Impact assessment of WHO TobReg proposals for mandated lowering of selected mainstream cigarette smoke toxicants

• Published in: Regulatory toxicology and pharmacology 2017-06, Vol.86, p.332-348
• Main Authors: Eldridge, Alison C., McAdam, Kevin G., Betson, Tatiana R., Gama, Marcos V., Proctor, Christopher J.
• Format: Article
• Language: English
• Subjects: Ceilings; Cigarette; Emissions; Internationality; Nicotine - analysis; Nitrosamines - analysis; Regulation; Smoke; Smoke - analysis; Tobacco Products - legislation & jurisprudence; Tobacco Products - toxicity; TobReg; Toxicants; World Health Organization
• ISSN: 0273-2300; 1096-0295; 1096-0295
• DOI: 10.1016/j.yrtph.2017.02.022

The WHO Tobacco Product Regulation Study Group (TobReg) has proposed three regulatory models for cigarettes, each creating mandatory limits for emissions of nine smoke toxicants. One approach proposes country-specific limits, using median or 1.25× median toxicant/nicotine emission ratios. A second model provides fixed toxicant-ratio limits. The third model limits were three times the lowest toxicant emission on a market. Currently, the practical implications of these models are largely unknown. An impact assessment was conducted using cigarette data from 79 countries to identify four diverse test markets. We sampled all products from each market but limited product availability led to incomplete (80–97%) sourcing. Analysis showed that the country-specific model led to diverse (up to threefold) toxicant limits across the four markets. 70%–80% of products were non-compliant, rising to 100% in some countries with the second and the third models. With each regulatory model the main drivers of non-compliance were the tobacco-specific nitrosamines, the simultaneous application of limits for nine poorly correlated smoke toxicants, and analytical variability. Use of nicotine ratios led to compliance of some high toxicant emission products due to high nicotine emissions. Our findings suggest that these proposals would have greater impact on global markets than TobReg's stated aims. •WHO TobReg proposals to reduce levels of 9 cigarette smoke toxicants were tested.•All available (80–97%) cigarette products from 4 diverse countries were analysed.•70–100% of cigarette products failed to meet the proposed WHO regulatory models.•These proposals would have greater impact on global markets than WHO's stated aims.