country is likely to focus on changes that purport to reduce risk. Because the main regulatory purpose of a requirement for no increased risk is to help establish the baseline for future comparisons and to stimulate development and use of protocols for tobacco product risk assessment, premarket notification is sufficient. The committee also did not want to see the regulatory agency burdened with a high volume of premarket approval decisions for products that have no claims of and no potential for improving the public health. Nevertheless, the regulatory agency should have the authority to seek the removal of a product from the market in the event that the “no increased risk” standard is not met.

Principle 8: Added-Ingredient Review

All added ingredients in tobacco products, including those already on the market, should be reported to the agency and be subject to a comprehensive toxicological review.

The ingredients added to tobacco products should be subject to a review that is similar to the FDA review of food additives conducted more than two decades ago to determine if those additives were generally recognized as safe and not subject to additional regulation. Although many of the ingredients added to tobacco products are generally recognized as safe when used as food additives, such an understanding may not apply when these substances are combusted and/or inhaled in smoke. A review of added ingredients would establish a baseline of knowledge about the ingredients, including chemicals, papers, and filters, as well as the toxicological testing that has been conducted on them; it would thereby facilitate an informed appraisal of the potential effects of product modifications. This review should be conducted by independent panels of experts reporting to the regulatory agency, with the objective of identifying those ingredients that add no significant toxicity to tobacco products and therefore can be considered safe in the context of this use. Sufficient knowledge of the toxicity of many of the constituents and ingredients of tobacco products may already be available (see Chapter 10) to begin this review. If adequate information is not yet available, the regulatory agency should have the authority to require the in vitro and animal testing that is judged necessary by the expert panels conducting the review. Such a review would begin to rationalize the risk assessment of ingredients in tobacco products. It would also open this field to the same scientific discourse that is now applied to food additives, environmental contaminants, and toxic chemicals, substances that are no longer introduced into use without independent scientific scrutiny or regulatory review. Tobacco products are the last remaining legally marketed toxic products in our marketplace that are tolerated without such review. A review of



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