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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.

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Early interest focused on pseudo cigarettes why
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
Interest has switched to other categories of PREPs

Different reasons for different categories


1 modified cigarettes e g omni and advance
#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
#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
#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
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
What have we learned to this point? (category #5)?

  • 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.



Filter tipped cigarettes the response to the lung cancer scare of the 1950s
Filter-tipped cigarettes, (category #5)?the response to the lungcancer scare of the 1950s


Filter tip share of the cigarette market
Filter-tip share of the cigarette market (category #5)?

Year % filters

1950 1

1960 51

(Current 98)


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


Low tar and nicotine share of the cigarette market response to the

Year % low t/n

1967-70 (avg.) 3

1971-74 (avg.) 8

1981 58


  • 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
Lessons from the risk-use equilibrium low tar/nicotine cigarettes believe their risk is well below that of “full-flavor” smokers.(Kozlowski et al., Tobacco Control, Sept. 2001)


Risk use equilibrium lessons
Risk/use equilibrium: lessons low tar/nicotine cigarettes believe their risk is well below that of “full-flavor” smokers.

  • 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
The great unknown… low tar/nicotine cigarettes believe their risk is well below that of “full-flavor” smokers.

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


Need for regulation
Need for regulation low tar/nicotine cigarettes believe their risk is well below that of “full-flavor” smokers.

  • 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
What low tar/nicotine cigarettes believe their risk is well below that of “full-flavor” smokers. is to be regulated?

  • All products?

  • All new products?

  • All new non-conventional products? (How define “conventional”?)


Methods of regulation
Methods of regulation low tar/nicotine cigarettes believe their risk is well below that of “full-flavor” smokers.

  • 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
Difficulties in regulating low tar/nicotine cigarettes believe their risk is well below that of “full-flavor” smokers.

  • 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?


Yet another issue low tar/nicotine cigarettes believe their risk is well below that of “full-flavor” smokers.

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


Concluding thoughts low tar/nicotine cigarettes believe their risk is well below that of “full-flavor” smokers.

  • 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 cont d
Concluding thoughts (cont’d.) low tar/nicotine cigarettes believe their risk is well below that of “full-flavor” smokers.

  • 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 d1
Concluding thoughts (cont’d.) low tar/nicotine cigarettes believe their risk is well below that of “full-flavor” smokers.

  • 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.