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Ending tobacco-caused mortality and morbidity: the case for performance standards for tobacco products
  1. Dorothy K Hatsukami
  1. Correspondence to Dr Dorothy K Hatsukami, Department of Psychiatry, University of Minnesota, 717 Delaware Street SE, Minneapolis, MN 55422, USA; hatsu001{at}


The US Family Smoking Prevention and Tobacco Control Act and WHO Framework Convention on Tobacco Control provide us with powerful tools to reduce the death and disease caused by the use of tobacco products. One tool that can contribute substantially toward this goal is the authority to establish performance standards for tobacco products. Conjointly with reducing levels of nicotine in cigarettes, performance and quality control standards need to be established for non-combusted tobacco products. Performance standards and incentives should be provided so that tobacco companies are compelled to manufacture and market products with very low or almost non-existent toxicity (eg, nicotine-only products).

  • Addiction
  • End game
  • Harm Reduction
  • Toxicology

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: and

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As described in a paper summarising the proceedings of a strategic dialogue on tobacco harm reduction,1 there is a continuum of risk for tobacco products with combustible products associated with the highest health risk, and pure nicotine delivery products (primarily medicinal nicotine) associated with the lowest risk. To improve public health, one potential ‘endgame’ goal would be to gradually move the population of tobacco users from the highest to the lowest risk product, with the eventual goal of making the population tobacco free. How can this be achieved?

One of the most powerful tools in the US Food and Drug Administration Family Smoking Prevention and Tobacco Control Act to substantially improve public health is the regulatory authority to establish performance standards for tobacco products. It is also a powerful tool provided in Article 9 (‘Regulation of Contents of Tobacco Products’) of the Framework Convention on Tobacco Control. The following describes a potential scenario of how performance standards for tobacco products, which, heretofore, have not been a primary focus for the tobacco control community, can be used as one of the means to shift the population away from the most deadly nicotine-containing products, and to reduce tobacco-related mortality and morbidity.

Scientific literature suggests that reducing nicotine in cigarettes to a specific level (most likely less than 1 mg nicotine content) can result in a significant reduction in cigarette smoking and may facilitate abstinence.2–5 This dose of nicotine has not been associated with clinically significant increases in withdrawal symptomology, significant compensatory smoking behaviour, nor greater exposure to tobacco carcinogens or increased cardiovascular risk factors. When the cigarette is also reduced in tobacco carcinogen levels, a significant reduction was observed in exposure to these carcinogens,4 thereby supporting the importance of reducing both the nicotine and toxicants in cigarettes. The sample sizes in these studies were relatively modest, pointing to the need for larger trials determining the dose that is likely to eliminate smoking (because in the USA, the dose cannot be reduced to zero) with relatively minimal adverse consequences (significant physiological, cognitive or psychological discomfort), ways to mitigate these effects, the best approach to reducing levels of nicotine on a national level, and ensuring that vulnerable populations of smokers (eg, individuals with comorbid psychiatric disorders) are not unduly affected. Other performance standards may also be considered to reduce the appeal of the product such as elimination of non-characterising flavorants, eliminating specific design features of cigarettes that enhance better particle deposition in the lungs or requiring a specific pH level in the cigarette.6 Instituting these performance standards would require a significant surveillance system to track any unintended consequences,6–8 and to mitigate them as best we can.

If sufficient science is generated to support reducing levels of nicotine in cigarettes and other combustible products, then we are left with the question of what to do with non-combusted tobacco products. To minimise initiation (serving as a starter product as described by Connolly9), a performance standard of high rather than low nicotine may be considered along with a ban on flavorants.10 Additionally, because of the substantial variability of toxicants in smokeless tobacco products within and across different countries,11–13 performance standards for toxicants in these products are needed (regardless of whether or not nicotine in cigarettes is reduced). There are already known ways to reduce toxicant levels in oral tobacco products including use of specific tobacco leaves, curing and manufacturing processes that could easily be implemented.11 Studies have shown that oral tobacco products that are reduced in toxicants are associated with negligible increases in oral cancers, pulmonary disease and non-fatal cardiovascular disease.14–16 Nonetheless, reduced toxin oral tobacco products are not harmless and may be associated with fetal toxicity, increased risk of fatal cardiovascular disease and pancreatic cancer.14 ,15 ,17 Ultimately, tobacco users need to be shifted towards a cleaner form of nicotine delivery.

Reducing nicotine in cigarettes, establishing increasingly strict standards for toxicants in non-combusted tobacco products, and establishing standards to make all tobacco products less appealing, may facilitate the development of less harmful methods of nicotine delivery by the industry, including devices or products that rapidly deliver nicotine without the toxicants. Products of high abuse potential (eg, pulmonary delivery of nicotine), sold only by prescription, could be used to substitute completely for cigarettes. On the other hand, nicotine used in a form without high abuse potential may be acceptable for prolonged or occasional use and made more accessible to consumers because persistent use is not likely to result in significant death and disease.16 ,18 Even if all smokers switched to rapid pulmonary delivery of nicotine, public health benefit may be observed.19

Innovations from industry may also take the form of research that contributes to a better understanding of the effects of nicotine on different nicotinic receptor subtypes. With increasing stringent performance standards, it is possible that tobacco companies will eventually evolve into developing pharmaceutics (ie, Targacept) that target specific nicotinic receptors that have specific functional value (eg, nicotinic receptors such as α4β2 or α7 for learning and memory, neuroprotective, antinociception or anxiolytic and antidepressant effects20–24).

In summary, the vision is a world in which consumers are not using products that have levels of constituents that lead to death and disease. Although this approach may not be appropriate for all countries, regulating tobacco constituents is an approach worth serious consideration.



  • Competing interests None.

  • Provenance and peer review Commissioned; externally peer reviewed.

  • Open Access This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: