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A Pragmatic Approach to Product Evaluation and Authorization It is worth considering the approach to premarket authorization recommended in the 2001 Institute of Medicine report Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction : In the absence of any claim of reduced exposure or reduced risk, manufacturers of tobacco products should be permitted to market new products or modify existing products without prior approval of the regulatory agency after informing the agency of the composition of the product and certifying that the product could not reasonably be expected to increase the risk of cancer, heart disease, pulmonary disease, adverse reproductive effects or other adverse health effects, compared to similar conventional tobacco products, as judged on the basis of the most current toxicological and epidemiological information