FLER at APE

Australia's Therapeutic Goods Administration published a final decision on September 25 to classify 6-methylnicotine as a Schedule 9 prohibited substance under the Poisons Standard, effective October 1, 2026. TGA said the chemical has been reported in e-cigarette liquids sold in Australia and marketed as nicotine-free or nicotine alternatives, while evidence also indicates its use in preparations such as oral pouches. The government originally proposed a Schedule 7 classification but ultimately adopted the stricter Schedule 9 designation, citing acute toxicity, dependence risk, use in unapproved consumer products and misleading marketing.

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.

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.

Germany's Magdeburg Main Customs Office seized 115,800 untaxed e-cigarettes containing a combined 4.366 million mL of e-liquid during four truck inspections between August 10 and September 4, 2026. The seizures prevented an estimated €1.397 million in tax losses and set a record for the customs office's jurisdiction. Criminal proceedings have been initiated against four truck drivers. The case follows a separate German investigation involving more than 7.6 million illicit vapes and an estimated €33.3 million in excise-tax losses.

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.

Alimentation Couche-Tard said U.S. same-store sales in its “other nicotine products” category grew at a double-digit rate in the first quarter of fiscal 2027, led by nicotine pouches, while overall U.S. same-store merchandise revenues increased 1.7%. The company also said its Canadian nicotine business continued to face regulatory pressure and illicit-market headwinds. The U.S. performance coincides with Couche-Tard's participation in efforts to reopen Canadian convenience-store access to authorized nicotine pouches, though the company has not established a direct causal link between the two.