products, as judged on the basis of the most current toxicological and epidemiological information.
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 regulatory agency should be empowered to set performance standards (e.g., maximum levels of toxicants; definitions of terms such as “low tar”) for all tobacco products, whether conventional or modified, or for classes of products.
The regulatory agency should have enforcement powers commensurate with its public health mission, including the power to issue subpoenas.
Exposure reduction and risk reduction claims for drugs and devices that are supported by appropriate scientific and clinical evidence should be allowed by the FDA.
The following sections elaborate on each of these principles.
Manufacturers of tobacco products, whether conventional or modified, should be required to obtain quantitative analytical data on the ingredients of each of their products and to disclose such information to the regulatory agency.
The manufacturers of tobacco products have detailed and extensive knowledge of the composition, curing, and blending of tobacco; the ingredients of their products; and the composition of tobacco smoke. They also have detailed quantitative information on the tobacco in each of their brands of cigarettes and smokeless products, since each is blended to achieve the desired taste and levels of nicotine and other ingredients. Manufacturers also conduct major research and development programs aimed at developing new products. Currently, there is no requirement for disclosure of this information to an appropriate regulatory body. Such disclosure is prerequisite to any meaningful scientific appraisal of the comparative risks of different tobacco-containing products or the potential for risk reduction offered by modified products. For smoked products, analytical information on the smoke and the concentrations of smoke components that are absorbed under actual smoking conditions may be even more important than knowledge of the product ingredients themselves. For smokeless tobacco products, whether conventional or modified, similar information on the concentrations of major ingredients in saliva and blood are equally important. The disclosure of quantitative information on ingredients (with appropriate safeguards to protect trade secrets) is a standard requirement in regulatory laws relating to drugs,