[111th Congress Public Law 31]
[From the U.S. Government Printing Office]



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  FAMILY SMOKING PREVENTION AND TOBACCO CONTROL AND FEDERAL RETIREMENT 
                                 REFORM

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Public Law 111-31
111th Congress

                                 An Act


 
      To protect the public health by providing the Food and Drug 
 Administration with certain authority to regulate tobacco products, to 
amend title 5, United States Code, to make certain modifications in the 
   Thrift Savings Plan, the Civil Service Retirement System, and the 
          Federal Employees' Retirement System, and for other 
            purposes. <<NOTE: June 22, 2009 -  [H.R. 1256]>> 

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

DIVISION A--FAMILY <<NOTE: Family Smoking Prevention and Tobacco Control 
Act.>>  SMOKING PREVENTION AND TOBACCO CONTROL ACT
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) <<NOTE: 21 USC 301 note.>>  Short Title.--This division may be 
cited as the ``Family Smoking Prevention and Tobacco Control Act''.

    (b) Table of Contents.--The table of contents of this division is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.
Sec. 6. Modification of deadlines for Secretarial action.

         TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION

Sec. 101. Amendment of Federal Food, Drug, and Cosmetic Act.
Sec. 102. Final rule.
Sec. 103. Conforming and other amendments to general provisions.
Sec. 104. Study on raising the minimum age to purchase tobacco products.
Sec. 105. Enforcement action plan for advertising and promotion 
           restrictions.
Sec. 106. Studies of progress and effectiveness.

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

Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Authority to revise cigarette warning label statements.
Sec. 203. State regulation of cigarette advertising and promotion.
Sec. 204. Smokeless tobacco labels and advertising warnings.
Sec. 205. Authority to revise smokeless tobacco product warning label 
           statements.
Sec. 206. Tar, nicotine, and other smoke constituent disclosure to the 
           public.

       TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS

Sec. 301. Labeling, recordkeeping, records inspection.
Sec. 302. Study and report.

SEC. 2. <<NOTE: 21 USC 387 note.>>  FINDINGS.

    The Congress finds the following:

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            (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 10,000,000 of today's children from 
        becoming regular, daily smokers, saving over 3,000,000 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

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        these activities have not been successful in adequately 
        preventing such increased use.
            (16) In 2005, the cigarette manufacturers spent more than 
        $13,000,000,000 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 marketing than 
        adults: more than 80 percent of youth smoke three heavily 
        marketed brands, while only 54 percent of adults, 26 and older, 
        smoke these same 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

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        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 of, 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 division.
            (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 play 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.

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            (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 
        ensuring 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 reviewed in advance of 
        marketing, and to require that the evidence relied on to support 
        claims be fully verified.
            (44) The Food and Drug Administration is a regulatory agency 
        with the scientific expertise to identify harmful substances in 
        products to which consumers are exposed, to design standards to 
        limit exposure to those substances, to evaluate scientific 
        studies supporting claims about the safety of products, and to 
        evaluate the impact of labels, labeling, and advertising on 
        consumer behavior in order to reduce the risk of harm and 
        promote understanding of the impact of the product on health. In 
        connection with its mandate to promote health and reduce the 
        risk of harm, the Food and Drug Administration

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        routinely makes decisions about whether and how products may be 
        marketed in the United States.
            (45) The Federal Trade Commission was created to protect 
        consumers from unfair or deceptive acts or practices, and to 
        regulate unfair methods of competition. Its focus is on those 
        marketplace practices that deceive or mislead consumers, and 
        those that give some competitors an unfair advantage. Its 
        mission is to regulate activities in the marketplace. Neither 
        the Federal Trade Commission nor any other Federal agency except 
        the Food and Drug Administration possesses the scientific 
        expertise needed to implement effectively all provisions of the 
        Family Smoking Prevention and Tobacco Control Act.
            (46) If manufacturers state or imply in communications 
        directed to consumers through the media or through a label, 
        labeling, or advertising, that a tobacco product is approved or 
        inspected by the Food and Drug Administration or complies with 
        Food and Drug Administration standards, consumers are likely to 
        be confused and misled. Depending upon the particular language 
        used and its context, such a statement could result in consumers 
        being misled into believing that the product is endorsed by the 
        Food and Drug Administration for use or in consumers being 
        misled about the harmfulness of the product because of such 
        regulation, inspection, approval, or compliance.
            (47) In August 2006 a United States district court judge 
        found that the major United States cigarette companies continue 
        to target and market to youth. USA v. Philip Morris, USA, Inc., 
        et al. (Civil Action No. 99-2496 (GK), August 17, 2006).
            (48) In August 2006 a United States district court judge 
        found that the major United States cigarette companies 
        dramatically increased their advertising and promotional 
        spending in ways that encourage youth to start smoking 
        subsequent to the signing of the Master Settlement Agreement in 
        1998. USA v. Philip Morris, USA, Inc., et al. (Civil Action No. 
        99-2496 (GK), August 17, 2006).
            (49) In August 2006 a United States district court judge 
        found that the major United States cigarette companies have 
        designed their cigarettes to precisely control nicotine delivery 
        levels and provide doses of nicotine sufficient to create and 
        sustain addiction while also concealing much of their nicotine-
        related research. USA v. Philip Morris, USA, Inc., et al. (Civil 
        Action No. 99-2496 (GK), August 17, 2006).
SEC. 3. <<NOTE: 21 USC 387 note.>>  PURPOSE.

    The purposes of this division 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 as 
        provided for in this division;
            (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;

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            (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. <<NOTE: 21 USC 387 note.>>  SCOPE AND EFFECT.

    (a) Intended Effect.--Nothing in this division (or an amendment made 
by this division) 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 division (or an 
amendment made by this division) 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.
    (c) Revenue Activities.--The provisions of this division (or an 
amendment made by this division) which authorize the Secretary to take 
certain actions with regard to tobacco products shall not be construed 
to affect any authority of the Secretary of the Treasury under chapter 
52 of the Internal Revenue Code of 1986.
SEC. 5. <<NOTE: 21 USC 387 note.>>  SEVERABILITY.

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

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SEC. 6. MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION.

    (a) Delayed Commencement of Dates for Secretarial Action.--
            (1) In general.--Except as provided in subsection (c), with 
        respect to any time periods specified in this division (or in an 
        amendment made by this division) that begin on the date of 
        enactment of this Act, within which the Secretary of Health and 
        Human Services is required to carry out and complete specified 
        activities, the calculation of such time periods shall commence 
        on the date described in subsection (b).
            (2) <<NOTE: Applicability.>>  Limitation.--Subsection (a) 
        shall only apply with respect to obligations of the Secretary of 
        Health and Human Services that must be completed within a 
        specified time period and shall not apply to the obligations of 
        any other person or to any other provision of this division 
        (including the amendments made by this division) that do not 
        create such obligations of the Secretary and are not contingent 
        on actions by the Secretary.

    (b) Date Described.--The date described in this subsection is the 
first day of the first fiscal quarter following the initial 2 
consecutive fiscal quarters of fiscal year 2010 for which the Secretary 
of Health and Human Services has collected fees under section 919 of the 
Federal Food, Drug, and Cosmetic Act (as added by section 101).
    (c) Exception.--Subsection (a) shall not apply to any time period 
(or date) contained--
            (1) in section 102, except that the reference to ``180 
        days'' in subsection (a)(1) of such section shall be deemed to 
        be ``270 days''; and
            (2) in sections 201 through 204 (or the amendments made by 
        any such sections).

    (d) Adjustment.--The Secretary of Health and Human Services may 
extend or reduce the duration of one or more time periods to which 
subsection (a) applies if the Secretary determines appropriate, except 
that no such period shall be extended for more than 90 days.

         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:
    ``(rr)(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 an article that is a 
drug under subsection (g)(1), a device under subsection (h), or a 
combination product described in section 503(g).
    ``(3) The products described in paragraph (2) shall be subject to 
chapter V of this Act.

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    ``(4) A tobacco product shall not be marketed in combination with 
any other article or product regulated under this Act (including a drug, 
biologic, food, cosmetic, 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 <<NOTE: 21 USC 3913et 
        seq. 21 USC 391, 301 note, 392 and note, 393-399a.>>  as chapter 
        X;
            (2) by redesignating sections 901 through 910 as sections 
        1001 through 1010; and
            (3) by inserting after chapter VIII the following:

                     ``CHAPTER IX--TOBACCO PRODUCTS

``SEC. 900. <<NOTE: 21 USC 387.>>  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 or 
        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, packaging, logo, 
        registered trademark, brand name, identifiable pattern of 
        colors, or any combination of such attributes.
            ``(3) Cigarette.--The term `cigarette'--
                    ``(A) means a product that--
                          ``(i) is a tobacco product; and
                          ``(ii) meets the definition of the term 
                      `cigarette' in section 3(1) of the Federal 
                      Cigarette Labeling and Advertising Act; and
                    ``(B) 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 applicable to cigarettes under this chapter 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.
            ``(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

[[Page 123 STAT. 1785]]

        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 country.--The term `Indian country' has the 
        meaning given such term in section 1151 of title 18, United 
        States Code.
            ``(10) 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.
            ``(11) Little cigar.--The term `little cigar' means a 
        product that--
                    ``(A) is a tobacco product; and
                    ``(B) meets the definition of the term `little 
                cigar' in section 3(7) of the Federal Cigarette Labeling 
                and Advertising Act.
            ``(12) 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.
            ``(13) 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.
            ``(14) Retailer.--The term `retailer' means any person, 
        government, or entity who sells tobacco products to individuals 
        for personal consumption, or who operates a facility where self-
        service displays of tobacco products are permitted.
            ``(15) Roll-your-own tobacco.--The term `roll-your-own 
        tobacco' means any tobacco product 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.
            ``(16) Small tobacco product manufacturer.--The term `small 
        tobacco product manufacturer' means a tobacco product 
        manufacturer that employs fewer than 350 employees. For purposes 
        of determining the number of employees of a manufacturer under 
        the preceding sentence, the employees of a manufacturer are 
        deemed to include the employees of each entity that controls, is 
        controlled by, or is under common control with such 
        manufacturer.
            ``(17) 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.
            ``(18) 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.
            ``(19) State; territory.--The terms `State' and `Territory' 
        shall have the meanings given to such terms in section 201.

[[Page 123 STAT. 1786]]

            ``(20) Tobacco product manufacturer.--The 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 tobacco product for sale or 
                distribution in the United States.
            ``(21) Tobacco warehouse.--
                    ``(A) Subject to subparagraphs (B) and (C), the term 
                `tobacco warehouse' includes any person--
                          ``(i) who--
                                    ``(I) removes foreign material from 
                                tobacco leaf through nothing other than 
                                a mechanical process;
                                    ``(II) humidifies tobacco leaf with 
                                nothing other than potable water in the 
                                form of steam or mist; or
                                    ``(III) de-stems, dries, and packs 
                                tobacco leaf for storage and shipment;
                          ``(ii) who performs no other actions with 
                      respect to tobacco leaf; and
                          ``(iii) who provides to any manufacturer to 
                      whom the person sells tobacco all information 
                      related to the person's actions described in 
                      clause (i) that is necessary for compliance with 
                      this Act.
                    ``(B) The term `tobacco warehouse' excludes any 
                person who--
                          ``(i) reconstitutes tobacco leaf;
                          ``(ii) is a manufacturer, distributor, or 
                      retailer of a tobacco product; or
                          ``(iii) applies any chemical, additive, or 
                      substance to the tobacco leaf other than potable 
                      water in the form of steam or mist.
                    ``(C) The definition of the term `tobacco warehouse' 
                in subparagraph (A) shall not apply to the extent to 
                which the Secretary determines, through rulemaking, that 
                regulation under this chapter of the actions described 
                in such subparagraph is appropriate for the protection 
                of the public health.
            ``(22) 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 <<NOTE: Regulations. 21 USC 387a.>>  
products, including modified risk tobacco products for which an order 
has been issued in accordance with section 911, shall be regulated by 
the Secretary under this chapter and shall not be subject to the 
provisions of chapter V.

    ``(b) Applicability.--This chapter shall apply to all cigarettes, 
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco 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 in sections

[[Page 123 STAT. 1787]]

        101(a), 102, or 103 of title I, title II, or title III of the 
        Family Smoking Prevention and Tobacco Control Act, shall be 
        construed to affect, expand, or limit the Secretary's authority 
        over (including the authority to determine whether products may 
        be regulated), 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 subparagraph (A), 
                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. 
                The exception in this subparagraph shall not apply to a 
                producer of tobacco leaf who grows tobacco under a 
                contract with a tobacco product manufacturer and who is 
                not otherwise engaged in the manufacturing process.
                    ``(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.

    ``(d) Rulemaking Procedures.--Each rulemaking under this chapter 
shall be in accordance with chapter 5 of title 5, United States Code. 
This subsection shall not be construed to affect the rulemaking 
provisions of section 102(a) of the Family Smoking Prevention and 
Tobacco Control Act.
    ``(e) Center for Tobacco Products.--Not 
later <<NOTE: Deadline. Establishment.>>  than 90 days after the date of 
enactment of the Family Smoking Prevention and Tobacco Control Act, the 
Secretary shall establish within the Food and Drug Administration the 
Center for Tobacco Products, which shall report to the Commissioner of 
Food and Drugs in the same manner as the other agency centers within the 
Food and Drug Administration. The Center shall be responsible for the 
implementation of this chapter and related matters assigned by the 
Commissioner.

    ``(f) Office To Assist Small Tobacco Product Manufacturers.--The 
Secretary <<NOTE: Establishment.>>  shall establish within the Food and 
Drug Administration an identifiable office to provide technical and 
other nonfinancial assistance to small tobacco product manufacturers to 
assist them in complying with the requirements of this Act.

    ``(g) Consultation Prior to Rulemaking.--Prior to promulgating rules 
under this chapter, the Secretary shall endeavor to consult with other 
Federal agencies as appropriate.
``SEC. 902. <<NOTE: 21 USC 387b.>>  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

[[Page 123 STAT. 1788]]

        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) the manufacturer or importer of the tobacco product 
        fails to pay a user fee assessed to such manufacturer or 
        importer pursuant to section 919 by the date specified in 
        section 919 or by the 30th day after final agency action on a 
        resolution of any dispute as to the amount of such fee;
            ``(5) 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;
            ``(6)(A) it is required by section 910(a) to have premarket 
        review and does not have an order in effect under section 
        910(c)(1)(A)(i); or
            ``(B) it is in violation of an order under section 
        910(c)(1)(A);
            ``(7) 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
            ``(8) it is in violation of section 911.
``SEC. 903. <<NOTE: Labeling. 21 USC 387c.>>  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 <<NOTE: Regulations.>>  statement required 
                under section 920(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;

[[Page 123 STAT. 1789]]

            ``(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 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 <<NOTE: Regulations. Hearings.>>  
                      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 to ensure that such statements do not violate the 
misbranding provisions of subsection (a) and that such statements comply 
with other provisions of the Family

[[Page 123 STAT. 1790]]

Smoking Prevention and Tobacco Control Act (including the amendments 
made by such Act). 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 Federal 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.
``SEC. 904. <<NOTE: 21 USC 387d.>>  SUBMISSION OF HEALTH 
                        INFORMATION TO THE SECRETARY.

