. "4 Products for Tobacco Exposure Reduction." Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction. Washington, DC: The National Academies Press, 2001.
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Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction
responsibility, again without regulatory review. Manufacturers are under no regulatory obligation to conduct postmarketing epidemiological studies or to collect and report adverse events.
The contrast between the regulatory systems for drugs or devices and for tobacco has been discussed by a number of authors (Henningfield, and Slade, 1998; O’Reilly, 1989; Page, 1998; Slade and Henningfield, 1998; Warner et al., 1997), who point out the paradox of a stringent regulatory system for exposure reduction products developed by the pharmaceutical industry and a weak regulatory system for exposure reduction products developed by tobacco manufacturers. Table 4–8 illustrates the problem.
TABLE 4–8 Comparison of Two Nicotine Inhalers
Feature
Eclipse (tobacco company)
Nicotrol Inhaler (pharmaceutical company)
Operation
Heat source volatizes nicotine and glycerol, and scorches tobacco
Ambient air passing through nicotine reservoir volatizes nicotine
Dose
Mimics cigarettes (lung delivery of nicotine)
Similar to low Nicorette dose (buccal delivery of nicotine)
Projected abuse liability
High
Low
Contaminants
High CO, acrolein, “soot,” and other contaminants
Not allowed
Claims or indications
Reduced delivery (unproven to FDA)
Smoking cessation (FDA-approved studies)
Intent
Cause and sustain dependence
Treat dependence
Cost
More than $3.00 per pack of 20 ($0.15 each)
$55.00 per pack of 42 ($1.30 each)
Modification oversight
Modified to be more palatable (and more toxic) without approval
Any modification requires FDA approval
Premarketing approval data
None submitted to FDA
Conventional new drug application submission and FDA approval
Availability
Over-the-counter
Prescription only
SOURCE: Slade and Henningfield, 1998. Reprinted with permission of the Food and Drug Law Institute.
