[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 2974 Considered and Passed Senate (CPS)]







108th CONGRESS
  2d Session
                                S. 2974

      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

                            October 10, 2004

Mr. DeWine (for himself, Mr. Kennedy, and Mr. Jeffords) introduced the 
following bill; which was read twice, considered, read the third time, 
                               and passed

_______________________________________________________________________

                                 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.

    This Act may be cited as the ``Family Smoking Prevention and 
Tobacco Control Act''.

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 subtitle 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 
        tobacco products;
            (2) to ensure that the Food and Drug Administration has the 
        authority to address issues of particular concern to public 
        health officials, especially the use of tobacco by young people 
        and dependence on tobacco;
            (3) to authorize the Food and Drug Administration to set 
        national standards controlling the manufacture of tobacco 
        products and the identity, public disclosure, and amount of 
        ingredients used in such products;
            (4) to provide new and flexible enforcement authority to 
        ensure that there is effective oversight of the tobacco 
        industry's efforts to develop, introduce, and promote less 
        harmful tobacco products;
            (5) to vest the Food and Drug Administration with the 
        authority to regulate the levels of tar, nicotine, and other 
        harmful components of tobacco products;
            (6) in order to ensure that consumers are better informed, 
        to require tobacco product manufacturers to disclose research 
        which has not previously been made available, as well as 
        research generated in the future, relating to the health and 
        dependency effects or safety of tobacco products;
            (7) to continue to permit the sale of tobacco products to 
        adults in conjunction with measures to ensure that they are not 
        sold or accessible to underage purchasers;
            (8) to impose appropriate regulatory controls on the 
        tobacco industry;
            (9) to promote cessation to reduce disease risk and the 
        social costs associated with tobacco related diseases; and
            (10) to strengthen legislation against illicit trade in 
        tobacco products.

SEC. 4. SCOPE AND EFFECT.

    (a) Intended Effect.--Nothing in this Act (or an amendment made by 
this Act) shall be construed to--
            (1) establish a precedent with regard to any other 
        industry, situation, circumstance, or legal action; or
            (2) affect any action pending in Federal, State, or Tribal 
        court, or any agreement, consent decree, or contract of any 
        kind.
    (b) Agricultural Activities.--The provisions of this Act (or an 
amendment made by this Act) which authorize the Secretary to take 
certain actions with regard to tobacco and tobacco products shall not 
be construed to affect any authority of the Secretary of Agriculture 
under existing law regarding the growing, cultivation, or curing of raw 
tobacco.

SEC. 5. SEVERABILITY.

    If any provision of this Act, the amendments made by this Act, or 
the application of any provision of this Act to any person or 
circumstance is held to be invalid, the remainder of this Act, the 
amendments made by this Act, and the application of the provisions of 
this Act to any other person or circumstance shall not be affected and 
shall continue to be enforced to the fullest extent possible.

         TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION

SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.

    (a) Definition of Tobacco Products.--Section 201 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at 
the end the following:
    ``(nn)(1) The term `tobacco product' means any product made or 
derived from tobacco that is intended for human consumption, including 
any component, part, or accessory of a tobacco product (except for raw 
materials other than tobacco used in manufacturing a component, part, 
or accessory of a tobacco product).
    ``(2) The term `tobacco product' does not mean--
            ``(A) a product in the form of conventional food (including 
        water and chewing gum), a product represented for use as or for 
        use in a conventional food, or a product that is intended for 
        ingestion in capsule, tablet, softgel, or liquid form; or
            ``(B) an article that is approved or is regulated as a drug 
        by the Food and Drug Administration.
    ``(3) The products described in paragraph (2)(A) shall be subject 
to chapter IV or chapter V of this Act and the articles described in 
paragraph (2)(B) shall be subject to chapter V of this Act.
    ``(4) A tobacco product may not be marketed in combination with any 
other article or product regulated under this Act (including a drug, 
biologic, food, cosmetics, medical device, or a dietary supplement).''.
    (b) FDA Authority Over Tobacco Products.--The Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
            (1) by redesignating chapter IX as chapter X;
            (2) by redesignating sections 901 through 907 as sections 
        1001 through 1007; and
            (3) by inserting after section 803 the following:

                     ``CHAPTER IX--TOBACCO PRODUCTS

``SEC. 900. DEFINITIONS.

    ``In this chapter:
            ``(1) Additive.--The term `additive' means any substance 
        the intended use of which results or may reasonably be expected 
        to result, directly or indirectly, in its becoming a component 
        or otherwise affecting the characteristic of any tobacco 
        product (including any substances intended for use as a 
        flavoring, coloring or in producing, manufacturing, packing, 
        processing, preparing, treating, packaging, transporting, or 
        holding), except that such term does not include tobacco or a 
        pesticide chemical residue in or on raw tobacco or a pesticide 
        chemical.
            ``(2) Brand.--The term `brand' means a variety of tobacco 
        product distinguished by the tobacco used, tar content, 
        nicotine content, flavoring used, size, filtration, or 
        packaging, logo, registered trademark or brand name, 
        identifiable pattern of colors, or any combination of such 
        attributes.
            ``(3) Cigarette.--The term `cigarette' has the meaning 
        given that term by section 3(1) of the Federal Cigarette 
        Labeling and Advertising Act (15 U.S.C. 1332(1)), but also 
        includes tobacco, in any form, that is functional in the 
        product, which, because of its appearance, the type of tobacco 
        used in the filler, or its packaging and labeling, is likely to 
        be offered to, or purchased by, consumers as a cigarette or as 
        roll-your-own tobacco.
            ``(4) Cigarette tobacco.--The term `cigarette tobacco' 
        means any product that consists of loose tobacco that is 
        intended for use by consumers in a cigarette. Unless otherwise 
        stated, the requirements for cigarettes shall also apply to 
        cigarette tobacco.
            ``(5) Commerce.--The term `commerce' has the meaning given 
        that term by section 3(2) of the Federal Cigarette Labeling and 
        Advertising Act (15 U.S.C. 1332(2)).
            ``(6) Counterfeit tobacco product.--The term `counterfeit 
        tobacco product' means a tobacco product (or the container or 
        labeling of such a product) that, without authorization, bears 
        the trademark, trade name, or other identifying mark, imprint 
        or device, or any likeness thereof, of a tobacco product listed 
        in a registration under section 905(i)(1).
            ``(7) Distributor.--The term `distributor' as regards a 
        tobacco product means any person who furthers the distribution 
        of a tobacco product, whether domestic or imported, at any 
        point from the original place of manufacture to the person who 
        sells or distributes the product to individuals for personal 
        consumption. Common carriers are not considered distributors 
        for purposes of this chapter.
            ``(8) Illicit trade.--The term `illicit trade' means any 
        practice or conduct prohibited by law which relates to 
        production, shipment, receipt, possession, distribution, sale, 
        or purchase of tobacco products including any practice or 
        conduct intended to facilitate such activity.
            ``(9) Indian tribe.--The term `Indian tribe' has the 
        meaning given such term in section 4(e) of the Indian Self 
        Determination and Education Assistance Act (25 U.S.C. 450b(e)).
            ``(10) Little cigar.--The term `little cigar' has the 
        meaning given that term by section 3(7) of the Federal 
        Cigarette Labeling and Advertising Act (15 U.S.C. 1332(7)).
            ``(11) Nicotine.--The term `nicotine' means the chemical 
        substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or 
        C[10]H[14]N[2], including any salt or complex of nicotine.
            ``(12) Package.--The term `package' means a pack, box, 
        carton, or container of any kind or, if no other container, any 
        wrapping (including cellophane), in which a tobacco product is 
        offered for sale, sold, or otherwise distributed to consumers.
            ``(13) Retailer.--The term `retailer' means any person who 
        sells tobacco products to individuals for personal consumption, 
        or who operates a facility where self-service displays of 
tobacco products are permitted.
            ``(14) Roll-your-own tobacco.--The term `roll-your-own 
        tobacco' means any tobacco which, because of its appearance, 
        type, packaging, or labeling, is suitable for use and likely to 
        be offered to, or purchased by, consumers as tobacco for making 
        cigarettes.
            ``(15) Smoke constituent.--The term `smoke constituent' 
        means any chemical or chemical compound in mainstream or 
        sidestream tobacco smoke that either transfers from any 
        component of the cigarette to the smoke or that is formed by 
        the combustion or heating of tobacco, additives, or other 
        component of the tobacco product.
            ``(16) Smokeless tobacco.--The term `smokeless tobacco' 
        means any tobacco product that consists of cut, ground, 
        powdered, or leaf tobacco and that is intended to be placed in 
        the oral or nasal cavity.
            ``(17) State.--The term `State' means any State of the 
        United States and, for purposes of this chapter, includes the 
        District of Columbia, the Commonwealth of Puerto Rico, Guam, 
        the Virgin Islands, American Samoa, Wake Island, Midway 
        Islands, Kingman Reef, Johnston Atoll, the Northern Mariana 
        Islands, and any other trust territory or possession of the 
        United States.
            ``(18) Tobacco product manufacturer.--Term `tobacco product 
        manufacturer' means any person, including any repacker or 
        relabeler, who--
                    ``(A) manufactures, fabricates, assembles, 
                processes, or labels a tobacco product; or
                    ``(B) imports a finished cigarette or smokeless 
                tobacco product for sale or distribution in the United 
                States.
            ``(19) United states.--The term `United States' means the 
        50 States of the United States of America and the District of 
        Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin 
        Islands, American Samoa, Wake Island, Midway Islands, Kingman 
        Reef, Johnston Atoll, the Northern Mariana Islands, and any 
        other trust territory or possession of the United States.

``SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.

     ``(a) In General.--Tobacco products shall be regulated by the 
Secretary under this chapter and shall not be subject to the provisions 
of chapter V, unless--
            ``(1) such products are intended for use in the diagnosis, 
        cure, mitigation, treatment, or prevention of disease (within 
        the meaning of section 201(g)(1)(B) or section 201(h)(2)); or
            ``(2) a claim is made for such products under section 
        201(g)(1)(C) or 201(h)(3);
        other than modified risk tobacco products approved in 
        accordance with section 911.
    ``(b) Applicability.--This chapter shall apply to all tobacco 
products subject to the regulations referred to in section 102 of the 
Family Smoking Prevention and Tobacco Control Act, and to any other 
tobacco products that the Secretary by regulation deems to be subject 
to this chapter.
    ``(c) Scope.--
            ``(1) In general.--Nothing in this chapter, or any policy 
        issued or regulation promulgated thereunder, or the Family 
        Smoking Prevention and Tobacco Control Act, shall be construed 
        to affect the Secretary's authority over, or the regulation of, 
        products under this Act that are not tobacco products under 
        chapter V or any other chapter.
            ``(2) Limitation of authority.--
                    ``(A) In general.--The provisions of this chapter 
                shall not apply to tobacco leaf that is not in the 
                possession of a manufacturer of tobacco products, or to 
                the producers of tobacco leaf, including tobacco 
                growers, tobacco warehouses, and tobacco grower 
                cooperatives, nor shall any employee of the Food and 
                Drug Administration have any authority to enter onto a 
                farm owned by a producer of tobacco leaf without the 
                written consent of such producer.
                    ``(B) Exception.--Notwithstanding any other 
                provision of this subparagraph, if a producer of 
                tobacco leaf is also a tobacco product manufacturer or 
                controlled by a tobacco product manufacturer, the 
                producer shall be subject to this chapter in the 
                producer's capacity as a manufacturer.
                    ``(C) Rule of construction.--Nothing in this 
                chapter shall be construed to grant the Secretary 
                authority to promulgate regulations on any matter that 
                involves the production of tobacco leaf or a producer 
                thereof, other than activities by a manufacturer 
                affecting production.

``SEC. 902. ADULTERATED TOBACCO PRODUCTS.

    ``A tobacco product shall be deemed to be adulterated if--
            ``(1) it consists in whole or in part of any filthy, 
        putrid, or decomposed substance, or is otherwise contaminated 
by any added poisonous or added deleterious substance that may render 
the product injurious to health;
            ``(2) it has been prepared, packed, or held under 
        insanitary conditions whereby it may have been contaminated 
        with filth, or whereby it may have been rendered injurious to 
        health;
            ``(3) its package is composed, in whole or in part, of any 
        poisonous or deleterious substance which may render the 
        contents injurious to health;
            ``(4) it is, or purports to be or is represented as, a 
        tobacco product which is subject to a tobacco product standard 
        established under section 907 unless such tobacco product is in 
        all respects in conformity with such standard;
            ``(5)(A) it is required by section 910(a) to have premarket 
        approval and does not have an approved application in effect;
            ``(B) it is in violation of the order approving such an 
        application; or
            ``(6) the methods used in, or the facilities or controls 
        used for, its manufacture, packing or storage are not in 
        conformity with applicable requirements under section 906(e)(1) 
        or an applicable condition prescribed by an order under section 
        906(e)(2); or
            ``(7) it is in violation of section 911.

``SEC. 903. MISBRANDED TOBACCO PRODUCTS.

    ``(a) In General.--A tobacco product shall be deemed to be 
misbranded--
            ``(1) if its labeling is false or misleading in any 
        particular;
            ``(2) if in package form unless it bears a label 
        containing--
                    ``(A) the name and place of business of the tobacco 
                product manufacturer, packer, or distributor;
                    ``(B) an accurate statement of the quantity of the 
                contents in terms of weight, measure, or numerical 
                count;
                    ``(C) an accurate statement of the percentage of 
                the tobacco used in the product that is domestically 
                grown tobacco and the percentage that is foreign grown 
                tobacco; and
                    ``(D) the statement required under section 921(a),
        except that under subparagraph (B) reasonable variations shall 
        be permitted, and exemptions as to small packages shall be 
        established, by regulations prescribed by the Secretary;
            ``(3) if any word, statement, or other information required 
        by or under authority of this chapter to appear on the label or 
        labeling is not prominently placed thereon with such 
        conspicuousness (as compared with other words, statements or 
        designs in the labeling) and in such terms as to render it 
        likely to be read and understood by the ordinary individual 
        under customary conditions of purchase and use;
            ``(4) if it has an established name, unless its label 
        bears, to the exclusion of any other nonproprietary name, its 
        established name prominently printed in type as required by the 
        Secretary by regulation;
            ``(5) if the Secretary has issued regulations requiring 
        that its labeling bear adequate directions for use, or adequate 
        warnings against use by children, that are necessary for the 
        protection of users unless its labeling conforms in all 
        respects to such regulations;
            ``(6) if it was manufactured, prepared, propagated, 
        compounded, or processed in any State in an establishment not 
        duly registered under section 905(b), 905(c), 905(d), or 
        905(h), if it was not included in a list required by section 
        905(i), if a notice or other information respecting it was not 
        provided as required by such section or section 905(j), or if 
        it does not bear such symbols from the uniform system for 
        identification of tobacco products prescribed under section 
        905(e) as the Secretary by regulation requires;
            ``(7) if, in the case of any tobacco product distributed or 
        offered for sale in any State--
                    ``(A) its advertising is false or misleading in any 
                particular; or
                    ``(B) it is sold or distributed in violation of 
                regulations prescribed under section 906(d);
            ``(8) unless, in the case of any tobacco product 
        distributed or offered for sale in any State, the manufacturer, 
        packer, or distributor thereof includes in all advertisements 
        and other descriptive printed matter issued or caused to be 
        issued by the manufacturer, packer, or distributor with respect 
        to that tobacco product--
                    ``(A) a true statement of the tobacco product's 
                established name as described in paragraph (4), printed 
                prominently; and
                    ``(B) a brief statement of--
                            ``(i) the uses of the tobacco product and 
                        relevant warnings, precautions, side effects, 
                        and contraindications; and
                            ``(ii) in the case of specific tobacco 
                        products made subject to a finding by the 
                        Secretary after notice and opportunity for 
                        comment that such action is appropriate to 
                        protect the public health, a full description 
                        of the components of such tobacco product or 
                        the formula showing quantitatively each 
                        ingredient of such tobacco product to the 
                        extent required in regulations which shall be 
                        issued by the Secretary after an opportunity 
                        for a hearing;
            ``(9) if it is a tobacco product subject to a tobacco 
        product standard established under section 907, unless it bears 
        such labeling as may be prescribed in such tobacco product 
        standard; or
            ``(10) if there was a failure or refusal--
                    ``(A) to comply with any requirement prescribed 
                under section 904 or 908; or
                    ``(B) to furnish any material or information 
                required under section 909.
    ``(b) Prior Approval of Label Statements.--The Secretary may, by 
regulation, require prior approval of statements made on the label of a 
tobacco product. No regulation issued under this subsection may require 
prior approval by the Secretary of the content of any advertisement, 
except for modified risk tobacco products as provided in section 911. 
No advertisement of a tobacco product published after the date of 
enactment of the Family Smoking Prevention and Tobacco Control Act 
shall, with respect to the language of label statements as prescribed 
under section 4 of the Cigarette Labeling and Advertising Act and 
section 3 of the Comprehensive Smokeless Tobacco Health Education Act 
of 1986 or the regulations issued under such sections, be subject to 
the provisions of sections 12 through 15 of the Federal Trade 
Commission Act (15 U.S.C. 52 through 55).

``SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE SECRETARY.

    ``(a) Requirement.--Not later than 6 months after the date of 
enactment of the Family Smoking Prevention and Tobacco Control Act, 
each tobacco product manufacturer or importer, or agents thereof, shall 
submit to the Secretary the following information:
            ``(1) A listing of all ingredients, including tobacco, 
        substances, compounds, and additives that are, as of such date, 
        added by the manufacturer to the tobacco, paper, filter, or 
        other part of each tobacco product by brand and by quantity in 
        each brand and subbrand.
            ``(2) A description of the content, delivery, and form of 
        nicotine in each tobacco product measured in milligrams of 
        nicotine in accordance with regulations promulgated by the 
        Secretary in accordance with section 4(a)(4) of the Federal 
        Cigarette Labeling and Advertising Act.
            ``(3) A listing of all constituents, including smoke 
        constituents as applicable, identified by the Secretary as 
        harmful or potentially harmful to health in each tobacco 
        product, and as applicable in the smoke of each tobacco 
        product, by brand and by quantity in each brand and subbrand. 
        Effective beginning 2 years after the date of enactment of this 
        chapter, the manufacturer, importer, or agent shall comply with 
        regulations promulgated under section 915 in reporting 
        information under this paragraph, where applicable.
            ``(4) All documents developed after the date of enactment 
        of the Family Smoking Prevention and Tobacco Control Act that 
        relate to health, toxicological, behavioral, or physiologic 
        effects of current or future tobacco products, their 
        constituents (including smoke constituents), ingredients, 
        components, and additives.
    ``(b) Data Submission.--At the request of the Secretary, each 
tobacco product manufacturer or importer of tobacco products, or agents 
thereof, shall submit the following:
            ``(1) Any or all documents (including underlying scientific 
        information) relating to research activities, and research 
        findings, conducted, supported, or possessed by the 
        manufacturer (or agents thereof) on the health, toxicological, 
        behavioral, or physiologic effects of tobacco products and 
        their constituents (including smoke constituents), ingredients, 
        components, and additives.
            ``(2) Any or all documents (including underlying scientific 
        information) relating to research activities, and research 
        findings, conducted, supported, or possessed by the 
        manufacturer (or agents thereof) that relate to the issue of 
        whether a reduction in risk to health from tobacco products can 
        occur upon the employment of technology available or known to 
        the manufacturer.
            ``(3) Any or all documents (including underlying scientific 
        or financial information) relating to marketing research 
        involving the use of tobacco products or marketing practices 
        and the effectiveness of such practices used by tobacco 
        manufacturers and distributors.
An importer of a tobacco product not manufactured in the United States 
shall supply the information required of a tobacco product manufacturer 
under this subsection.
    ``(c) Time for Submission.--
            ``(1) In general.--At least 90 days prior to the delivery 
        for introduction into interstate commerce of a tobacco product 
        not on the market on the date of enactment of the Family 
        Smoking Prevention and Tobacco Control Act, the manufacturer of 
        such product shall provide the information required under 
        subsection (a).
            ``(2) Disclosure of additive.--If at any time a tobacco 
        product manufacturer adds to its tobacco products a new tobacco 
        additive or increases the quantity of an existing tobacco 
        additive, the manufacturer shall, except as provided in 
        paragraph (3), at least 90 days prior to such action so advise 
        the Secretary in writing.
            ``(3) Disclosure of other actions.--If at any time a 
        tobacco product manufacturer eliminates or decreases an 
        existing additive, or adds or increases an additive that has by 
        regulation been designated by the Secretary as an additive that 
        is not a human or animal carcinogen, or otherwise harmful to 
        health under intended conditions of use, the manufacturer shall 
        within 60 days of such action so advise the Secretary in 
        writing.
    ``(d) Data List.--
            ``(1) In general.--Not later than 3 years after the date of 
        enactment of the Family Smoking Prevention and Tobacco Control 
        Act, and annually thereafter, the Secretary shall publish in a 
        format that is understandable and not misleading to a lay 
        person, and place on public display (in a manner determined by 
        the Secretary) the list established under subsection (e).
            ``(2) Consumer research.--The Secretary shall conduct 
        periodic consumer research to ensure that the list published 
        under paragraph (1) is not misleading to lay persons. Not later 
        than 5 years after the date of enactment of the Family Smoking 
        Prevention and Tobacco Control Act, the Secretary shall submit 
        to the appropriate committees of Congress a report on the 
        results of such research, together with recommendations on 
        whether such publication should be continued or modified.
    ``(e) Data Collection.--Not later than 12 months after the date of 
enactment of the Family Smoking Prevention and Tobacco Control Act, the 
Secretary shall establish a list of harmful and potentially harmful 
constituents, including smoke constituents, to health in each tobacco 
product by brand and by quantity in each brand and subbrand. The 
Secretary shall publish a public notice requesting the submission by 
interested persons of scientific and other information concerning the 
harmful and potentially harmful constituents in tobacco products and 
tobacco smoke.

``SEC. 905. ANNUAL REGISTRATION.

    ``(a) Definitions.--In this section:
            ``(1) Manufacture, preparation, compounding, or 
        processing.--The term `manufacture, preparation, compounding, 
        or processing' shall include repackaging or otherwise changing 
        the container, wrapper, or labeling of any tobacco product 
        package in furtherance of the distribution of the tobacco 
        product from the original place of manufacture to the person 
        who makes final delivery or sale to the ultimate consumer or 
        user.
            ``(2) Name.--The term `name' shall include in the case of a 
        partnership the name of each partner and, in the case of a 
        corporation, the name of each corporate officer and director, 
        and the State of incorporation.
    ``(b) Registration by Owners and Operators.--On or before December 
31 of each year every person who owns or operates any establishment in 
any State engaged in the manufacture, preparation, compounding, or 
processing of a tobacco product or tobacco products shall register with 
the Secretary the name, places of business, and all such establishments 
of that person.
    ``(c) Registration of New Owners and Operators.--Every person upon 
first engaging in the manufacture, preparation, compounding, or 
processing of a tobacco product or tobacco products in any 
establishment owned or operated in any State by that person shall 
immediately register with the Secretary that person's name, place of 
business, and such establishment.
    ``(d) Registration of Added Establishments.--Every person required 
to register under subsection (b) or (c) shall immediately register with 
the Secretary any additional establishment which that person owns or 
operates in any State and in which that person begins the manufacture, 
preparation, compounding, or processing of a tobacco product or tobacco 
products.
    ``(e) Uniform Product Identification System.--The Secretary may by 
regulation prescribe a uniform system for the identification of tobacco 
products and may require that persons who are required to list such 
tobacco products under subsection (i) shall list such tobacco products 
in accordance with such system.
    ``(f) Public Access to Registration Information.--The Secretary 
shall make available for inspection, to any person so requesting, any 
registration filed under this section.
    ``(g) Biennial Inspection of Registered Establishments.--Every 
establishment in any State registered with the Secretary under this 
section shall be subject to inspection under section 704, and every 
such establishment engaged in the manufacture, compounding, or 
processing of a tobacco product or tobacco products shall be so 
inspected by 1 or more officers or employees duly designated by the 
Secretary at least once in the 2-year period beginning with the date of 
registration of such establishment under this section and at least once 
in every successive 2-year period thereafter.
    ``(h) Foreign Establishments Shall Register.--Any establishment 
within any foreign country engaged in the manufacture, preparation, 
compounding, or processing of a tobacco product or tobacco products, 
shall register under this section under regulations promulgated by the 
Secretary. Such regulations shall require such establishment to provide 
the information required by subsection (i) of this section and shall 
include provisions for registration of any such establishment upon 
condition that adequate and effective means are available, by 
arrangement with the government of such foreign country or otherwise, 
to enable the Secretary to determine from time to time whether tobacco 
products manufactured, prepared, compounded, or processed in such 
establishment, if imported or offered for import into the United 
States, shall be refused admission on any of the grounds set forth in 
section 801(a).
    ``(i) Registration Information.--
            ``(1) Product list.--Every person who registers with the 
        Secretary under subsection (b), (c), (d), or (h) shall, at the 
        time of registration under any such subsection, file with the 
        Secretary a list of all tobacco products which are being 
        manufactured, prepared, compounded, or processed by that person 
        for commercial distribution and which has not been included in 
        any list of tobacco products filed by that person with the 
        Secretary under this paragraph or paragraph (2) before such 
        time of registration. Such list shall be prepared in such form 
        and manner as the Secretary may prescribe and shall be 
        accompanied by--
                    ``(A) in the case of a tobacco product contained in 
                the applicable list with respect to which a tobacco 
                product standard has been established under section 907 
                or which is subject to section 910, a reference to the 
                authority for the marketing of such tobacco product and 
                a copy of all labeling for such tobacco product;
                    ``(B) in the case of any other tobacco product 
                contained in an applicable list, a copy of all consumer 
                information and other labeling for such tobacco 
                product, a representative sampling of advertisements 
                for such tobacco product, and, upon request made by the 
                Secretary for good cause, a copy of all advertisements 
                for a particular tobacco product; and
                    ``(C) if the registrant filing a list has 
                determined that a tobacco product contained in such 
                list is not subject to a tobacco product standard 
                established under section 907, a brief statement of the 
                basis upon which the registrant made such determination 
                if the Secretary requests such a statement with respect 
                to that particular tobacco product.
            ``(2) Biannual report of any change in product list.--Each 
        person who registers with the Secretary under this section 
shall report to the Secretary once during the month of June of each 
year and once during the month of December of each year the following:
                    ``(A) A list of each tobacco product introduced by 
                the registrant for commercial distribution which has 
                not been included in any list previously filed by that 
                person with the Secretary under this subparagraph or 
                paragraph (1). A list under this subparagraph shall 
                list a tobacco product by its established name and 
                shall be accompanied by the other information required 
                by paragraph (1).
                    ``(B) If since the date the registrant last made a 
                report under this paragraph that person has 
                discontinued the manufacture, preparation, compounding, 
                or processing for commercial distribution of a tobacco 
                product included in a list filed under subparagraph (A) 
                or paragraph (1), notice of such discontinuance, the 
                date of such discontinuance, and the identity of its 
                established name.
                    ``(C) If since the date the registrant reported 
                under subparagraph (B) a notice of discontinuance that 
                person has resumed the manufacture, preparation, 
                compounding, or processing for commercial distribution 
                of the tobacco product with respect to which such 
                notice of discontinuance was reported, notice of such 
                resumption, the date of such resumption, the identity 
                of such tobacco product by established name, and other 
                information required by paragraph (1), unless the 
                registrant has previously reported such resumption to 
                the Secretary under this subparagraph.
                    ``(D) Any material change in any information 
                previously submitted under this paragraph or paragraph 
                (1).
    ``(j) Report Preceding Introduction of Certain Substantially-
Equivalent Products Into Interstate Commerce.--
            ``(1) In general.--Each person who is required to register 
        under this section and who proposes to begin the introduction 
        or delivery for introduction into interstate commerce for 
        commercial distribution of a tobacco product intended for human 
        use that was not commercially marketed (other than for test 
        marketing) in the United States as of June 1, 2003, shall, at 
        least 90 days prior to making such introduction or delivery, 
        report to the Secretary (in such form and manner as the 
        Secretary shall prescribe)--
                    ``(A) the basis for such person's determination 
                that the tobacco product is substantially equivalent, 
                within the meaning of section 910, to a tobacco product 
                commercially marketed (other than for test marketing) 
                in the United States as of June 1, 2003, that is in 
                compliance with the requirements of this Act; and
                    ``(B) action taken by such person to comply with 
                the requirements under section 907 that are applicable 
                to the tobacco product.
            ``(2) Application to certain post june 1, 2003 products.--A 
        report under this subsection for a tobacco product that was 
        first introduced or delivered for introduction into interstate 
        commerce for commercial distribution in the United States after 
        June 1, 2003, and prior to the date that is 15 months after the 
        date of enactment of the Family Smoking Prevention and Tobacco 
        Control Act shall be submitted to the Secretary not later than 
        15 months after such date of enactment.
            ``(3) Exemptions.--
                    ``(A) In general.--The Secretary may by regulation, 
                exempt from the requirements of this subsection tobacco 
                products that are modified by adding or deleting a 
                tobacco additive, or increasing or decreasing the 
                quantity of an existing tobacco additive, if the 
                Secretary determines that--
                            ``(i) such modification would be a minor 
                        modification of a tobacco product authorized 
                        for sale under this Act;
                            ``(ii) a report under this subsection is 
                        not necessary to ensure that permitting the 
                        tobacco product to be marketed would be 
                        appropriate for protection of the public 
                        health; and
                            ``(iii) an exemption is otherwise 
                        appropriate.
                    ``(B) Regulations.--Not later than 9 months after 
                the date of enactment of the Family Smoking Prevention 
                and Tobacco Control Act, the Secretary shall issue 
                regulations to implement this paragraph.

``SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO PRODUCTS.