    ``(a) Requirement.--Each tobacco product manufacturer or importer, 
or agents thereof, shall submit to the Secretary the following 
information:
            ``(1) Not <<NOTE: Deadline.>>  later than 6 months after the 
        date of enactment of the Family Smoking Prevention and Tobacco 
        Control Act, 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(e) of the Federal 
        Cigarette Labeling and Advertising Act.
            ``(3) Beginning <<NOTE: Effective date.>>  3 years after the 
        date of enactment of the Family Smoking Prevention and Tobacco 
        Control Act, 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 3 years after such date of enactment, the 
        manufacturer, importer, or agent shall comply with regulations 
        promulgated under section 915 in reporting information under 
        this paragraph, where applicable.
            ``(4) Beginning <<NOTE: Effective date.>>  6 months after 
        the date of enactment of the Family Smoking Prevention and 
        Tobacco Control Act, all documents developed after such date of 
        enactment 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

[[Page 123 STAT. 1791]]

        (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 <<NOTE: Deadlines. Publication. Public information.>>  
        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. <<NOTE: Deadline. Reports. Recommenda- tions.>>  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 <<NOTE: Deadline.>>  than 24 
months after the date of enactment of the Family Smoking Prevention and 
Tobacco Control Act, the Secretary shall establish, and periodically 
revise

[[Page 123 STAT. 1792]]

as appropriate, 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. <<NOTE: Publication. Notice.>>  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. <<NOTE: 21 USC 387e.>>  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. <<NOTE: Deadline.>>  If enactment of the Family Smoking 
Prevention and Tobacco Control Act occurs in the second half of the 
calendar year, the Secretary shall designate a date no later than 6 
months into the subsequent calendar year by which registration pursuant 
to this subsection shall occur.

    ``(c) Registration by 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 registered with the Secretary under this section shall be 
subject to inspection under section 704 or subsection (h), 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

[[Page 123 STAT. 1793]]

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) <<NOTE: Regulations.>>  Registration by Foreign 
Establishments.--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) 
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 have 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) Consultation with respect to forms.--The Secretary 
        shall consult with the Secretary of the Treasury in developing 
        the forms to be used for registration under this section to 
        minimize the burden on those persons required to register with 
        both the Secretary and the Tax and Trade Bureau of the 
        Department of the Treasury.

[[Page 123 STAT. 1794]]

            ``(3) 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 <<NOTE: Notice.>>  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 <<NOTE: Notice.>>  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 February 15, 2007, 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--
                          ``(i) 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 February 15, 2007, or to a tobacco product that 
                      the Secretary has previously determined, pursuant 
                      to subsection (a)(3) of section 910, is 
                      substantially equivalent and that is in compliance 
                      with the requirements of this Act; or
                          ``(ii) the tobacco product is modified within 
                      the meaning of paragraph (3), the modifications 
                      are to a product that is commercially marketed and 
                      in compliance with the requirements of this Act, 
                      and all of the modifications are covered by 
                      exemptions granted by the Secretary pursuant to 
                      paragraph (3); and

[[Page 123 STAT. 1795]]

                    ``(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-february 15, 2007, 
        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 February 15, 2007, and prior to the date that is 21 
        months after the date of enactment of the Family Smoking 
        Prevention and Tobacco Control Act shall be submitted to the 
        Secretary not later than 21 months after such date of enactment.
            ``(3) Exemptions.--
                    ``(A) In general.--The Secretary may exempt from the 
                requirements of this subsection relating to the 
                demonstration that a tobacco product is substantially 
                equivalent within the meaning of section 910, 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 that can be sold 
                      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 <<NOTE: Deadline.>>  
                than 15 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. <<NOTE: 21 USC 387f.>>  GENERAL PROVISIONS RESPECTING 
                        CONTROL OF TOBACCO PRODUCTS.

    ``(a) In General.--Any requirement <<NOTE: Applicability.>>  
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) <<NOTE: Notice. Federal Register, publication.>>  Information 
on Public Access and Comment.--Each notice of proposed rulemaking or 
other notification 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

[[Page 123 STAT. 1796]]

            ``(2) the <<NOTE: Time period.>>  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 
        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.
        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

[[Page 123 STAT. 1797]]

                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.
            ``(4) Remote sales.--
                    ``(A) <<NOTE: Deadlines. Regulations.>>  In 
                general.--The Secretary shall--
                          ``(i) within 18 months after the date of 
                      enactment of the Family Smoking Prevention and 
                      Tobacco Control Act, promulgate regulations 
                      regarding the sale and distribution of tobacco 
                      products that occur through means other than a 
                      direct, face-to-face exchange between a retailer 
                      and a consumer in order to prevent the sale and 
                      distribution of tobacco products to individuals 
                      who have not attained the minimum age established 
                      by applicable law for the purchase of such 
                      products, including requirements for age 
                      verification; and
                          ``(ii) within 2 years after such date of 
                      enactment, issue regulations to address the 
                      promotion and marketing of tobacco products that 
                      are sold or distributed through means other than a 
                      direct, face-to-face exchange between a retailer 
                      and a consumer in order to protect individuals who 
                      have not attained the minimum age established by 
                      applicable law for the purchase of such products.
                    ``(B) Relation to other authority.--Nothing in this 
                paragraph limits the authority of the Secretary to take 
                additional actions under the other paragraphs of this 
                subsection.

    ``(e) Good Manufacturing Practice Requirements.--
            ``(1) Methods, facilities, and controls to conform.--
                    ``(A) <<NOTE: Regulations.>>  In general.--In 
                applying manufacturing restrictions to tobacco, the 
                Secretary shall, 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, preproduction 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, 
                or hazard analysis and critical control point 
                methodology, as prescribed in such regulations to assure 
                that the public health is protected and that the tobacco 
                product is in compliance with this chapter. Such 
                regulations may provide for 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) <<NOTE: Recommenda- tions.>>  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;

[[Page 123 STAT. 1798]]

                          ``(ii) before <<NOTE: Hearings.>>  
                      promulgating any regulation under subparagraph 
                      (A), afford opportunity for an oral hearing;
                          ``(iii) provide the Tobacco Products 
                      Scientific Advisory Committee a reasonable time to 
                      make its recommendation with respect to proposed 
                      regulations under subparagraph (A);
                          ``(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; and
                          ``(v) not <<NOTE: Compliance date.>>  require 
                      any small tobacco product manufacturer to comply 
                      with a regulation under subparagraph (A) for at 
                      least 4 years following the effective date 
                      established by the Secretary for such regulation.
            ``(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). <<NOTE: Reports. Deadline.>>  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

[[Page 123 STAT. 1799]]

                      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, facilities, and 
                      controls 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 end of the 3-year 
        period following 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.
``SEC. 907. <<NOTE: 21 USC 387g.>>  TOBACCO PRODUCT STANDARDS.

    ``(a) In General.--
            ``(1) <<NOTE: Effective dates.>>  Special rules.--
                    ``(A) Special rule for cigarettes.--Beginning 3 
                months after the date of enactment of the Family Smoking 
                Prevention and Tobacco Control Act, 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 subparagraph.
                    ``(B) Additional special rule.--Beginning 2 years 
                after the date of enactment of the Family Smoking 
                Prevention and Tobacco Control Act, a tobacco product 
                manufacturer shall not use tobacco, including foreign 
                grown tobacco, that contains a pesticide chemical 
                residue that is at a level greater than is specified by 
                any tolerance applicable under Federal law to 
                domestically grown tobacco.

[[Page 123 STAT. 1800]]

            ``(2) Revision of tobacco product standards.--The Secretary 
        may revise the tobacco product standards in paragraph (1) in 
        accordance with subsection (c).
            ``(3) Tobacco product standards.--
                    ``(A) In general.--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.
                    ``(B) Determinations.--
                          ``(i) Considerations.--In making a finding 
                      described in subparagraph (A), the Secretary shall 
                      consider scientific evidence concerning--
                                    ``(I) the risks and benefits to the 
                                population as a whole, including users 
                                and nonusers of tobacco products, of the 
                                proposed standard;
                                    ``(II) the increased or decreased 
                                likelihood that existing users of 
                                tobacco products will stop using such 
                                products; and
                                    ``(III) the increased or decreased 
                                likelihood that those who do not use 
                                tobacco products will start using such 
                                products.
                          ``(ii) Additional considerations.--In the 
                      event that the Secretary makes a determination, 
                      set forth in a proposed tobacco product standard 
                      in a proposed rule, that it is appropriate for the 
                      protection of public health to require the 
                      reduction or elimination of an additive, 
                      constituent (including a smoke constituent), or 
                      other component of a tobacco product because the 
                      Secretary has found that the additive, 
                      constituent, or other component is or may be 
                      harmful, any party objecting to the proposed 
                      standard on the ground that the proposed standard 
                      will not reduce or eliminate the risk of illness 
                      or injury may provide for the Secretary's 
                      consideration scientific evidence that 
                      demonstrates that the proposed standard will not 
                      reduce or eliminate the risk of illness or injury.
            ``(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 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 subparagraph (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;

[[Page 123 STAT. 1801]]

                          ``(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);
                    ``(C) shall, where appropriate, require the use and 
                prescribe the form and content of labeling for the 
                proper use of the tobacco product; and
                    ``(D) shall require tobacco products containing 
                foreign-grown tobacco to meet the same standards 
                applicable to tobacco products containing domestically 
                grown tobacco.
            ``(5) Periodic reevaluation 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 <<NOTE: Consultation.>>  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) Considerations by Secretary.--
            ``(1) Technical achievability.--The Secretary shall consider 
        information submitted in connection with a proposed standard 
        regarding the technical achievability of compliance with such 
        standard.
            ``(2) Other considerations.--The Secretary shall consider 
        all other 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 nontobacco 
        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.

    ``(c) Proposed Standards.--
            ``(1) In general.--The Secretary <<NOTE: Federal Register, 
        publication. Notice.>>  shall publish in the Federal Register a 
        notice of proposed rulemaking for the establishment, amendment, 
        or revocation of any tobacco product standard.

[[Page 123 STAT. 1802]]

            ``(2) Requirements of notice.--A notice of proposed 
        rulemaking for the establishment or amendment of a tobacco 
        product standard for a tobacco product shall--
                    ``(A) set forth a finding with supporting 
                justification that the tobacco product standard is 
                appropriate for the protection of the public health;
                    ``(B) invite interested persons to submit a draft or 
                proposed tobacco product standard for consideration by 
                the Secretary;
                    ``(C) invite interested persons to submit comments 
                on structuring the standard so that it does not 
                advantage foreign-grown tobacco over domestically grown 
                tobacco; and
                    ``(D) invite the Secretary of Agriculture to provide 
                any information or analysis which the Secretary of 
                Agriculture believes is relevant to the proposed tobacco 
                product standard.
            ``(3) 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.
            ``(4) Comment.--The Secretary shall provide for a comment 
        period of not less than 60 days.

    ``(d) Promulgation.--
            ``(1) In general.--After the expiration of the period for 
        comment on a notice of proposed rulemaking published under 
        subsection (c) respecting a tobacco product standard and after 
        consideration of comments submitted under subsections (b) and 
        (c) and any report from the Tobacco Products Scientific Advisory 
        Committee, the Secretary shall--
                    ``(A) if <<NOTE: Regulations. Federal Register, 
                publication.>>  the Secretary determines that the 
                standard would be appropriate for the protection of the 
                public health, promulgate a regulation establishing a 
                tobacco product standard and publish in the Federal 
                Register findings on the matters referred to in 
                subsection (c); or
                    ``(B) publish <<NOTE: Publication. Notice.>>  a 
                notice terminating the proceeding for the development of 
                the standard together with the reasons for such 
                termination.
            ``(2) 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. In 
        establishing such effective date or dates, the Secretary shall 
        consider information submitted in connection with a proposed 
        product standard by interested parties, including manufacturers 
        and tobacco growers, regarding the technical achievability of 
        compliance with the standard, and including information 
        concerning the existence of patents that make it impossible to 
        comply in the timeframe envisioned in the proposed standard. If 
        the Secretary determines, based on the Secretary's evaluation of 
        submitted comments, that a product standard can be met only by 
        manufacturers requiring substantial changes to the methods of 
        farming the domestically grown tobacco used by the manufacturer, 
        the

[[Page 123 STAT. 1803]]

        effective date of that product standard shall be not less than 2 
        years after the date of publication of the final regulation 
        establishing the standard.
            ``(3) Limitation on power granted to the food and drug 
        administration.--Because of the importance of a decision of the 
        Secretary to issue a regulation--
                    ``(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,
        the Secretary is prohibited from taking such actions under this 
        Act.
            ``(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 subsection (c) and 
                paragraph (2), 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) Referral to advisory committee.--
                    ``(A) In general.--The Secretary may refer a 
                proposed regulation for the establishment, amendment, or 
                revocation of a tobacco product standard 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.
                    ``(B) Initiation of referral.--The Secretary may 
                make a referral under this paragraph--
                          ``(i) on the Secretary's own initiative; or
                          ``(ii) upon the request of an interested 
                      person that--
                                    ``(I) demonstrates good cause for 
                                the referral; and
                                    ``(II) is <<NOTE: Deadline.>>  made 
                                before the expiration of the period for 
                                submission of comments on the proposed 
                                regulation.
                    ``(C) Provision of data.--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.
                    ``(D) <<NOTE: Statement.>>  Report and 
                recommendation.--The Tobacco Products Scientific 
                Advisory Committee shall, within 60 days after the 
                referral of a proposed regulation under this paragraph 
                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.

[[Page 123 STAT. 1804]]

                    ``(E) Public availability.--The Secretary shall make 
                a copy of each report and recommendation under 
                subparagraph (D) publicly available.

    ``(e) Menthol Cigarettes.--
            ``(1) Referral; considerations.--Immediately upon the 
        establishment of the Tobacco Products Scientific Advisory 
        Committee under section 917(a), the Secretary shall refer to the 
        Committee for report and recommendation, under section 
        917(c)(4), the issue of the impact of the use of menthol in 
        cigarettes on the public health, including such use among 
        children, African-Americans, Hispanics, and other racial and 
        ethnic minorities. In its review, the Tobacco Products 
        Scientific Advisory Committee shall address the considerations 
        listed in subsections (a)(3)(B)(i) and (b).
            ``(2) Report and recommendation.--Not later than 1 year 
        after its establishment, the Tobacco Product Scientific Advisory 
        Committee shall submit to the Secretary the report and 
        recommendations required pursuant to paragraph (1).
            ``(3) Rule of construction.--Nothing in this subsection 
        shall be construed to limit the Secretary's authority to take 
        action under this section or other sections of this Act 
        applicable to menthol.

