Early interest focused on pseudo-cigarettes. Why? Fascination with high-tech products First “splash” (Premier, mid-1980s) Promised large decreases in a major class of toxicants, with a new delivery mechanism

Interest has switched to other categories of PREPs Different reasons for different categories

#1 Modified cigarettes (e.g., Omni and Advance) Most likely to appeal to smokers (closest approximation to the “real thing”) Least likely to produce great risk reduction for the individual Most likely to increase population harm Therefore, the greatest source of concern

#3 Smokeless tobacco products, including modified (e.g., Exalt, Revel) Snus history and controversy Advertising as “fill in” for times when can’t smoke (e.g., Revel) Fear of substitution for NRT products Fear of leading to smoking

#4 Presumed lowest-risk novel products (e.g., Ariva Cigaletts) Sheer novelty and our bewilderment about them Fear of attraction to children (with risk of subsequent shift to cigarettes) “Affront” to the idea of using these products when there are proven pharmaceuticals to substitute for tobacco products

Little interest focused on nicotine pharmaceuticals (category #5)? No longer “sexy” Regulatory approval limited to short-term use for cessation Pharmaceutical companies timid about taking on the tobacco industry Pharmaceutical companies’ worries about the public image associated with advocating long-term use. –Sustaining nicotine addiction vs. overcoming it. –Public’s perception of nicotine as a very dangerous drug.

What have we learned to this point? Experience with earlier generations of “harm- reducing” cigarettes recommends skepticism. The risk/use equilibrium addresses the acceptability of the highest- and lowest-risk classes of PREPs, but not those in between. The need for formal, government-sanctioned regulation is clear…but its methods are not.

Earlier generations of “harm- reducing” cigarettes

Filter-tipped cigarettes, the response to the lung cancer scare of the 1950s

Filter-tip share of the cigarette market Year% filters (Current  98)

“Low-yield” (low tar and nicotine) cigarettes, the response to the smoking-and-health scare of the late 1960s, early 1970s

Year% low t/n (avg.) (avg.) Low tar and nicotine share of the cigarette market

Even today, 30 years after their introduction, smokers of low tar/nicotine cigarettes believe their risk is well below that of “full-flavor” smokers. Yet ample evidence demonstrates that low t/n smokers compensate… And the consequence is that low t/n smokers are developing cancers further down in the lung.

Lessons from the risk-use equilibrium (Kozlowski et al., Tobacco Control, Sept. 2001)

Risk/use equilibrium: lessons Any combusted tobacco product likely constitutes a very poor prospect for harm reduction. At a population level, it is likely to be harm increasing. Combusted products should not be marketed as harm-reducing. Medicinal nicotine likely represents an excellent prospect for harm reduction. It should be encouraged by health professionals today, and (more controversially) marketed by the pharmaceutical industry (with FDA approval secured) – for smokers who cannot or will not quit altogether.

The great unknown… Should smokeless tobacco products be promoted as potential harm- reduction products? (Risks being accused of tobacco control heresy…)

Need for regulation Establish the toxic exposures associated with new products (old and new exposures; e.g., Eclipse) Estimate (guestimate?) the health consequences Estimate population exposures Evaluate the implications of risk communication to health professionals and the public (and define acceptable risk communication) Monitor legitimacy of claims “Level the playing field” between highly regulated pharmaceuticals and unregulated tobacco products

What is to be regulated? All products? All new products? All new non-conventional products? (How define “conventional”?)

Methods of regulation Approve claims (IOM) Adopt performance standards (with or without permitting claims concerning them) Pre-marketing approval based on probable degree of decrease in individual risk Pre-marketing approval based on probable degree of net benefit or net harm to public

Difficulties in regulating How establish individual exposure reduction? How estimate harm reduction from individual exposure reduction? (the limits of surveillance) How assess population responses to claims and marketing? (again, the limits of surveillance) How combine (weak) estimates of individual harm reduction potential with (weak) estimates of population response? How address the political barriers to regulation?

How can we properly educate health professionals and the public about harm reduction? What do we tell them? Yet another issue

Is an era of harm reduction inevitably upon us? –In today’s (non)regulatory world, yes Tobacco industry innovation assures it. Will we ever see more explicit and aggressive competition from the pharmaceutical industry? Concluding thoughts

Concluding thoughts (cont’d.) Potential societal benefits of harm reduction are considerable: –Could conceivably lead to more eventual complete renunciation of nicotine and tobacco –May decrease the toll of tobacco Potential risks are substantial too: –Sustain and potentially increase the level of nicotine dependence in contemporary society (Necessarily bad?) –Slow progress against the devastating toll of tobacco –Increase nicotine dependence in future generations –Create new health hazards in the process?

Concluding thoughts (cont’d.) Over time, harm reduction may play a large and increasingly important role within tobacco control. For the foreseeable future, its contribution is likely to be small, and possibly negative. –The most consumer-attractive products not likely to produce net improvement in public health (modified cigarettes) –Products with the greatest potential for true harm reduction not likely to be popular (medicinal nicotine) Harm reduction should never supplant emphasis on prevention and cessation.