[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1261 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 1261

To protect the public health by establishing the Tobacco Harm Reduction 
Center within the Department of Health and Human Services with certain 
    authority to regulate tobacco products, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 3, 2009

 Mr. Buyer (for himself, Mr. McIntyre, Mr. Deal of Georgia, Mr. Wilson 
of South Carolina, Mr. Coble, Mr. Burgess, Mr. Gingrey of Georgia, Mrs. 
  Myrick, Mr. Shadegg, and Mr. Shuler) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To protect the public health by establishing the Tobacco Harm Reduction 
Center within the Department of Health and Human Services with certain 
    authority to regulate tobacco products, and for other purposes.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.
Sec. 6. Effective date.
        TITLE I--AUTHORITY OF THE TOBACCO HARM REDUCTION CENTER

Sec. 100. Definitions.
Sec. 101. Center authority over tobacco products.
Sec. 102. Exclusion of other regulatory programs.
Sec. 103. Existing Federal statutes maintained.
Sec. 104. Proceedings in the name of the United States; subpoenas; 
                            preemption of State and local law; no 
                            private right of action.
Sec. 105. Illicit trade.
Sec. 106. Adulterated tobacco products.
Sec. 107. Misbranded tobacco products.
Sec. 108. Submission of health information to the Administrator.
Sec. 109. Registration and listing.
Sec. 110. General provisions respecting control of tobacco products.
Sec. 111. Smoking article standards.
Sec. 112. Notification and other remedies.
Sec. 113. Records and reports on tobacco products.
Sec. 114. Application for review of certain smoking articles.
Sec. 115. Modified risk tobacco products.
Sec. 116. Judicial review.
Sec. 117. Jurisdiction of and coordination with the Federal Trade 
                            Commission.
Sec. 118. Regulation requirement.
Sec. 119. Preservation of State and local authority.
Sec. 120. Tobacco Products Scientific Advisory Committee.
Sec. 121. Drug products used to treat tobacco dependence.
Sec. 122. Advertising and marketing of tobacco products.
TITLE II--TOBACCO PRODUCTS WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT 
                               DISCLOSURE

Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Smokeless tobacco labels and advertising warnings.
     TITLE III--PUBIC DISCLOSURES BY TOBACCO PRODUCTS MANUFACTURERS

Sec. 301. Disclosures on packages of tobacco products.
Sec. 302. Disclosures on packages of smokeless tobacco.
Sec. 303. Public disclosure of ingredients.
       TITLE IV--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS

Sec. 401. Study and report on illicit trade.
Sec. 402. Amendment to section 1926 of the Public Health Service Act.
Sec. 403. Establishment of rankings.
                    TITLE V--ENFORCEMENT PROVISIONS

Sec. 501. Prohibited acts.
Sec. 502. Injunction proceedings.
Sec. 503. Penalties.
Sec. 504. Seizure.
Sec. 505. Report of minor violations.
Sec. 506. Inspection.
Sec. 507. Effect of compliance.
Sec. 508. Imports.
Sec. 509. Tobacco products for export.
                   TITLE VI--MISCELLANEOUS PROVISIONS

Sec. 601. Use of payments under the master settlement agreement and 
                            individual State settlement agreements.
Sec. 602. Preemption of State Laws Implementing Fire Safety Standard 
                            for Cigarettes.
Sec. 603. Inspection by the alcohol and tobacco tax trade bureau of 
                            records of certain cigarette and smokeless 
                            tobacco sellers.
Sec. 604. Severability.
                  TITLE VII--TOBACCO GROWER PROTECTION

Sec. 701. Tobacco grower protection.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) Cigarette smoking is a leading cause of preventable 
        deaths in the United States. Cigarette smoking significantly 
        increases the risk of developing lung cancer, heart disease, 
        chronic bronchitis, emphysema and other serious diseases with 
        adverse health conditions.
            (2) The risk for serious diseases is significantly affected 
        by the type of tobacco product and the frequency, duration and 
        manner of use.
            (3) No tobacco product has been shown to be safe and 
        without risks. The health risks associated with cigarettes are 
        significantly greater than those associated with the use of 
        smoke-free tobacco and nicotine products.
            (4) Nicotine in tobacco products is addictive but is not 
        considered a significant threat to health.
            (5) It is the smoke inhaled from burning tobacco which 
        poses the most significant risk of serious diseases.
            (6) Quitting cigarette smoking significantly reduces the 
        risk for serious diseases.
            (7) Adult tobacco consumers have a right to be fully and 
        accurately informed about the risks of serious diseases, the 
        significant differences in the comparative risks of different 
        tobacco and nicotine-based products, and the benefits of 
        quitting. This information should be based on sound science.
            (8) Governments, public health officials, tobacco 
        manufacturers and others share a responsibility to provide 
        adult tobacco consumers with accurate information about the 
        various health risks and comparative risks associated with the 
        use of different tobacco and nicotine products.
            (9) Tobacco products should be regulated in a manner that 
        is designed to achieve significant and measurable reductions in 
        the morbidity and mortality associated with tobacco use. 
        Regulations should enhance the information available to adult 
        consumers to permit them to make informed choices, and 
        encourage the development of tobacco and nicotine products with 
        lower risks than cigarettes currently sold in the United 
        States.
            (10) The form of regulation should be based on the risks 
        and comparative risks of tobacco and nicotine products and 
        their respective product categories.
            (11) The regulation of marketing of tobacco products should 
        be consistent with constitutional protections and enhance an 
        adult consumer's ability to make an informed choice by 
        providing accurate information on the risks and comparative 
        risks of tobacco products.
            (12) Reducing the diseases and deaths associated with the 
        use of cigarettes serves public health goals and is in the best 
        interest of consumers and society. Harm reduction should be the 
        critical element of any comprehensive public policy surrounding 
        the health consequences of tobacco use.
            (13) Significant reductions in the harm associated with the 
        use of cigarettes can be achieved by providing accurate 
        information regarding the comparative risks of tobacco products 
        to adult tobacco consumers, thereby encouraging smokers to 
        migrate to the use of smoke-free tobacco and nicotine products, 
        and by developing new smoke-free tobacco and nicotine products 
        and other actions.
            (14) Governments, public health officials, manufacturers, 
        tobacco producers and consumers should support the development, 
        production, and commercial introduction of tobacco leaf, and 
        tobacco and nicotine-based products that are scientifically 
        shown to reduce the risks associated with the use of existing 
        tobacco products, particularly cigarettes.
            (15) Adult tobacco consumers should have access to a range 
        of commercially viable tobacco and nicotine-based products.
            (16) There is substantial scientific evidence that selected 
        smokeless tobacco products can satisfy the nicotine addiction 
        of inveterate smokers while eliminating most, if not all, risk 
        of pulmonary and cardiovascular complications of smoking and 
        while reducing the risk of cancer by more than 95 percent.
            (17) Transitioning smokers to selected smokeless tobacco 
        products will eliminate environmental tobacco smoke and fire-
        related hazards.
            (18) Current ``abstain, quit, or die'' tobacco control 
        policies in the United States may have reached their maximum 
        possible public health benefit because of the large number of 
        cigarette smokers either unwilling or unable to discontinue 
        their addiction to nicotine.
            (19) There is evidence that harm reduction works and can be 
        accomplished in a way that will not increase initiation or 
        impede smoking cessation.
            (20) Health-related agencies and organizations, both within 
        the United States and abroad have already gone on record 
        endorsing Harm Reduction as an approach to further reducing 
        tobacco related illness and death.
            (21) Current Federal policy requires tobacco product 
        labeling that leaves the incorrect impression that all tobacco 
        product present equal risk.

SEC. 3. PURPOSE.

    The purposes of this Act are--
            (1) to provide authority to the Tobacco Harm Reduction 
        Center by recognizing it as the primary Federal regulatory 
        authority with respect to tobacco products as provided for in 
        this Act;
            (2) to ensure that the Center 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 Center 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 Center with the authority to regulate the 
        levels of tar, nicotine, and other harmful components of 
        tobacco products;
            (6) to ensure that consumers are better informed regarding 
        the relative risks for death and disease between categories of 
        tobacco products;
            (7) to continue to allow 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 prevention, cessation, and harm reduction 
        policies and regulations to reduce disease risk and the social 
        costs associated with tobacco-related diseases;
            (10) to provide authority to the Department of Health and 
        Human Services to regulate tobacco products;
            (11) to establish national policies that effectively reduce 
        disease and death associated with cigarette smoking and other 
        tobacco use;
            (12) to establish national policies that encourage 
        prevention, cessation, and harm reduction measures regarding 
        the use of tobacco products;
            (13) to encourage current cigarette smokers who will not 
        quit to use noncombustible tobacco or nicotine products that 
        have significantly less risk than cigarettes;
            (14) to establish national policies that accurately and 
        consistently inform adult tobacco consumers of significant 
        differences in risk between respective tobacco products;
            (15) to establish national policies that encourage and 
        assist the development and awareness of noncombustible tobacco 
        and nicotine products;
            (16) to coordinate national and State prevention, 
        cessation, and harm reduction programs;
            (17) to impose measures to ensure tobacco products are not 
        sold or accessible to underage purchasers; and
            (18) to strengthen Federal and State legislation to prevent 
        illicit trade in tobacco products.

SEC. 4. SCOPE AND EFFECT.

    (a) Intended Effect.--Nothing in this Act (or an amendment made by 
this Act) shall be construed to--
            (1) establish a precedent with regard to any other 
        industry, situation, circumstance, or legal action;
            (2) affect any action pending in Federal, State, or Tribal 
        court, or any agreement, consent decree, or contract of any 
        kind; or
            (3) be applicable to tobacco products or component parts 
        manufactured in the United States for export.
    (b) Agricultural Activities.--The provisions of this Act (or an 
amendment made by this Act) which authorize the Administrator 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 Act (or an 
amendment made by this Act) which authorize the Administrator 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 Act, the amendments made by this Act, or 
the application of any provision of this Act to any person or 
circumstance is held to be invalid, the remainder of this Act, the 
amendments made by this Act, and the application of the provisions of 
this Act to any other person or circumstance shall not be affected and 
shall continue to be enforced to the fullest extent possible.

SEC. 6. EFFECTIVE DATE.

    Except as otherwise specifically provided, the effective date of 
this Act shall be the date of its enactment.

        TITLE I--AUTHORITY OF THE TOBACCO HARM REDUCTION CENTER

SEC. 100. DEFINITIONS.

    In this Act:
            (1) The term ``Administrator'' means the chief executive of 
        the Tobacco Harm Reduction Center.
            (2) The term ``adult'' means any individual who has 
        attained the minimum age under applicable State law to be an 
        individual to whom tobacco products may lawfully be sold.
            (3) The term ``adult-only facility'' means a facility or 
        restricted area, whether open-air or enclosed, where the 
        operator ensures, or has a reasonable basis to believe, that no 
        youth is present. A facility or restricted area need not be 
        permanently restricted to adults in order to constitute an 
        adult-only facility, if the operator ensures, or has a 
        reasonable basis to believe, that no youth is present during 
        any period of operation as an adult-only facility.
            (4) The term ``affiliate'' means a person that directly or 
        indirectly owns or controls, is owned or controlled by, or is 
        under common ownership or control with, another person. The 
        terms ``owns,'' ``is owned'', and ``ownership'' refer to 
        ownership of an equity interest, or the equivalent thereof, of 
        50 percent or more.
            (5) The term ``annual report'' means a tobacco product 
        manufacturer's annual report to the Center, which provides 
        ingredient information and nicotine yield ratings for each 
        brand style that tobacco product manufacturer manufactures for 
        commercial distribution domestically.
            (6) The term ``brand name'' means a brand name of a tobacco 
        product distributed or sold domestically, alone, or in 
        conjunction with any other word, trademark, logo, symbol, 
        motto, selling message, recognizable pattern of colors, or any 
        other indicium of product identification identical or similar 
        to, or identifiable with, those used for any domestic brand of 
        tobacco product. The term shall not include the corporate name 
        of any tobacco product manufacturer that does not, after the 
        effective date of this Act, sell a brand style of tobacco 
        product in the United States that includes such corporate name.
            (7) The term ``brand style'' means a tobacco product having 
        a brand name, and distinguished by the selection of the 
        tobacco, ingredients, structural materials, format, 
        configuration, size, package, product descriptor, amount of 
        tobacco, or yield of ``tar'' or nicotine.
            (8) The term ``Center'' means the Tobacco Harm Reduction 
        Center.
            (9) The term ``cigar'' has the meaning assigned that term 
        by the Alcohol and Tobacco Tax and Trade Bureau in section 
        40.11 of title 27, Code of Federal Regulations.
            (10) The term ``cigarette'' means--
                    (A) any roll of tobacco wrapped in paper or in any 
                substance not containing tobacco; or
                    (B) any roll of tobacco wrapped in any substance 
                containing tobacco which, because of the appearance of 
                the roll of tobacco, the type of tobacco used in the 
                filler, or its package or labeling, is likely to be 
                offered to, or purchased by, consumers as a cigarette 
                described in paragraph (1).
            (11) The term ``competent and reliable scientific 
        evidence'' means evidence based on tests, analyses, research, 
        or studies, conducted and evaluated in an objective manner by 
        individuals qualified to do so, using procedures generally 
        accepted in the relevant scientific disciplines to yield 
        accurate and reliable results.
            (12) The term ``distributor'' means any person who furthers 
        the distribution of tobacco products, whether domestic or 
        imported, at any point from the original place of manufacture 
        to the person who sells or distributes the tobacco product to 
        individuals for personal consumption. Common carriers, 
        retailers, and those engaged solely in advertising are not 
        considered distributors for purposes of this Act.
            (13) The terms ``domestic'' and ``domestically'' mean 
        within the United States, including activities within the 
        United States involving advertising, marketing, distribution, 
        or sale of tobacco products that are intended for consumption 
        within the United States.
            (14) The term ``illicit tobacco product'' means any tobacco 
        product intended for use by consumers in the United States--
                    (A) as to which not all applicable duties or taxes 
                have been paid in full;
                    (B) that has been stolen, smuggled, or is otherwise 
                contraband;
                    (C) that is counterfeit; or
                    (D) that has or had a label, labeling, or packaging 
                stating, or that stated, that the product is or was for 
                export only, or that it is or was at any time 
                restricted by section 5704 of title 26, United States 
                Code.
            (15) The term ``illicit trade'' means any transfer, 
        distribution, or sale in interstate commerce of any illicit 
        tobacco product.
            (16) The term ``immediate container'' does not include 
        package liners.
            (17) The term ``Indian tribe'' has the meaning assigned 
        that term in section 4(e) of the Indian Self Determination and 
        Education Assistance Act.
            (18) The term ``ingredient'' means tobacco and any 
        substance added to tobacco to have an effect in the final 
        tobacco product or when the final tobacco product is used by a 
        consumer.
            (19) The term ``International Organization for 
        Standardization (ISO) testing regimen'' means the methods for 
        measuring cigarette smoke yields, as set forth in the most 
        recent version of ISO 3308, entitled ``Routine analytical 
        cigarette-smoking machine--Definition of standard conditions''; 
        ISO 4387, entitled ``Cigarettes--Determination of total and 
        nicotine-free dry particulate matter using a routine analytical 
        smoking machine''; ISO 10315, entitled ``Cigarettes--
        Determination of nicotine in smoke condensates--Gas-
        chromatographic method''; ISO 10362-1, entitled ``Cigarettes--
        Determination of water in smoke condensates--Part 1: Gas-
        chromatographic method''; and ISO 8454, entitled ``Cigarettes--
        Determination of carbon monoxide in the vapour phase of 
        cigarette smoke--NDIR method''. A cigarette that does not burn 
        down in accordance with the testing regimen standards may be 
        measured under the same puff regimen using the number of puffs 
        that such a cigarette delivers before it extinguishes, plus an 
        additional three puffs, or with such other modifications as the 
        Administrator may approve.
            (20) The term ``interstate commerce'' means all trade, 
        traffic, or other commerce--
                    (A) within the District of Columbia, or any 
                territory or possession of the United States;
                    (B) between any point in a State and any point 
                outside thereof;
                    (C) between points within the same State through 
                any place outside such State; or
                    (D) over which the United States has jurisdiction.
            (21) The term ``label'' means a display of written, 
        printed, or graphic matter upon or applied securely to the 
        immediate container of a tobacco product.
            (22) The term ``labeling'' means all labels and other 
        written, printed, or graphic matter (1) upon or applied 
        securely to any tobacco product or any of its containers or 
        wrappers, or (2) accompanying a tobacco product.
            (23) The term ``little cigar'' has the meaning assigned 
        that term by the Alcohol and Tobacco Tax and Trade Bureau in 
        section 40.11 of title 27, Code of Federal Regulations.
            (24) The term ``loose tobacco'' means any form of tobacco, 
        alone or in combination with any other ingredient or material, 
        that, because of its appearance, form, type, packaging, or 
        labeling, is suitable for use and likely to be offered to, or 
        purchased by, consumers as tobacco for making or assembling 
        cigarettes, incorporation into pipes, or otherwise used by 
        consumers to make any tobacco product.
            (25) The term ``manufacture'' means to design, manufacture, 
        fabricate, assemble, process, package, or repackage, label, or 
        relabel, import, or hold or store in a commercial quantity, but 
        does not include--
                    (A) the growing, curing, de-stemming, or aging of 
                tobacco; or
                    (B) the holding, storing or transporting of a 
                tobacco product by a common carrier for hire, a public 
                warehouse, a testing laboratory, a distributor, or a 
                retailer.
            (26) The term ``nicotine-containing product'' means a 
        product, other than a tobacco product, that contains added 
        nicotine, whether or not in the form of a salt or solvate, that 
        has been--
                    (A) synthetically produced, or
                    (B) obtained from tobacco or other source of 
                nicotine.
            (27) The term ``package'' means a pack, box, carton, pouch, 
        or container of any kind in which a tobacco product or tobacco 
        products are offered for sale, sold, or otherwise distributed 
        to consumers. The term ``package'' does not include an outer 
        container used solely for shipping one or more packages of a 
        tobacco product or tobacco products.
            (28) The term ``person'' means any individual, partnership, 
        corporation, committee, association, organization or group of 
        persons, or other legal or business entity.
            (29) The term ``proof of age'' means a driver's license or 
        other form of identification that is issued by a governmental 
        authority and includes a photograph and a date of birth of the 
        individual.
            (30) The term ``raw tobacco'' means tobacco in a form that 
        is received by a tobacco product manufacturer as an 
        agricultural commodity, whether in a form that is natural, 
        stem, or leaf, cured or aged, or as parts or pieces, but not in 
        a reconstituted form, extracted pulp form, or extract form.
            (31) The term ``reduced-exposure claim'' means a statement 
        in advertising or labeling intended for one or more consumers 
        of tobacco products, that a tobacco product provides a reduced 
        exposure of users of that tobacco product to one or more 
        toxicants, as compared to an appropriate reference tobacco 
        product or category of tobacco products. A statement or 
        representation that a tobacco product or the tobacco in a 
        tobacco product contains ``no additives'' or is ``natural'' or 
        that uses a substantially similar term is not a reduced-
        exposure claim if the advertising or labeling that contains 
        such statement or representation also contains the disclosure 
        required by section 108(h) of this Act.
            (32) The term ``reduced-risk claim'' means a statement in 
        advertising or labeling intended for one or more consumers of 
        smoking articles, that a smoking article provides to users of 
        that product a reduced risk of morbidity or mortality resulting 
        from one or more chronic diseases or serious adverse health 
        conditions associated with tobacco use, as compared to an 
        appropriate reference smoking article or category of smoking 
        articles, even if it is not stated, represented, or implied 
        that all health risks associated with using that smoking 
        article have been reduced or eliminated. A statement or 
        representation that a smoking article or the tobacco in a 
        smoking article contains ``no additives,'' or is ``natural,'' 
        or that uses a substantially similar term is not a reduced-risk 
        claim if the advertising or labeling that contains such 
        statement or representation also contains the disclosure 
        required by section 108(h).
            (33) The term ``retailer'' means any person that--
                    (A) sells tobacco products to individuals for 
                personal consumption; or
                    (B) operates a facility where the sale of tobacco 
                products to individuals for personal consumption is 
                permitted.
            (34) The term ``small business'' means a tobacco product 
        manufacturer that--
                    (A) has 150 or fewer employees; and
                    (B) during the 3-year period prior to the current 
                calendar year, had an average annual gross revenue from 
                tobacco products that did not exceed $40,000,000.
            (35) The term ``smokeless tobacco product'' means any form 
        of finely cut, ground, powdered, reconstituted, processed or 
        shaped tobacco, leaf tobacco, or stem tobacco, whether or not 
        combined with any other ingredient, whether or not in extract 
        or extracted form, and whether or not incorporated within any 
        carrier or construct, that is intended to be placed in the oral 
        or nasal cavity, including dry snuff, moist snuff, and chewing 
        tobacco.
            (36) The term ``smoking article'' means any tobacco-
        containing article that is intended, when used by a consumer, 
        to be burned or otherwise to employ heat to produce a vapor, 
        aerosol or smoke that--
                    (A) incorporates components of tobacco or derived 
                from tobacco; and
                    (B) is intended to be inhaled by the user.
            (37) The term ``State'' means any State of the United 
        States and, except as otherwise specifically provided, includes 
        any Indian tribe or tribal organization, the District of 
        Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin 
        Islands, American Samoa, Wake Island, Midway Island, Kingman 
        Reef, Johnston Atoll, the Northern Marianas, and any other 
        trust territory or possession of the United States.
            (38) The term ``tar'' means nicotine-free dry particulate 
        matter as defined in ISO 4387, entitled ``Cigarettes--
        Determination of total and nicotine-free dry particulate matter 
        using a routine analytical smoking machine''.
            (39) The term ``tobacco'' means a tobacco plant or any part 
        of a harvested tobacco plant intended for use in the production 
        of a tobacco product, including leaf, lamina, stem, or stalk, 
        whether in green, cured, or aged form, whether in raw, treated, 
        or processed form, and whether or not combined with other 
        materials, including any by-product, extract, extracted pulp 
        material, or any other material (other than purified nicotine) 
        derived from a tobacco plant or any component thereof, and 
        including strip, filler, stem, powder, and granulated, blended, 
        or reconstituted forms of tobacco.
            (40) The term ``tobacco product'' means--
                    (A) the singular of ``tobacco products'' as defined 
                in section 5702(c) of the Internal Revenue Code of 
                1986;
                    (B) any other product that contains tobacco as a 
                principal ingredient and that, because of its 
                appearance, type, or the tobacco used in the product, 
                or its packaging and labeling, is likely to be offered 
                to, or purchased by, consumers as a tobacco product as 
                described in subparagraph (A); and
                    (C) any form of tobacco or any construct 
                incorporating tobacco, intended for human consumption, 
                whether by--
                            (i) placement in the oral or nasal cavity;
                            (ii) inhalation of vapor, aerosol, or 
                        smoke; or
                            (iii) any other means.
            (41) The term ``tobacco product category'' means a type of 
        tobacco product characterized by its composition, components, 
        and intended use, and includes tobacco products classified as 
        cigarettes, loose tobacco for roll-your-own tobacco products, 
        little cigars, cigars, pipe tobacco, moist snuff, dry snuff, 
        chewing tobacco, and other forms of tobacco products (which are 
        treated in this Act collectively as a single category).
            (42) The term ``tobacco product communication'' means any 
        means, medium, or manner for providing information relating to 
        any tobacco product, including face-to-face interaction, 
        mailings by postal service or courier to an individual who is 
        an addressee, and electronic mail to an individual who is an 
        addressee.
            (43) The term ``tobacco product manufacturer'' means an 
        entity that directly--
                    (A) manufactures anywhere a tobacco product that is 
                intended to be distributed commercially in the United 
                States, including a tobacco product intended to be 
                distributed commercially in the United States through 
                an importer;
                    (B) is the first purchaser for resale in the United 
                States of tobacco products manufactured outside the 
                United States for distribution commercially in the 
                United States; or
                    (C) is a successor or assign of any of the 
                foregoing.
            (44) The term ``toxicant'' means a chemical or physical 
        agent that produces an adverse biological effect.
            (45) The term ``tribal organization'' has the meaning 
        assigned that term in section 4(1) of the Indian Self 
        Determination and Education Assistance Act.
            (46) The term ``United States'' means the several States, 
        as defined in this Act.
            (47) The term ``youth'' means any individual who in not an 
        adult.