    ``(f) Dissolvable Tobacco Products.--
            ``(1) Referral; considerations.--The Secretary shall refer 
        to the Tobacco Products Scientific Advisory Committee for report 
        and recommendation, under section 917(c)(4), the issue of the 
        nature and impact of the use of dissolvable tobacco products on 
        the public health, including such use among children. In its 
        review, the Tobacco Products Scientific Advisory Committee shall 
        address the considerations listed in subsection (a)(3)(B)(i).
            ``(2) Report and recommendation.--Not later than 2 years 
        after its establishment, the Tobacco Product Scientific Advisory 
        Committee shall submit to the Secretary the report and 
        recommendations required pursuant to paragraph (1).
            ``(3) Rule of construction.--Nothing in this subsection 
        shall be construed to limit the Secretary's authority to take 
        action under this section or other sections of this Act at any 
        time applicable to any dissolvable tobacco product.
``SEC. 908. <<NOTE: 21 USC 387h.>>  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.

[[Page 123 STAT. 1805]]

Before issuing <<NOTE: Consultation.>>  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 <<NOTE: Order.>>  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 <<NOTE: Deadline.>>  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 <<NOTE: Timetable. Reports.>>  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. <<NOTE: Notification.>>  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).
``SEC. 909. <<NOTE: Regulations. 21 USC 387i.>>  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

[[Page 123 STAT. 1806]]

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. <<NOTE: Applicability.>>  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

[[Page 123 STAT. 1807]]

        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. <<NOTE: 21 USC 387j.>>  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 February 15, 2007; 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 February 15, 2007.
            ``(2) Premarket review required.--
                    ``(A) New products.--An order under subsection 
                (c)(1)(A)(i) for a new tobacco product is required 
                unless--
                          ``(i) the manufacturer has submitted a report 
                      under section 905(j); and 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 February 15, 2007; 
                                and
                                    ``(II) is in compliance with the 
                                requirements of this Act; or
                          ``(ii) the tobacco product is exempt from the 
                      requirements of section 905(j) pursuant to a 
                      regulation issued under section 905(j)(3).
                    ``(B) Application to certain post-february 15, 2007, 
                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 
                      February 15, 2007, and prior to the date that is 
                      21 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 21-month period,
                except that subparagraph (A) shall apply to the tobacco 
                product if 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 term `substantially equivalent' or 
                `substantial equivalence' means, with respect to the 
                tobacco product being compared to the predicate tobacco 
                product, that the Secretary by order has found that the 
                tobacco product--

[[Page 123 STAT. 1808]]

                          ``(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 <<NOTE: Public information. Deadline.>>  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 under this section 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;

[[Page 123 STAT. 1809]]

                    ``(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) Referral 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 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 subsection (b)(2), shall--
                          ``(i) issue an order that the new product may 
                      be introduced or delivered for introduction into 
                      interstate commerce if the Secretary finds that 
                      none of the grounds specified in paragraph (2) of 
                      this subsection applies; or
                          ``(ii) issue an order that the new product may 
                      not be introduced or delivered for introduction 
                      into interstate commerce 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 under subparagraph (A)(i) may require 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 application.--The Secretary shall deny an 
        application submitted under subsection (b) 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

[[Page 123 STAT. 1810]]

                section 907, and there is a lack of adequate information 
                to justify the deviation from such standard.
            ``(3) Denial information.--Any denial <<NOTE: Statement.>>  
        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 remove such application 
        from deniable 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 the marketing of a tobacco product for 
        which an application has been submitted 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 <<NOTE: Notice. Hearings.>>  shall, upon obtaining, 
        where appropriate, advice on scientific matters from the Tobacco 
        Products Scientific Advisory Committee, and after due notice and 
        opportunity for informal hearing for a tobacco product for which 
        an order was issued under subsection (c)(1)(A)(i), issue an 
        order withdrawing the order 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;

[[Page 123 STAT. 1811]]

                          ``(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 reviewed, 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 reviewed, 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 such order was issued, 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 
                the issuance of an order relating to 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 an order issued 
        pursuant to subsection (c)(1)(A)(i) 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 section 912.
            ``(3) <<NOTE: Order.>>  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 order 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 authority of 
        the manufacturer to market the product. 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 <<NOTE: Reports.>>  
        case of any tobacco product for which an order issued pursuant 
        to subsection

[[Page 123 STAT. 1812]]

        (c)(1)(A)(i) for 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 
        order.
            ``(2) Access to records.--Each person required under this 
        section to maintain records, and each person in charge of 
        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. <<NOTE: 21 USC 387k.>>  MODIFIED RISK TOBACCO 
                        PRODUCTS.

    ``(a) In General.--No person may introduce or deliver for 
introduction into interstate commerce any modified risk tobacco product 
unless an order issued pursuant to subsection (g) 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--
                          ``(i) 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

[[Page 123 STAT. 1813]]

                      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) Smokeless tobacco product.--No smokeless 
                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' solely because its label, 
                labeling, or advertising uses the following phrases to 
                describe such product and its use: `smokeless tobacco', 
                `smokeless tobacco product', `not consumed by smoking', 
                `does not produce smoke', `smokefree', `smoke-free', 
                `without smoke', `no smoke', or `not smoke'.
            ``(3) Effective date.--The provisions of paragraph 
        (2)(A)(ii) shall take effect 12 months after the date of 
        enactment of the Family Smoking Prevention and Tobacco Control 
        Act for those products whose label, labeling, or advertising 
        contains the terms described in such paragraph on such date of 
        enactment. The effective date shall be with respect to the date 
        of manufacture, provided that, in any case, beginning 30 days 
        after such effective date, a manufacturer shall not introduce 
        into the domestic commerce of the United States any product, 
        irrespective of the date of manufacture, that is not in 
        conformance with paragraph (2)(A)(ii).

    ``(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 if 
it has been approved as a drug or device by the Food and Drug 
Administration 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 <<NOTE: Comment period.>>  
shall make the application described in subsection (d) publicly 
available (except

[[Page 123 STAT. 1814]]

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 the Tobacco 
        Products Scientific Advisory Committee any application submitted 
        under this section.
            ``(2) Recommendations.--Not 
        later <<NOTE: Deadline. Reports.>>  than 60 days after the date 
        an application is referred to the Tobacco Products Scientific 
        Advisory Committee under paragraph (1), the Advisory Committee 
        shall report its recommendations on the application to the 
        Secretary.

    ``(g) Marketing.--
            ``(1) <<NOTE: Order.>>  Modified risk products.--Except as 
        provided in paragraph (2), the Secretary shall, with respect to 
        an application submitted under this section, issue an order that 
        a modified risk product may be commercially marketed 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 issue an order 
                that a tobacco product may be introduced or delivered 
                for introduction into interstate commerce, pursuant to 
                an application under this section, with respect to a 
                tobacco product that may not be commercially marketed 
                under paragraph (1) if the Secretary makes the findings 
                required under this paragraph and determines that the 
                applicant has demonstrated that--
                          ``(i) such order 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) is limited to an 
                      explicit or implicit representation that such 
                      tobacco product or its smoke does not contain 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 
                      reasonably likely in subsequent studies.

[[Page 123 STAT. 1815]]

                    ``(B) Additional findings required.--To issue an 
                order 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 
                      reasonably likely 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) issuance of an order with respect to 
                      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 marketing.--
                          ``(i) In general.--Applications subject to an 
                      order 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.--An 
                      order <<NOTE: Study.>>  under this paragraph shall 
                      be conditioned on the applicant's agreement to 
                      conduct postmarket surveillance and studies and to 
                      submit to the Secretary the results of such 
                      surveillance and studies to determine the impact 
                      of the order on consumer perception, behavior, and 
                      health and to enable the Secretary to review the 
                      accuracy of the determinations upon which the 
                      order was based in accordance with a protocol 
                      approved by the Secretary.
                          ``(iii) Annual submission.--The results of 
                      such postmarket 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

[[Page 123 STAT. 1816]]

                    ``(B) scientific evidence and other information that 
                is made 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 Marketing.--
            ``(1) Modified risk products.--The Secretary shall require 
        for the marketing of a product 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 
                marketing of a product 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.

[[Page 123 STAT. 1817]]

            ``(4) Time.--An order issued under subsection (g)(1) shall 
        be effective for a specified period of time.
            ``(5) Advertising.--The Secretary may require, with respect 
        to a product for which an applicant obtained an order under 
        subsection (g)(1), that the product comply with requirements 
        relating to advertising and promotion of the tobacco product.

    ``(i) Postmarket Surveillance and Studies.--
            ``(1) In general.--The Secretary shall require, with respect 
        to a product for which an applicant obtained an order under 
        subsection (g)(1), that the applicant conduct postmarket 
        surveillance and studies for such a tobacco product to determine 
        the impact of the order issuance on consumer perception, 
        behavior, and health, to enable the Secretary to review the 
        accuracy of the determinations upon which the order was based, 
        and to provide information that the Secretary determines is 
        otherwise necessary regarding the use or health risks involving 
        the tobacco product. <<NOTE: Deadline.>>  The results of 
        postmarket surveillance and studies shall be submitted to the 
        Secretary on an annual basis.
            ``(2) <<NOTE: Deadlines. Notice.>>  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 Authorization.--The 
Secretary, <<NOTE: Hearings.>>  after an opportunity for an informal 
hearing, shall withdraw an order under subsection (g) 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 order 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 subsection (i); or
            ``(5) the applicant failed to meet a condition imposed under 
        subsection (h).

[[Page 123 STAT. 1818]]

    ``(k) Chapter IV or V.--A product for which the Secretary has issued 
an order pursuant to subsection (g) shall not be subject to chapter IV 
or V.
    ``(l) Implementing Regulations or Guidance.--
            ``(1) Scientific evidence.--Not later <<NOTE: Deadline.>>  
        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) to the extent that adequate scientific 
                evidence exists, establish minimum standards for 
                scientific studies needed prior to issuing an order 
                under subsection (g) to show that a substantial 
                reduction in morbidity or mortality among individual 
                tobacco users occurs for products described in 
                subsection (g)(1) or is reasonably likely for products 
                described in subsection (g)(2);
                    ``(B) include validated biomarkers, intermediate 
                clinical endpoints, and other feasible outcome measures, 
                as appropriate;
                    ``(C) establish minimum standards for postmarket 
                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;
                    ``(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; and
                    ``(F) establish a reasonable timetable for the 
                Secretary to review an application under this section.
            ``(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 <<NOTE: Deadline.>>  
        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 which the applicant seeks to 
        commercially market under this section.

    ``(m) Distributors.--Except as provided in this section, 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

[[Page 123 STAT. 1819]]

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. <<NOTE: 21 USC 387l.>>  JUDICIAL REVIEW.

    ``(a) Right To Review.--
            ``(1) In general.--Not later <<NOTE: Deadline.>>  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 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 <<NOTE: Statement.>>  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.

[[Page 123 STAT. 1820]]

    ``(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 <<NOTE: Statement.>>  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. <<NOTE: Regulations. 21 USC 387m.>>  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. <<NOTE: 21 USC 387n.>>  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 and shall be considered a violation 
        of a rule promulgated under section 18 of that Act.

    ``(b) Coordination.--With respect to the requirements of section 4 
of the Federal Cigarette Labeling and Advertising Act and section 3 of 
the Comprehensive Smokeless Tobacco Health Education Act of 1986--
            ``(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 <<NOTE: Consultation.>>  Secretary shall consult 
        with the Chairman of such Commission in revising the label 
        statements and requirements under such sections.
``SEC. 915. <<NOTE: 21 USC 387o.>>  REGULATION REQUIREMENT.

    ``(a) Testing, Reporting, and Disclosure.--Not later than 36 months 
after the date of enactment of the Family Smoking Prevention and Tobacco 
Control Act, the Secretary shall promulgate regulations under this Act 
that meet the requirements of subsection (b).
    ``(b) Contents of Rules.--The regulations promulgated under 
subsection (a)--
            ``(1) shall require testing and reporting of tobacco product 
        constituents, ingredients, and additives, including smoke 
        constituents, by brand and subbrand that the Secretary 
        determines should be tested to protect the public health, 
        provided that, for purposes of the testing requirements of this 
        paragraph,

[[Page 123 STAT. 1821]]

        tobacco products manufactured and sold by a single tobacco 
        product manufacturer that are identical in all respects except 
        the labels, packaging design, logo, trade dress, trademark, 
        brand name, or any combination thereof, shall be considered as a 
        single brand; and
            ``(2) 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 Secretary shall have the authority under this 
chapter to conduct or to require the testing, reporting, or disclosure 
of tobacco product constituents, including smoke constituents.
    ``(d) Small Tobacco Product Manufacturers.--
            ``(1) First compliance date.--The initial regulations 
        promulgated under subsection (a) shall not impose requirements 
        on small tobacco product manufacturers before the later of--
                    ``(A) the end of the 2-year period following the 
                final promulgation of such regulations; and
                    ``(B) the initial date set by the Secretary for 
                compliance with such regulations by manufacturers that 
                are not small tobacco product manufacturers.
            ``(2) Testing and reporting initial compliance period.--
                    ``(A) 4-year period.--The initial regulations 
                promulgated under subsection (a) shall give each small 
                tobacco product manufacturer a 4-year period over which 
                to conduct testing and reporting for all of its tobacco 
                products. Subject to paragraph (1), the end of the first 
                year of such 4-year period shall coincide with the 
                initial date of compliance under this section set by the 
                Secretary with respect to manufacturers that are not 
                small tobacco product manufacturers or the end of the 2-
                year period following the final promulgation of such 
                regulations, as described in paragraph (1)(A). A small 
                tobacco product manufacturer shall be required--
                          ``(i) to conduct such testing and reporting 
                      for 25 percent of its tobacco products during each 
                      year of such 4-year period; and
                          ``(ii) to conduct such testing and reporting 
                      for its largest-selling tobacco products (as 
                      determined by the Secretary) before its other 
                      tobacco products, or in such other order of 
                      priority as determined by the Secretary.
                    ``(B) Case-by-case delay.--Notwithstanding 
                subparagraph (A), the Secretary may, on a case-by-case 
                basis, delay the date by which an individual small 
                tobacco product manufacturer must conduct testing and 
                reporting for its tobacco products under this section 
                based upon a showing of undue hardship to such 
                manufacturer. Notwithstanding the preceding sentence, 
                the Secretary shall not extend the deadline for a small 
                tobacco product manufacturer to conduct testing and 
                reporting for all of its tobacco products

[[Page 123 STAT. 1822]]

                beyond a total of 5 years after the initial date of 
                compliance under this section set by the Secretary with 
                respect to manufacturers that are not small tobacco 
                product manufacturers.
            ``(3) Subsequent and additional testing and reporting.--The 
        regulations promulgated under subsection (a) shall provide that, 
        with respect to any subsequent or additional testing and 
        reporting of tobacco products required under this section, such 
        testing and reporting by a small tobacco product manufacturer 
        shall be conducted in accordance with the timeframes described 
        in paragraph (2)(A), except that, in the case of a new product, 
        or if there has been a modification described in section 
        910(a)(1)(B) of any product of a small tobacco product 
        manufacturer since the last testing and reporting required under 
        this section, the Secretary shall require that any subsequent or 
        additional testing and reporting be conducted in accordance with 
        the same timeframe applicable to manufacturers that are not 
        small tobacco product manufacturers.
            ``(4) Joint laboratory testing services.--The Secretary 
        shall allow any 2 or more small tobacco product manufacturers to 
        join together to purchase laboratory testing services required 
        by this section on a group basis in order to ensure that such 
        manufacturers receive access to, and fair pricing of, such 
        testing services.

