HEADLINE

The U.S. Food and Drug Administration has revised the rules under Import Alert 98-07 to incorporate its May 2026 enforcement-priority policy for certain electronic nicotine delivery systems marketed without premarket authorization. The alert continues to allow detention without physical examination, or DWPE, for ENDS lacking required marketing authorization, while directing field divisions to apply the May risk-based framework. When necessary, detention or refusal decisions must also undergo review by the FDA's Center for Tobacco Products. Products including PACHA and Vuse Pro have already emerged as industry examples of the May policy, although enforcement discretion does not constitute FDA marketing authorization.

Swedish nicotine pouch brand Kelly White is building its strategy around adult female consumers. Founder and CEO Sophia Wilsby told 2Firsts that women accounted for around 70% of the brand’s repeat customers on HAYPP in Sweden in 2025. The interview explores female consumer segmentation, product and design differentiation, gender stereotypes, packaging regulation, and how independent brands can compete with global players such as ZYN and VELO while considering funding, partnerships and future ownership options.

Nicotine analogues such as 6-methylnicotine are already appearing in e-cigarettes and oral pouches, even as key human evidence remains limited. A new Nixodine-S study adds nonclinical data showing differences from nicotine in cytotoxicity and receptor activity, while independent studies point to a more complex toxicological picture. With supply-chain activity growing and FDA seeking clearer authority over nicotine analogues, the industry now faces a larger question: what evidence is needed before these substances can credibly replace nicotine?

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.

At InterTabac 2026, nicotine pouch growth was visible not only in brands but across equipment, raw materials and OEM manufacturing. 2Firsts interviewed AIRSCREAM commercial head Steve Moore on how many pouch factories Europe may ultimately need and where manufacturers can differentiate, from formulation and flavour to pouch materials, production consistency and customer service. The category continues to expand, but questions remain over future capacity, consolidation and the long-term structure of the supply chain.