    ``(a) In General.--Any requirement established by or under section 
902, 903, 905, or 909 applicable to a tobacco product shall apply to 
such tobacco product until the applicability of the requirement to the 
tobacco product has been changed by action taken under section 907, 
section 910, section 911, or subsection (d) of this section, and any 
requirement established by or under section 902, 903, 905, or 909 which 
is inconsistent with a requirement imposed on such tobacco product 
under section 907, section 910, section 911, or subsection (d) of this 
section shall not apply to such tobacco product.
    ``(b) Information on Public Access and Comment.--Each notice of 
proposed rulemaking under section 907, 908, 909, 910, or 911 or under 
this section, any other notice which is published in the Federal 
Register with respect to any other action taken under any such section 
and which states the reasons for such action, and each publication of 
findings required to be made in connection with rulemaking under any 
such section shall set forth--
            ``(1) the manner in which interested persons may examine 
        data and other information on which the notice or findings is 
        based; and
            ``(2) the period within which interested persons may 
        present their comments on the notice or findings (including the 
        need therefore) orally or in writing, which period shall be at 
        least 60 days but may not exceed 90 days unless the time is 
        extended by the Secretary by a notice published in the Federal 
Register stating good cause therefore.
    ``(c) Limited Confidentiality of Information.--Any information 
reported to or otherwise obtained by the Secretary or the Secretary's 
representative under section 903, 904, 907, 908, 909, 910, 911, or 704, 
or under subsection (e) or (f) of this section, which is exempt from 
disclosure under subsection (a) of section 552 of title 5, United 
States Code, by reason of subsection (b)(4) of that section shall be 
considered confidential and shall not be disclosed, except that the 
information may be disclosed to other officers or employees concerned 
with carrying out this chapter, or when relevant in any proceeding 
under this chapter.
    ``(d) Restrictions.--
            ``(1) In general.--The Secretary may by regulation require 
        restrictions on the sale and distribution of a tobacco product, 
        including restrictions on the access to, and the advertising 
        and promotion of, the tobacco product, if the Secretary 
        determines that such regulation would be appropriate for the 
        protection of the public health. The Secretary may by 
        regulation impose restrictions on the advertising and promotion 
        of a tobacco product consistent with and to full extent 
        permitted by the first amendment to the Constitution. The 
        finding as to whether such regulation would be appropriate for 
        the protection of the public health shall be determined with 
        respect to the risks and benefits to the population as a whole, 
        including users and non-users of the tobacco product, and 
        taking into account--
                    ``(A) the increased or decreased likelihood that 
                existing users of tobacco products will stop using such 
                products; and
                    ``(B) the increased or decreased likelihood that 
                those who do not use tobacco products will start using 
                such products.
        No such regulation may require that the sale or distribution of 
        a tobacco product be limited to the written or oral 
        authorization of a practitioner licensed by law to prescribe 
        medical products.
            ``(2) Label statements.--The label of a tobacco product 
        shall bear such appropriate statements of the restrictions 
        required by a regulation under subsection (a) as the Secretary 
        may in such regulation prescribe.
            ``(3) Limitations.--
                    ``(A) In general.--No restrictions under paragraph 
                (1) may--
                            ``(i) prohibit the sale of any tobacco 
                        product in face-to-face transactions by a 
                        specific category of retail outlets; or
                            ``(ii) establish a minimum age of sale of 
                        tobacco products to any person older than 18 
                        years of age.
                    ``(B) Matchbooks.--For purposes of any regulations 
                issued by the Secretary, matchbooks of conventional 
                size containing not more than 20 paper matches, and 
                which are customarily given away for free with the 
                purchase of tobacco products shall be considered as 
                adult written publications which shall be permitted to 
                contain advertising. Notwithstanding the preceding 
                sentence, if the Secretary finds that such treatment of 
                matchbooks is not appropriate for the protection of the 
                public health, the Secretary may determine by 
                regulation that matchbooks shall not be considered 
                adult written publications.
    ``(e) Good Manufacturing Practice Requirements.--
            ``(1) Methods, facilities, and controls to conform.--
                    ``(A) In general.--The Secretary may, in accordance 
                with subparagraph (B), prescribe regulations (which may 
                differ based on the type of tobacco product involved) 
                requiring that the methods used in, and the facilities 
                and controls used for, the manufacture, pre-production 
                design validation (including a process to assess the 
                performance of a tobacco product), packing and storage 
                of a tobacco product, conform to current good 
                manufacturing practice, as prescribed in such 
                regulations, to assure that the public health is 
                protected and that the tobacco product is in compliance 
                with this chapter. Good manufacturing practices may 
                include the testing of raw tobacco for pesticide 
                chemical residues regardless of whether a tolerance for 
                such chemical residues has been established.
                    ``(B) Requirements.--The Secretary shall--
                            ``(i) before promulgating any regulation 
                        under subparagraph (A), afford the Tobacco 
                        Products Scientific Advisory Committee an 
                        opportunity to submit recommendations with 
                        respect to the regulation proposed to be 
                        promulgated;
                            ``(ii) before promulgating any regulation 
                        under subparagraph (A), afford opportunity for 
                        an oral hearing;
                            ``(iii) provide the advisory committee a 
                        reasonable time to make its recommendation with 
                        respect to proposed regulations under 
                        subparagraph (A); and
                            ``(iv) in establishing the effective date 
                        of a regulation promulgated under this 
                        subsection, take into account the differences 
                        in the manner in which the different types of 
                        tobacco products have historically been 
                        produced, the financial resources of the 
                        different tobacco product manufacturers, and 
                        the state of their existing manufacturing 
                        facilities, and shall provide for a reasonable 
                        period of time for such manufacturers to 
                        conform to good manufacturing practices.
            ``(2) Exemptions; variances.--
                    ``(A) Petition.--Any person subject to any 
                requirement prescribed under paragraph (1) may petition 
                the Secretary for a permanent or temporary exemption or 
                variance from such requirement. Such a petition shall 
                be submitted to the Secretary in such form and manner 
                as the Secretary shall prescribe and shall--
                            ``(i) in the case of a petition for an 
                        exemption from a requirement, set forth the 
                        basis for the petitioner's determination that 
                        compliance with the requirement is not required 
                        to assure that the tobacco product will be in 
                        compliance with this chapter;
                            ``(ii) in the case of a petition for a 
                        variance from a requirement, set forth the 
                        methods proposed to be used in, and the 
                        facilities and controls proposed to be used 
                        for, the manufacture, packing, and storage of 
                        the tobacco product in lieu of the methods, 
                        facilities, and controls prescribed by the 
                        requirement; and
                            ``(iii) contain such other information as 
                        the Secretary shall prescribe.
                    ``(B) Referral to the tobacco products scientific 
                advisory committee.--The Secretary may refer to the 
                Tobacco Products Scientific Advisory Committee any 
                petition submitted under subparagraph (A). The Tobacco 
                Products Scientific Advisory Committee shall report its 
recommendations to the Secretary with respect to a petition referred to 
it within 60 days after the date of the petition's referral. Within 60 
days after--
                            ``(i) the date the petition was submitted 
                        to the Secretary under subparagraph (A); or
                            ``(ii) the day after the petition was 
                        referred to the Tobacco Products Scientific 
                        Advisory Committee,
                whichever occurs later, the Secretary shall by order 
                either deny the petition or approve it.
                    ``(C) Approval.--The Secretary may approve--
                            ``(i) a petition for an exemption for a 
                        tobacco product from a requirement if the 
                        Secretary determines that compliance with such 
                        requirement is not required to assure that the 
                        tobacco product will be in compliance with this 
                        chapter; and
                            ``(ii) a petition for a variance for a 
                        tobacco product from a requirement if the 
                        Secretary determines that the methods to be 
                        used in, and the facilities and controls to be 
                        used for, the manufacture, packing, and storage 
                        of the tobacco product in lieu of the methods, 
                        controls, and facilities prescribed by the 
                        requirement are sufficient to assure that the 
                        tobacco product will be in compliance with this 
                        chapter.
                    ``(D) Conditions.--An order of the Secretary 
                approving a petition for a variance shall prescribe 
                such conditions respecting the methods used in, and the 
                facilities and controls used for, the manufacture, 
                packing, and storage of the tobacco product to be 
                granted the variance under the petition as may be 
                necessary to assure that the tobacco product will be in 
                compliance with this chapter.
                    ``(E) Hearing.--After the issuance of an order 
                under subparagraph (B) respecting a petition, the 
                petitioner shall have an opportunity for an informal 
                hearing on such order.
            ``(3) Compliance.--Compliance with requirements under this 
        subsection shall not be required before the period ending 3 
        years after the date of enactment of the Family Smoking 
        Prevention and Tobacco Control Act.
    ``(f) Research and Development.--The Secretary may enter into 
contracts for research, testing, and demonstrations respecting tobacco 
products and may obtain tobacco products for research, testing, and 
demonstration purposes without regard to section 3324(a) and (b) of 
title 31, United States Code, and section 5 of title 41, United States 
Code.

``SEC. 907. TOBACCO PRODUCT STANDARDS.

    ``(a) In General.--
            ``(1) Special rule for cigarettes.--A cigarette or any of 
        its component parts (including the tobacco, filter, or paper) 
        shall not contain, as a constituent (including a smoke 
        constituent) or additive, an artificial or natural flavor 
        (other than tobacco or menthol) or an herb or spice, including 
        strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, 
        coconut, licorice, cocoa, chocolate, cherry, or coffee, that is 
        a characterizing flavor of the tobacco product or tobacco 
        smoke. Nothing in this subparagraph shall be construed to limit 
        the Secretary's authority to take action under this section or 
        other sections of this Act applicable to menthol or any 
        artificial or natural flavor, herb, or spice not specified in 
        this paragraph.
            ``(2) Revision of tobacco product standards.--The Secretary 
        may revise the tobacco product standards in paragraph (1) in 
        accordance with subsection (b).
            ``(3) Tobacco product standards.--The Secretary may adopt 
        tobacco product standards in addition to those in paragraph (1) 
        if the Secretary finds that a tobacco product standard is 
        appropriate for the protection of the public health. This 
        finding shall be determined with respect to the risks and 
        benefits to the population as a whole, including users and non-
        users of the tobacco product, and taking into account--
                    ``(A) the increased or decreased likelihood that 
                existing users of tobacco products will stop using such 
                products; and
                    ``(B) the increased or decreased likelihood that 
                those who do not use tobacco products will start using 
                such products.
            ``(4) Content of tobacco product standards.--A tobacco 
        product standard established under this section for a tobacco 
        product--
                    ``(A) shall include provisions that are appropriate 
                for the protection of the public health, including 
                provisions, where appropriate--
                            ``(i) for the reduction of nicotine yields 
                        of the product;
                            ``(ii) for the reduction or elimination of 
                        other constituents, including smoke 
                        constituents, or harmful components of the 
                        product; or
                            ``(iii) relating to any other requirement 
                        under (B);
                    ``(B) shall, where appropriate for the protection 
                of the public health, include--
                            ``(i) provisions respecting the 
                        construction, components, ingredients, 
                        additives, constituents, including smoke 
                        constituents, and properties of the tobacco 
                        product;
                            ``(ii) provisions for the testing (on a 
                        sample basis or, if necessary, on an individual 
                        basis) of the tobacco product;
                            ``(iii) provisions for the measurement of 
                        the tobacco product characteristics of the 
                        tobacco product;
                            ``(iv) provisions requiring that the 
                        results of each or of certain of the tests of 
                        the tobacco product required to be made under 
                        clause (ii) show that the tobacco product is in 
                        conformity with the portions of the standard 
                        for which the test or tests were required; and
                            ``(v) a provision requiring that the sale 
                        and distribution of the tobacco product be 
                        restricted but only to the extent that the sale 
                        and distribution of a tobacco product may be 
                        restricted under a regulation under section 
                        906(d); and
                    ``(C) shall, where appropriate, require the use and 
                prescribe the form and content of labeling for the 
                proper use of the tobacco product.
            ``(5) Periodic re-evaluation of tobacco product 
        standards.--The Secretary shall provide for periodic evaluation 
        of tobacco product standards established under this section to 
        determine whether such standards should be changed to reflect 
        new medical, scientific, or other technological data. The 
        Secretary may provide for testing under paragraph (4)(B) by any 
        person.
            ``(6) Involvement of other agencies; informed persons.--In 
        carrying out duties under this section, the Secretary shall 
        endeavor to--
                    ``(A) use personnel, facilities, and other 
                technical support available in other Federal agencies;
                    ``(B) consult with other Federal agencies concerned 
                with standard-setting and other nationally or 
                internationally recognized standard-setting entities; 
                and
                    ``(C) invite appropriate participation, through 
                joint or other conferences, workshops, or other means, 
                by informed persons representative of scientific, 
                professional, industry, agricultural, or consumer 
                organizations who in the Secretary's judgment can make 
                a significant contribution.
    ``(b) Establishment of Standards.--
            ``(1) Notice.--
                    ``(A) In general.--The Secretary shall publish in 
                the Federal Register a notice of proposed rulemaking 
                for the establishment, amendment, or revocation of any 
                tobacco product standard.
                    ``(B) Requirements of notice.--A notice of proposed 
                rulemaking for the establishment or amendment of a 
                tobacco product standard for a tobacco product shall--
                            ``(i) set forth a finding with supporting 
                        justification that the tobacco product standard 
                        is appropriate for the protection of the public 
                        health;
                            ``(ii) set forth proposed findings with 
                        respect to the risk of illness or injury that 
                        the tobacco product standard is intended to 
                        reduce or eliminate; and
                            ``(iii) invite interested persons to submit 
                        an existing tobacco product standard for the 
                        tobacco product, including a draft or proposed 
                        tobacco product standard, for consideration by 
                        the Secretary.
                    ``(C) Standard.--Upon a determination by the 
                Secretary that an additive, constituent (including 
                smoke constituent), or other component of the product 
                that is the subject of the proposed tobacco product 
                standard is harmful, it shall be the burden of any 
                party challenging the proposed standard to prove that 
                the proposed standard will not reduce or eliminate the 
                risk of illness or injury.
                    ``(D) Finding.--A notice of proposed rulemaking for 
                the revocation of a tobacco product standard shall set 
                forth a finding with supporting justification that the 
                tobacco product standard is no longer appropriate for 
                the protection of the public health.
                    ``(E) Consideration by secretary.--The Secretary 
                shall consider all information submitted in connection 
                with a proposed standard, including information 
                concerning the countervailing effects of the tobacco 
                product standard on the health of adolescent tobacco 
                users, adult tobacco users, or non-tobacco users, such 
                as the creation of a significant demand for contraband 
                or other tobacco products that do not meet the 
                requirements of this chapter and the significance of 
                such demand, and shall issue the standard if the 
                Secretary determines that the standard would be 
                appropriate for the protection of the public health.
                    ``(F) Comment.--The Secretary shall provide for a 
                comment period of not less than 60 days.
            ``(2) Promulgation.--
                    ``(A) In general.--After the expiration of the 
                period for comment on a notice of proposed rulemaking 
                published under paragraph (1) respecting a tobacco 
                product standard and after consideration of such 
                comments and any report from the Tobacco Products 
                Scientific Advisory Committee, the Secretary shall--
                            ``(i) promulgate a regulation establishing 
                        a tobacco product standard and publish in the 
                        Federal Register findings on the matters 
                        referred to in paragraph (1); or
                            ``(ii) publish a notice terminating the 
                        proceeding for the development of the standard 
                        together with the reasons for such termination.
                    ``(B) Effective date.--A regulation establishing a 
                tobacco product standard shall set forth the date or 
                dates upon which the standard shall take effect, but no 
                such regulation may take effect before 1 year after the 
                date of its publication unless the Secretary determines 
                that an earlier effective date is necessary for the 
                protection of the public health. Such date or dates 
                shall be established so as to minimize, consistent with 
                the public health, economic loss to, and disruption or 
                dislocation of, domestic and international trade.
            ``(3) Power reserved to congress.--Because of the 
        importance of a decision of the Secretary to issue a regulation 
        establishing a tobacco product standard--
                    ``(A) banning all cigarettes, all smokeless tobacco 
                products, all little cigars, all cigars other than 
                little cigars, all pipe tobacco, or all roll your own 
                tobacco products; or
                    ``(B) requiring the reduction of nicotine yields of 
                a tobacco product to zero,
        Congress expressly reserves to itself such power.
            ``(4) Amendment; revocation.--
                    ``(A) Authority.--The Secretary, upon the 
                Secretary's own initiative or upon petition of an 
                interested person may by a regulation, promulgated in 
                accordance with the requirements of paragraphs (1) and 
                (2)(B), amend or revoke a tobacco product standard.
                    ``(B) Effective date.--The Secretary may declare a 
                proposed amendment of a tobacco product standard to be 
                effective on and after its publication in the Federal 
                Register and until the effective date of any final 
                action taken on such amendment if the Secretary 
                determines that making it so effective is in the public 
                interest.
            ``(5) Reference to advisory committee.--The Secretary may--
                    ``(A) on the Secretary's own initiative, refer a 
                proposed regulation for the establishment, amendment, 
                or revocation of a tobacco product standard; or
                    ``(B) upon the request of an interested person 
                which demonstrates good cause for referral and which is 
                made before the expiration of the period for submission 
                of comments on such proposed regulation,
refer such proposed regulation to the Tobacco Products Scientific 
Advisory Committee, for a report and recommendation with respect to any 
matter involved in the proposed regulation which requires the exercise 
of scientific judgment. If a proposed regulation is referred under this 
paragraph to the Tobacco Products Scientific Advisory Committee, the 
Secretary shall provide the advisory committee with the data and 
information on which such proposed regulation is based. The Tobacco 
Products Scientific Advisory Committee shall, within 60 days after the 
referral of a proposed regulation and after independent study of the 
data and information furnished to it by the Secretary and other data 
and information before it, submit to the Secretary a report and 
recommendation respecting such regulation, together with all underlying 
data and information and a statement of the reason or basis for the 
recommendation. A copy of such report and recommendation shall be made 
public by the Secretary.

``SEC. 908. NOTIFICATION AND OTHER REMEDIES.

    ``(a) Notification.--If the Secretary determines that--
            ``(1) a tobacco product which is introduced or delivered 
        for introduction into interstate commerce for commercial 
        distribution presents an unreasonable risk of substantial harm 
        to the public health; and
            ``(2) notification under this subsection is necessary to 
        eliminate the unreasonable risk of such harm and no more 
        practicable means is available under the provisions of this 
        chapter (other than this section) to eliminate such risk,
the Secretary may issue such order as may be necessary to assure that 
adequate notification is provided in an appropriate form, by the 
persons and means best suited under the circumstances involved, to all 
persons who should properly receive such notification in order to 
eliminate such risk. The Secretary may order notification by any 
appropriate means, including public service announcements. Before 
issuing an order under this subsection, the Secretary shall consult 
with the persons who are to give notice under the order.
    ``(b) No Exemption From Other Liability.--Compliance with an order 
issued under this section shall not relieve any person from liability 
under Federal or State law. In awarding damages for economic loss in an 
action brought for the enforcement of any such liability, the value to 
the plaintiff in such action of any remedy provided under such order 
shall be taken into account.
    ``(c) Recall Authority.--
            ``(1) In general.--If the Secretary finds that there is a 
        reasonable probability that a tobacco product contains a 
        manufacturing or other defect not ordinarily contained in 
        tobacco products on the market that would cause serious, 
        adverse health consequences or death, the Secretary shall issue 
        an order requiring the appropriate person (including the 
        manufacturers, importers, distributors, or retailers of the 
        tobacco product) to immediately cease distribution of such 
        tobacco product. The order shall provide the person subject to 
        the order with an opportunity for an informal hearing, to be 
        held not later than 10 days after the date of the issuance of 
        the order, on the actions required by the order and on whether 
        the order should be amended to require a recall of such tobacco 
        product. If, after providing an opportunity for such a hearing, 
        the Secretary determines that inadequate grounds exist to 
        support the actions required by the order, the Secretary shall 
        vacate the order.
            ``(2) Amendment of order to require recall.--
                    ``(A) In general.--If, after providing an 
                opportunity for an informal hearing under paragraph 
                (1), the Secretary determines that the order should be 
                amended to include a recall of the tobacco product with 
                respect to which the order was issued, the Secretary 
                shall, except as provided in subparagraph (B), amend 
                the order to require a recall. The Secretary shall 
                specify a timetable in which the tobacco product recall 
                will occur and shall require periodic reports to the 
                Secretary describing the progress of the recall.
                    ``(B) Notice.--An amended order under subparagraph 
                (A)--
                            ``(i) shall not include recall of a tobacco 
                        product from individuals; and
                            ``(ii) shall provide for notice to persons 
                        subject to the risks associated with the use of 
                        such tobacco product.
                In providing the notice required by clause (ii), the 
                Secretary may use the assistance of retailers and other 
                persons who distributed such tobacco product. If a 
                significant number of such persons cannot be 
                identified, the Secretary shall notify such persons 
                under section 705(b).
            ``(3) Remedy not exclusive.--The remedy provided by this 
        subsection shall be in addition to remedies provided by 
        subsection (a) of this section.

``SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS.

    ``(a) In General.--Every person who is a tobacco product 
manufacturer or importer of a tobacco product shall establish and 
maintain such records, make such reports, and provide such information, 
as the Secretary may by regulation reasonably require to assure that 
such tobacco product is not adulterated or misbranded and to otherwise 
protect public health. Regulations prescribed under the preceding 
sentence--
            ``(1) may require a tobacco product manufacturer or 
        importer to report to the Secretary whenever the manufacturer 
        or importer receives or otherwise becomes aware of information 
        that reasonably suggests that one of its marketed tobacco 
        products may have caused or contributed to a serious unexpected 
        adverse experience associated with the use of the product or 
        any significant increase in the frequency of a serious, 
        expected adverse product experience;
            ``(2) shall require reporting of other significant adverse 
        tobacco product experiences as determined by the Secretary to 
        be necessary to be reported;
            ``(3) shall not impose requirements unduly burdensome to a 
        tobacco product manufacturer or importer, taking into account 
        the cost of complying with such requirements and the need for 
        the protection of the public health and the implementation of 
        this chapter;
            ``(4) when prescribing the procedure for making requests 
        for reports or information, shall require that each request 
        made under such regulations for submission of a report or 
        information to the Secretary state the reason or purpose for 
        such request and identify to the fullest extent practicable 
        such report or information;
            ``(5) when requiring submission of a report or information 
        to the Secretary, shall state the reason or purpose for the 
        submission of such report or information and identify to the 
        fullest extent practicable such report or information; and
            ``(6) may not require that the identity of any patient or 
        user be disclosed in records, reports, or information required 
        under this subsection unless required for the medical welfare 
        of an individual, to determine risks to public health of a 
        tobacco product, or to verify a record, report, or information 
        submitted under this chapter.
In prescribing regulations under this subsection, the Secretary shall 
have due regard for the professional ethics of the medical profession 
and the interests of patients. The prohibitions of paragraph (6) 
continue to apply to records, reports, and information concerning any 
individual who has been a patient, irrespective of whether or when he 
ceases to be a patient.
    ``(b) Reports of Removals and Corrections.--
            ``(1) In general.--Except as provided in paragraph (2), the 
        Secretary shall by regulation require a tobacco product 
        manufacturer or importer of a tobacco product to report 
        promptly to the Secretary any corrective action taken or 
        removal from the market of a tobacco product undertaken by such 
        manufacturer or importer if the removal or correction was 
        undertaken--
                    ``(A) to reduce a risk to health posed by the 
                tobacco product; or
                    ``(B) to remedy a violation of this chapter caused 
                by the tobacco product which may present a risk to 
                health.
        A tobacco product manufacturer or importer of a tobacco product 
        who undertakes a corrective action or removal from the market 
        of a tobacco product which is not required to be reported under 
        this subsection shall keep a record of such correction or 
        removal.
            ``(2) Exception.--No report of the corrective action or 
        removal of a tobacco product may be required under paragraph 
        (1) if a report of the corrective action or removal is required 
        and has been submitted under subsection (a).

``SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TOBACCO PRODUCTS.

    ``(a) In General.--
            ``(1) New tobacco product defined.--For purposes of this 
        section the term `new tobacco product' means--
                    ``(A) any tobacco product (including those products 
                in test markets) that was not commercially marketed in 
                the United States as of June 1, 2003; or
                    ``(B) any modification (including a change in 
                design, any component, any part, or any constituent, 
                including a smoke constituent, or in the content, 
                delivery or form of nicotine, or any other additive or 
                ingredient) of a tobacco product where the modified 
                product was commercially marketed in the United States 
                after June 1, 2003.
            ``(2) Premarket approval required.--
                    ``(A) New products.--Approval under this section of 
                an application for premarket approval for any new 
                tobacco product is required unless--
                            ``(i) the manufacturer has submitted a 
                        report under section 905(j); and
                            ``(ii) the Secretary has issued an order 
                        that the tobacco product--
                                    ``(I) is substantially equivalent 
                                to a tobacco product commercially 
                                marketed (other than for test 
                                marketing) in the United States as of 
                                June 1, 2003; and
                                    ``(II)(aa) is in compliance with 
                                the requirements of this Act; or
                                    ``(bb) is exempt from the 
                                requirements of section 905(j) pursuant 
                                to a regulation issued under section 
                                905(j)(3).
                    ``(B) Application to certain post june 1, 2003 
                products.--Subparagraph (A) shall not apply to a 
                tobacco product--
                            ``(i) that was first introduced or 
                        delivered for introduction into interstate 
                        commerce for commercial distribution in the 
                        United States after June 1, 2003, and prior to 
                        the date that is 15 months after the date of 
                        enactment of the Family Smoking Prevention and 
                        Tobacco Control Act; and
                            ``(ii) for which a report was submitted 
                        under section 905(j) within such 15-month 
                        period, until the Secretary issues an order 
                        that the tobacco product is not substantially 
                        equivalent.
            ``(3) Substantially equivalent defined.--
                    ``(A) In general.--In this section and section 
                905(j), the terms `substantially equivalent' or 
                `substantial equivalence' mean, with respect to the 
                tobacco product being compared to the predicate tobacco 
                product, that the Secretary by order has found that the 
                tobacco product--
                            ``(i) has the same characteristics as the 
                        predicate tobacco product; or
                            ``(ii) has different characteristics and 
                        the information submitted contains information, 
                        including clinical data if deemed necessary by 
                        the Secretary, that demonstrates that it is not 
                        appropriate to regulate the product under this 
                        section because the product does not raise 
                        different questions of public health.
                    ``(B) Characteristics.--In subparagraph (A), the 
                term `characteristics' means the materials, 
                ingredients, design, composition, heating source, or 
                other features of a tobacco product.
                    ``(C) Limitation.--A tobacco product may not be 
                found to be substantially equivalent to a predicate 
                tobacco product that has been removed from the market 
                at the initiative of the Secretary or that has been 
                determined by a judicial order to be misbranded or 
                adulterated.
            ``(4) Health information.--
                    ``(A) Summary.--As part of a submission under 
                section 905(j) respecting a tobacco product, the person 
                required to file a premarket notification under such 
                section shall provide an adequate summary of any health 
                information related to the tobacco product or state 
                that such information will be made available upon 
                request by any person.
                    ``(B) Required information.--Any summary under 
                subparagraph (A) respecting a tobacco product shall 
                contain detailed information regarding data concerning 
                adverse health effects and shall be made available to 
                the public by the Secretary within 30 days of the 
                issuance of a determination that such tobacco product 
                is substantially equivalent to another tobacco product.
    ``(b) Application.--
            ``(1) Contents.--An application for premarket approval 
        shall contain--
                    ``(A) full reports of all information, published or 
                known to, or which should reasonably be known to, the 
                applicant, concerning investigations which have been 
                made to show the health risks of such tobacco product 
                and whether such tobacco product presents less risk 
                than other tobacco products;
                    ``(B) a full statement of the components, 
                ingredients, additives, and properties, and of the 
                principle or principles of operation, of such tobacco 
                product;
                    ``(C) a full description of the methods used in, 
                and the facilities and controls used for, the 
                manufacture, processing, and, when relevant, packing 
                and installation of, such tobacco product;
                    ``(D) an identifying reference to any tobacco 
                product standard under section 907 which would be 
                applicable to any aspect of such tobacco product, and 
                either adequate information to show that such aspect of 
                such tobacco product fully meets such tobacco product 
                standard or adequate information to justify any 
                deviation from such standard;
                    ``(E) such samples of such tobacco product and of 
                components thereof as the Secretary may reasonably 
                require;
                    ``(F) specimens of the labeling proposed to be used 
                for such tobacco product; and
                    ``(G) such other information relevant to the 
                subject matter of the application as the Secretary may 
                require.
            ``(2) Reference to tobacco products scientific advisory 
        committee.--Upon receipt of an application meeting the 
        requirements set forth in paragraph (1), the Secretary--
                    ``(A) may, on the Secretary's own initiative; or
                    ``(B) may, upon the request of an applicant,
        refer such application to the Tobacco Products Scientific 
        Advisory Committee for reference and for submission (within 
        such period as the Secretary may establish) of a report and 
        recommendation respecting approval of the application, together 
        with all underlying data and the reasons or basis for the 
        recommendation.
    ``(c) Action on Application.--
            ``(1) Deadline.--
                    ``(A) In general.--As promptly as possible, but in 
                no event later than 180 days after the receipt of an 
                application under subsection (b), the Secretary, after 
considering the report and recommendation submitted under paragraph (2) 
of such subsection, shall--
                            ``(i) issue an order approving the 
                        application if the Secretary finds that none of 
                        the grounds for denying approval specified in 
                        paragraph (2) of this subsection applies; or
                            ``(ii) deny approval of the application if 
                        the Secretary finds (and sets forth the basis 
                        for such finding as part of or accompanying 
                        such denial) that 1 or more grounds for denial 
                        specified in paragraph (2) of this subsection 
                        apply.
                    ``(B) Restrictions on sale and distribution.--An 
                order approving an application for a tobacco product 
                may require as a condition to such approval that the 
                sale and distribution of the tobacco product be 
                restricted but only to the extent that the sale and 
                distribution of a tobacco product may be restricted 
                under a regulation under section 906(d).
            ``(2) Denial of approval.--The Secretary shall deny 
        approval of an application for a tobacco product if, upon the 
        basis of the information submitted to the Secretary as part of 
        the application and any other information before the Secretary 
        with respect to such tobacco product, the Secretary finds 
        that--
                    ``(A) there is a lack of a showing that permitting 
                such tobacco product to be marketed would be 
                appropriate for the protection of the public health;
                    ``(B) the methods used in, or the facilities or 
                controls used for, the manufacture, processing, or 
                packing of such tobacco product do not conform to the 
                requirements of section 906(e);
                    ``(C) based on a fair evaluation of all material 
                facts, the proposed labeling is false or misleading in 
                any particular; or
                    ``(D) such tobacco product is not shown to conform 
                in all respects to a tobacco product standard in effect 
                under section 907, compliance with which is a condition 
                to approval of the application, and there is a lack of 
                adequate information to justify the deviation from such 
                standard.
            ``(3) Denial information.--Any denial of an application 
        shall, insofar as the Secretary determines to be practicable, 
        be accompanied by a statement informing the applicant of the 
        measures required to place such application in approvable form 
        (which measures may include further research by the applicant 
        in accordance with 1 or more protocols prescribed by the 
        Secretary).
            ``(4) Basis for finding.--For purposes of this section, the 
        finding as to whether approval of a tobacco product is 
        appropriate for the protection of the public health shall be 
        determined with respect to the risks and benefits to the 
        population as a whole, including users and nonusers of the 
        tobacco product, and taking into account--
                    ``(A) the increased or decreased likelihood that 
                existing users of tobacco products will stop using such 
                products; and
                    ``(B) the increased or decreased likelihood that 
                those who do not use tobacco products will start using 
                such products.
            ``(5) Basis for action.--
                    ``(A) Investigations.--For purposes of paragraph 
                (2)(A), whether permitting a tobacco product to be 
                marketed would be appropriate for the protection of the 
                public health shall, when appropriate, be determined on 
                the basis of well-controlled investigations, which may 
                include 1 or more clinical investigations by experts 
                qualified by training and experience to evaluate the 
                tobacco product.
                    ``(B) Other evidence.--If the Secretary determines 
                that there exists valid scientific evidence (other than 
                evidence derived from investigations described in 
                subparagraph (A)) which is sufficient to evaluate the 
                tobacco product the Secretary may authorize that the 
                determination for purposes of paragraph (2)(A) be made 
                on the basis of such evidence.
    ``(d) Withdrawal and Temporary Suspension.--
            ``(1) In general.--The Secretary shall, upon obtaining, 
        where appropriate, advice on scientific matters from an 
        advisory committee, and after due notice and opportunity for 
        informal hearing to the holder of an approved application for a 
        tobacco product, issue an order withdrawing approval of the 
        application if the Secretary finds--
                    ``(A) that the continued marketing of such tobacco 
                product no longer is appropriate for the protection of 
                the public health;
                    ``(B) that the application contained or was 
                accompanied by an untrue statement of a material fact;
                    ``(C) that the applicant--
                            ``(i) has failed to establish a system for 
                        maintaining records, or has repeatedly or 
                        deliberately failed to maintain records or to 
                        make reports, required by an applicable 
                        regulation under section 909;
                            ``(ii) has refused to permit access to, or 
                        copying or verification of, such records as 
                        required by section 704; or
                            ``(iii) has not complied with the 
                        requirements of section 905;
                    ``(D) on the basis of new information before the 
                Secretary with respect to such tobacco product, 
                evaluated together with the evidence before the 
                Secretary when the application was approved, that the 
                methods used in, or the facilities and controls used 
                for, the manufacture, processing, packing, or 
                installation of such tobacco product do not conform 
                with the requirements of section 906(e) and were not 
                brought into conformity with such requirements within 
a reasonable time after receipt of written notice from the Secretary of 
nonconformity;
                    ``(E) on the basis of new information before the 
                Secretary, evaluated together with the evidence before 
                the Secretary when the application was approved, that 
                the labeling of such tobacco product, based on a fair 
                evaluation of all material facts, is false or 
                misleading in any particular and was not corrected 
                within a reasonable time after receipt of written 
                notice from the Secretary of such fact; or
                    ``(F) on the basis of new information before the 
                Secretary, evaluated together with the evidence before 
                the Secretary when the application was approved, that 
                such tobacco product is not shown to conform in all 
                respects to a tobacco product standard which is in 
                effect under section 907, compliance with which was a 
                condition to approval of the application, and that 
                there is a lack of adequate information to justify the 
                deviation from such standard.
            ``(2) Appeal.--The holder of an application subject to an 
        order issued under paragraph (1) withdrawing approval of the 
        application may, by petition filed on or before the 30th day 
        after the date upon which such holder receives notice of such 
        withdrawal, obtain review thereof in accordance with subsection 
        (e).
            ``(3) Temporary suspension.--If, after providing an 
        opportunity for an informal hearing, the Secretary determines 
        there is reasonable probability that the continuation of 
        distribution of a tobacco product under an approved application 
        would cause serious, adverse health consequences or death, that 
        is greater than ordinarily caused by tobacco products on the 
        market, the Secretary shall by order temporarily suspend the 
        approval of the application approved under this section. If the 
        Secretary issues such an order, the Secretary shall proceed 
        expeditiously under paragraph (1) to withdraw such application.
    ``(e) Service of Order.--An order issued by the Secretary under 
this section shall be served--
            ``(1) in person by any officer or employee of the 
        department designated by the Secretary; or
            ``(2) by mailing the order by registered mail or certified 
        mail addressed to the applicant at the applicant's last known 
        address in the records of the Secretary.
    ``(f) Records.--
            ``(1) Additional information.--In the case of any tobacco 
        product for which an approval of an application filed under 
        subsection (b) is in effect, the applicant shall establish and 
        maintain such records, and make such reports to the Secretary, 
        as the Secretary may by regulation, or by order with respect to 
        such application, prescribe on the basis of a finding that such 
        records and reports are necessary in order to enable the 
        Secretary to determine, or facilitate a determination of, 
        whether there is or may be grounds for withdrawing or 
        temporarily suspending such approval.
            ``(2) Access to records.--Each person required under this 
        section to maintain records, and each person in charge or 
        custody thereof, shall, upon request of an officer or employee 
        designated by the Secretary, permit such officer or employee at 
        all reasonable times to have access to and copy and verify such 
        records.
    ``(g) Investigational Tobacco Product Exemption for Investigational 
Use.--The Secretary may exempt tobacco products intended for 
investigational use from the provisions of this chapter under such 
conditions as the Secretary may by regulation prescribe.

``SEC. 911. MODIFIED RISK TOBACCO PRODUCTS.

