[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 2568 Introduced in Senate (IS)]







106th CONGRESS
  2d Session
                                S. 2568

      To protect the public health by providing the Food and Drug 
  Administration with certain authority to regulate tobacco products.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 16, 2000

 Mr. Kennedy (for himself, Mr. Lautenberg, Mr. Durbin, Mr. Kerry, and 
Mr. Wellstone) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
      To protect the public health by providing the Food and Drug 
  Administration with certain authority to regulate tobacco products.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

Sec. 1. Short title.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
         TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION

Sec. 101. Amendment of Federal Food, Drug, and Cosmetic Act.
                     ``CHAPTER IX--TOBACCO PRODUCTS

        ``Sec. 900. Definitions.
        ``Sec. 901. FDA authority over tobacco products
        ``Sec. 902. Adulterated tobacco products.
        ``Sec. 903. Misbranded tobacco products.
        ``Sec. 904. Submission of health information to the Secretary.
        ``Sec. 905. Annual registration.
        ``Sec. 906. General provisions respecting control of tobacco 
                            products.
        ``Sec. 907. Performance standards.
        ``Sec. 908. Notification and other remedies
        ``Sec. 909. Records and reports on tobacco products.
        ``Sec. 910. Premarket review of certain tobacco products.
        ``Sec. 911. Judicial review.
        ``Sec. 912. Postmarket surveillance
        ``Sec. 913. Reduced risk tobacco products.
        ``Sec. 914. Equal treatment of retail outlets.
        ``Sec. 915. Jurisdiction of and coordination with the Federal 
                            Trade Commission.
        ``Sec. 916. Congressional review provisions.
        ``Sec. 917. Regulation requirement.
        ``Sec. 918. Preservation of State and local authority.
Sec. 102. Construction of current regulations.
Sec. 103. Conforming and other amendments to general provisions.
  TITLE II--TOBACCO PRODUCT WARNINGS AND SMOKE CONSTITUENT DISCLOSURE

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

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) The use of tobacco products by the Nation's children is 
        a pediatric disease of epic and worsening proportions that 
        results in new generations of tobacco-dependent children and 
        adults.
            (2) A consensus exists within the scientific and medical 
        communities that tobacco products are inherently dangerous and 
        cause cancer, heart disease, and other serious adverse health 
        effects.
            (3) Nicotine is an addictive drug.
            (4) Virtually all new users of tobacco products are under 
        the minimum legal age to purchase such products.
            (5) Tobacco advertising and marketing contribute 
        significantly to the use of nicotine-containing tobacco 
        products by adolescents.
            (6) Because past efforts to restrict advertising and 
        marketing of tobacco products have failed adequately to curb 
        tobacco use by adolescents, comprehensive restrictions on the 
        sale, promotion, and distribution of such products are needed.
            (7) Federal and State governments have lacked the legal and 
        regulatory authority and resources they need to address 
        comprehensively the public health and societal problems caused 
        by the use of tobacco products.
            (8) Federal and State public health officials, the public 
        health community, and the public at large recognize that the 
        tobacco industry should be subject to ongoing oversight.
            (9) Under Article I, Section 8 of the Constitution, the 
        Congress is vested with the responsibility for regulating 
        interstate commerce and commerce with Indian tribes.
            (10) The sale, distribution, marketing, advertising, and 
        use of tobacco products are activities in and substantially 
        affecting interstate commerce because they are sold, marketed, 
        advertised, and distributed in interstate commerce on a 
        nationwide basis, and have a substantial effect on the Nation's 
        economy.
            (11) The sale, distribution, marketing, advertising, and 
        use of such products substantially affect interstate commerce 
        through the health care and other costs attributable to the use 
        of tobacco products.
            (12) The citizens of the several States are exposed to, and 
        adversely affected by, environmental smoke in public buildings 
        and other facilities which imposes a burden on interstate 
        commerce.
            (13) It is in the public interest for Congress to adopt 
        legislation that provides the Food and Drug Administration with 
        the authority to regulate tobacco products because of tobacco's 
        unique position in the Nation's history and economy; the need 
        to prevent the sale, distribution, marketing and advertising of 
tobacco products to persons under the minimum legal age to purchase 
such products; and the need to educate the public, especially young 
people, regarding the health effects of using tobacco products.
            (14) Public health authorities estimate that the benefits 
        to the Nation of enacting Federal legislation to accomplish 
        these goals would be significant in human and economic terms.
            (15) Reducing the use of tobacco by minors by 50 percent 
        would prevent well over 60,000 early deaths each year and save 
        up to $43,000,000,000 each year in reduced medical costs, 
        improved productivity, and the avoidance of premature deaths.
            (16) Advertising, marketing, and promotion of tobacco 
        products have been especially directed to attract young persons 
        to use tobacco products and these efforts have resulted in 
        increased use of such products by youth. Past efforts to 
        oversee these activities have not been successful in adequately 
        preventing such increased use.
            (17) In 1995, the tobacco industry spent close to 
        $4,900,000,000 to attract new users, retain current users, 
        increase current consumption, and generate favorable long-term 
        attitudes toward smoking and tobacco use.
            (18) Tobacco product advertising often misleadingly 
        portrays the use of tobacco as socially acceptable and 
        healthful to minors.
            (19) Tobacco product advertising is regularly seen by 
        persons under the age of 18, and persons under the age of 18 
        are regularly exposed to tobacco product promotional efforts.
            (20) Through advertisements during and sponsorship of 
        sporting events, tobacco has become strongly associated with 
        sports and has become portrayed as an integral part of sports 
        and the healthy lifestyle associated with rigorous sporting 
        activity.
            (21) Children are exposed to substantial and unavoidable 
        tobacco advertising that leads to favorable beliefs about 
        tobacco use, plays a role in leading young people to 
        overestimate the prevalence of tobacco use, and increases the 
        number of young people who begin to use tobacco.
            (22) Tobacco advertising increases the size of the tobacco 
        market by increasing consumption of tobacco products including 
        increasing tobacco use by young people.
            (23) Children are more influenced by tobacco advertising 
        than adults, they smoke the most advertised brands, and 
        children as young as 3 to 6 years old can recognize a character 
        associated with smoking at the same rate as they recognize 
        cartoons and fast food characters.
            (24) Tobacco company documents indicate that young people 
        are an important and often crucial segment of the tobacco 
        market.
            (25) Comprehensive advertising restrictions will have a 
        positive effect on the smoking rates of young people.
            (26) Restrictions on advertising are necessary to prevent 
        unrestricted tobacco advertising from undermining legislation 
        prohibiting access to young people and providing for education 
        about tobacco use.
            (27) International experience shows that advertising 
        regulations that are stringent and comprehensive have a greater 
        impact on overall tobacco use and young people's use than 
        weaker or less comprehensive ones. Text-only requirements, 
        while not as stringent as a ban, will help reduce underage use 
        of tobacco products while preserving the informational function 
        of advertising.
            (28) It is in the public interest for Congress to adopt 
        legislation to address the public health crisis created by 
        actions of the tobacco industry.
            (29) The use of tobacco products in motion pictures and 
        other mass media glamorizes its use for young people and 
        encourages them to use tobacco products.

SEC. 3. PURPOSE.

    The purposes of this Act are--
            (1) to provide authority to the Food and Drug 
        Administration to regulate tobacco products under the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), by 
        recognizing it as the primary Federal regulatory authority with 
        respect to the manufacture, marketing, and distribution of 
        tobacco products;
            (2) to ensure that the Food and Drug Administration has the 
        authority to address issues of particular concern to public 
        health officials, especially the use of tobacco by young people 
        and dependence on tobacco;
            (3) to authorize the Food and Drug Administration to set 
        national standards controlling the manufacture of tobacco 
        products and the identity, public disclosure, and amount of 
        ingredients used in such products;
            (4) to provide new and flexible enforcement authority to 
        ensure that there is effective oversight of the tobacco 
        industry's efforts to develop and introduce less harmful 
        tobacco products;
            (5) to vest the Food and Drug Administration with the 
        authority to regulate the levels of tar, nicotine, and other 
        harmful components of tobacco products;
            (6) in order to ensure that adults are better informed, to 
        require tobacco product manufacturers to disclose research 
        which has not previously been made available, as well as 
        research generated in the future, relating to the health and 
        dependency effects or safety of tobacco products;
            (7) to continue to permit the sale of tobacco products to 
        adults in conjunction with measures to ensure that they are not 
        sold or accessible to underage purchasers; and
            (8) to impose appropriate regulatory controls on the 
        tobacco industry

SEC. 4. SCOPE AND EFFECT.

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

         TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION

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

    (a) Definition of Tobacco Products.--Section 201 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at 
the end the following:
            ``(kk) The term `tobacco product' means any product made or 
        derived from tobacco that is intended for human consumption, 
        including any component, part, or accessory of a tobacco 
        product (except for raw materials other than tobacco used in 
        manufacturing a component, part, or accessory of a tobacco 
        product).''.
    (b) FDA Authority Over Tobacco Products.--The Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
            (1) by redesignating chapter IX as chapter X;
            (2) by redesignating sections 901 through 907 as sections 
        1001 through 1007; and
            (3) by inserting after section 803 the following:

                     ``CHAPTER IX--TOBACCO PRODUCTS

``SEC. 900. DEFINITIONS.