    ``(e) Extensions for Limited Laboratory Capacity.--
            ``(1) In general.--The regulations promulgated under 
        subsection (a) shall provide that a small tobacco product 
        manufacturer shall not be considered to be in violation of this 
        section before the deadline applicable under paragraphs (3) and 
        (4), if--
                    ``(A) the tobacco products of such manufacturer are 
                in compliance with all other requirements of this 
                chapter; and
                    ``(B) the conditions described in paragraph (2) are 
                met.
            ``(2) Conditions.--Notwithstanding 
        the <<NOTE: Deadline. Evidence.>>  requirements of this section, 
        the Secretary may delay the date by which a small tobacco 
        product manufacturer must be in compliance with the testing and 
        reporting required by this section until such time as the 
        testing is reported if, not later than 90 days before the 
        deadline for reporting in accordance with this section, a small 
        tobacco product manufacturer provides evidence to the Secretary 
        demonstrating that--
                    ``(A) the manufacturer has submitted the required 
                products for testing to a laboratory and has done so 
                sufficiently in advance of the deadline to create a 
                reasonable expectation of completion by the deadline;
                    ``(B) the products currently are awaiting testing by 
                the laboratory; and
                    ``(C) neither that laboratory nor any other 
                laboratory is able to complete testing by the deadline 
                at customary, nonexpedited testing fees.
            ``(3) Extension.--The Secretary, taking into account the 
        laboratory testing capacity that is available to tobacco product 
        manufacturers, shall review and verify the evidence submitted by 
        a small tobacco product manufacturer in accordance with 
        paragraph (2). <<NOTE: Notification.>>  If the Secretary finds 
        that the conditions described in such paragraph are met, the 
        Secretary shall notify

[[Page 123 STAT. 1823]]

        the small tobacco product manufacturer that the manufacturer 
        shall not be considered to be in violation of the testing and 
        reporting requirements of this section until the testing is 
        reported or until 1 year after the reporting deadline has 
        passed, whichever occurs sooner. If, however, the Secretary has 
        not made a finding before the reporting deadline, the 
        manufacturer shall not be considered to be in violation of such 
        requirements until the Secretary finds that the conditions 
        described in paragraph (2) have not been met, or until 1 year 
        after the reporting deadline, whichever occurs sooner.
            ``(4) Additional extension.--In addition to the time that 
        may be provided under paragraph (3), the Secretary may provide 
        further extensions of time, in increments of no more than 1 
        year, for required testing and reporting to occur if the 
        Secretary determines, based on evidence properly and timely 
        submitted by a small tobacco product manufacturer in accordance 
        with paragraph (2), that a lack of available laboratory capacity 
        prevents the manufacturer from completing the required testing 
        during the period described in paragraph (3).

    ``(f) Rule of Construction.--Nothing in subsection (d) or (e) shall 
be construed to authorize the extension of any deadline, or to otherwise 
affect any timeframe, under any provision of this Act or the Family 
Smoking Prevention and Tobacco Control Act other than this section.
``SEC. 916. <<NOTE: 21 USC 387p.>>  PRESERVATION OF STATE AND 
                        LOCAL AUTHORITY.

    ``(a) In General.--
            ``(1) Preservation.--Except as provided in paragraph (2)(A), 
        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.--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 review, adulteration, 
                misbranding, labeling, registration, good manufacturing 
                standards, or modified risk tobacco 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

[[Page 123 STAT. 1824]]

                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 552(b)(4) of title 5, United 
                States Code, shall be treated as a 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. 917. <<NOTE: 21 USC 387q.>>  TOBACCO PRODUCTS SCIENTIFIC 
                        ADVISORY COMMITTEE.

    ``(a) Establishment.--Not later <<NOTE: Deadline.>>  than 6 months 
after the date of enactment of the Family Smoking Prevention and Tobacco 
Control Act, the Secretary shall establish a 12-member advisory 
committee, to be known as the Tobacco Products Scientific Advisory 
Committee (in this section referred to as the `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 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 of the tobacco manufacturing industry;
                          ``(v) 1 individual as a representative of the 
                      interests of the small business tobacco 
                      manufacturing industry, which position may be 
                      filled on a rotating, sequential basis by 
                      representatives of different small business 
                      tobacco manufacturers based on areas of expertise 
                      relevant to the topics being considered by the 
                      Advisory Committee; and
                          ``(vi) 1 individual as a representative of the 
                      interests of the tobacco growers.
                    ``(B) Nonvoting members.--The members of the 
                committee appointed under clauses (iv), (v), and (vi) of 
                subparagraph (A) shall serve as consultants to those 
                described in clauses (i) through (iii) of subparagraph 
                (A) and shall be nonvoting representatives.
                    ``(C) Conflicts of interest.--No members of the 
                committee, other than members appointed pursuant to 
                clauses (iv), (v), and (vi) of subparagraph (A) shall, 
                during the member's tenure on the committee or for the 
                18-month

[[Page 123 STAT. 1825]]

                period prior to becoming such a member, receive any 
                salary, grants, or other payments or support from any 
                business that manufactures, distributes, markets, or 
                sells cigarettes or other tobacco products.
            ``(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 appointed under clauses (i), (ii), and (iii) of 
        paragraph (1)(A) 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 
        under 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 does not apply to the Advisory Committee.

    ``(e) <<NOTE: Records.>>  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. 918. <<NOTE: 21 USC 387r.>>  DRUG PRODUCTS USED TO TREAT 
                        TOBACCO DEPENDENCE.

    ``(a) In General.--The Secretary shall--
            ``(1) at the request of the applicant, consider designating 
        products for smoking cessation, including nicotine replacement 
        products as fast track research and approval products within the 
        meaning of section 506;

[[Page 123 STAT. 1826]]

            ``(2) consider approving the extended use of nicotine 
        replacement products (such as nicotine patches, nicotine gum, 
        and nicotine lozenges) for the treatment of tobacco dependence; 
        and
            ``(3) review and consider the evidence for additional 
        indications for nicotine replacement products, such as for 
        craving relief or relapse prevention.

    ``(b) Report on Innovative Products.--
            ``(1) In general.--Not later than 3 years after the date of 
        enactment of the Family Smoking Prevention and Tobacco Control 
        Act, the Secretary, after consultation with recognized 
        scientific, medical, and public health experts (including both 
        Federal agencies and nongovernmental entities, the Institute of 
        Medicine of the National Academy of Sciences, and the Society 
        for Research on Nicotine and Tobacco), shall submit to the 
        Congress a report that examines how best to regulate, promote, 
        and encourage the development of innovative products and 
        treatments (including nicotine-based and non-nicotine-based 
        products and treatments) to better achieve, in a manner that 
        best protects and promotes the public health--
                    ``(A) total abstinence from tobacco use;
                    ``(B) reductions in consumption of tobacco; and
                    ``(C) reductions in the harm associated with 
                continued tobacco use.
            ``(2) Recommendations.--The report under paragraph (1) shall 
        include the recommendations of the Secretary on how the Food and 
        Drug Administration should coordinate and facilitate the 
        exchange of information on such innovative products and 
        treatments among relevant offices and centers within the 
        Administration and within the National Institutes of Health, the 
        Centers for Disease Control and Prevention, and other relevant 
        agencies.
``SEC. 919. <<NOTE: 21 USC 387s.>>  USER FEES.

    ``(a) Establishment of Quarterly Fee.--Beginning 
on <<NOTE: Effective date.>>  the date of enactment of the Family 
Smoking Prevention and Tobacco Control Act, the Secretary shall in 
accordance with this section assess user fees on, and collect such fees 
from, each manufacturer and importer of tobacco products subject to this 
chapter. The fees shall be assessed and collected with respect to each 
quarter of each fiscal year, and the total amount assessed and collected 
for a fiscal year shall be the amount specified in subsection (b)(1) for 
such year, subject to subsection (c).

    ``(b) Assessment of User Fee.--
            ``(1) Amount of assessment.--The total amount of user fees 
        authorized to be assessed and collected under subsection (a) for 
        a fiscal year is the following, as applicable to the fiscal year 
        involved:
                    ``(A) For fiscal year 2009, $85,000,000 (subject to 
                subsection (e)).
                    ``(B) For fiscal year 2010, $235,000,000.
                    ``(C) For fiscal year 2011, $450,000,000.
                    ``(D) For fiscal year 2012, $477,000,000.
                    ``(E) For fiscal year 2013, $505,000,000.
                    ``(F) For fiscal year 2014, $534,000,000.
                    ``(G) For fiscal year 2015, $566,000,000.
                    ``(H) For fiscal year 2016, $599,000,000.

[[Page 123 STAT. 1827]]

                    ``(I) For fiscal year 2017, $635,000,000.
                    ``(J) For fiscal year 2018, $672,000,000.
                    ``(K) For fiscal year 2019 and each subsequent 
                fiscal year, $712,000,000.
            ``(2) Allocations of assessment by class of tobacco 
        products.--
                    ``(A) In general.--The total user fees assessed and 
                collected under subsection (a) each fiscal year with 
                respect to each class of tobacco products shall be an 
                amount that is equal to the applicable percentage of 
                each class for the fiscal year multiplied by the amount 
                specified in paragraph (1) for the fiscal year.
                    ``(B) Applicable percentage.--
                          ``(i) In general.--For purposes of 
                      subparagraph (A), the applicable percentage for a 
                      fiscal year for each of the following classes of 
                      tobacco products shall be determined in accordance 
                      with clause (ii):
                                    ``(I) Cigarettes.
                                    ``(II) Cigars, including small 
                                cigars and cigars other than small 
                                cigars.
                                    ``(III) Snuff.
                                    ``(IV) Chewing tobacco.
                                    ``(V) Pipe tobacco.
                                    ``(VI) Roll-your-own tobacco.
                          ``(ii) Allocations.--The applicable percentage 
                      of each class of tobacco product described in 
                      clause (i) for a fiscal year shall be the 
                      percentage determined under section 625(c) of 
                      Public Law 108-357 for each such class of product 
                      for such fiscal year.
                          ``(iii) Requirement of regulations.--
                      Notwithstanding clause (ii), no user fees shall be 
                      assessed on a class of tobacco products unless 
                      such class of tobacco products is listed in 
                      section 901(b) or is deemed by the Secretary in a 
                      regulation under section 901(b) to be subject to 
                      this chapter.
                          ``(iv) Reallocations.--In the case of a class 
                      of tobacco products that is not listed in section 
                      901(b) or deemed by the Secretary in a regulation 
                      under section 901(b) to be subject to this 
                      chapter, the amount of user fees that would 
                      otherwise be assessed to such class of tobacco 
                      products shall be reallocated to the classes of 
                      tobacco products that are subject to this chapter 
                      in the same manner and based on the same relative 
                      percentages otherwise determined under clause 
                      (ii).
            ``(3) Determination of user fee by company.--
                    ``(A) In general.--The total user fee to be paid by 
                each manufacturer or importer of a particular class of 
                tobacco products shall be determined for each quarter by 
                multiplying--
                          ``(i) such manufacturer's or importer's 
                      percentage share as determined under paragraph 
                      (4); by
                          ``(ii) the portion of the user fee amount for 
                      the current quarter to be assessed on all 
                      manufacturers and importers of such class of 
                      tobacco products as determined under paragraph 
                      (2).

[[Page 123 STAT. 1828]]

                    ``(B) No fee in excess of percentage share.--No 
                manufacturer or importer of tobacco products shall be 
                required to pay a user fee in excess of the percentage 
                share of such manufacturer or importer.
            ``(4) Allocation of assessment within each class of tobacco 
        product.--The percentage share of each manufacturer or importer 
        of a particular class of tobacco products of the total user fee 
        to be paid by all manufacturers or importers of that class of 
        tobacco products shall be the percentage determined for purposes 
        of allocations under subsections (e) through (h) of section 625 
        of Public Law 108-357.
            ``(5) Allocation for cigars.--Notwithstanding paragraph (4), 
        if a user fee assessment is imposed on cigars, the percentage 
        share of each manufacturer or importer of cigars shall be based 
        on the excise taxes paid by such manufacturer or importer during 
        the prior fiscal year.
            ``(6) Timing of assessment.--The 
        Secretary <<NOTE: Notification.>>  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 this subsection for each 
        quarter of each fiscal year. <<NOTE: Deadlines.>>  Such 
        notifications shall occur not later than 30 days prior to the 
        end of the quarter for which such assessment is made, and 
        payments of all assessments shall be made by the last day of the 
        quarter involved.
            ``(7) Memorandum of understanding.--
                    ``(A) In general.--The Secretary shall request the 
                appropriate Federal agency to enter into a memorandum of 
                understanding that provides for the regular and timely 
                transfer from the head of such agency to the Secretary 
                of the information described in paragraphs (2)(B)(ii) 
                and (4) and all necessary information regarding all 
                tobacco product manufacturers and importers required to 
                pay user fees. <<NOTE: Disclosure.>>  The Secretary 
                shall maintain all disclosure restrictions established 
                by the head of such agency regarding the information 
                provided under the memorandum of understanding.
                    ``(B) Assurances.--Beginning not <<NOTE: Effective 
                dates.>>  later than fiscal year 2015, and for each 
                subsequent fiscal year, the Secretary shall ensure that 
                the Food and Drug Administration is able to determine 
                the applicable percentages described in paragraph (2) 
                and the percentage shares described in paragraph (4). 
                The Secretary may carry out this subparagraph by 
                entering into a contract with the head of the Federal 
                agency referred to in subparagraph (A) to continue to 
                provide the necessary information.