SEC. 101. CENTER 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 
117, shall be regulated by the Administrator under this Act.
    (b) Applicability.--This Act shall apply to all cigarettes, 
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to 
any other tobacco products that the Administrator by regulation deems 
to be subject to this Act.
    (c) Center.--The Secretary of Health and Human Services shall 
establish within the Department of Health and Human Services the 
Tobacco Harm Reduction Center. The head of the Center shall be an 
Administrator, who shall assume the statutory authority conferred by 
this Act, perform the functions that relate to the subject matter of 
this Act, and have the authority to promulgate regulations for the 
efficient enforcement of this Act. In promulgating any regulations 
under such authority, in whole or in part or any regulation that is 
likely to have an annual effect on the economy of $50,000,000 or more 
or have a material adverse effect on adult users of tobacco products, 
tobacco product manufacturers, distributors, or retailers, the 
Administrator shall--
            (1) determine the technological and economic ability of 
        parties that would be required to comply with the regulation to 
        comply with it;
            (2) consider experience gained under any relevantly similar 
        regulations at the Federal or State level;
            (3) determine the reasonableness of the relationship 
        between the costs of complying with such regulation and the 
        public health benefits to be achieved by such regulation;
            (4) determine the reasonable likelihood of measurable and 
        substantial reductions in morbidity and mortality among 
        individual tobacco users;
            (5) determine the impact to United States tobacco producers 
        and farm operations;
            (6) determine the impact on the availability and use of 
        tobacco products by minors; and
            (7) determine the impact on illicit trade of tobacco 
        products.
    (d) Limitation of Authority.--
            (1) In general.--The provisions of this Act 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 Center have 
        any authority to enter onto a farm owned by a producer of 
        tobacco leaf without the written consent of such producer.
            (2) Exception.--Notwithstanding paragraph (1), 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 Act 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.
            (3) Rule of construction.--Nothing in this Act shall be 
        construed to grant the Administrator authority to promulgate 
        regulations on any matter that involves the production of 
        tobacco leaf or a producer thereof.
    (e) Rulemaking Procedures.--Each rulemaking under this Act shall be 
in accordance with chapter 5 of title 5, United States Code.
    (f) Consultation Prior to Rulemaking.--Prior to promulgating rules 
under this Act, the Administrator shall endeavor to consult with other 
Federal agencies as appropriate.

SEC. 102. EXCLUSION OF OTHER REGULATORY PROGRAMS.

    (a) Exclusion of Tobacco Products and Nicotine-Containing Products 
From the Federal Food, Drug, and Cosmetic Act.--No tobacco product and 
no nicotine-containing product shall be regulated as a food, drug, or 
device in accordance with section 201 (f), (g) or (h) or Chapter IV or 
V of the Federal Food, Drug, and Cosmetic Act, except that any tobacco 
product commercially distributed domestically and any nicotine-
containing product commercially distributed domestically shall be 
subject to Chapter V of the Federal Food, Drug, and Cosmetic Act if the 
manufacturer or a distributor of such product markets it with an 
explicit claim that the product is intended for use in the cure, 
mitigation, treatment, or prevention of disease in man or other 
animals, within the meaning of section 201(g)(1)(C) or section 
201(h)(2) of that Act.
    (b) Limitation on Effect of This Act.--Nothing in this Act shall be 
construed to--
            (1) establish a precedent with regard to any other 
        industry, situation, circumstance, or legal action; or
            (2) affect any action pending in any Federal, State, or 
        Tribal court, or any agreement, consent decree, or contract of 
        any kind.
    (c) Exclusions From Authority of Administrator.--The authority 
granted to the Administrator under this Act shall not apply to--
            (1) raw tobacco that is not in the possession or control of 
        a tobacco product manufacturer;
            (2) raw tobacco that is grown for a tobacco product 
        manufacturer by a grower, and that is in the possession of that 
        grower or of a person that is not a tobacco product 
        manufacturer and is within the scope of subparagraphs (A) 
        through(F) of paragraph (3); or
            (3) the activities, materials, facilities, or practices of 
        persons that are not tobacco product manufacturers and that 
        are--
                    (A) producers of raw tobacco, including tobacco 
                growers;
                    (B) tobacco warehouses, and other persons that 
                receive raw tobacco from growers;
                    (C) tobacco grower cooperatives;
                    (D) persons that cure raw tobacco;
                    (E) persons that process raw tobacco; and
                    (F) persons that store raw tobacco for aging.
        If a producer of raw tobacco is also a tobacco product 
        manufacturer, an affiliate of a tobacco product manufacturer, 
        or a person producing raw tobacco for a tobacco product 
        manufacturer, then that producer shall be subject to this Act 
        only to the extent of that producer's capacity as a tobacco 
        product manufacturer.

SEC. 103. EXISTING FEDERAL STATUTES MAINTAINED.

    Except as amended or repealed by this Act, all Federal statutes in 
effect as of the effective date of this Act that regulate tobacco, 
tobacco products, or tobacco product manufacturers shall remain in full 
force and effect. Such statutes include, without limitation--
            (1) the Federal Cigarette Labeling and Advertising Act, 
        sections 1331-1340 of title 15, United States Code, except that 
        section 1335 of title 15, United States Code, is repealed;
            (2) the Comprehensive Smokeless Tobacco Health Education 
        Act of 1986, sections 4401-4408 of title 15, United States 
        Code, except that section 4402(f) of title 15, United States 
        Code, is repealed;
            (3) section 300x-26 of title 42, United States Code; and
            (4) those statutes authorizing regulation of tobacco, 
        tobacco products, or tobacco product manufacturers by the 
        Federal Trade Commission, the Department of Agriculture, the 
        Environmental Protection Agency, the Internal Revenue Service, 
        and the Alcohol and Tobacco Tax and Trade Bureau of the 
        Department of the Treasury.

SEC. 104. PROCEEDINGS IN THE NAME OF THE UNITED STATES; SUBPOENAS; 
              PREEMPTION OF STATE AND LOCAL LAW; NO PRIVATE RIGHT OF 
              ACTION.

    In furtherance of this Act:
            (1) All proceedings for the enforcement, or to restrain 
        violations, of this Act shall be by and in the name of the 
        United States. Subpoenas for witnesses who are required to 
        attend a court of the United States, in any district, may run 
        into any other district in any proceeding under this section. 
        No State, or political subdivision thereof, may proceed or 
        intervene in any Federal or State court under this Act or under 
        any regulation promulgated under it, or allege any violation 
        thereof except a violation by the Administrator. Nothing in 
        this Act shall be construed to create a right of action by any 
        private person for any violation of any provision of this Act 
        or of any regulation promulgated under it.
            (2) With respect to any subject matter addressed by this 
        Act or by any regulation promulgated under it, no requirement 
        or prohibition shall be imposed under State or local law upon 
        any tobacco product manufacturer or distributor.
            (3) Paragraph (2) shall not apply to any requirement or 
        prohibition imposed under State or local law before the date of 
        introduction of the bill that was enacted as this Act.

SEC. 105. ILLICIT TRADE.

    The Administrator shall not promulgate any regulation or take any 
other action that has the effect of--
            (1) increasing illicit trade involving tobacco or any 
        tobacco product, or
            (2) making affected tobacco products unacceptable to a 
        substantial number of then current users of such products, 
        thereby creating a substantial risk that such users will resort 
        to illicit tobacco products, or tobacco products that are 
        otherwise noncompliant or unlawful.

SEC. 106. ADULTERATED TOBACCO PRODUCTS.

    A tobacco product shall be deemed to be adulterated--
            (1) if it bears or contains any poisonous or deleterious 
        substance other than--
                    (A) tobacco;
                    (B) a substance naturally present in tobacco;
                    (C) a pesticide or fungicide chemical residue in or 
                on tobacco if such pesticide or fungicide chemical is 
                registered by the Environmental Protection Agency for 
                use on tobacco in the United States; or
                    (D) in the case of imported tobacco, a residue of a 
                pesticide or fungicide chemical that--
                            (i) is approved for use in the country of 
                        origin of the tobacco; and
                            (ii) has not been banned, and the 
                        registration of which has not been canceled, by 
                        the Environmental Protection Agency for use on 
                        tobacco in the United States) that may render 
                        it injurious to health; but, in case the 
                        substance is not an added substance, such 
                        tobacco product shall not be considered 
                        adulterated under this subsection if the 
                        quantity of such substance in such tobacco 
                        product does not ordinarily render it injurious 
                        to health;
            (2) if there is significant scientific agreement that, as a 
        result of the tobacco it contains, the tobacco product presents 
        a risk to human health that is materially higher than the risk 
        presented by--
                    (A) such product on the effective date of this Act; 
                or
                    (B) if such product was not distributed 
                commercially domestically on that date, by comparable 
                tobacco products of the same style and within the same 
                category that were commercially distributed 
                domestically on that date;
            (3) if it has been prepared, packed, or held under 
        unsanitary conditions whereby it may have become contaminated 
        with filth;
            (4) if its package is composed, in whole or in part, of any 
        poisonous or deleterious substance that may render the contents 
        injurious to health; or
            (5) if its ``tar'' yield is in violation of section 111.

SEC. 107. MISBRANDED TOBACCO PRODUCTS.

    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) an identification of the type of product it is, 
                by the common or usual name of such type of product;
                    (B) an accurate statement of the quantity of the 
                contents in the package in terms of weight, measure, or 
                numerical count, except that reasonable variations 
                shall be permitted, and exemptions as to small packages 
                shall be established by regulations promulgated by the 
                Administrator;
                    (C) the name and place of business of the tobacco 
                product manufacturer, packer, or distributor; and
                    (D) the information required by section 201(c) and 
                (e) or section 202(c) and (e), as applicable;
            (3) if any word, statement, or other information required 
        by or under authority of this Act to appear on the label, 
        labeling, or advertising is not prominently placed thereon with 
        such conspicuousness (as compared with other words, statements, 
        or designs on the label, labeling, or advertising, as 
        applicable) and in such terms as to render it reasonably likely 
        to be read and understood by the ordinary individual under 
        customary conditions of purchase and use;
            (4) if any word, statement, or other information is 
        required by or under this Act to appear on the label, unless 
        such word, statement, or other information also appears on the 
        outside container or wrapper, if any, of the retail package of 
        such tobacco product, or is easily legible through the outside 
        container or wrapper;
            (5) if it was manufactured, prepared, or processed in an 
        establishment not duly registered under section 109, if it was 
        not included in a list required by section 109, or if a notice 
        or other information respecting it was not provided as required 
        by section 109;
            (6) if its packaging, labeling, or advertising is in 
        violation of this Act or of an applicable regulation 
        promulgated in accordance with this Act;
            (7) if it contains tobacco or another ingredient as to 
        which a required disclosure under this Act was not made;
            (8) if it is labeled or advertised, or the tobacco 
        contained in it is advertised, as--
                    (A) containing ``no additives,'' or any 
                substantially similar term, unless the labeling or 
                advertising, as applicable, also contains, clearly and 
                prominently, the following disclosure: ``No additives 
                in our tobacco does NOT mean safer.''; or
                    (B) being ``natural,'' or any substantially similar 
                term, unless the labeling or advertising, as 
                applicable, also contains, clearly and prominently, the 
                following disclosure: ``Natural does NOT mean safer.'';
            (9) if in its labeling or advertising a term descriptive of 
        the tobacco in the tobacco product is used otherwise than in 
        accordance with a sanction or approval granted by a Federal 
        agency;
            (10) if with respect to such tobacco product a disclosure 
        required by section 603 was not made;
            (11) if with respect to such tobacco product a 
        certification required by section 803 was not submitted or is 
        materially false or misleading; or
            (12) if its manufacturer or distributor made with respect 
        to it a claim prohibited by section 115.

SEC. 108. SUBMISSION OF HEALTH INFORMATION TO THE ADMINISTRATOR.

