[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 2764 Introduced in Senate (IS)]







107th CONGRESS
  2d Session
                                S. 2764

To eliminate the Federal quota and price support programs for tobacco, 
   to compensate quota holders and active producers for the loss of 
 tobacco quota asset value, to establish a permanent advisory board to 
  determine and describe the physical characteristics of domestic and 
               imported tobacco, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 19, 2002

  Mr. Miller introduced the following bill; which was read twice and 
                  referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
To eliminate the Federal quota and price support programs for tobacco, 
   to compensate quota holders and active producers for the loss of 
 tobacco quota asset value, to establish a permanent advisory board to 
  determine and describe the physical characteristics of domestic and 
               imported tobacco, and for other purposes.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Tobacco Livelihood 
and Economic Assistance for Our Farmers Act of 2002''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
            TITLE I--TERMINATION OF CURRENT TOBACCO PROGRAMS

Sec. 101. Termination of tobacco production adjustment programs.
Sec. 102. Termination of tobacco price support program.
Sec. 103. Geographical restrictions on expansion of tobacco production.
Sec. 104. Continued availability of Federal crop insurance.
       TITLE II--PAYMENTS TO TOBACCO QUOTA HOLDERS AND PRODUCERS

Sec. 201. Definitions.
Sec. 202. Payments to tobacco quota holders.
Sec. 203. Transition payments for active producers of quota tobacco.
                    TITLE III--TOBACCO QUALITY BOARD

Sec. 301. Definitions.
Sec. 302. Establishment of Board.
Sec. 303. Duties.
Sec. 304. Administration.
     TITLE IV--TOBACCO PRODUCT MANUFACTURER AND IMPORTER USER FEES

Sec. 401. User fee.
Sec. 402. Allocation of user fees.
              TITLE V--FDA REGULATION OF TOBACCO PRODUCTS

Sec. 501. Findings.
           Subtitle A--FDA Jurisdiction Over Tobacco Products

Sec. 511. Definition of tobacco product.
Sec. 512. Tobacco products.
Sec. 513. Conforming and technical amendments.
             Subtitle B--Cigarette Labeling and Advertising

Sec. 521. Definition of cigarette.
Sec. 522. Cigarette label and advertising warnings.
     Subtitle C--Smokeless Tobacco Labels and Advertising Warnings

Sec. 531. Smokeless tobacco labels and advertising warnings.
                       Subtitle D--Administration

Sec. 541. FTC jurisdiction not affected.

            TITLE I--TERMINATION OF CURRENT TOBACCO PROGRAMS

SEC. 101. TERMINATION OF TOBACCO PRODUCTION ADJUSTMENT PROGRAMS.

    (a) Tobacco Control.--The Act of April 25, 1936 (commonly known as 
the Tobacco Control Act; 7 U.S.C. 515 et seq.), is repealed.
    (b) Commodity Handling Orders.--Section 8c(2)(A) of the 
Agricultural Adjustment Act (7 U.S.C. 608c(2)(A)), reenacted with 
amendments by the Agricultural Marketing Agreement Act of 1937, is 
amended by striking ``tobacco,''.
    (c) Processing Tax.--Section 9(b) of the Agricultural Adjustment 
Act (7 U.S.C. 609(b)), reenacted with amendments by the Agricultural 
Marketing Agreement Act of 1937, is amended--
            (1) in paragraph (2), by striking ``tobacco,''; and
            (2) in paragraph (6)(B)(i), by striking ``, or, in the case 
        of tobacco, is less than the fair exchange value by not more 
        than 10 per centum,''.
    (d) Burley Tobacco Import Review.--Section 3 of Public Law 98-59 (7 
U.S.C. 625) is repealed.
    (e) Declaration of Policy.--Section 2 of the Agricultural 
Adjustment Act of 1938 (7 U.S.C. 1282) is amended by striking 
``tobacco,''.
    (f) Definitions.--Section 301(b) of the Agricultural Adjustment Act 
of 1938 (7 U.S.C. 1301(b)) is amended--
            (1) in paragraph (3)--
                    (A) by striking subparagraph (C); and
                    (B) by redesignating subparagraph (D) as 
                subparagraph (C);
            (2) in paragraph (6)(A), by striking ``tobacco,'';
            (3) in paragraph (7), by striking the following:
                    ``Tobacco (Flue-cured), July 1-June 30;
                    ``Tobacco (other than Flue-cured), October 1-
                September 30;'';
            (4) in paragraph (10)--
                    (A) by striking subparagraph (B); and
                    (B) by redesignating subparagraph (C) as 
                subparagraph (B);
            (5) in paragraph (11)(B), by striking ``and tobacco'';
            (6) in paragraph (12), by striking ``tobacco,'';
            (7) in paragraph (14)--
                    (A) in subparagraph (A), by striking ``(A)''; and
                    (B) by striking subparagraphs (B), (C), and (D);
            (8) by striking paragraph (15);
            (9) in paragraph (16)--
                    (A) by striking subparagraph (B); and
                    (B) by redesignating subparagraph (C) as 
                subparagraph (B);
            (10) by striking paragraph (17); and
            (11) by redesignating paragraph (16) as paragraph (15).
    (g) Parity Payments.--Section 303 of the Agricultural Adjustment 
Act of 1938 (7 U.S.C. 1303) is amended in the first sentence by 
striking ``rice, or tobacco,'' and inserting ``or rice,''.
    (h) Marketing Quotas.--Part I of subtitle B of title III of the 
Agricultural Adjustment Act of 1938 (7 U.S.C. 1311 et seq.) is 
repealed.
    (i) Administrative Provisions.--Section 361 of the Agricultural 
Adjustment Act of 1938 (7 U.S.C. 1361) is amended by striking 
``tobacco,''.
    (j) Adjustment of Quotas.--Section 371 of the Agricultural 
Adjustment Act of 1938 (7 U.S.C. 1371) is amended--
            (1) in the first sentence of subsection (a), by striking 
        ``rice, or tobacco'' and inserting ``or rice''; and
            (2) in the first sentence of subsection (b), by striking 
        ``rice, or tobacco'' and inserting ``or rice''.
    (k) Reports and Records.--Section 373 of the Agricultural 
Adjustment Act of 1938 (7 U.S.C. 1373) is amended--
            (1) by striking ``rice, or tobacco'' each place it appears 
        in subsections (a) and (b) and inserting ``or rice''; and
            (2) in subsection (a)--
                    (A) in the first sentence, by striking ``all 
                persons engaged in the business of redrying, prizing, 
                or stemming tobacco for producers,''; and
                    (B) in the last sentence, by striking ``$500;'' and 
                all that follows through the period at the end of the 
                sentence and inserting ``$500.''.
    (l) Regulations.--Section 375(a) of the Agricultural Adjustment Act 
of 1938 (7 U.S.C. 1375(a)) is amended by striking ``peanuts, or 
tobacco'' and inserting ``or peanuts''.
    (m) Eminent Domain.--Section 378 of the Agricultural Adjustment Act 
of 1938 (7 U.S.C. 1378) is amended--
            (1) in the first sentence of subsection (c), by striking 
        ``cotton, and tobacco'' and inserting ``and cotton''; and
            (2) by striking subsections (d), (e), and (f).
    (n) Burley Tobacco Farm Reconstitution.--Section 379 of the 
Agricultural Adjustment Act of 1938 (7 U.S.C. 1379) is amended--
            (1) in subsection (a)--
                    (A) by striking ``(a)''; and
                    (B) in paragraph (6), by striking ``, but this 
                clause (6) shall not be applicable in the case of 
                burley tobacco''; and
            (2) by striking subsections (b) and (c).
    (o) Acreage-Poundage Quotas.--Section 4 of the Act of April 16, 
1955 (Public Law 89-12; 7 U.S.C. 1314c note), is repealed.
    (p) Burley Tobacco Acreage Allotments.--The Act of July 12, 1952 (7 
U.S.C. 1315), is repealed.
    (q) Transfer of Allotments.--Section 703 of the Food and 
Agriculture Act of 1965 (7 U.S.C. 1316) is repealed.
    (r) Advance Recourse Loans.--Section 13(a)(2)(B) of the Food 
Security Improvements Act of 1986 (7 U.S.C. 1433c-1(a)(2)(B)) is 
amended by striking ``tobacco and''.
    (s) Tobacco Field Measurement.--Section 1112 of the Omnibus Budget 
Reconciliation Act of 1987 (Public Law 100-203) is amended by striking 
subsection (c).
    (t) Liability.--The amendments made by this section shall not 
affect the liability of any person under any provision of law as in 
effect before the effective date under subsection (u).
    (u) Crops.--This section and the amendments made by this section 
shall apply with respect to the 2003 and subsequent crops of the kind 
of tobacco involved.

SEC. 102. TERMINATION OF TOBACCO PRICE SUPPORT PROGRAM.