    ``In this chapter:
            ``(1) Brand.--The term `brand' means a variety of tobacco 
        product distinguished by the tobacco used, tar content, 
        nicotine content, flavoring used, size, filtration, or 
        packaging, logo, registered trademark or brand name, 
        identifiable pattern of colors, or any combination of such 
        attributes.
            ``(2) Cigarette.--The term `cigarette' has the meaning 
        given that term by section 3(1) of the Federal Cigarette 
        Labeling and Advertising Act (15 U.S.C. 1332(1)), but also 
        includes tobacco, in any form, that is functional in the 
        product, which, because of its appearance, the type of tobacco 
        used in the filler, or its packaging and labeling, is likely to 
        be offered to, or purchased by, consumers as a cigarette or as 
        roll-your-own tobacco.
            ``(3) Cigarette tobacco.--The term `cigarette tobacco' 
        means any product that consists of loose tobacco that is 
        intended for use by consumers in a cigarette. Unless otherwise 
        stated, the requirements for cigarettes shall also apply to 
        cigarette tobacco.
            ``(4) Commerce.--The term `commerce' has the meaning given 
        that term by section 3(2) of the Federal Cigarette Labeling and 
        Advertising Act (15 U.S.C. 1332(2)).
            ``(5) Distributor.--The term `distributor' as regards a 
        tobacco product means any person who furthers the distribution 
        of cigarette or smokeless tobacco, whether domestic or 
        imported, at any point from the original place of manufacture 
        to the person who sells or distributes the product to 
        individuals for personal consumption. Common carriers are not 
        considered distributors for purposes of this chapter.
            ``(6) Indian tribe.--The term `Indian tribe' has the 
        meaning given such term in section 4(e) of the Indian Self 
        Determination and Education Assistance Act (25 U.S.C. 450b(e)).
            ``(7) Little cigar.--The term `little cigar' has the 
        meaning given that term by section 3(7) of the Federal 
        Cigarette Labeling and Advertising Act (15 U.S.C. 1332(7)).
            ``(8) Nicotine.--The term `nicotine' means the chemical 
        substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or 
        C[10]H[14]N[2], including any salt or complex of nicotine.
            ``(9) Package.--The term `package' means a pack, box, 
        carton, or container of any kind or, if no other container, any 
        wrapping (including cellophane), in which cigarettes or 
        smokeless tobacco are offered for sale, sold, or otherwise 
        distributed to consumers.
            ``(10) Retailer.--The term `retailer' means any person who 
        sells cigarettes or smokeless tobacco to individuals for 
        personal consumption, or who operates a facility where self-
        service displays of tobacco products are permitted.
            ``(11) Roll-your-own tobacco.--The term `roll-your-own 
        tobacco' means any tobacco which, because of its appearance, 
        type, packaging, or labeling, is suitable for use and likely to 
        be offered to, or purchased by, consumers as tobacco for making 
        cigarettes.
            ``(12) Smokeless tobacco.--The term `smokeless tobacco' 
        means any product that consists of cut, ground, powdered, or 
        leaf tobacco and that is intended to be placed in the oral or 
        nasal cavity.
            ``(13) State.--The term `State' means any State of the 
        United States and, for purposes of this chapter, includes the 
        District of Columbia, the Commonwealth of Puerto Rico, Guam, 
        the Virgin Islands, American Samoa, Wake Island, Midway 
        Islands, Kingman Reef, Johnston Atoll, the Northern Mariana 
        Islands, and any other trust territory or possession of the 
        United States.
            ``(14) Tobacco product.--The term `tobacco product' means 
        cigarettes, cigarette tobacco, smokeless tobacco, little 
        cigars, roll-your-own tobacco, and fine cut products.
            ``(15) Tobacco product manufacturer.--Term `tobacco product 
        manufacturer' means any person, including any repacker or 
        relabeler, who--
                    ``(A) manufactures, fabricates, assembles, 
                processes, or labels a finished cigarette or smokeless 
                tobacco product; or
                    ``(B) imports a finished cigarette or smokeless 
                tobacco product for sale or distribution in the United 
                States.
            ``(16) United states.--The term `United States' means the 
        50 States of the United States of America and the District of 
        Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin 
        Islands, American Samoa, Wake Island, Midway Islands, Kingman 
        Reef, Johnston Atoll, the Northern Mariana Islands, and any 
        other trust territory or possession of the United States.

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

     ``(a) In General.--Tobacco products shall be regulated by the 
Secretary under this chapter and shall not be subject to the provisions 
of chapter V, unless--
            ``(1) such products are intended for use in the diagnosis, 
        cure, mitigation, treatment, or prevention of disease (within 
        the meaning of section 201(g)(1)(B) or section 201(h)(2)); or
            ``(2) a health claim is made for such products under 
        section 201(g)(1)(C) or 201(h)(3).
    ``(b) Applicability.--This chapter shall apply to all tobacco 
products subject to the provisions of part 897 of title 21, Code of 
Federal Regulations, and to any other tobacco products that the 
Secretary by regulation deems to be subject to this chapter.
    ``(c) Scope.--
            ``(1) In general.--Nothing in this chapter, or any policy 
        issued or regulation promulgated thereunder, or the Youth 
        Smoking Prevention and Public Health Protection Act, shall be 
        construed to affect the Secretary's authority over, or the 
        regulation of, products under this Act that are not tobacco 
        products under chapter V or any other chapter.
            ``(2) Tobacco leaf.--
                    ``(A) In general.--The provisions of this chapter 
                shall not apply to tobacco leaf that is not in the 
                possession of the manufacturer, or to the producers of 
                tobacco leaf, including tobacco growers, tobacco 
                warehouses, and tobacco grower cooperatives, nor shall 
                any employee of the Food and Drug Administration have 
                any authority to enter onto a farm owned by a producer 
                of tobacco leaf without the written consent of such 
                producer.
                    ``(B) Exception.--Notwithstanding any other 
                provision of this subparagraph, if a producer of 
                tobacco leaf is also a tobacco product manufacturer or 
                controlled by a tobacco product manufacturer, the 
                producer shall be subject to this chapter in the 
                producer's capacity as a manufacturer.
                    ``(C) Rule of construction.--Nothing in this 
                chapter shall be construed to grant the Secretary 
                authority to promulgate regulations on any matter that 
                involves the production of tobacco leaf or a producer 
                thereof, other than activities by a manufacturer 
                affecting production. For purposes of the preceding 
                sentence, the term `controlled by' means a member of 
                the same controlled group of corporations as that term 
                is used in section 52(a) of the Internal Revenue Code 
                of 1986, or under common control within the meaning of 
                the regulations promulgated under section 52(b) of such 
                Code.

``SEC. 902. ADULTERATED TOBACCO PRODUCTS.

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

``SEC. 903. MISBRANDED TOBACCO PRODUCTS.

    ``(a) In General.--A tobacco product shall be deemed to be 
misbranded--
            ``(1) if its labeling is false or misleading in any 
        particular;
            ``(2) if in package form unless it bears a label 
        containing--
                    ``(A) the name and place of business of the tobacco 
                product manufacturer, packer, or distributor; and
                    ``(B) an accurate statement of the quantity of the 
                contents in terms of weight, measure, or numerical 
                count,
        except that under subparagraph (B) reasonable variations shall 
        be permitted, and exemptions as to small packages shall be 
        established, by regulations prescribed by the Secretary;
            ``(3) if any word, statement, or other information required 
        by or under authority of this chapter to appear on the label or 
        labeling is not prominently placed thereon with such 
        conspicuousness (as compared with other words, statements or 
        designs in the labeling) and in such terms as to render it 
        likely to be read and understood by the ordinary individual 
        under customary conditions of purchase and use;
            ``(4) if it has an established name, unless its label 
        bears, to the exclusion of any other nonproprietary name, its 
        established name prominently printed in type as required by the 
        Secretary by regulation;
            ``(5) if the Secretary has issued regulations requiring 
        that its labeling bear adequate directions for use, or adequate 
        warnings against use by children, that are necessary for the 
        protection of users unless its labeling conforms in all 
        respects to such regulations;
            ``(6) if it was manufactured, prepared, propagated, 
        compounded, or processed in any State in an establishment not 
        duly registered under section 905(b), if it was not included in 
        a list required by section 905(i), if a notice or other 
        information respecting it was not provided as required by such 
        section or section 905(j), or if it does not bear such symbols 
        from the uniform system for identification of tobacco products 
        prescribed under section 905(e) as the Secretary by regulation 
        requires;
            ``(7) if, in the case of any tobacco product distributed or 
        offered for sale in any State--
                    ``(A) its advertising is false or misleading in any 
                particular; or
                    ``(B) it is sold, distributed, or used in violation 
                of regulations prescribed under section 906(d);
            ``(8) unless, in the case of any tobacco product 
        distributed or offered for sale in any State, the manufacturer, 
        packer, or distributor thereof includes in all advertisements 
        and other descriptive printed matter issued or caused to be 
        issued by the manufacturer, packer, or distributor with respect 
        to that tobacco product--
                    ``(A) a true statement of the tobacco product's 
                established name as defined in paragraph (4), printed 
                prominently; and
                    ``(B) a brief statement of--
                            ``(i) the uses of the tobacco product and 
                        relevant warnings, precautions, side effects, 
                        and contraindications; and
                            ``(ii) in the case of specific tobacco 
                        products made subject to a finding by the 
                        Secretary after notice and opportunity for 
                        comment that such action is necessary to 
                        protect the public health, a full description 
                        of the components of such tobacco product or 
                        the formula showing quantitatively each 
                        ingredient of such tobacco product to the 
                        extent required in regulations which shall be 
                        issued by the Secretary after an opportunity 
                        for a hearing;
            ``(9) if it is a tobacco product subject to a performance 
        standard established under section 907, unless it bears such 
        labeling as may be prescribed in such performance standard; or
            ``(10) if there was a failure or refusal--
                    ``(A) to comply with any requirement prescribed 
                under section 904 or 908;
                    ``(B) to furnish any material or information 
                required by or under section 909; or
                    ``(C) to comply with a requirement under section 
                912.
    ``(b) Prior Approval of Label Statements.--The Secretary may, by 
regulation, require prior approval of statements made on the label of a 
tobacco product. No regulation issued under this subsection may require 
prior approval by the Secretary of the content of any advertisement. No 
advertisement of a tobacco product, published after the date of 
enactment of the Youth Smoking Prevention and Public Health Protection 
Act shall, with respect to the language of label statements as 
prescribed under section 4 of the Cigarette Labeling and Advertising 
Act and section 3 of the Comprehensive Smokeless Tobacco Health 
Education Act of 1986 or the regulations issued under such sections, be 
subject to the provisions of sections 12 through 15 of the Federal 
Trade Commission Act (15 U.S.C. 52 through 55).

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

    ``(a) Requirement.--Not later than 6 months after the date of 
enactment of the Youth Smoking Prevention and Public Health Protection 
Act, each tobacco product manufacturer or importer of tobacco products, 
or agents thereof, shall submit to the Secretary the following 
information:
            ``(1) A listing of all tobacco ingredients, substances and 
        compounds that are, on such date, added by the manufacturer to 
        the tobacco, paper, filter, or other component of each tobacco 
        product by brand and by quantity in each brand and subbrand.
            ``(2) A description of the content, delivery, and form of 
        nicotine in each tobacco product measured in milligrams of 
        nicotine.
            ``(3) 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, behavioral, or 
        physiologic effects of tobacco products, their constituents, 
        ingredients, and components, and tobacco additives, described 
        in paragraph (1).
            ``(4) All documents (including underlying scientific 
        information) relating to research activities, and research 
        findings, conducted, supported, or possessed by the 
        manufacturer (or agents thereof) that relate to the issue of 
        whether a reduction in risk to health from tobacco products can 
        occur upon the employment of technology available or known to 
        the manufacturer.
            ``(5) All documents (including underlying scientific 
        information) relating to marketing research involving the use 
        of tobacco products.
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.
    ``(b) Annual Submission.--A tobacco product manufacturer or 
importer that is required to submit information under subsection (a) 
shall update such information on an annual basis under a schedule 
determined by the Secretary.
    ``(c) Time for Submission.--
            ``(1) New products.--At least 90 days prior to the delivery 
        for introduction into interstate commerce of a tobacco product 
        not on the market on the date of enactment of the Youth Smoking 
        Prevention and Public Health Protection Act, the manufacturer 
        of such product shall provide the information required under 
        subsection (a) and such product shall be subject to the annual 
        submission under subsection (b).
            ``(2) Modification of existing products.--If at any time a 
        tobacco product manufacturer adds to its tobacco products a new 
        tobacco additive, increases or decreases the quantity of an 
        existing tobacco additive or the nicotine content, delivery, or 
        form, or eliminates a tobacco additive from any tobacco 
        product, the manufacturer shall within 60 days of such action 
        so advise the Secretary in writing and reference such 
        modification in submissions made under subsection (b).