    ``(c) Crediting and Availability of Fees.--
            ``(1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to the 
        extent and in the amount provided in advance in appropriations 
        Acts, subject to paragraph (2)(D). Such fees are authorized to 
        remain available until expended. Such sums as may be necessary 
        may be transferred from the Food and Drug Administration 
        salaries and expenses appropriation account without fiscal year 
        limitation to such appropriation account for salaries and 
        expenses with such fiscal year limitation.
            ``(2) Availability.--

[[Page 123 STAT. 1829]]

                    ``(A) In general.--Fees appropriated under paragraph 
                (3) are available only for the purpose of paying the 
                costs of the activities of the Food and Drug 
                Administration related to the regulation of tobacco 
                products under this chapter and the Family Smoking 
                Prevention and Tobacco Control Act (referred to in this 
                subsection as `tobacco regulation activities'), except 
                that such fees may be used for the reimbursement 
                specified in subparagraph (C).
                    ``(B) Prohibition against use of other funds.--
                          ``(i) In general.--Except as provided in 
                      clause (ii), fees collected under subsection (a) 
                      are the only funds authorized to be made available 
                      for tobacco regulation activities.
                          ``(ii) Startup costs.--Clause 
                      (i) <<NOTE: Effective date.>>  does not apply 
                      until October 1, 2009. Until such date, any 
                      amounts available to the Food and Drug 
                      Administration (excluding user fees) shall be 
                      available and allocated as needed to pay the costs 
                      of tobacco regulation activities.
                    ``(C) Reimbursement of start-up amounts.--
                          ``(i) In general.--Any amounts allocated for 
                      the start-up period pursuant to subparagraph 
                      (B)(ii) shall be reimbursed through any 
                      appropriated fees collected under subsection (a), 
                      in such manner as the Secretary determines 
                      appropriate to ensure that such allocation results 
                      in no net change in the total amount of funds 
                      otherwise available, for the period from October 
                      1, 2008, through September 30, 2010, for Food and 
                      Drug Administration programs and activities (other 
                      than tobacco regulation activities) for such 
                      period.
                          ``(ii) <<NOTE: Deadline.>>  Treatment of 
                      reimbursed amounts.--Amounts reimbursed under 
                      clause (i) shall be available for the programs and 
                      activities for which funds allocated for the 
                      start-up period were available, prior to such 
                      allocation, until September 30, 2010, 
                      notwithstanding any otherwise applicable limits on 
                      amounts for such programs or activities for a 
                      fiscal year.
                    ``(D) <<NOTE: Deadline.>>  Fee collected during 
                start-up period.--Notwithstanding the first sentence of 
                paragraph (1), fees under subsection (a) may be 
                collected through September 30, 2009 under subparagraph 
                (B)(ii) and shall be available for obligation and remain 
                available until expended. Such offsetting collections 
                shall be credited to the salaries and expenses account 
                of the Food and Drug Administration.
                    ``(E) Obligation of start-up costs in anticipation 
                of available fee collections.--Notwithstanding any other 
                provision of law, following the enactment of an 
                appropriation for fees under this section for fiscal 
                year 2010, or any portion thereof, obligations for costs 
                of tobacco regulation activities during the start-up 
                period may be incurred in anticipation of the receipt of 
                offsetting fee collections through procedures specified 
                in section 1534 of title 31, United States Code.
            ``(3) Authorization of appropriations.--For fiscal year 2009 
        and each subsequent fiscal year, there is authorized to be 
        appropriated for fees under this section an amount equal to the 
        amount specified in subsection (b)(1) for the fiscal year.

[[Page 123 STAT. 1830]]

    ``(d) Collection of Unpaid Fees.--In any <<NOTE: Deadline.>>  case 
where the Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 days after it is due, such fee shall be treated 
as a claim of the United States Government subject to subchapter II of 
chapter 37 of title 31, United States Code.

    ``(e) Applicability to Fiscal Year 2009.--If the date of enactment 
of the Family Smoking Prevention and Tobacco Control Act occurs during 
fiscal year 2009, the following applies, subject to subsection (c):
            ``(1) The <<NOTE: Fees.>>  Secretary shall determine the 
        fees that would apply for a single quarter of such fiscal year 
        according to the application of subsection (b) to the amount 
        specified in paragraph (1)(A) of such subsection (referred to in 
        this subsection as the `quarterly fee amounts').
            ``(2) For the quarter in which such date of enactment 
        occurs, the amount of fees assessed shall be a pro rata amount, 
        determined according to the number of days remaining in the 
        quarter (including such date of enactment) and according to the 
        daily equivalent of the quarterly fee amounts. Fees assessed 
        under the preceding sentence shall not be collected until the 
        next quarter.
            ``(3) For the quarter following the quarter to which 
        paragraph (2) applies, the full quarterly fee amounts shall be 
        assessed and collected, in addition to collection of the pro 
        rata fees assessed under paragraph (2).''.

    (c) Conforming Amendment.--Section 9(1) of the Comprehensive 
Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 4408(i)) is 
amended to read as follows:
            ``(1) The term `smokeless tobacco' has the meaning given 
        such term by section 900(18) of the Federal Food, Drug, and 
        Cosmetic Act.''.
SEC. 102. <<NOTE: 21 USC 387a-1.>>  FINAL RULE.

    (a) Cigarettes and Smokeless Tobacco.--
            (1) In general.--On the <<NOTE: Deadline. Federal Register, 
        publication.>>  first day of publication of the Federal Register 
        that is 180 days or more after the date of enactment of this 
        Act, the Secretary of Health and Human Services shall publish in 
        the Federal Register a final rule regarding cigarettes and 
        smokeless tobacco, which--
                    (A) is deemed to be issued under chapter 9 of the 
                Federal Food, Drug, and Cosmetic Act, as added by 
                section 101 of this division; and
                    (B) shall be deemed to be in compliance with all 
                applicable provisions of chapter 5 of title 5, United 
                States Code, and all other provisions of law relating to 
                rulemaking procedures.
            (2) Contents of rule.--Except as provided in this 
        subsection, the 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 in 
                accordance with this division and the amendments made by 
                this division;
                    (B) strike Subpart C--Labels and section 897.32(c);

[[Page 123 STAT. 1831]]

                    (C) strike paragraphs (a), (b), and (i) of section 
                897.3 and insert definitions of the terms ``cigarette'', 
                ``cigarette tobacco'', and ``smokeless tobacco'' as 
                defined in section 900 of the Federal Food, Drug, and 
                Cosmetic Act;
                    (D) insert ``or roll-your-own paper'' in section 
                897.34(a) after ``other than cigarettes or smokeless 
                tobacco'';
                    (E) include such modifications to section 897.30(b), 
                if any, that the Secretary determines are appropriate in 
                light of governing First Amendment case law, including 
                the decision of the Supreme Court of the United States 
                in Lorillard Tobacco Co. v. Reilly (533 U.S. 525 
                (2001));
                    (F) become <<NOTE: Effective date.>>  effective on 
                the date that is 1 year after the date of enactment of 
                this Act; and
                    (G) amend paragraph (d) of section 897.16 to read as 
                follows:

    ``(d)(1) Except as provided in subparagraph (2), no manufacturer, 
distributor, or retailer may distribute or cause to be distributed any 
free samples of cigarettes, smokeless tobacco, or other tobacco products 
(as such term is defined in section 201 of the Federal Food, Drug, and 
Cosmetic Act).
    ``(2)(A) Subparagraph (1) does not prohibit a manufacturer, 
distributor, or retailer from distributing or causing to be distributed 
free samples of smokeless tobacco in a qualified adult-only facility.
    ``(B) This subparagraph does not affect the authority of a State or 
local government to prohibit or otherwise restrict the distribution of 
free samples of smokeless tobacco.
    ``(C) For purposes of this paragraph, the term `qualified adult-only 
facility' means a facility or restricted area that--
            ``(i) requires each person present to provide to a law 
        enforcement officer (whether on or off duty) or to a security 
        guard licensed by a governmental entity government-issued 
        identification showing a photograph and at least the minimum age 
        established by applicable law for the purchase of smokeless 
        tobacco;
            ``(ii) does not sell, serve, or distribute alcohol;
            ``(iii) is not located adjacent to or immediately across 
        from (in any direction) a space that is used primarily for 
        youth-oriented marketing, promotional, or other activities;
            ``(iv) is a temporary structure constructed, designated, and 
        operated as a distinct enclosed area for the purpose of 
        distributing free samples of smokeless tobacco in accordance 
        with this subparagraph;
            ``(v) is enclosed by a barrier that--
                    ``(I) is constructed of, or covered with, an opaque 
                material (except for entrances and exits);
                    ``(II) extends from no more than 12 inches above the 
                ground or floor (which area at the bottom of the barrier 
                must be covered with material that restricts visibility 
                but may allow airflow) to at least 8 feet above the 
                ground or floor (or to the ceiling); and
                    ``(III) prevents persons outside the qualified 
                adult-only facility from seeing into the qualified 
                adult-only facility, unless they make unreasonable 
                efforts to do so; and
            ``(vi) does not display on its exterior--
                    ``(I) any tobacco product advertising;

[[Page 123 STAT. 1832]]

                    ``(II) a brand name other than in conjunction with 
                words for an area or enclosure to identify an adult-only 
                facility; or
                    ``(III) any combination of words that would imply to 
                a reasonable observer that the manufacturer, 
                distributor, or retailer has a sponsorship that would 
                violate section 897.34(c).

    ``(D) Distribution of samples of smokeless tobacco under this 
subparagraph permitted to be taken out of the qualified adult-only 
facility shall be limited to 1 package per adult consumer containing no 
more than 0.53 ounces (15 grams) of smokeless tobacco. If such package 
of smokeless tobacco contains individual portions of smokeless tobacco, 
the individual portions of smokeless tobacco shall not exceed 8 
individual portions and the collective weight of such individual 
portions shall not exceed 0.53 ounces (15 grams). Any manufacturer, 
distributor, or retailer who distributes or causes to be distributed 
free samples also shall take reasonable steps to ensure that the above 
amounts are limited to one such package per adult consumer per day.
    ``(3) Notwithstanding subparagraph (2), no manufacturer, 
distributor, or retailer may distribute or cause to be distributed any 
free samples of smokeless tobacco--
            ``(A) to a sports team or entertainment group; or
            ``(B) at any football, basketball, baseball, soccer, or 
        hockey event or any other sporting or entertainment event 
        determined by the Secretary to be covered by this subparagraph.

    ``(4) The <<NOTE: Reports. Deadline.>>  Secretary shall implement a 
program to ensure compliance with this paragraph and submit a report to 
the Congress on such compliance not later than 18 months after the date 
of enactment of the Family Smoking Prevention and Tobacco Control Act.

    ``(5) Nothing in this paragraph shall be construed to authorize any 
person to distribute or cause to be distributed any sample of a tobacco 
product to any individual who has not attained the minimum age 
established by applicable law for the purchase of such product.''.
            (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 chapter 5 of title 
        5, United States Code.
            (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 chapter 
        5 of title 5, United States Code, the regulation promulgated 
        pursuant to this section, including the provisions of such 
        regulation relating to distribution of free samples.
            (5) Enforcement of retail sale provisions.--The Secretary of 
        Health and Human Services shall ensure that the provisions of 
        this division, the amendments made by this division, and the 
        implementing regulations (including such provisions, amendments, 
        and regulations relating to the retail sale of tobacco products) 
        are enforced with respect to the United States and Indian 
        tribes.
            (6) Qualified adult-only facility.--A 
        qualified <<NOTE: Penalties.>>  adult-only facility (as such 
        term is defined in section 897.16(d) of the final rule published 
        under paragraph (1)) that is also a retailer and that commits a 
        violation as a retailer shall not

[[Page 123 STAT. 1833]]

        be subject to the limitations in section 103(q) and shall be 
        subject to penalties applicable to a qualified adult-only 
        facility.
            (7) Congressional review provisions.--Section 801 of title 
        5, United States Code, shall not apply to the final rule 
        published under paragraph (1).

    (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 titled 
        ``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 titled ``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 titled 
        ``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 titled ``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)--
                    (A) by striking the period after ``572(i)''; and
                    (B) by striking ``or 761 or the refusal to permit 
                access to'' and inserting ``761, 909, or 920 or the 
                refusal to permit access to'';
            (5) in subsection (g), by inserting ``tobacco product,'' 
        after ``device,'';
            (6) in subsection (h), by inserting ``tobacco product,'' 
        after ``device,'';
            (7) in subsection (j)--
                    (A) by striking the period after ``573''; and

[[Page 123 STAT. 1834]]

                    (B) by striking ``708, or 721'' and inserting ``708, 
                721, 904, 905, 906, 907, 908, 909, or 920(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)(3).'';
            (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), 907, 908, or 915;
            ``(B) to furnish any notification or other material or 
        information required by or under section 519, 520(g), 904, 909, 
        or 920; 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 the term ``device'' each time that such term appears; and
            (13) by adding at the end the following:

    ``(oo) The sale of tobacco products in violation of a no-tobacco-
sale order issued under section 303(f).
    ``(pp) The introduction or delivery for introduction into interstate 
commerce of a tobacco product in violation of section 911.
    ``(qq)(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.
    ``(rr) The charitable distribution of tobacco products.
    ``(ss) The failure of a manufacturer or distributor to notify the 
Attorney General and the Secretary of the Treasury of their knowledge of 
tobacco products used in illicit trade.
    ``(tt) Making any express or implied statement or representation 
directed to consumers with respect to a tobacco product, in a label or 
labeling or through the media or advertising, that either conveys, or 
misleads or would mislead consumers into believing, that--
            ``(1) the product is approved by the Food and Drug 
        Administration;
            ``(2) the Food and Drug Administration deems the product to 
        be safe for use by consumers;

[[Page 123 STAT. 1835]]

            ``(3) the product is endorsed by the Food and Drug 
        Administration for use by consumers; or
            ``(4) the product is safe or less harmful by virtue of--
                    ``(A) its regulation or inspection by the Food and 
                Drug Administration; or
                    ``(B) its compliance with regulatory requirements 
                set by the Food and Drug Administration;
        including any such statement or representation rendering the 
        product misbranded under section 903.''.

    (c) Section 303.--Section 303(f) (21 U.S.C. 333(f)) is amended--
            (1) in paragraph (5)--
                    (A) by striking ``paragraph (1), (2), (3), or (4)'' 
                each place such appears and inserting ``paragraph (1), 
                (2), (3), (4), or (9)'';
                    (B) 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'' the second time 
                      it appears and inserting ``penalty, or upon whom a 
                      no-tobacco-sale order is to be imposed,'';
                    (C) 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
                    (D) by adding at the end the following:

    ``(D) The Secretary may compromise, modify, or terminate, with or 
without conditions, any no-tobacco-sale order.'';
            (2) in paragraph (6)--
                    (A) by inserting ``or the imposition of a no-
                tobacco-sale order'' after the term ``penalty'' each 
                place such term appears; and
                    (B) by striking ``issued.'' and inserting ``issued, 
                or on which the no-tobacco-sale order was imposed, as 
                the case may be.''; and
            (3) by adding at the end the following:

    ``(8) 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). Prior to the entry of a no-sale order under this 
paragraph, a person shall be entitled to a hearing pursuant to the 
procedures established through regulations of the Food and Drug 
Administration for assessing civil money penalties, including at a 
retailer's request a hearing by telephone, or at the nearest regional or 
field office of the Food and Drug Administration, or at a Federal, 
State, or county facility within 100 miles from the location of the 
retail outlet, if such a facility is available.