    (a) Requirement.--Each tobacco product manufacturer or importer, or 
agents thereof, shall submit to the Administrator the following 
information:
            (1) Not later than 18 months after the date of enactment of 
        the 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 brand style.
            (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 
        Administrator in accordance with section 4(e) of the Federal 
        Cigarette Labeling and Advertising Act.
            (3) Beginning 4 years after the date of enactment of this 
        Act, a listing of all constituents, including smoke 
        constituents as applicable, identified by the Administrator as 
        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.
    (b) Data Submission.--At the request of the Administrator, 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, 
        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 significant reduction in risk to health from tobacco 
        products can occur upon the employment of technology available 
        to the manufacturer.
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) Data List.--
            (1) In general.--Not later than 4 years after the date of 
        enactment of the Act, and annually thereafter, the 
        Administrator 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 Administrator) the list 
        established under subsection (d).
            (2) Consumer research.--The Administrator 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 Act, the 
        Administrator 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.
    (d) Data Collection.--Not later than 36 months after the date of 
enactment of this Act, the Administrator shall establish, and 
periodically revise as appropriate, a list of harmful constituents, 
including smoke constituents, to health in each tobacco product by 
brand and by quantity in each brand and subbrand.

SEC. 109. REGISTRATION AND LISTING.

    (a) Definitions.--As used in this section:
            (1) The term ``manufacture, preparation, or processing'' 
        shall include repackaging or otherwise changing the container, 
        wrapper, or label of any tobacco product package other than the 
        carton in furtherance of the distribution of the tobacco 
        product from the original place of manufacture to the person 
        that makes final delivery or sale to the ultimate consumer or 
        user, but shall not include the addition of a tax marking or 
        other marking required by law to an already packaged tobacco 
        product.
            (2) The term ``name'' shall include in the case of a 
        partnership the name of the general partner and, in the case of 
        a privately held corporation, the name of the chief executive 
        officer of the corporation and the State of incorporation.
    (b) Annual Registration.--Commencing one year after enactment, on 
or before December 31 of each year, every person that owns or operates 
any establishment in any State engaged in the manufacture, preparation, 
or processing of a tobacco product or products for commercial 
distribution domestically shall register with the Administrator its 
name, places of business, and all such establishments.
    (c) New Producers.--Every person upon first engaging, for 
commercial distribution domestically, in the manufacture, preparation, 
or processing of a tobacco product or products in any establishment 
that it owns or operates in any State shall immediately register with 
the Administrator its name, places of business, and such establishment.
    (d) Registration of Foreign Establishments.--
            (1) Commencing one year after enactment of this Act, on or 
        before December 31 of each year, the person that, within any 
        foreign country, owns or operates any establishment engaged in 
        the manufacture, preparation, or processing of a tobacco 
        product that is imported or offered for import into the United 
        States shall, through electronic means or other means permitted 
        by the Administrator, register with the Administrator the name 
        and place of business of each such establishment, the name of 
        the United States agent for the establishment, and the name of 
        each importer of such tobacco product in the United States that 
        is known to such person.
            (2) Such person also shall provide the information required 
        by subsection (j), including sales made by mail, or through the 
        Internet, or other electronic means.
            (3) The Administrator is authorized to enter into 
        cooperative arrangements with officials of foreign countries to 
        ensure that adequate and effective means are available for 
        purposes of determining, from time to time, whether tobacco 
        products manufactured, prepared, or processed by an 
        establishment described in paragraph (1), if imported or 
        offered for import into the United States, shall be refused 
        admission on any of the grounds set forth in section 708.
    (e) Additional Establishments.--Every person duly registered in 
accordance with the foregoing subsections of this section shall 
immediately register with the Administrator any additional 
establishment that it owns or operates and in which it begins the 
manufacture, preparation, or processing of a tobacco product or 
products for commercial distribution domestically or for import into 
the United States.
    (f) Exclusions From Application of This Section.--The foregoing 
subsections of this section shall not apply to--
            (1) persons that manufacture, prepare, or process tobacco 
        products solely for use in research, teaching, chemical or 
        biological analysis, or export; or
            (2) such other classes of persons as the Administrator may 
        by regulation exempt from the application of this section upon 
        a finding that registration by such classes of persons in 
        accordance with this section is not necessary for the 
        protection of the public health.
    (g) Inspection of Premises.--Every establishment registered with 
the Administrator pursuant to this section shall be subject to 
inspection pursuant to section 706; and every such establishment 
engaged in the manufacture, preparation, or processing of a tobacco 
product or products shall be so inspected by one or more officers or 
employees duly designated by the Administrator at least once in the 
two-year period beginning with the date of registration of such 
establishment pursuant to this section and at least once in every 
successive two-year period thereafter, except that inspection of 
establishments outside the United States may be conducted by other 
personnel pursuant to a cooperative arrangement under subsection 
(d)(3).
    (h) Filing of Lists of Tobacco Products Manufactured, Prepared, or 
Processed by Registrants; Statements; Accompanying Disclosures.--
            (1) Every person that registers with the Administrator 
        under subsection (b), (c), (d), or (e) shall, at the time of 
        registration under any such subsection, file with the 
        Administrator a list of all brand styles (with each brand style 
        in each list listed by the common or usual name of the tobacco 
        product category to which it belongs and by any proprietary 
        name) that are being manufactured, prepared, or processed by 
        such person for commercial distribution domestically or for 
        import into the United States, and that such person has not 
        included in any list of tobacco products filed by such person 
        with the Administrator under this paragraph or paragraph (2) 
        before such time of registration. Such list shall be prepared 
        in such form and manner as the Administrator may prescribe, and 
        shall be accompanied by the label for each such brand style and 
        a representative sampling of any other labeling and advertising 
        for each;
            (2) Each person that registers with the Administrator under 
        this section shall report to the Administrator each August for 
        the preceding six-month period from January through June, and 
        each February for the preceding six-month period form July 
        through December, following information:
                    (A) A list of each brand style introduced by the 
                registrant for commercial distribution domestically or 
                for import into the United States that has not been 
                included in any list previously filed by such 
                registrant with the Administrator under this 
                subparagraph or paragraph (1). A list under this 
                subparagraph shall list a brand style by the common or 
                usual name of the tobacco product category to which it 
                belongs and by any proprietary 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 (or if such registrant has 
                not previously made a report under this paragraph, 
                since the effective date of this Act) such registrant 
                has discontinued the manufacture, preparation, or 
                processing for commercial distribution domestically or 
                for import into the United States of a brand style 
                included in a list filed by such registrant under 
                subparagraph (A) or paragraph (1), notice of such 
                discontinuance, the date of such discontinuance, and 
                the identity (by the common or usual name of the 
                tobacco product category to which it belongs and by any 
                proprietary name) of such tobacco product.
                    (C) If, since the date the registrant reported 
                pursuant to subparagraph (B) a notice of discontinuance 
                of a tobacco product, the registrant has resumed the 
                manufacture, preparation, or processing for commercial 
                distribution domestically or for import into the United 
                States of that brand style, notice of such resumption, 
                the date of such resumption, the identity of such brand 
                style (by the common or usual name of the tobacco 
                product category to which it belongs and by any 
                proprietary name), and the other information required 
                by paragraph (1), unless the registrant has previously 
                reported such resumption to the Administrator pursuant 
                to this subparagraph.
                    (D) Any material change in any information 
                previously submitted pursuant to this paragraph (2) or 
                paragraph (1).
    (i) Electronic Registration.--Registrations under subsections (b), 
(c), (d), and (e) (including the submission of updated information) 
shall be submitted to the Administrator by electronic means, unless the 
Administrator grants a request for waiver of such requirement because 
use of electronic means is not reasonable for the person requesting 
such waiver.

SEC. 110. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO PRODUCTS.

    (a) In General.--Any requirement established by or under section 
106, 107, or 113 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 111, 
section 114, section 115, or subsection (d) of this section, and any 
requirement established by or under section 106, 107, or 113 which is 
inconsistent with a requirement imposed on such tobacco product under 
section 111, section 114, section 115, 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 111, 112, 113, 
114, or 115 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 Administrator 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 Administrator or the 
Administrator's representative under section 107, 108, 111, 112, 113, 
114, 115, or 504, 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 Act, or when relevant in any 
proceeding under this Act.
    (d) Restrictions.--
            (1) In general.--The Administrator may issue regulations, 
        consistent with this Act, regarding tobacco products if the 
        Administrator determines that such regulation would be 
        appropriate for the protection of the public health. 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 users of the tobacco 
        product, and taking into account that the standard is 
        reasonably likely to result in measurable and substantial 
        reductions in morbidly and mortality among individual tobacco 
        users.
            (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 Administrator may 
        in such regulation prescribe.
    (e) Good Manufacturing Practice Requirements.--
            (1) Methods, facilities, and controls to conform.--
                    (A) In general.--In applying manufacturing 
                restrictions to tobacco, the Administrator 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 Act. Such regulations may provide for the 
                testing of raw tobacco for pesticide chemical residues 
                after a tolerance for such chemical residues has been 
                established.
                    (B) Requirements.--The Administrator 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); 
                        and
                            (iv) in establishing the effective date of 
                        a regulation promulgated under this subsection, 
                        take into account the differences in the manner 
                        in which the different types of tobacco 
                        products have historically been produced, the 
                        financial resources of the different tobacco 
                        product manufacturers, and the state of their 
                        existing manufacturing facilities, and shall 
                        provide for a reasonable period of time for 
                        such manufacturers to conform to good 
                        manufacturing practices but no earlier than 
                        four years from date of enactment.
                    (C) Additional special rule.--A tobacco product 
                manufactured in or imported into the United States 
                shall not contain foreign-grown flue-cured or burley 
                tobacco that--
                            (i) was knowingly grown or processed using 
                        a pesticide chemical that is not approved under 
                        applicable Federal law for use in domestic 
                        tobacco farming and processing; or
                            (ii) in the case of a pesticide chemical 
                        that is so approved, was grown or processed 
                        using the pesticide chemical in a manner 
                        inconsistent with the approved labeling for use 
                        of the pesticide chemical in domestic tobacco 
                        farming and processing.
                    (D) Exclusion.--Subparagraph (C)(ii) shall not 
                apply to tobacco products manufactured with foreign-
                grown flue-cured or burley tobacco so long as that 
                foreign grown tobacco was either--
                            (i) in the inventory of a manufacturer 
                        prior to the effective date, or
                            (ii) planted by the farmer prior to the 
                        effective date of this Act and utilized by the 
                        manufacturer no later than 3 years after the 
                        effective date.
                    (E) Setting of maximum residue limits.--The 
                Administrator shall adopt the following pesticide 
                residue standards:
    Pesticide residue standards
    The maximum concentration of residues of the following pesticides 
allowed in flue-cured or burley tobacco, expressed as parts by weight 
of the residue per one million parts by weight of the tobacco (PPM) 
are:
    CHLORDANE.....3.0
    DIBROMOCHLOROPROPANE (DBCP).....1.0
    DICAMBA (Temporary).... 5.0
    ENDRIN....0.1
    ETHYLENE DIBROMIDE (EDB)....0.1
    FORMOTHION.....0.5
    HEXACHLOROBENZENE (HCB)....0.1
    METHOXYCHLOR.....0.1
    TOXAPHENE.....0.3
    2,4-D (Temporary).....5.0
    2,4,5-T.....0.1
    Sum of ALDRIN and DIELDRIN.....0.1
    Sum of CYPERMETHRIN and PERMETHRIN (Temporary).....3.0
    Sum of DDT, TDE (DDD), and DDE .....0.4
    Sum of HEPTACHLOR and HEPTACHLOR EPOXIDE.....0.1
                    (F) Maximum residue limits.--The Administrator 
                shall adopt regulations within one year of the 
                effective date of this Act to establish maximum residue 
                limits for pesticides identified under subparagraph (E) 
                but not included in the table of such subparagraph to 
                account for the fact that weather and agronomic 
                conditions will cause pesticides identified in 
                subparagraph (E) to be detected in foreign-grown 
                tobacco even where the farmer has not knowingly added 
                such pesticide.
            (2) Exemptions; variances.--
                    (A) Petition.--Any person subject to any 
                requirement prescribed under paragraph (1) may petition 
                the Administrator for a permanent or temporary 
                exemption or variance from such requirement. Such a 
                petition shall be submitted to the Administrator in 
                such form and manner as the Administrator 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 Act;
                            (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 
                        Administrator shall prescribe.
                    (B) Referral to the tobacco products scientific 
                advisory committee.--The Administrator 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 Administrator 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 Administrator under subparagraph (A); or
                            (ii) the day after the petition was 
                        referred to the Tobacco Products Scientific 
                        Advisory Committee,
                whichever occurs later, the Administrator shall by 
                order either deny the petition or approve it.
                    (C) Approval.--The Administrator may approve--
                            (i) a petition for an exemption for a 
                        tobacco product from a requirement if the 
                        Administrator determines that compliance with 
                        such requirement is not required to assure that 
                        the tobacco product will be in compliance with 
                        this Act; and
                            (ii) a petition for a variance for a 
                        tobacco product from a requirement if the 
                        Administrator 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 
                        Act.
                    (D) Conditions.--An order of the Administrator 
                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 Act.
                    (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 this Act.
    (f) Research and Development.--The Administrator may enter into 
contracts for research, testing, and demonstrations respecting tobacco 
products and may obtain tobacco products for research, testing, and 
demonstration purposes.

SEC. 111. SMOKING ARTICLE STANDARDS.