``SEC. 905. ANNUAL REGISTRATION.

    ``(a) Definitions.--In this section:
            ``(1) Manufacture, preparation, compounding, or 
        processing.--The term `manufacture, preparation, compounding, 
        or processing' shall include repackaging or otherwise changing 
        the container, wrapper, or labeling of any tobacco product 
        package in furtherance of the distribution of the tobacco 
        product from the original place of manufacture to the person 
        who makes final delivery or sale to the ultimate consumer or 
        user.
            ``(2) Name.--The term `name' shall include in the case of a 
        partnership the name of each partner and, in the case of a 
        corporation, the name of each corporate officer and director, 
        and the State of incorporation.
    ``(b) Registration by Owners and Operators.--On or before December 
31 of each year every person who owns or operates any establishment in 
any State engaged in the manufacture, preparation, compounding, or 
processing of a tobacco product or tobacco products shall register with 
the Secretary the name, places of business, and all such establishments 
of that person.
    ``(c) Registration of New Owners and Operators.--Every person upon 
first engaging in the manufacture, preparation, compounding, or 
processing of a tobacco product or tobacco products in any 
establishment owned or operated in any State by that person shall 
immediately register with the Secretary that person's name, place of 
business, and such establishment.
    ``(d) Registration of Added Establishments.--Every person required 
to register under subsection (b) or (c) shall immediately register with 
the Secretary any additional establishment which that person owns or 
operates in any State and in which that person begins the manufacture, 
preparation, compounding, or processing of a tobacco product or tobacco 
products.
    ``(e) Uniform Product Identification System.--The Secretary may by 
regulation prescribe a uniform system for the identification of tobacco 
products and may require that persons who are required to list such 
tobacco products under subsection (i) shall list such tobacco products 
in accordance with such system.
    ``(f) Public Access to Registration Information.--The Secretary 
shall make available for inspection, to any person so requesting, any 
registration filed under this section.
    ``(g) Biennial Inspection of Registered Establishments.--Every 
establishment in any State registered with the Secretary under this 
section shall be subject to inspection under section 704, and every 
such establishment engaged in the manufacture, compounding, or 
processing of a tobacco product or tobacco products shall be so 
inspected by one or more officers or employees duly designated by the 
Secretary at least once in the 2-year period beginning with the date of 
registration of such establishment under this section and at least once 
in every successive 2-year period thereafter.
    ``(h) Foreign Establishments May Register.--Any establishment 
within any foreign country engaged in the manufacture, preparation, 
compounding, or processing of a tobacco product or tobacco products, 
may register under this section under regulations promulgated by the 
Secretary. Such regulations shall require such establishment to provide 
the information required by subsection (i) of this section and shall 
include provisions for registration of any such establishment upon 
condition that adequate and effective means are available, by 
arrangement with the government of such foreign country or otherwise, 
to enable the Secretary to determine from time to time whether tobacco 
products manufactured, prepared, compounded, or processed in such 
establishment, if imported or offered for import into the United 
States, shall be refused admission on any of the grounds set forth in 
section 801(a).
    ``(i) Registration Information.--
            ``(1) Product list.--Every person who registers with the 
        Secretary under subsection (b), (c),  or (d) shall, at the time 
of registration under any such subsection, file with the Secretary a 
list of all tobacco products which are being manufactured, prepared, 
compounded, or processed by that person for commercial distribution and 
which has not been included in any list of tobacco products filed by 
that person with the Secretary under this paragraph or paragraph (2) 
before such time of registration. Such list shall be prepared in such 
form and manner as the Secretary may prescribe and shall be accompanied 
by--
                    ``(A) in the case of a tobacco product contained in 
                the applicable list with respect to which a performance 
                standard has been established under section 907 or 
                which is subject to section 910, a reference to the 
                authority for the marketing of such tobacco product and 
                a copy of all labeling for such tobacco product;
                    ``(B) in the case of any other tobacco product 
                contained in an applicable list, a copy of all consumer 
                information and other labeling for such tobacco 
                product, a representative sampling of advertisements 
                for such tobacco product, and, upon request made by the 
                Secretary for good cause, a copy of all advertisements 
                for a particular tobacco product; and
                    ``(C) if the registrant filing a list has 
                determined that a tobacco product contained in such 
                list is not subject to a performance standard 
                established under section 907, a brief statement of the 
                basis upon which the registrant made such determination 
                if the Secretary requests such a statement with respect 
                to that particular tobacco product.
            ``(2) Biannual report of any change in product list.--Each 
        person who registers with the Secretary under this section 
        shall report to the Secretary once during the month of June of 
        each year and once during the month of December of each year 
        the following:
                    ``(A) A list of each tobacco product introduced by 
                the registrant for commercial distribution which has 
                not been included in any list previously filed by that 
                person with the Secretary under this subparagraph or 
                paragraph (1). A list under this subparagraph shall 
                list a tobacco product by its established name and 
                shall be accompanied by the other information required 
                by paragraph (1).
                    ``(B) If since the date the registrant last made a 
                report under this paragraph that person has 
                discontinued the manufacture, preparation, compounding, 
                or processing for commercial distribution of a tobacco 
                product included in a list filed under subparagraph (A) 
                or paragraph (1), notice of such discontinuance, the 
                date of such discontinuance, and the identity of its 
                established name.
                    ``(C) If since the date the registrant reported 
                under subparagraph (B) a notice of discontinuance that 
                person has resumed the manufacture, preparation, 
                compounding, or processing for commercial distribution 
                of the tobacco product with respect to which such 
                notice of discontinuance was reported, notice of such 
                resumption, the date of such resumption, the identity 
                of such tobacco product by established name, and other 
                information required by paragraph (1), unless the 
                registrant has previously reported such resumption to 
                the Secretary under this subparagraph.
                    ``(D) Any material change in any information 
                previously submitted under this paragraph or paragraph 
                (1).
    ``(j) Report Preceding Introduction of Certain Substantially-
equivalent Products Into Interstate Commerce.--
            ``(1) In general.--Each person who is required to register 
        under this section and who proposes to begin the introduction 
        or delivery for introduction into interstate commerce for 
        commercial distribution of a tobacco product intended for human 
        use that was not commercially marketed (other than for test 
        marketing) in the United States as of August 11, 1995, as 
        defined by the Secretary by regulation shall, at least 90 days 
        before making such introduction or delivery, report to the 
        Secretary (in such form and manner as the Secretary shall by 
        regulation prescribe)--
                    ``(A) the basis for such person's determination 
                that the tobacco product is substantially equivalent, 
                within the meaning of section 910, to a tobacco product 
                commercially marketed (other than for test marketing) 
                in the United States as of August 11, 1995, that is in 
                compliance with the requirements of this Act; and
                    ``(B) action taken by such person to comply with 
                the requirements under section 907 that are applicable 
                to the tobacco product.
            ``(2) Application to certain post-august 11th products.--A 
        report under this subsection for a tobacco product that was 
        first introduced or delivered for introduction into interstate 
        commerce for commercial distribution in the United States after 
        August 11, 1995, and before the date of enactment of the Youth 
        Smoking Prevention and Public Health Protection Act shall be 
        submitted to the Secretary within 6 months after the date of 
        enactment of that Act.

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

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

``SEC. 907. PERFORMANCE STANDARDS.

    ``(a) In General.--
            ``(1) Finding required.--The Secretary may adopt 
        performance standards for a tobacco product if the Secretary 
        finds that a performance standard is appropriate for the 
        protection of the public health. This finding shall be 
        determined with respect to the risks and benefits to the 
        population as a whole, including users and non-users of the 
        tobacco product, and taking into account--
                    ``(A) the increased or decreased likelihood that 
                existing users of tobacco products will stop using such 
                products; and
                    ``(B) the increased or decreased likelihood that 
                those who do not use tobacco products will start using 
                such products.
            ``(2) Content of performance standards.--A performance 
        standard established under this section for a tobacco product--
                    ``(A) shall include provisions to provide 
                performance that is appropriate for the protection of 
                the public health, including provisions, where 
                appropriate--
                            ``(i) for the reduction or elimination of 
                        nicotine yields of the product;
                            ``(ii) for the reduction or elimination of 
                        other constituents or harmful components of the 
                        product; or
                            ``(iii) relating to any other requirement 
                        under (B);
                    ``(B) shall, where necessary to be appropriate for 
                the protection of the public health, include--
                            ``(i) provisions respecting the 
                        construction, components, ingredients, and 
                        properties of the tobacco product;
                            ``(ii) provisions for the testing (on a 
                        sample basis or, if necessary, on an individual 
                        basis) of the tobacco product;
                            ``(iii) provisions for the measurement of 
                        the performance characteristics of the tobacco 
                        product;
                            ``(iv) provisions requiring that the 
                        results of each or of certain of the tests of 
                        the tobacco product required to be made under 
                        clause (ii) show that the tobacco product is in 
                        conformity with the portions of the standard 
                        for which the test or tests were required; and
                            ``(v) a provision requiring that the sale 
                        and distribution of the tobacco product be 
                        restricted but only to the extent that the sale 
                        and distribution of a tobacco product may be 
                        restricted under a regulation under section 
                        906(d); and
                    ``(C) shall, where appropriate, require the use and 
                prescribe the form and content of labeling for the 
                proper use of the tobacco product.
            ``(3) Periodic re-evaluation of performance standards.--The 
        Secretary shall provide for periodic evaluation of performance 
        standards established under this section to determine whether 
        such standards should be changed to reflect new medical, 
        scientific, or other technological data. The Secretary may 
        provide for testing under paragraph (2) by any person.
            ``(4) Involvement of other agencies; informed persons.--In 
        carrying out duties under this section, the Secretary shall, to 
        the maximum extent practicable--
                    ``(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, or consumer organizations who 
                in the Secretary's judgment can make a significant 
                contribution.
    ``(b) Establishment of Standards.--
            ``(1) Notice.--
                    ``(A) In general.--The Secretary shall publish in 
                the Federal Register a notice of proposed rulemaking 
                for the establishment, amendment, or revocation of any 
                performance standard for a tobacco product.
                    ``(B) Requirements of notice.--A notice of proposed 
                rulemaking for the establishment or amendment of a 
                performance standard for a tobacco product shall--
                            ``(i) set forth a finding with supporting 
                        justification that the performance standard is 
                        appropriate for the protection of the public 
                        health;
                            ``(ii) set forth proposed findings with 
                        respect to the risk of illness or injury that 
                        the performance standard is intended to reduce 
                        or eliminate; and
                            ``(iii) invite interested persons to submit 
                        an existing performance standard for the 
                        tobacco product, including a draft or proposed 
                        performance standard, for consideration by the 
                        Secretary.
                    ``(C) Finding.--A notice of proposed rulemaking for 
                the revocation of a performance standard shall set 
                forth a finding with supporting justification that the 
                performance standard is no longer necessary to be 
                appropriate for the protection of the public health.
                    ``(D) Consideration by secretary.--The Secretary 
                shall consider all information submitted in connection 
                with a proposed standard, including information 
                concerning the countervailing effects of the 
                performance standard on the health of adolescent 
                tobacco users, adult tobacco users, or non-tobacco 
                users, such as the creation of a significant demand for 
                contraband or other tobacco products that do not meet 
                the requirements of this chapter and the significance 
                of such demand, and shall issue the standard if the 
                Secretary determines that the standard would be 
                appropriate for the protection of the public health.
                    ``(E) Comment.--The Secretary shall provide for a 
                comment period of not less than 60 days.
            ``(2) Promulgation.--
                    ``(A) In general.--After the expiration of the 
                period for comment on a notice of proposed rulemaking 
                published under paragraph (1) respecting a performance 
                standard and after consideration of such comments and 
                any report from an advisory committee, the Secretary 
                shall--
                            ``(i) promulgate a regulation establishing 
                        a performance standard and publish in the 
                        Federal Register findings on the matters 
                        referred to in paragraph (1); or
                            ``(ii) publish a notice terminating the 
                        proceeding for the development of the standard 
                        together with the reasons for such termination.
                    ``(B) Effective date.--A regulation establishing a 
                performance standard shall set forth the date or dates 
                upon which the standard shall take effect, but no such 
                regulation may take effect before one year after the 
                date of its publication unless the Secretary determines 
                that an earlier effective date is necessary for the 
                protection of the public health. Such date or dates 
                shall be established so as to minimize,  consistent 
with the public health, economic loss to, and disruption or dislocation 
of, domestic and international trade.
            ``(3) Special rule for standard banning class of product or 
        eliminating nicotine content.--Because of the importance of a 
        decision of the Secretary to issue a regulation establishing a 
        performance standard--
                    ``(A) eliminating all cigarettes, all smokeless 
                tobacco products, or any similar class of tobacco 
                products, or
                    ``(B) requiring the reduction of nicotine yields of 
                a tobacco product to zero,
        it is appropriate for the Congress to have the opportunity to 
        review such a decision. Therefore, any such standard may not 
        take effect before a date that is 2 years after the President 
        notifies the Congress that a final regulation imposing the 
        restriction has been issued.
            ``(4) Amendment; revocation.--
                    ``(A) Authority.--The Secretary, upon the 
                Secretary's own initiative or upon petition of an 
                interested person may by a regulation, promulgated in 
                accordance with the requirements of paragraphs (1) and 
                (2)(B), amend or revoke a performance standard.
                    ``(B) Effective date.--The Secretary may declare a 
                proposed amendment of a performance standard to be 
                effective on and after its publication in the Federal 
                Register and until the effective date of any final 
                action taken on such amendment if the Secretary 
                determines that making it so effective is in the public 
                interest.
            ``(5) Reference to Advisory Committee.--The Secretary--
                    ``(A) may, on the Secretary's own initiative, refer 
                a proposed regulation for the establishment, amendment, 
                or revocation of a performance standard; or
                    ``(B) shall, upon the request of an interested 
                person which demonstrates good cause for referral and 
                which is made before the expiration of the period for 
                submission of comments on such proposed regulation,
refer such proposed regulation to an advisory committee, for a report 
and recommendation with respect to any matter involved in the proposed 
regulation which requires the exercise of scientific judgment. If a 
proposed regulation is referred under this paragraph to the advisory 
committee, the Secretary shall provide the advisory committee with the 
data and information on which such proposed regulation is based. The 
advisory committee shall, within 60 days after the referral of a 
proposed regulation and after independent study of the data and 
information furnished to it by the Secretary and other data and 
information before it, submit to the Secretary a report and 
recommendation respecting such regulation, together with all underlying 
data and information and a statement of the reason or basis for the 
recommendation. A copy of such report and recommendation shall be made 
public by the Secretary.

