TABLE 5–1 Tobacco and PREP Risk Assessment


Hazard Identification

Dose Response

Exposure Assessment

Risk Characterization

Risk Management

1983 “Red Book”


Animal bioassay

Short-term Studies

Comparisons of molecular structure


Low-dose extrapolation

Animal to human extrapolation

Dose to which humans are exposed

Dose of special populations

Estimation of size of population potentially exposed

Estimate of the magnitude of the public health problem

A risk-assessment (qualitative or quantitative) may be one of the bases of risk management

Challenges in risk assessment of tobacco

Complex mixture

Animal models are limited

Constituents and additives are proprietary information

Dose changes for an individual over time

Dose of individual toxicants varies over time

Exposure at time of disease progression

Changes in smoking topography

Complex mixture

For which disease? At which point in smoking history?

FTC regarding advertising

Additional challenges of PREP risk assessment

Products will change rapidly with time

Assessing effect of moving backwards on a dose-exposure curve, assuming long-time previous higher exposure

Changing exposure after long-term higher dose exposure

Some toxicants could increase

Need models to consider effects on initiation, cessation, and relapse

FDA authority currently exerted only over pharmaceutical PREPs

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