    (a) Parity Price Support.--Section 101 of the Agricultural Act of 
1949 (7 U.S.C. 1441) is amended--
            (1) in the first sentence of subsection (a), by striking 
        ``tobacco (except as otherwise provided herein), corn,'' and 
        inserting ``corn'';
            (2) by striking subsections (c), (g), (h), and (i);
            (3) in subsection (d)(3)--
                    (A) by striking ``, except tobacco,''; and
                    (B) by striking ``and no price support shall be 
                made available for any crop of tobacco for which 
                marketing quotas have been disapproved by producers;''; 
                and
            (4) by redesignating subsections (d) and (e) as subsections 
        (c) and (d), respectively.
    (b) Termination of Tobacco Price Support and No Net Cost 
Provisions.--Sections 106, 106A, and 106B of the Agricultural Act of 
1949 (7 U.S.C. 1445, 1445-1, 1445-2) are repealed.
    (c) Definition of Basic Agricultural Commodity.--Section 408(c) of 
the Agricultural Act of 1949 (7 U.S.C. 1428(c)) is amended by striking 
``tobacco,''.
    (d) Review of Burley Tobacco Imports.--Section 3 of Public Law 98-
59 (7 U.S.C. 625) is repealed.
    (e) Powers of Commodity Credit Corporation.--Section 5 of the 
Commodity Credit Corporation Charter Act (15 U.S.C. 714c) is amended by 
inserting ``(other than tobacco)'' after ``agricultural commodities'' 
each place it appears.
    (f) Transition Provisions.--
            (1) Liability.--The amendments made by this section shall 
        not affect the liability of any person under any provision of 
        law as in effect before the date of enactment of this Act.
            (2) Tobacco stocks and loans.--The Secretary of Agriculture 
        shall promulgate regulations that require--
                    (A) the orderly disposition of quota tobacco held 
                by any producer-owned cooperative marketing association 
                that has entered into a loan agreement with the 
                Commodity Credit Corporation to make price support 
                available to producers of quota tobacco; and
                    (B) the repayment of all tobacco price support 
                loans or surrender of collateral by the associations 
                not later than 1 year after the date of enactment of 
                this Act.
            (3) Special rules for termination of no net cost funds and 
        accounts.--Notwithstanding any other provision of law, on the 
        repeal by subsection (b) of the authority under section 106A 
        and 106B of the Agricultural Act of 1949 (7 U.S.C. 1445-1, 
        1445-2) for the establishment of the No Net Cost Tobacco Funds 
        and Accounts, respectively--
                    (A) any obligation of a tobacco producer, 
                purchaser, or importer to make payments into the Fund 
                or Account shall terminate; and
                    (B) any amounts in the Fund or Account shall be 
                disposed of in the manner prescribed by the Secretary 
                of Agriculture, except that--
                            (i) to the extent necessary, the amounts 
                        shall be applied or used for the purposes 
                        prescribed by that section; and
                            (ii) if any funds remain, the Secretary 
                        shall transfer the funds to the Secretary of 
                        Health and Human Services for use in accordance 
                        with section 402.
    (g) Crops.--This section and the amendments made by this section 
shall apply with respect to the 2003 and subsequent crops of the kind 
of tobacco involved.

SEC. 103. GEOGRAPHICAL RESTRICTIONS ON EXPANSION OF TOBACCO PRODUCTION.

    (a) Purposes.--The purposes of this section are--
            (1) to provide an orderly economic transition from the 
        marketing of tobacco based on quotas and price support; and
            (2) to address the economic dislocation, and the resulting 
        impact on interstate commerce, that the termination of the 
        tobacco program might cause for producers of certain 
        agricultural communities.
    (b) Definitions.--In this section:
            (1) Marketing quota.--The term ``marketing quota in the 
        2002 marketing year'' means a quota established for the 2002 
        marketing year pursuant to part I of subtitle B of title III of 
        the Agricultural Adjustment Act of 1938 (7 U.S.C. 1311 et seq.) 
        (as in effect before the amendment made by section 101(h)) and 
        related provisions of law, as in effect for that marketing 
        year.
            (2) Marketing year.--The term ``marketing year'' means--
                    (A) in the case of Flue-cured tobacco, July 1 
                through June 30; and
                    (B) in the case of each other kind of tobacco, 
                October 1 through September 30.
    (c) Penalty Applicable to Tobacco Grown in Nonquota Counties and 
States.--The marketing in the 2003 or subsequent marketing years of a 
kind of tobacco that was subject to a marketing quota in the 2002 
marketing year shall be subject to a penalty equal to 100 percent of 
the total amount received for the marketing of the tobacco, unless the 
Secretary of Agriculture determines that the tobacco was grown in a 
county in which the kind of tobacco was grown pursuant to a marketing 
quota in the 2002 marketing year.

SEC. 104. CONTINUED AVAILABILITY OF FEDERAL CROP INSURANCE.

    Nothing in this title affects the eligibility of a tobacco producer 
to obtain crop insurance for a crop of the producer under the Federal 
Crop Insurance Act (7 U.S.C. 1501 et seq.).

       TITLE II--PAYMENTS TO TOBACCO QUOTA HOLDERS AND PRODUCERS

SEC. 201. DEFINITIONS.

    In this title:
            (1) Active producer of quota tobacco.--The term ``active 
        producer of quota tobacco'' means a person that was the actual 
        producer of tobacco marketed under a marketing quota for the 
        2001 tobacco marketing year, as determined by the Secretary.
            (2) Quota tobacco.--The term ``quota tobacco'' means a kind 
        of tobacco that is subject to a farm marketing quota or farm 
        acreage allotment for the 1999, 2000, 2001, and 2002 tobacco 
        marketing years under a marketing quota or allotment program 
        established under part I of subtitle B of title III of the 
        Agricultural Adjustment Act of 1938 (7 U.S.C. 1281 et seq.) (as 
        in effect before the amendment made by section 101(h)).
            (3) Secretary.--The term ``Secretary'' means the Secretary 
        of Agriculture.
            (4) Tobacco quota holder.--The term ``tobacco quota 
        holder'' means an owner of a farm on January 1, 2002, for which 
        a tobacco farm marketing quota or farm acreage allotment for 
        quota tobacco was established with respect to the 2002 tobacco 
        marketing year under a marketing quota program established 
        under part I of subtitle B of title III of the Agricultural 
        Adjustment Act of 1938 (7 U.S.C. 1281 et seq.) (as in effect 
        before the amendment made by section 101(h)).

SEC. 202. PAYMENTS TO TOBACCO QUOTA HOLDERS.

    (a) Payment Required.--The Secretary shall make payments to each 
eligible tobacco quota holder for the termination of tobacco marketing 
quotas and related price support under the amendments made by title I, 
which shall constitute full and fair compensation for any losses 
relating to the termination of the quotas and support.
    (b) Eligibility.--
            (1) In general.--To be eligible to receive a payment under 
        this section, a person shall submit to the Secretary an 
        application containing such information as the Secretary may 
        require to demonstrate to the satisfaction of the Secretary 
        that the person is a tobacco quota holder.
            (2) Administration.--The application shall be submitted 
        within such time, in such form, and in such manner as the 
        Secretary may require.
    (c) Base Quota Level.--
            (1) In general.--The Secretary shall establish a base quota 
        level applicable to each eligible tobacco quota holder, as 
        determined under subsection (b).
            (2) Poundage quotas.--For each kind of tobacco for which a 
        marketing quota is expressed in pounds, the base quota level 
        for each tobacco quota holder shall be equal to the basic 
        tobacco marketing quota under part I of subtitle B of title III 
        of the Agricultural Adjustment Act of 1938 (7 U.S.C. 1281 et 
        seq.) (as in effect before the amendment made by section 
        101(h)) for the 1998 marketing year for quota tobacco on the 
        farm owned by the tobacco quota holder.
            (3) Marketing quotas other than poundage quotas.--For each 
        kind of tobacco for which there is a marketing quota or 
        allotment on an acreage basis, the base quota level for each 
        tobacco quota holder shall be the quantity obtained by 
        multiplying--
                    (A) the basic tobacco farm marketing quota or 
                allotment for the 1998 marketing year established by 
                the Secretary for quota tobacco on the farm owned by 
                the tobacco quota holder; by
                    (B) the average county production yield per acre 
                for the county in which the farm is located for the 
                kind of tobacco for the 1998 marketing year.
    (d) Payment.--The Secretary shall make payments to each eligible 
tobacco quota holder under subsection (b) in an amount obtained by 
multiplying--
            (1) $8 per pound; by
            (2) the base quota level established for the quota holder 
        under subsection (c).
    (e) Time for Payment.--The payments to eligible tobacco quota 
holders required under this section shall be made in 5 equal 
installments during fiscal years 2003, 2004, 2005, 2006, and 2007.
    (f) Resolution of Disputes.--Any dispute regarding the eligibility 
of a person to receive a payment under this section, or the amount of 
the payment, shall be resolved by the county committee established 
under section 8(b)(5) of the Soil Conservation and Domestic Allotment 
Act (16 U.S.C. 590h(b)(5)) for the county or other area in which the 
farm owned by the person is located.
    (g) Commodity Credit Corporation.--The Secretary shall use the 
funds, facilities, and authorities of the Commodity Credit Corporation 
to carry out this section.

