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S. 2462 (is) Entitled the ``Lisa De Land Financial Protection Act''. ...


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108th CONGRESS
  2d Session
                                S. 2461

      To protect the public health by providing the Food and Drug 
  Administration with certain authority to regulate tobacco products.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 20, 2004

Mr. DeWine (for himself and Mr. Kennedy) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
      To protect the public health by providing the Food and Drug 
  Administration with certain authority to regulate tobacco products.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Family Smoking 
Prevention and Tobacco Control Act''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.
         TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION

Sec. 101. Amendment of Federal food, drug, and cosmetic act.
Sec. 102. Construction of current regulations.
Sec. 103. Conforming and other amendments to general provisions.
 TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT 
                               DISCLOSURE

Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Authority to revise cigarette warning label Statements.
Sec. 203. State regulation of cigarette advertising and promotion.
Sec. 204. Smokeless tobacco labels and advertising warnings.
Sec. 205. Authority to revise smokeless tobacco product warning label 
                            Statements.
Sec. 206. Tar, nicotine, and other smoke constituent disclosure to the 
                            public.
       TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS

Sec. 301. Labeling, record keeping, records inspection.
Sec. 302. Study and report.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) The use of tobacco products by the Nation's children is 
        a pediatric disease of considerable proportions that results in 
        new generations of tobacco-dependent children and adults.
            (2) A consensus exists within the scientific and medical 
        communities that tobacco products are inherently dangerous and 
        cause cancer, heart disease, and other serious adverse health 
        effects.
            (3) Nicotine is an addictive drug.
            (4) Virtually all new users of tobacco products are under 
        the minimum legal age to purchase such products.
            (5) Tobacco advertising and marketing contribute 
        significantly to the use of nicotine-containing tobacco 
        products by adolescents.
            (6) Because past efforts to restrict advertising and 
        marketing of tobacco products have failed adequately to curb 
        tobacco use by adolescents, comprehensive restrictions on the 
        sale, promotion, and distribution of such products are needed.
            (7) Federal and State governments have lacked the legal and 
        regulatory authority and resources they need to address 
        comprehensively the public health and societal problems caused 
        by the use of tobacco products.
            (8) Federal and State public health officials, the public 
        health community, and the public at large recognize that the 
        tobacco industry should be subject to ongoing oversight.
            (9) Under article I, section 8 of the Constitution, the 
        Congress is vested with the responsibility for regulating 
        interstate commerce and commerce with Indian tribes.
            (10) The sale, distribution, marketing, advertising, and 
        use of tobacco products are activities in and substantially 
        affecting interstate commerce because they are sold, marketed, 
        advertised, and distributed in interstate commerce on a 
        nationwide basis, and have a substantial effect on the Nation's 
        economy.
            (11) The sale, distribution, marketing, advertising, and 
        use of such products substantially affect interstate commerce 
        through the health care and other costs attributable to the use 
        of tobacco products.
            (12) It is in the public interest for Congress to enact 
        legislation that provides the Food and Drug Administration with 
        the authority to regulate tobacco products and the advertising 
        and promotion of such products. The benefits to the American 
        people from enacting such legislation would be significant in 
        human and economic terms.
            (13) Tobacco use is the foremost preventable cause of 
        premature death in America. It causes over 400,000 deaths in 
        the United States each year and approximately 8,600,000 
        Americans have chronic illnesses related to smoking.
            (14) Reducing the use of tobacco by minors by 50 percent 
        would prevent well over 6,500,000 of today's children from 
        becoming regular, daily smokers, saving over 2,000,000 of them 
        from premature death due to tobacco induced disease. Such a 
        reduction in youth smoking would also result in approximately 
        $75,000,000,000 in savings attributable to reduced health care 
        costs.
            (15) Advertising, marketing, and promotion of tobacco 
        products have been especially directed to attract young persons 
        to use tobacco products and these efforts have resulted in 
        increased use of such products by youth. Past efforts to 
        oversee these activities have not been successful in adequately 
        preventing such increased use.
            (16) In 2001, the tobacco industry spent more than 
        $11,000,000,000 to attract new users, retain current users, 
        increase current consumption, and generate favorable long-term 
        attitudes toward smoking and tobacco use.
            (17) Tobacco product advertising often misleadingly 
        portrays the use of tobacco as socially acceptable and 
        healthful to minors.
            (18) Tobacco product advertising is regularly seen by 
        persons under the age of 18, and persons under the age of 18 
        are regularly exposed to tobacco product promotional efforts.
            (19) Through advertisements during and sponsorship of 
        sporting events, tobacco has become strongly associated with 
        sports and has become portrayed as an integral part of sports 
        and the healthy lifestyle associated with rigorous sporting 
        activity.
            (20) Children are exposed to substantial and unavoidable 
        tobacco advertising that leads to favorable beliefs about 
        tobacco use, plays a role in leading young people to 
        overestimate the prevalence of tobacco use, and increases the 
        number of young people who begin to use tobacco.
            (21) The use of tobacco products in motion pictures and 
        other mass media glamorizes its use for young people and 
        encourages them to use tobacco products.
            (22) Tobacco advertising expands the size of the tobacco 
        market by increasing consumption of tobacco products including 
        tobacco use by young people.
            (23) Children are more influenced by tobacco advertising 
        than adults, they smoke the most advertised brands.
            (24) Tobacco company documents indicate that young people 