``SEC. 908. NOTIFICATION AND OTHER REMEDIES.

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

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

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

``SEC. 910. PREMARKET REVIEW OF CERTAIN TOBACCO PRODUCTS.

    ``(a) In General.--
            ``(1) Premarket approval required.--
                    ``(A) New products.--Approval under this section of 
                an application for premarket approval for any tobacco 
                product that is not commercially marketed (other than 
                for test marketing) in the United States as of August 
                11, 1995, is required unless the manufacturer has 
                submitted a report under section 905(j), and the 
                Secretary has issued an order that the tobacco product 
                is substantially equivalent to a tobacco product 
                commercially marketed (other than for test marketing) 
                in the United States as of August 11, 1995, that is in 
                compliance with the requirements of this Act.
                    ``(B) Products introduced between August 11, 1995, 
                and enactment of this chapter.--Subparagraph (A) does 
                not apply to a tobacco product that--
                            ``(i) was first introduced or delivered for 
                        introduction into interstate commerce for 
                        commercial distribution in the United States 
                        after August 11, 1995, and before the date of 
                        enactment of the Youth Smoking Prevention and 
                        Public Health Protection Act; and
                            ``(ii) for which a report was submitted 
                        under section 905(j) within 6 months after such 
                        date,
                until the Secretary issues an order that the tobacco 
                product is substantially equivalent for purposes of 
                this section or requires premarket approval.
            ``(2) Substantially equivalent defined.--
                    ``(A) In general.--For purposes of this section and 
                section 905(j), the terms `substantially equivalent' or 
                `substantial equivalence' mean, with respect to the 
                tobacco product being compared to the predicate tobacco 
                product, that the Secretary by order has found that the 
                tobacco product--
                            ``(i) has the same characteristics as the 
                        predicate tobacco product; or
                            ``(ii) has different characteristics and 
                        the information submitted contains information, 
                        including clinical data if deemed necessary by 
                        the Secretary, that demonstrates that it is not 
                        appropriate to regulate the product under this 
                        section because the product does not raise 
                        different questions of public health.
                    ``(B) Characteristics.--For purposes of 
                subparagraph (A), the term `characteristics' means the 
                materials, ingredients, design, composition, heating 
                source, or other features of a tobacco product.
                    ``(C) Limitation.--A tobacco product may not be 
                found to be substantially equivalent to a predicate 
                tobacco product that has been removed from the market 
                at the initiative of the Secretary or that has been 
                determined by a judicial order to be misbranded or 
                adulterated.
            ``(3) Health information.--
                    ``(A) Summary.--As part of a submission under 
                section 905(j) respecting a tobacco product, the person 
                required to file a premarket notification under such 
                section shall provide an adequate summary of any health 
                information related to the tobacco product or state 
                that such information will be made available upon 
                request by any person.
                    ``(B) Required information.--Any summary under 
                subparagraph (A) respecting a tobacco product shall 
                contain detailed information regarding data concerning 
                adverse health effects and shall be made available to 
                the public by the Secretary within 30 days of the 
                issuance of a determination that such tobacco product 
                is substantially equivalent to another tobacco product.
    ``(b) Application.--
            ``(1) Contents.--An application for premarket approval 
        shall contain--
                    ``(A) full reports of all information, published or 
                known to, or which should reasonably be known to, the 
                applicant, concerning investigations which have been 
                made to show the health risks of such tobacco product 
                and whether such tobacco product presents less risk 
                than other tobacco products;
                    ``(B) a full statement of the components, 
                ingredients, and properties, and of the principle or 
                principles of operation, of such tobacco product;
                    ``(C) a full description of the methods used in, 
                and the facilities and controls used for, the 
                manufacture, processing, and, when relevant, packing 
                and installation of, such tobacco product;
                    ``(D) an identifying reference to any performance 
                standard under section 907 which would be applicable to 
                any aspect of such tobacco product, and either adequate 
                information to show that such aspect of such tobacco 
                product fully meets such performance standard or 
                adequate information to justify any deviation from such 
                standard;
                    ``(E) such samples of such tobacco product and of 
                components thereof as the Secretary may reasonably 
                require;
                    ``(F) specimens of the labeling proposed to be used 
                for such tobacco product; and
                    ``(G) such other information relevant to the 
                subject matter of the application as the Secretary may 
                require.
            ``(2) Reference to advisory committee.--Upon receipt of an 
        application meeting the requirements set forth in paragraph 
        (1), the Secretary--
                    ``(A) may, on the Secretary's own initiative; or
                    ``(B) shall, upon the request of an applicant,
        refer such application to an advisory committee and for 
        submission (within such period as the Secretary  may establish) 
of a report and recommendation respecting approval of the application, 
together with all underlying data and the reasons or basis for the 
recommendation.
    ``(c) Action on Application.--
            ``(1) Deadline.--
                    ``(A) In general.--As promptly as possible, but in 
                no event later than 180 days after the receipt of an 
                application under subsection (b), the Secretary, after 
                considering the report and recommendation submitted 
                under paragraph (2) of such subsection, shall--
                            ``(i) issue an order approving the 
                        application if the Secretary finds that none of 
                        the grounds for denying approval specified in 
                        paragraph (2) of this subsection applies; or
                            ``(ii) deny approval of the application if 
                        the Secretary finds (and sets forth the basis 
                        for such finding as part of or accompanying 
                        such denial) that one or more grounds for 
                        denial specified in paragraph (2) of this 
                        subsection apply.
                    ``(B) Restrictions on sale and distribution.--An 
                order approving an application for a tobacco product 
                may require as a condition to such approval that the 
                sale and distribution of the tobacco product be 
                restricted but only to the extent that the sale and 
                distribution of a tobacco product may be restricted 
                under a regulation under section 906(d).
            ``(2) Denial of approval.--The Secretary shall deny 
        approval of an application for a tobacco product if, upon the 
        basis of the information submitted to the Secretary as part of 
        the application and any other information before the Secretary 
        with respect to such tobacco product, the Secretary finds 
        that--
                    ``(A) there is a lack of a showing that permitting 
                such tobacco product to be marketed would be 
                appropriate for the protection of the public health;
                    ``(B) the methods used in, or the facilities or 
                controls used for, the manufacture, processing, or 
                packing of such tobacco product do not conform to the 
                requirements of section 906(e);
                    ``(C) based on a fair evaluation of all material 
                facts, the proposed labeling is false or misleading in 
                any particular; or
                    ``(D) such tobacco product is not shown to conform 
                in all respects to a performance standard in effect 
                under section 907, compliance with which is a condition 
                to approval of the application, and there is a lack of 
                adequate information to justify the deviation from such 
                standard.
            ``(3) Denial information.--Any denial of an application 
        shall, insofar as the Secretary determines to be practicable, 
        be accompanied by a statement informing the applicant of the 
        measures required to place such application in approvable form 
        (which measures may include further research by the applicant 
        in accordance with one or more protocols prescribed by the 
        Secretary).
            ``(4) Basis for finding.--For purposes of this section, the 
        finding as to whether approval of a tobacco product is 
        appropriate for the protection of the public health shall be 
        determined with respect to the risks and benefits to the 
        population as a whole, including users and non-users of the 
        tobacco product, and taking into account--
                    ``(A) the increased or decreased likelihood that 
                existing users of tobacco products will stop using such 
                products; and
                    ``(B) the increased or decreased likelihood that 
                those who do not use tobacco products will start using 
                such products.
            ``(5) Basis for action.--
                    ``(A) Investigations.--For purposes of paragraph 
                (2)(A), whether permitting a tobacco product to be 
                marketed would be appropriate for the protection of the 
                public health shall, when appropriate, be determined on 
                the basis of well-controlled investigations, which may 
                include one or more clinical investigations by experts 
                qualified by training and experience to evaluate the 
                tobacco product.
                    ``(B) Other evidence.--If the Secretary determines 
                that there exists valid scientific evidence (other than 
                evidence derived from investigations described in 
                subparagraph (A)) which is sufficient to evaluate the 
                tobacco product the Secretary may authorize that the 
                determination for purposes of paragraph (2)(A) be made 
                on the basis of such evidence.
    ``(d) Withdrawal and Temporary Suspension.--
            ``(1) In general.--The Secretary shall, upon obtaining, 
        where appropriate, advice on scientific matters from an 
        advisory committee, and after due notice and opportunity for 
        informal hearing to the holder of an approved application for a 
        tobacco product, issue an order withdrawing approval of the 
        application if the Secretary finds--
                    ``(A) that the continued marketing of such tobacco 
                product no longer is appropriate for the protection of 
                the public health;
                    ``(B) that the application contained or was 
                accompanied by an untrue statement of a material fact;
                    ``(C) that the applicant--
                            ``(i) has failed to establish a system for 
                        maintaining records, or has repeatedly or 
                        deliberately failed to maintain records or to 
                        make reports, required by an applicable 
                        regulation under section 909;
                            ``(ii) has refused to permit access to, or 
                        copying or verification of, such records as 
                        required by section 704; or
                            ``(iii) has not complied with the 
                        requirements of section 905;
                    ``(D) on the basis of new information before the 
                Secretary with respect to such tobacco product, 
                evaluated together with the evidence before the 
                Secretary when the application was  approved, that the 
methods used in, or the facilities and controls used for, the 
manufacture, processing, packing, or installation of such tobacco 
product do not conform with the requirements of section 906(e) and were 
not brought into conformity with such requirements within a reasonable 
time after receipt of written notice from the Secretary of 
nonconformity;
                    ``(E) on the basis of new information before the 
                Secretary, evaluated together with the evidence before 
                the Secretary when the application was approved, that 
                the labeling of such tobacco product, based on a fair 
                evaluation of all material facts, is false or 
                misleading in any particular and was not corrected 
                within a reasonable time after receipt of written 
                notice from the Secretary of such fact; or
                    ``(F) on the basis of new information before the 
                Secretary, evaluated together with the evidence before 
                the Secretary when the application was approved, that 
                such tobacco product is not shown to conform in all 
                respects to a performance standard which is in effect 
                under section 907, compliance with which was a 
                condition to approval of the application, and that 
                there is a lack of adequate information to justify the 
                deviation from such standard.
            ``(2) Appeal.--The holder of an application subject to an 
        order issued under paragraph (1) withdrawing approval of the 
        application may, by petition filed on or before the 30th day 
        after the date upon which such holder receives notice of such 
        withdrawal, obtain review thereof in accordance with subsection 
        (e).
            ``(3) Temporary suspension.--If, after providing an 
        opportunity for an informal hearing, the Secretary determines 
        there is reasonable probability that the continuation of 
        distribution of a tobacco product under an approved application 
        would cause serious, adverse health consequences or death, that 
        is greater than ordinarily caused by tobacco products on the 
        market, the Secretary shall by order temporarily suspend the 
        approval of the application approved under this section. If the 
        Secretary issues such an order, the Secretary shall proceed 
        expeditiously under paragraph (1) to withdraw such application.
    ``(e) Service of Order.--An order issued by the Secretary under 
this section shall be served--
            ``(1) in person by any officer or employee of the 
        department designated by the Secretary; or
            ``(2) by mailing the order by registered mail or certified 
        mail addressed to the applicant at the applicant's last known 
        address in the records of the Secretary.

