[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 190 Introduced in Senate (IS)]







107th CONGRESS
  1st Session
                                 S. 190

    To amend the Federal Food, Drug, and Cosmetic Act to grant the 
   Secretary of Health and Human Services the authority to regulate 
               tobacco products, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            January 25, 2001

   Mr. Frist introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
    To amend the Federal Food, Drug, and Cosmetic Act to grant the 
   Secretary of Health and Human Services the authority to regulate 
               tobacco products, and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``National Youth Smoking Reduction 
Act''.

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 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 addictive.
            (4) Virtually all new users of tobacco products are under 
        the minimum legal age to purchase such products.
            (5) Tobacco advertising and marketing contribute 
        significantly to the use of nicotine-containing tobacco 
        products by adolescents.
            (6) Because past efforts to restrict advertising and 
        marketing of tobacco products have failed adequately to curb 
        tobacco use by adolescents, comprehensive restrictions on the 
        sale, promotion, and distribution of such products are needed.
            (7) Federal and State governments have lacked the legal and 
        regulatory authority and resources they need to address 
        comprehensively the public health and societal problems caused 
        by the use of tobacco products.
            (8) Federal and State public health officials, the public 
        health community, and the public at large recognize that the 
        tobacco industry should be subject to ongoing oversight.
            (9) Under article I, section 8 of the Constitution, the 
        Congress is vested with the responsibility for regulating 
        interstate commerce and commerce with Indian tribes.
            (10) The sale, distribution, marketing, advertising, and 
        use of tobacco products are activities in and substantially 
        affecting interstate commerce because they are sold, marketed, 
        advertised, and distributed in interstate commerce on a 
        nationwide basis, and have a substantial effect on the Nation's 
        economy.
            (11) The sale, distribution, marketing, advertising, and 
        use of such products substantially affect interstate commerce 
        through the health care and other costs attributable to the use 
        of tobacco products.
            (12) It is in the public interest for Congress to adopt 
        comprehensive public health legislation because of tobacco's 
        unique position in the Nation's history and economy and the 
        need to prevent the sale, distribution, marketing and 
        advertising of tobacco products to persons under the minimum 
        legal age to purchase such products.
            (13) The public interest requires a timely, fair, 
        equitable, and consistent result that will serve the public 
        interest by restricting throughout the Nation the sale, 
        distribution, marketing, and advertising of tobacco products 
        only to persons of legal age to purchase such 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 billion 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) Tobacco advertising increases the size of the tobacco 
        market by increasing consumption of tobacco products including 
        increasing tobacco use by young people.
            (18) Children are more influenced by tobacco advertising 
        than adults and they smoke the most advertised brands.
            (19) Tobacco company documents indicate that young people 
        are an important and often crucial segment of the tobacco 
        market.
            (20) Advertising restrictions will have a positive effect 
        on the smoking rates of young people.
            (21) Restrictions on advertising are necessary to prevent 
        unrestricted tobacco advertising from undermining legislation 
        prohibiting access to young people.
            (22) It is in the public interest for Congress to adopt 
        legislation to address the public health crisis created by 
        actions of the tobacco industry.

SEC. 3. DEFINITIONS.

    In this Act:
            (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) Constituent.--The term ``constituent'' in relation to 
        cigarettes means any element of mainstream or sidestream smoke.
            (6) 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 Act.
            (7) Ingredient.--The term ``ingredient'' in relation to 
        cigarettes or smokeless tobacco products means any substance, 
        chemical, or compound (other than tobacco, water, or 
        reconstituted tobacco sheet made wholly from tobacco) added, or 
        specified for addition, by the manufacturer to the tobacco, 
        paper, or filter of a cigarette, or to the tobacco of a 
        smokeless tobacco product, including flavorants, processing 
        aids, casing sauces, preservatives, and combustion modifiers.
            (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) Secretary.--Except where the context otherwise 
        requires, the term ``Secretary'' means the Secretary of Health 
        and Human Services.
            (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.

SEC. 4. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT OF 1938.