SEC. 203. TRANSITION PAYMENTS FOR ACTIVE PRODUCERS OF QUOTA TOBACCO.

    (a) Transition Payments Required.--The Secretary shall make 
transition payments under this section to eligible active producers of 
quota tobacco.
    (b) Eligibility.--
            (1) In general.--To be eligible to receive a transition 
        payment under this section, a person shall submit to the 
        Secretary an application containing such information as the 
        Secretary may require to demonstrate to the satisfaction of the 
        Secretary that the person is an active producer of quota 
        tobacco.
            (2) Administration.--The application shall be submitted 
        within such time, in such form, and in such manner as the 
        Secretary may require.
    (c) Production Base.--
            (1) In general.--The Secretary shall establish a production 
        base applicable to each eligible active producer of quota 
        tobacco, as determined under subsection (b).
            (2) Quantity.--The production base of a producer shall be 
        equal to the quantity, in pounds, of quota tobacco subject to 
        the basic marketing quota produced and marketed by the producer 
        under part I of subtitle B of title III of the Agricultural 
        Adjustment Act of 1938 (7 U.S.C. 1281 et seq.) (as in effect 
        before the amendment made by section 101(h)) for the 2001 
        marketing year.
    (d) Payment.--The Secretary shall make payments to each eligible 
active producer of quota tobacco, as determined under subsection (b), 
in an amount obtained by multiplying--
            (1) $4 per pound; by
            (2) the production base established for the active producer 
        under subsection (c).
    (e) Time for Payment.--The payments to eligible active producers of 
quota tobacco required under this section shall be made in 5 equal 
installments during fiscal years 2003, 2004, 2005, 2006, and 2007.
    (f) Resolution of Disputes.--Any dispute regarding the eligibility 
of a person to receive a payment under this section, or the amount of 
the payment, shall be resolved by the county committee established 
under section 8(b)(5) of the Soil Conservation and Domestic Allotment 
Act (16 U.S.C. 590h(b)(5)) for the county or other area in which the 
farming operation of the person is located.
    (g) Commodity Credit Corporation.--The Secretary shall use the 
funds, facilities, and authorities of the Commodity Credit Corporation 
to carry out this section.

                    TITLE III--TOBACCO QUALITY BOARD

SEC. 301. DEFINITIONS.

    In this title:
            (1) Board.--The term ``Board'' means the Tobacco Quality 
        Board established under section 302.
            (2) Secretary.--The term ``Secretary'' means the Secretary 
        of Agriculture.

SEC. 302. ESTABLISHMENT OF BOARD.

    (a) In General.--The Secretary shall establish a permanent advisory 
board within the Department of Agriculture to be known as the Tobacco 
Quality Board.
    (b) Nomination and Appointment.--The Board shall consist of 11 
members, of which--
            (1) 5 members shall be appointed by the Secretary from 
        nominations submitted by representatives of tobacco producers 
        in the United States;
            (2) 5 members shall be appointed by the Secretary from 
        nominations submitted by representatives of tobacco product 
        manufacturers in the United States; and
            (3) 1 member shall be an officer or employee of the 
        Department of Agriculture appointed by the Secretary, who shall 
        serve as Chairperson of the Board.
    (c) Terms.--
            (1) Chairperson.--The Chairperson of the Board shall serve 
        at the pleasure of the Secretary.
            (2) Other members.--Other members of the Board shall serve 
        for 2-year terms, except that of the members first appointed to 
        the Board, 2 producer representatives and 2 manufacturer 
        representatives shall have initial terms of 1 year, as 
        determined by the Secretary.

SEC. 303. DUTIES.

    The Board shall--
            (1) determine and describe the physical characteristics of 
        tobacco produced in the United States and unmanufactured 
        tobacco imported into the United States;
            (2) assemble and evaluate, in a systematic manner, concerns 
        and problems with the quality of tobacco produced in the United 
        States, expressed by domestic and foreign buyers and 
        manufacturers of tobacco products;
            (3) review data collected by Federal agencies on the 
        physical and chemical integrity of tobacco produced in the 
        United States and unmanufactured tobacco imported into the 
        United States, to ensure that tobacco being used in 
        domestically-manufactured tobacco products is of the highest 
        quality and is free from prohibited physical and chemical 
        agents;
            (4) investigate and communicate to the Secretary--
                    (A) conditions with respect to the production of 
                tobacco that discourage improvements in the quality of 
                tobacco produced in the United States; and
                    (B) recommendations for regulatory changes that 
                would address tobacco quality issues; and
            (5) carry out such other related activities as are assigned 
        to the Board by the Secretary.

SEC. 304. ADMINISTRATION.

    (a) In General.--The Secretary shall provide the Board with (as 
determined by the Secretary)--
            (1) a staff that is--
                    (A) experienced in the sampling and analysis of 
                unmanufactured tobacco; and
                    (B) capable of collecting data and monitoring 
                tobacco production information; and
            (2) other resources necessary for the Board to perform the 
        duties of the Board under this title.
    (b) Commodity Credit Corporation.--The Secretary shall use the 
funds, facilities, and authorities of the Commodity Credit Corporation 
to carry out this title.

     TITLE IV--TOBACCO PRODUCT MANUFACTURER AND IMPORTER USER FEES

SEC. 401. USER FEE.

    (a) In General.--
            (1) Assessment.--The Secretary of Health and Human Services 
        shall assess an annual user fee, calculated in accordance with 
        this section, on each tobacco product manufacturer and tobacco 
        product importer that sells tobacco products in domestic 
        commerce in the United States.
            (2) Commencement.--The assessments shall commence during 
        calendar year 2003, based on domestic sales of tobacco products 
        during fiscal year 2003.
    (b) Base Amount of User Fee for Each Class of Tobacco Product.--The 
base amount of the user fee shall be--
            (1) for cigarette manufacturers and importers, 
        $2,116,252,000;
            (2) for small cigar manufacturers and importers, 
        $1,051,000;
            (3) for large cigar manufacturers and importers, 
        $164,274,000;
            (4) for snuff manufacturers and importers, $9,920,000;
            (5) for chewing tobacco manufacturers and importers, 
        $2,275,000;
            (6) for pipe tobacco manufacturers and importers, 
        $1,505,000; and
            (7) for roll-your-own tobacco manufacturers and importers, 
        $3,231,000.
    (c) Determination of Annual User Fee for Each Class of Tobacco 
Product.--The total user fee to be assessed on, and paid by, the 
manufacturers and importers of each class of tobacco product in each 
calendar year, as allocated pursuant to subsection (d), shall be the 
amount obtained by multiplying--
            (1) the base amount for that class of tobacco product 
        provided under subsection (b); by
            (2) a fraction--
                    (A) the numerator of which is the total volume of 
                domestic sales of that class of tobacco product during 
                the fiscal year ending on September 30 of that calendar 
                year; and
                    (B) the denominator of which is the total volume of 
                domestic sales of that class of tobacco product during 
                fiscal year 2003.
    (d) Allocation of Total User Fee Amounts by Market Share--
            (1) Definition of market share.--In this subsection, the 
        term ``market share'' means the share of each manufacturer or 
        importer of a class of tobacco product (expressed as a decimal 
        to the fourth place) of the total volume of domestic sales of 
        the class of tobacco product during the calendar year 
        immediately preceding the calendar year of an assessment under 
        this section.
            (2) Allocation.--The amount of the user fee for each class 
        of tobacco product to be paid by each manufacturer or importer 
        of the class of tobacco product under subsection (a) shall be 
        determined for each calendar year by multiplying--
                    (A) the market share of the manufacturer or 
                importer, as calculated with respect to the calendar 
                year, of the class of tobacco product; by
                    (B) the total user fee amount for the calendar 
                year, as determined under subsection (c), for the class 
                of tobacco product.
    (e) Determination of Volume of Domestic Sales.--
            (1) In general.--The calculation of the volume of domestic 
        sales of a class of tobacco product by a manufacturer or 
        importer, and by all manufacturers and importers as a group, 
        shall be made by the Secretary of Health and Human Services 
        based on certified reports submitted by the manufacturers and 
        importers pursuant to subsection (f).
            (2) Measurement.--For purposes of the calculations under 
        this subsection and the certifications under subsection (f) by 
        the Secretary of Health and Human Services, the volumes of 
        domestic sales shall be measured by--
                    (A) in the case of cigarettes, the numbers of 
                cigarettes sold; and
                    (B) in the case of each other class of tobacco 
                products, such unit as is specified by regulation by 
                the Secretary.
    (f) Certification of Volume of Domestic Sales.--
            (1) In general.--Each manufacturer and importer of tobacco 
        products shall submit for each year a certified report to the 
        Secretary of Health and Human Services setting forth for each 
        class of tobacco products marketed or imported the total, for 
        the preceding year, of domestic sales of the tobacco products 
        by the manufacturer and importer, respectively, to wholesalers 
        and retailers and directly to consumers.
            (2) Deadline.--The certified report shall be submitted to 
        the Secretary of Health and Human Services not later than March 
        1 of the year after the year for which the certified report is 
        made.

