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[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1256 Enrolled Bill (ENR)]

        H.R.1256

                      One Hundred Eleventh Congress

                                 of the

                        United States of America

                          AT THE FIRST SESSION

          Begun and held at the City of Washington on Tuesday,
             the sixth day of January, two thousand and nine

                                 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.

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

     DIVISION A--FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
    (a) 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. FINDINGS.
    The Congress finds the following:
        (1) The use of tobacco products by the Nation's children is a 
    pediatric disease of considerable proportions that results in new 
    generations of tobacco-dependent children and adults.
        (2) A consensus exists within the scientific and medical 
    communities that tobacco products are inherently dangerous and 
    cause cancer, heart disease, and other serious adverse health 
    effects.
        (3) Nicotine is an addictive drug.
        (4) Virtually all new users of tobacco products are under the 
    minimum legal age to purchase such products.
        (5) Tobacco advertising and marketing contribute significantly 
    to the use of nicotine-containing tobacco products by adolescents.
        (6) Because past efforts to restrict advertising and marketing 
    of tobacco products have failed adequately to curb tobacco use by 
    adolescents, comprehensive restrictions on the sale, promotion, and 
    distribution of such products are needed.
        (7) Federal and State governments have lacked the legal and 
    regulatory authority and resources they need to address 
    comprehensively the public health and societal problems caused by 
    the use of tobacco products.
        (8) Federal and State public health officials, the public 
    health community, and the public at large recognize that the 
    tobacco industry should be subject to ongoing oversight.
        (9) Under article I, section 8 of the Constitution, the 
    Congress is vested with the responsibility for regulating 
    interstate commerce and commerce with Indian tribes.
        (10) The sale, distribution, marketing, advertising, and use of 
    tobacco products are activities in and substantially affecting 
    interstate commerce because they are sold, marketed, advertised, 
    and distributed in interstate commerce on a nationwide basis, and 
    have a substantial effect on the Nation's economy.
        (11) The sale, distribution, marketing, advertising, and use of 
    such products substantially affect interstate commerce through the 
    health care and other costs attributable to the use of tobacco 
    products.
        (12) It is in the public interest for Congress to enact 
    legislation that provides the Food and Drug Administration with the 
    authority to regulate tobacco products and the advertising and 
    promotion of such products. The benefits to the American people 
    from enacting such legislation would be significant in human and 
    economic terms.
        (13) Tobacco use is the foremost preventable cause of premature 
    death in America. It causes over 400,000 deaths in the United 
    States each year, and approximately 8,600,000 Americans have 
    chronic illnesses related to smoking.
        (14) Reducing the use of tobacco by minors by 50 percent would 
    prevent well over 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 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 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.
        (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 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. 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;
        (3) to authorize the Food and Drug Administration to set 
    national standards controlling the manufacture of tobacco products 
    and the identity, public disclosure, and amount of ingredients used 
    in such products;
        (4) to provide new and flexible enforcement authority to ensure 
    that there is effective oversight of the tobacco industry's efforts 
    to develop, introduce, and promote less harmful tobacco products;
        (5) to vest the Food and Drug Administration with the authority 
    to regulate the levels of tar, nicotine, and other harmful 
    components of tobacco products;
        (6) in order to ensure that consumers are better informed, to 
    require tobacco product manufacturers to disclose research which 
    has not previously been made available, as well as research 
    generated in the future, relating to the health and dependency 
    effects or safety of tobacco products;
        (7) to continue to permit the sale of tobacco products to 
    adults in conjunction with measures to ensure that they are not 
    sold or accessible to underage purchasers;
        (8) to impose appropriate regulatory controls on the tobacco 
    industry;
        (9) to promote cessation to reduce disease risk and the social 
    costs associated with tobacco-related diseases; and
        (10) to strengthen legislation against illicit trade in tobacco 
    products.
SEC. 4. SCOPE AND EFFECT.
    (a) Intended Effect.--Nothing in this 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. 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.
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) 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.
    ``(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 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. 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 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.
        ``(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 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 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 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 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. ADULTERATED TOBACCO PRODUCTS.
    ``A tobacco product shall be deemed to be adulterated if--
        ``(1) it consists in whole or in part of any filthy, putrid, or 
    decomposed substance, or is otherwise contaminated by any added 
    poisonous or added deleterious substance that may render the 
    product injurious to health;
        ``(2) it has been prepared, packed, or held under insanitary 
    conditions whereby it may have been contaminated with filth, or 
    whereby it may have been rendered injurious to health;
        ``(3) its package is composed, in whole or in part, of any 
    poisonous or deleterious substance which may render the contents 
    injurious to health;
        ``(4) 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. MISBRANDED TOBACCO PRODUCTS.
    ``(a) In General.--A tobacco product shall be deemed to be 