    (a) In General.--
            (1) Restrictions on descriptors used in marketing of 
        cigarettes.--
                    (A) In general.--Except as provided in subparagraph 
                (B), no person shall use, with respect to any cigarette 
                brand style commercially distributed domestically, on 
                the portion of the package of such cigarette brand 
                style that customarily is visible to consumers before 
                purchase, or in advertising of such cigarette brand 
                style any of the following as a descriptor of any 
                cigarette brand style--
                            (i) the name of any candy or fruit;
                            (ii) the word ``candy,'' ``citrus,'' 
                        ``cream,'' ``fruit,'' ``sugar,'' ``sweet,'' 
                        ``tangy,'' or ``tart,''; or
                            (iii) any extension or variation of any of 
                        the words ``candy,'' ``citrus,'' ``cream,'' 
                        ``fruit,'' ``sugar,'' ``sweet,'' ``tangy,'' or 
                        ``tart,'' including but not limited to 
                        ``creamy,'' or ``fruity.''
                    (B) Limitation.--Subparagraph (A) shall not apply 
                to the use of the following words or to any extension 
                or variation of any of them: ``coffee,'' ``mint,'' and 
                ``menthol''.
                    (C) Scented materials.--No person shall use, in the 
                advertising or labeling of any cigarette commercially 
                distributed domestically, any scented materials, except 
                in an adult-only facility.
                    (D) Definitions.--In this section:
                            (i) The term ``candy'' means a confection 
                        made from sugar or sugar substitute, including 
                        any confection identified generically or by 
                        brand, and shall include the words ``cacao,'' 
                        ``chocolate,'' ``cinnamon,'' ``cocoa,'' 
                        ``honey,'' ``licorice,'' ``maple,'' ``mocha,'' 
                        and ``vanilla.''
                            (ii) The term ``fruit'' means any fruit 
                        identified by generic name, type, or variety, 
                        including but not limited to ``apple,'' 
                        ``banana,'' ``cherry,'' and ``orange.'' The 
                        term ``fruit'' does not include words that 
                        identify seeds, nuts or peppers, or types or 
                        varieties thereof or words that are extensions 
                        or variations of such words.
            (2) Smoking article standards.--
                    (A) In general.--The Administrator may adopt 
                smoking article standards in addition to those in 
                paragraph (1) if the Administrator finds that a smoking 
                article standard is appropriate for the protection of 
                the public health.
                    (B) Determinations.--
                            (i) Considerations.--In making a finding 
                        described in subparagraph (A), the 
                        Administrator shall consider scientific 
                        evidence concerning--
                                    (I) the risks and benefits to the 
                                users of smoking articles of the 
                                proposed standard; and
                                    (II) that the standard is 
                                reasonably likely to result in 
                                measurable and substantial reductions 
                                in morbidity and mortality among 
                                individual tobacco users.
                            (ii) Additional considerations.--In the 
                        event that the Administrator makes a 
                        determination, set forth in a proposed smoking 
                        article 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 smoking 
                        article because the Administrator has found 
                        that the additive, constituent, or other 
                        component is 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 Administrator's consideration scientific 
                        evidence that demonstrates that the proposed 
                        standard will not reduce or eliminate the risk 
                        of illness or injury.
            (3) Content of smoking article standards.--A smoking 
        article standard established under this section for a smoking 
        article--
                    (A) may include provisions that are appropriate for 
                the protection of the public health, including 
                provisions, where appropriate--
                            (i) for ``tar'' and nicotine yields of the 
                        product;
                            (ii) for the reduction of other 
                        constituents, including smoke constituents, or 
                        harmful components of the product; or
                            (iii) relating to any other requirement 
                        under subparagraph (B); and
                    (B) may, 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 smoking article;
                            (ii) provisions for the testing (on a 
                        sample basis or, if necessary, on an individual 
                        basis) of the smoking article;
                            (iii) provisions for the measurement of the 
                        smoking article characteristics of the smoking 
                        article; and
                            (iv) provisions requiring that the results 
                        of each or of certain of the tests of the 
                        smoking article required to be made under 
                        clause (ii) show that the smoking article is in 
                        conformity with the portions of the standard 
                        for which the test or tests were required.
            (4) Periodic reevaluation of smoking article standards.--
        The Administrator may provide for periodic evaluation of 
        smoking article standards established under this section to 
        determine whether such standards should be changed to reflect 
        new medical, scientific, or other technological data.
            (5) Cigarette ``tar'' limits.--
                    (A) No increase in ``tar'' yields.--No cigarette 
                manufacturer shall distribute for sale domestically a 
                brand style of cigarettes that generates a ``tar'' 
                yield greater than the ``tar'' yield of that brand 
                style of cigarettes on the date of introduction of this 
                Act, as determined by the ISO smoking regimen and its 
                associated tolerances. The ``tar'' tolerances for 
                cigarettes with ISO ``tar'' yields in the range of 1 to 
                20 milligrams per cigarette, based on variations 
                arising from sampling procedure, test method, and 
                sampled product, itself, are the greater of plus or 
                minus--
                            (i) 15 percent; or
                            (ii) 1 milligram per cigarette.
                    (B) Limit on new cigarettes.--After the effective 
                date of this Act, no cigarette manufacturer shall 
                manufacture for commercial distribution domestically a 
                brand style of cigarettes that both--
                            (i) was not in commercial distribution 
                        domestically on the effective date of this Act, 
                        and
                            (ii) generates a ``tar'' yield of greater 
                        than 20 milligrams per cigarette as determined 
                        by the ISO smoking regimen and its associated 
                        tolerances.
                    (C) Limit on all cigarettes.--After December 31, 
                2010, no cigarette manufacturer shall manufacture for 
                commercial distribution domestically a brand style of 
                cigarettes that generates a ``tar'' yield greater than 
                20 milligrams per cigarette as determined by the ISO 
                smoking regimen and its associated tolerances.
                    (D) Review by administrator.--After the effective 
                date of this Act, the Administrator shall evaluate the 
                available scientific evidence addressing the potential 
                relationship between historical ``tar'' yield values 
                and risk of harm to smokers. If upon a review of that 
                evidence, and after consultation with technical experts 
                of the Tobacco Harm Reduction Center and the Centers 
                for Disease Control and Prevention and notice and an 
                opportunity for public comment, the Administrator 
                determines, that a reduction in ``tar'' yield may 
                reasonably be expected to provide a meaningful 
                reduction of the risk or risks of harm to smokers, the 
                Administrator shall issue an order that--
                            (i) provides that no cigarette manufacturer 
                        shall manufacture for commercial distribution 
                        domestically a cigarette that generates a 
                        ``tar'' yield that exceeds 14 milligrams as 
                        determined by the ISO smoking regimen and its 
                        associated tolerances; and
                            (ii) provides a reasonable time for 
                        manufacturers to come into compliance with such 
                        prohibition.
            (6) Involvement of other agencies; informed persons.--In 
        carrying out duties under this section, the Administrator 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 Administrator's judgment can 
                make a significant contribution.
    (b) Considerations by Administrator.--
            (1) Technical achievability.--The Administrator shall 
        consider information submitted in connection with a proposed 
        standard regarding the technical achievability of compliance 
        with such standard.
            (2) Other considerations.--The Administrator shall consider 
        all other information submitted in connection with a proposed 
        standard, such as the creation of a significant demand for 
        contraband or other tobacco products that do not meet the 
        requirements of this Act and the significance of such demand.
    (c) Proposed Standards.--
            (1) In general.--The Administrator shall publish in the 
        Federal Register a notice of proposed rulemaking for the 
        establishment, amendment, or revocation of any smoking article 
        standard.
            (2) Requirements of notice.--A notice of proposed 
        rulemaking for the establishment or amendment of a smoking 
        article standard shall--
                    (A) set forth a finding with supporting 
                justification that the smoking article standard is 
                appropriate for the protection of the public health;
                    (B) invite interested persons to submit a draft or 
                proposed smoking article standard for consideration by 
                the Administrator;
                    (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 
                smoking article standard.
            (3) Finding.--A notice of proposed rulemaking for the 
        revocation of a smoking article standard shall set forth a 
        finding with supporting justification that the smoking article 
        standard is no longer appropriate for the protection of the 
        public health.
            (4) Comment.--The Administrator shall provide for a comment 
        period of not less than 90 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 standard and after consideration of 
        comments submitted under subsections (b) and (c) and any report 
        from the Tobacco Products Scientific Advisory Committee, if the 
        Administrator determines that the standard would be appropriate 
        for the protection of the public health, the Administrator 
        shall--
                    (A) promulgate a regulation establishing a smoking 
                article 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 smoking 
        article 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 Administrator 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 Administrator 
        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.
            (3) Limitation on power granted.--Because of the importance 
        of a decision of the Administrator to issue a regulation--
                    (A) banning cigarettes, smokeless smoking articles, 
                little cigars, cigars other than little cigars, pipe 
                tobacco, or roll-your-own smoking articles;
                    (B) requiring the reduction of ``tar'' or nicotine 
                yields of a smoking article to zero;
                    (C) prohibiting the sale of any smoking article in 
                face-to-face transactions by a specific category of 
                retail outlets;
                    (D) establishing a minimum age of sale of smoking 
                articles to any person older than 18 years of age; or
                    (E) requiring that the sale or distribution of a 
                smoking article be limited to the written or oral 
                authorization of a practitioner licensed by law to 
                prescribe medical products,
        the Administrator is prohibited from taking such actions under 
        this Act.
            (4) Matchbooks.--For purposes of any regulations issued by 
        the Administrator under this Act, matchbooks of conventional 
        size containing not more than 20 paper matches, and which are 
        customarily given away for free with the purchase of smoking 
        articles, shall be considered as adult-written publications 
        which shall be permitted to contain advertising.
            (5) Amendment; revocation.--
                    (A) Authority.--The Administrator, upon the 
                Administrator'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 smoking article 
                standard.
                    (B) Effective date.--The Administrator may declare 
                a proposed amendment of a smoking article 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 
                Administrator determines that making it so effective is 
                in the public interest.
            (6) Referral to advisory committee.--
                    (A) In general.--The Administrator shall refer a 
                proposed regulation for the establishment, amendment, 
                or revocation of a smoking article 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 Administrator 
                shall make a referral under this paragraph--
                            (i) on the Administrator'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 Administrator 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 90 
                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 Administrator 
                and other data and information before it, submit to the 
                Administrator 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 Administrator shall 
                make a copy of each report and recommendation under 
                subparagraph (D) publicly available.

SEC. 112. NOTIFICATION AND OTHER REMEDIES.

    (a) Notification.--If the Administrator 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 
        materially above the risk for death and disease of tobacco 
        products currently in interstate commerce, 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 Act 
        (other than this section) to eliminate such risk,
the Administrator 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 Administrator may order notification by any 
appropriate means, including public service announcements. Before 
issuing an order under this subsection, the Administrator 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 Administrator 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, acute 
        adverse health consequences or death, the Administrator 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 Administrator determines that inadequate grounds exist to 
        support the actions required by the order, the Administrator 
        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 
                Administrator determines that the order should be 
                amended to include a recall of the tobacco product with 
                respect to which the order was issued, the 
                Administrator shall, except as provided in subparagraph 
                (B), amend the order to require a recall. The 
                Administrator shall specify a timetable in which the 
                tobacco product recall will occur and shall require 
                periodic reports to the Administrator 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 
                Administrator 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 Administrator 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. 113. RECORDS AND REPORTS ON TOBACCO PRODUCTS.

    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 Administrator may by 
regulation reasonably require to assure that such tobacco product is 
not adulterated or misbranded.

SEC. 114. APPLICATION FOR REVIEW OF CERTAIN SMOKING ARTICLES.

    (a) In General.--
            (1) New smoking article defined.--For purposes of this 
        section the term ``new smoking article'' means--
                    (A) any smoking article that was not commercially 
                marketed in the United States as of the date of 
                enactment of this Act; and
                    (B) any smoking article that incorporates a 
                significant modification (including changes in design, 
                component, part, or constituent, including a smoke 
                constituent, or in the content, delivery or form of 
                nicotine, or other additive or ingredient) of a smoking 
                article where the modified product was commercially 
                marketed in the United States after the date of 
                enactment of this Act.
            (2) Premarket review required.--
                    (A) New products.--An order under subsection 
                (c)(1)(A) for a new smoking article is required unless 
                the product--
                            (i) is substantially equivalent to a 
                        smoking article commercially marketed in the 
                        United States as of date of enactment of this 
                        Act; and
                            (ii) is in compliance with the requirements 
                        of this Act.
                    (B) Consumer testing.--This section shall not apply 
                to smoking articles that are provided to adult tobacco 
                consumers for purposes of consumer testing. For 
                purposes of this section, the term ``consumer testing'' 
                means an assessment of smoking articles that is 
                conducted by or under the control and direction of a 
                manufacturer for the purpose of evaluating consumer 
                acceptance of such smoking articles, utilizing only the 
                quantity of cigarettes that is reasonably necessary for 
                such assessment
            (3) Substantially equivalent defined.--
                    (A) In general.--In this section, the term 
                ``substantially equivalent'' or ``substantial 
                equivalence'' means, with respect to the smoking 
                article being compared to the predicate smoking 
                article, that the Administrator by order has found that 
                the smoking article--
                            (i) has the same general characteristics as 
                        the predicate smoking article; or
                            (ii) has different characteristics and the 
                        information submitted contains information, 
                        including clinical data if deemed necessary by 
                        the Administrator, 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 for the 
                        consumer of the product.
                    (B) Characteristics.--In subparagraph (A), the term 
                ``characteristics'' means the materials, ingredients, 
                design, composition, heating source, or other features 
                of a smoking article.
                    (C) Limitation.--A smoking article may not be found 
                to be substantially equivalent to a predicate smoking 
                article that has been removed from the market at the 
                initiative of the Administrator or that has been 
                determined by a judicial order to be misbranded or 
                adulterated.
            (4) Health information.--As part of a submission respecting 
        a smoking article, the person required to file a premarket 
        notification shall provide an adequate summary of any health 
        information related to the smoking article or state that such 
        information will be made available upon request by any person.
    (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 smoking article 
                and whether such smoking article presents less risk 
                than other smoking articles;
                    (B) a full statement of the components, 
                ingredients, additives, and properties, and of the 
                principle or principles of operation, of such smoking 
                article;
                    (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 smoking article;
                    (D) an identifying reference to any smoking article 
                standard under section 111 which would be applicable to 
                any aspect of such smoking article, and either adequate 
                information to show that such aspect of such smoking 
                article fully meets such smoking article standard or 
                adequate information to justify any deviation from such 
                standard;
                    (E) such samples of such smoking article and of 
                components thereof as the Administrator may reasonably 
                require;
                    (F) specimens of the labeling proposed to be used 
                for such smoking article; and
                    (G) such other information relevant to the subject 
                matter of the application as the Administrator may 
                require.
            (2) Referral to tobacco products scientific advisory 
        committee.--Upon receipt of an application meeting the 
        requirements set forth in paragraph (1), the Administrator--
                    (A) may, on the Administrator'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 Administrator 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.--As promptly as possible, but in no event 
        later than 90 days after the receipt of an application under 
        subsection (b), the Administrator, after considering the report 
        and recommendation submitted under subsection (b)(2), shall--
                    (A) issue an order that the new product may be 
                introduced or delivered for introduction into 
                interstate commerce if the Administrator finds that 
                none of the grounds specified in paragraph (2) of this 
                subsection applies; or
                    (B) issue an order that the new product may not be 
                introduced or delivered for introduction into 
                interstate commerce if the Administrator 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.
            (2) Denial of application.--The Administrator shall deny an 
        application submitted under subsection (b) if, upon the basis 
        of the information submitted to the Administrator as part of 
        the application and any other information before the 
        Administrator with respect to such smoking article, the 
        Administrator finds that--
                    (A) there is a lack of a showing that permitting 
                such smoking article 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 smoking article do not conform to the 
                requirements of section 110(e);
                    (C) based on a fair evaluation of all material 
                facts, the proposed labeling is false or misleading in 
                any particular; or
                    (D) such smoking article is not shown to conform to 
                a smoking article standard in effect under section 111, 
                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 Administrator 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 Administrator).
            (4) Basis for finding.--For purposes of this section, the 
        finding as to whether the commercial introduction of a smoking 
        article 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 users 
        of the smoking article, and taking into account whether such 
        commercial introduction is reasonably likely to increase the 
        morbidly and mortality among individual tobacco users.
    (d) Withdrawal and Temporary Suspension.--
            (1) In general.--The Administrator 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 smoking 
        article for which an order was issued under subsection 
        (c)(1)(A), issue an order withdrawing the order if the 
        Administrator finds--
                    (A) that the continued marketing of such smoking 
                article 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 113; or
                            (ii) has refused to permit access to, or 
                        copying or verification of, such records as 
                        required by section 110; or
                    (D) on the basis of new information before the 
                Administrator with respect to such smoking article, 
                evaluated together with the evidence before the 
                Administrator 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 smoking article do not conform 
                with the requirements of section 110(e) and were not 
                brought into conformity with such requirements within a 
                reasonable time after receipt of written notice from 
                the Administrator of nonconformity;
                    (E) on the basis of new information before the 
                Administrator, evaluated together with the evidence 
                before the Administrator when the application was 
                reviewed, that the labeling of such smoking article, 
                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 Administrator of such fact; or
                    (F) on the basis of new information before the 
                Administrator, evaluated together with the evidence 
                before the Administrator when such order was issued, 
                that such smoking article is not shown to conform in 
                all respects to a smoking article standard which is in 
                effect under section 111, 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) 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 116.
            (3) Temporary suspension.--If, after providing an 
        opportunity for an informal hearing, the Administrator 
        determines there is reasonable probability that the 
        continuation of distribution of a smoking article under an 
        order would cause serious, adverse health consequences or 
        death, that is greater than ordinarily caused by smoking 
        articles on the market, the Administrator shall by order 
        temporarily suspend the authority of the manufacturer to market 
        the product. If the Administrator issues such an order, the 
        Administrator shall proceed expeditiously under paragraph (1) 
        to withdraw such application.
    (e) Service of Order.--An order issued by the Administrator under 
this section shall be served--
            (1) in person by any officer or employee of the department 
        designated by the Administrator; 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 Administrator.
    (f) Records.--
            (1) Additional information.--In the case of any smoking 
        article for which an order issued pursuant to subsection 
        (c)(1)(A) for an application filed under subsection (b) is in 
        effect, the applicant shall establish and maintain such 
        records, and make such reports to the Administrator, as the 
        Administrator 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 
        Administrator 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 Administrator, permit such officer or 
        employee at all reasonable times to have access to and copy and 
        verify such records.
    (g) Investigational Smoking Article Exemption for Investigational 
Use.--The Administrator may exempt smoking articles intended for 
investigational use from the provisions of this Act under such 
conditions as the Administrator may by regulation prescribe.

SEC. 115. 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'', 
                        ``low'', ``medium'', ``ultra light'', ``low 
                        tar'' or ``ultra low tar''; 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 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''.
            (3) Effective date.--The provisions of paragraph (2)(A)(ii) 
        shall take effect 12 months after the date of enactment of the 
        Act.
    (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 Center and is subject 
to the requirements of chapter V.
    (d) Filing.--Any person may file with the Administrator 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 Administrator may 
        require.
    (e) Public Availability.--The Administrator 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 Administrator 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 
        Administrator.
    (g) Marketing.--
            (1) Modified risk products.--Except as provided in 
        paragraph (2), the Administrator 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 
        Administrator 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) is reasonably likely to result in measurable 
                and substantial reductions in morbidity and mortality 
                among individual tobacco users.
            (2) Special rule for certain products.--
                    (A) In general.--The Administrator 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 Administrator 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 significantly less harmful; or
                                    (II) presents or has been 
                                demonstrated to present significant 
                                less of a risk of disease than other 
                                commercially marketed tobacco products; 
                                and
                            (iv) issuance of an order with respect to 
                        the application is expected to benefit the 
                        health of users of tobacco products.
            (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 Administrator.
    (h) Additional Conditions for Marketing.--
            (1) Modified risk products.--The Administrator 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 Administrator may require for 
                the marketing of a product under this subsection that a 
                claim comparing a tobacco product to 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 Administrator 
                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.
    (i) Postmarket Surveillance and Studies.--
            (1) In general.--The Administrator 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 Administrator 
        to review the accuracy of the determinations upon which the 
        order was based, and to provide information that the 
        Administrator 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 Administrator 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 Administrator, a protocol for the required 
        surveillance. The Administrator, within 30 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 Administrator as necessary to 
        protect the public health.
    (j) Withdrawal of Authorization.--The Administrator, after an 
opportunity for an informal hearing, shall withdraw an order under 
subsection (g) if the Administrator determines that--
            (1) the applicant, based on new information, can no longer 
        make the demonstrations required under subsection (g), or the 
        Administrator 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 111;
                    (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 Administrator has 
issued an order pursuant to subsection (g) shall not be subject to 
chapter IV or V of the Federal Food, Drug, and Cosmetic Act.
    (l) Implementing Regulations or Guidance.--
            (1) Scientific evidence.--Not later than 2 years after the 
        date of enactment of the Act, the Administrator 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 a reasonable likelihood 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; and
                    (E) establish a reasonable timetable for the 
                Administrator to review an application under this 
                section.
            (2) Consultation.--The regulations or guidance issued under 
        paragraph (1) may 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 Act, the Administrator 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 114 and which the applicant seeks to 
        commercially market under this section.

SEC. 116. JUDICIAL REVIEW.

    (a) Right To Review.--
            (1) In general.--Not later than 60 days after--
                    (A) the promulgation of a regulation under section 
                111 establishing, amending, or revoking a tobacco 
                product standard; or
                    (B) a denial of an application under section 
                114(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 Administrator.
                    (B) Record of proceedings.--On receipt of a 
                petition under subparagraph (A), the Administrator 
                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 
                        Administrator 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 
                        Administrator, 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 
110, 111, 112, 113, 114, or 119 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. 117. JURISDICTION OF AND COORDINATION WITH THE FEDERAL TRADE 
              COMMISSION.

    Except where expressly provided in this Act, nothing in this Act 
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.

SEC. 118. REGULATION REQUIREMENT.