SEC. 402. ALLOCATION OF USER FEES.

    (a) In General.--The user fees collected pursuant to section 401 
and any funds transferred to the Secretary of Health and Human Services 
by the Secretary of Agriculture pursuant to section 102(f)(3)(B)(ii) 
shall be available, without further appropriation, in accordance with, 
and for the purposes described in, this section, to remain available 
until expended.
    (b) Funding for FDA Regulation of Tobacco Products.--The Secretary 
of Health and Human Services shall make 15 percent of the user fee 
amounts collected pursuant to section 401 for each year available to 
the Secretary, acting through the Commissioner of Food and Drugs, for 
the regulation of tobacco products under chapter IX of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.).
    (c) Funding for Other Tobacco-Related Programs.--The Secretary of 
Health and Human Services shall use the remaining 85 percent of the 
user fee amounts collected each year pursuant to section 401 and any 
amounts transferred to the Secretary of Health and Human Services by 
the Secretary of Agriculture pursuant to section 102(f)(3)(B)(ii)--
            (1) to reimburse the Commodity Credit Corporation for the 
        expenditures made by the Commodity Credit Corporation under 
        title II; and
            (2) if any funds remain after carrying out paragraph (1), 
        to fund any other program that relates to tobacco products.

              TITLE V--FDA REGULATION OF TOBACCO PRODUCTS

SEC. 501. FINDINGS.

    Congress finds that--
            (1) the use of tobacco products by the children of the 
        United States 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 tobacco products;
            (5) tobacco advertising and marketing contribute 
        significantly to the use of nicotine-containing tobacco 
        products by adolescents;
            (6) since 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 tobacco products are 
        needed;
            (7) Federal and State governments have lacked the legal and 
        regulatory authority and resources 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, 
        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 
        affect interstate commerce because tobacco products are sold, 
        marketed, advertised, and distributed in interstate commerce on 
        a nationwide basis;
            (11) the sale, distribution, marketing, advertising, and 
        use of tobacco 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--
                    (A) the unique position of tobacco in the history 
                and economy of the United States; and
                    (B) the need to prevent the sale, distribution, 
                marketing and advertising of tobacco products to 
                persons under the minimum legal age to purchase tobacco 
                products;
            (13) the public interest requires a timely, fair, 
        equitable, and consistent result that will serve the public 
        interest by restricting throughout the United States the sale, 
        distribution, marketing, and advertising of tobacco products 
        only to persons of legal age to purchase tobacco products;
            (14) public health authorities estimate that the benefits 
        to the United States of enacting Federal legislation to 
        accomplish the goals described in this section would be 
        significant in human and economic terms;
            (15) reducing the use of tobacco by minors by 50 percent 
        would prevent well over 60,000 early deaths each year and save 
        up to $43,000,000,000 each year in reduced medical costs, 
        improved productivity, and the avoidance of premature deaths;
            (16)(A) advertising, marketing, and promotion of tobacco 
        products have been especially directed to attract young persons 
        to use tobacco products, resulting in increased use of tobacco 
        products by youth; and
            (B) past efforts to oversee those activities have not been 
        successful in adequately preventing the increased use;
            (17) tobacco advertising increases the size of the market 
        consumption of tobacco products and the use of tobacco by young 
        people;
            (18) children--
                    (A) are more influenced by tobacco advertising than 
                adults; and
                    (B) 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; and
            (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.

           Subtitle A--FDA Jurisdiction Over Tobacco Products

SEC. 511. DEFINITION OF TOBACCO PRODUCT.

    Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321) is amended by adding at the end the following:
            ``(ll) Tobacco product.--
                    ``(A) In general.--The term `tobacco product' means 
                any product made or derived from tobacco that is 
                intended for human consumption.
                    ``(B) Inclusions.--The term `tobacco product' 
                includes any component, part, or accessory of a tobacco 
                product.
                    ``(C) Exclusions.--The term `tobacco product' does 
                not include any raw material, other than tobacco, used 
                in manufacturing a component, part, or accessory of a 
                tobacco product.''.

SEC. 512. TOBACCO PRODUCTS.

    The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is 
amended--
            (1) by redesignating chapter IX (21 U.S.C. 391 et seq.) as 
        chapter X;
            (2) by redesignating sections 901 through 907 (21 U.S.C. 
        391 through 397) as sections 1001 through 1007, respectively; 
        and
            (3) by inserting after chapter VIII (21 U.S.C. 381 et seq.) 
        the following:

                     ``CHAPTER IX--TOBACCO PRODUCTS

``SEC. 901. DEFINITIONS.

    ``In this title:
            ``(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 those 
        attributes.
            ``(2) Cigarette.--The term `cigarette' has the meaning 
        given the term in section 3 of the Federal Cigarette Labeling 
        and Advertising Act (15 U.S.C. 1332).
            ``(3) Commerce.--The term `commerce' has the meaning given 
        the term in section 3 of the Federal Cigarette Labeling and 
        Advertising Act (15 U.S.C. 1332).
            ``(4) Constituent.--The term `constituent' means, with 
        respect to cigarettes, any element of mainstream or sidestream 
        smoke.
            ``(5) Distributor.--
                    ``(A) In general.--The term `distributor' means, 
                with respect to a tobacco product, any person that 
                furthers the distribution of cigarette or smokeless 
                tobacco, whether domestic or imported, at any point 
                from the original place of manufacture to the place of 
                business of a person that sells or distributes the 
                product to individuals for personal consumption.
                    ``(B) Exclusion.--The term `distributor' does not 
                include a common carrier.
            ``(6) Ingredient.--
                    ``(A) In general.--The term `ingredient' means, 
                with respect to cigarettes or smokeless tobacco 
                products, any substance, chemical, or compound (other 
                than tobacco, water, or reconstituted tobacco sheet 
                made wholly from tobacco) added, or specified for 
                addition, by a manufacturer to the tobacco, paper, or 
                filter of a cigarette, or to the tobacco of a smokeless 
                tobacco product.
                    ``(B) Inclusions.--The term `ingredient' includes, 
                with respect to cigarettes or smokeless tobacco 
                products, flavorants, processing aids, casing sauces, 
                preservatives, and combustion modifiers.
            ``(7) Manufacturer.--
                    ``(A) In general.--The term `manufacturer' means 
                any person that manufactures a tobacco product intended 
                to be sold in the United States.
                    ``(B) Inclusions.--The term ``manufacturer'' 
                includes an importer, or other first purchaser for 
                resale in the United States, of--
                            ``(i) a tobacco product manufactured 
                        outside of the United States; or
                            ``(ii a tobacco product manufactured in the 
                        United States but not intended for sale in the 
                        United States.
            ``(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) a pack, box, carton, or container of any 
                kind; or
                    ``(B) if no other container is used, any wrapping 
                (including cellophane) in which cigarettes or smokeless 
                tobacco is offered for sale, sold, or otherwise 
                distributed to consumers.
            ``(10) Retailer.--The term `retailer' means any person 
        that--
                    ``(A) sells cigarettes or smokeless tobacco to 
                individuals for personal consumption; or
                    ``(B) operates a facility at which self-service 
                displays of tobacco products are permitted.
            ``(11) Smokeless tobacco.--The term `smokeless tobacco' 
        means any product that--
                    ``(A) consists of cut, ground, powdered, or leaf 
                tobacco; and
                    ``(B) is intended to be placed in the oral or nasal 
                cavity.

``SEC. 902. FDA JURISDICTION OVER TOBACCO PRODUCTS.

