Tobacco Asia

52 tobaccoasia Issue 4, 2026 July / August Tomasz Płaska added that the key issue is not simply whether nicotine is labelled as pharmaceutical-grade, but whether its quality is "sufficiently defined, controlled or documented." Without rigorous standards and traceability, manufacturers face greater challenges in ensuring product safety and consistency. Mark McQuillan pointed out the importance of controlling impurities such as heavy metals, residual solvents, and nitrosamines, noting that these can originate from both agricultural and processing stages. "These need to be tightly controlled and rou- tinely monitored," he told Tobacco Asia. Global standards and regulatory frameworks Pharmaceutical-grade nicotine is governed by a network of international standards, including the United States Pharmacopeia (USP), the European Pharmacopoeia (EP), and Good Manufacturing Practice (GMP) guidelines. Additional certifications—such as Certificates of Suitability (CEP) and Drug Master Files (DMF)—provide further validation of quality and compliance. However, as all three companies pointed out, regulatory requirements vary sig- nificantly across markets. While the EU and US maintain relatively stringent frame- works, other regions may lack comprehensive regulations, creating opportunities for lower-quality products to enter the market. This uneven landscape has contributed to instances of misrepresentation. Both Chemnovatic and Alchem have in the past reported cases where suppliers falsely la- beled products as pharmaceutical-grade. "The industry does face instances of mis- representation," Balconi acknowledged, reinforcing the need for independent audits, detailed documentation, and full traceability. Supply chains, sustainability, and traceability Purity aside, pharmaceutical-grade nicotine is also increasingly defined by the integrity of its supply chain. Chemnovatic's STC Nicotine® framework, which covers sustain- ability, traceability and compliance, is an internally developed nicotine manufacturing standard that extends beyond pharmacopeial requirements. It integrates quality con- trol, sustainable practices, involvement in the STP, and batch-level traceability, into one unified system designed to control and optimize each stage of nicotine manufac- turing, supporting consistent quality, batch-to-batch repeatability and sensory consis- tency in demanding NGP applications. Similarly, Alchem emphasized dur- ing the interview with Tobacco Asia its alignment with the STP, ensuring ethi- cal sourcing and compliance with global ESG standards. Meanwhile, with Nico- brand's parent company CNT being one of the largest tobacco leaf suppliers in the world since as early as 2015, it has uti- lized its knowledge of agronomy, tobac- co, and experience of STP to initiate the implementation of its own Sustainable Nicotine Program (SNP), which fully encompasses STP and more. This ma- ture program now involves some 12,000 farmers in India. McQuillan explicitly stressed the importance of traceability, noting that cus- tomers now demand visibility "right back to the tobacco seed." He went on to say that such supply chain integrity and ESG compliance is not an overnight fix and that would-be customers should look beyond any marketing information and "check under the hood" for concrete evidence on the ground." This focus on traceability re- flects a broader shift in the industry, where quality is no longer solely judged by chem- ical composition but also by the processes and ethics behind production. Market dynamics and global production Despite its growing importance, phar- maceutical-grade nicotine remains a rela- tively niche market in terms of volume. According to McQuillan, global produc- tion of pure nicotine is "maybe between 1,000 to 1,500 metric tons per annum," far lower than commonly assumed. Nicobrand's QC lab. Credit: Nicobrand.CNT Mark McQuillan, Nicobrand Ltd. Credit: Nicobrand.CNT

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