Page:United States Statutes at Large Volume 123.djvu/1800

123STA T . 1 780PUBLIC LA W 111 – 31 —J U NE 22 , 200 9(37)Unles s tobac co pr o du cts t h at purport to reduce the r i s k s to the public o f tobacco use actuall y reduce such risks , those products can cause substantial har m to the public health tothee x tent that the indi v iduals, w ho would otherwise not consume tobacco products or would consume such products less, use tobacco products purportin g to reduce risk .T hose who use products sold or distributed as modified risk products that do not in fact reduce risk, rather than q uitting or reducing their use of tobacco products, have a substantially increased likelihood of suffering disability and premature death. The costs to society of the widespread use of products sold or distrib - uted as modified risk products that do not in fact reduce risk or that increase risk include thousands of unnecessary deaths and in j uries and huge costs to our health care system. (3 8 ) A s the N ational C ancer I nstitute has found, many smokers mistakenly believe that ‘ ‘low tar ’ ’ and ‘‘light’’ cigarettes cause fewer health problems than other cigarettes. As the National Cancer Institute has also found, mistaken beliefs about the health consequences of smoking ‘‘low tar’’ and ‘‘light’’ cigarettes can reduce the motivation to quit smoking entirely and thereby lead to disease and death. (3 9 ) R ecent studies have demonstrated that there has been no reduction in risk on a population-wide basis from ‘‘low tar’’ and ‘‘light’’ cigarettes, and such products may actually increase the risk of tobacco use. ( 40 ) The dangers of products sold or distributed as modified risk tobacco products that do not in fact reduce risk are so high that there is a compelling governmental interest in ensuring that statements about modified risk tobacco products are complete, accurate, and relate to the overall disease risk of the product. (4 1 )Asthe F ederal Trade Commission has found, con- sumers have misinterpreted advertisements in which one product is claimed to be less harmful than a comparable product, even in the presence of disclosures and advisories intended to provide clarification. (4 2 ) P ermitting manufacturers to make unsubstantiated statements concerning modified risk tobacco products, whether express or implied, even if accompanied by disclaimers would be detrimental to the public health. (43) The only way to effectively protect the public health from the dangers of unsubstantiated modified risk tobacco prod- ucts is to empower the Food and D rug Administration to require that products that tobacco manufacturers sold or distributed for risk reduction be reviewed in advance of marketing, and to require that the evidence relied on to support claims be fully verified. (44) The Food and Drug Administration is a regulatory agency with the scientific expertise to identify harmful sub- stances in products to which consumers are exposed, to design standards to limit exposure to those substances, to evaluate scientific studies supporting claims about the safety of products, and to evaluate the impact of labels, labeling, and advertising on consumer behavior in order to reduce the risk of harm and promote understanding of the impact of the product on health. In connection with its mandate to promote health and reduce the risk of harm, the Food and Drug Administration