     ``(a) In General.--A tobacco product shall be regulated by the 
Secretary under this chapter and shall not be subject to the provisions 
of chapter V, except to the extent that--
            ``(1) the tobacco product is intended for use in the 
        diagnosis, cure, mitigation, treatment, or prevention of 
        disease (within the meaning of section 201(g)(1)(B) or 
        201(h)(2)); or
            ``(2) a health claim is made for the tobacco product under 
        section 201(g)(1)(C) or 201(h)(3), except that this paragraph 
        shall not apply to a reduced exposure tobacco product or a 
        reduced risk tobacco product covered by section 913.
    ``(b) Applicability.--This chapter shall apply to--
            ``(1) all tobacco products subject to part 897 of title 21, 
        Code of Federal Regulations and any successor regulations; and
            ``(2) any other tobacco product that the Secretary by 
        regulation determines to be subject to this chapter.
    ``(c) Scope.--
            ``(1) Other products.--Nothing in this chapter affects the 
        authority of the Secretary over, or the regulation of, products 
        under this Act that are not tobacco products under chapter V or 
        any other chapter of this Act.
            ``(2) Leaf tobacco.--
                    ``(A) Definition of controlled by.--In this 
                paragraph, the term `controlled by' means, when used 
                with respect to a tobacco product manufacturer, that 
                the tobacco product manufacturer--
                            ``(i) is 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
                            ``(ii) is under common control (within the 
                        meaning of the regulations promulgated under 
                        section 52(b) of that Code).
                    ``(B) Nonapplicability.--This chapter shall not 
                apply to--
                            ``(i) leaf tobacco that is not in the 
                        possession of a manufacturer; or
                            ``(ii) a producer of leaf tobacco, 
                        including a tobacco grower, tobacco warehouse, 
                        and tobacco grower cooperative.
                    ``(C) Entry onto farms.--An officer or employee of 
                the Food and Drug Administration shall not have any 
                authority to enter onto a farm owned by a producer of 
                leaf tobacco without the written consent of the 
                producer.
                    ``(D) Dual capacity as leaf tobacco producer and 
                manufacturer.--Notwithstanding any other provision of 
                this subparagraph, if a producer of leaf tobacco is 
                also a tobacco product manufacturer or is controlled by 
                a tobacco product manufacturer, the producer shall be 
                subject to this chapter in the producer's capacity as a 
                manufacturer.
                    ``(E) Regulations on leaf tobacco production.--
                Nothing in this chapter grants the Secretary authority 
                to promulgate regulations on any matter that involves 
                the production of leaf tobacco or a producer of leaf 
                tobacco, other than activities by a manufacturer 
                affecting production.

``SEC. 903. ADULTERATED TOBACCO PRODUCTS.

    ``(a) Contaminated Substances.--A tobacco product shall be deemed 
adulterated if the tobacco product--
            ``(1) consists in whole or in part of any filthy, putrid, 
        or decomposed substance; or
            ``(2) is otherwise contaminated by any poisonous or 
        deleterious substance that may render the tobacco product more 
        injurious to health.
    ``(b) Unsanitary Conditions.--A tobacco product shall be deemed 
adulterated if the tobacco product has been prepared, packed, or held 
under unsanitary conditions under which the tobacco product may have 
been contaminated with filth, or under which the tobacco product may 
have been rendered more injurious to health.
    ``(c) Containers.--A tobacco product shall be deemed adulterated if 
the container of the tobacco product is composed, in whole or in part, 
of any poisonous or deleterious substance that may render the contents 
more injurious to health.
    ``(d) Performance Standards.--A tobacco product shall be deemed 
adulterated if the tobacco product is, purports to be, or is 
represented as a tobacco product that is subject to a performance 
standard established under section 908 unless the tobacco product is in 
all respects in conformity with the standard.
    ``(e) Premarket Approval.--A tobacco product shall be deemed 
adulterated if the tobacco product--
            ``(1) is required by section 911(b) to have premarket 
        approval;
            ``(2) is not exempt under section 907(f); and
            ``(3) does not have an approved application in effect.
    ``(f) Manufacturing Practices.--A tobacco product shall be deemed 
adulterated if the methods used in, or the facilities or controls used 
for, the manufacture, packing, or storage of the tobacco product are 
not in conformity with applicable requirements under section 907(e)(1) 
or an applicable condition prescribed by an order under section 
907(e)(2).
    ``(g) Investigational Use.--A tobacco product shall be deemed 
adulterated if--
            ``(1) the tobacco product is a tobacco product for which an 
        exemption has been granted under section 907(f) for 
        investigational use; and
            ``(2) the person that is granted the exemption or any 
        investigator that uses the tobacco product under the exemption 
        fails to comply with a requirement prescribed by or under 
        section 907(f).
    ``(h) Imported Cigarettes.--A tobacco product shall be deemed 
adulterated if the tobacco product is imported, or offered for import, 
into the United States in violation of section 5754 of the Internal 
Revenue Code of 1986 or title VIII of the Tariff Act of 1930 (19 U.S.C. 
1681 et seq.).

``SEC. 904. MISBRANDED TOBACCO PRODUCTS.

    ``(a) False Labeling.--A tobacco product shall be deemed misbranded 
if the labeling of the tobacco product is false or misleading.
    ``(b) Mislabeled Packages.--
            ``(1) In general.--Subject to paragraph (2), a tobacco 
        product in package form shall be deemed misbranded unless the 
        tobacco product 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.
            ``(2) Administration.--In carrying out paragraph (1)(B), 
        the Secretary shall (by regulation)--
                    ``(A) permit reasonable variations; and
                    ``(B) establish exemptions for small packages.
    ``(c) Information.--A tobacco product shall be deemed misbranded 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 on the label or labeling with such conspicuousness 
(as compared with other words, statements, or designs in the labeling) 
and in such terms as to render the information likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use.
    ``(d) Established Name.--A tobacco product shall be deemed 
misbranded if--
            ``(1) the tobacco product has an established name; and
            ``(2) the label of the tobacco product does not bear, to 
        the exclusion of any other nonproprietary name, the established 
        name of the tobacco product prominently printed in type, as 
        required by the Secretary by regulation.
    ``(e) Directions.--A tobacco product shall be deemed misbranded if 
the Secretary has promulgated regulations requiring that the labeling 
of the tobacco product bear adequate directions for use, or adequate 
warnings against use by children, that are necessary for the protection 
of users unless the labeling of the tobacco product conforms in all 
respects to the regulations.
    ``(f) Processing.--A tobacco product shall be deemed misbranded 
if--
            ``(1) the tobacco product was manufactured, prepared, 
        propagated, compounded, or processed in any State in an 
        establishment not duly registered under section 906(b);
            ``(2) the tobacco product was not included in a list 
        required by section 906(i);
            ``(3) a notice or other information with respect to the 
        tobacco product was not provided as required by section 906(i) 
        or 906(j); or
            ``(4) the tobacco product does not bear such symbols from 
        the uniform system for identification of tobacco products 
        prescribed under section 906(e) as the Secretary by regulation 
        requires.
    ``(g) False Advertising.--In the case of any tobacco product 
distributed or offered for sale in any State, a tobacco product shall 
be deemed misbranded if--
            ``(1) the advertising of the tobacco product is false or 
        misleading; or
            ``(2) the tobacco product is sold, distributed, advertised, 
        or promoted in violation of section 916 or regulations 
        prescribed under section 907(d).
    ``(h) Required Statements.--In the case of any tobacco product 
distributed or offered for sale in any State, a tobacco product shall 
be deemed misbranded unless the manufacturer, packer, or distributor of 
the tobacco product includes in all advertisements and other 
descriptive printed matter issued or caused to be issued by the 
manufacturer, packer, or distributor with respect to the tobacco 
product--
            ``(1) a true statement of the established name of the 
        tobacco product (as required under subsection (d)), printed 
        prominently; and
            ``(2) a brief description of--
                    ``(A) the uses of the tobacco product and relevant 
                warnings, precautions, side effects, and 
                contraindications; and
                    ``(B) in the case of specific tobacco products made 
                subject to a finding by the Secretary after notice and 
                opportunity for comment that the action is necessary to 
                protect the public health, a full description of the 
                components of the tobacco product or the formula 
                showing quantitatively each ingredient of the tobacco 
                product, to the extent required in regulations which 
                shall be promulgated by the Secretary after an 
                opportunity for a hearing.
    ``(i) Mandatory Disclaimers.--In the case of any tobacco product 
distributed or offered for sale in any State, a tobacco product shall 
be deemed misbranded unless the manufacturer, packer, or distributor of 
the tobacco product includes in all advertisements the information 
required by section 917(c).
    ``(j) Performance Standards.--A tobacco product shall be deemed 
misbranded if the tobacco product is a tobacco product subject to a 
performance standard established under section 908, unless the tobacco 
product bears such labeling as may be prescribed in the performance 
standard.
    ``(k) Notice.--A tobacco product shall be deemed misbranded if 
there is a failure or refusal--
            ``(1) to comply with any requirement prescribed under 
        section 905 or 909; or
            ``(2) to furnish any material or information required by or 
        under section 910.
    ``(l) Labeling.--A tobacco product shall be deemed misbranded if 
the tobacco product is not in compliance with--
            ``(1) the Federal Cigarette Labeling and Advertising Act 
        (15 U.S.C. 1331 et seq.); or
            ``(2) the Comprehensive Smokeless Tobacco Health Education 
        Act of 1986 (15 U.S.C. 4401 et seq.).
    ``(m) Prior Approval of Statements on Label.--
            ``(1) In general.--Subject to paragraphs (2) and (3), the 
        Secretary may, by regulation, require prior approval of 
        statements made on the label of a tobacco product.
            ``(2) Advertisement content.--In the case of matters 
        specified in this section or covered by regulations promulgated 
        under this section--
                    ``(A) no regulation promulgated under this 
                subsection may require prior approval by the Secretary 
                of the content of any advertisement; and
                    ``(B) no advertisement of a tobacco product, 
                published after the date of enactment of the Tobacco 
                Livelihood and Economic Assistance for Our Farmers Act 
                of 2002, shall be subject to sections 12 through 15 of 
                the Federal Trade Commission Act (15 U.S.C. 52 through 
                55).
            ``(3) Labeling.--This subsection does not apply to any 
        printed matter that the Secretary determines to be labeling (as 
        defined in section 201).

