while Bold Black combines woody and subtle floral notes. Both are sold in 20-stick packs at €8, approximately 2.6% above standard TEREA products. Germany's TEREA range now includes 11 flavor variants, alongside a separate 26-stick XL format priced at €10. IQOS Germany announced the new products on October 12, followed by a phased retail rollout from late October and an IQOS Club campaign running through December.

Several U.S. states have incorporated the September 9, 2020 PMTA filing deadline into eligibility rules for certain vaping products. CrossBar 20K drew attention after appearing on Pennsylvania's 163-entry directory. A broader 2Firsts investigation found that related registration businesses also listed KUMI and CROSSBAR SIX products, with 171 KUMI-related entries across Louisiana, Nebraska and Wisconsin. Corporate records link Scott Silverman to Blue Nine LLC and VR Products I LLC. PMTA compliance expert Mr. K said historical applications and nicotine-analogue products may offer two different approaches to state-directory access.