misbranded--
        ``(1) if its labeling is false or misleading in any particular;
        ``(2) if in package form unless it bears a label containing--
            ``(A) the name and place of business of the tobacco product 
        manufacturer, packer, or distributor;
            ``(B) an accurate statement of the quantity of the contents 
        in terms of weight, measure, or numerical count;
            ``(C) an accurate statement of the percentage of the 
        tobacco used in the product that is domestically grown tobacco 
        and the percentage that is foreign grown tobacco; and
            ``(D) the statement required under section 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;
        ``(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 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 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. 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 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 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 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 
    (including smoke constituents), ingredients, components, and 
    additives.
        ``(2) Any or all documents (including underlying scientific 
    information) relating to research activities, and research 
    findings, conducted, supported, or possessed by the manufacturer 
    (or agents thereof) that relate to the issue of whether a reduction 
    in risk to health from tobacco products can occur upon the 
    employment of technology available or known to the manufacturer.
        ``(3) Any or all documents (including underlying scientific or 
    financial information) relating to marketing research involving the 
    use of tobacco products or marketing practices and the 
    effectiveness of such practices used by tobacco manufacturers and 
    distributors.
An importer of a tobacco product not manufactured in the United States 
shall supply the information required of a tobacco product manufacturer 
under this subsection.
    ``(c) Time for Submission.--
        ``(1) In general.--At least 90 days prior to the delivery for 
    introduction into interstate commerce of a tobacco product not on 
    the market on the date of enactment of the Family Smoking 
    Prevention and Tobacco Control Act, the manufacturer of such 
    product shall provide the information required under subsection 
    (a).
        ``(2) Disclosure of additive.--If at any time a tobacco product 
    manufacturer adds to its tobacco products a new tobacco additive or 
    increases the quantity of an existing tobacco additive, the 
    manufacturer shall, except as provided in paragraph (3), at least 
    90 days prior to such action so advise the Secretary in writing.
        ``(3) Disclosure of other actions.--If at any time a tobacco 
    product manufacturer eliminates or decreases an existing additive, 
    or adds or increases an additive that has by regulation been 
    designated by the Secretary as an additive that is not a human or 
    animal carcinogen, or otherwise harmful to health under intended 
    conditions of use, the manufacturer shall within 60 days of such 
    action so advise the Secretary in writing.
    ``(d) Data List.--
        ``(1) In general.--Not later than 3 years after the date of 
    enactment of the Family Smoking Prevention and Tobacco Control Act, 
    and annually thereafter, the Secretary shall publish in a format 
    that is understandable and not misleading to a lay person, and 
    place on public display (in a manner determined by the Secretary) 
    the list established under subsection (e).
        ``(2) Consumer research.--The Secretary shall conduct periodic 
    consumer research to ensure that the list published under paragraph 
    (1) is not misleading to lay persons. Not later than 5 years after 
    the date of enactment of the Family Smoking Prevention and Tobacco 
    Control Act, the Secretary shall submit to the appropriate 
    committees of Congress a report on the results of such research, 
    together with recommendations on whether such publication should be 
    continued or modified.
    ``(e) Data Collection.--Not later than 24 months after the date of 
enactment of the Family Smoking Prevention and Tobacco Control Act, the 
Secretary shall establish, and periodically revise 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. The Secretary shall publish a 
public notice requesting the submission by interested persons of 
scientific and other information concerning the harmful and potentially 
harmful constituents in tobacco products and tobacco smoke.
    ``SEC. 905. ANNUAL REGISTRATION.
    ``(a) Definitions.--In this section:
        ``(1) Manufacture, preparation, compounding, or processing.--
    The term `manufacture, preparation, compounding, or processing' 
    shall include repackaging or otherwise changing the container, 
    wrapper, or labeling of any tobacco product package in furtherance 
    of the distribution of the tobacco product from the original place 
    of manufacture to the person who makes final delivery or sale to 
    the ultimate consumer or user.
        ``(2) Name.--The term `name' shall include in the case of a 
    partnership the name of each partner and, in the case of a 
    corporation, the name of each corporate officer and director, and 
    the State of incorporation.
    ``(b) Registration by Owners and Operators.--On or before December 
31 of each year, every person who owns or operates any establishment in 
any State engaged in the manufacture, preparation, compounding, or 
processing of a tobacco product or tobacco products shall register with 
the Secretary the name, places of business, and all such establishments 
of that person. 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 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) 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.
        ``(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 since the date the registrant last made a report 
        under this paragraph that person has discontinued the 
        manufacture, preparation, compounding, or processing for 
        commercial distribution of a tobacco product included in a list 
        filed under subparagraph (A) or paragraph (1), notice of such 
        discontinuance, the date of such discontinuance, and the 
        identity of its established name.
            ``(C) If since the date the registrant reported under 
        subparagraph (B) a notice of discontinuance that person has 
        resumed the manufacture, preparation, compounding, or 
        processing for commercial distribution of the tobacco product 
        with respect to which such notice of discontinuance was 
        reported, notice of such resumption, the date of such 
        resumption, the identity of such tobacco product by established 
        name, and other information required by paragraph (1), unless 