    ``(a) In General.--No person may introduce or deliver for 
introduction into interstate commerce any modified risk tobacco product 
unless approval of an application filed pursuant to subsection (d) is 
effective with respect to such product.
    ``(b) Definitions.--In this section:
            ``(1) Modified risk tobacco product.--The term `modified 
        risk tobacco product' means any tobacco product that is sold or 
        distributed for use to reduce harm or the risk of tobacco-
        related disease associated with commercially marketed tobacco 
        products.
            ``(2) Sold or distributed.--
                    ``(A) In general.--With respect to a tobacco 
                product, the term `sold or distributed for use to 
                reduce harm or the risk of tobacco-related disease 
                associated with commercially marketed tobacco products' 
                means a tobacco product--
                            ``(A) the label, labeling, or advertising 
                        of which represents explicitly or implicitly 
                        that--
                                    ``(I) the tobacco product presents 
                                a lower risk of tobacco-related disease 
                                or is less harmful than one or more 
                                other commercially marketed tobacco 
                                products;
                                    ``(II) the tobacco product or its 
                                smoke contains a reduced level of a 
                                substance or presents a reduced 
                                exposure to a substance; or
                                    ``(III) the tobacco product or its 
                                smoke does not contain or is free of a 
                                substance;
                            ``(ii) the label, labeling, or advertising 
                        of which uses the descriptors `light', `mild', 
                        or `low' or similar descriptors; or
                            ``(iii) the tobacco product manufacturer of 
                        which has taken any action directed to 
                        consumers through the media or otherwise, other 
                        than by means of the tobacco product's label, 
                        labeling or advertising, after the date of 
                        enactment of the Family Smoking Prevention and 
                        Tobacco Control Act, respecting the product 
                        that would be reasonably expected to result in 
                        consumers believing that the tobacco product or 
                        its smoke may present a lower risk of disease 
                        or is less harmful than one or more 
                        commercially marketed tobacco products, or 
                        presents a reduced exposure to, or does not 
                        contain or is free of, a substance or 
                        substances.
                    ``(B) Limitation.--No tobacco product shall be 
                considered to be `sold or distributed for use to reduce 
                harm or the risk of tobacco-related disease associated 
                with commercially marketed tobacco products', except as 
                described in subparagraph (A).
    ``(c) Tobacco Dependence Products.--A product that is intended to 
be used for the treatment of tobacco dependence, including smoking 
cessation, is not a modified risk tobacco product under this section 
and is subject to the requirements of chapter V.
    ``(d) Filing.--Any person may file with the Secretary an 
application for a modified risk tobacco product. Such application shall 
include--
            ``(1) a description of the proposed product and any 
        proposed advertising and labeling;
            ``(2) the conditions for using the product;
            ``(3) the formulation of the product;
            ``(4) sample product labels and labeling;
            ``(5) all documents (including underlying scientific 
        information) relating to research findings conducted, 
        supported, or possessed by the tobacco product manufacturer 
relating to the effect of the product on tobacco related diseases and 
health-related conditions, including information both favorable and 
unfavorable to the ability of the product to reduce risk or exposure 
and relating to human health;
            ``(6) data and information on how consumers actually use 
        the tobacco product; and
            ``(7) such other information as the Secretary may require.
    ``(e) Public Availability.--The Secretary shall make the 
application described in subsection (d) publicly available (except 
matters in the application which are trade secrets or otherwise 
confidential, commercial information) and shall request comments by 
interested persons on the information contained in the application and 
on the label, labeling, and advertising accompanying such application.
    ``(f) Advisory Committee.--
            ``(1) In general.--The Secretary shall refer to an advisory 
        committee any application submitted under this subsection.
            ``(2) Recommendations.--Not later than 60 days after the 
        date an application is referred to an advisory committee under 
        paragraph (1), the advisory committee shall report its 
        recommendations on the application to the Secretary.
    ``(g) Approval.--
            ``(1) Modified risk products.--Except as provided in 
        paragraph (2), the Secretary shall approve an application for a 
        modified risk tobacco product filed under this section only if 
        the Secretary determines that the applicant has demonstrated 
        that such product, as it is actually used by consumers, will--
                    ``(A) significantly reduce harm and the risk of 
                tobacco-related disease to individual tobacco users; 
                and
                    ``(B) 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.
            ``(2) Special rule for certain products.--
                    ``(A) In general.--The Secretary may approve an 
                application for a tobacco product that has not been 
                approved as a modified risk tobacco product pursuant to 
                paragraph (1) if the Secretary makes the findings 
                required under this paragraph and determines that the 
                applicant has demonstrated that--
                            ``(i) the approval of the application would 
                        be appropriate to promote the public health;
                            ``(ii) any aspect of the label, labeling, 
                        and advertising for such product that would 
                        cause the tobacco product to be a modified risk 
                        tobacco product under subsection (b)(2) is 
                        limited to an explicit or implicit 
                        representation that such tobacco product or its 
                        smoke contains or is free of a substance or 
                        contains a reduced level of a substance, or 
                        presents a reduced exposure to a substance in 
                        tobacco smoke.
                            ``(iii) scientific evidence is not 
                        available and, using the best available 
                        scientific methods, cannot be made available 
                        without conducting long-term epidemiological 
                        studies for an application to meet the 
                        standards set forth in paragraph (1); and
                            ``(iv) the scientific evidence that is 
                        available without conducting long-term 
                        epidemiological studies demonstrates that a 
                        measurable and substantial reduction in 
                        morbidity or mortality among individual tobacco 
                        users is anticipated in subsequent studies.
                    ``(B) Additional findings required.--In order to 
                approve an application under subparagraph (A) the 
                Secretary must also find that the applicant has 
                demonstrated that--
                            ``(i) the magnitude of the overall 
                        reductions in exposure to the substance or 
                        substances which are the subject of the 
                        application is substantial, such substance or 
                        substances are harmful, and the product as 
                        actually used exposes consumers to the 
                        specified reduced level of the substance or 
                        substances;
                            ``(ii) the product as actually used by 
                        consumers will not expose them to higher levels 
                        of other harmful substances compared to the 
                        similar types of tobacco products then on the 
                        market unless such increases are minimal and 
                        the anticipated overall impact of use of the 
                        product remains a substantial and measurable 
                        reduction in overall morbidity and mortality 
                        among individual tobacco users;
                            ``(iii) testing of actual consumer 
                        perception shows that, as the applicant 
                        proposes to label and market the product, 
                        consumers will not be misled into believing 
                        that the product--
                                    ``(I) is or has been demonstrated 
                                to be less harmful; or
                                    ``(II) presents or has been 
                                demonstrated to present less of a risk 
                                of disease than 1 or more other 
                                commercially marketed tobacco products; 
                                and
                            ``(iv) approval of the application is 
                        expected to 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.
                    ``(C) Conditions of approval.--
                            ``(i) In general.--Applications approved 
                        under this paragraph shall be limited to a term 
                        of not more than 5 years, but may be renewed 
                        upon a finding by the Secretary that the 
                        requirements of this paragraph continue to be 
                        satisfied based on the filing of a new 
                        application.
                            ``(ii) Agreements by applicant.--
                        Applications approved under this paragraph 
                        shall be conditioned on the applicant's 
                        agreement to conduct post-market surveillance 
                        and studies and to submit to the Secretary the 
                        results of such surveillance and studies to 
                        determine the impact of the application 
                        approval on consumer perception, behavior, and 
                        health and to enable the Secretary to review 
                        the accuracy of the determinations upon which 
                        the approval was based in accordance with a 
                        protocol approved by the Secretary.
                            ``(iii) Annual submission.--The results of 
                        such post-market surveillance and studies 
                        described in clause (ii) shall be submitted 
                        annually.
            ``(3) Basis.--The determinations under paragraphs (1) and 
        (2) shall be based on--
                    ``(A) the scientific evidence submitted by the 
                applicant; and
                    ``(B) scientific evidence and other information 
                that is available to the Secretary.
            ``(4) Benefit to health of individuals and of population as 
        a whole.--In making the determinations under paragraphs (1) and 
(2), the Secretary shall take into account--
                    ``(A) the relative health risks to individuals of 
                the tobacco product that is the subject of the 
                application;
                    ``(B) the increased or decreased likelihood that 
                existing users of tobacco products who would otherwise 
                stop using such products will switch to the tobacco 
                product that is the subject of the application;
                    ``(C) the increased or decreased likelihood that 
                persons who do not use tobacco products will start 
                using the tobacco product that is the subject of the 
                application;
                    ``(D) the risks and benefits to persons from the 
                use of the tobacco product that is the subject of the 
                application as compared to the use of products for 
                smoking cessation approved under chapter V to treat 
                nicotine dependence; and
                    ``(E) comments, data, and information submitted by 
                interested persons.
    ``(h) Additional Conditions for Approval.--
            ``(1) Modified risk products.--The Secretary shall require 
        for the approval of an application under this section that any 
        advertising or labeling concerning modified risk products 
        enable the public to comprehend the information concerning 
        modified risk and to understand the relative significance of 
        such information in the context of total health and in relation 
        to all of the diseases and health-related conditions associated 
        with the use of tobacco products.
            ``(2) Comparative claims.--
                    ``(A) In general.--The Secretary may require for 
                the approval of an application under this subsection 
                that a claim comparing a tobacco product to 1 or more 
                other commercially marketed tobacco products shall 
                compare the tobacco product to a commercially marketed 
                tobacco product that is representative of that type of 
                tobacco product on the market (for example the average 
                value of the top 3 brands of an established regular 
                tobacco product).
                    ``(B) Quantitative comparisons.--The Secretary may 
                also require, for purposes of subparagraph (A), that 
                the percent (or fraction) of change and identity of the 
                reference tobacco product and a quantitative comparison 
                of the amount of the substance claimed to be reduced 
                shall be stated in immediate proximity to the most 
                prominent claim.
            ``(3) Label disclosure.--
                    ``(A) In general.--The Secretary may require the 
                disclosure on the label of other substances in the 
                tobacco product, or substances that may be produced by 
                the consumption of that tobacco product, that may 
                affect a disease or health-related condition or may 
                increase the risk of other diseases or health-related 
                conditions associated with the use of tobacco products.
                    ``(B) Conditions of use.--If the conditions of use 
                of the tobacco product may affect the risk of the 
                product to human health, the Secretary may require the 
                labeling of conditions of use.
            ``(4) Time.--The Secretary shall limit an approval under 
        subsection (g)(1) for a specified period of time.
            ``(5) Advertising.--The Secretary may require that an 
        applicant, whose application has been approved under this 
        subsection, comply with requirements relating to advertising 
        and promotion of the tobacco product.
    ``(i) Postmarket Surveillance and Studies.--
            ``(1) In general.--The Secretary shall require that an 
        applicant under subsection (g)(1) conduct post market 
        surveillance and studies for a tobacco product for which an 
        application has been approved to determine the impact of the 
        application approval on consumer perception, behavior, and 
        health, to enable the Secretary to review the accuracy of the 
        determinations upon which the approval was based, and to 
        provide information that the Secretary determines is otherwise 
        necessary regarding the use or health risks involving the 
        tobacco product. The results of post-market surveillance and 
        studies shall be submitted to the Secretary on an annual basis.
            ``(2) Surveillance protocol.--Each applicant required to 
        conduct a surveillance of a tobacco product under paragraph (1) 
        shall, within 30 days after receiving notice that the applicant 
        is required to conduct such surveillance, submit, for the 
        approval of the Secretary, a protocol for the required 
        surveillance. The Secretary, within 60 days of the receipt of 
        such protocol, shall determine if the principal investigator 
        proposed to be used in the surveillance has sufficient 
        qualifications and experience to conduct such surveillance and 
        if such protocol will result in collection of the data or other 
        information designated by the Secretary as necessary to protect 
        the public health.
    ``(j) Withdrawal of Approval.--The Secretary, after an opportunity 
for an informal hearing, shall withdraw the approval of an application 
under this section if the Secretary determines that--
            ``(1) the applicant, based on new information, can no 
        longer make the demonstrations required under subsection (g), 
        or the Secretary can no longer make the determinations required 
        under subsection (g);
            ``(2) the application failed to include material 
        information or included any untrue statement of material fact;
            ``(3) any explicit or implicit representation that the 
        product reduces risk or exposure is no longer valid, including 
        if--
                    ``(A) a tobacco product standard is established 
                pursuant to section 907;
                    ``(B) an action is taken that affects the risks 
                presented by other commercially marketed tobacco 
                products that were compared to the product that is the 
                subject of the application; or
                    ``(C) any postmarket surveillance or studies reveal 
                that the approval of the application is no longer 
                consistent with the protection of the public health;
            ``(4) the applicant failed to conduct or submit the 
        postmarket surveillance and studies required under subsection 
        (g)(2)(C)(ii) or (i); or
            ``(5) the applicant failed to meet a condition imposed 
        under subsection (h).
    ``(k) Chapter IV or V.--A product approved in accordance with this 
section shall not be subject to chapter IV or V.
    ``(l) Implementing Regulations or Guidance.--
            ``(1) Scientific evidence.--Not later than 2 years after 
        the date of enactment of the Family Smoking Prevention and 
        Tobacco Control Act, the Secretary shall issue regulations or 
        guidance (or any combination thereof) on the scientific 
        evidence required for assessment and ongoing review of modified 
        risk tobacco products. Such regulations or guidance shall--
                    ``(A) establish minimum standards for scientific 
                studies needed prior to approval to show that a 
                substantial reduction in morbidity or mortality among 
                individual tobacco users is likely;
                    ``(B) include validated biomarkers, intermediate 
                clinical endpoints, and other feasible outcome 
                measures, as appropriate;
                    ``(C) establish minimum standards for post market 
                studies, that shall include regular and long-term 
                assessments of health outcomes and mortality, 
                intermediate clinical endpoints, consumer perception of 
                harm reduction, and the impact on quitting behavior and 
                new use of tobacco products, as appropriate;
                    ``(D) establish minimum standards for required 
                postmarket surveillance, including ongoing assessments 
                of consumer perception; and
                    ``(E) require that data from the required studies 
                and surveillance be made available to the Secretary 
                prior to the decision on renewal of a modified risk 
                tobacco product.
            ``(2) Consultation.--The regulations or guidance issued 
        under paragraph (1) shall be developed in consultation with the 
        Institute of Medicine, and with the input of other appropriate 
        scientific and medical experts, on the design and conduct of 
        such studies and surveillance.
            ``(3) Revision.--The regulations or guidance under 
        paragraph (1) shall be revised on a regular basis as new 
        scientific information becomes available.
            ``(4) New tobacco products.--Not later than 2 years after 
        the date of enactment of the Family Smoking Prevention and 
        Tobacco Control Act, the Secretary shall issue a regulation or 
        guidance that permits the filing of a single application for 
        any tobacco product that is a new tobacco product under section 
        910 and for which the applicant seeks approval as a modified 
        risk tobacco product under this section.
    ``(m) Distributors.--No distributor may take any action, after the 
date of enactment of the Family Smoking Prevention and Tobacco Control 
Act, with respect to a tobacco product that would reasonably be 
expected to result in consumers believing that the tobacco product or 
its smoke may present a lower risk of disease or is less harmful than 
one or more commercially marketed tobacco products, or presents a 
reduced exposure to, or does not contain or is free of, a substance or 
substances.

``SEC. 912. JUDICIAL REVIEW.

    ``(a) Right To Review.--
            ``(1) In general.--Not later than 30 days after--
                    ``(A) the promulgation of a regulation under 
                section 907 establishing, amending, or revoking a 
                tobacco product standard; or
                    ``(B) a denial of an application for approval under 
                section 910(c),
        any person adversely affected by such regulation or denial may 
        file a petition for judicial review of such regulation or 
        denial with the United States Court of Appeals for the District 
        of Columbia or for the circuit in which such person resides or 
        has their principal place of business.
            ``(2) Requirements.--
                    ``(A) Copy of petition.--A copy of the petition 
                filed under paragraph (1) shall be transmitted by the 
                clerk of the court involved to the Secretary.
                    ``(B) Record of proceedings.--On receipt of a 
                petition under subparagraph (A), the Secretary shall 
                file in the court in which such petition was filed--
                            ``(i) the record of the proceedings on 
                        which the regulation or order was based; and
                            ``(ii) a statement of the reasons for the 
                        issuance of such a regulation or order.
                    ``(C) Definition of record.--In this section, the 
                term `record' means--
                            ``(i) all notices and other matter 
                        published in the Federal Register with respect 
                        to the regulation or order reviewed;
                            ``(ii) all information submitted to the 
                        Secretary with respect to such regulation or 
                        order;
                            ``(iii) proceedings of any panel or 
                        advisory committee with respect to such 
                        regulation or order;
                            ``(iv) any hearing held with respect to 
                        such regulation or order; and
                            ``(v) any other information identified by 
                        the Secretary, in the administrative proceeding 
                        held with respect to such regulation or order, 
                        as being relevant to such regulation or order.
    ``(b) Standard of Review.--Upon the filing of the petition under 
subsection (a) for judicial review of a regulation or order, the court 
shall have jurisdiction to review the regulation or order in accordance 
with chapter 7 of title 5, United States Code, and to grant appropriate 
relief, including interim relief, as provided for in such chapter. A 
regulation or denial described in subsection (a) shall be reviewed in 
accordance with section 706(2)(A) of title 5, United States Code.
    ``(c) Finality of Judgment.--The judgment of the court affirming or 
setting aside, in whole or in part, any regulation or order shall be 
final, subject to review by the Supreme Court of the United States upon 
certiorari or certification, as provided in section 1254 of title 28, 
United States Code.
    ``(d) Other Remedies.--The remedies provided for in this section 
shall be in addition to, and not in lieu of, any other remedies 
provided by law.
    ``(e) Regulations and Orders Must Recite Basis in Record.--To 
facilitate judicial review, a regulation or order issued under section 
906, 907, 908, 909, 910, or 916 shall contain a statement of the 
reasons for the issuance of such regulation or order in the record of 
the proceedings held in connection with its issuance.

``SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS.

