In the highly regulated nicotine pouch industry, compliance isn’t just a box-ticking exercise—it’s the foundation of product safety, market access, and brand trust. For manufacturers and brands aiming to compete globally, mastering key international standards like GMP, FDA nicotine regulation, and ISO is non-negotiable. As a R&D-driven high-tech enterprise, HENO integrates these rigorous requirements into every link of production, delivering compliant, reliable solutions that break through market barriers.
Good Manufacturing Practices (GMP) are the gold standard for ensuring nicotine pouch production meets strict safety and consistency criteria. HENO operates a Class 100,000 cleanroom fully compliant with GMP standards, where automated production lines handle batching, mixing, filling, and packaging. This eliminates human error and cross-contamination risks, guaranteeing uniform weight, nicotine content, and flavor intensity across every pouch.
We’ve established over 256 critical quality control points from raw material intake to finished product delivery. Precision instruments like HPLC and GC-MS monitor nicotine levels, moisture content, and microbial counts in real time, ensuring no non-compliant product leaves our facility. Our 73,757-square-meter factory, with an annual capacity of 600 tons of natural nicotine, is built to uphold GMP rigor at scale.
For brands targeting the U.S. market, adhering to FDA nicotine regulation is mandatory—including PMTA (Premarket Tobacco Product Application) submissions and compliance with labeling, ingredient disclosure, and safety requirements. HENO has proactively completed FDA and EU TPD (Tobacco Products Directive) document submissions and registrations, laying a solid foundation for clients’ market entry.
Our dedicated regulatory affairs team tracks dynamic changes in nicotine pouch regulations across key markets (EU, U.S., Southeast Asia, etc.). We don’t just ensure our own production compliance—we also provide clients with tailored market access strategies, assisting in preparing ingredient lists, toxicology reports, and other essential registration documents. This end-to-end support turns complex regulatory hurdles into a smooth path to market.
Beyond GMP and FDA requirements, ISO standards (such as ISO 9001 for quality management) further validate a manufacturer’s operational maturity. HENO aligns its entire supply chain and R&D process with ISO principles, from the sourcing of herbal-derived L-nicotine (structurally compatible with human acetylcholine receptors for safer metabolism) to custom product development.
Our commitment to ISO-driven quality management ensures consistent performance, continuous improvement, and accountability—traits that resonate with global partners seeking long-term, compliant collaborations. Whether it’s optimizing production efficiency or enhancing product safety, ISO standards guide our every decision.
At HENO, compliance isn’t an afterthought—it’s embedded in our identity as a technology partner, not just a manufacturer. We combine GMP manufacturing excellence, FDA nicotine regulation expertise, and ISO-aligned systems to empower brands with products that meet the world’s strictest standards. Our open laboratory and flexible custom R&D capabilities also let us co-create differentiated, compliant products that stand out in international competition.
Ready to navigate global nicotine pouch compliance with confidence? Let HENO’s technical strength and regulatory insights support your brand’s expansion. Whether you need GMP-certified production, FDA/TPD registration assistance, or ISO-aligned quality control, we’ve got you covered.