        the registrant has previously reported such resumption to the 
        Secretary under this subparagraph.
            ``(D) Any material change in any information previously 
        submitted under this paragraph or paragraph (1).
    ``(j) Report Preceding Introduction of Certain Substantially 
Equivalent Products Into Interstate Commerce.--
        ``(1) In general.--Each person who is required to register 
    under this section and who proposes to begin the introduction or 
    delivery for introduction into interstate commerce for commercial 
    distribution of a tobacco product intended for human use that was 
    not commercially marketed (other than for test marketing) in the 
    United States as of 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
            ``(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 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. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO 
      PRODUCTS.
    ``(a) In General.--Any requirement established by or under section 
902, 903, 905, or 909 applicable to a tobacco product shall apply to 
such tobacco product until the applicability of the requirement to the 
tobacco product has been changed by action taken under section 907, 
section 910, section 911, or subsection (d) of this section, and any 
requirement established by or under section 902, 903, 905, or 909 which 
is inconsistent with a requirement imposed on such tobacco product 
under section 907, section 910, section 911, or subsection (d) of this 
section shall not apply to such tobacco product.
    ``(b) Information on Public Access and Comment.--Each notice of 
proposed rulemaking 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
        ``(2) the period within which interested persons may present 
    their comments on the notice or findings (including the need 
    therefore) orally or in writing, which period shall be at least 60 
    days but may not exceed 90 days unless the time is extended by the 
    Secretary by a notice published in the Federal Register stating 
    good cause therefore.
    ``(c) Limited Confidentiality of Information.--Any information 
reported to or otherwise obtained by the Secretary or the Secretary's 
representative under section 903, 904, 907, 908, 909, 910, 911, or 704, 
or under subsection (e) or (f) of this section, which is exempt from 
disclosure under subsection (a) of section 552 of title 5, United 
States Code, by reason of subsection (b)(4) of that section shall be 
considered confidential and shall not be disclosed, except that the 
information may be disclosed to other officers or employees concerned 
with carrying out this chapter, or when relevant in any proceeding 
under this chapter.
    ``(d) Restrictions.--
        ``(1) In general.--The Secretary may by regulation require 
    restrictions on the sale and distribution of a tobacco product, 
    including restrictions on the access to, and the advertising and 
    promotion of, the tobacco product, if the Secretary determines that 
    such regulation would be appropriate for the protection of the 
    public health. The Secretary may by regulation impose restrictions 
    on the advertising and promotion of a tobacco product consistent 
    with and to full extent permitted by the first amendment to the 
    Constitution. The finding as to whether such regulation would be 
    appropriate for the protection of the public health shall be 
    determined with respect to the risks and benefits to the population 
    as a whole, including users and 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 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) 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) 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) before promulgating any regulation under 
            subparagraph (A), afford the Tobacco Products Scientific 
            Advisory Committee an opportunity to submit recommendations 
            with respect to the regulation proposed to be promulgated;
                ``(ii) before promulgating any regulation under 
            subparagraph (A), afford opportunity for an oral hearing;
                ``(iii) provide the 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 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). The Tobacco Products Scientific Advisory 
        Committee shall report its recommendations to the Secretary 
        with respect to a petition referred to it within 60 days after 
        the date of the petition's referral. Within 60 days after--
                ``(i) the date the petition was submitted to the 
            Secretary under subparagraph (A); or
                ``(ii) the day after the petition was referred to the 
            Tobacco Products Scientific Advisory Committee,
        whichever occurs later, the Secretary shall by order either 
        deny the petition or approve it.
            ``(C) Approval.--The Secretary may approve--
                ``(i) a petition for an exemption for a tobacco product 
            from a requirement if the Secretary determines that 
            compliance with such requirement is not required to assure 
            that the tobacco product will be in compliance with this 
            chapter; and
                ``(ii) a petition for a variance for a tobacco product 
            from a requirement if the Secretary determines that the 
            methods to be used in, and the facilities and controls to 
            be used for, the manufacture, packing, and storage of the 
            tobacco product in lieu of the methods, 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. TOBACCO PRODUCT STANDARDS.
    ``(a) In General.--
        ``(1) 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.
        ``(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;
                ``(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 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 shall publish in the Federal 
    Register a notice of proposed rulemaking for the establishment, 
    amendment, or revocation of any tobacco product standard.
        ``(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 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 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 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 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) 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.
            ``(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. NOTIFICATION AND OTHER REMEDIES.
    ``(a) Notification.--If the Secretary determines that--
        ``(1) a tobacco product which is introduced or delivered for 
    introduction into interstate commerce for commercial distribution 
    presents an unreasonable risk of substantial harm to the public 
    health; and
        ``(2) notification under this subsection is necessary to 
    eliminate the unreasonable risk of such harm and no more 
