absolute content together with a statement of the range of expected systemic yield determined according to number of puffs or other behavioral factors. Currently, marketed cigarettes typically contain 8–9 mg nicotine in the tobacco rod, and have an expected actual yield to the smoker of 0.5–3.0 mg nicotine. Stating the nicotine content of the tobacco contained in the cigarettes is important because the content reflects the maximum possible yield, and reduction of content would be expected to result in a reduction in actual yield. Manufacturers might be required to convey this information on the package or through package inserts. In order to avoid misunderstanding, the agency might require consumers to be told that small differences in nominal yield do not reflect significant differences in health risks. Regulations of this nature will improve risk perception among consumers, and will correct any misleading impression about the relative hazards of cigarettes containing different levels of tar and nicotine. From the same perspective, the agency should be authorized to ban or regulate use of misleading terms (such as “light”) in advertising or on packaging, and should be authorized to require the use of standard terms.
Manufacturers of all PREPs should be required to conduct appropriate toxicological testing in preclinical laboratory and animal models and appropriate clinical testing in humans to support the health-related claims associated with each product and to disclose the methods and results of such testing to the regulatory agency.
Under the regulatory arrangements recommended by the committee, tobacco manufacturers would have to obtain appropriate toxicological data from the scientific literature or conduct toxicological testing in connection with any new product or modification of an existing product (1) to support a claim of reduced exposure or reduced risk (see principle 5), (2) to demonstrate that a new ingredient does not increase the product risk (see principle 7), or (3) to satisfy the requirements of the added-ingredients review described in principle 8.
Because clinical trials on the long-term health risks of individual ingredients in tobacco-related PREPs cannot reasonably be conducted in humans, any scientific assessment of the risks, except perhaps low birthweight and sudden cardiac death, of added ingredients must necessarily be based on animal studies, short-term human studies, and epidemiological studies. For ingredients that have not previously been used in conventional or modified tobacco products, animal studies to support their safety should be conducted by the manufacturer prior to human exposure to those ingredients. The committee believes that the practice of introducing new ingredients into smoked products without full and adequate testing of such ingredients, as judged by a competent regulatory agency, poses a substantial risk to the consumer and should cease. A requirement for