``SEC. 905. SUBMISSION OF HEALTH INFORMATION TO THE SECRETARY.

    ``(a) Requirement.--Not later than 180 days after the date of 
enactment of the Tobacco Livelihood and Economic Assistance for Our 
Farmers Act of 2002, each tobacco product manufacturer or importer of 
tobacco products, or their agents, shall submit to the Secretary the 
following information:
            ``(1) A listing of all tobacco ingredients, substances, and 
        compounds that are, as of that 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) on the health, behavioral, or physiological 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) that relate to the issue of whether a 
        reduction in risk to health from tobacco products can occur on 
        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.
    ``(b) Annual Submission of Information.--A tobacco product 
manufacturer or importer that is required to submit information under 
subsection (a) shall update the information on an annual basis in 
accordance with a schedule determined by the Secretary.
    ``(c) Time for Submission.--
            ``(1) New products.--At least 90 days prior to the delivery 
        for introduction into interstate commerce of a tobacco product 
        not on the market on the date of enactment of the Tobacco 
        Livelihood and Economic Assistance for Our Farmers Act of 
        2002--
                    ``(A) the manufacturer of the tobacco product shall 
                provide the information required under subsection (a); 
                and
                    ``(B) the tobacco product shall be subject to the 
                annual submission requirement under subsection (b).
            ``(2) Modification of existing products.--Not later than 60 
        days after the date of an action described in this paragraph, a 
        tobacco product manufacturer shall advise the Secretary of the 
        action in writing, and reference the action in submissions made 
        under subsection (b), if the manufacturer--
                    ``(A) adds to the tobacco product a new tobacco 
                additive;
                    ``(B) increases or decreases the quantity of an 
                existing tobacco additive or the nicotine content, 
                delivery, or form; or
                    ``(C) eliminates a tobacco additive from the 
                tobacco product.

``SEC. 906. ANNUAL REGISTRATION.

    ``(a) Definitions.--In this section:
            ``(1) Manufacture, preparation, compounding, or 
        processing.--The term `manufacture, preparation, compounding, 
        or processing' includes (consistent with section 902(c)(2)) 
        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 of the tobacco product to the place of business of 
        the person that makes final delivery or sale to the ultimate 
        consumer or user.
            ``(2) Name.--The term `name' includes--
                    ``(A) in the case of a partnership, the name of 
                each partner; and
                    ``(B) in the case of a corporation--
                            ``(i) the name of each corporate officer 
                        and director; and
                            ``(ii) the State of incorporation.
    ``(b) Registration by Owners and Operators.--On or before December 
31 of each year, each person that owns or operates any establishment in 
any State engaged in the manufacture, preparation, compounding, or 
processing of 1 or more tobacco products shall register with the 
Secretary the name, places of business, and all such establishments of 
the person.
    ``(c) Registration of New Owners and Operators.--On first engaging 
in the manufacture, preparation, compounding, or processing of a 
tobacco product or tobacco products in an establishment owned or 
operated in any State by a person, the person shall immediately 
register with the Secretary the person's name, place of business, and 
the establishment.
    ``(d) Registration of Added Establishments.--Each person required 
to register under subsection (b) or (c) shall immediately register with 
the Secretary any additional establishment that person owns or operates 
in any State and at which the person begins the manufacture, 
preparation, compounding, or processing of 1 or more tobacco products.
    ``(e) Uniform Product Identification System.--The Secretary may by 
regulation--
            ``(1) prescribe a uniform system for the identification of 
        tobacco products; and
            ``(2) require that persons that are required to list the 
        tobacco products under subsection (i) shall list the tobacco 
        products in accordance with the system.
    ``(f) Public Access to Registration Information.--On request, the 
Secretary shall make available for inspection any registration filed 
under this section.
    ``(g) Biennial Inspection of Registered Establishments.--
            ``(1) In general.--Each establishment in any State 
        registered with the Secretary under this section shall be 
        subject to inspection under section 704.
            ``(2) Administration.--Each such establishment engaged in 
        the manufacture, compounding, or processing of a tobacco 
        product or tobacco products shall be so inspected by 1 or more 
        officers or employees duly designated by the Secretary--
                    ``(A) at least once during the 2-year period 
                beginning with the date of registration of the 
                establishment under this section; and
                    ``(B) at least once in every successive 2-year 
                period thereafter.
    ``(h) Foreign Establishments.--
            ``(1) Registration.--Any establishment within any foreign 
        country engaged in the manufacture of a tobacco product that is 
        imported, or offered for import, into the United States shall 
        register with the Secretary the name and place of business of 
        the establishment and the name of the United States agent for 
        the establishment.
            ``(2) Registration information.--Any establishment required 
        to be registered under paragraph (1) shall--
                    ``(A) provide to the Secretary the information 
                required by subsection (i); and
                    ``(B) comply with any other requirement of this 
                section that is applicable to domestic manufacturers.
            ``(3) Inspections.--Any establishment required to be 
        registered under paragraph (1) shall--
                    ``(A) be subject to inspection under section 704; 
                and
                    ``(B) be inspected under that section by 1 or more 
                officers or employees designated by the Secretary at 
                least once during--
                            ``(i) the 2-year period beginning on the 
                        date of the registration of the establishment 
                        under paragraph (1); and
                            ``(ii) each 2-year period thereafter.
            ``(4) Cooperative agreements.--The Secretary may enter into 
        cooperative agreements with officials of foreign countries to 
        ensure that adequate and effective means are available for 
        purposes of determining, from time to time, whether tobacco 
        products manufactured by an establishment required to be 
        registered under paragraph (1), if imported or offered for 
        import into the United States, shall be refused admission under 
        section 801(a).
    ``(i) Registration Information.--
            ``(1) Product list.--Each person that registers with the 
        Secretary under subsection (b), (c), or (d) shall, at the time 
        of registration under any of those subsections, file with the 
        Secretary a list of all tobacco products that--
                    ``(A) are being manufactured, prepared, compounded, 
                or processed by the person for commercial distribution; 
                and
                    ``(B) have not been included in any list of tobacco 
                products filed by that person with the Secretary under 
                this paragraph or paragraph (2) before the time of 
                registration.
            ``(2) Contents of list.--The 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 908 or that 
                is subject to section 911--
                            ``(i) a reference to the authority for the 
                        marketing of the tobacco product; and
                            ``(ii) a copy of all labeling for the 
                        tobacco product;
                    ``(B) in the case of any other tobacco product 
                contained in an applicable list--
                            ``(i) a copy of all consumer information 
                        and other labeling for the tobacco product;
                            ``(ii) a representative sampling of 
                        advertisements for the tobacco product; and
                            ``(iii) on 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 the list 
                is not subject to a performance standard established 
                under section 908, a brief statement of the basis on 
                which the registrant made the determination, if the 
                Secretary requests such a statement with respect to the 
                particular tobacco product.
            ``(3) Semiannual report of any change in product list.--
        Each person that registers with the Secretary under this 
        subsection 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)(i) A list of each tobacco product introduced 
                by the registrant for commercial distribution that has 
                not been included in any list previously filed by the 
                person with the Secretary under this subparagraph or 
                paragraph (1).
                    ``(ii) A list under this subparagraph shall list a 
                tobacco product by the established name of the tobacco 
                product and shall be accompanied by the other 
                information required by paragraphs (1) and (2).
                    ``(B) If, since the date the registrant last made a 
                report under this paragraph, the 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)--
                            ``(i) notice of the discontinuance;
                            ``(ii) the date of the discontinuance; and
                            ``(iii) the identity of the established 
                        name of the tobacco product.
                    ``(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 a notice 
                of discontinuance was reported, notice of the 
                resumption, the date of the resumption, the identity of 
                the tobacco product by established name, and other 
                information required by paragraphs (1) and (2), unless 
                the registrant has previously reported the 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 that is 
required to register under this section and that 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 in the United States as of the date 
of enactment of the Tobacco Livelihood and Economic Assistance for Our 
Farmers Act of 2002 (as defined by the Secretary by regulation) shall, 
at least 90 days before making the introduction or delivery, report to 
the Secretary (in such form and manner as the Secretary shall by 
regulation prescribe)--
            ``(1) the basis for the person's determination that the 
        tobacco product is substantially equivalent (as defined in 
        section 911) to a tobacco product commercially marketed in the 
        United States as of the date of enactment of the Tobacco 
        Livelihood and Economic Assistance for Our Farmers Act of 2002 
        that is in compliance with the requirements of this Act; and
            ``(2) action taken by the person to comply with the 
        requirements under section 908 that are applicable to the 
        tobacco product.