    practicable means is available under the provisions of this chapter 
    (other than this section) to eliminate such risk,
the Secretary may issue such order as may be necessary to assure that 
adequate notification is provided in an appropriate form, by the 
persons and means best suited under the circumstances involved, to all 
persons who should properly receive such notification in order to 
eliminate such risk. The Secretary may order notification by any 
appropriate means, including public service announcements. Before 
issuing an order under this subsection, the Secretary shall consult 
with the persons who are to give notice under the order.
    ``(b) No Exemption From Other Liability.--Compliance with an order 
issued under this section shall not relieve any person from liability 
under Federal or State law. In awarding damages for economic loss in an 
action brought for the enforcement of any such liability, the value to 
the plaintiff in such action of any remedy provided under such order 
shall be taken into account.
    ``(c) Recall Authority.--
        ``(1) In general.--If the Secretary finds that there is a 
    reasonable probability that a tobacco product contains a 
    manufacturing or other defect not ordinarily contained in tobacco 
    products on the market that would cause serious, adverse health 
    consequences or death, the Secretary shall issue an order requiring 
    the appropriate person (including the manufacturers, importers, 
    distributors, or retailers of the tobacco product) to immediately 
    cease distribution of such tobacco product. The order shall provide 
    the person subject to the order with an opportunity for an informal 
    hearing, to be held not later than 10 days after the date of the 
    issuance of the order, on the actions required by the order and on 
    whether the order should be amended to require a recall of such 
    tobacco product. If, after providing an opportunity for such a 
    hearing, the Secretary determines that inadequate grounds exist to 
    support the actions required by the order, the Secretary shall 
    vacate the order.
        ``(2) Amendment of order to require recall.--
            ``(A) In general.--If, after providing an opportunity for 
        an informal hearing under paragraph (1), the Secretary 
        determines that the order should be amended to include a recall 
        of the tobacco product with respect to which the order was 
        issued, the Secretary shall, except as provided in subparagraph 
        (B), amend the order to require a recall. The Secretary shall 
        specify a timetable in which the tobacco product recall will 
        occur and shall require periodic reports to the Secretary 
        describing the progress of the recall.
            ``(B) Notice.--An amended order under subparagraph (A)--
                ``(i) shall not include recall of a tobacco product 
            from individuals; and
                ``(ii) shall provide for notice to persons subject to 
            the risks associated with the use of such tobacco product.
        In providing the notice required by clause (ii), the Secretary 
        may use the assistance of retailers and other persons who 
        distributed such tobacco product. If a significant number of 
        such persons cannot be identified, the Secretary shall notify 
        such persons under section 705(b).
        ``(3) Remedy not exclusive.--The remedy provided by this 
    subsection shall be in addition to remedies provided by subsection 
    (a).
    ``SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS.
    ``(a) In General.--Every person who is a tobacco product 
manufacturer or importer of a tobacco product shall establish and 
maintain such records, make such reports, and provide such information, 
as the Secretary may by regulation reasonably require to assure that 
such tobacco product is not adulterated or misbranded and to otherwise 
protect public health. Regulations prescribed under the preceding 
sentence--
        ``(1) may require a tobacco product manufacturer or importer to 
    report to the Secretary whenever the manufacturer or importer 
    receives or otherwise becomes aware of information that reasonably 
    suggests that one of its marketed tobacco products may have caused 
    or contributed to a serious unexpected adverse experience 
    associated with the use of the product or any significant increase 
    in the frequency of a serious, expected adverse product experience;
        ``(2) shall require reporting of other significant adverse 
    tobacco product experiences as determined by the Secretary to be 
    necessary to be reported;
        ``(3) shall not impose requirements unduly burdensome to a 
    tobacco product manufacturer or importer, taking into account the 
    cost of complying with such requirements and the need for the 
    protection of the public health and the implementation of this 
    chapter;
        ``(4) when prescribing the procedure for making requests for 
    reports or information, shall require that each request made under 
    such regulations for submission of a report or information to the 
    Secretary state the reason or purpose for such request and identify 
    to the fullest extent practicable such report or information;
        ``(5) when requiring submission of a report or information to 
    the Secretary, shall state the reason or purpose for the submission 
    of such report or information and identify to the fullest extent 
    practicable such report or information; and
        ``(6) may not require that the identity of any patient or user 
    be disclosed in records, reports, or information required under 
    this subsection unless required for the medical welfare of an 
    individual, to determine risks to public health of a tobacco 
    product, or to verify a record, report, or information submitted 
    under this chapter.
In prescribing regulations under this subsection, the Secretary shall 
have due regard for the professional ethics of the medical profession 
and the interests of patients. The prohibitions of paragraph (6) 
continue to apply to records, reports, and information concerning any 
individual who has been a patient, irrespective of whether or when he 
ceases to be a patient.
    ``(b) Reports of Removals and Corrections.--
        ``(1) In general.--Except as provided in paragraph (2), the 
    Secretary shall by regulation require a tobacco product 
    manufacturer or importer of a tobacco product to report promptly to 
    the Secretary any corrective action taken or removal from the 
    market of a tobacco product undertaken by such manufacturer or 
    importer if the removal or correction was undertaken--
            ``(A) to reduce a risk to health posed by the tobacco 
        product; or
            ``(B) to remedy a violation of this chapter caused by the 
        tobacco product which may present a risk to health.
    A tobacco product manufacturer or importer of a tobacco product who 