    ``The Secretary shall issue regulations to require that retail 
establishments for which the predominant business is the sale of 
tobacco products comply with any advertising restrictions applicable to 
retail establishments accessible to individuals under the age of 18.

``SEC. 914. JURISDICTION OF AND COORDINATION WITH THE FEDERAL TRADE 
              COMMISSION.

    ``(a) Jurisdiction.--
            ``(1) In general.--Except where expressly provided in this 
        chapter, nothing in this chapter shall be construed as limiting 
        or diminishing the authority of the Federal Trade Commission to 
        enforce the laws under its jurisdiction with respect to the 
        advertising, sale, or distribution of tobacco products.
            ``(2) Enforcement.--Any advertising that violates this 
        chapter or a provision of the regulations referred to in 
        section 102 of the Family Smoking Prevention and Tobacco 
        Control Act, is an unfair or deceptive act or practice under 
        section 5(a) of the Federal Trade Commission Act (15 U.S.C. 
        45(a)) and shall be considered a violation of a rule 
        promulgated under section 18 of that Act (15 U.S.C. 57a).
    ``(b) Coordination.--With respect to the requirements of section 4 
of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) 
and section 3 of the Comprehensive Smokeless Tobacco Health Education 
Act of 1986 (15 U.S.C. 4402)--
            ``(1) the Chairman of the Federal Trade Commission shall 
        coordinate with the Secretary concerning the enforcement of 
        such Act as such enforcement relates to unfair or deceptive 
        acts or practices in the advertising of cigarettes or smokeless 
        tobacco; and
            ``(2) the Secretary shall consult with the Chairman of such 
        Commission in revising the label statements and requirements 
        under such sections.

``SEC. 915. CONGRESSIONAL REVIEW PROVISIONS.

    ``In accordance with section 801 of title 5, United States Code, 
Congress shall review, and may disapprove, any rule under this chapter 
that is subject to section 801. This section and section 801 do not 
apply to the regulations referred to in section 102 of the Family 
Smoking Prevention and Tobacco Control Act.

``SEC. 916. REGULATION REQUIREMENT.

    ``(a) Testing, Reporting, and Disclosure.--Not later than 24 months 
after the date of enactment of the Family Smoking Prevention and 
Tobacco Control Act, the Secretary, acting through the Commissioner of 
the Food and Drug Administration, shall promulgate regulations under 
this Act that meet the requirements of subsection (b).
    ``(b) Contents of Rules.--The regulations promulgated under 
subsection (a) shall require testing and reporting of tobacco product 
constituents, ingredients, and additives, including smoke constituents, 
by brand and sub-brand that the Secretary determines should be tested 
to protect the public health. The regulations may require that tobacco 
product manufacturers, packagers, or importers make disclosures 
relating to the results of the testing of tar and nicotine through 
labels or advertising or other appropriate means, and make disclosures 
regarding the results of the testing of other constituents, including 
smoke constituents, ingredients, or additives, that the Secretary 
determines should be disclosed to the public to protect the public 
health and will not mislead consumers about the risk of tobacco related 
disease.
    ``(c) Authority.--The Food and Drug Administration shall have the 
authority under this chapter to conduct or to require the testing, 
reporting, or disclosure of tobacco product constituents, including 
smoke constituents.

``SEC. 917. PRESERVATION OF STATE AND LOCAL AUTHORITY.

    ``(a) In General.--
            ``(1) Preservation.--Nothing in this chapter, or rules 
        promulgated under this chapter, shall be construed to limit the 
        authority of a Federal agency (including the Armed Forces), a 
        State or political subdivision of a State, or the government of 
        an Indian tribe to enact, adopt, promulgate, and enforce any 
        law, rule, regulation, or other measure with respect to tobacco 
        products that is in addition to, or more stringent than, 
        requirements established under this chapter, including a law, 
        rule, regulation, or other measure relating to or prohibiting 
        the sale, distribution, possession, exposure to, access to, 
        advertising and promotion of, or use of tobacco products by 
        individuals of any age, information reporting to the State, or 
        measures relating to fire safety standards for tobacco 
        products. No provision of this chapter shall limit or otherwise 
        affect any State, Tribal, or local taxation of tobacco 
        products.
            ``(2) Preemption of certain state and local requirements.--
                    ``(A) In general.--Except as provided in paragraph 
                (1) and subparagraph (B), no State or political 
                subdivision of a State may establish or continue in 
                effect with respect to a tobacco product any 
                requirement which is different from, or in addition to, 
                any requirement under the provisions of this chapter 
                relating to tobacco product standards, premarket 
                approval, adulteration, misbranding, labeling, 
                registration, good manufacturing standards, or reduced 
                risk products.
                    ``(B) Exception.--Subparagraph (A) does not apply 
                to requirements relating to the sale, distribution, 
                possession, information reporting to the State, 
                exposure to, access to, the advertising and promotion 
                of, or use of, tobacco products by individuals of any 
                age, or relating to fire safety standards for tobacco 
                products. Information disclosed to a State under 
                subparagraph (A) that is exempt from disclosure under 
                section 554(b)(4) of title 5, United States Code, shall 
                be treated as trade secret and confidential information 
                by the State.
    ``(b) Rule of Construction Regarding Product Liability.--No 
provision of this chapter relating to a tobacco product shall be 
construed to modify or otherwise affect any action or the liability of 
any person under the product liability law of any State.

``SEC. 918. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.

    ``(a) Establishment.--Not later than 1 year after the date of 
enactment of the Family Smoking Prevention and Tobacco Control Act, the 
Secretary shall establish a 11-member advisory committee, to be known 
as the `Tobacco Products Scientific Advisory Committee'.
    ``(b) Membership.--
            ``(1) In general.--
                    ``(A) Members.--The Secretary shall appoint as 
                members of the Tobacco Products Scientific Advisory 
                Committee individuals who are technically qualified by 
                training and experience in the medicine, medical 
                ethics, science, or technology involving the 
                manufacture, evaluation, or use of tobacco products, 
                who are of appropriately diversified professional 
                backgrounds. The committee shall be composed of--
                            ``(i) 7 individuals who are physicians, 
                        dentists, scientists, or health care 
                        professionals practicing in the area of 
                        oncology, pulmonology, cardiology, toxicology, 
                        pharmacology, addiction, or any other relevant 
                        specialty;
                            ``(ii) 1 individual who is an officer or 
                        employee of a State or local government or of 
                        the Federal Government;
                            ``(iii) 1 individual as a representative of 
                        the general public;
                            ``(iv) 1 individual as a representative of 
                        the interests in the tobacco manufacturing 
                        industry; and
                            ``(v) 1 individual as a representative of 
                        the interests of the tobacco growers.
                    ``(B) Nonvoting members.--The members of the 
                committee appointed under clauses (iv) and (v) of 
                subparagraph (A) shall serve as consultants to those 
                described in clauses (i) through (iii) of subparagraph 
                (A) and shall be nonvoting representatives.
            ``(2) Limitation.--The Secretary may not appoint to the 
        Advisory Committee any individual who is in the regular full-
        time employ of the Food and Drug Administration or any agency 
        responsible for the enforcement of this Act. The Secretary may 
        appoint Federal officials as ex officio members.
            ``(3) Chairperson.--The Secretary shall designate 1 of the 
        members of the Advisory Committee to serve as chairperson.
    ``(c) Duties.--The Tobacco Products Scientific Advisory Committee 
shall provide advice, information, and recommendations to the 
Secretary--
            ``(1) as provided in this chapter;
            ``(2) on the effects of the alteration of the nicotine 
        yields from tobacco products;
            ``(3) on whether there is a threshold level below which 
        nicotine yields do not produce dependence on the tobacco 
        product involved; and
            ``(4) on its review of other safety, dependence, or health 
        issues relating to tobacco products as requested by the 
        Secretary.
    ``(d) Compensation; Support; FACA.--
            ``(1) Compensation and travel.--Members of the Advisory 
        Committee who are not officers or employees of the United 
        States, while attending conferences or meetings of the 
        committee or otherwise engaged in its business, shall be 
        entitled to receive compensation at rates to be fixed by the 
        Secretary, which may not exceed the daily equivalent of the 
        rate in effect for level 4 of the Senior Executive Schedule 
        under section 5382 of title 5, United States Code, for each day 
        (including travel time) they are so engaged; and while so 
        serving away from their homes or regular places of business 
        each member may be allowed travel expenses, including per diem 
        in lieu of subsistence, as authorized by section 5703 of title 
        5, United States Code, for persons in the Government service 
        employed intermittently.
            ``(2) Administrative support.--The Secretary shall furnish 
        the Advisory Committee clerical and other assistance.
            ``(3) Nonapplication of faca.--Section 14 of the Federal 
        Advisory Committee Act (5 U.S.C. 
        App.) does not apply to the Advisory Committee.
    ``(e) Proceedings of Advisory Panels and Committees.--The Advisory 
Committee shall make and maintain a transcript of any proceeding of the 
panel or committee. Each such panel and committee shall delete from any 
transcript made under this subsection information which is exempt from 
disclosure under section 552(b) of title 5, United States Code.

``SEC. 919. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.

    The Secretary shall consider--
            ``(1) at the request of the applicant, designating nicotine 
        replacement products as fast track research and approval 
        products within the meaning of section 506;
            ``(2) direct the Commissioner to consider approving the 
        extended use of nicotine replacement products (such as nicotine 
        patches, nicotine gum, and nicotine lozenges) for the treatment 
        of tobacco dependence;
            ``(3) review and consider the evidence for additional 
        indications for nicotine replacement products, such as for 
        craving relief or relapse prevention; and
            ``(4) consider--
                    ``(A) relieving companies of premarket burdens 
                under section 505 if the requirement is redundant 
                considering other nicotine replacement therapies 
                already on the market; and
                    ``(B) time and extent applications for nicotine 
                replacement therapies that have been approved by a 
                regulatory body in a foreign country and have marketing 
                experience in such country.

``SEC. 920. USER FEE.

    ``(a) Establishment of Quarterly User Fee.--The Secretary shall 
assess a quarterly user fee with respect to every quarter of each 
fiscal year commencing fiscal year 2004, calculated in accordance with 
this section, upon each manufacturer and importer of tobacco products 
subject to this chapter.
    ``(b) Funding of FDA Regulation of Tobacco Products.--The Secretary 
shall make user fees collected pursuant to this section available to 
pay, in each fiscal year, for the costs of the activities of the Food 
and Drug Administration related to the regulation of tobacco products 
under this chapter.
    ``(c) Assessment of User Fee.--
            ``(1) Amount of assessment.--Except as provided in 
        paragraph (4), the total user fees assessed each year pursuant 
        to this section shall be sufficient, and shall not exceed what 
        is necessary, to pay for the costs of the activities described 
        in subsection (b) for each fiscal year.
            ``(2) Allocation of assessment by class of tobacco 
        products.--
                    ``(A) In general.--Subject to paragraph (3), the 
                total user fees assessed each fiscal year with respect 
                to each class of importers and manufacturers shall be 
                equal to an amount that is the applicable percentage of 
                the total costs of activities of the Food and Drug 
                Administration described in subsection (b).
                    ``(B) Applicable percentage.--For purposes of 
                subparagraph (A) the applicable percentage for a fiscal 
                year shall be the following:
                            ``(i) 92.07 percent shall be assessed on 
                        manufacturers and importers of cigarettes;
                            ``(ii) 0.05 percent shall be assessed on 
                        manufacturers and importers of little cigars;
                            ``(iii) 7.15 percent shall be assessed on 
                        manufacturers and importers of cigars other 
                        than little cigars;
                            ``(iv) 0.43 percent shall be assessed on 
                        manufacturers and importers of snuff;
                            ``(v) 0.10 percent shall be assessed on 
                        manufacturers and importers of chewing tobacco;
                            ``(vi) 0.06 percent shall be assessed on 
                        manufacturers and importers of pipe tobacco; 
                        and
                            ``(vii) 0.14 percent shall be assessed on 
                        manufacturers and importers of roll-your-own 
                        tobacco.
            ``(3) Distribution of fee shares of manufacturers and 
        importers exempt from user fee.--Where a class of tobacco 
        products is not subject to a user fee under this section, the 
        portion of the user fee assigned to such class under subsection 
        (d)(2) shall be allocated by the Secretary on a pro rata basis 
        among the classes of tobacco products that are subject to a 
        user fee under this section. Such pro rata allocation for each 
        class of tobacco products that are subject to a user fee under 
        this section shall be the quotient of--
                    ``(A) the sum of the percentages assigned to all 
                classes of tobacco products subject to this section; 
                divided by
                    ``(B) the percentage assigned to such class under 
                paragraph (2).
            ``(4) Annual limit on assessment.--The total assessment 
        under this section--
                    ``(A) for fiscal year 2004 shall be $85,000,000;
                    ``(B) for fiscal year 2005 shall be $175,000,000;
                    ``(C) for fiscal year 2006 shall be $300,000,000; 
                and
                    ``(D) for each subsequent fiscal year, shall not 
                exceed the limit on the assessment imposed during the 
                previous fiscal year, as adjusted by the Secretary 
                (after notice, published in the Federal Register) to 
                reflect the greater of--
                            ``(i) the total percentage change that 
                        occurred in the Consumer Price Index for all 
                        urban consumers (all items; United States city 
                        average) for the 12-month period ending on June 
                        30 of the preceding fiscal year for which fees 
                        are being established; or
                            ``(ii) the total percentage change for the 
                        previous fiscal year in basic pay under the 
                        General Schedule in accordance with section 
                        5332 of title 5, United States Code, as 
                        adjusted by any locality-based comparability 
                        payment pursuant to section 5304 of such title 
                        for Federal employees stationed in the District 
                        of Columbia.
            ``(5) Timing of user fee assessment.--The Secretary shall 
        notify each manufacturer and importer of tobacco products 
        subject to this section of the amount of the quarterly 
        assessment imposed on such manufacturer or importer under 
        subsection (f) during each quarter of each fiscal year. Such 
        notifications shall occur not earlier than 3 months prior to 
        the end of the quarter for which such assessment is made, and 
        payments of all assessments shall be made not later than 60 
        days after each such notification.
    ``(d) Determination of User Fee by Company Market Share.--
            ``(1) In general.--The user fee to be paid by each 
        manufacturer or importer of a given class of tobacco products 
        shall be determined in each quarter by multiplying--
                    ``(A) such manufacturer's or importer's market 
                share of such class of tobacco products; by
                    ``(B) the portion of the user fee amount for the 
                current quarter to be assessed on manufacturers and 
                importers of such class of tobacco products as 
                determined under subsection (e).
            ``(2) No fee in excess of market share.--No manufacturer or 
        importer of tobacco products shall be required to pay a user 
        fee in excess of the market share of such manufacturer or 
        importer.
    ``(e) Determination of Volume of Domestic Sales.--
            ``(1) In general.--The calculation of gross domestic volume 
        of a class of tobacco product by a manufacturer or importer, 
        and by all manufacturers and importers as a group, shall be 
        made by the Secretary using information provided by 
        manufacturers and importers pursuant to subsection (f), as well 
        as any other relevant information provided to or obtained by 
        the Secretary.
            ``(2) Measurement.--For purposes of the calculations under 
        this subsection and the information provided under subsection 
        (f) by the Secretary, gross domestic volume shall be measured 
        by--
                    ``(A) in the case of cigarettes, the number of 
                cigarettes sold;
                    ``(B) in the case of little cigars, the number of 
                little cigars sold;
                    ``(C) in the case of large cigars, the number of 
                cigars weighing more than 3 pounds per thousand sold; 
                and
                    ``(D) in the case of other classes of tobacco 
                products, in terms of number of pounds, or fraction 
                thereof, of these products sold.
    ``(f) Measurement of Gross Domestic Volume.--
            ``(1) In general.--Each manufacturer and importer of 
        tobacco products shall submit to the Secretary a certified copy 
        of each of the returns or forms described by this paragraph 
        that are required to be filed with a Government agency on the 
        same date that those returns or forms are filed, or required to 
        be filed, with such agency. The returns and forms described by 
        this paragraph are those returns and forms related to the 
        release of tobacco products into domestic commerce, as defined 
        by section 5702(k) of the Internal Revenue Code of 1986, and 
        the repayment of the taxes imposed under chapter 52 of such 
        Code (ATF Form 500.24 and United States Customs Form 7501 under 
        currently applicable regulations).
            ``(2) Penalties.--Any person that knowingly fails to 
        provide information required under this subsection or that 
        provides false information under this subsection shall be 
        subject to the penalties described in section 1003 of title 18, 
        United States Code. In addition, such person may be subject to 
        a civil penalty in an amount not to exceed 2 percent of the 
        value of the kind of tobacco products manufactured or imported 
        by such person during the applicable quarter, as determined by 
        the Secretary.
    ``(h) Effective Date.--The user fees prescribed by this section 
shall be assessed in fiscal year 2004, based on domestic sales of 
tobacco products during fiscal year 2003 and shall be assessed in each 
fiscal year thereafter.''.

SEC. 102. INTERIM FINAL RULE.

