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[House Report 111-72]
[From the U.S. Government Publishing Office]

111th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 1st Session                                                     111-72

======================================================================

 
  PROVIDING FOR CONSIDERATION OF THE BILL (H.R. 1256) TO PROTECT THE 
   PUBLIC HEALTH BY PROVIDING THE FOOD AND DRUG ADMINISTRATION WITH 
             CERTAIN AUTHORITY TO REGULATE TOBACCO PRODUCTS

                                _______
                                

   March 31, 2009.--Referred to the House Calendar and ordered to be 
                                printed

                                _______
                                

                Mr. Polis, from the Committee on Rules, 
                        submitted the following

                              R E P O R T

                       [To accompany H. Res. 307]

    The Committee on Rules, having had under consideration 
House Resolution 307, by a nonrecord vote, report the same to 
the House with the recommendation that the resolution be 
adopted.

                SUMMARY OF PROVISIONS OF THE RESOLUTION

    The resolution provides for consideration of H.R. 1256, the 
``Family Smoking Prevention and Tobacco Control Act,'' under a 
structured rule. The resolution provides one hour of general 
debate equally divided and controlled by the chair and ranking 
minority member of the Committee on Energy and Commerce.
    The resolution waives all points of order against 
consideration of the bill except those arising under clause 9 
or 10 of rule XXI. It provides that the amendment printed in 
part A of this report shall be considered as adopted and the 
bill, as amended, shall be considered as read. The resolution 
waives all points of order against provisions in the bill, as 
amended. This waiver does not affect the point of order 
available under clause 9 of rule XXI (regarding earmark 
disclosure).
    The resolution makes in order the amendment printed in part 
B of this report if offered by Rep. Steve Buyer of Indiana or 
his designee. The amendment printed in part B of this report 
shall be considered as read and shall be debatable for 30 
minutes equally divided and controlled by the proponent and an 
opponent. The resolution waives all points of order against the 
amendment printed in part B of this report except those arising 
under clause 9 or 10 of rule XXI. The resolution provides one 
motion to recommit with or without instructions.
    The resolution provides that, in the engrossment of H.R. 
1256, the Clerk shall add at the end of H.R. 1256 as new matter 
the text of H.R. 1804, as passed by the House. H.R. 1804 shall 
be laid on the table.

                         EXPLANATION OF WAIVERS

    Although the rule waives all points of order against 
consideration of the bill (except those arising under clause 9 
or 10 of rule XXI), the Committee is not aware of any points of 
order against consideration of the bill. The waiver of all 
points of order against consideration of the bill is 
prophylactic.
    Although the resolution waives all points of order against 
the bill, the Committee is not aware of any points of order. 
The waiver of all points of order against the bill is 
prophylactic.

                            COMMITTEE VOTES

    The results of each record vote on an amendment or motion 
to report, together with the names of those voting for and 
against, are printed below:

Rules Committee record vote No. 56

    Date: March 31, 2009.
    Measure: H.R. 1256.
    Motion by: Mr. Dreier.
    Summary of motion: To make in order and provide appropriate 
waivers for an amendment by Rep. Rogers, Mike (MI) #4, which 
would ensure that no FDA general funds would be used to fund 
the regulation of tobacco.
    Results: Defeated 2-7.
    Vote by Members: McGovern--Nay; Hastings--Nay; Arcuri--Nay; 
Perlmutter--Nay; Pingree--Nay; Polis--Nay; Dreier--Yea; Foxx--
Yea; Slaughter--Nay.

Rules Committee record vote No. 57

    Date: March 31, 2009.
    Measure: H.R. 1256.
    Motion by: Dr. Foxx.
    Summary of motion: To make in order and provide appropriate 
waivers for an amendment by Rep. Burgess, Michael (TX) #1, 
which would give the FDA the power to reduce nicotine levels to 
zero.
    Results: Defeated 2-7.
    Vote by Members: McGovern--Nay; Hastings--Nay; Arcuri--Nay; 
Perlmutter--Nay; Pingree--Nay; Polis--Nay; Dreier--Yea; Foxx--
Yea; Slaughter--Nay.

       SUMMARY OF AMENDMENT IN PART A TO BE CONSIDERED AS ADOPTED

    The amendment adds language making clear that the report 
required by section 907(e) will examine the impact of the use 
of menthol in cigarettes among children. It makes technical 
corrections to fully integrate new tobacco provisions contained 
in the bill into the Federal Food, Drug, and Cosmetic Act. It 
adds language clarifying application of the bill's provisions 
to exported tobacco products. It adds language making clear 
that the Secretary should consult as appropriate with the 
Departments of Treasury and Justice in carrying out section 301 
of the bill. Finally, it strikes Title IV of the bill (relating 
to TSP and other federal programs).

           SUMMARY OF AMENDMENT IN PART B TO BE MADE IN ORDER

    The amendment in the nature of a substitute would create a 
Tobacco Harm Reduction Center under the Department of HHS to 
regulate all tobacco products and establishes a regulatory 
scheme to provide for tobacco prevention, education, and 
cessation programs.

         PART A: TEXT OF AMENDMENT TO BE CONSIDERED AS ADOPTED

  Page 75, line 1, insert ``children,'' before ``African 
Americans''.
  Page 157, lines 8 to 24, move the margin of paragraph (8) 2 
ems to the left.
  Page 159, lines 19 through 24, strike paragraphs (1) and (2) 
and insert the following:
          (1) in subsection (a)(1)--
                  (A) by striking ``devices, or cosmetics'' 
                each place it appears and inserting ``devices, 
                tobacco products, or cosmetics'';
                  (B) by striking ``or restricted devices'' 
                each place it appears and inserting 
                ``restricted devices, or tobacco products'';
                  (C) by striking ``and devices and subject 
                to'' and all that follows through ``other drugs 
                or devices'' and inserting ``devices, and 
                tobacco products and subject to reporting and 
                inspection under regulations lawfully issued 
                pursuant to section 505(i) or (k), section 519, 
                section 520(g), or chapter IX and data relating 
                to other drugs, devices, or tobacco products'';
  Page 160, lines 1 and 3, redesignate paragraphs (3) and (4) 
as paragraphs (2) and (3), respectively.
  Page 160, lines 20 and 21, strike paragraph (2) and insert 
the following:
          (2) in subsection (e)(1)--
                  (A) by inserting ``tobacco product'' after 
                ``drug, device,''; and
                  (B) by inserting ``, and a tobacco product 
                intended for export shall not be deemed to be 
                in violation of section 906(e), 907, 911, or 
                920(a),'' before ``if it--'';
  Page 194, line 6, strike the close quotation mark and the 
period at the end and insert the following:
  ``(e) Consultation.--In carrying out this section, the 
Secretary shall consult with the Attorney General of the United 
States and the Secretary of the Treasury, as appropriate.''.

  Strike title IV of the bill (and make such conforming changes 
to the table of contents in section 1(b) of the bill as may be 
appropriate).

             PART B: TEXT OF AMENDMENT TO BE MADE IN ORDER

  Strike all after the enacting clause and insert the 
following:

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.

  Amend the title so as to read: ``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.''.

                                  
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