    undertakes a corrective action or removal from the market of a 
    tobacco product which is not required to be reported under this 
    subsection shall keep a record of such correction or removal.
        ``(2) Exception.--No report of the corrective action or removal 
    of a tobacco product may be required under paragraph (1) if a 
    report of the corrective action or removal is required and has been 
    submitted under subsection (a).
    ``SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TOBACCO PRODUCTS.
    ``(a) In General.--
        ``(1) New tobacco product defined.--For purposes of this 
    section the term `new tobacco product' means--
            ``(A) any tobacco product (including those products in test 
        markets) that was not commercially marketed in the United 
        States as of 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--
                ``(i) has the same characteristics as the predicate 
            tobacco product; or
                ``(ii) has different characteristics and the 
            information submitted contains information, including 
            clinical data if deemed necessary by the Secretary, that 
            demonstrates that it is not appropriate to regulate the 
            product under this section because the product does not 
            raise different questions of public health.
            ``(B) Characteristics.--In subparagraph (A), the term 
        `characteristics' means the materials, ingredients, design, 
        composition, heating source, or other features of a tobacco 
        product.
            ``(C) Limitation.--A tobacco product may not be found to be 
        substantially equivalent to a predicate tobacco product that 
        has been removed from the market at the initiative of the 
        Secretary or that has been determined by a judicial order to be 
        misbranded or adulterated.
        ``(4) Health information.--
            ``(A) Summary.--As part of a submission under section 
        905(j) respecting a tobacco product, the person required to 
        file a premarket notification under such section shall provide 
        an adequate summary of any health information related to the 
        tobacco product or state that such information will be made 
        available upon request by any person.
            ``(B) Required information.--Any summary under subparagraph 
        (A) respecting a tobacco product shall contain detailed 
        information regarding data concerning adverse health effects 
        and shall be made available to the public by the Secretary 
        within 30 days of the issuance of a determination that such 
        tobacco product is substantially equivalent to another tobacco 
        product.
    ``(b) Application.--
        ``(1) Contents.--An application 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;
            ``(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 section 
        907, and there is a lack of adequate information to justify the 
        deviation from such standard.
        ``(3) Denial information.--Any denial of an application shall, 
    insofar as the Secretary determines to be practicable, be 
    accompanied by a statement informing the applicant of the measures 
    required to 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 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;
                ``(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) 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 case of any tobacco 
    product for which an order issued pursuant to subsection 
    (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. 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 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 shall make the 
application described in subsection (d) publicly available (except 
matters in the application which are trade secrets or otherwise 
confidential, commercial information) and shall request comments by 
interested persons on the information contained in the application and 
on the label, labeling, and advertising accompanying such application.
    ``(f) Advisory Committee.--
        ``(1) In general.--The Secretary shall refer to the Tobacco 
    Products Scientific Advisory Committee any application submitted 
    under this section.
        ``(2) Recommendations.--Not later 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) 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.
            ``(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 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
            ``(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.
        ``(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. The results of 
    postmarket surveillance and studies shall be submitted to the 
    Secretary on an annual basis.
        ``(2) Surveillance protocol.--Each applicant required to 
    conduct a surveillance of a tobacco product under paragraph (1) 
    shall, within 30 days after receiving notice that the applicant is 
    required to conduct such surveillance, submit, for the approval of 
    the Secretary, a protocol for the required surveillance. The 
    Secretary, within 60 days of the receipt of such protocol, shall 
    determine if the principal investigator proposed to be used in the 
    surveillance has sufficient qualifications and experience to 
    conduct such surveillance and if such protocol will result in 
    collection of the data or other information designated by the 
    Secretary as necessary to protect the public health.
    ``(j) Withdrawal of Authorization.--The Secretary, 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).
    ``(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 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 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 than one or more commercially 
marketed tobacco products, or presents a reduced exposure to, or does 
not contain or is free of, a substance or substances.
    ``SEC. 912. JUDICIAL REVIEW.
    ``(a) Right To Review.--
        ``(1) In general.--Not later than 30 days after--
            ``(A) the promulgation of a regulation under section 907 
        establishing, amending, or revoking a tobacco product standard; 
        or
            ``(B) a denial of an application under section 910(c),
    any person adversely affected by such regulation or denial may file 
    a petition for judicial review of such regulation or denial with 
    the United States Court of Appeals for the District of Columbia or 
    for the circuit in which such person resides or has their principal 
    place of business.
        ``(2) Requirements.--
            ``(A) Copy of petition.--A copy of the petition filed under 
        paragraph (1) shall be transmitted by the clerk of the court 
        involved to the Secretary.
            ``(B) Record of proceedings.--On receipt of a petition 