    (a) Cigarettes and Smokeless Tobacco.--
            (1) In general.--Not later than 30 days after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall publish in the Federal Register an interim final 
        rule regarding cigarettes and smokeless tobacco, which is 
        hereby deemed to be in compliance with the Administrative 
        Procedures Act and other applicable law.
            (2) Contents of rule.--Except as provided in this 
        subsection, the interim final rule published under paragraph 
        (1), shall be identical in its provisions to part 897 of the 
        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). Such rule shall--
                    (A) provide for the designation of jurisdictional 
                authority that is in accordance with this subsection;
                    (B) strike Subpart C--Labeling and section 
                897.32(c); and
                    (C) become effective not later than 1 year after 
                the date of enactment of this Act.
            (3) Amendments to rule.--Prior to making amendments to the 
        rule published under paragraph (1), the Secretary shall 
        promulgate a proposed rule in accordance with the 
        Administrative Procedures Act.
            (4) Rule of construction.--Except as provided in paragraph 
        (3), nothing in this section shall be construed to limit the 
        authority of the Secretary to amend, in accordance with the 
        Administrative Procedures Act, the regulation promulgated 
        pursuant to this section.
    (b) Limitation on Advisory Opinions.--As of the date of enactment 
of this Act, the following documents issued by the Food and Drug 
Administration shall not constitute advisory opinions under section 
10.85(d)(1) of title 21, Code of Federal Regulations, except as they 
apply to tobacco products, and shall not be cited by the Secretary of 
Health and Human Services or the Food and Drug Administration as 
binding precedent:
            (1) The preamble to the proposed rule in the document 
        entitled ``Regulations Restricting the Sale and Distribution of 
        Cigarettes and Smokeless Tobacco Products to Protect Children 
        and Adolescents'' (60 Fed. Reg. 41314-41372 (August 11, 1995)).
            (2) The document entitled ``Nicotine in Cigarettes and 
        Smokeless Tobacco Products is a Drug and These Products Are 
        Nicotine Delivery Devices Under the Federal Food, Drug, and 
        Cosmetic Act'' (60 Fed. Reg. 41453-41787 (August 11, 1995)).
            (3) The preamble to the final rule in the document entitled 
        ``Regulations Restricting the Sale and Distribution of 
        Cigarettes and Smokeless Tobacco to Protect Children and 
        Adolescents'' (61 Fed. Reg. 44396-44615 (August 28, 1996)).
            (4) The document entitled ``Nicotine in Cigarettes and 
        Smokeless Tobacco is a Drug and These Products are Nicotine 
        Delivery Devices Under the Federal Food, Drug, and Cosmetic 
        Act; Jurisdictional Determination'' (61 Fed. Reg. 44619-45318 
        (August 28, 1996)).

SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL PROVISIONS.

    (a) Amendment of Federal Food, Drug, and Cosmetic Act.--Except as 
otherwise expressly provided, whenever in this section an amendment is 
expressed in terms of an amendment to, or repeal of, a section or other 
provision, the reference is to a section or other provision of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
    (b) Section 301.--Section 301 (21 U.S.C. 331) is amended--
            (1) in subsection (a), by inserting ``tobacco product,'' 
        after ``device,'';
            (2) in subsection (b), by inserting ``tobacco product,'' 
        after ``device,'';
            (3) in subsection (c), by inserting ``tobacco product,'' 
        after ``device,'';
            (4) in subsection (e), by striking ``515(f), or 519'' and 
        inserting ``515(f), 519, or 909'';
            (5) in subsection (g), by inserting ``tobacco product,'' 
        after ``device,'';
            (6) in subsection (h), by inserting ``tobacco product,'' 
        after ``device,'';
            (7) in subsection (j), by striking ``708, or 721'' and 
        inserting ``708, 721, 904, 905, 906, 907, 908, 909, or section 
        921(b)'';
            (8) in subsection (k), by inserting ``tobacco product,'' 
        after ``device,'';
            (9) by striking subsection (p) and inserting the following:
    ``(p) The failure to register in accordance with section 510 or 
905, the failure to provide any information required by section 510(j), 
510(k), 905(i), or 905(j), or the failure to provide a notice required 
by section 510(j)(2) or 905(i)(2).'';
            (10) by striking subsection (q)(1) and inserting the 
        following:
    ``(q)(1) The failure or refusal--
            ``(A) to comply with any requirement prescribed under 
        section 518, 520(g), 903(b)(8), or 908, or condition prescribed 
        under section 903(b)(6)(B)(ii)(II);
            ``(B) to furnish any notification or other material or 
        information required by or under section 519, 520(g), 904, 909, 
        or section 921; or
            ``(C) to comply with a requirement under section 522 or 
        913.'';
            (11) in subsection (q)(2), by striking ``device,'' and 
        inserting ``device or tobacco product,'';
            (12) in subsection (r), by inserting ``or tobacco product'' 
        after ``device'' each time that it appears; and
            (13) by adding at the end the following:
            ``(aa) The sale of tobacco products in violation of a no-
        tobacco-sale order issued under section 303(f).
            ``(bb) The introduction or delivery for introduction into 
        interstate commerce of a tobacco product in violation of 
        section 911.
            ``(cc)(1) Forging, counterfeiting, simulating, or falsely 
        representing, or without proper authority using any mark, stamp 
        (including tax stamp), tag, label, or other identification 
        device upon any tobacco product or container or labeling 
        thereof so as to render such tobacco product a counterfeit 
        tobacco product.
            ``(2) Making, selling, disposing of, or keeping in 
        possession, control, or custody, or concealing any punch, die, 
        plate, stone, or other item that is designed to print, imprint, 
        or reproduce the trademark, trade name, or other identifying 
        mark, imprint, or device of another or any likeness of any of 
        the foregoing upon any tobacco product or container or labeling 
        thereof so as to render such tobacco product a counterfeit 
        tobacco product.
            ``(3) The doing of any act that causes a tobacco product to 
        be a counterfeit tobacco product, or the sale or dispensing, or 
        the holding for sale or dispensing, of a counterfeit tobacco 
        product.
            ``(dd) The charitable distribution of tobacco products.
            ``(ee) The failure of a manufacturer or distributor to 
        notify the Attorney General of their knowledge of tobacco 
        products used in illicit trade.''.
    (c) Section 303.--Section 303 (21 U.S.C. 333(f)) is amended in 
subsection (f)--
            (1) by striking the subsection heading and inserting the 
        following:
    ``(f) Civil Penalties; No-Tobacco-Sale Orders.--'';
            (2) in paragraph (1)(A), by inserting ``or tobacco 
        products'' after ``devices'';
            (3) by redesignating paragraphs (3), (4), and (5) as 
        paragraphs (4), (5), and (6), and inserting after paragraph (2) 
        the following:
            ``(3) If the Secretary finds that a person has committed 
        repeated violations of restrictions promulgated under section 
        906(d) at a particular retail outlet then the Secretary may 
        impose a no-tobacco-sale order on that person prohibiting the 
        sale of tobacco products in that outlet. A no-tobacco-sale 
        order may be imposed with a civil penalty under paragraph 
        (1).'';
            (4) in paragraph (4) as so redesignated--
                    (A) in subparagraph (A)--
                            (i) by striking ``assessed'' the first time 
                        it appears and inserting ``assessed, or a no-
                        tobacco-sale order may be imposed,''; and
                            (ii) by striking ``penalty'' and inserting 
                        ``penalty, or upon whom a no-tobacco-order is 
                        to be imposed,'';
                    (B) in subparagraph (B)--
                            (i) by inserting after ``penalty,'' the 
                        following: ``or the period to be covered by a 
                        no-tobacco-sale order,''; and
                            (ii) by adding at the end the following: 
                        ``A no-tobacco-sale order permanently 
                        prohibiting an individual retail outlet from 
                        selling tobacco products shall include 
                        provisions that allow the outlet, after a 
                        specified period of time, to request that the 
                        Secretary compromise, modify, or terminate the 
                        order.''; and
                    (C) by adding at the end, the following:
                    ``(D) The Secretary may compromise, modify, or 
                terminate, with or without conditions, any no-tobacco-
                sale order.'';
            (5) in paragraph (5) as so redesignated--
                    (A) by striking ``(3)(A)'' as redesignated, and 
                inserting ``(4)(A)'';
                    (B) by inserting ``or the imposition of a no-
                tobacco-sale order'' after ``penalty'' the first 2 
                places it appears; and
                    (C) by striking ``issued.'' and inserting ``issued, 
                or on which the no-tobacco-sale order was imposed, as 
                the case may be.''; and
            (6) in paragraph (6), as so redesignated, by striking 
        ``paragraph (4)'' each place it appears and inserting 
        ``paragraph (5)''.
    (d) Section 304.--Section 304 (21 U.S.C. 334) is amended--
            (1) in subsection (a)(2)--
                    (A) by striking ``and'' before ``(D)''; and
                    (B) by striking ``device.'' and inserting the 
                following: ``, (E) Any adulterated or misbranded 
                tobacco product.'';
            (2) in subsection (d)(1), by inserting ``tobacco product,'' 
        after ``device,'';
            (3) in subsection (g)(1), by inserting ``or tobacco 
        product'' after ``device'' each place it appears; and
            (4) in subsection (g)(2)(A), by inserting ``or tobacco 
        product'' after ``device'' each place it appears.
    (e) Section 702.--Section 702(a) (21 U.S.C. 372(a)) is amended--
            (1) by inserting ``(1)'' after ``(a)''; and
            (2) by adding at the end thereof the following:
    ``(2) For a tobacco product, to the extent feasible, the Secretary 
shall contract with the States in accordance with paragraph (1) to 
carry out inspections of retailers in connection with the enforcement 
of this Act.''.
    (f) Section 703.--Section 703 (21 U.S.C. 373) is amended--
            (1) by inserting ``tobacco product,'' after ``device,'' 
        each place it appears; and
            (2) by inserting ``tobacco products,'' after ``devices,'' 
        each place it appears.
    (g) Section 704.--Section 704 (21 U.S.C. 374) is amended--
            (1) in subsection (a)(1)(A), by inserting ``tobacco 
        products,'' after ``devices,'' each place it appears;
            (2) in subsection (a)(1)(B), by inserting ``or tobacco 
        product'' after ``restricted devices'' each place it appears; 
        and
            (3) in subsection (b), by inserting ``tobacco product,'' 
        after ``device,''.
    (h) Section 705.--Section 705(b) (21 U.S.C. 375(b)) is amended by 
inserting ``tobacco products,'' after ``devices,''.
    (i) Section 709.--Section 709 (21 U.S.C. 379) is amended by 
inserting ``or tobacco product'' after ``device''.
    (j) Section 801.--Section 801 (21 U.S.C. 381) is amended--
            (1) in subsection (a)--
                    (A) by inserting ``tobacco products,'' after 
                ``devices,'' the first time it appears;
                    (B) by inserting ``or section 905(j)'' after 
                ``section 510''; and
                    (C) by striking ``drugs or devices'' each time it 
                appears and inserting ``drugs, devices, or tobacco 
                products'';
            (2) in subsection (e)(1), by inserting ``tobacco product,'' 
        after ``device,''; and
            (3) by adding at the end the following:
    ``(p)(1) Not later than 2 years after the date of enactment of the 
Family Smoking Prevention and Tobacco Control Act, and annually 
thereafter, the Secretary shall submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives, a report 
regarding--
            ``(A) the nature, extent, and destination of United States 
        tobacco product exports that do not conform to tobacco product 
        standards established pursuant to this Act;
            ``(B) the public health implications of such exports, 
        including any evidence of a negative public health impact; and
            ``(C) recommendations or assessments of policy alternatives 
        available to Congress and the Executive Branch to reduce any 
        negative public health impact caused by such exports.
    ``(2) The Secretary is authorized to establish appropriate 
information disclosure requirements to carry out this subsection.''.
    (k) Section 1003.--Section 1003(d)(2)(C) (as redesignated by 
section 101(a)) is amended--
            (1) by striking ``and'' after ``cosmetics,''; and
            (2) inserting a comma and ``and tobacco products'' after 
        ``devices''.
    (l) Effective Date for No-Tobacco-Sale Order Amendments.--The 
amendments made by subsection (c), other than the amendment made by 
paragraph (2) of such subsection, shall take effect upon the issuance 
of guidance by the Secretary of Health and Human Services--
            (1) defining the term ``repeated violation'', as used in 
        section 303(f) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 333(f)) as amended by subsection (c), by identifying the 
        number of violations of particular requirements over a 
        specified period of time at a particular retail outlet that 
        constitute a repeated violation;
            (2) providing for timely and effective notice to the 
        retailer of each alleged violation at a particular retail 
        outlet and an expedited procedure for the administrative appeal 
        of an alleged violation;
            (3) providing that a person may not be charged with a 
        violation at a particular retail outlet unless the Secretary 
        has provided notice to the retailer of all previous violations 
        at that outlet;
            (4) establishing a period of time during which, if there 
        are no violations by a particular retail outlet, that outlet 
        will not be considered to have been the site of repeated 
        violations when the next violation occurs; and
            (5) providing that good faith reliance on the presentation 
        of a false government issued photographic identification that 
        contains the bearer's date of birth does not constitute a 
        violation of any minimum age requirement for the sale of 
        tobacco products if the retailer has taken effective steps to 
        prevent such violations, including--
                    (A) adopting and enforcing a written policy against 
                sales to minors;
                    (B) informing its employees of all applicable laws;
                    (C) establishing disciplinary sanctions for 
                employee noncompliance; and
                    (D) requiring its employees to verify age by way of 
                photographic identification or electronic scanning 
                device.

 TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT 
                               DISCLOSURE

SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.

    Section 4 of the Federal Cigarette Labeling and Advertising Act (15 
U.S.C. 1333) is amended to read as follows:

``SEC. 4. LABELING.