    (a) Testing, Reporting, and Disclosure.--Not later than 36 months 
after the date of enactment of the Act, the Administrator 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 annual testing and reporting of tobacco 
        product constituents, ingredients, and additives, including 
        smoke constituents, by brand style that the Administrator 
        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 style; 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.
    (c) Authority.--The Administrator shall have the authority under 
this Act to conduct or to require the testing, reporting, or disclosure 
of tobacco product constituents, including smoke constituents.
    (d) Joint Laboratory Testing Services.--The Administrator shall 
allow any 2 or more 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 tobacco product 
        manufacturer shall not be considered to be in violation of this 
        section before the applicable deadline, if--
                    (A) the tobacco products of such manufacturer are 
                in compliance with all other requirements of this Act; 
                and
                    (B) the conditions described in paragraph (2) are 
                met.
            (2) Conditions.--Notwithstanding the requirements of this 
        section, the Administrator may delay the date by which a 
        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 
        tobacco product manufacturer provides evidence to the 
        Administrator 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 Administrator, taking into account the 
        laboratory testing capacity that is available to tobacco 
        product manufacturers, shall review and verify the evidence 
        submitted by a tobacco product manufacturer in accordance with 
        paragraph (2). If the Administrator finds that the conditions 
        described in such paragraph are met, the Administrator shall 
        notify the 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 Administrator 
        has not made a finding before the reporting deadline, the 
        manufacturer shall not be considered to be in violation of such 
        requirements until the Administrator 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 Administrator may provide 
        further extensions of time, in increments of no more than 1 
        year, for required testing and reporting to occur if the 
        Administrator determines, based on evidence properly and timely 
        submitted by a 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 other 
than this section.

SEC. 119. PRESERVATION OF STATE AND LOCAL AUTHORITY.

    (a) In General.--
            (1) Preservation.--Except as provided in paragraph (2)(A), 
        nothing in this Act, or rules promulgated under this Act, 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 requirements established under this Act, including 
        a law, rule, regulation, or other measure relating to or 
        prohibiting the sale, distribution, possession, or use of 
        tobacco products by individuals of any age, information 
        reporting to the State. No provision of this Act 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 Act 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, use of, 
                tobacco product by individuals of any age. 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 Act 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. 120. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.

    (a) Establishment.--Not later than 6 months after the date of 
enactment of this Act, the Administrator shall establish a 16-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 Administrator shall appoint as 
                members of the Tobacco Harm Reduction 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) 6 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) 2 individuals who are an officer or 
                        employee of a State or local government or of 
                        the Federal Government;
                            (iii) 2 representatives of the general 
                        public;
                            (iv) 2 representatives of the interests of 
                        the tobacco manufacturing industry;
                            (v) 1 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;
                            (vi) 1 individual as a representative of 
                        the interests of the tobacco growers; and
                            (vii) 1 individual who is an expert in 
                        illicit trade of tobacco products.
                    (B) 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 or government agency with any form of 
                jurisdiction over tobacco products.
            (2) Limitation.--The Administrator may not appoint to the 
        Advisory Committee any individual who is in the regular full-
        time employ of the Tobacco Harm Reduction Center or any agency 
        responsible for the enforcement of this Act. The Administrator 
        may appoint Federal officials as ex officio members.
            (3) Chairperson.--The Administrator 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 
Administrator--
            (1) as provided in this Act;
            (2) on the implementation of prevention, cessation, and 
        harm reduction policies;
            (3) on implementation of policies and programs to fully 
        inform consumers of the respective risks of tobacco products; 
        and
            (4) on its review of other safety, dependence, or health 
        issues relating to tobacco products as requested by the 
        Administrator.
    (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 
        Administrator, 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 Administrator 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. 121. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.

    (a) Report on Innovative Products.--
            (1) In general.--Not later than 3 years after the date of 
        enactment of this Act, the Administrator, 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 
        promote, and encourage the development and use by current 
        tobacco users of innovative tobacco and nicotine 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 by moving current users to 
                noncombustible tobacco products.
            (2) Recommendations.--The report under paragraph (1) shall 
        include the recommendations of the Administrator on how the 
        Tobacco Harm and Reduction Center should coordinate and 
        facilitate the exchange of information on such innovative 
        products and treatments among relevant offices and centers 
        within the Center and within the National Institutes of Health, 
        the Centers for Disease Control and Prevention, and other 
        relevant Federal and State agencies.

SEC. 122. ADVERTISING AND MARKETING OF TOBACCO PRODUCTS.

    (a) Within 18 months of enactment of the Act, the Administrator 
shall report to Congress on the benefits to public health of imposing 
restrictions or prohibitions on the advertising and marketing, 
consistent with or in addition to such restrictions or prohibitions 
contained in the Master Settlement Agreement, on tobacco products.
    (b) The Administrator shall specify in the report constitutional 
free speech implications for each recommended restriction or 
prohibition.
    (c) The Administrator shall also specify the class of tobacco 
products to which the prohibition or restriction would be applicable 
and the impact of such actions on harm reduction policies, practices, 
and accurate information available to tobacco users.
    (d) The Administrator shall establish and consult with an advisory 
committee consisting of experts in constitutional law, harm reduction 
policies, marketing practices, and consumer behavior in preparing this 
report.

TITLE II--TOBACCO PRODUCTS 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 lower portion 
        of the front panel of the package, directly on the package 
        underneath the cellophane or other clear wrapping. Each label 
        statement shall comprise at least the bottom 25 percent of the 
        front panel 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 smoking article 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 bottom of each advertisement within the trim 
        area. 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 smokeless tobacco 
        products, each label statement required by subsection (a) may 
        be printed on the inside cover of the matchbook.
    ``(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 smokeless 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 smokeless 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 smokeless 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).''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
take effect 24 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 4 of the Federal Cigarette 
Labeling and Advertising Act (15 U.S.C. 1333), as amended by subsection 
(a).

SEC. 202. 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 has significantly lower 
                risks for diseases associated with cigarettes.
                    ``WARNING: Smokeless tobacco is addictive.
            ``(2) The label statements required by paragraph (1) shall 
        be introduced by each smokeless tobacco product manufacturer, 
        packager, importer, distributor, or retailer of smokeless 
        tobacco products concurrently into the distribution chain of 
        such products.
            ``(3) The provisions of this subsection do not apply to a 
        smokeless 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.
            ``(4) 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 smokeless 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 smokeless 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 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 smokeless 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 smokeless 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 smokeless 
                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.
    ``(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 24 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).

     TITLE III--PUBIC DISCLOSURES BY TOBACCO PRODUCTS MANUFACTURERS

SEC. 301. DISCLOSURES ON PACKAGES OF TOBACCO PRODUCTS.

    (a) Back Face for Required Disclosures.--For purposes of this 
section--
            (1) the principal face of a package of a tobacco product is 
        the face that has the largest surface area or, for faces with 
        identical surface areas, any of the faces that have the largest 
        surface area; a package shall not be characterized as having 
        more than 2 principal faces;
            (2) the front face shall be the principal face of the 
        package;
            (3) if the front and back faces are of different sizes in 
        terms of area, then the larger face shall be the front face;
            (4) the back face shall be the principal face of a package 
        that is opposite the front face of the package;
            (5) the bottom 50 percent of the back face of the package 
        shall be allocated for required package disclosures in 
        accordance with this section; and
            (6) if a package of a tobacco product is cylindrical, a 
        contiguous area constituting 30 percent of the total surface 
        area of the cylinder shall be deemed the back face.
    (b) Required Information on Back Face.--Not later than 24 months 
after the effective date of this Act, the bottom 50 percent of the back 
face of a package of a tobacco product shall be available solely for 
disclosures required by or under this Act, the Federal Cigarette 
Labeling and Advertising Act, sections 1331-1340 of title 15, United 
States Code, and any other Federal statute. Such disclosures shall 
include--
            (1) the printed name and address of the manufacturer, 
        packer, or distributor, and any other identification associated 
        with the manufacturer, packer, or distributor or with the 
        tobacco product that the Administrator may require;
            (2) a list of ingredients as required by subsection (e); 
        and
            (3) the appropriate tax registration number.
    (c) Package Disclosure of Ingredients.--Not later than 24 months 
after the effective date of this Act, the package of a tobacco product 
shall bear a list of the common or usual names of the ingredients 
present in the tobacco product in an amount greater than 0.1 percent of 
the total dry weight of the tobacco (including all ingredients), that 
shall comply with the following:
            (1) Such listing of ingredients shall appear under, or be 
        conspicuously accompanied by, the heading ``Tobacco and 
        principal tobacco ingredients''.
            (2) Tobacco may be listed as ``tobacco,'' and shall be the 
        first listed ingredient.
            (3) After tobacco, the ingredients shall be listed in 
        descending order of predominance, by weight.
            (4) Spices and natural and artificial flavors may be 
        listed, respectively, as ``spices'' and ``natural and 
        artificial flavors'' without naming each.
            (5) Preservatives may be listed as ``preservatives'' 
        without naming each.
            (6) The disclosure of any ingredient in accordance with 
        this section may, at the option of the tobacco product 
        manufacturer, designate the functionality or purpose of that 
        ingredient.
            (7) The package say state ``Not for sale to minors''.
            (8) In the case of a package of cigarettes, the package 
        shall state that smokeless tobacco has significantly lower 
        risks for disease and death than cigarettes.

SEC. 302. DISCLOSURES ON PACKAGES OF SMOKELESS TOBACCO.

    (a) Back Face for Required Disclosures.--For purposes of this 
section--
            (1) the principal face of a package of smokeless tobacco is 
        the face that has the largest surface area or, for faces with 
        identical surface areas, any of the faces that have the largest 
        surface area; a package shall not be characterized as having 
        more than two principal faces;
            (2) the front or top face shall be the principal face of 
        the package;
            (3) if the front or top and back or bottom faces are of 
        different sizes in terms of area, then the larger face shall be 
        the front or top face;
            (4) the back or bottom face of the package shall be the 
        principal face of a package that is opposite the front or top 
        face of the package;
            (5) beginning 24 months after the effective date of this 
        Act, 50 percent of the back or bottom face of the package shall 
        be allocated for required package disclosures in accordance 
        with this section; and
            (6) if the package is cylindrical, a contiguous area 
        constituting 30 percent of the total surface area of the 
        cylinder shall be deemed the back face.
    (b) Required Information on Back or Bottom Face.--50 percent of the 
back or bottom face of a package of smokeless tobacco shall be 
available solely for disclosures required by or under this Act, the 
Comprehensive Smokeless Tobacco Health Education Act of 1986, sections 
4401-4408 of title 15, United States Code, and any other Federal 
statute. Such disclosures shall include a list of ingredients as 
required by subsection (e).
    (c) Package Disclosure of Ingredients.--Commencing 24 months after 
the effective date of this Act, a package of smokeless tobacco shall 
bear a list of the common or usual names of the ingredients present in 
the smokeless tobacco in an amount greater than 0.1 percent of the 
total dry weight of the tobacco (including all ingredients).
            (1) Such listing of ingredients shall appears under, or be 
        conspicuously accompanied by, the heading ``Tobacco and 
        principal tobacco ingredients''.
            (2) Tobacco may be listed as ``tobacco,'' and shall be the 
        first listed ingredient.
            (3) After tobacco, the ingredients shall be listed in 
        descending order of predominance, by weight.
            (4) Spices and natural and artificial flavors may be 
        listed, respectively, as ``spices'' and ``natural and 
        artificial flavors'' without naming each.
            (5) Preservatives may be listed as ``preservatives'' 
        without naming each.
            (6) The disclosure of any ingredient in accordance with 
        this section may, at the option of the tobacco product 
        manufacturer, designate the functionality or purpose of that 
        ingredient.
            (7) Not for sale to minors.

SEC. 303. PUBLIC DISCLOSURE OF INGREDIENTS.

    (a) Regulations.--Not later than 24 months after the effective date 
of this Act, the Administrator shall, by regulation, establish 
standards under which each tobacco product manufacturer shall disclose 
publicly, and update at least annually--
            (1) a list of the ingredients it uses in each brand style 
        it manufactures for commercial distribution domestically, as 
        provided in subsection (b); and
            (2) a composite list of all the ingredients it uses in any 
        of the brand styles it manufactures for commercial distribution 
        domestically, as provided in subsection (c).
    (b) Ingredients To Be Disclosed as to Each Brand Style.--
            (1) In general.--With respect to the public disclosure 
        required by subsection (a)(1), as to each brand style, the 
        tobacco product manufacture shall disclose the common or usual 
        name of each ingredient present in the brand style in an amount 
        greater than 0.1 percent of the total dry weight of the tobacco 
        (including all ingredients).
            (2) Requirements.--Disclosure under paragraph (1) shall 
        comply with the following:
                    (A) Tobacco may be listed as ``tobacco,'' and shall 
                be the first listed ingredient.
                    (B) After tobacco, the ingredients shall be listed 
                in descending order of predominance, by weight.
                    (C) Spices and natural and artificial flavors may 
                be listed, respectively, as ``spices'' and ``natural 
                and artificial flavors'' without naming each.
                    (D) Preservatives may be listed as 
                ``preservatives'' without naming each.
                    (E) The disclosure of any ingredient in accordance 
                with this section may, at the option of the tobacco 
                product manufacturer, designate the functionality or 
                purpose of that ingredient.
    (c) Aggregate Disclosure of Ingredients.--
            (1) In general.--The public disclosure required of a 
        tobacco product manufacturer by subsection (a)(2) shall consist 
        of a single list of all ingredients used in any brand style a 
        tobacco product manufacturer manufactures for commercial 
        distribution domestically, without regard to the quantity used, 
        and including, separately, each spice, each natural or 
        artificial flavoring, and each preservative.
            (2) Listing.--The ingredients shall be listed by their 
        respective common or usual names in descending order of 
        predominance by the total weight used annually by the tobacco 
        product manufacturer in manufacturing tobacco products for 
        commercial distribution domestically.
    (d) No Required Disclosure of Quantities.--The Administrator shall 
not require any public disclosure of quantitative information about any 
ingredient in a tobacco product.
    (e) Disclosure on Website.--The public disclosures required by 
subsection (a) of this section may be by posting on an Internet-
accessible website, or other location electronically accessible to the 
public, which is identified on all packages of a tobacco product 
manufacturer's tobacco products.
    (f) Timing of Initial Required Disclosures.--No disclosure pursuant 
to this section shall be required to commence until the regulations 
under subsection (a) have been in effect for not less than 1 year.

       TITLE IV--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS

SEC. 401. STUDY AND REPORT ON ILLICIT TRADE.

    (a) The Administrator shall, after consultation with other relevant 
agencies including Customs and Tobacco Tax Bureau, conduct a study of 
trade in tobacco products that involves passage of tobacco products 
either between the States or from or to any other country across any 
border of the United States to--
            (1) collect data on such trade in tobacco products, 
        including illicit trade involving tobacco products, and make 
        recommendations on the monitoring and enforcement of such 
        trade;
            (2) collect data on any advertising intended to be 
        broadcast, transmitted, or distributed from or to the United 
        States from or to another country and make recommendations on 
        how to prevent or eliminate, and what technologies could help 
        facilitate the elimination of, such advertising; and
            (3) collect data on such trade in tobacco products by 
        person that is not--
                    (A) a participating manufacturer (as that term is 
                defined in section II(jj) of the Master Settlement 
                Agreement of November 23, 1998, between certain of the 
                States and certain tobacco product manufacturers); or
                    (B) an affiliate or subsidiary of a participating 
                manufacturer.
    (b) Not later than 18 months after the effective date of this Act, 
the Administrator shall submit to the Secretary, and committees of 
relevant jurisdiction in Congress, a report the recommendations of the 
study conducted under subsection (a).

SEC. 402. AMENDMENT TO SECTION 1926 OF THE PUBLIC HEALTH SERVICE ACT.

    Section 1926 of the Public Health Service Act (42 U.S.C. Sec.  
300x-26) is amended by adding at the end thereof the following:
    ``(e)(1) Subject to paragraphs (2) and (3), for the first fiscal 
year after enactment and each subsequent fiscal year, the Secretary 
shall reduce, as provided in subsection (h), the amount of any grant 
under section 300x-21 of this title for any State that does not have in 
effect a statute with substantially the following provisions:

```SEC. 1. DISTRIBUTION TO MINORS.

    ```(a) No person shall distribute a tobacco product to an 
individual under 18 years of age or a different minimum age established 
under State law. A person who violates this subsection is liable for a 
civil money penalty of not less than $25 nor more than $125 for each 
violation of this subsection;
    ```(b) The employer of an employee who has violated subsection (a) 
twice while in the employ of such employer is liable for a civil money 
penalty of $125 for each subsequent violation by such employee.
    ```(c) It shall be a defense to a charge brought under subsection 
(a) that--
            ```(1) the defendant--
                    ```(A) relied upon proof of age that appeared on 
                its face to be valid in accordance with the Federal 
                Tobacco Act of 2007;
                    ```(B) had complied with the requirements of 
                section 5 and, if applicable, section 7; or
                    ```(C) relied upon a commercially available 
                electronic age verification service to confirm that the 
                person was an age-verified adult; or
            ```(2) the individual to whom the tobacco product was 
        distributed was at the time of the distribution used in 
        violation of subsection 8(b).

```SEC. 2. PURCHASE, RECEIPT, OR POSSESSION BY MINORS PROHIBITED.

    ```(a) An individual under 18 years of age or a different minimum 
age established under State law shall not purchase or attempt to 
purchase, receive or attempt to receive, possess or attempt to possess, 
a tobacco product. An individual who violates this subsection is liable 
for a civil money penalty of not less than $25 nor more than $125 for 
each such violation, and shall be required to perform not less than 
four hours nor more than ten hours of community service. Upon the 
second or each subsequent violation of this subsection, such individual 
shall be required to perform not less than eight hours nor more than 
twenty hours of community service.
    ```(b) A law enforcement agency, upon determining that an 
individual under 18 years of age or a different minimum age established 
under State law allegedly purchased, received, possessed, or attempted 
to purchase, receive, or possess, a tobacco product in violation of 
subsection (a) shall notify the individual's parent or parents, 
custodian, or guardian as to the nature of the alleged violation if the 
name and address of a parent or parents, guardian, or custodian is 
reasonably ascertainable by the law enforcement agency. The notice 
required by this subsection shall be made not later than 48 hours after 
the individual who allegedly violated subsection (a) is cited by such 
agency for the violation. The notice may be made by any means 
reasonably calculated to give prompt actual notice, including notice in 
person, by telephone, or by first-class mail.
    ```(c) Subsection (a) does not prohibit an individual under 18 
years of age or a different minimum age established under State law 
from possessing a tobacco product during regular working hours and in 
the course of such individual's employment if the tobacco product is 
not possessed for such individual's consumption.

```SEC. 3. OUT-OF-PACKAGE DISTRIBUTION.

    ```It shall be unlawful for any person to distribute cigarettes or 
a smokeless tobacco product other than in an unopened package that 
complies in full with section 108 of the Federal Tobacco Act of 2007. A 
person who distributes a cigarette or a smokeless tobacco product in 
violation of this section is liable for a civil money penalty of not 
less than $25 nor more than $125 for each such violation.