    (a) Definition.--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).
            ``(ll) The definitions contained in section 3 of the 
        National Youth Smoking Reduction Act shall apply with respect 
        to chapter IX.''.
    (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. 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), unless the product is a 
        reduced risk product pursuant to section 912.
    ``(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) Nothing in this chapter 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 of 
        the Federal Food, Drug and Cosmetic Act or any other chapter of 
        that Act.
            ``(2) 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 whatsoever to enter onto a farm owned by a producer 
        of tobacco leaf without the written consent of such producer. 
        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. 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 more 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 more injurious 
        to health;
            ``(3) its container is composed, in whole or in part, of 
        any poisonous or deleterious substance which may render the 
        contents more 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) of this paragraph 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) of this 
                subsection, 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; or
                    ``(B) to furnish any material or information 
                required by or under section 909.
    ``(b) Prior Approval of Statements on Label.--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 and 
no advertisement of a tobacco product, published after the date of 
enactment of this Act shall, with respect to the matters specified in 
this section or covered by regulations issued hereunder, be subject to 
the provisions of sections 12 through 15 of the Federal Trade 
Commission Act (15 U.S.C. 52 through 55). This subsection does not 
apply to any printed matter which the Secretary determines to be 
labeling as defined in section 201(m).

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

    ``(a) Requirement.--Not later than 6 months after the date of 
enactment of this 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 this chapter, 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.--As used in this section--
            ``(1) consistent with the provisions of section 901(c)(2), 
        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; and
            ``(2) 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) of this section 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) of this section 
        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) of this subsection. 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.--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 the date of enactment of this Act, 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)--
            ``(1) 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 the 
        date of this Act's enactment, that is in compliance with the 
        requirements of this Act; and
            ``(2) action taken by such person to comply with the 
        requirements under section 907 that are applicable to the 
        tobacco product.

``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 thereof) 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 therefor.
    ``(c) Limited Confidentiality of Information.--Any information 
reported to or otherwise obtained by the Secretary or the Secretary's 
representative under section 904, 905, 907, 908, 909, 910, 912, 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) The Secretary may by regulation require that a 
        tobacco product be restricted to sale or distribution 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 the Secretary 
        determines that such regulation would be appropriate for the 
        prevention of, or decrease in, the use of tobacco products by 
        children under the age at which tobacco products may be legally 
        purchased. 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) 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) 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) 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 for an agricultural product, 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) 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) 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) 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) 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) 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) 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.
    ``(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 of nicotine yields 
                        of the product;
                            ``(ii) for the reduction or elimination of 
                        other harmful 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; and
                            ``(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
                    ``(C) shall not render the tobacco product 
                unacceptable for adult consumption.
            ``(3) Periodic reevaluation 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) 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) 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) 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) 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) The Secretary shall provide for a comment 
                period of not less than 60 days.
            ``(2) Promulgation.--
                    ``(A) 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) 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) Power reserved to congress.--Because of the 
        importance of any decision 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,
        Congress expressly reserves to itself the power to make such a 
        decision.
            ``(4) Amendment; revocation.--
                    ``(A) 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) of this 
                subsection, amend or revoke a performance standard.
                    ``(B) 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 subparagraph 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 a risk of substantial harm to the public 
        health exceeding the risks posed by tobacco products marketed 
        before the date of enactment of this Act; 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.
    ``(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) 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) 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) of 
this subsection 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) Except as provided in paragraph (3), 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) 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) of this section.