        are an important and often crucial segment of the tobacco 
        market. Children, who tend to be more price-sensitive than 
        adults, are influenced by advertising and promotion practices 
        that result in drastically reduced cigarette prices.
            (25) Comprehensive advertising restrictions will have a 
        positive effect on the smoking rates of young people.
            (26) Restrictions on advertising are necessary to prevent 
        unrestricted tobacco advertising from undermining legislation 
        prohibiting access to young people and providing for education 
        about tobacco use.
            (27) International experience shows that advertising 
        regulations that are stringent and comprehensive have a greater 
        impact on overall tobacco use and young people's use than 
        weaker or less comprehensive ones.
            (28) Text only requirements, although not as stringent as a 
        ban, will help reduce underage use of tobacco products while 
        preserving the informational function of advertising.
            (29) It is in the public interest for Congress to adopt 
        legislation to address the public health crisis created by 
        actions of the tobacco industry.
            (30) The final regulations promulgated by the Secretary of 
        Health and Human Services in the August 28, 1996, issue of the 
        Federal Register (61 Fed. Reg. 44615-44618) for inclusion as 
        part 897 of title 21, Code of Federal Regulations, are 
        consistent with the First Amendment to the United States 
        Constitution and with the standards set forth in the amendments 
        made by this Act for the regulation of tobacco products by the 
        Food and Drug Administration and the restriction on the sale 
        and distribution, including access to and the advertising and 
        promotion of, tobacco products contained in such regulations 
        are substantially related to accomplishing the public health 
        goals of this Act.
            (31) The regulations described in paragraph (30) will 
        directly and materially advance the Federal Government's 
        substantial interest in reducing the number of children and 
        adolescents who use cigarettes and smokeless tobacco and in 
        preventing the life-threatening health consequences associated 
        with tobacco use. An overwhelming majority of Americans who use 
        tobacco products begin using such products while they are 
        minors and become addicted to the nicotine in those products 
        before reaching the age of 18. Tobacco advertising and 
        promotion plays a crucial role in the decision of these minors 
        to begin using tobacco products. Less restrictive and less 
        comprehensive approaches have not and will not be effective in 
        reducing the problems addressed by such regulations. The 
        reasonable restrictions on the advertising and promotion of 
        tobacco products contained in such regulations will lead to a 
        significant decrease in the number of minors using and becoming 
        addicted to those products.
            (32) The regulations described in paragraph (30) impose no 
        more extensive restrictions on communication by tobacco 
        manufacturers and sellers than are necessary to reduce the 
        number of children and adolescents who use cigarettes and 
        smokeless tobacco and to prevent the life-threatening health 
        consequences associated with tobacco use. Such regulations are 
        narrowly tailored to restrict those advertising and promotional 
        practices which are most likely to be seen or heard by youth 
        and most likely to entice them into tobacco use, while 
        affording tobacco manufacturers and sellers ample opportunity 
        to convey information about their products to adult consumers.
            (33) Tobacco dependence is a chronic disease, one that 
        typically requires repeated interventions to achieve long-term 
        or permanent abstinence.
            (34) Because the only known safe alternative to smoking is 
        cessation, interventions should target all smokers to help them 
        quit completely.
            (35) Tobacco products have been used to facilitate and 
        finance criminal activities both domestically and 
        internationally. Illicit trade of tobacco products has been 
        linked to organized crime and terrorist groups.
            (36) It is essential that the Food and Drug Administration 
        review products sold or distributed for use to reduce risks or 
        exposures associated with tobacco products and that it be 
        empowered to review any advertising and labeling for such 
        products. It is also essential that manufacturers, prior to 
        marketing such products, be required to demonstrate that such 
        products will meet a series of rigorous criteria, and will 
        benefit the health of the population as a whole, taking into 
        account both users of tobacco products and persons who do not 
        currently use tobacco products.
            (37) Unless tobacco products that purport to reduce the 
        risks to the public of tobacco use actually reduce such risks, 
        those products can cause substantial harm to the public health 
        to the extent that the individuals, who would otherwise not 
        consume tobacco products or would consume such products less, 
        use tobacco products purporting to reduce risk. Those who use 
        products sold or distributed as modified risk products that do 
        not in fact reduce risk, rather than quitting 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 
        distributed as modified risk products that do not in fact 
        reduce risk or that increase risk include thousands of 
        unnecessary deaths and injuries and huge costs to our health 
        care system.
            (38) As the National Cancer Institute 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.
            (39) Recent 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 
        insuring that statements about modified risk tobacco products 
        are complete, accurate, and relate to the overall disease risk 
        of the product.
            (41) As the Federal Trade Commission has found, consumers 
        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.
            (42) Permitting 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 
        products is to empower the Food and Drug Administration to 
        require that products that tobacco manufacturers sold or 
        distributed for risk reduction be approved in advance of 
        marketing, and to require that the evidence relied on to 
        support approval of these products is rigorous.

SEC. 3. PURPOSE.

    The purposes of this Act are--
            (1) to provide authority to the Food and Drug 
        Administration to regulate tobacco products under the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), by 
        recognizing it as the primary Federal regulatory authority with 
        respect to the manufacture, marketing, and distribution of 

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