        under subparagraph (A), the Secretary shall file in the court 
        in which such petition was filed--
                ``(i) the record of the proceedings on which the 
            regulation or order was based; and
                ``(ii) a statement of the reasons for the issuance of 
            such a regulation or order.
            ``(C) Definition of record.--In this section, the term 
        `record' means--
                ``(i) all notices and other matter published in the 
            Federal Register with respect to the regulation or order 
            reviewed;
                ``(ii) all information submitted to the Secretary with 
            respect to such regulation or order;
                ``(iii) proceedings of any panel or advisory committee 
            with respect to such regulation or order;
                ``(iv) any hearing held with respect to such regulation 
            or order; and
                ``(v) any other information identified by the 
            Secretary, in the administrative proceeding held with 
            respect to such regulation or order, as being relevant to 
            such regulation or order.
    ``(b) Standard of Review.--Upon the filing of the petition under 
subsection (a) for judicial review of a regulation or order, the court 
shall have jurisdiction to review the regulation or order in accordance 
with chapter 7 of title 5, United States Code, and to grant appropriate 
relief, including interim relief, as provided for in such chapter. A 
regulation or denial described in subsection (a) shall be reviewed in 
accordance with section 706(2)(A) of title 5, United States Code.
    ``(c) Finality of Judgment.--The judgment of the court affirming or 
setting aside, in whole or in part, any regulation or order shall be 
final, subject to review by the Supreme Court of the United States upon 
certiorari or certification, as provided in section 1254 of title 28, 
United States Code.
    ``(d) Other Remedies.--The remedies provided for in this section 
shall be in addition to, and not in lieu of, any other remedies 
provided by law.
    ``(e) Regulations and Orders Must Recite Basis in Record.--To 
facilitate judicial review, a regulation or order issued under section 
906, 907, 908, 909, 910, or 916 shall contain a statement of the 
reasons for the issuance of such regulation or order in the record of 
the proceedings held in connection with its issuance.
    ``SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS.
    ``The Secretary shall issue regulations to require that retail 
establishments for which the predominant business is the sale of 
tobacco products comply with any advertising restrictions applicable to 
retail establishments accessible to individuals under the age of 18.
    ``SEC. 914. JURISDICTION OF AND COORDINATION WITH THE FEDERAL TRADE 
      COMMISSION.
    ``(a) Jurisdiction.--
        ``(1) In general.--Except where expressly provided in this 
    chapter, nothing in this chapter shall be construed as limiting or 
    diminishing the authority of the Federal Trade Commission to 
    enforce the laws under its jurisdiction with respect to the 
    advertising, sale, or distribution of tobacco products.
        ``(2) Enforcement.--Any advertising that violates this chapter 
    or a provision of the regulations referred to in section 102 of the 
    Family Smoking Prevention and Tobacco Control Act, is an unfair or 
    deceptive act or practice under section 5(a) of the Federal Trade 
    Commission Act 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 Secretary shall consult with the Chairman of such 
    Commission in revising the label statements and requirements under 
    such sections.
    ``SEC. 915. 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, 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 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 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). If the Secretary finds that the conditions described in such 
    paragraph are met, the Secretary shall notify 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. 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 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. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.
    ``(a) Establishment.--Not later 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 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) 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. 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;
        ``(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. USER FEES.
    ``(a) Establishment of Quarterly Fee.--Beginning on 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.
            ``(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).
            ``(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 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. 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. 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 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.--
            ``(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) 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) 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) 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.
    ``(d) Collection of Unpaid Fees.--In any 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 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. FINAL RULE.
    (a) Cigarettes and Smokeless Tobacco.--
        (1) In general.--On the 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);
            (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 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;
            ``(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 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 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 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
            (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;
        ``(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.
    ``(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 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 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''.
    (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)) is amended--
        (1) by striking ``(a)(1)'' and inserting ``(a)(1)(A)''; and
        (2) by adding at the end the following:
    ``(B)(i) For 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
            (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 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 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)) 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 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) 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) 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, 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) 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.