```SEC. 4. SIGNAGE.

    ```It shall be unlawful for any person who sells tobacco products 
over-the-counter to fail to post conspicuously on the premises where 
such person sells tobacco products over-the-counter a sign 
communicating that--
            ```(1) the sale of tobacco products to individuals under 18 
        years of age or a different minimum age established under State 
        law is prohibited by law;
            ```(2) the purchase of tobacco products by individuals 
        under 18 years of age or a different minimum age established 
        under State law is prohibited by law; and
            ```(3) proof of age may be demanded before tobacco products 
        are sold.
A person who fails to post a sign that complies fully with this section 
is liable for a civil money penalty of not less than $25 nor more than 
$125.

```SEC. 5. NOTIFICATION OF EMPLOYEES.

    ```(a) Within 180 days of the effective date of the Youth 
Prevention and Tobacco Harm Reduction Act, every person engaged in the 
business of selling tobacco products at retail shall implement a 
program to notify each employee employed by that person who sells 
tobacco products at retail that--
            ```(1) the sale or other distribution of tobacco products 
        to any individual under 18 years of age or a different minimum 
        age established under State law, and the purchase, receipt, or 
        possession of tobacco products in a place open to the public by 
        any individual under 18 years of age or a different minimum age 
        established under State law, is prohibited; and
            ```(2) out-of-package distribution of cigarettes and 
        smokeless tobacco products is prohibited.
Any employer failing to provide the required notice to any employee 
shall be liable for a civil money penalty of not less than $25 nor more 
than $125 for each such violation.
    ```(b) It shall be a defense to a charge that an employer violated 
subsection (a) of this section that the employee acknowledged receipt, 
either in writing or by electronic means, prior to the alleged 
violation, of a statement in substantially the following form:
    ``I understand that State law prohibits the distribution of tobacco 
products to individuals under 18 years of age or a different minimum 
age established under State law and out-of-package distribution of 
cigarettes and smokeless tobacco products, and permits a defense based 
on evidence that a prospective purchaser's proof of age was reasonably 
relied upon and appeared on its face to be valid. I understand that if 
I sell, give, or voluntarily provide a tobacco product to an individual 
under 18 years of age or a different minimum age established under 
State law, I may be found responsible for a civil money penalty of not 
less than $25 nor more than $125 for each violation. I promise to 
comply with this law.''''
    ```(c) If an employer is charged with a violation of subsection (a) 
and the employer uses as a defense to such charge the defense provided 
by subsection (b), the employer shall be deemed to be liable for such 
violation if such employer pays the penalty imposed on the employee 
involved in such violation or in any way reimburses the employee for 
such penalty.

```SEC. 6. SELF-SERVICE DISPLAYS.

    ```(a) It shall be unlawful for any person who sells tobacco 
products over-the-counter at retail to maintain packages of such 
products in any location accessible to customers that is not under the 
control of a cashier or other employee during regular business hours. 
This subsection does not apply to any adult-only facility.
    ```(b) Any person who violates subsection (a) is liable for a civil 
money penalty of not less than $25 nor more than $125 for each such 
violation, except that no person shall be responsible for more than one 
violation per day at any one retail store.

```SEC. 7. DISTRIBUTION BY MAIL OR COURIER.

    ```(a) It shall be unlawful to distribute or sell tobacco products 
directly to consumers by mail or courier, unless the person receiving 
purchase requests for tobacco products takes reasonable action to 
prevent delivery to individuals who are not adults by--
            ```(1) requiring that addressees of the tobacco products be 
        age-verified adults;
            ```(2) making good faith efforts to verify that such 
        addressees have attained the minimum age for purchase of 
        tobacco products established by the respective States wherein 
        the addresses of the addressees are located; and
            ```(3) addressing the tobacco products delivered by mail or 
        courier to a physical addresses and not to post office boxes.
    ```(b) Any person who violates subsection (a) is liable for a civil 
money penalty of not less than $25 nor more than $125 for each such 
violation.

```SEC. 8. RANDOM UNANNOUNCED INSPECTIONS; REPORTING; AND COMPLIANCE.

    ```(a) The State Police, or a local law enforcement authority duly 
designated by the State Police, shall enforce this Act in a manner that 
can reasonably be expected to reduce the extent to which tobacco 
products are distributed to individuals under 18 years of age or a 
different minimum age established under State law and shall conduct 
random, unannounced inspections in accordance with the procedures set 
forth in this Act and in regulations issued under section 1926 of the 
Federal Public Health Service Act (42 U.S.C. Sec.  300x-26).
    ```(b) The State may engage an individual under 18 years of age or 
a different minimum age established under State law to test compliance 
with this Act, except that such an individual may be used to test 
compliance with this Act only if the testing is conducted under the 
following conditions:
            ```(1) Prior to use of any individual under 18 years of age 
        or a different minimum age established under State law in a 
        random, unannounced inspection, written consent shall be 
        obtained from a parent, custodian, or guardian of such 
        individual;
            ```(2) An individual under 18 years of age or a different 
        minimum age established under State law shall act solely under 
        the supervision and direction of the State Police or a local 
        law enforcement authority duly designated by the State Police 
        during a random, unannounced inspection;
            ```(3) An individual under 18 years of age or a different 
        minimum age established under State law used in random, 
        unannounced inspections shall not be used in any such 
        inspection at a store in which such individual is a regular 
        customer; and
            ```(4) If an individual under 18 years of age or a 
        different minimum age established under State law participating 
        in random, unannounced inspections is questioned during such an 
        inspection about such individual's age, such individual shall 
        state his or her actual age and shall present a true and 
        correct proof of age if requested at any time during the 
        inspection to present it.
    ```(c) Any person who uses any individual under 18 years of age or 
a different minimum age established under State law, other than as 
permitted by subsection (b), to test compliance with this Act, is 
liable for a civil money penalty of not less than $25 nor more than 
$125 for each such violation.
    ```(d) Civil money penalties collected for violations of this Act 
and fees collected under section 9 shall be used only to defray the 
costs of administration and enforcement of this Act.

```SEC. 9. LICENSURE.

    ```(a) Each person engaged in the over-the-counter distribution at 
retail of tobacco products shall hold a license issued under this 
section. A separate license shall be required for each place of 
business where tobacco products are distributed at retail. A license 
issued under this section is not assignable and is valid only for the 
person in whose name it is issued and for the place of business 
designated in the license.
    ```(b) The annual license fee is $25 for each place of business 
where tobacco products are distributed at retail.
    ```(c) Every application for a license, including renewal of a 
license, under this section shall be made upon a form provided by the 
appropriate State agency or department, and shall set forth the name 
under which the applicant transacts or intends to transact business, 
the location of the place of business for which the license is to be 
issued, the street address to which all notices relevant to the license 
are to be sent (in this Act referred to as ``notice address''), and any 
other identifying information that the appropriate State agency or 
department may require.
    ```(d) The appropriate State agency or department shall issue or 
renew a license or deny an application for a license or the renewal of 
a license within 30 days of receiving a properly completed application 
and the license fee. The appropriate State agency or department shall 
provide notice to an applicant of action on an application denying the 
issuance of a license or refusing to renew a license.
    ```(e) Every license issued by the appropriate State agency or 
department pursuant to this section shall be valid for 1 year from the 
date of issuance and shall be renewed upon application except as 
otherwise provided in this Act.
    ```(f) Upon notification of a change of address for a place of 
business for which a license has been issued, a license shall be 
reissued for the new address without the filing of a new application.
    ```(g) The appropriate State agency or department shall notify 
every person in the State who is engaged in the distribution at retail 
of tobacco products of the license requirements of this section and of 
the date by which such person should have obtained a license.
    ```(h)(1) Except as provided in paragraph (2), any person who 
engages in the distribution at retail of tobacco products without a 
license required by this section is liable for a civil money penalty in 
an amount equal to (i) two times the applicable license fee, and (ii) 
$50 for each day that such distribution continues without a license.
            ```(2) Any person who engages in the distribution at retail 
        of tobacco products after a license issued under this section 
        has been suspended or revoked is liable for a civil money 
        penalty of $100 per day for each day on which such distribution 
        continues after the date such person received notice of such 
        suspension or revocation.
    ```(i) No person shall engage in the distribution at retail of 
tobacco products on or after 180 days after the date of enactment this 
Act unless such person is authorized to do so by a license issued 
pursuant to this section or is an employee or agent of a person that 
has been issued such a license.

```SEC. 10. SUSPENSION, REVOCATION, DENIAL, AND NONRENEWAL OF LICENSES.

    ```(a) Upon a finding that a licensee has been determined by a 
court of competent jurisdiction to have violated this Act during the 
license term, the State shall notify the licensee in writing, served 
personally or by registered mail at the notice address, that any 
subsequent violation of this Act at the same place of business may 
result in an administrative action to suspend the license for a period 
determined by the specify the appropriate State agency or department.
    ```(b) Upon finding that a further violation by this Act has 
occurred involving the same place of business for which the license was 
issued and the licensee has been served notice once under subsection 
(a), the appropriate State agency or department may initiate an 
administrative action to suspend the license for a period to be 
determined by the appropriate State agency or department but not to 
exceed six months. If an administrative action to suspend a license is 
initiated, the appropriate State agency or department shall immediately 
notify the licensee in writing at the notice address of the initiation 
of the action and the reasons therefor and permit the licensee an 
opportunity, at least 30 days after written notice is served personally 
or by registered mail upon the licensee, to show why suspension of the 
license would be unwarranted or unjust.
    ```(c) The appropriate State agency or department may initiate an 
administrative action to revoke a license that previously has been 
suspended under subsection (b) if, after the suspension and during the 
one-year period for which the license was issued, the licensee 
committed a further violation of this Act, at the same place of 
business for which the license was issued. If an administrative action 
to revoke a license is initiated, the appropriate State agency or 
department shall immediately notify the licensee in writing at the 
notice address of the initiation of the action and the reasons therefor 
and permit the licensee an opportunity, at least 30 days after written 
notice is served personally or by registered mail upon the licensee, to 
show why revocation of the license would be unwarranted or unjust.
    ```(d) A person whose license has been suspended or revoked with 
respect to a place of business pursuant to this section shall pay a fee 
of $50 for the renewal or reissuance of the license at that same place 
of business, in addition to any applicable annual license fees.
    ```(e) Revocation of a license under subsection (c) with respect to 
a place of business shall not be grounds to deny an application by any 
person for a new license with respect to such place of business for 
more than 12 months subsequent to the date of such revocation. 
Revocation or suspension of a license with respect to a particular 
place of business shall not be grounds to deny an application for a new 
license, to refuse to renew a license, or to revoke or suspend an 
existing license at any other place of business.
    ```(f) A licensee may seek judicial review of an action of the 
appropriate State agency or department suspending, revoking, denying, 
or refusing to renew a license under this section by filing a complaint 
in a court of competent jurisdiction. Any such complaint shall be filed 
within 30 days after the date on which notice of the action is received 
by the licensee. The court shall review the evidence de novo.
    ```(g) The State shall not report any action suspending, revoking, 
denying, or refusing to renew a license under this section to the 
Federal Secretary of Health and Human Services, unless the opportunity 
for judicial review of the action pursuant to subsection (f), if any, 
has been exhausted or the time for seeking such judicial review has 
expired.

```SEC. 11. NO PRIVATE RIGHT OF ACTION.

    ```Nothing in this Act shall be construed to create a right of 
action by any private person for any violation of any provision of this 
Act.

```SEC. 12. JURISDICTION AND VENUE.

