Global Compliance Requirements for Nicotine Pouches Products

The global nicotine pouch market is expanding at a compound annual growth rate (CAGR) of 35%-38%. It is projected that by 2030, the market size will reach nearly 8 times that of 2025, exceeding the $40 billion mark. North America, as the core consumer market, accounts for over 65%, by Western Europe and the Asia-Pacific market. The global layout of industry benchmarks such as Zyn and Velo has long confirmed that "compliance first" is the core logic for seizing the track—Zyn successfully captured over 40% of the North American market by obtaining PMTA approval from the US FDA, becoming a model for compliant overseas expansion.

The global regulatory framework is accelerating improvement. Although regional differences are significant, there are hidden common requirements. At the EU level, the Tobacco Products Directive (TPD) does not yet fully cover synthetic nicotine pouches, but Poland requires product ingredient notification by January 2026, and France's XP V37-500 standard specifies that the nicotine content shall not exceed 16.6 mg per pouch, with mandatory toxicological risk assessment (TRA). The US FDA regulates all nicotine-containing products, whether natural or synthetic, which all need to obtain pre-market authorization through PMTA. Meanwhile, marketing to groups under 35 is prohibited, and digital advertisements must set up age verification mechanisms. The Southeast Asian market is also upgrading its regulations: Indonesia restricts the nicotine content per pouch to less than 16.6 mg, while Malaysia, Singapore and other countries require 50%-75% of the packaging to be covered with health warnings and prohibit misleading descriptions.

Compliance is not only an entry threshold but also the core of brand competitiveness. Currently, the CR5 of the global nicotine pouch market reaches as high as 88.2%. Giants such as Philip Morris International (PMI), to which Zyn belongs, and British American Tobacco (BAT), behind Velo, have built competitive barriers with strict compliance systems. From ingredient traceability to production control, compliance requirements run through the entire chain: the EU CLP Regulation requires the submission of Poison Center Notification (PCN) and acquisition of UFI code; Italy mandates product registration with ADM Customs Monopoly Bureau and provision of Safety Data Sheet (SDS); while GMP production standards and raw material traceability have become global universal hard indicators.

HENO, relying on its profound technical accumulation in plant extraction and fine chemicals, specializes in compliant solutions for the nicotine field, empowering enterprises to break through with "global regulatory adaptation + solid quality assurance". Having completed full registration with the US FDA and EU TPD, HENO has established over 256 key quality control points covering the entire process from raw material warehousing to finished product delivery. Its Class 100,000 cleanroom and fully automated production lines strictly adhere to GMP standards, ensuring each batch of products meets food-grade or pharmaceutical-grade ingredient requirements. With an annual production capacity of 600 tons of natural nicotine and a global compliance team, HENO provides target market access consulting, registration document support and customized formula R&D, adapting to differentiated requirements such as nicotine content, pH value and packaging labels in different regions.

Whether entering mature European and American markets or potential-rich Asia-Pacific tracks, compliance capability determines market boundaries. Choosing HENO as your partner, you can leverage professional compliance support and a stable supply chain to accurately adapt to global regulatory differences like Zyn and Velo, steadily expand in the $40 billion blue ocean market, and achieve long-term sustainable growth!

#NicotinePouches #GlobalCompliance #Zyn #Velo #NewTobacco #OverseasCompliance