[[Page 123 STAT. 1836]]

    ``(9) Civil Monetary Penalties for Violation of Tobacco Product 
Requirements.--
            ``(A) In general.--Subject to subparagraph (B), any person 
        who violates a requirement of this Act which relates to tobacco 
        products shall be liable to the United States for a civil 
        penalty in an amount not to exceed $15,000 for each such 
        violation, and not to exceed $1,000,000 for all such violations 
        adjudicated in a single proceeding.
            ``(B) Enhanced penalties.--
                    ``(i) Any person who intentionally violates a 
                requirement of section 902(5), 902(6), 904, 908(c), or 
                911(a), shall be subject to a civil monetary penalty 
                of--
                          ``(I) not to exceed $250,000 per violation, 
                      and not to exceed $1,000,000 for all such 
                      violations adjudicated in a single proceeding; or
                          ``(II) in <<NOTE: Notice.>>  the case of a 
                      violation that continues after the Secretary 
                      provides written notice to such person, $250,000 
                      for the first 30-day period (or any portion 
                      thereof) that the person continues to be in 
                      violation, and such amount shall double for every 
                      30-day period thereafter that the violation 
                      continues, not to exceed $1,000,000 for any 30-day 
                      period, and not to exceed $10,000,000 for all such 
                      violations adjudicated in a single proceeding.
                    ``(ii) Any person who violates a requirement of 
                section 911(g)(2)(C)(ii) or 911(i)(1), shall be subject 
                to a civil monetary penalty of--
                          ``(I) not to exceed $250,000 per violation, 
                      and not to exceed $1,000,000 for all such 
                      violations adjudicated in a single proceeding; or
                          ``(II) in <<NOTE: Notice.>>  the case of a 
                      violation that continues after the Secretary 
                      provides written notice to such person, $250,000 
                      for the first 30-day period (or any portion 
                      thereof) that the person continues to be in 
                      violation, and such amount shall double for every 
                      30-day period thereafter that the violation 
                      continues, not to exceed $1,000,000 for any 30-day 
                      period, and not to exceed $10,000,000 for all such 
                      violations adjudicated in a single proceeding.
                    ``(iii) In determining the amount of a civil penalty 
                under clause (i)(II) or (ii)(II), the Secretary shall 
                take into consideration whether the person is making 
                efforts toward correcting the violation of the 
                requirements of the section for which such person is 
                subject to such civil penalty.''.

    (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: ``device, and (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 the term ``device'' each place such term 
        appears; and
            (4) in subsection (g)(2)(A), by inserting ``or tobacco 
        product'' after ``device''.

[[Page 123 STAT. 1837]]

    (e) Section 505.--Section 505(n)(2) (21 U.S.C. 355(n)(2)) is amended 
by striking ``section 904'' and inserting ``section 1004''.
    (f) Section 523.--Section 523(b)(2)(D) (21 U.S.C. 360m(b)(2)(D)) is 
amended by striking ``section 903(g)'' and inserting ``section 
1003(g)''.
    (g) Section 702.--Section 702(a)(1) (U.S.C. 372(a)(1)) <<NOTE: 21 
USC 372.>>  is amended--
            (1) by striking ``(a)(1)'' and inserting ``(a)(1)(A)''; and
            (2) by adding at the end the following:

    ``(B)(i) For <<NOTE: Contracts. Inter- governmental relations.>>  a 
tobacco product, to the extent feasible, the Secretary shall contract 
with the States in accordance with this paragraph to carry out 
inspections of retailers within that State in connection with the 
enforcement of this Act.

    ``(ii) The Secretary shall not enter into any contract under clause 
(i) with the government of any of the several States to exercise 
enforcement authority under this Act on Indian country without the 
express written consent of the Indian tribe involved.''.
    (h) Section 703.--Section 703 (21 U.S.C. 373) is amended--
            (1) by inserting ``tobacco product,'' after the term 
        ``device,'' each place such term appears; and
            (2) by inserting ``tobacco products,'' after the term 
        ``devices,'' each place such term appears.

    (i) Section 704.--Section 704 (21 U.S.C. 374) is amended--
            (1) in subsection (a)(1)--
                    (A) by striking ``devices, or cosmetics'' each place 
                it appears and inserting ``devices, tobacco products, or 
                cosmetics'';
                    (B) by striking ``or restricted devices'' each place 
                it appears and inserting ``restricted devices, or 
                tobacco products''; and
                    (C) by striking ``and devices and subject to'' and 
                all that follows through ``other drugs or devices'' and 
                inserting ``devices, and tobacco products and subject to 
                reporting and inspection under regulations lawfully 
                issued pursuant to section 505 (i) or (k), section 519, 
                section 520(g), or chapter IX and data relating to other 
                drugs, devices, or tobacco products'';
            (2) in subsection (b), by inserting ``tobacco product,'' 
        after ``device,''; and
            (3) in subsection (g)(13), by striking ``section 903(g)'' 
        and inserting ``section 1003(g)''.

    (j) Section 705.--Section 705(b) (21 U.S.C. 375(b)) is amended by 
inserting ``tobacco products,'' after ``devices,''.
    (k) Section 709.--Section 709 (21 U.S.C. 379a) is amended by 
inserting ``tobacco product,'' after ``device,''.
    (l) Section 801.--Section 801 (21 U.S.C. 381) is amended--
            (1) in subsection (a)--
                    (A) by inserting ``tobacco products,'' after the 
                term ``devices,'';
                    (B) by inserting ``or section 905(h)'' after 
                ``section 510''; and
                    (C) by striking the term ``drugs or devices'' each 
                time such term appears and inserting ``drugs, devices, 
                or tobacco products'';
            (2) in subsection (e)(1)--
                    (A) by inserting ``tobacco product'' after ``drug, 
                device,''; and

[[Page 123 STAT. 1838]]

                    (B) by inserting ``, and a tobacco product intended 
                for export shall not be deemed to be in violation of 
                section 906(e), 907, 911, or 920(a),'' before ``if it--
                ''; and
            (3) by adding at the end the following:

    ``(p)(1) Not <<NOTE: Deadline. Reports.>>  later than 36 months 
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 <<NOTE: Requirements.>>  Secretary is authorized to 
establish appropriate information disclosure requirements to carry out 
this subsection.''.

    (m) Section 1003.--Section 1003(d)(2)(C) (as redesignated by section 
101(b)) <<NOTE: 21 USC 393.>>  is amended--
            (1) by striking ``and'' after ``cosmetics,''; and
            (2) inserting ``, and tobacco products'' after ``devices''.

    (n) Section 1009.--Section 1009(b) (as redesignated by section 
101(b)) is <<NOTE: 21 USC 399.>>  amended by striking ``section 908'' 
and inserting ``section 1008''.

    (o) Section 409 of the Federal Meat Inspection Act.--Section 409(a) 
of the Federal Meat Inspection Act (21 U.S.C. 679(a)) is amended by 
striking ``section 902(b)'' and inserting ``section 1002(b)''.
    (p) <<NOTE: 21 USC 331 note.>>  Rule of Construction.--Nothing in 
this section is intended or shall be construed to expand, contract, or 
otherwise modify or amend the existing limitations on State government 
authority over tribal restricted fee or trust lands.

    (q) Guidance and Effective Dates.--
            (1) <<NOTE: 21 USC 333 note.>>  In general.--The Secretary 
        of Health and Human Services shall issue guidance--
                    (A) defining the term ``repeated violation'', as 
                used in section 303(f)(8) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 333(f)(8)) as amended by 
                subsection (c), as including at least 5 violations of 
                particular requirements over a 36-month period at a 
                particular retail outlet that constitute a repeated 
                violation and providing for civil penalties in 
                accordance with paragraph (2);
                    (B) providing for timely and effective notice by 
                certified or registered mail or personal delivery to the 
                retailer of each alleged violation at a particular 
                retail outlet prior to conducting a followup compliance 
                check, such notice to be sent to the location specified 
                on the retailer's registration or to the retailer's 
                registered agent if the retailer has provider such agent 
                information to the Food and Drug Administration prior to 
                the violation;
                    (C) providing for a hearing pursuant to the 
                procedures established through regulations of the Food 
                and Drug Administration for assessing civil money 
                penalties,

[[Page 123 STAT. 1839]]

                including at a retailer's request a hearing by telephone 
                or at the nearest regional or field office of the Food 
                and Drug Administration, and providing for an expedited 
                procedure for the administrative appeal of an alleged 
                violation;
                    (D) 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;
                    (E) establishing that civil money penalties for 
                multiple violations shall increase from one violation to 
                the next violation pursuant to paragraph (2) within the 
                time periods provided for in such paragraph;
                    (F) providing that good faith reliance on the 
                presentation of a false government-issued photographic 
                identification that contains a 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--
                          (i) adopting and enforcing a written policy 
                      against sales to minors;
                          (ii) informing its employees of all applicable 
                      laws;
                          (iii) establishing disciplinary sanctions for 
                      employee noncompliance; and
                          (iv) requiring its employees to verify age by 
                      way of photographic identification or electronic 
                      scanning device; and
                    (G) providing for the Secretary, in determining 
                whether to impose a no-tobacco-sale order and in 
                determining whether to compromise, modify, or terminate 
                such an order, to consider whether the retailer has 
                taken effective steps to prevent violations of the 
                minimum age requirements for the sale of tobacco 
                products, including the steps listed in subparagraph 
                (F).
            (2) <<NOTE: 21 USC 333 note.>>  Penalties for violations.--
                    (A) In general.--The amount of the civil penalty to 
                be applied for violations of restrictions promulgated 
                under section 906(d), as described in paragraph (1), 
                shall be as follows:
                          (i) With respect to a retailer with an 
                      approved training program, the amount of the civil 
                      penalty shall not exceed--
                                    (I) in the case of the first 
                                violation, $0.00 together with the 
                                issuance of a warning letter to the 
                                retailer;
                                    (II) in the case of a second 
                                violation within a 12-month period, 
                                $250;
                                    (III) in the case of a third 
                                violation within a 24-month period, 
                                $500;
                                    (IV) in the case of a fourth 
                                violation within a 24-month period, 
                                $2,000;
                                    (V) in the case of a fifth violation 
                                within a 36-month period, $5,000; and
                                    (VI) in the case of a sixth or 
                                subsequent violation within a 48-month 
                                period, $10,000 as determined by the 
                                Secretary on a case-by-case basis.

[[Page 123 STAT. 1840]]

                          (ii) With respect to a retailer that does not 
                      have an approved training program, the amount of 
                      the civil penalty shall not exceed--
                                    (I) in the case of the first 
                                violation, $250;
                                    (II) in the case of a second 
                                violation within a 12-month period, 
                                $500;
                                    (III) in the case of a third 
                                violation within a 24-month period, 
                                $1,000;
                                    (IV) in the case of a fourth 
                                violation within a 24-month period, 
                                $2,000;
                                    (V) in the case of a fifth violation 
                                within a 36-month period, $5,000; and
                                    (VI) in the case of a sixth or 
                                subsequent violation within a 48-month 
                                period, $10,000 as determined by the 
                                Secretary on a case-by-case basis.
                    (B) Training program.--For purposes of subparagraph 
                (A), the term ``approved training program'' means a 
                training program that complies with standards developed 
                by the Food and Drug Administration for such programs.
                    (C) Consideration of state penalties.--The Secretary 
                shall coordinate with the States in enforcing the 
                provisions of this Act and, for purposes of mitigating a 
                civil penalty to be applied for a violation by a 
                retailer of any restriction promulgated under section 
                906(d), shall consider the amount of any penalties paid 
                by the retailer to a State for the same violation.
            (3) <<NOTE: 21 USC 333 note.>>  General effective date.--The 
        amendments made by paragraphs (2), (3), and (4) of subsection 
        (c) shall take effect upon the issuance of guidance described in 
        paragraph (1) of this subsection.
            (4) <<NOTE: 21 USC 333 note.>>  Special effective date.--The 
        amendment made by subsection (c)(1) shall take effect on the 
        date of enactment of this Act.
            (5) <<NOTE: 21 USC 387c note.>>  Package label 
        requirements.--The package label requirements of paragraphs (3) 
        and (4) of section 903(a) of the Federal Food, Drug, and 
        Cosmetic Act (as amended by this division) shall take effect on 
        the date that is 12 months after the date of enactment of this 
        Act. The package label requirements of paragraph (2) of such 
        section 903(a) for cigarettes shall take effect on the date that 
        is 15 months after the issuance of the regulations required by 
        section 4(d) of the Federal Cigarette Labeling and Advertising 
        Act (15 U.S.C. 1333), as amended by section 201 of this 
        division. The package label requirements of paragraph (2) of 
        such section 903(a) for tobacco products other than cigarettes 
        shall take effect on the date that is 12 months after the date 
        of enactment of this Act. The effective date shall be with 
        respect to the date of manufacture, provided that, in any case, 
        beginning 30 days after such effective date, a manufacturer 
        shall not introduce into the domestic commerce of the United 
        States any product, irrespective of the date of manufacture, 
        that is not in conformance with section 903(a) (2), (3), and (4) 
        and section 920(a) of the Federal Food, Drug, and Cosmetic Act.
            (6) Advertising requirements.--The advertising requirements 
        of section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act 
        (as amended by this division) shall take effect on

[[Page 123 STAT. 1841]]

        the date that is 12 months after the date of enactment of this 
        Act.
SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PURCHASE TOBACCO 
                        PRODUCTS.

    The Secretary of Health and Human Services shall--
            (1) convene an expert panel to conduct a study on the public 
        health implications of raising the minimum age to purchase 
        tobacco products; and
            (2) not <<NOTE: Deadline. Reports.>>  later than 5 years 
        after the date of enactment of this Act, submit a report to the 
        Congress on the results of such study.
SEC. 105. <<NOTE: 21 USC 387f-1.>>  ENFORCEMENT ACTION PLAN FOR 
                        ADVERTISING AND PROMOTION RESTRICTIONS.

    (a) Action Plan.--
            (1) Development.--Not 
        later <<NOTE: Deadline. Publication.>>  than 6 months after the 
        date of enactment of this Act, the Secretary of Health and Human 
        Services (in this section referred to as the ``Secretary'') 
        shall develop and publish an action plan to enforce restrictions 
        adopted pursuant to section 906 of the Federal Food, Drug, and 
        Cosmetic Act, as added by section 101(b) of this division, or 
        pursuant to section 102(a) of this division, on promotion and 
        advertising of menthol and other cigarettes to youth.
            (2) Consultation.--The action plan required by paragraph (1) 
        shall be developed in consultation with public health 
        organizations and other stakeholders with demonstrated expertise 
        and experience in serving minority communities.
            (3) Priority.--The action plan required by paragraph (1) 
        shall include provisions designed to ensure enforcement of the 
        restrictions described in paragraph (1) in minority communities.