``SEC. 911. JUDICIAL REVIEW.

    ``(a) Right To Review.--
            ``(1) In general.--Not later than 30 days after--
                    ``(A) the promulgation of a regulation under 
                section 907 establishing, amending, or revoking a 
                performance standard for a tobacco product; or
                    ``(B) a denial of an application for approval under 
                section 910(c),
        any person adversely affected by such regulation or order may 
        file a petition with the United States Court of Appeals for the 
        District of Columbia or for the circuit wherein such person 
        resides or has his or her principal place of business for 
        judicial review of such regulation or order.
            ``(2) Requirements.--
                    ``(A) Copy of petition.--A copy of the petition 
                filed under paragraph (1) shall be transmitted by the 
                clerk of the court to the Secretary or other officer 
                designated by the Secretary for that purpose.
                    ``(B) Record of proceedings.--With respect to an 
                action under paragraph (1), the Secretary shall file in 
                the court the record of the proceedings on which the 
                Secretary based the Secretary's regulation or order and 
                each record or order shall contain a statement of the 
                reasons for its issuance and the basis, on the record, 
                for its issuance.
                    ``(C) Definition.--For purposes of this section, 
                the term `record' means all notices and other matter 
                published in the Federal Register with respect to the 
                regulation or order reviewed, all information submitted 
                to the Secretary with respect to such regulation or 
                order, proceedings of any panel or advisory committee 
                with respect to such regulation or order, any hearing 
                held with respect to such regulation or order, and any 
                other information identified by the Secretary, in the 
                administrative proceeding held with respect to such 
                regulation or order, as being relevant to such 
                regulation or order.
    ``(b) Court May Order Secretary To Make Additional Findings.--
            ``(1) In general.--If the petitioner in an action under 
        subsection (a)(1) applies to the court for leave to adduce 
        additional data, views, or arguments respecting the regulation 
        or order being reviewed and shows to the satisfaction of the 
        court that such additional data, views, or arguments are 
        material and that there were reasonable grounds for the 
        petitioner's failure to adduce such data, views, or arguments 
        in the proceedings before the Secretary, the court may order 
        the Secretary to provide additional opportunity for the oral 
        presentation of data, views, or arguments and for written 
        submissions.
            ``(2) Modification of or additional findings.--The 
        Secretary may modify the Secretary's findings, or make new 
        findings by reason of the additional data, views, or arguments 
        under paragraph (1) and shall file with the court such modified 
        or new findings, and the Secretary's recommendation, if any, 
        for the modification or setting aside of the regulation or 
        order being reviewed, with the return of such additional data, 
        views, or arguments.
    ``(c) 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 in such chapter. A 
regulation or order described in paragraph (1) or (2) of subsection (a) 
shall not be affirmed if it is found to be unsupported by substantial 
evidence on the record taken as a whole.
    ``(d) 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.
    ``(e) 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.
    ``(f) Regulations and Orders Must Recite Basis in Record.--To 
facilitate judicial review under this section or under any other 
provision of law or a regulation or order issued under section 906, 
907, 908, 909, 910, or 914, each such regulation or order shall contain 
a statement of the reasons for its issuance and the basis, in the 
record of the proceedings held in connection with its issuance, for its 
issuance.

``SEC. 912. POSTMARKET SURVEILLANCE.

    ``(a) Discretionary Surveillance.--The Secretary may require a 
tobacco product manufacturer to conduct postmarket surveillance for a 
tobacco product of the manufacturer if the Secretary determines that 
postmarket surveillance of the tobacco product is necessary to protect 
the public health or is necessary to provide information regarding the 
health risks and other safety issues involving the tobacco product.
    ``(b) Surveillance Approval.--Each tobacco product manufacturer 
required to conduct a surveillance of a tobacco product under 
subsection (a) shall, within 30 days after receiving notice that the 
manufacturer is required to conduct such surveillance, submit, for the 
approval of the Secretary, a protocol for the required surveillance. 
The Secretary, within 60 days of the receipt of such protocol, shall 
determine if the principal investigator proposed to be used in the 
surveillance has sufficient qualifications and experience to conduct 
such surveillance and if such protocol will result in collection of 
useful data or other information necessary to protect the public 
health. The Secretary may not approve such a protocol until it has been 
reviewed by an appropriately qualified scientific and technical review 
committee established by the Secretary.

``SEC. 913. REDUCED RISK TOBACCO PRODUCTS.

    ``(a) Requirements.--
            ``(1) In general.--For purposes of this section, the term 
        `reduced risk tobacco product' means a tobacco product 
        designated by the Secretary under paragraph (2).
            ``(2) Designation.--
                    ``(A) In general.--A product may be designated by 
                the Secretary as a reduced risk tobacco product if the 
                Secretary finds that the product will significantly 
                reduce harm to individuals caused by a tobacco product 
                and is otherwise appropriate to protect public health, 
                based on an application submitted by the manufacturer 
                of the product (or other responsible person) that--
                            ``(i) demonstrates through testing on 
                        animals and short-term human testing that use 
                        of such product results in ingestion or 
                        inhalation of a substantially lower yield of 
                        toxic substances than use of conventional 
                        tobacco products in the same category as the 
                        proposed reduced risk product; and
                            ``(ii) if required by the Secretary, 
                        includes studies of the long-term health 
                        effects of the product.
                If such studies are required, the manufacturer may 
                consult with the Secretary regarding protocols for 
                conducting the studies.
                    ``(B) Basis for finding.--In making the finding 
                under subparagraph (A), the Secretary shall take into 
                account--
                            ``(i) the risks and benefits to the 
                        population as a whole, including both users of 
                        tobacco products and non-users of tobacco 
                        products;
                            ``(ii) the increased or decreased 
                        likelihood that existing users of tobacco 
                        products will stop using such products 
                        including reduced risk tobacco products;
                            ``(iii) the increased or decreased 
                        likelihood that those who do not use tobacco 
                        products will start to use such products, 
                        including reduced risk tobacco products; and
                            ``(iv) the risks and benefits to consumers 
                        from the use of a reduced risk tobacco product 
                        as compared to the use of products approved 
                        under chapter V to reduce exposure to tobacco.
            ``(3) Marketing requirements.--A tobacco product may be 
        marketed and labeled as a reduced risk tobacco product if it--
                    ``(A) has been designated as a reduced risk tobacco 
                product by the Secretary under paragraph (2);
                    ``(B) bears a label prescribed by the Secretary 
                concerning the product's contribution to reducing harm 
                to health; and
                    ``(C) complies with requirements prescribed by the 
                Secretary relating to marketing and advertising of the 
                product, and other provisions of this chapter as 
                prescribed by the Secretary.
    ``(b) Revocation of Designation.--At any time after the date on 
which a tobacco product is designated as a reduced risk tobacco product 
under this section the Secretary may, after providing an opportunity 
for an informal hearing, revoke such designation if the Secretary 
determines, based on information not available at the time of the 
designation, that--
            ``(1) the finding made under subsection (a)(2) is no longer 
        valid; or
            ``(2) the product is being marketed in violation of 
        subsection (a)(3).
    ``(c) Limitation.--A tobacco product that is designated as a 
reduced risk tobacco product that is in compliance with subsection (a) 
shall not be regulated as a drug or device.
    ``(d) Development of Reduced Risk Tobacco Product Technology.--A 
tobacco product manufacturer shall provide written notice to the 
Secretary upon the development or acquisition by the manufacturer of 
any technology that would reduce the risk of a tobacco product to the 
health of the user for which the manufacturer is not seeking 
designation as a `reduced risk tobacco product' under subsection (a).

