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.



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