    (b) State and Local Activities.--
            (1) Information on authority.--Not 
        later <<NOTE: Deadline.>>  than 3 months after the date of 
        enactment of this Act, the Secretary shall inform State, local, 
        and tribal governments of the authority provided to such 
        entities under section 5(c) of the Federal Cigarette Labeling 
        and Advertising Act, as added by section 203 of this division, 
        or preserved by such entities under section 916 of the Federal 
        Food, Drug, and Cosmetic Act, as added by section 101(b) of this 
        division.
            (2) Community assistance.--At the request of communities 
        seeking assistance to prevent underage tobacco use, the 
        Secretary shall provide such assistance, including assistance 
        with strategies to address the prevention of underage tobacco 
        use in communities with a disproportionate use of menthol 
        cigarettes by minors.
SEC. 106. <<NOTE: 21 USC 387u.>>  STUDIES OF PROGRESS AND 
                        EFFECTIVENESS.

    (a) FDA Report.--Not later than 3 years after the date of enactment 
of this Act, and not less than every 2 years thereafter, the Secretary 
of Health and Human Services 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 concerning--
            (1) the progress of the Food and Drug Administration in 
        implementing this division, including major accomplishments, 
        objective measurements of progress, and the identification of 
        any areas that have not been fully implemented;

[[Page 123 STAT. 1842]]

            (2) impediments identified by the Food and Drug 
        Administration to progress in implementing this division and to 
        meeting statutory timeframes;
            (3) data on the number of new product applications received 
        under section 910 of the Federal Food, Drug, and Cosmetic Act 
        and modified risk product applications received under section 
        911 of such Act, and the number of applications acted on under 
        each category; and
            (4) data on the number of full time equivalents engaged in 
        implementing this division.

    (b) GAO Report.--Not later <<NOTE: Study.>>  than 5 years after the 
date of enactment of this Act, the Comptroller General of the United 
States shall conduct a study of, and submit to the Committees described 
in subsection (a) a report concerning--
            (1) the adequacy of the authority and resources provided to 
        the Secretary of Health and Human Services for this division to 
        carry out its goals and purposes; and
            (2) any recommendations for strengthening that authority to 
        more effectively protect the public health with respect to the 
        manufacture, marketing, and distribution of tobacco products.

    (c) Public Availability.--The Secretary <<NOTE: Web posting.>>  of 
Health and Human Services and the Comptroller General of the United 
States, respectively, shall make the reports required under subsection 
(a) and (b) available to the public, including by posting such reports 
on the respective Internet websites of the Food and Drug Administration 
and the Government Accountability Office.

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

SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.

    (a) Amendment.--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 nonsmokers.

[[Page 123 STAT. 1843]]

                    ``WARNING: Quitting smoking now greatly reduces 
                serious risks to your health.
            ``(2) Placement; typography; etc.--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. Each 
        label statement shall comprise the top 50 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 (c).
            ``(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--
                    ``(A) contains a warning label;
                    ``(B) is supplied to the retailer by a license- or 
                permit-holding tobacco product manufacturer, importer, 
                or distributor; and
                    ``(C) is not altered by the retailer in a way that 
                is material to the requirements of 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).
            ``(2) Typography, etc.--Each label statement required by 
        subsection (a) 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 
        subsection (c). 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'

[[Page 123 STAT. 1844]]

        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--
                    ``(A) in the case of 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; the text, format, and type sizes of 
        any required tar, nicotine yield, or other constituent 
        (including smoke constituent) disclosures; or the text, format, 
        and type sizes for any other disclosures required under the 
        Federal Food, Drug, and Cosmetic Act. 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). <<NOTE: Regulations.>>  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.

    ``(c) Marketing Requirements.--
            ``(1) Random display.--The label <<NOTE: Time period.>>  
        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.
            ``(2) Rotation.--The label <<NOTE: Deadline.>>  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.
            ``(3) Review.--The Secretary shall review each plan 
        submitted under paragraph (2) and approve it if the plan--

[[Page 123 STAT. 1845]]

                    ``(A) will provide for the equal distribution and 
                display on packaging and the rotation required in 
                advertising under this subsection; and
                    ``(B) 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.
            ``(4) Applicability to retailers.--This subsection and 
        subsection (b) apply 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 does not contain a 
        warning label or has been altered by the retailer in a way that 
        is material to the requirements of this subsection and 
        subsection (b).

    ``(d) Graphic Label Statements.--Not 
later <<NOTE: Deadline. Regulations.>>  than 24 months after the date of 
enactment of the Family Smoking Prevention and Tobacco Control Act, the 
Secretary shall issue regulations that require color graphics depicting 
the negative health consequences of smoking to accompany the label 
statements specified in subsection (a)(1). The Secretary may adjust the 
type size, text and format of the label statements specified in 
subsections (a)(2) and (b)(2) as the Secretary determines appropriate so 
that both the graphics and the accompanying label statements are clear, 
conspicuous, legible and appear within the specified area.''.

    (b) Effective Date.--The amendment <<NOTE: 15 USC 1333 note.>>  made 
by subsection (a) shall take effect 15 months after the issuance of the 
regulations required by subsection (a). Such effective date shall be 
with respect to the date of manufacture, provided that, in any case, 
beginning 30 days after such effective date, a manufacturer shall not 
introduce into the domestic commerce of the United States any product, 
irrespective of the date of manufacture, that is not in conformance with 
section 4 of the Federal Cigarette Labeling and Advertising Act (15 
U.S.C. 1333), as amended by subsection (a).
SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING LABEL STATEMENTS.

    (a) Preemption.--Section 5(a) of the Federal Cigarette Labeling and 
Advertising Act (15 U.S.C. 1334(a)) is amended by striking ``No'' and 
inserting ``Except to the extent the Secretary requires additional or 
different statements on any cigarette package by a regulation, by an 
order, by a standard, by an authorization to market a product, or by a 
condition of marketing a product, pursuant to the Family Smoking 
Prevention and Tobacco Control Act (and the amendments made by that 
Act), or as required under section 903(a)(2) or section 920(a) of the 
Federal Food, Drug, and Cosmetic Act, no''.
    (b) Change in Required 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:
    ``(d) Change in Required Statements.--The Secretary through a 
rulemaking conducted under section 553 of title 5, United States Code, 
may adjust the format, type size, color graphics, and text of any of the 
label requirements, or establish the format, type size, and text of any 
other disclosures required under the Federal Food, Drug, and Cosmetic 
Act, if the Secretary finds that

[[Page 123 STAT. 1846]]

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.

    (a) Amendment.--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.

[[Page 123 STAT. 1847]]

            ``(5) A retailer of smokeless tobacco products shall not be 
        in violation of this subsection for packaging that--
                    ``(A) contains a warning label;
                    ``(B) is supplied to the retailer by a license- or 
                permit-holding tobacco product manufacturer, importer, 
                or distributor; and
                    ``(C) is not altered by the retailer in a way that 
                is material to the requirements of 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)(A) Each label statement required by subsection (a) in 
        smokeless tobacco advertising shall comply with the standards 
        set forth in this paragraph.
            ``(B) For press and poster advertisements, each such 
        statement and (where applicable) any required statement relating 
        to tar, nicotine, or other constituent yield shall comprise at 
        least 20 percent of the area of the advertisement.
            ``(C) The word `WARNING' shall appear in capital letters, 
        and each label statement shall appear in conspicuous and legible 
        type.
            ``(D) 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).
            ``(E) 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.
            ``(F) 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.
            ``(G) The label statements shall be in English, except 
        that--
                    ``(i) in the case of 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
                    ``(ii) 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)(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

[[Page 123 STAT. 1848]]

        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 
        subparagraphs (A) and (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 <<NOTE: Applicability.>>  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 does not contain a warning label or has been altered by the 
        retailer in a way that is material to the requirements of this 
        subsection.
            ``(4) 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; the 
        text, format, and type sizes of any required tar, nicotine 
        yield, or other constituent disclosures; or the text, format, 
        and type sizes for any other disclosures required under the 
        Federal Food, Drug, and Cosmetic Act. The text of any such label 
        statements or disclosures shall be required to appear only 
        within the 20 percent area of advertisements provided by 
        paragraph (2). <<NOTE: Regulations.>>  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.

    ``(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.''.
    (b) <<NOTE: 15 USC 4402 note.>>  Effective Date.--The amendment made 
by subsection (a) shall take effect 12 months after the date of 
enactment of this Act. Such effective date shall be with respect to the 
date of manufacture, provided that, in any case, beginning 30 days after 
such effective date, a manufacturer shall not introduce into the 
domestic commerce of the United States any product, irrespective of the 
date of manufacture, that is not in conformance with section 3 of the 
Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 
4402), as amended by subsection (a).
SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT WARNING 
                        LABEL STATEMENTS.

    (a) In General.--Section 3 of the Comprehensive Smokeless Tobacco 
Health Education Act of 1986 (15 U.S.C. 4402), as amended by section 
204, 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

[[Page 123 STAT. 1849]]

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, if the Secretary finds that such a 
change would promote greater public understanding of the risks 
associated with the use of smokeless tobacco products.''.
    (b) Preemption.--Section 7(a) of the Comprehensive Smokeless Tobacco 
Health Education Act of 1986 (15 U.S.C. 4406(a)) is amended by striking 
``No'' and inserting ``Except as provided in the Family Smoking 
Prevention and Tobacco Control Act (and the amendments made by that 
Act), no''.
SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT DISCLOSURE TO 
                        THE PUBLIC.

    Section 4 of the Federal Cigarette Labeling and Advertising Act (15 
U.S.C. 1333), as amended by sections 201 and 202, is further amended by 
adding at the end the following:
    ``(e) Tar, Nicotine, and Other Smoke Constituent Disclosure.--
            ``(1) In general.--The Secretary <<NOTE: Regulations.>>  
        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.
            ``(2) <<NOTE: Memorandum.>>  Resolution of differences.--Any 
        differences between the requirements established by the 
        Secretary under paragraph (1) 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.
            ``(3) Cigarette and other tobacco product constituents.--In 
        addition to the disclosures required by paragraph (1), 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.

[[Page 123 STAT. 1850]]

            ``(4) Retailers.--This subsection <<NOTE: Applicability.>>  
        applies to a retailer only if that retailer is responsible for 
        or directs the label statements required under this section.''.

       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. 920. <<NOTE: 21 USC 387t.>>  LABELING, RECORDKEEPING, 
                        RECORDS INSPECTION.

    ``(a) Origin Labeling.--
            ``(1) Requirement.--Beginning 1 <<NOTE: Effective dates.>>  
        year after the date of enactment of the Family Smoking 
        Prevention and Tobacco Control Act, the label, packaging, and 
        shipping containers of tobacco products other than cigarettes 
        for introduction or delivery for introduction into interstate 
        commerce in the United States shall bear the statement `sale 
        only allowed in the United States'. Beginning 15 months after 
        the issuance of the regulations required by section 4(d) of the 
        Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333), 
        as amended by section 201 of Family Smoking Prevention and 
        Tobacco Control Act, the label, packaging, and shipping 
        containers of cigarettes for introduction or delivery for 
        introduction into interstate commerce in the United States shall 
        bear the statement `Sale only allowed in the United States'.
            ``(2) Effective date.--The effective date specified in 
        paragraph (1) shall be with respect to the date of manufacture, 
        provided that, in any case, beginning 30 days after such 
        effective date, a manufacturer shall not introduce into the 
        domestic commerce of the United States any product, irrespective 
        of the date of manufacture, that is not in conformance with such 
        paragraph.

    ``(b) Regulations Concerning Recordkeeping for Tracking and 
Tracing.--
            ``(1) In general.--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.

[[Page 123 STAT. 1851]]

            ``(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 <<NOTE: Notice.>>  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. The Secretary shall 
not authorize an officer or employee of the government of any of the 
several States to exercise authority under the preceding sentence on 
Indian country without the express written consent of the Indian tribe 
involved.

    ``(d) Knowledge of Illegal Transaction.--
            ``(1) Notification.--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 and the Secretary of the Treasury 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.

    ``(e) Consultation.--In carrying out this section, the Secretary 
shall consult with the Attorney General of the United States and the 
Secretary of the Treasury, as appropriate.''.
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; and

[[Page 123 STAT. 1852]]

            (3) collect data on the health effects (particularly with 
        respect to individuals under 18 years of age) resulting from 
        cross-border trade in tobacco products, including the health 
        effects resulting from--
                    (A) the illicit trade of tobacco products and the 
                trade of counterfeit tobacco products; and
                    (B) the differing tax rates applicable to tobacco 
                products.

    (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).
    (c) Definition.--In this section:
            (1) The term ``cross-border trade'' means trade across a 
        border of the United States, a State or Territory, or Indian 
        country.
            (2) The term ``Indian country'' has the meaning given to 
        such term in section 1151 of title 18, United States Code.
            (3) The terms ``State'' and ``Territory'' have the meanings 
        given to those terms in section 201 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 321).

 DIVISION <<NOTE: Federal Retirement Reform Act of 2009.>>  B--FEDERAL 
RETIREMENT REFORM ACT
SEC. 100. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This division <<NOTE: 5 USC 101 note.>>  may be 
cited as the ``Federal Retirement Reform Act of 2009''.

    (b) Table of Contents.--The table of contents for this division is 
as follows:

                DIVISION B--FEDERAL RETIREMENT REFORM ACT

Sec. 100. Short title; table of contents.

      TITLE I--PROVISIONS RELATING TO FEDERAL EMPLOYEES RETIREMENT

Sec. 101. Short title.
Sec. 102. Automatic enrollments and immediate employing agency 
           contributions.
Sec. 103. Qualified Roth contribution program.
Sec. 104. Authority to establish mutual fund window.
Sec. 105. Reporting requirements.
Sec. 106. Acknowledgment of risk.
Sec. 107. Subpoena authority.
Sec. 108. Amounts in Thrift Savings Funds subject to legal proceedings.
Sec. 109. Accounts for surviving spouses.
Sec. 110. Treatment of members of the uniformed services under the 
           Thrift Savings Plan.

TITLE II--SPECIAL SURVIVOR INDEMNITY ALLOWANCE FOR SURVIVING SPOUSES OF 
                          ARMED FORCES MEMBERS

Sec. 201. Increase in monthly amount of special survivor indemnity 
           allowance for widows and widowers of deceased members of the 
           Armed Forces affected by required Survivor Benefit Plan 
           annuity offset for dependency and indemnity compensation.

[[Page 123 STAT. 1853]]

    TITLE <<NOTE: Thrift Savings Plan Enhancement Act of 2009.>>  I--
PROVISIONS RELATING TO FEDERAL EMPLOYEES RETIREMENT
SEC. 101. <<NOTE: 5 USC 101 note.>>  SHORT TITLE.