``SEC. 914. EQUAL TREATMENT OF RETAIL OUTLETS.

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

``SEC. 915. JURISDICTION OF AND COORDINATION WITH THE FEDERAL TRADE 
              COMMISSION.

    ``(a) Jurisdiction.--
            ``(1) In general.--Except where expressly provided in this 
        chapter, nothing in this chapter shall be construed as limiting 
        or diminishing the authority of the Federal Trade Commission to 
        enforce the laws under its jurisdiction with respect to the 
        advertising, sale, or distribution of tobacco products.
            ``(2) Enforcement.--Any advertising that violates this 
        chapter or part 897 of title 21, Code of Federal Regulations, 
        is an unfair or deceptive act or practice under section 5(a) of 
        the Federal Trade Commission Act (15 U.S.C. 45(a)) and shall be 
        considered a violation of a rule promulgated under section 18 
        of that Act (15 U.S.C. 57a).
    ``(b) Coordination.--With respect to the requirements of section 4 
of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) 
and section 3 of the Comprehensive Smokeless Tobacco Health Education 
Act of 1986 (15 U.S.C. 4402)--
            ``(1) the Chairman of the Federal Trade Commission shall 
        coordinate with the Secretary concerning the enforcement of 
        such Act as such enforcement relates to unfair or deceptive 
        acts or practices in the advertising of cigarettes or smokeless 
        tobacco; and
            ``(2) the Secretary shall consult with the Chairman of such 
        Commission in revising the label statements and requirements 
        under such sections.

``SEC. 916. CONGRESSIONAL REVIEW PROVISIONS.

    ``In accordance with section 801 of title 5, United States Code, 
the Congress shall review, and may disapprove, any rule under this 
chapter that is subject to section 801. This section does not apply to 
the rule set forth in part 897 of title 21, Code of Federal 
Regulations.

``SEC. 917. REGULATION REQUIREMENT.

    ``(a) Testing, Reporting, and Disclosure.--Not later than 24 months 
after the date of enactment of the Youth Smoking Prevention and Public 
Health Protection Act, the Secretary, acting through the Commissioner 
of the Food and Drug Administration, shall promulgate regulations under 
this Act that meet the requirements of subsection (b).
    ``(b) Contents of Rules.--The regulations promulgated under 
subsection (a) shall require the testing, reporting, and disclosure of 
tobacco product smoke constituents and ingredients that the Secretary 
determines should be disclosed to the public in order to protect the 
public health. Such constituents shall include tar, nicotine, carbon 
monoxide, and such other smoke constituents or ingredients as the 
Secretary may determine to be appropriate. The regulations may require 
that tobacco product manufacturers, packagers, or importers make such 
disclosures relating to tar and nicotine through labels or advertising, 
and make such disclosures regarding other smoke constituents or 
ingredients as the Secretary determines are necessary to protect the 
public health.
    ``(c) Authority.--The Food and Drug Administration shall have the 
authority under this chapter to conduct or to require the testing, 
reporting, or disclosure of tobacco product smoke constituents.

``SEC. 918. PRESERVATION OF STATE AND LOCAL AUTHORITY.

    ``(a) Additional Requirements.--
            ``(1) In general.--Except as provided in paragraph (2), 
        nothing in this chapter, or rules promulgated under this 
        chapter, shall be construed to limit the authority of a Federal 
        agency (including the Armed Forces), a State or political 
        subdivision of a State, or the government of an Indian tribe to 
        enact, adopt, promulgate, and enforce any law, rule, 
        regulation, or other measure with respect to tobacco products, 
        including laws, rules, regulations, or other measures relating 
        to or prohibiting the sale, distribution, possession, exposure 
        to, or use of tobacco products by individuals of any age that 
        are in addition to, or more stringent than, requirements 
        established under this chapter. No provision of this chapter 
        shall limit or otherwise affect any State, Tribal, or local 
        taxation of tobacco products.
            ``(2) Preemption of certain state and local requirements.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), no State or political subdivision of 
                a State may establish or continue in effect with 
                respect to a tobacco product any requirement which is 
                different from, or in addition to, any requirement 
                applicable under the provisions of this chapter 
                relating to performance standards, premarket approval, 
                adulteration, misbranding, registration, reporting, 
                good manufacturing standards, or reduced risk products.
                    ``(B) Exception.--Subparagraph (A) does not apply 
                to requirements relating to the sale, use, or 
                distribution of a tobacco product including 
                requirements related to the access to, and the 
                advertising and promotion of, a tobacco product.
    ``(b) Additional Restrictions on Underage Usage.--Nothing in this 
chapter shall be construed to prevent a Federal agency (including the 
Armed Forces), a State or a political subdivision of a State, or the 
government of an Indian tribe from adopting and enforcing additional 
measures that further restrict or prohibit tobacco product sale to, use 
by, and accessibility to individuals under the legal age of purchase 
established by such agency, State, subdivision, or government of an 
Indian tribe.
    ``(c) No Less Stringent.--Nothing in this chapter is intended to 
supersede any State, local, or Tribal law that is not less stringent 
than this chapter.
    ``(d) Rule of Construction Regarding Product Liability.--No 
provision of this chapter relating to a tobacco product shall be 
construed to modify or otherwise affect any action or the liability of 
any person under the product liability law of any State.
    ``(e) Waivers.--Upon the application of a State or political 
subdivision thereof, the Secretary may, by regulation promulgated after 
notice and an opportunity for an oral hearing, exempt from subsection 
(a), under such conditions as may be prescribed in such regulation, a 
requirement of such State or political subdivision applicable to a 
tobacco product if--
            ``(1) the requirement is more stringent than a requirement 
        applicable under the provisions described in subsection (a)(1) 
        which would be applicable to the tobacco product if an 
        exemption were not in effect under this subsection; or
            ``(2) the requirement--
                    ``(A) is required by compelling local conditions; 
                and
                    ``(B) compliance with the requirement would not 
                cause the tobacco product to be in violation of any 
                applicable requirement of this chapter.''.

SEC. 102. CONSTRUCTION OF CURRENT REGULATIONS.

    (a) In General.--The final regulations promulgated by the Secretary 
of Health and Human Services in the August 28, 1996, issue of the 
Federal Register (62 Fed. Reg. 44615-44618) and codified at part 897 of 
title 21, Code of Federal Regulations, are hereby deemed to be lawful 
and to have been lawfully promulgated by the Secretary under chapter IX 
and section 701 of the Federal Food, Drug, and Cosmetic Act, as amended 
by this Act, and not under chapter V of the Federal Food, Drug, and 
Cosmetic Act. The provisions of such part 897 shall take effect on the 
date of enactment of this Act or upon such later date as determined by 
the Secretary by order. The Secretary shall amend the designation of 
authority in such regulations in accordance with this subsection.
    (b) Limitation on Advisory Opinions.--As of the date of enactment 
of this Act, the following documents issued by the Food and Drug 
Administration shall not constitute advisory opinions under section 
10.85(d)(1) of title 21, Code of Federal Regulations, except as they 
apply to tobacco products, and shall not be cited by the Secretary of 
Health and Human Services or the Food and Drug Administration as 
binding precedent:
            (1) The preamble to the proposed rule in the document 
        entitled ``Regulations Restricting the Sale and Distribution of 
        Cigarettes and Smokeless Tobacco Products to Protect Children 
        and Adolescents'' (60 Fed. Reg. 41314-41372 (August 11, 1995)).
            (2) The document entitled ``Nicotine in Cigarettes and 
        Smokeless Tobacco Products is a Drug and These Products Are 
        Nicotine Delivery Devices Under the Federal Food, Drug, and 
        Cosmetic Act'' (60 Fed. Reg. 41453-41787 (August 11, 1995)).
            (3) The preamble to the final rule in the document entitled 
        ``Regulations Restricting the Sale and Distribution of 
        Cigarettes and Smokeless Tobacco to Protect Children and 
        Adolescents'' (61 Fed. Reg. 44396-44615 (August 28, 1996)).
            (4) The document entitled ``Nicotine in Cigarettes and 
        Smokeless Tobacco is a Drug and These Products are Nicotine 
        Delivery Devices Under the Federal Food, Drug, and Cosmetic 
        Act; Jurisdictional Determination'' (61 Fed. Reg. 44619-45318 
        (August 28, 1996)).

