individual compared to the risk for that individual from the usual smoking behavior before switching to the PREP.

Is There a Threshold for Cancer Risk and Does It Matter?

It is important to consider whether a threshold exists for risk of cancer from tobacco products. This is important for new smokers who might initiate smoking with a PREP. It is possible that the delivered exposures from a PREP would be below the threshold, or at least this should be the goal of such a product. It is recognized that ETS data would suggest that the threshold, if any, is very low.

Do All New Products Need to Be Tested or Only Some That Would Serve as Indicators for Similar Products?

It would be efficient to have data that are representative of a class or type of product, where some screening tests could be used to ensure that a potential product fits within that class or type. However, data are needed to validate the assumption that representative products actually are representative.

Which Carcinogens Should Be Prioritized for Study, Given the Large Number Delivered By Tobacco Products?

While there is a need to study both individual carcinogens and tobacco exposure as a complex mixture, it will not be possible to evaluate all possible carcinogens. Thus, additional studies are needed that can compare the harmful effects of tobacco constituents, and models should be developed to prioritize their study. Further data are needed to achieve confidence that only a few key, but high-priority, carcinogens are sufficient to evaluate a PREP.


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