``SEC. 907. GENERAL PROVISIONS CONCERNING CONTROL OF TOBACCO PRODUCTS.

    ``(a) In General.--
            ``(1) Applicable requirements.--Any requirement established 
        by or under section 903, 904, 906, or 910 that is applicable to 
        a tobacco product shall apply to the tobacco product until the 
        applicability of the requirement to the tobacco product has 
        been changed by action taken under section 908, section 911, or 
        subsection (d).
            ``(2) Inapplicable requirements.--Any requirement 
        established by or under section 903, 904, 906, or 910 that is 
        inconsistent with a requirement imposed on the tobacco product 
        under section 908, section 911, or subsection (d) shall not 
        apply to the tobacco product.
    ``(b) Information on Public Access and Comment.--
            ``(1) Application.--This subsection applies to--
                    ``(A) each notice of proposed rulemaking under this 
                section or section 908, 909, 910, or 911;
                    ``(B) any other notice that is published in the 
                Federal Register with respect to any other action taken 
                under any such section and that states the reasons for 
                the action; and
                    ``(C) each publication of findings required to be 
                made in connection with rulemaking under any such 
                section.
            ``(2) Information.--Each notice and publication described 
        in paragraph (1) shall set forth--
                    ``(A) the manner in which interested persons may 
                examine data and other information on which the notice 
                or findings are based; and
                    ``(B) the period within which interested persons 
                may present their comments on the notice or findings 
                (including the need for the notice or findings) orally 
                or in writing, which period shall be not less than 60 
                days, and not more than 90 days, unless the period is 
                extended by the Secretary by a notice published in the 
                Federal Register stating good cause for the extension.
    ``(c) Limited Confidentiality of Information.--
            ``(1) In general.--Except as provided in paragraph (2), any 
        information reported to or otherwise obtained by the Secretary 
        or the Secretary's representative under section 704, 905, 906, 
        908, 909, 910, 911, or 913, or under subsection (e) or (f), 
        that is exempt from disclosure under section 552(a) of title 5, 
        United States Code, by reason of section 552(b)(4) of that 
        title shall be considered confidential and shall not be 
        disclosed.
            ``(2) Exceptions.--Information described in paragraph (1) 
        may be disclosed--
                    ``(A) to other officers or employees that are 
                carrying out this chapter; or
                    ``(B) when relevant in any proceeding under this 
                chapter.
    ``(d) Restrictions.--
            ``(1) In general.--The Secretary may by regulation require 
        that a tobacco product be restricted to sale or distribution on 
        such conditions (including restrictions on the access to, and 
        the advertising and promotion of, the tobacco product) as the 
        Secretary may prescribe in the regulation if the Secretary 
        determines that the 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.
            ``(2) Prescriptions.--No condition under paragraph (1) 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.
            ``(3) Labels.--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 by 
        regulation prescribe.
            ``(4) Face-to-face transactions.--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 Practices.--
            ``(1) Methods, facilities, and controls.--
                    ``(A) In general.--The Secretary may, in accordance 
                with subparagraph (B), prescribe regulations requiring 
                that the methods used in, and the facilities and 
                controls used for, the manufacture, pre-production 
                design validation (including a process to assess the 
                performance of a tobacco product), and packing, and 
                storage of a tobacco product conform to current good 
                manufacturing practice for an agricultural product, as 
                prescribed in the regulations, to ensure that the 
                public health is protected and that the tobacco product 
                is in compliance with this chapter.
                    ``(B) Administration.--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 the recommendation of 
                        the advisory committee with respect to a 
                        proposed regulation under subparagraph (A); and
                            ``(iv) in establishing the effective date 
                        of a regulation promulgated under this 
                        subsection--
                                    ``(I) take into account the 
                                differences in--
                                            ``(aa) the manner in which 
                                        the different types of tobacco 
                                        products have historically been 
                                        produced;
                                            ``(bb) the financial 
                                        resources of the different 
                                        tobacco product manufacturers; 
                                        and
                                            ``(cc) the state of their 
                                        existing manufacturing 
                                        facilities; and
                                    ``(II) provide for a reasonable 
                                period of time for the manufacturers to 
                                conform to good manufacturing 
                                practices.
            ``(2) Exemptions; variances.--
                    ``(A) In general.--Any person subject to any 
                requirement prescribed under paragraph (1) may petition 
                the Secretary for a permanent or temporary exemption or 
                variance from the requirement.
                    ``(B) Content.--The 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 ensure 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.
                    ``(C) Advisory committee.--
                            ``(i) Referral.--The Secretary may refer to 
                        an advisory committee any petition submitted 
                        under subparagraph (A).
                            ``(ii) Recommendations.--The advisory 
                        committee shall report the recommendations of 
                        the advisory committee to the Secretary with 
                        respect to a petition referred to the advisory 
                        committee within 60 days after the date of the 
                        petition's referral.
                            ``(iii) Deadline for approval or denial.--
                        The Secretary shall by order either approve or 
                        deny the petition not later than 60 days after 
                        the later of--
                                    ``(I) the date on which the 
                                petition was submitted to the Secretary 
                                under subparagraph (A); or
                                    ``(II) the day after the date on 
                                which the petition was referred to an 
                                advisory committee.
                    ``(D) Grounds for approval.--The Secretary may 
                approve--
                            ``(i) a petition for an exemption for a 
                        tobacco product from a requirement if the 
                        Secretary determines that compliance with the 
                        requirement is not required to ensure 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 ensure that the 
                        tobacco product will be in compliance with this 
                        chapter.
                    ``(E) Conditions.--An order of the Secretary 
                approving a petition for a variance shall prescribe 
                such conditions respecting the methods used in, and the 
                facilities and controls used for, the manufacture, 
                packing, and storage of the tobacco product to be 
                granted the variance under the petition as may be 
                necessary to ensure that the tobacco product will be in 
                compliance with this chapter.
                    ``(F) Hearing.--After the issuance of an order 
                under subparagraph (C) with respect to a petition, the 
                petitioner shall have an opportunity for an informal 
                hearing on the 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 with respect to 
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. 908. PERFORMANCE STANDARDS.