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

    (a) Amendment of Federal Food, Drug, and Cosmetic Act.--Except as 
otherwise expressly provided, whenever in this section an amendment is 
expressed in terms of an amendment to, or repeal of, a section or other 
provision, the reference is to a section or other provision of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
    (b) Section 301.--Section 301 (21 U.S.C. 331) is amended--
            (1) in subsection (a), by inserting ``tobacco product,'' 
        after ``device,'';
            (2) in subsection (b), by inserting ``tobacco product,'' 
        after ``device,'';
            (3) in subsection (c), by inserting ``tobacco product,'' 
        after ``device,'';
            (4) in subsection (e), by striking ``515(f), or 519'' and 
        inserting ``515(f), 519, or 909'';
            (5) in subsection (g), by inserting ``tobacco product,'' 
        after ``device,'';
            (6) in subsection (h), by inserting ``tobacco product,'' 
        after ``device,'';
            (7) in subsection (j), by striking ``708, or 721'' and 
        inserting ``708, 721, 904, 905, 906, 907, 908, or 909'';
            (8) in subsection (k), by inserting ``tobacco product,'' 
        after ``device,'';
            (9) by striking subsection (p) and inserting the following:
    ``(p) The failure to register in accordance with section 510 or 
905, the failure to provide any information required by section 510(j), 
510(k), 905(i), or 905(j), or the failure to provide a notice required 
by section 510(j)(2) or 905(j)(2).'';
            (10) by striking subsection (q)(1) and inserting the 
        following:
    ``(q)(1) The failure or refusal--
            ``(A) to comply with any requirement prescribed under 
        section 518, 520(g), 906(f), or 908;
            ``(B) to furnish any notification or other material or 
        information required by or under section 519, 520(g), 904, 
        906(f), or 909; or
            ``(C) to comply with a requirement under section 522 or 
        912.'';
            (11) in subsection (q)(2), by striking ``device,'' and 
        inserting ``device or tobacco product,'';
            (12) in subsection (r), by inserting ``or tobacco product'' 
        after ``device'' each time that it appears; and
            (13) by adding at the end the following:
            ``(aa) The sale of tobacco products in violation of a no-
        tobacco-sale order issued under section 303(f).''.
    (c) Section 303.--Section 303(f) (21 U.S.C. 333(f)) is amended--
            (1) by striking the subsection heading and inserting the 
        following:
    ``(f) Civil Penalties; No-Tobacco-Sale Orders.--'';
            (2) in paragraph (1)(A), by inserting ``or tobacco 
        products'' after ``devices'';
            (3) by redesignating paragraphs (3), (4), and (5) as 
        paragraphs (4), (5), and (6), and inserting after paragraph (2) 
        the following:
            ``(3) If the Secretary finds that a person has committed 
        repeated violations of restrictions promulgated under section 
        906(d) at a particular retail outlet then the Secretary may 
        impose a no-tobacco-sale order on that person prohibiting the 
        sale of tobacco products in that outlet. A no-tobacco-sale 
        order may be imposed with a civil penalty under paragraph 
        (1).'';
            (4) in paragraph (4) as so redesignated--
                    (A) in subparagraph (A)--
                            (i) by striking ``assessed'' the first time 
                        it appears and inserting ``assessed, or a no-
                        tobacco-sale order may be imposed,''; and
                            (ii) by striking ``penalty'' and inserting 
                        ``penalty, or upon whom a no-tobacco-order is 
                        to be imposed,'';
                    (B) in subparagraph (B)--
                            (i) by inserting after ``penalty,'' the 
                        following: ``or the period to be covered by a 
                        no-tobacco-sale order,''; and
                            (ii) by adding at the end the following: 
                        ``A no-tobacco-sale order permanently 
                        prohibiting an individual retail outlet from 
                        selling tobacco products shall include 
                        provisions that allow the outlet, after a 
                        specified period of time, to request that the 
                        Secretary compromise, modify, or terminate the 
                        order.''; and
                    (C) by adding at the end, the following:
                    ``(D) The Secretary may compromise, modify, or 
                terminate, with or without conditions, any no-tobacco-
                sale order.'';
            (5) in paragraph (5) as so redesignated--
                    (A) by striking ``(3)(A)'' as resdesignated, and 
                inserting ``(4)(A)'';
                    (B) by inserting ``or the imposition of a no-
                tobacco-sale order'' after ``penalty'' the first 2 
                places it appears; and
                    (C) by striking ``issued.'' and inserting ``issued, 
                or on which the no-tobacco-sale order was imposed, as 
                the case may be.''; and
            (6) in paragraph (6), as so redesignated, by striking 
        ``paragraph (4)'' each place it appears and inserting 
        ``paragraph (5)''.
    (d) Section 304.--Section 304 (21 U.S.C. 334) is amended--
            (1) in subsection (a)(2)--
                    (A) by striking ``and'' before ``(D)''; and
                    (B) by striking ``device.'' and inserting the 
                following: ``, (E) Any adulterated or misbranded 
                tobacco product.'';
            (2) in subsection (d)(1), by inserting ``tobacco product,'' 
        after ``device,'';
            (3) in subsection (g)(1), by inserting ``or tobacco 
        product'' after ``device'' each place it appears; and
            (4) in subsection (g)(2)(A), by inserting ``or tobacco 
        product'' after ``device'' each place it appears.
    (e) Section 702.--Section 702(a) (21 U.S.C. 372(a)) is amended--
            (1) by inserting ``(1)'' after ``(a)''; and
            (2) by adding at the end thereof the following:
    ``(2) For a tobacco product, to the extent feasible, the Secretary 
shall contract with the States in accordance with paragraph (1) to 
carry out inspections of retailers in connection with the enforcement 
of this Act.''.
    (f) Section 703.--Section 703 (21 U.S.C. 373) is amended--
            (1) by inserting ``tobacco product,'' after ``device,'' 
        each place it appears; and
            (2) by inserting ``tobacco products,'' after ``devices,'' 
        each place it appears.
    (g) Section 704.--Section 704 (21 U.S.C. 374) is amended--
            (1) in subsection (a)(1)(A), by inserting ``tobacco 
        products,'' after ``devices,'' each place it appears;
            (2) in subsection (a)(1)(B), by inserting ``or tobacco 
        product'' after ``restricted devices'' each place it appears; 
        and
            (3) in subsection (b), by inserting ``tobacco product,'' 
        after ``device,''.
    (h) Section 705.--Section 705(b) (21 U.S.C. 375(b)) is amended by 
inserting ``tobacco products,'' after ``devices,''.
    (i) Section 709.--Section 709 (21 U.S.C. 379) is amended by 
inserting ``or tobacco product'' after ``device''.
    (j) Section 801.--Section 801 (21 U.S.C. 381) is amended--
            (1) in subsection (a)--
                    (A) by inserting ``tobacco products,'' after 
                ``devices,'' the first time it appears;
                    (B) by inserting ``or subsection (j) of section 
                905'' after ``section 510''; and
                    (C) by striking ``drugs or devices'' each time it 
                appears and inserting ``drugs, devices, or tobacco 
                products'';
            (2) in subsection (e)--
                    (A) in paragraph (1), by inserting ``tobacco 
                product,'' after ``device,''; and
                    (B) by redesignating paragraph (4) as paragraph (5) 
                and inserting after paragraph (3), the following:
            ``(4) Paragraph (1) does not apply to any tobacco product--
                    ``(A) which does not comply with an applicable 
                requirement of section 907 or 910; or
                    ``(B) which under section 906(f) is exempt from 
                either such section.
        This paragraph does not apply if the Secretary has determined 
        that the exportation of the tobacco product is not contrary to 
        the public health and safety and has the approval of the 
        country to which it is intended for export or the tobacco 
        product is eligible for export under section 802.''.
    (k) Section 802.--Section 802 (21 U.S.C. 382) is amended--
            (1) in subsection (a), by striking ``device--'' and 
        inserting ``device or tobacco product--'';
            (2) in subsection (a)(1)(C), by striking ``and'' after the 
        semicolon;
            (3) in subsection (a)(2), by striking subparagraph (C) and 
        all that follows in that subsection and inserting the 
        following:
                    ``(C) is a banned device under section 516; or
            ``(3) which, in the case of a tobacco product--
                    ``(A) does not comply with an applicable 
                requirement of section 907 or 910; or
                    ``(B) under section 906(f) is exempt from either 
                such section,
        is adulterated, misbranded, and in violation of such sections 
        or Act unless the export of the drug, device, or tobacco 
        product is, except as provided in subsection (f), authorized 
        under subsection (b), (c), (d), or (e) of this section or 
        section 801(e)(2) or 801(e)(4). If a drug, device, or tobacco 
        product described in paragraph (1), (2), or (3) may be exported 
        under subsection (b) and if an application for such drug or 
        device under section 505, 515, or 910 of this Act or section 
        351 of the Public Health Service Act (42 U.S.C. 262) was 
        disapproved, the Secretary shall notify the appropriate public 
        health official of the country to which such drug, device, or 
        tobacco product will be exported of such disapproval.'';
            (4) in subsection (b)(1)(A), by inserting ``or tobacco 
        product'' after ``device'' each time it appears;
            (5) in subsection (c), by inserting ``or tobacco product'' 
        after ``device'' and inserting ``or section 906(f)'' after 
        ``520(g).'';
            (6) in subsection (f), by inserting ``or tobacco product'' 
        after ``device'' each time it appears; and
            (7) in subsection (g), by inserting ``or tobacco product'' 
        after ``device'' each time it appears.
    (l) Section 1003.--Section 1003(d)(2)(C) (as redesignated by 
section 101(a)) is amended--
            (1) by striking ``and'' after ``cosmetics,''; and
            (2) inserting a comma and ``and tobacco products'' after 
        ``devices''.
    (m) Effective Date for No-Tobacco-Sale Order Amendments.--The 
amendments made by subsection (c), other than the amendment made by 
paragraph (2) of such subsection, shall take effect only upon the 
promulgation of final regulations by the Secretary of Health and Human 
Services--
            (1) defining the term ``repeated violation'', as used in 
        section 303(f) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 333(f)) as amended by subsection (c), by identifying the 
        number of violations of particular requirements over a 
        specified period of time that constitute a repeated violation;
            (2) providing for notice to the retailer of each violation 
        at a particular retail outlet;
            (3) providing that a person may not be charged with a 
        violation at a particular retail outlet unless the Secretary 
        has provided notice to the retailer of all previous violations 
        at that outlet;
            (4) establishing a period of time during which, if there 
        are no violations by a particular retail outlet, that outlet 
        will not considered to have been the site of repeated 
        violations when the next violation occurs; and
            (5) providing that good faith reliance on false 
        identification does not constitute a violation of any minimum 
        age requirement for the sale of tobacco products.

  TITLE II--TOBACCO PRODUCT WARNINGS AND SMOKE CONSTITUENT DISCLOSURE

SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.

