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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?
  • 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 tip share of the cigarette market
Filter-tip share of the cigarette market

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

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.
risk use equilibrium lessons
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
The great unknown…

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

need for regulation
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
What is to be regulated?
  • All products?
  • All new products?
  • All new non-conventional products? (How define “conventional”?)
methods of regulation
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
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?

Yet another issue

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


Concluding thoughts

  • 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.)
  • 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.)
  • 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.