                (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) 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) Special effective date.--The amendment made by subsection 
    (c)(1) shall take effect on the date of enactment of this Act.
        (5) 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 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 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. ENFORCEMENT ACTION PLAN FOR ADVERTISING AND PROMOTION 
      RESTRICTIONS.
    (a) Action Plan.--
        (1) Development.--Not later 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 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. 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;
        (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 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 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.
            ``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' 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). 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 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 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--
            ``(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 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 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 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.
        ``(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 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 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). 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) 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 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 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) 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.
        ``(4) Retailers.--This subsection 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. LABELING, RECORDKEEPING, RECORDS INSPECTION.
    ``(a) Origin Labeling.--
        ``(1) Requirement.--Beginning 1 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.
        ``(5) Recordkeeping by retailers.--The Secretary shall not 
    require any retailer to maintain records relating to individual 
    purchasers of tobacco products for personal consumption.
    ``(c) Records Inspection.--If the Secretary has a reasonable belief 
that a tobacco product is part of an illicit trade or smuggling or is a 
counterfeit product, each person who manufactures, processes, 
transports, distributes, receives, holds, packages, exports, or imports 
tobacco products shall, at the request of an officer or employee duly 
designated by the Secretary, permit such officer or employee, at 
reasonable times and within reasonable limits and in a reasonable 
manner, upon the presentation of appropriate credentials and a written 
notice to such person, to have access to and copy all records 
(including financial records) relating to such article that are needed 
to assist the Secretary in investigating potential illicit trade, 
smuggling, or counterfeiting of tobacco products. 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
        (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 B--FEDERAL RETIREMENT REFORM ACT

    SEC. 100. SHORT TITLE; TABLE OF CONTENTS.
    (a) Short Title.--This division 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.

      TITLE I--PROVISIONS RELATING TO FEDERAL EMPLOYEES RETIREMENT

    SEC. 101. 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 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 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.
    ``(b) Authority To Establish.--The Executive 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 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''.
    SEC. 105. 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 
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. 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--
        ``(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 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 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 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--
        (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''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.
```