    ```Any action alleging a violation of this Act may be brought only 
in a court of general jurisdiction in the city or county where the 
violation is alleged to have occurred.

```SEC. 13. REPORT.

    ```The appropriate State agency or department shall prepare for 
submission annually to the Federal Secretary of Health and Human 
Services the report required by section 1926 of the Federal Public 
Health Service Act (42 U.S.C. 300x-26).'''.
            ``(2) In the case of a State whose legislature does not 
        convene a regular session in fiscal year 2007, and in the case 
        of a State whose legislature does not convene a regular session 
        in fiscal year 2008, the requirement described in subsection 
        (e)(1) as a condition of a receipt of a grant under section 
        300x-21 of this title shall apply only for fiscal year 2009 and 
        subsequent fiscal years.
            ``(3) Subsection (e)(1) shall not affect any State or local 
        law that (A) was in effect on the date of introduction of the 
        Federal Tobacco Act of 2007, and (B) covers the same subject 
        matter as the law described in subsection (e)(1). Any State law 
        that meets the conditions of this paragraph shall also be 
        deemed to meet the requirement described in subsection (e)(1) 
        as a condition of a receipt of a grant under section 300x-21 of 
        this title, if such State law is at least as stringent as the 
        law described in subsection (e)(1).
    ``(f)(1) For the first applicable fiscal year and for each 
subsequent fiscal year, a funding agreement for a grant under section 
300x-21 of this title is a funding agreement under which the State 
involved will enforce the law described in subsection (e)(1) of this 
section in a manner that can reasonably be expected to reduce the 
extent to which tobacco products are available to individuals under the 
age of 18 or a different minimum age established under State law for 
the purchase of tobacco products.
    ``(2) For the first applicable fiscal year and for each subsequent 
fiscal year, a funding agreement for a grant under section 300x-21 of 
this title is a funding agreement under which the State involved will--
            ``(A) conduct random, unannounced inspections to ensure 
        compliance with the law described in subsection (e)(1); and
            ``(B) annually submit to the Secretary a report 
        describing--
                    ``(i) the activities carried out by the State to 
                enforce such law during the fiscal year preceding the 
                fiscal year for which the State is seeking the grant;
                    ``(ii) the extent of success the State has achieved 
                in reducing the availability of tobacco products to 
                individuals under 18 years of age or a different 
                minimum age established under State law, including the 
                results of the inspections conducted under subparagraph 
                (A); and
                    ``(iii) the strategies to be utilized by the State 
                for enforcing such law during the fiscal year for which 
                the grant is sought.
    ``(g) The law specified in subsection (e)(1) may be administered 
and enforced by a State using--
            ``(1) any amounts made available to the State through a 
        grant under section 300x-21 of this title;
            ``(2) any amounts made available to the State under section 
        300w of this title;
            ``(3) any fees collected for licenses issued pursuant to 
        the law described in subsection (e)(1);
            ``(4) any fines or penalties assessed for violations of the 
        law specified in subsection (e)(1); or
            ``(5) any other funding source that the legislature of the 
        State may prescribe by statute.
    ``(h) Before making a grant under section 300x-21 of this title to 
a State for the first applicable fiscal year or any subsequent fiscal 
year, the Secretary shall make a determination of whether the State has 
maintained compliance with subsections (e) and (f) of this section. If, 
after notice to the State and an opportunity for a hearing, the 
Secretary determines that the State is not in compliance with such 
subsections, the Secretary shall reduce the amount of the allotment 
under section 300x-21 of this title for the State for the fiscal year 
involved by an amount equal to--
            ``(1) In the case of the first applicable fiscal year, 10 
        percent of the amount determined under section 300x-33 for the 
        State for the fiscal year;
            ``(2) In the case of the first fiscal year following such 
        applicable fiscal year, 20 percent of the amount determined 
        under section 300x-33 for the State for the fiscal year;
            ``(3) In the case of the second such fiscal year, 30 
        percent of the amount determined under section 300x-33 for the 
        State for the fiscal year; and
            ``(4) In the case of the third such fiscal year or any 
        subsequent fiscal year, 40 percent of the amount determined 
        under section 300x-33 for the State for the fiscal year.
The Secretary shall not have authority or discretion to grant to any 
State a waiver of the terms and requirements of this subsection or 
subsection (e) or (f).
    ``(i) For the purposes of subsections (e) through (h) of this 
section the term `first applicable fiscal year' means--
            ``(1) fiscal year 2009, in the case of any State described 
        in subsection (e)(2) of this section; and
            ``(2) fiscal year 2008, in the case of any other State.
    ``(j) For purposes of subsections (e) through (h) of this section, 
references to section 300x-21 shall include any successor grant 
programs.`'
    ``(k) As required by paragraph (1), and subject to paragraph (4), 
an Indian tribe shall satisfy the requirements of subsection (e)(1) of 
this section by enacting a law or ordinance with substantially the same 
provisions as the law described in subsection (e)(1).
            ``(1) An Indian tribe shall comply with subsection (e)(1) 
        of this section within 180 days after the Administrator finds, 
        in accordance with this paragraph, that--
                    ``(A) the Indian tribe has a governing body 
                carrying out substantial governmental powers and 
                duties;
                    ``(B) the functions to be exercised by the Indian 
                tribe under this Act pertain to activities on trust 
                land within the jurisdiction of the tribe; and
                    ``(C) the Indian tribe is reasonably expected to be 
                capable of carrying out the functions required under 
                this section.
        Within 2 years of the date of enactment of the Federal Tobacco 
        Act of 2007, as to each Indian tribe in the United States, the 
        Administrator shall make the findings contemplated by this 
        paragraph or determine that such findings cannot be made, in 
        accordance with the procedures specified in paragraph (4).
            ``(2) As to Indian tribes subject to subsection (e)(1) of 
        this section, the Administrator shall promulgate regulations 
        that--
                    ``(A) provide whether and to what extent, if any, 
                the law described in subsection (e)(1) may be modified 
                as adopted by Indian tribes; and
                    ``(B) ensure, to the extent possible, that each 
                Indian tribe's retailer licensing program under 
                subsection (e)(1) is no less stringent than the program 
                of the State or States in which the Indian tribe is 
                located.
            ``(3) If with respect to any Indian tribe the Administrator 
        determines that compliance with the requirements of subsection 
        (e)(1) is inappropriate or administratively infeasible, the 
        Administrator shall specify other means for the Indian tribe to 
        achieve the purposes of the law described in subsection (e)(1) 
        with respect to persons who engage in the distribution at 
        retail of tobacco products on tribal lands.
            ``(4) The findings and regulations promulgated under 
        paragraphs (1) and (2) shall be promulgated in conformance with 
        section 553 of title 5, United States Code, and shall comply 
        with the following provisions:
                    ``(A) In making findings as provided in paragraph 
                (1), and in drafting and promulgating regulations as 
                provided in paragraph (2) (including drafting and 
                promulgating any revised regulations), the 
                Administrator shall confer with, and allow for active 
                participation by, representatives and members of Indian 
                tribes, and tribal organizations.
                    ``(B) In carrying out rulemaking processes under 
                this subsection, the Administrator shall follow the 
                guidance of subchapter III of chapter 5 of title 5, 
                United States Code, commonly known as the `Negotiated 
                Rulemaking Act of 1990.'
                    ``(C) The tribal participants in the negotiation 
                process referred to in subparagraph (B) shall be 
                nominated by and shall represent the groups described 
                in this subsection and shall include tribal 
                representatives from all geographic regions.
                    ``(D) The negotiations conducted under this 
                paragraph (4) shall be conducted in a timely manner.
                    ``(E) If the Administrator determines that an 
                extension of the deadlines under subsection (k)(1) of 
                this section is appropriate, the Secretary may submit 
                proposed legislation to Congress for the extension of 
                such deadlines.
            ``(5) This subsection shall not affect any law or ordinance 
        that (A) was in effect on tribal lands on the date of 
        introduction of the Youth Prevention and Tobacco Harm Reduction 
        Act, and (B) covers the same subject matter as the law 
        described in subsection (e)(1). Any law or ordinance that meets 
        the conditions of this paragraph shall also be deemed to meet 
        the requirement described in subsection (k)(1), if such law or 
        ordinance is at least as stringent as the law described in 
        subsection (e)(1).
            ``(6) For purposes of this subsection--
                    ``(A) `Administrator' means the Administrator of 
                the Tobacco Harm Reduction Center.
                    ``(B) `Indian tribe' has the meaning assigned that 
                term in section 4(e) of the Indian Self Determination 
                and Education Assistance Act, section 450b(e) of title 
                25, United States Code.
                    ``(C) `Tribal lands' means all lands within the 
                exterior boundaries of any Indian reservation, all 
                lands the title to which is held by the United States 
                in trust for an Indian tribe, or lands the title to 
                which is held by an Indian tribe subject to a 
                restriction by the United States against alienation, 
                and all dependent Indian communities.
                    ``(D) `tribal organization' has the meaning 
                assigned that term in section 4(l) of the Indian Self 
                Determination and Education Assistance Act, section 
                450b(l) of title 25, United States Code.''.

SEC. 403. ESTABLISHMENT OF RANKINGS.

    (a) Standards and Procedures for Rankings.--Within 24 months after 
the effective date of this Act, the Administrator shall, by regulation, 
after consultation with an Advisory Committee established for such 
purpose, establish the standards and procedures for promulgating 
rankings, comprehensible to consumers of tobacco products, of the 
following categories of tobacco products and also nicotine-containing 
products on the basis of the relative risks of serious or chronic 
tobacco-related diseases and adverse health conditions those categories 
of tobacco products and also nicotine-containing products respectively 
present--
            (1) cigarettes;
            (2) loose tobacco for roll-your-own tobacco products;
            (3) little cigars;
            (4) cigars;
            (5) pipe tobacco;
            (6) moist snuff;
            (7) dry snuff;
            (8) chewing tobacco;
            (9) other forms of tobacco products, including pelletized 
        tobacco and compressed tobacco, treated collectively as a 
        single category; and
            (10) other nicotine-containing products, treated 
        collectively as a single category.
The Administrator shall not have authority or discretion to establish a 
relative-risk ranking of any category or subcategory of tobacco 
products or any category or subcategory of nicotine-containing products 
other than the ten categories specified in this subsection.
    (b) Considerations in Promulgating Regulations.--In promulgating 
regulations under this section, the Administrator--
            (1) shall take into account relevant epidemiologic studies 
        and other relevant competent and reliable scientific evidence; 
        and
            (2) in assessing the risks of serious or chronic tobacco-
        related diseases and adverse health conditions presented by a 
        particular category, shall consider the range of tobacco 
        products or nicotine-containing products within the category, 
        and shall give appropriate weight to the market shares of the 
        respective products in the category.
    (c) Promulgation of Rankings of Categories.--Once the initial 
regulations required by subsection (a) are in effect, the Administrator 
shall promptly, by order, after notice and an opportunity for comment, 
promulgate to the general public rankings of the categories of tobacco 
products and nicotine-containing products in accordance with those 
regulations. The Administrator shall promulgate the initial rankings of 
those categories of tobacco products and nicotine-containing products 
to the general public not later than January 1, 2010. Thereafter, on an 
annual basis, the Administrator shall, by order, promulgate to the 
general public updated rankings that are (1) in accordance with those 
regulations, and (2) reflect the scientific evidence available at the 
time of promulgation. The Administrator shall open and maintain an 
ongoing public docket for receipt of data and other information 
submitted by any person with respect to such annual promulgation of 
rankings.

                    TITLE V--ENFORCEMENT PROVISIONS

SEC. 501. PROHIBITED ACTS.

    The following acts and the causing thereof are hereby prohibited--
            (1) the introduction or delivery for introduction into 
        interstate commerce of any tobacco product that is adulterated 
        or misbranded;
            (2) the adulteration or misbranding of any tobacco product 
        in interstate commerce;
            (3) the receipt in interstate commerce of any tobacco 
        product that is known to be adulterated or misbranded, and the 
        delivery or proffered delivery thereof for pay or otherwise;
            (4) the failure to establish or maintain any record, or 
        make any report or other submission, or to provide any notice 
        required by or under this Act; or the refusal to permit access 
        to, verification of, or copying of any record as required by 
        this Act;
            (5) the refusal to permit entry or inspection as authorized 
        by this Act;
            (6) the making to the Administrator of a statement, report, 
        certification or other submission required by this Act, with 
        knowledge that such statement, report, certification, or other 
        submission is false in a material aspect;
            (7) the manufacturing, shipping, receiving, storing, 
        selling, distributing, possession, or use of any tobacco 
        product with knowledge that it is an illicit tobacco product;
            (8) the forging, simulating without proper permission, 
        falsely representing, or without proper authority using any 
        brand name;
            (9) the using by any person to his or her own advantage, or 
        revealing, other than to the Administrator or officers or 
        employees of the Agency, or to the courts when relevant in any 
        judicial proceeding under this Act, any information acquired 
        under authority of this Act concerning any item which as a 
        trade secret is entitled to protection; except that the 
        foregoing does not authorize the withholding of information 
        from either House of Congress or from, to the extent of matter 
        within its jurisdiction, any committee or subcommittee of such 
        committee or any joint committee of Congress or any 
        subcommittee of such joint committee;
            (10) the alteration, mutilation, destruction, obliteration, 
        or removal of the whole or any part of the labeling of, or the 
        doing of any other act with respect to, a tobacco product, if 
        such act is done while such tobacco product is held for sale 
        (whether or not the first sale) after shipment in interstate 
        commerce, and results in such tobacco product being adulterated 
        or misbranded;
            (11) the importation of any tobacco product that is 
        adulterated, misbranded, or otherwise not in compliance with 
        this Act; and
            (12) the commission of any act prohibited by section 201 of 
        this Act.

SEC. 502. INJUNCTION PROCEEDINGS.

    (a) The district courts of the United States shall have 
jurisdiction, for cause shown, to restrain violations of this Act, 
except for violations of section 701(k).
    (b) In case of an alleged violation of an injunction or restraining 
order issued under this section, which also constitutes a violation of 
this Act, trial shall be by the court, or upon demand of the defendant, 
by a jury.

SEC. 503. PENALTIES.

    (a) Criminal Penalties.--Any person who willfully violates a 
provision of section 501 of this Act shall be imprisoned for not more 
than one year or fined not more than $25,000, or both.
    (b) Civil Penalties for Violation of Section 803.--
            (1) Any person who knowingly distributes or sells, other 
        than through retail sale or retail offer for sale, any 
        cigarette brand style in violation of section 803(a)--
                    (A) for a first offense shall be liable for a civil 
                penalty not to exceed $10,000 for each distribution or 
                sale, or
                    (B) for a second offense shall be liable for a 
                civil penalty not to exceed $25,000 for each 
                distribution or sale,
        except that the penalty imposed against any person with respect 
        to violations during any 30-day period shall not exceed 
        $100,000.
            (2) Any retailer who knowingly distributes, sells or offers 
        for sale any cigarette brand style in violation of section 
        803(a) shall--
                    (A) for a first offense for each sale or offer for 
                sale of cigarettes, if the total number of packages of 
                cigarettes sold or offered for sale--
                            (i) does not exceed 50 packages of 
                        cigarettes, be liable for a civil penalty not 
                        to exceed $500 for each sale or offer for sale, 
                        and
                            (ii) exceeds 50 packages of cigarettes, be 
                        liable for a civil penalty not to exceed $1,000 
                        for each sale or offer for sale;
                    (B) for each subsequent offense for each sale or 
                offer for sale of cigarettes, if the total number of 
                cigarettes sold or offered for sale--
                            (i) does not exceed 50 packages of 
                        cigarettes, be liable for a civil penalty not 
                        to exceed $2,000 for each sale or offer for 
                        sale, and
                            (ii) exceeds 50 packages of cigarettes, be 
                        liable for a civil penalty not to exceed $5,000 
                        for each sale or offer for sale;
                except that the penalty imposed against any person 
                during any 30-day period shall not exceed $25,000.

SEC. 504. SEIZURE.

    (a) Articles Subject to Seizure.--
            (1) Any tobacco product that is adulterated or misbranded 
        when introduced into or while in interstate commerce or while 
        held for sale (whether or not the first sale) after shipment in 
        interstate commerce, or which may not, under the provisions of 
        this Act, be introduced into interstate commerce, shall be 
        liable to be proceeded against while in interstate commerce, or 
        at any time thereafter, on libel of information and condemned 
        in any district court of the United States within the 
        jurisdiction of which the tobacco product is found. No libel 
        for condemnation shall be instituted under this Act for any 
        alleged misbranding if there is pending in any court a libel 
        for condemnation proceeding under this Act based upon the same 
        alleged misbranding, and not more than one such proceeding 
        shall be instituted if no such proceeding is so pending, except 
        that such limitations shall not apply--
                    (A) when such misbranding has been the basis of a 
                prior judgment in favor of the United States, in a 
                criminal, injunction, or libel for condemnation 
                proceeding under this Act, or
                    (B) when the Administrator has probable cause to 
                believe from facts found, without hearing, by the 
                Administrator or any officer or employee of the Agency 
                that the misbranded tobacco product is dangerous to 
                health beyond the inherent danger to health posed by 
                tobacco, or that the labeling of the misbranded tobacco 
                product is fraudulent, or would be in a material 
                respect misleading to the injury or damage of the 
                purchaser or consumer. In any case where the number of 
                libel for condemnation proceedings is limited as above 
                provided, the proceeding pending or instituted shall, 
                on application of the claimant, seasonably made, be 
                removed for trial to any district agreed upon by 
                stipulation between the parties, or, in case of failure 
                to so stipulate within a reasonable time, the claimant 
                may apply to the court of the district in which the 
                seizure has been made, and such court (after giving the 
                United States attorney for such district reasonable 
                notice and opportunity to be heard) shall by order, 
                unless good cause to the contrary is shown, specify a 
                district of reasonable proximity to the claimant's 
                principal place of business, to which the case shall be 
                removed for trial.
            (2) The following shall be liable to be proceeded against 
        at any time on libel of information and condemned in any 
        district court of the United States within the jurisdiction of 
        which they are found--
                    (A) any tobacco product that is an illicit tobacco 
                product;
                    (B) any container of an illicit tobacco product;
                    (C) any equipment or thing used in making an 
                illicit tobacco product; and
                    (D) any adulterated or misbranded tobacco product.
            (3)(A) Except as provided in subparagraph (B), no libel for 
        condemnation may be instituted under paragraph (1) or (2) 
        against any tobacco product which--
                            (i) is misbranded under this Act because of 
                        its advertising, and
                            (ii) is being held for sale to the ultimate 
                        consumer in an establishment other than an 
                        establishment owned or operated by a 
                        manufacturer, packer, or distributor of the 
                        tobacco product.
                    (B) A libel for condemnation may be instituted 
                under paragraph (1) or (2) against a tobacco product 
                described in subparagraph (A) if the tobacco product's 
                advertising which resulted in the tobacco product being 
                misbranded was disseminated in the establishment in 
                which the tobacco product is being held for sale to the 
                ultimate consumer--
                            (i) such advertising was disseminated by, 
                        or under the direction of, the owner or 
                        operator of such establishment, or
                            (ii) all or part of the cost of such 
                        advertising was paid by such owner or operator.
    (b) Procedures.--The tobacco product, equipment, or other thing 
proceeded against shall be liable to seizure by process pursuant to the 
libel, and the procedure in cases under this section shall conform, as 
nearly as may be, to the procedure in admiralty; except that on demand 
of either party any issue of fact joined in any such case shall be 
tried by jury. When libel for condemnation proceedings under this 
section, involving the same claimant and the same issues of 
adulteration or misbranding, are pending in two or more jurisdictions, 
such pending proceedings, upon application of the claimant seasonably 
made to the court of one such jurisdiction, shall be consolidated for 
trial by order of such court, and tried in (1) any district selected by 
the claimant where one of such proceedings is pending; or (2) a 
district agreed upon by stipulation between the parties. If no order 
for consolidation is so made within a reasonable time, the claimant may 
apply to the court of one such jurisdiction and such court (after 
giving the United States attorney for such district reasonable notice 
and opportunity to be heard) shall by order, unless good cause to the 
contrary is shown, specify a district of reasonable proximity to the 
claimant's principal place of business, in which all such pending 
proceedings shall be consolidated for trial and tried. Such order of 
consolidation shall not apply so as to require the removal of any case 
the date for trial of which has been fixed. The court granting such 
order shall give prompt notification thereof to the other courts having 
jurisdiction of the cases covered thereby.
    (c) Samples and Analyses.--The court at any time after seizure up 
to a reasonable time before trial shall by order allow any party to a 