    (a) In General.--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, or import for sale or distribution within 
        the United States any cigarettes the package of which fails to 
        bear, in accordance with the requirements of this section, one 
        of the following labels:
        ``WARNING: Cigarettes are addictive''
        ``WARNING: Tobacco smoke can harm your children''
        ``WARNING: Cigarettes cause fatal lung disease''
        ``WARNING: Cigarettes cause cancer''
        ``WARNING: Cigarettes cause strokes and heart disease''
        ``WARNING: Smoking during pregnancy can harm your baby''
        ``WARNING: Smoking can kill you''
        ``WARNING: Tobacco smoke causes fatal lung disease in non-
        smokers''
        ``WARNING: Quitting smoking now greatly reduces serious risks 
        to your health''
            ``(2) Placement; typography; etc.--
                    ``(A) In general.--Each label statement required by 
                paragraph (1) shall be located in the upper portion of 
                the front and rear panels of the package, directly on 
                the package underneath the cellophane or other clear 
                wrapping. Except as provided in subparagraph (B), each 
                label statement shall comprise at least the top 25 
                percent of the front and rear panels of the package. 
                The word ``WARNING'' shall appear in capital letters 
                and all text shall be in conspicuous and legible 17-
                point type, unless the text of the label statement 
                would occupy more than 70 percent of such area, in 
                which case the text may be in a smaller conspicuous and 
                legible type size, provided that at least 60 percent of 
                such area is occupied by required text. The text shall 
                be black on a white background, or white on a black 
                background, in a manner that contrasts, by typography, 
                layout, or color, with all other printed material on 
                the package, in an alternating fashion under the plan 
                submitted under subsection (b)(4).
                    ``(B) Flip-top boxes.--For any cigarette brand 
                package manufactured or distributed before January 1, 
                2000, which employs a flip-top style (if such packaging 
                was used for that brand in commerce prior to June 21, 
                1997), the label statement required by paragraph (1) 
                shall be located on the flip-top area of the package, 
                even if such area is less than 25 percent of the area 
                of the front panel. Except as provided in this 
                paragraph, the provisions of this subsection shall 
                apply to such packages.
            ``(3) Does not apply to foreign distribution.--The 
        provisions of this subsection do not apply to a tobacco product 
        manufacturer or distributor of cigarettes which does not 
        manufacture, package, or import cigarettes for sale or 
        distribution within the United States.
    ``(b) Advertising Requirements.--
            ``(1) In general.--It shall be unlawful for any tobacco 
        product manufacturer, importer, distributor, or retailer of 
        cigarettes to advertise or cause to be advertised within the 
        United States any cigarette unless its advertising bears, in 
        accordance with the requirements of this section, one of the 
        labels specified in subsection (a) of this section.
            ``(2) Typography, etc.--Each label statement required by 
        subsection (a) of this section in cigarette advertising shall 
        comply with the standards set forth in this paragraph. For 
        press and poster advertisements, each such statement and (where 
        applicable) any required statement relating to tar, nicotine, 
        or other constituent yield shall comprise at least 20 percent 
        of the area of the advertisement and shall appear in a 
        conspicuous and prominent format and location at the top of 
        each advertisement within the trim area. The Secretary may 
        revise the required type sizes in such area in such manner as 
        the Secretary determines appropriate. The word ``WARNING'' 
        shall appear in capital letters, and each label statement shall 
        appear in conspicuous and legible type. The text of the label 
        statement shall be black if the background is white and white 
        if the background is black, under the plan submitted under 
        paragraph (4) of this subsection. The label statements shall be 
        enclosed by a rectangular border that is the same color as the 
        letters of the statements and that is the width of the first 
        downstroke of the capital ``W'' of the word ``WARNING'' in the 
        label statements. The text of such label statements shall be in 
        a typeface pro rata to the following requirements: 45-point 
        type for a whole-page broadsheet newspaper advertisement; 39-
        point type for a half-page broadsheet newspaper advertisement; 
        39-point type for a whole-page tabloid newspaper advertisement; 
        27-point type for a half-page tabloid newspaper advertisement; 
        31.5-point type for a double page spread magazine or whole-page 
        magazine advertisement; 22.5-point type for a 28 centimeter by 
        3 column advertisement; and 15-point type for a 20 centimeter 
        by 2 column advertisement. The label statements shall be in 
        English, except that in the case of--
                    ``(A) an advertisement that appears in a newspaper, 
                magazine, periodical, or other publication that is not 
                in English, the statements shall appear in the 
                predominant language of the publication; and
                    ``(B) in the case of any other advertisement that 
                is not in English, the statements shall appear in the 
                same language as that principally used in the 
                advertisement.
            ``(3) Adjustment by secretary.--The Secretary may, through 
        a rulemaking under section 553 of title 5, United States Code, 
        adjust the format and type sizes for the label statements 
        required by this section or the text, format, and type sizes of 
        any required tar, nicotine yield, or other constituent 
        disclosures, or to establish the text, format, and type sizes 
        for any other disclosures required under the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 301 et. seq.). The text of 
        any such label statements or disclosures shall be required to 
        appear only within the  20 percent area of cigarette 
advertisements provided by paragraph (2) of this subsection. The 
Secretary shall promulgate regulations which provide for adjustments in 
the format and type sizes of any text required to appear in such area 
to ensure that the total text required to appear by law will fit within 
such area.
            ``(4) Marketing requirements.--
                    ``(A) The label statements specified in subsection 
                (a)(1) shall be randomly displayed in each 12-month 
                period, in as equal a number of times as is possible on 
                each brand of the product and be randomly distributed 
                in all areas of the United States in which the product 
                is marketed in accordance with a plan submitted by the 
                tobacco product manufacturer, importer, distributor, or 
                retailer and approved by the Secretary.
                    ``(B) The label statements specified in subsection 
                (a)(1) shall be rotated quarterly in alternating 
                sequence in advertisements for each brand of cigarettes 
                in accordance with a plan submitted by the tobacco 
                product manufacturer, importer, distributor, or 
                retailer to, and approved by, the Secretary.
                    ``(C) The Secretary shall review each plan 
                submitted under subparagraph (B) and approve it if the 
                plan--
                            ``(i) will provide for the equal 
                        distribution and display on packaging and the 
                        rotation required in advertising under this 
                        subsection; and
                            ``(ii) assures that all of the labels 
                        required under this section will be displayed 
                        by the tobacco product manufacturer, importer, 
                        distributor, or retailer at the same time.''.
    (b) Repeal of Prohibition on State Restriction.--Section 5 of the 
Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1334) is 
amended--
            (1) by striking ``(a) Additional Statements.--'' in 
        subsection (a); and
            (2) by striking subsection (b).

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

    Section 4 of the Federal Cigarette Labeling and Advertising Act ( 
15 U.S.C. 1333), as amended by section 301 of this title, is further 
amended by adding at the end the following:
    ``(c) Change in Required Statements.--The Secretary may, by a 
rulemaking conducted under section 553 of title 5, United States Code, 
adjust the format, type size, and text of any of the warning label 
statements required by subsection (a) of this section, or establish the 
format, type size, and text of any other disclosures required under the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), if the 
Secretary finds that such a change would promote greater public 
understanding of the risks associated with the use of smokeless tobacco 
products.''.

SEC. 203. SMOKELESS TOBACCO LABELS AND ADVERTISING WARNINGS.

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

``SEC. 3. SMOKELESS TOBACCO WARNING.

    ``(a) General Rule.--
            ``(1) It shall be unlawful for any person to manufacture, 
        package, or import for sale or distribution within the United 
        States any smokeless tobacco product unless the product package 
        bears, in accordance with the requirements of this Act, one of 
        the following labels:
        ``WARNING: This product can cause mouth cancer''
        ``WARNING: This product can cause gum disease and tooth loss''
        ``WARNING: This product is not a safe alternative to 
        cigarettes''
        ``WARNING: Smokeless tobacco is addictive''
            ``(2) Each label statement required by paragraph (1) shall 
        be--
                    ``(A) located on the 2 principal display panels of 
                the package, and each label statement shall comprise at 
                least 25 percent of each such display panel; and
                    ``(B) in 17-point conspicuous and legible type and 
                in black text on a white background, or white text on a 
                black background, in a manner that contrasts by 
                typography, layout, or color, with all other printed 
                material on the package, in an alternating fashion 
                under the plan submitted under subsection (b)(3), 
                except that if the text of a label statement would 
                occupy more than 70 percent of the area specified by 
                subparagraph (A), such text may appear in a smaller 
                type size, so long as at least 60 percent of such 
                warning area is occupied by the label statement.
            ``(3) The label statements required by paragraph (1) shall 
        be introduced by each tobacco product manufacturer, packager, 
        importer, distributor, or retailer of smokeless tobacco 
        products concurrently into the distribution chain of such 
        products.
            ``(4) The provisions of this subsection do not apply to a 
        tobacco product manufacturer or distributor of any smokeless 
        tobacco product that does not manufacture, package, or import 
        smokeless tobacco products for sale or distribution within the 
        United States.
    ``(b) Required Labels.--
            ``(1) It shall be unlawful for any tobacco product 
        manufacturer, packager, importer, distributor, or retailer of 
        smokeless tobacco products to advertise or cause to be 
        advertised within the United States any smokeless tobacco 
        product unless its advertising bears, in accordance with the 
        requirements of this section, one of the labels specified in 
        subsection (a).
            ``(2) Each label statement required by subsection (a) in 
        smokeless tobacco advertising shall comply with the standards 
        set forth in this paragraph. For press and poster 
        advertisements, each such statement and (where applicable) any 
        required  statement relating to tar, nicotine, or other 
constituent yield shall--
                    ``(A) comprise at least 20 percent of the area of 
                the advertisement, and the warning area shall be 
                delineated by a dividing line of contrasting color from 
                the advertisement; and
                    ``(B) the word ``WARNING'' shall appear in capital 
                letters and each label statement shall appear in 
                conspicuous and legible type. The text of the label 
                statement shall be black on a white background, or 
                white on a black background, in an alternating fashion 
                under the plan submitted under paragraph (3).
            ``(3)(A) The label statements specified in subsection 
        (a)(1) shall be randomly displayed in each 12-month period, in 
        as equal a number of times as is possible on each brand of the 
        product and be randomly distributed in all areas of the United 
        States in which the product is marketed in accordance with a 
        plan submitted by the tobacco product manufacturer, importer, 
        distributor, or retailer and approved by the Secretary.
            ``(B) The label statements specified in subsection (a)(1) 
        shall be rotated quarterly in alternating sequence in 
        advertisements for each brand of smokeless tobacco product in 
        accordance with a plan submitted by the tobacco product 
        manufacturer, importer, distributor, or retailer to, and 
        approved by, the Secretary.
            ``(C) The Secretary shall review each plan submitted under 
        subparagraph (B) and approve it if the plan--
                    ``(i) will provide for the equal distribution and 
                display on packaging and the rotation required in 
                advertising under this subsection; and
                    ``(ii) assures that all of the labels required 
                under this section will be displayed by the tobacco 
                product manufacturer, importer, distributor, or 
                retailer at the same time.
    ``(c) Television and Radio Advertising.--It is unlawful to 
advertise smokeless tobacco on any medium of electronic communications 
subject to the jurisdiction of the Federal Communications 
Commission.''.

SEC. 204. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT WARNING LABEL 
              STATEMENTS.

    Section 3 of, as amended by section 303 of this title, is further 
amended by adding at the end the following:
    ``(d) Authority To Revise Warning Label Statements.--The Secretary 
may, by a rulemaking conducted under section 553 of title 5, United 
States Code, adjust the format, type size, and text of any of the 
warning label statements required by subsection (a) of this section, or 
establish the format, type size, and text of any other disclosures 
required under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.), if the Secretary finds that such a change would promote 
greater public understanding of the risks associated with the use of 
smokeless tobacco products.''.

SEC. 205. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT DISCLOSURE TO THE 
              PUBLIC.

    Section 4(a) of the Federal Cigarette Labeling and Advertising Act 
(15 U.S.C. 1333 (a)), as amended by section 301 of this title, is 
further amended by adding at the end the following:
            ``(4)(A) The Secretary shall, by a rulemaking conducted 
        under section 553 of title 5, United States Code, determine (in 
        the Secretary's sole discretion) whether cigarette and other 
        tobacco product manufacturers shall be required to include in 
        the area of each cigarette advertisement specified by 
        subsection (b) of this section, or on the package label, or 
        both, the tar and nicotine yields of the advertised or packaged 
        brand. Any such disclosure shall be in accordance with the 
        methodology established under such regulations, shall conform 
        to the type size requirements of subsection (b) of this 
        section, and shall appear within the area specified in 
        subsection (b) of this section.
            ``(B) Any differences between the requirements established 
        by the Secretary under subparagraph (A) and tar and nicotine 
        yield reporting requirements established by the Federal Trade 
        Commission shall be resolved by a memorandum of understanding 
        between the Secretary and the Federal Trade Commission.
            ``(C) In addition to the disclosures required by 
        subparagraph (A) of this paragraph, the Secretary may, under a 
        rulemaking conducted under section 553 of title 5, United 
        States Code, prescribe disclosure requirements regarding the 
        level of any cigarette or other tobacco product smoke 
        constituent. Any such disclosure may be required if the 
        Secretary determines that disclosure would be of benefit to the 
        public health, or otherwise would increase consumer awareness 
        of the health consequences of the use of tobacco products, 
        except that no such prescribed disclosure shall be required on 
        the face of any cigarette package or advertisement. Nothing in 
        this section shall prohibit the Secretary from requiring such 
        prescribed disclosure through a cigarette or other tobacco 
        product package or advertisement insert, or by any other means 
        under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
        et seq.).''.
                                 <all>