    ``(a) Label Requirements.--
            ``(1) In general.--It shall be unlawful for any person to 
        manufacture, package, sell, offer to sell, distribute, or 
        import for sale or distribution within the United States any 
        cigarettes the package of which fails to bear, in accordance 
        with the requirements of this section, one of the following 
        labels:
        `WARNING: Cigarettes are addictive'.
        `WARNING: Tobacco smoke can harm your children'.
        `WARNING: Cigarettes cause fatal lung disease'.
        `WARNING: Cigarettes cause cancer'.
        `WARNING: Cigarettes cause strokes and heart disease'.
        `WARNING: Smoking during pregnancy can harm your baby'.
        `WARNING: Smoking can kill you'.
        `WARNING: Tobacco smoke causes fatal lung disease in non-
        smokers'.
        `WARNING: Quitting smoking now greatly reduces serious risks to 
        your health'.
            ``(2) Placement; typography; etc.--
                    ``(A) In general.--Each label statement required by 
                paragraph (1) shall be located in the upper portion of 
                the front and rear panels of the package, directly on 
                the package underneath the cellophane or other clear 
                wrapping. Except as provided in subparagraph (B), each 
                label statement shall comprise at least the top 30 
                percent of the front and rear panels of the package. 
                The word `WARNING' shall appear in capital letters and 
                all text shall be in conspicuous and legible 17-point 
                type, unless the text of the label statement would 
                occupy more than 70 percent of such area, in which case 
                the text may be in a smaller conspicuous and legible 
                type size, provided that at least 60 percent of such 
                area is occupied by required text. The text shall be 
                black on a white background, or white on a black 
                background, in a manner that contrasts, by typography, 
                layout, or color, with all other printed material on 
                the package, in an alternating fashion under the plan 
                submitted under subsection (b)(4).
                    ``(B) Flip-top boxes.--For any cigarette brand 
                package manufactured or distributed before January 1, 
                2000, which employs a flip-top style (if such packaging 
                was used for that brand in commerce prior to June 21, 
                1997), the label statement required by paragraph (1) 
                shall be located on the flip-top area of the package, 
                even if such area is less than 25 percent of the area 
                of the front panel. Except as provided in this 
                paragraph, the provisions of this subsection shall 
                apply to such packages.
            ``(3) Does not apply to foreign distribution.--The 
        provisions of this subsection do not apply to a tobacco product 
        manufacturer or distributor of cigarettes which does not 
        manufacture, package, or import cigarettes for sale or 
        distribution within the United States.
            ``(4) Applicability to retailers.--A retailer of cigarettes 
        shall not be in violation of this subsection for packaging that 
        is supplied to the retailer by a tobacco product manufacturer, 
        importer, or distributor and is not altered by the retailer in 
        a way that is material to the requirements of this subsection 
        except that this paragraph shall not relieve a retailer of 
        liability if the retailer sells or distributes tobacco products 
        that are not labeled in accordance with this subsection.
    ``(b) Advertising Requirements.--
            ``(1) In general.--It shall be unlawful for any tobacco 
        product manufacturer, importer, distributor, or retailer of 
        cigarettes to advertise or cause to be advertised within the 
        United States any cigarette unless its advertising bears, in 
        accordance with the requirements of this section, one of the 
        labels specified in subsection (a) of this section.
            ``(2) Typography, etc.--Each label statement required by 
        subsection (a) of this section in cigarette advertising shall 
        comply with the standards set forth in this paragraph. For 
        press and poster advertisements, each such statement and (where 
        applicable) any required statement relating to tar, nicotine, 
        or other constituent (including a smoke constituent) yield 
        shall comprise at least 20 percent of the area of the 
        advertisement and shall appear in a conspicuous and prominent 
        format and location at the top of each advertisement within the 
        trim area. The Secretary may revise the required type sizes in 
        such area in such manner as the Secretary determines 
        appropriate. The word `WARNING' shall appear in capital 
        letters, and each label statement shall appear in conspicuous 
        and legible type. The text of the label statement shall be 
        black if the background is white and white if the background is 
        black, under the plan submitted under paragraph (4) of this 
        subsection. The label statements shall be enclosed by a 
        rectangular border that is the same color as the letters of the 
        statements and that is the width of the first downstroke of the 
        capital `W' of the word `WARNING' in the label statements. The 
        text of such label statements shall be in a typeface pro rata 
        to the following requirements: 45-point type for a whole-page 
        broadsheet newspaper advertisement; 39-point type for a half-
        page broadsheet newspaper advertisement; 39-point type for a 
        whole-page tabloid newspaper advertisement; 27-point type for a 
        half-page tabloid newspaper advertisement; 31.5-point type for 
        a double page spread magazine or whole-page 
magazine advertisement; 22.5-point type for a 28 centimeter by 3 column 
advertisement; and 15-point type for a 20 centimeter by 2 column 
advertisement. The label statements shall be in English, except that in 
the case of--
                    ``(A) an advertisement that appears in a newspaper, 
                magazine, periodical, or other publication that is not 
                in English, the statements shall appear in the 
                predominant language of the publication; and
                    ``(B) in the case of any other advertisement that 
                is not in English, the statements shall appear in the 
                same language as that principally used in the 
                advertisement.
            ``(3) Matchbooks.--Notwithstanding paragraph (2), for 
        matchbooks (defined as containing not more than 20 matches) 
        customarily given away with the purchase of tobacco products, 
        each label statement required by subsection (a) may be printed 
        on the inside cover of the matchbook.
            ``(4) Adjustment by secretary.--The Secretary may, through 
        a rulemaking under section 553 of title 5, United States Code, 
        adjust the format and type sizes for the label statements 
        required by this section or the text, format, and type sizes of 
        any required tar, nicotine yield, or other constituent 
        (including smoke constituent) disclosures, or to establish the 
        text, format, and type sizes for any other disclosures required 
        under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
        et. seq.). The text of any such label statements or disclosures 
        shall be required to appear only within the 20 percent area of 
        cigarette advertisements provided by paragraph (2) of this 
        subsection. The Secretary shall promulgate regulations which 
        provide for adjustments in the format and type sizes of any 
        text required to appear in such area to ensure that the total 
        text required to appear by law will fit within such area.
            ``(5) Marketing requirements.--
                    ``(A) The label statements specified in subsection 
                (a)(1) shall be randomly displayed in each 12-month 
                period, in as equal a number of times as is possible on 
                each brand of the product and be randomly distributed 
                in all areas of the United States in which the product 
                is marketed in accordance with a plan submitted by the 
                tobacco product manufacturer, importer, distributor, or 
                retailer and approved by the Secretary.
                    ``(B) The label statements specified in subsection 
                (a)(1) shall be rotated quarterly in alternating 
                sequence in advertisements for each brand of cigarettes 
                in accordance with a plan submitted by the tobacco 
                product manufacturer, importer, distributor, or 
retailer to, and approved by, the Secretary.
                    ``(C) The Secretary shall review each plan 
                submitted under subparagraph (B) and approve it if the 
                plan--
                            ``(i) will provide for the equal 
                        distribution and display on packaging and the 
                        rotation required in advertising under this 
                        subsection; and
                            ``(ii) assures that all of the labels 
                        required under this section will be displayed 
                        by the tobacco product manufacturer, importer, 
                        distributor, or retailer at the same time.
            ``(6) Applicability to retailers.--This subsection applies 
        to a retailer only if that retailer is responsible for or 
        directs the label statements required under this section except 
        that this paragraph shall not relieve a retailer of liability 
        if the retailer displays, in a location open to the public, an 
        advertisement that is not labeled in accordance with the 
        requirements of this subsection.''.

SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING LABEL STATEMENTS.

    Section 4 of the Federal Cigarette Labeling and Advertising Act (15 
U.S.C. 1333), as amended by section 201, is further amended by adding 
at the end the following:
    ``(c) Change in Required Statements.--The Secretary may, by a 
rulemaking conducted under section 553 of title 5, United States Code, 
adjust the format, type size, and text of any of the label 
requirements, require color graphics to accompany the text, increase 
the required label area from 30 percent up to 50 percent of the front 
and rear panels of the package, or establish the format, type size, and 
text of any other disclosures required under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary finds that 
such a change would promote greater public understanding of the risks 
associated with the use of tobacco products.''.

SEC. 203. STATE REGULATION OF CIGARETTE ADVERTISING AND PROMOTION.

    Section 5 of the Federal Cigarette Labeling and Advertising Act (15 
U.S.C. 1334) is amended by adding at the end the following:
    ``(c) Exception.--Notwithstanding subsection (b), a State or 
locality may enact statutes and promulgate regulations, based on 
smoking and health, that take effect after the effective date of the 
Family Smoking Prevention and Tobacco Control Act, imposing specific 
bans or restrictions on the time, place, and manner, but not content, 
of the advertising or promotion of any cigarettes.''.

SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING WARNINGS.

    Section 3 of the Comprehensive Smokeless Tobacco Health Education 
Act of 1986 (15 U.S.C. 4402) is amended to read as follows:

``SEC. 3. SMOKELESS TOBACCO WARNING.

    ``(a) General Rule.--
            ``(1) It shall be unlawful for any person to manufacture, 
        package, sell, offer to sell, distribute, or import for sale or 
        distribution within the United States any smokeless tobacco 
        product unless the product package bears, in accordance with 
        the requirements of this Act, one of the following labels:
        `WARNING: This product can cause mouth cancer'.
        `WARNING: This product can cause gum disease and tooth loss'.
        `WARNING: This product is not a safe alternative to 
        cigarettes'.
        `WARNING: Smokeless tobacco is addictive'.
            ``(2) Each label statement required by paragraph (1) shall 
        be--
                    ``(A) located on the 2 principal display panels of 
                the package, and each label statement shall comprise at 
                least 30 percent of each such display panel; and
                    ``(B) in 17-point conspicuous and legible type and 
                in black text on a white background, or white text on a 
                black background, in a manner that contrasts by 
                typography, layout, or color, with all other printed 
                material on the package, in an alternating fashion 
                under the plan submitted under subsection (b)(3), 
                except that if the text of a label statement would 
                occupy more than 70 percent of the area specified by 
                subparagraph (A), such text may appear in a smaller 
                type size, so long as at least 60 percent of such 
                warning area is occupied by the label statement.
            ``(3) The label statements required by paragraph (1) shall 
        be introduced by each tobacco product manufacturer, packager, 
        importer, distributor, or retailer of smokeless tobacco 
        products concurrently into the distribution chain of such 
        products.
            ``(4) The provisions of this subsection do not apply to a 
        tobacco product manufacturer or distributor of any smokeless 
        tobacco product that does not manufacture, package, or import 
        smokeless tobacco products for sale or distribution within the 
        United States.
            ``(5) A retailer of smokeless tobacco products shall not be 
        in violation of this subsection for packaging that is supplied 
        to the retailer by a tobacco products manufacturer, importer, 
        or distributor and that is not altered by the retailer unless 
        the retailer offers for sale, sells, or distributes a smokeless 
        tobacco product that is not labeled in accordance with this 
        subsection.
    ``(b) Required Labels.--
            ``(1) It shall be unlawful for any tobacco product 
        manufacturer, packager, importer, distributor, or retailer of 
        smokeless tobacco products to advertise or cause to be 
        advertised within the United States any smokeless tobacco 
        product unless its advertising bears, in accordance with the 
        requirements of this section, one of the labels specified in 
        subsection (a).
            ``(2) Each label statement required by subsection (a) in 
        smokeless tobacco advertising shall comply with the standards 
        set forth in this paragraph. For press and poster 
        advertisements, each such statement and (where applicable) any 
        required statement relating to tar, nicotine, or other 
        constituent yield shall--
                    ``(A) comprise at least 20 percent of the area of 
                the advertisement, and the warning area shall be 
                delineated by a dividing line of contrasting color from 
                the advertisement; and
                    ``(B) the word `WARNING' shall appear in capital 
                letters and each label statement shall appear in 
                conspicuous and legible type. The text of the label 
                statement shall be black on a white background, or 
                white on a black background, in an alternating fashion 
                under the plan submitted under paragraph (3).
            ``(3)(A) The label statements specified in subsection 
        (a)(1) shall be randomly displayed in each 12-month period, in 
        as equal a number of times as is possible on each brand of the 
        product and be randomly distributed in all areas of the United 
        States in which the product is marketed in accordance with a 
        plan submitted by the tobacco product manufacturer, importer, 
        distributor, or retailer and approved by the Secretary.
            ``(B) The label statements specified in subsection (a)(1) 
        shall be rotated quarterly in alternating sequence in 
        advertisements for each brand of smokeless tobacco product in 
        accordance with a plan submitted by the tobacco product 
        manufacturer, importer, distributor, or retailer to, and 
        approved by, the Secretary.
            ``(C) The Secretary shall review each plan submitted under 
        subparagraph (B) and approve it if the plan--
                    ``(i) will provide for the equal distribution and 
                display on packaging and the rotation required in 
                advertising under this subsection; and
                    ``(ii) assures that all of the labels required 
                under this section will be displayed by the tobacco 
                product manufacturer, importer, distributor, or 
                retailer at the same time.
            ``(D) This paragraph applies to a retailer only if that 
        retailer is responsible for or directs the label statements 
        under this section, unless the retailer displays in a location 
        open to the public, an advertisement that is not labeled in 
        accordance with the requirements of this subsection.
    ``(c) Television and Radio Advertising.--It is unlawful to 
advertise smokeless tobacco on any medium of electronic communications 
subject to the jurisdiction of the Federal Communications 
Commission.''.

SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT WARNING LABEL 
              STATEMENTS.

    Section 3 of the Comprehensive Smokeless Tobacco Health Education 
Act of 1986 (15 U.S.C. 4402), as amended by section 203, is further 
amended by adding at the end the following:
    ``(d) Authority To Revise Warning Label Statements.--The Secretary 
may, by a rulemaking conducted under section 553 of title 5, United 
States Code, adjust the format, type size, and text of any of the label 
requirements, require color graphics to accompany the text, increase 
the required label area from 30 percent up to 50 percent of the front 
and rear panels of the package, or establish the format, type size, and 
text of any other disclosures required under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary finds that 
such a change would promote greater public understanding of the risks 
associated with the use of smokeless tobacco products.''.

SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT DISCLOSURE TO THE 
              PUBLIC.

    Section 4(a) of the Federal Cigarette Labeling and Advertising Act 
(15 U.S.C. 1333 (a)), as amended by section 201, is further amended by 
adding at the end the following:
            ``(4)(A) The Secretary shall, by a rulemaking conducted 
        under section 553 of title 5, United States Code, determine (in 
        the Secretary's sole discretion) whether cigarette and other 
        tobacco product manufacturers shall be required to include in 
        the area of each cigarette advertisement specified by 
        subsection (b) of this section, or on the package label, or 
        both, the tar and nicotine yields of the advertised or packaged 
        brand. Any such disclosure shall be in accordance with the 
        methodology established under such regulations, shall conform 
        to the type size requirements of subsection (b) of this 
        section, and shall appear within the area specified in 
        subsection (b) of this section.
            ``(B) Any differences between the requirements established 
        by the Secretary under subparagraph (A) and tar and nicotine 
        yield reporting requirements established by the Federal Trade 
        Commission shall be resolved by a memorandum of understanding 
        between the Secretary and the Federal Trade Commission.
            ``(C) In addition to the disclosures required by 
        subparagraph (A) of this paragraph, the Secretary may, under a 
        rulemaking conducted under section 553 of title 5, United 
        States Code, prescribe disclosure requirements regarding the 
        level of any cigarette or other tobacco product constituent 
        including any smoke constituent. Any such disclosure may be 
        required if the Secretary determines that disclosure would be 
        of benefit to the public health, or otherwise would increase 
        consumer awareness of the health consequences of the use of 
        tobacco products, except that no such prescribed disclosure 
        shall be required on the face of any cigarette package or 
        advertisement. Nothing in this section shall prohibit the 
        Secretary from requiring such prescribed disclosure through a 
        cigarette or other tobacco product package or advertisement 
        insert, or by any other means under the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 301 et seq.).
            ``(D) This paragraph applies to a retailer only if that 
        retailer is responsible for or directs the label statements 
        required under this section, except that this paragraph shall 
        not relieve a retailer of liability if the retailer sells or 
        distributes tobacco products that are not labeled in accordance 
        with the requirements of this subsection.''.

       TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS

SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPECTION.

    Chapter IX of the Federal Food, Drug, and Cosmetic Act, as added by 
section 101, is further amended by adding at the end the following:

``SEC. 921. LABELING, RECORDKEEPING, RECORDS INSPECTION.

    ``(a) Origin Labeling.--The label, packaging, and shipping 
containers of tobacco products for introduction or delivery for 
introduction into interstate commerce shall bear the statement `sale 
only allowed in the United States.'
    ``(b) Regulations Concerning Recordkeeping for Tracking and 
Tracing.--
            ``(1) In general.--Not later than 9 months after the date 
        of enactment of the Family Smoking Prevention and Tobacco 
        Control Act, the Secretary shall promulgate regulations 
        regarding the establishment and maintenance of records by any 
        person who manufactures, processes, transports, distributes, 
        receives, packages, holds, exports, or imports tobacco 
        products.
            ``(2) Inspection.--In promulgating the regulations 
        described in paragraph (1), the Secretary shall consider which 
        records are needed for inspection to monitor the movement of 
        tobacco products from the point of manufacture through 
        distribution to retail outlets to assist in investigating 
        potential illicit trade, smuggling or counterfeiting of tobacco 
        products.
            ``(3) Codes.--The Secretary may require codes on the labels 
        of tobacco products or other designs or devices for the purpose 
        of tracking or tracing the tobacco product through the 
        distribution system.
            ``(4) Size of business.--The Secretary shall take into 
        account the size of a business in promulgating regulations 
        under this section.
            ``(5) Recordkeeping by retailers.--The Secretary shall not 
        require any retailer to maintain records relating to individual 
        purchasers of tobacco products for personal consumption.
    ``(c) Records Inspection.--If the Secretary has a reasonable belief 
that a tobacco product is part of an illicit trade or smuggling or is a 
counterfeit product, each person who manufactures, processes, 
transports, distributes, receives, holds, packages, exports, or imports 
tobacco products shall, at the request of an officer or employee 
duly designated by the Secretary, permit such officer or employee, at 
reasonable times and within reasonable limits and in a reasonable 
manner, upon the presentation of appropriate credentials and a written 
notice to such person, to have access to and copy all records 
(including financial records) relating to such article that are needed 
to assist the Secretary in investigating potential illicit trade, 
smuggling or counterfeiting of tobacco products.
    ``(d) Knowledge of Illegal Transaction.--If the manufacturer or 
distributor of a tobacco product has knowledge which reasonably 
supports the conclusion that a tobacco product manufactured or 
distributed by such manufacturer or distributor that has left the 
control of such person may be or has been--
                    ``(A) imported, exported, distributed or offered 
                for sale in interstate commerce by a person without 
                paying duties or taxes required by law; or
                    ``(B) imported, exported, distributed or diverted 
                for possible illicit marketing,
the manufacturer or distributor shall promptly notify the Attorney 
General of such knowledge.
            ``(2) Knowledge defined.--For purposes of this subsection, 
        the term `knowledge' as applied to a manufacturer or 
        distributor means--
                    ``(A) the actual knowledge that the manufacturer or 
                distributor had; or
                    ``(B) the knowledge which a reasonable person would 
                have had under like circumstances or which would have 
                been obtained upon the exercise of due care.''.

SEC. 302. STUDY AND REPORT.

    (a) Study.--The Comptroller General of the United States shall 
conduct a study of cross-border trade in tobacco products to--
            (1) collect data on cross-border trade in tobacco products, 
        including illicit trade and trade of counterfeit tobacco 
        products and make recommendations on the monitoring of such 
        trade;
            (2) collect data on cross-border advertising (any 
        advertising intended to be broadcast, transmitted, or 
        distributed from the United States to another country) of 
        tobacco products and make recommendations on how to prevent or 
        eliminate, and what technologies could help facilitate the 
        elimination of, cross-border advertising.
    (b) Report.--Not later than 18 months after the date of enactment 
of this Act, the Comptroller General of the United States shall submit 
to the Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the House of 
Representatives a report on the study described in subsection (a).
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