condemnation proceeding, the party's attorney or agent, to obtain a 
representative sample of the article seized and a true copy of the 
analysis, if any, on which the proceeding is based and the identifying 
marks or numbers, if any, of the packages from which the samples 
analyzed were obtained.
    (d) Disposition of Condemned Tobacco Products.--(1) Any tobacco 
product condemned under this section shall, after entry of the decree, 
be disposed of by destruction or sale as the court may, in accordance 
with the provisions of this section, direct; and the proceeds thereof, 
if sold, less the legal costs and charges, shall be paid into the 
Treasury of the United States; but such tobacco product shall not be 
sold under such decree contrary to the provisions of this Act or the 
laws of the jurisdiction in which sold. After entry of the decree and 
upon the payment of the costs of such proceedings and the execution of 
a good and sufficient bond conditioned that such article shall not be 
sold or disposed of contrary to the provisions of this Act or the laws 
of any State in which sold, the court may by order direct that such 
tobacco product be delivered to the owner thereof to be destroyed or 
brought into compliance with the provisions of this Act, under the 
supervision of an officer or employee duly designated by the 
Administrator; and the expenses of such supervision shall be paid by 
the person obtaining release of the tobacco product under bond. If the 
tobacco product was imported into the United States and the person 
seeking its release establishes (A) that the adulteration, misbranding, 
or violation did not occur after the tobacco product was imported, and 
(B) that the person seeking the release of the tobacco product had no 
cause for believing that it was adulterated, misbranded, or in 
violation before it was released from customs custody, the court may 
permit the tobacco product to be delivered to the owner for exportation 
under section 709 in lieu of destruction upon a showing by the owner 
that there is a reasonable certainty that the tobacco product will not 
be re-imported into the United States.
    (2) The provisions of paragraph (1) of this subsection shall, to 
the extent deemed appropriate by the court, apply to any equipment or 
other thing which is not otherwise within the scope of such paragraph 
and which is referred to in paragraph (2) of subsection (a).
    (3) Whenever in any proceeding under this section, involving 
paragraph (2) of subsection (a), the condemnation of any equipment or 
thing (other than a tobacco product) is decreed, the court shall allow 
the claim of any claimant, to the extent of such claimant's interest, 
for remission or mitigation of such forfeiture if such claimant proves 
to the satisfaction of the court (A) that such claimant has not caused 
the equipment or thing to be within one of the categories referred to 
in such paragraph (2) and has no interest in any tobacco product 
referred to therein, (B) that such claimant has an interest in such 
equipment or other thing as owner or lienor or otherwise, acquired by 
such claimant in good faith, and (C) that such claimant at no time had 
any knowledge or reason to believe that such equipment or other thing 
was being or would be used in, or to facilitate, the violation of laws 
of the United States relating to any illicit tobacco product.
    (e) Costs and Fees.--When a decree of condemnation is entered 
against the tobacco product or other article, court costs and fees, and 
storage and other proper expenses shall be awarded against the person, 
if any, intervening as claimant of the tobacco product or other 
article.
    (f) Removal for Trial.--In the case of removal for trial of any 
case as provided by subsection (a) or (b)--
            (1) The clerk of the court from which removal is made shall 
        promptly transmit to the court in which the case is to be tried 
        all records in the case necessary in order that such court may 
        exercise jurisdiction.
            (2) The court to which such case was removed shall have the 
        powers and be subject to the duties, for purposes of such case, 
        which the court from which removal was made would have had, or 
        to which such court would have been subject, if such case had 
        not been removed.
    (g) Administrative Detention of Tobacco Products.--
            (1) Detention authority.--
                    (A) In general.--An officer or qualified employee 
                of the Agency may order the detention, in accordance 
                with this subsection, of any tobacco product that is 
                found during an inspection, examination, or 
                investigation under this Act conducted by such officer 
                or qualified employee, if the officer or qualified 
                employee has credible evidence or information 
                indicating that such article presents a threat of 
                serious adverse health consequences beyond those 
                normally inherent in the use of tobacco products.
                    (B) Administrator's approval.--A tobacco product or 
                component thereof may be ordered detained under 
                subparagraph (A) if, but only if, the Administrator or 
                an official designated by the Administrator approves 
                the order. An official may not be so designated unless 
                the official is an officer with supervisory 
                responsibility for the inspection, examination, or 
                investigation that led to the order.
            (2) Period of detention.--A tobacco product may be detained 
        under paragraph (1) for a reasonable period, not to exceed 20 
        days, unless a greater period, not to exceed 30 days, is 
        necessary, to institute an action under subsection (a) or 
        section 702.
            (3) Security of detained tobacco product.--An order under 
        paragraph (1) may require that the tobacco product to be 
        detained be labeled or marked as detained, and shall require 
        that the tobacco product be maintained in or removed to a 
        secure facility, as appropriate. A tobacco product subject to 
        such an order shall not be transferred by any person from the 
        place at which the tobacco product is ordered detained, or from 
        the place to which the tobacco product is so removed, as the 
        case may be, until released by the Administrator or until the 
        expiration of the detention period applicable under such order, 
        whichever occurs first. This subsection may not be construed as 
        authorizing the delivery of the tobacco product pursuant to the 
        execution of a bond while the tobacco product is subject to the 
        order, and section 709 does not authorize the delivery of the 
        tobacco product pursuant to the execution of a bond while the 
        article is subject to the order.
            (4) Appeal of detention order.--
                    (A) In general.--With respect to a tobacco product 
                ordered detained under paragraph (1), any person who 
                would be entitled to be a claimant of such tobacco 
                product if the tobacco product were seized under 
                subsection (a) may appeal the order to the 
                Administrator. Within five days after such an appeal is 
                filed, the Administrator, after providing opportunity 
                for an informal hearing, shall confirm or terminate the 
                order involved, and such confirmation by the 
                Administrator shall be considered a final agency action 
                for purposes of section 702 of title 5, United States 
                Code. If during such five-day period the Administrator 
                fails to provide such an opportunity, or to confirm or 
                terminate such order, the order is deemed to be 
                terminated.
                    (B) Effect of instituting court action.--The 
                process under subparagraph (A) for the appeal of an 
                order under paragraph (1) terminates if the 
                Administrator institutes an action under subsection (a) 
                or section 702 regarding the tobacco product involved.

SEC. 505. REPORT OF MINOR VIOLATIONS.

    Nothing in this Act shall be construed as requiring the 
Administrator to report for prosecution, or for institution of libel or 
injunction proceedings, minor violations of this Act whenever the 
Administrator believes that the public interest will be adequately 
served by a suitable written notice or warning.

SEC. 506. INSPECTION.

    (a) Authority To Inspect.--The Administrator shall have the power 
to inspect the premises of a tobacco product manufacturer for purposes 
of determining compliance with this Act, or the regulations promulgated 
under it. Officers of the Agency designated by the Administrator, upon 
presenting appropriate credentials and a written notice to the person 
in charge of the premises, are authorized to enter, at reasonable 
times, without a search warrant, any factory, warehouse, or other 
establishment in which tobacco products are manufactured, processed, 
packaged, or held for domestic distribution. Any such inspection shall 
be conducted within reasonable limits and in a reasonable manner, and 
shall be limited to examining only those things, including but not 
limited to records, relevant to determining whether violations of this 
Act, or regulations under it, have occurred. No inspection authorized 
by this section shall extend to financial data, sales data other than 
shipment data, pricing data, personnel data (other than data as to 
qualifications of technical and professional personnel performing 
functions subject to this Act), or research data. A separate notice 
shall be given for each such inspection, but a notice shall not be 
required for each entry made during the period covered by the 
inspection. Each such inspection shall be commenced and completed with 
reasonable promptness.
    (b) Report of Observations.--Before leaving the premises, the 
officer of the Agency who has supervised or conducted the inspection 
shall give to the person in charge of the premises a report in writing 
setting forth any conditions or practices that appear to manifest a 
violation of this Act, or the regulations under it.
    (c) Samples.--If the officer has obtained any sample in the course 
of inspection, prior to leaving the premises that officer shall give to 
the person in charge of the premises a receipt describing the samples 
obtained. As to each sample obtained, the officer shall furnish 
promptly to the person in charge of the premises a copy of the sample 
and of any analysis made upon the sample.

SEC. 507. EFFECT OF COMPLIANCE.

    Compliance with the provisions of this Act and the regulations 
promulgated under it shall constitute a complete defense to any civil 
action, including but not limited to any products liability action, 
that seeks to recover damages, whether compensatory or punitive, based 
upon an alleged defect in the labeling or advertising of any tobacco 
product distributed for sale domestically.

SEC. 508. IMPORTS.

    (a) Imports; List of Registered Foreign Establishments; Samples 
From Unregistered Foreign Establishments; Examination and Refusal of 
Admission.--The Secretary of Homeland Security shall deliver to the 
Administrator, upon request by the Administrator, samples of tobacco 
products that are being imported or offered for import into the United 
States, giving notice thereof to the owner or consignee, who may appear 
before the Administrator and have the right to introduce testimony. The 
Administrator shall furnish to the Secretary of Homeland Security a 
list of establishments registered pursuant to subsection (d) of section 
109 of this Act, and shall request that, if any tobacco products 
manufactured, prepared, or processed in an establishment not so 
registered are imported or offered for import into the United States, 
samples of such tobacco products be delivered to the Administrator, 
with notice of such delivery to the owner or consignee, who may appear 
before the Administrator and have the right to introduce testimony. If 
it appears from the examination of such samples or otherwise that (1) 
such tobacco product is forbidden or restricted in sale in the country 
in which it was produced or from which it was exported, or (2) such 
tobacco product is adulterated, misbranded, or otherwise in violation 
of this Act, then such tobacco product shall be refused admission, 
except as provided in subsection (b) of this section. The Secretary of 
Homeland Security shall cause the destruction of any such tobacco 
product refused admission unless such tobacco product is exported, 
under regulations prescribed by the Secretary of Homeland Security, 
within ninety days of the date of notice of such refusal or within such 
additional time as may be permitted pursuant to such regulations.
    (b) Disposition of Refused Tobacco Products.--Pending decision as 
to the admission of a tobacco product being imported or offered for 
import, the Secretary of Homeland Security may authorize delivery of 
such tobacco product to the owner or consignee upon the execution by 
such consignee of a good and sufficient bond providing for the payment 
of such liquidated damages in the event of default as may be required 
pursuant to regulations of the Secretary of Homeland Security. If it 
appears to the Administrator that a tobacco product included within the 
provisions of clause (3) of subsection (a) of this section can, by 
relabeling or other action, be brought into compliance with this Act or 
rendered other than a tobacco product, final determination as to 
admission of such tobacco product may be deferred and, upon filing of 
timely written application by the owner or consignee and the execution 
by such consignee of a bond as provided in the preceding provisions of 
this subsection, the Administrator may, in accordance with regulations, 
authorize the applicant to perform such relabeling or other action 
specified in such authorization (including destruction or export of 
rejected tobacco products or portions thereof, as may be specified in 
the Administrator's authorization). All such relabeling or other action 
pursuant to such authorization shall in accordance with regulations be 
under the supervision of an officer or employee of the Agency 
designated by the Administrator, or an officer or employee of the 
Department of Homeland Security designated by the Secretary of Homeland 
Security.
    (c) Charges Concerning Refused Tobacco Products.--All expenses 
(including travel, per diem or subsistence, and salaries of officers or 
employees of the United States) in connection with the destruction 
provided for in subsection (a) of this section and the supervision of 
the relabeling or other action authorized under the provisions of 
subsection (b) of this section, the amount of such expenses to be 
determined in accordance with regulations, and all expenses in 
connection with the storage, cartage, or labor with respect to any 
tobacco product refused admission under subsection (a) of this section, 
shall be paid by the owner or consignee and, in default of such 
payment, shall constitute a lien against any future importations made 
by such owner or consignee.

SEC. 509. TOBACCO PRODUCTS FOR EXPORT.

    (a) Exemption for Tobacco Products Exported.--Except as provided in 
subsection (b), a tobacco product intended for export shall be exempt 
from this Act if--
            (1) it is not in conflict with the laws of the country to 
        which it is intended fore export, as shown by either (A) a 
        document issued by the government of that country or (B) a 
        document provided by a person knowledgeable with respect to the 
        relevant laws of that country and qualified by training and 
        experience to opine on whether the tobacco product is or is not 
        in conflict with such laws;
            (2) it is labeled on the outside of the shipping package 
        that it is intended for export; and
            (3) the particular units of tobacco product intended for 
        export have not been sold or offered for sale in domestic 
        commerce.
    (b) Products for U.S. Armed Forces Overseas.--A tobacco product 
intended for export shall not be exempt from this Act if it is intended 
for sale or distribution to members or units of the Armed Forces of the 
United States located outside of the United States.
    (c) This Act shall not apply to a person that manufactures and/or 
distributes tobacco products solely for export under subsection (a), 
except to the extent such tobacco products are subject to subsection 
(b).

                   TITLE VI--MISCELLANEOUS PROVISIONS

SEC. 601. USE OF PAYMENTS UNDER THE MASTER SETTLEMENT AGREEMENT AND 
              INDIVIDUAL STATE SETTLEMENT AGREEMENTS.

    (a) Reduction of Grant Amounts.--(1) For fiscal year 2010 and each 
subsequent fiscal year, the Secretary shall reduce, as provided in 
subsection (b), the amount of any grant under section 1921 of the 
Public Health Service Act (42 U.S.C. Sec.  300x-21) for any State that 
spends on tobacco control programs from the funds received by such 
State pursuant to the Master Settlement Agreement, the Florida 
Settlement Agreement, the Minnesota Settlement Agreement, the 
Mississippi Memorandum of Understanding, or the Texas Settlement 
Agreement, as applicable, less than 20 percent of the amounts received 
by that State from settlement payments.
    (2) In the case of a State whose legislature does not convene a 
regular session in fiscal year 2009 or 2010, and in the case of a State 
whose legislature does not convene a regular session in fiscal year 
2010, the requirement described in subsection (a)(1) as a condition of 
receipt of a grant under section 1921 of the Public Health Service Act 
shall apply only for fiscal year 2009 and subsequent fiscal years.
    (b) Determination of State Spending.--Before making a grant under 
section 1921 of the Public Health Service Act, section 300x-21 of title 
42, United States Code, to a State for the first applicable fiscal year 
or any subsequent fiscal year, the Secretary shall make a determination 
of whether, during the immediately preceding fiscal year, the State has 
spent on tobacco control programs, from the funds received by such 
State pursuant to the Master Settlement Agreement, the Florida 
Settlement Agreement, the Minnesota Settlement Agreement, the 
Mississippi Memorandum of Understanding, or the Texas Settlement 
Agreement, as applicable, at least the amount referenced in (a)(1). If, 
after notice to the State and an opportunity for a hearing, the 
Secretary determines that the State has spent less than such amount, 
the Secretary shall reduce the amount of the allotment under section 
300x-21 of title 42, United States Code, for the State for the fiscal 
year involved by an amount equal to--
            (1) in the case of the first applicable fiscal year, 10 
        percent of the amount determined under section 300x-33 of title 
        42, United States Code, for the State for the fiscal year;
            (2) in the case of the first fiscal year following such 
        applicable fiscal year, 20 percent of the amount determined 
        under section 300x-33 of title 42, United States Code, for the 
        State for the fiscal year;
            (3) in the case of the second such fiscal year, 30 percent 
        of the amount determined under section 300x-33 of title 42, 
        United States Code, for the State for the fiscal year; and
            (4) in the case of the third such fiscal year or any 
        subsequent fiscal year, 40 percent of the amount determined 
        under section 300x-33 of title 42, United States Code, for the 
        State for the fiscal year.
The Secretary shall not have authority or discretion to grant to any 
State a waiver of the terms and requirements of this subsection or 
subsection (a).
    (c) Definitions.--For the purposes of this section--
            (1) The term ``first applicable fiscal year'' means--
                    (A) fiscal year 2011, in the case of any State 
                described in subsection (a)(2) of this section; and
                    (B) fiscal year 2010, in the case of any other 
                State.
            (2) The term ``Florida Settlement Agreement'' means the 
        Settlement Agreement, together with the exhibits thereto, 
        entered into on August 25, 1997, between the State of Florida 
        and signatory tobacco product manufacturers, as specified 
        therein.
            (3) The term ``Master Settlement Agreement'' means the 
        Master Settlement Agreement, together with the exhibits 
        thereto, entered into on November 23, 1998, between the 
        signatory States and signatory tobacco product manufacturers, 
        as specified therein.
            (4) The term ``Minnesota Settlement Agreement'' means the 
        Settlement Agreement, together with the exhibits thereto, 
        entered into on May 8, 1998, between the State of Minnesota and 
        signatory tobacco product manufacturers, as specified therein.
            (5) The term ``Mississippi Memorandum of Understanding'' 
        means the Memorandum of Understanding, together with the 
        exhibits thereto and Settlement Agreement contemplated therein, 
        entered into on July 2, 1997, between the State of Mississippi 
        and signatory tobacco product manufacturers, as specified 
        therein.
            (6) The term ``Secretary'' means the Secretary of Health 
        and Human Services.
            (7) The term ``Texas Settlement Agreement'' means the 
        Settlement Agreement, together with the exhibits thereto, 
        entered into on January 16, 1998, between the State of Texas 
        and signatory tobacco product manufacturers, as specified 
        therein.

SEC. 602. PREEMPTION OF STATE LAWS IMPLEMENTING FIRE SAFETY STANDARD 
              FOR CIGARETTES.

    (a) In General.--With respect to fire safety standards for 
cigarettes, no State or political subdivision shall--
            (1) require testing of cigarettes that would be in addition 
        to, or different from, the testing prescribed in subsection 
        (b); or
            (2) require a performance standard that is in addition to, 
        or different from, the performance standard set forth in 
        subsection (b).
    (b) Test Method and Performance Standard.--
            (1) To the extent a State or political subdivision enacts 
        or has enacted legislation or a regulation setting a fire 
        safety standard for cigarettes, the test method employed shall 
        be--
                    (A) the American Society of Testing and Materials 
                (``ASTM'') standard E2187-4, entitled ``Standard Test 
                Method for Measuring the Ignition Strength of 
                Cigarettes'';
                    (B) for each cigarette on 10 layers of filter 
                paper;
                    (C) so that a replicate test of 40 cigarettes for 
                each brand style of cigarettes comprises a complete 
                test trial for that brand style; and
                    (D) in a laboratory that has been accredited in 
                accordance with ISO/IEC 17205 of the International 
                Organization for Standardization (``ISO'') and that has 
                an implemented quality control and quality assurance 
                program that includes a procedure capable of 
                determining the repeatability of the testing results to 
                a repeatability value that is no greater than 0.19.
            (2) To the extent a State or political subdivision enacts 
        or has enacted legislation or a regulation setting a fire 
        safety standard for cigarettes, the performance standard 
        employed shall be that no more than 25 percent of the 
        cigarettes of that brand style tested in a complete test in 
        accordance with paragraph (1) exhibit full-length burns
    (c) Exception to Subsection (b).--In the event that a manufacturer 
of a cigarette that a State or political subdivision or its respective 
delegated agency determines cannot be tested in accordance with the 
test method prescribed in subsection (b)(1)(A), the manufacturer shall 
propose a test method and performance standard for the cigarette to the 
State or political subdivision. Upon approval of the proposed test 
method and a determination by the State or political division that the 
performance standard proposed by the manufacturer is equivalent to the 
performance standard prescribed in subsection (b)(2), the manufacturer 
may employ such test method and performance standard to certify such 
cigarette pursuant to this subsection notwithstanding subsection (b).

SEC. 603. INSPECTION BY THE ALCOHOL AND TOBACCO TAX TRADE BUREAU OF 
              RECORDS OF CERTAIN CIGARETTE AND SMOKELESS TOBACCO 
              SELLERS.

    (a) In General.--Any officer of the Bureau of the Alcohol and 
Tobacco Tax Trade Bureau may, during normal business hours, enter the 
premises of any person described in subsection (b) for the purposes of 
inspecting--
            (1) any records or information required to be maintained by 
        such person under the provisions of law referred to in 
        subsection (d); or
            (2) any cigarettes or smokeless tobacco kept or stored by 
        such person at such premises.
    (b) Covered Persons.--Subsection (a) applies to any person who 
engages in a delivery sale, and who ships, sells, distributes, or 
receives any quantity in excess of 10,000 cigarettes, or any quantity 
in excess of 500 single-unit consumer-sized cans or packages of 
smokeless tobacco, within a single month.
    (c) Relief.--
            (1) In general.--The district courts of the United States 
        shall have the authority in a civil action under this 
        subsection to compel inspections authorized by subsection (a).
            (2) Violations.--Whoever violates subsection (a) or an 
        order issued pursuant to paragraph (1) shall be subject to a 
        civil penalty in an amount not to exceed $10,000 for each 
        violation.
    (d) Covered Provisions of Law.--The provisions of law referred to 
in this subsection are--
            (1) the Act of October 19, 1949 (15 U.S.C. 375; commonly 
        referred to as the ``Jenkins Act'');
            (2) chapter 114 of title 18, United States Code; and
            (3) this Act.
    (e) Delivery Sale Defined.--In this section, the term ``delivery 
sale'' has the meaning given that term in 2343(e) of title 18, United 
States Code, as amended by this Act.

SEC. 604. SEVERABILITY.

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

                  TITLE VII--TOBACCO GROWER PROTECTION

SEC. 701. TOBACCO GROWER PROTECTION.

    No provision in this Act shall allow the Administrator or any other 
person to require changes to traditional farming practices, including 
standard cultivation practices, curing processes, seed composition, 
tobacco type, fertilization, soil, record keeping, or any other 
requirement affecting farming practices.
                                 <all>