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

    ``(a) In General.--
            ``(1) Premarket approval required.--Approval under this 
        section of an application for premarket approval for any 
        tobacco product, other than a reduced risk product under 
        section 912, that is not commercially marketed (other than for 
        test marketing) in the United States as of the date of this 
        Act's enactment, is required unless the manufacturer has 
        submitted a report under section 905(j), and the Secretary has 
        issued an order within 90 days under  section 905(j) that the 
tobacco product is substantially equivalent to a tobacco product 
commercially marketed (other than for test marketing) in the United 
States as of the date of this Act's enactment, that is in compliance 
with the requirements of this Act.
            ``(2) Substantially equivalent defined.--
                    ``(A) For purposes of this section and section 
                905(j), the term `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) For purposes of subparagraph (A), the term 
                `characteristics' means the materials, ingredients, 
                design, composition, heating source, or other features 
                of a tobacco product.
                    ``(C) 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) 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) 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. The communication that such product is a reduced risk product 
may comply with requirements prescribed by the Secretary relating to 
such communication, and the Secretary may require prior approval of the 
communication.
    ``(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) As promptly as possible, but in no event 
                later than 180 days after the receipt of an application 
                under subsection (b) of this section, 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) 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 pose no 
                greater risk to the public health than currently 
                marketed tobacco products;
                    ``(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) 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) 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 poses greater risks to the public health than 
                other available products;
                    ``(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 thirtieth 
        day after the date upon which he receives notice of such 
        withdrawal, obtain review thereof in accordance with subsection 
        (e) of this section.
            ``(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) In General.--Not later than 30 days after--
            ``(1) the promulgation of a regulation under section 907 
        establishing, amending, or revoking a performance standard for 
        a tobacco product; or
            ``(2) 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 
principal place of business for judicial review of such regulation or 
order. A copy of the petition shall be transmitted by the clerk of the 
court to the Secretary or other officer designated by the Secretary for 
that purpose. 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. 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.--If 
the petitioner 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. 
The Secretary may modify the Secretary's findings, or make new findings 
by reason of the additional data, views, or arguments so taken 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) of this section 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) of this section 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 of a regulation or order issued under section 906, 
907, 908, 909, 910, or 913, 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. 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, although in no event shall 
such requirements prohibit the communication that such product is a 
reduced risk product. The communication that such product is a reduced 
risk product may comply with requirements prescribed by the Secretary 
relating to such communication, and the Secretary may require prior 
approval of the communication.
    ``(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).
    ``(e) Postmarket Surveillance.--
            ``(1) Discretionary surveillance.--The Secretary may 
        require a tobacco product manufacturer to conduct postmarket 
        surveillance for reduced risk 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.
            ``(2) Surveillance approval.--Each tobacco product 
        manufacturer required to conduct a surveillance of a reduced 
        risk tobacco product under paragraph (1) 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. PRESERVATION OF STATE AND LOCAL AUTHORITY.

    ``(a) Additional Requirements.--
            ``(1) In general.--Except as provided in paragraph (2), 
        nothing in this Act shall be construed as prohibiting a State 
        or political subdivision thereof from adopting or enforcing a 
        requirement applicable to a tobacco product that is in addition 
        to, or more stringent than, requirements established under this 
        chapter.
            ``(2) Preemption of certain state and local requirements.--
                    ``(A) 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, labeling, good manufacturing standards, 
                or reduced risk products.
                    ``(B) 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) Rule of Construction Regarding Product Liability.--No 
provision of this chapter relating to a tobacco product shall be 
construed to modify or otherwise affect any action or the liability of 
any person under the product liability law of any State.

``SEC. 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. 5. REGULATORY RECORD.

    Notwithstanding the provisions of subchapter II of chapter 5 of 
title 5, United States Code, in promulgating regulations under this 
chapter, the record developed and utilized by the Secretary for the 
purposes of promulgating subparts (B) and (D) of the regulations 
relating to the sale, distribution, and use of tobacco products on or 
about August 28, 1996, as reflected in articles IV and VI of the 
preamble to the 1996 Food and Drug Administration Tobacco Rule 
(including public comments, Food and Drug Administration documents, and 
any other information generated or compiled for purposes of 
promulgating such regulations), shall be deemed to have the same legal 
status as if such record had been developed under a rulemaking 
proceeding conducted pursuant to section 906(d)(1). In all other 
respects, including with respect to the issue of whether such 
regulations conform to section 906(d)(1), the procedural requirements 
of this chapter and the Administration Procedure Act will apply.

