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Brand differences of free?base nicotine delivery in cigarette smoke: the view of the tobacco industry documents

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The public release of internal tobacco industry documents has led to increasing sophistication by independent scientists in the characterisation of the design and function of tobacco products. One critical area of research is the role of smoke chemistry in determining the delivery, absorption, and effects of smoke constituents, especially harm producing or pharmacologically active compounds. The adverse health effects of smoking are a function of the toxicity of smoke constituents, as well as the amount and duration of exposure to those toxins, in combination with individual differences in metabolism of toxic compounds and susceptibility. Conventional measurements of smoke delivery, such as ISO measures, have generally focused on &#x0201c tar&#x0201d or nicotine in smoke PM as collected from the Cambridge filter using standard machine smoking protocols. Recent findings suggest that these measures fail to account for or describe important design&#x02010 based differences in smoke chemistry, which may alter exposure or toxicological impact.

Tobacco industry documents indicate that the major US tobacco manufacturers have routinely sought to measure the amounts of free&#x02010 base nicotine delivered by their own as well as competing brands using a range of internal methods. Many of the documents make reference to specific, brand&#x02010 dependent free&#x02010 base nicotine deliveries in units such as mg per cigarette. While those historic determinations are now understood to have been unreliable in absolute terms, they may nevertheless retain utility as relative measures of smoke alkalinity and free&#x02010 base nicotine delivery. For example, the differences observed among brands by these methods were found to correlate with differences in sensory perception and &#x0201c impact&#x0201d in a manner that appears to be best explained in terms of different relative free&#x02010 base nicotine deliveries.

Because of the enormous historic interest in &#x0201c smoke pH&#x0201d values that is made evident in the tobacco industry documents, public health researchers and governmental entities (for example, Texas, Massachusetts) have recently focused attention on &#x0201c smoke pH&#x0201d as a proxy to determine free&#x02010 base nicotine delivery. For example, since 1997, Massachusetts has required &#x0201c smoke pH&#x0201d testing as a component of its nicotine disclosure regulations.105 This requirement has been the subject of industry criticisms, including the claim that the resulting measurements of &#x0201c smoke pH&#x0201d show only minor differences across brands, and that any differences in these &#x0201c smoke pH&#x0201d values are likely due to differences in methodologies across companies.97,98

The public statements made by tobacco manufacturers are not consistent with decades of industry use of &#x0201c smoke pH&#x0201d and other methods to differentiate commercial brands according to smoke alkalinity. They are also not consistent with the recent determinations by Pankow et al and Watson et al.25,29 Criticisms by Pankow and others, that &#x0201c smoke pH&#x0201d methods are not capable of providing absolute measures of free&#x02010 base nicotine delivery,3,29,31 suggest that traditional &#x0201c smoke pH&#x0201d methods should be supplanted by more accurate approaches for measuring free&#x02010 base nicotine delivery. This point is confirmed by observations made internally by tobacco manufacturers. The method of Pankow et al for measuring effective pH values of collected smoke PM samples holds promise in this regard.29 The Watson et al research from the Centers for Disease Control and Prevention laboratory is particularly important because it used sophisticated techniques to measure directly the free base fraction of nicotine in cigarette smoke.25 These findings largely substantiated those of Pankow. Watson et al also found that the free base fraction increased in direct relation to increasing ventilation, consistent with the hypothesis that decreasing concentrations of smoke aerosol may result in an increasing fraction of nicotine &#x0201c off gassing&#x0201d in the unionized free&#x02010 base form.

The FTC has requested comments on its tobacco smoke testing methods and has asked the Secretary of Health and Human Services for guidance on how to improve the current testing programme. The World Health Organization Framework Convention on Tobacco Control has also proposed additional in&#x02010 depth testing of tobacco products to provide more meaningful assessments as to the actual deliveries and exposure of nicotine and other substances.106,107,108,109,110 We conclude that government and public health agencies must seek to better understand the role of smoke chemistry in determining exposure, including how free&#x02010 base nicotine deliveries interact with other substances to influence cigarette addiction potential. One possible regulatory strategy would include the required disclosure by manufacturers of free&#x02010 base nicotine deliveries for marketed brands. In addition, regulatory strategies targeting tobacco product dependence could consider imposing limits on free base nicotine delivery.

For the scientific community, areas requiring study include (1) patterns of free&#x02010 base nicotine deliveries among regular and low yield cigarettes (2) correlation of free&#x02010 base nicotine deliveries with market share (3) differences in measurable effects of percent free&#x02010 base nicotine versus total free&#x02010 base nicotine delivery and (4) effects of free&#x02010 base nicotine delivery on addiction potential. The latter should include studies that measure (a) &#x0201c impact&#x0201d response and sensory effects (b) EEG and other studies that directly measure physiological effects (c) the mechanisms and locations of free&#x02010 base nicotine deposition in the respiratory tract (d) uptake rates within the lung and (e) delivery rates to the brain.