    This title may be cited as the ``Thrift Savings Plan Enhancement Act 
of 2009''.
SEC. 102. AUTOMATIC ENROLLMENTS AND IMMEDIATE EMPLOYING AGENCY 
                        CONTRIBUTIONS.

    (a) In General.--Section 8432(b) of title 5, United States Code, is 
amended by striking paragraphs (2) through (4) and inserting the 
following:
    ``(2)(A) The <<NOTE: Regulations.>>  Executive Director shall by 
regulation provide for an eligible individual to be automatically 
enrolled to make contributions under subsection (a) at the default 
percentage of basic pay.

    ``(B) For purposes of this paragraph, the default percentage shall 
be equal to 3 percent or such other percentage, not less than 2 percent 
nor more than 5 percent, as the Board may prescribe.
    ``(C) The regulations shall include provisions under which any 
individual who would otherwise be automatically enrolled in accordance 
with subparagraph (A) may--
            ``(i) modify the percentage or amount to be contributed 
        pursuant to automatic enrollment, effective not later than the 
        first full pay period following receipt of the election by the 
        appropriate processing entity; or
            ``(ii) decline automatic enrollment altogether.

    ``(D)(i) Except as provided in clause (ii), for purposes of this 
paragraph, the term `eligible individual' means any individual who, 
after any regulations under subparagraph (A) first take effect, is 
appointed, transferred, or reappointed to a position in which that 
individual becomes eligible to contribute to the Thrift Savings Fund.
    ``(ii) Members of the uniformed services shall not be eligible 
individuals for purposes of this paragraph.
    ``(E) Sections <<NOTE: Applicability.>>  8351(a)(1), 8440a(a)(1), 
8440b(a)(1), 8440c(a)(1), 8440d(a)(1), and 8440e(a)(1) shall be applied 
in a manner consistent with the purposes of this paragraph.''.

    (b) Technical Amendment.--Section 8432(b)(1) of title 5, United 
States Code, is amended by striking the parenthetical matter in 
subparagraph (B).
SEC. 103. QUALIFIED ROTH CONTRIBUTION PROGRAM.

    (a) In General.--Subchapter III of chapter 84 of title 5, United 
States Code, is amended by inserting after section 8432c the following:
``Sec. 8432d. Qualified Roth contribution program

    ``(a) Definitions.--For purposes of this section--
            ``(1) the term `qualified Roth contribution program' means a 
        program described in paragraph (1) of section 402A(b) of the 
        Internal Revenue Code of 1986 which meets the requirements of 
        paragraph (2) of such section; and
            ``(2) the terms `designated Roth contribution' and `elective 
        deferral' have the meanings given such terms in section 402A of 
        the Internal Revenue Code of 1986.

[[Page 123 STAT. 1854]]

    ``(b) Authority To Establish.--The Executive <<NOTE: Regulations.>>  
Director shall by regulation provide for the inclusion in the Thrift 
Savings Plan of a qualified Roth contribution program, under such terms 
and conditions as the Board may prescribe.

    ``(c) Required Provisions.--The regulations under subsection (b) 
shall include--
            ``(1) provisions under which an election to make designated 
        Roth contributions may be made--
                    ``(A) by any individual who is eligible to make 
                contributions under section 8351, 8432(a), 8440a, 8440b, 
                8440c, 8440d, or 8440e; and
                    ``(B) by any individual, not described in 
                subparagraph (A), who is otherwise eligible to make 
                elective deferrals under the Thrift Savings Plan;
            ``(2) any provisions which may, as a result of enactment of 
        this section, be necessary in order to clarify the meaning of 
        any reference to an `account' made in section 8432(f), 8433, 
        8434(d), 8435, 8437, or any other provision of law; and
            ``(3) any other provisions which may be necessary to carry 
        out this section.''.

    (b) Clerical Amendment.--The analysis for chapter 84 of title 5, 
United States Code, is amended by inserting after the item relating to 
section 8432c the following:

``8432d. Qualified Roth contribution program.''.

SEC. 104. AUTHORITY TO ESTABLISH MUTUAL FUND WINDOW.

    (a) In General.--Section 8438(b)(1) of title 5, United States Code, 
is amended--
            (1) in subparagraph (D), by striking ``and'' at the end;
            (2) in subparagraph (E), by striking the period and 
        inserting ``; and''; and
            (3) by adding after subparagraph (E) the following:
                    ``(F) a service that enables participants to invest 
                in mutual funds, if the Board authorizes the mutual fund 
                window under paragraph (5).''.

    (b) Requirements.--Section 8438(b) of title 5, United States Code, 
is amended by adding at the end the following:
    ``(5)(A) The Board may authorize the addition of a mutual fund 
window under the Thrift Savings Plan if the Board determines that such 
addition would be in the best interests of participants.
    ``(B) The Board shall ensure that any expenses charged for use of 
the mutual fund window are borne solely by the participants who use such 
window.
    ``(C) The Board may establish such other terms and conditions for 
the mutual fund window as the Board considers appropriate to protect the 
interests of participants, including requirements relating to risk 
disclosure.
    ``(D) The <<NOTE: Consultation.>>  Board shall consult with the 
Employee Thrift Advisory Council (established under section 8473) before 
authorizing the addition of a mutual fund window or establishing a 
service that enables participants to invest in mutual funds.''.

    (c) Technical and Conforming Amendment.--Section 8438(d)(1) of title 
5, United States Code, is amended by inserting ``and options'' after 
``investment funds''.

[[Page 123 STAT. 1855]]

SEC. 105. <<NOTE: 5 USC 8439 note.>>  REPORTING REQUIREMENTS.

    (a) Annual Report.--The Board shall, not later than June 30 of each 
year, submit to Congress an annual report on the operations of the 
Thrift Savings Plan. Such report shall include, for the prior calendar 
year, information on the number of participants as of the last day of 
such prior calendar year, the median balance in participants' accounts 
as of such last day, demographic information on participants, the 
percentage allocation of amounts among investment funds or options, the 
status of the development and implementation of the mutual fund window, 
the diversity demographics of any company, investment adviser, or other 
entity retained to invest and manage the assets of the Thrift Savings 
Fund, and such other information as the Board considers appropriate. 
A <<NOTE: Public information. Web posting.>>  copy of each annual report 
under this subsection shall be made available to the public through an 
Internet website.

    (b) Reporting of Fees and Other Information.--
            (1) In general.--The Board shall include in the periodic 
        statements provided to participants under section 8439(c) of 
        title 5, United States Code, the amount of the investment 
        management fees, administrative expenses, and any other fees or 
        expenses paid with respect to each investment fund and option 
        under the Thrift Savings Plan. <<NOTE: Notification.>>  Any such 
        statement shall also provide a statement notifying participants 
        as to how they may access the annual report described in 
        subsection (a), as well as any other information concerning the 
        Thrift Savings Plan that might be useful.
            (2) Use of estimates.--For purposes of providing the 
        information required under this subsection, the Board may 
        provide a reasonable and representative estimate of any fees or 
        expenses described in paragraph (1) and shall indicate any such 
        estimate as being such an estimate. Any such estimate shall be 
        based on the previous year's experience.

    (c) Definitions.--For purposes of this section--
            (1) the term ``Board'' has the meaning given such term by 
        8401(5) of title 5, United States Code;
            (2) the term ``participant'' has the meaning given such term 
        by section 8471(3) of title 5, United States Code; and
            (3) the term ``account'' means an account established under 
        section 8439 of title 5, United States Code.
SEC. 106. ACKNOWLEDGMENT OF RISK.

    (a) In General.--Section 8439(d) of title 5, United States Code, is 
amended--
            (1) by striking the matter after ``who elects to invest in'' 
        and before ``shall sign an acknowledgment'' and inserting ``any 
        investment fund or option under this chapter, other than the 
        Government Securities Investment Fund,''; and
            (2) by striking ``either such Fund'' and inserting ``any 
        such fund or option''.

    (b) Coordination With Provisions Relating to Fiduciary 
Responsibilities, Liabilities, and Penalties.--Section 8477(e)(1)(C) of 
title 5, United States Code, is amended--
            (1) by redesignating subparagraph (C) as subparagraph 
        (C)(i); and
            (2) by adding at the end the following:

    ``(ii) A fiduciary shall not be liable under subparagraph (A), and 
no civil action may be brought against a fiduciary--

[[Page 123 STAT. 1856]]

            ``(I) for providing for the automatic enrollment of a 
        participant in accordance with section 8432(b)(2)(A);
            ``(II) for enrolling a participant in a default investment 
        fund in accordance with section 8438(c)(2); or
            ``(III) for allowing a participant to invest through the 
        mutual fund window or for establishing restrictions applicable 
        to participants' ability to invest through the mutual fund 
        window.''.
SEC. 107. SUBPOENA AUTHORITY.

    (a) In General.--Chapter 84 of title 5, United States Code, is 
amended by inserting after section 8479 the following:
``Sec. 8480. Subpoena authority

    ``(a) In order to carry out the responsibilities specified in this 
subchapter and subchapter III of this chapter, the Executive Director 
may issue subpoenas commanding each person to whom the subpoena is 
directed to produce designated books, documents, records, electronically 
stored information, or tangible materials in the possession or control 
of that individual.
    ``(b) Notwithstanding any Federal, State, or local law, any person, 
including officers, agents, and employees, receiving a subpoena under 
this section, who complies in good faith with the subpoena and thus 
produces the materials sought, shall not be liable in any court of any 
State or the United States to any individual, domestic or foreign 
corporation or upon a partnership or other unincorporated association 
for such production.
    ``(c) When a person fails to obey a subpoena issued under this 
section, the district court of the United States for the district in 
which the investigation is conducted or in which the person failing to 
obey is found, shall on proper application issue an order directing that 
person to comply with the subpoena. The court may punish as contempt any 
disobedience of its order.
    ``(d) The <<NOTE: Regulations.>>  Executive Director shall prescribe 
regulations to carry out subsection (a).''.

    (b) Technical and Conforming Amendment.--The table of sections for 
chapter 84 of title 5, United States Code, is amended by inserting after 
the item relating to section 8479 the following:

``8480. Subpoena authority.''.

SEC. 108. AMOUNTS IN THRIFT SAVINGS FUNDS SUBJECT TO LEGAL 
                        PROCEEDINGS.

    Section 8437(e)(3) of title 5, United States Code, is amended in the 
first sentence by striking ``or relating to the enforcement of a 
judgment for the physically, sexually, or emotionally abusing a child as 
provided under section 8467(a)'' and inserting ``the enforcement of an 
order for restitution under section 3663A of title 18, forfeiture under 
section 8432(g)(5) of this title, or an obligation of the Executive 
Director to make a payment to another person under section 8467 of this 
title''.
SEC. 109. ACCOUNTS FOR SURVIVING SPOUSES.

    Section 8433(e) of title 5, United States Code, is amended--
            (1) by inserting ``(1)'' after ``(e)''; and
            (2) by adding at the end the following:

    ``(2) Notwithstanding section 8424(d), if an employee, Member, 
former employee, or former Member dies and has designated as

[[Page 123 STAT. 1857]]

sole or partial beneficiary his or her spouse at the time of death, or, 
if an employee, Member, former employee, or former Member, dies with no 
designated beneficiary and is survived by a spouse, the spouse may 
maintain the portion of the employee's or Member's account to which the 
spouse is entitled in accordance with the following terms:
            ``(A) Subject to the limitations of subparagraph (B), the 
        spouse shall have the same withdrawal options under subsection 
        (b) as the employee or Member were the employee or Member 
        living.
            ``(B) The spouse may not make withdrawals under subsection 
        (g) or (h).
            ``(C) The spouse may not make contributions or transfers to 
        the account.
            ``(D) The account shall be disbursed upon the death of the 
        surviving spouse. A beneficiary or surviving spouse of a 
        deceased spouse who has inherited an account is ineligible to 
        maintain the inherited spousal account.

    ``(3) The <<NOTE: Regulations.>>  Executive Director shall prescribe 
regulations to carry out this subsection.''.
SEC. 110. TREATMENT OF MEMBERS OF THE UNIFORMED SERVICES UNDER THE 
                        THRIFT SAVINGS PLAN.

    (a) Sense of Congress.--It is the sense of Congress that--
            (1) members of the uniformed services should have a 
        retirement system that is at least as generous as the one which 
        is available to Federal civilian employees; and
            (2) Federal civilian employees receive matching 
        contributions from their employing agencies for their 
        contributions to the Thrift Savings Fund, but the costs of 
        requiring such a matching contribution from the Department of 
        Defense could be significant.

    (b) Reporting Requirement.--Not later than 180 days after the date 
of the enactment of this Act, the Secretary of Defense shall report to 
Congress on--
            (1) the cost to the Department of Defense of providing a 
        matching payment with respect to contributions made to the 
        Thrift Savings Fund by members of the Armed Forces;
            (2) the effect that requiring such a matching payment would 
        have on recruitment and retention; and
            (3) any other information that the Secretary of Defense 
        considers appropriate.

TITLE II--SPECIAL SURVIVOR INDEMNITY ALLOWANCE FOR SURVIVING SPOUSES OF 
                          ARMED FORCES MEMBERS

SEC. 201. INCREASE IN MONTHLY AMOUNT OF SPECIAL SURVIVOR INDEMNITY 
                        ALLOWANCE FOR WIDOWS AND WIDOWERS OF 
                        DECEASED MEMBERS OF THE ARMED FORCES 
                        AFFECTED BY REQUIRED SURVIVOR BENEFIT PLAN 
                        ANNUITY OFFSET FOR DEPENDENCY AND 
                        INDEMNITY COMPENSATION.

    (a) Payment Amount Per Fiscal Year.--Paragraph (2) of section 
1450(m) of title 10, United States Code, is amended--

[[Page 123 STAT. 1858]]

            (1) in subparagraph (E), by striking ``and'' after the 
        semicolon; and
            (2) by striking subparagraph (F) and inserting the following 
        new subparagraphs:
                    ``(F) for months during fiscal year 2014, $150;
                    ``(G) for months during fiscal year 2015, $200;
                    ``(H) for months during fiscal year 2016, $275; and
                    ``(I) for months during fiscal year 2017, $310.''.

    (b) Duration.--Paragraph (6) of such section is amended--
            (1) by striking ``February 28, 2016'' and inserting 
        ``September 30, 2017''; and
            (2) by striking ``March 1, 2016'' both places it appears and 
        inserting ``October 1, 2017''.

    Approved June 22, 2009.

LEGISLATIVE HISTORY--H.R. 1256:
---------------------------------------------------------------------------

HOUSE REPORTS: No. 111-58, Pt. 1 (Comm. on Energy and Commerce) and 
Pt. 2 (Comm. on Oversight and Government Reform).
CONGRESSIONAL RECORD, Vol. 155 (2009):
            Apr. 1, 2, considered and passed House.
            June 3, 4, 8-11, considered and passed Senate, amended.
            June 12, House concurred in Senate amendment.
DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2009):
            June 22, Presidential remarks.

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