SEC. 6. 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, 903, 904, 905, 906, 907, 908, 909, 910, 
        or 912'';
            (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) in subsection (q), by striking paragraph (1) and 
        inserting the following:
    ``(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.'';
            (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), respectively;
            (4) by 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).'';
            (5) in subparagraph (A) of paragraph (4), as so 
        redesignated--
                    (A) by striking ``assessed'' the first time it 
                appears and inserting ``assessed, or a no-tobacco-sale 
                order may be imposed,''; and
                    (B) by striking ``penalty'' and inserting 
                ``penalty, or upon whom a no-tobacco-order is to be 
                imposed,'';
            (6) in subparagraph (B) of paragraph (4), as so 
        redesignated--
                    (A) by inserting after ``penalty,'' the following: 
                ``or the period to be covered by a no-tobacco-sale 
                order,''; and
                    (B) 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.'';
            (7) by adding at the end of paragraph (4), as so 
        redesignated, the following:
                    ``(D) The Secretary may compromise, modify, or 
                terminate, with or without conditions, any no-tobacco-
                sale order.'';
            (8) in paragraph (5), as so redesignated--
                    (A) by striking ``(3)(A)'' and inserting 
                ``(4)(A)'';
                    (B) by inserting ``or the imposition of a no-
                tobacco-sale order'' after ``penalty'' the first 2 
                places it appears;
                    (C) by striking ``issued.'' and inserting ``issued, 
                or on which the no-tobacco-sale order was imposed, as 
                the case may be.''; and
            (9) 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), by striking ``and'' before 
        ``(D)'';
            (2) in subsection (a)(2), by striking ``device.'' and 
        inserting a comma and the following:
                    ``(E) Any adulterated or misbranded tobacco 
                product.'';
            (3) in subsection (d)(1), by inserting ``tobacco product,'' 
        after ``device,'';
            (4) in subsection (g)(1), by inserting ``or tobacco 
        product'' after ``device'' each place it appears; and
            (5) 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 
        products'' 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), by inserting ``tobacco products,'' 
        after ``devices,'' the first time it appears;
            (2) in subsection (a), by inserting ``or subsection (j) of 
        section 905'' after ``section 510''; and
            (3) in subsection (a), by striking ``drugs or devices'' 
        each time it appears and inserting ``drugs, devices, or tobacco 
        products''.
    (k) 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''.
    (l) Effective Date for No-Tobacco-Sale Order Amendments.--The 
amendments made by subsection (c), other than the amendment made by 
paragraph (2) thereof, shall take effect only upon the promulgation of 
final regulations by the Secretary--
            (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 
        repeated violations at a particular retail outlet unless the 
        Secretary has provided notice of 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.

SEC. 7. CIGARETTE LABEL AND ADVERTISING WARNINGS.

    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.''.

SEC. 8. 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 4, 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 subject to the 
limitation on proportional size of the warning contained in subsections 
(a)(2) and (b)(2), 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. 9. 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. 10. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT WARNING LABEL 
              STATEMENTS.

    Section 3 of the Comprehensive Smokeless Tobacco Health Education 
Act of 1986 (15 U.S.C. 4402), as amended by section 6, 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, 
subject to the limitations on proportional size of the warning 
contained in paragraphs (2) and (3) of subsection (a), 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. 11. 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 4, 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.).''.

SEC. 12. REGULATION REQUIREMENT.

    (a) Testing, Reporting, and Disclosure.--Not later than 24 months 
after the date of enactment of this Act, the Secretary, through the 
Commissioner of the Food and Drug Administration, shall promulgate 
regulations under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.) that meet the requirements of subsection (b) of this 
section.
    (b) Contents of Rules.--The rules 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 rule 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 
authority to conduct or to require the testing, reporting, or 
disclosure of tobacco product smoke constituents.

SEC. 13. FTC JURISDICTION NOT AFFECTED.

    (a) In General.--Except where expressly provided in this Act, 
nothing in this Act shall be construed as limiting or diminishing the 
authority of the Federal Trade Commission to enforce the laws under its 
jurisdiction with respect to the advertising, sale, or distribution of 
tobacco products.
    (b) Enforcement by FTC.--Any advertising that violates this Act 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).
                                 <all>