    ``(a) In General.--
            ``(1) Finding.--
                    ``(A) Requirement.--The Secretary may adopt a 
                performance standard for a tobacco product if the 
                Secretary finds that the performance standard is 
                appropriate for the protection of the public health.
                    ``(B) Basis.--The 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--
                            ``(i) the increased or decreased likelihood 
                        that existing users of tobacco products will 
                        stop using tobacco products; and
                            ``(ii) the increased or decreased 
                        likelihood that those individuals who do not 
                        use tobacco products will start using tobacco 
                        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 tobacco product;
                            ``(ii) for the reduction or elimination of 
                        other harmful constituents or harmful 
                        components of the tobacco product; or
                            ``(iii) relating to any other requirement 
                        under subparagraph (B);
                    ``(B) shall, if necessary for the protection of 
                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) demonstrate 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.--
                    ``(A) In general.--The Secretary shall provide for 
                periodic evaluation of performance standards 
                established under this section to determine whether the 
                standards should be changed to reflect new medical, 
                scientific, or other technological data.
                    ``(B) Tester.--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 available personnel, facilities, and 
                other technical support of 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, Amendment, or Revocation of Standards.--
            ``(1) Notice.--
                    ``(A) In general.--The Secretary shall publish in 
                the Federal Register a notice of proposed rulemaking 
                for the establishment, amendment, or revocation of any 
                performance standard for a tobacco product.
                    ``(B) Establishment or amendment.--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) Revocation.--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 for the 
                protection of the public health.
                    ``(D) Administration.--The Secretary shall--
                            ``(i) 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 the demand; and
                            ``(ii) issue the standard, if the Secretary 
                        determines that the standard would be 
                        appropriate for the protection of the public 
                        health.
                    ``(E) Comment period.--In issuing a standard under 
                this subsection, the Secretary shall provide for a 
                comment period of not less than 60 days.
            ``(2) Promulgation.--
                    ``(A) In general.--After the expiration of the 
                period for comment on a notice of proposed rulemaking 
                published under paragraph (1) with respect to a 
                performance standard and after consideration of the 
                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 the termination.
                    ``(B) Effective date.--
                            ``(i) In general.--Subject to clauses (ii) 
                        and (iii), a regulation establishing a 
                        performance standard shall set forth the 1 or 
                        more dates on which the standard takes effect.
                            ``(ii) Earliest effective date.--No such 
                        regulation may take effect before the date that 
                        is 1 year after the date of the publication of 
                        the regulation unless the Secretary determines 
                        that an earlier effective date is necessary for 
                        the protection of the public health.
                            ``(iii) Basis.--The 1 or more effective 
                        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) Powers reserved to congress.--Congress expressly 
        reserves the power to make a decision 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.
            ``(4) Amendment; revocation.--
                    ``(A) In general.--On the Secretary's own 
                initiative or on petition of an interested person, the 
                Secretary may, by regulation promulgated in accordance 
                with paragraphs (1) and (2)(B), amend or revoke a 
                performance standard.
                    ``(B) Interim effectiveness.--The Secretary may 
                declare a proposed amendment of a performance standard 
                to be effective on and after the publication of the 
                amendment in the Federal Register and until the 
                effective date of any final action taken on the 
                amendment, if the Secretary determines that making it 
                so effective is in the public interest.
            ``(5) Reference to advisory committee.--
                    ``(A) In general.--In the case of a proposed 
                regulation for the establishment, amendment, or 
                revocation of a performance standard, the Secretary--
                            ``(i) on the Secretary's own initiative, 
                        may refer to an advisory committee, for a 
                        report and recommendation, any matter involved 
                        in the proposed regulation that requires the 
                        exercise of scientific judgment; and
                            ``(ii) on the request of an interested 
                        person that demonstrates good cause for 
                        referral and that is made before the expiration 
                        of the period for submission of comments on a 
                        proposed regulation, shall refer to an advisory 
                        committee, for a report and recommendation, any 
                        matter described in clause (i).
                    ``(B) Information.--If a proposed regulation is 
                referred to the advisory committee under this 
                paragraph, the Secretary shall provide the advisory 
                committee with the data and information on which the 
                proposed regulation is based.
                    ``(C) Report and recommendation.--Not later than 60 
                days after the referral of a proposed regulation, the 
                advisory committee shall--
                            ``(i) conduct an independent study of the 
                        data and information furnished to the advisory 
                        committee by the Secretary and other data and 
                        information before the advisory committee; and
                            ``(ii) submit to the Secretary a report and 
                        recommendation with respect to the proposed 
                        regulation, together with all underlying data 
                        and information and a statement of the reason 
                        or basis for the recommendation.
                    ``(D) Copy.--A copy of the report and 
                recommendation shall be made public by the Secretary.

``SEC. 909. NOTIFICATION AND OTHER REMEDIES.

    ``(a) Notification.--
            ``(1) Conditions.--The Secretary may issue an order 
        described in paragraph (2) if the Secretary determines that--
                    ``(A) a tobacco product that is introduced or 
                delivered for introduction into interstate commerce for 
                commercial distribution presents a risk of substantial 
                harm to the public health that exceeds the risks posed 
                by similar tobacco products marketed before the date of 
                enactment of the Tobacco Livelihood and Economic 
                Assistance for Our Farmers Act of 2002; and
                    ``(B)(i) notification under this subsection is 
                necessary to eliminate the unreasonable risk of the 
                harm; and
                    ``(ii) no more practicable means is available under 
                the provisions of this chapter (other than this 
                section) to eliminate the risk.
            ``(2) Order.--If the Secretary makes a determination 
        described in paragraph (2), the Secretary may issue such order 
        as may be necessary to ensure that adequate notification is 
        provided in an appropriate form, by the persons and means best 
        suited under the circumstances involved, to all persons that 
        should properly receive the notification in order to eliminate 
        the risk.
            ``(3) Means.--The Secretary may order notification by any 
        appropriate means, including public service announcements.
            ``(4) Consultation.--Before issuing an order under this 
        subsection, the Secretary shall consult with the persons that 
        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 the 
        tobacco product.
            ``(2) Hearing.--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 the tobacco 
        product.
            ``(3) Vacation of order.--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.
            ``(4) Amendment of order to require recall.--
                    ``(A) In general.--Except as provided in 
                subparagraph (C), 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 
                amend the order to require a recall.
                    ``(B) Timetable.--The Secretary shall specify a 
                timetable during which the tobacco product recall will 
                occur and shall require periodic reports to the 
                Secretary describing the progress of the recall.
                    ``(C) Contents.--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 
                        the tobacco product.
                    ``(D) Notification by retailers.--In providing the 
                notice required by subparagraph (C)(ii), the Secretary 
                may use the assistance of retailers and other persons 
                that distribute the tobacco product.
                    ``(E) Notification by secretary.--If a significant 
                number of persons described in subparagraph (D) cannot 
                be identified, the Secretary shall notify the persons 
                under section 705(b).
            ``(3) Remedy not exclusive.--The remedy provided by this 
        subsection shall be in addition to remedies provided by 
        subsection (a).

``SEC. 910. RECORDS AND REPORTS ON TOBACCO PRODUCTS.

    ``(a) In General.--Each person that 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 ensure that 
the tobacco product is not adulterated or misbranded and to otherwise 
protect public health.
    ``(b) Administration.--Regulations promulgated under subsection 
(a)--
            ``(1) may require a tobacco product manufacturer or 
        importer to report to the Secretary in any case in which the 
        manufacturer or importer receives or otherwise becomes aware of 
        information that reasonably suggests that 1 of the marketed 
        tobacco products of the manufacturer or importer 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 that are unduly 
        burdensome to a tobacco product manufacturer or importer, 
        taking into account the cost of complying with the 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 the regulations for submission of a report or 
        information to the Secretary state the reason or purpose for 
        the request and identify, to the maximum extent practicable, 
        the 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 the report or information and identify to the 
        maximum extent practicable the 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 disclosure is necessary--
                    ``(A) to protect the medical welfare of an 
                individual;
                    ``(B) to determine risks to public health of a 
                tobacco product; or
                    ``(C) to verify a record, report, or information 
                submitted under this chapter.
    ``(c) Medical Ethics and Patient Interests.--
            ``(1) In general.--In promulgating regulations under this 
        section, the Secretary shall have due regard for the 
        professional ethics of the medical profession and the interests 
        of patients.
            ``(2) Confidentiality.--The prohibitions of subsection 
        (b)(6) shall continue to apply to records, reports, and 
        information concerning any individual that has been a patient, 
        irrespective of whether or when the individual ceases to be a 
        patient.
    ``(d) Reports of Removals and Corrections.--
            ``(1) In general.--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 the 
        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 that may present a risk to 
                health.
            ``(2) Record.--A tobacco product manufacturer or importer 
        of a tobacco product that undertakes a corrective action or 
        removal from the market of a tobacco product that is not 
        required to be reported under this subsection shall keep a 
        record of the correction or removal.
            ``(3) Previous report.--No report of the corrective action 
        or removal of a tobacco product may be required under paragraph 
        (1) if a report of the corrective action or removal is required 
        and has been submitted under subsection (a).

``SEC. 911. PREMARKET REVIEW OF CERTAIN TOBACCO PRODUCTS.

    ``(a) Definition of Substantially Equivalent.--
            ``(1) In general.--In this section and section 906(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 
        determined that--
                    ``(A) the tobacco product has the same 
                characteristics as the predicate tobacco product; or
                    ``(B) the tobacco product has different 
                characteristics, and the information for the tobacco 
                product submitted contains information, including 
                clinical data if considered necessary by the Secretary, 
                that demonstrates that it is not appropriate to 
                regulate the product under the applicable section 
                because the product could not reasonably be expected to 
                increase the health risks to consumers compared to a 
                conventional tobacco product that is commercially 
                marketed in the United States and that is in compliance 
                with the requirements of this Act.
            ``(2) Definition of characteristics.--In subparagraph (A), 
        the term `characteristics' means the materials, ingredients, 
        design, composition, heating source, or other features of a 
        tobacco product.
            ``(3) Inapplicable tobacco products.--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.
    ``(b) Requirement for Premarket Approval.--
            ``(1) In general.--Approval under this section of an 
        application for premarket approval for any tobacco product, 
        other than a reduced exposure tobacco product or a reduced risk 
        tobacco product under section 913, that is not commercially 
        marketed in the United States as of the date of enactment of 
        the Tobacco Livelihood and Economic Assistance for Our Farmers 
        Act of 2002 shall be required unless--
                    ``(A) the manufacturer has submitted a report under 
                section 906(j); and
                    ``(B) the Secretary has not suspended the 
                distribution of the product under this paragraph.
            ``(2) Suspension of distribution.--Not later than 90 days 
        after the submission of a report under section 906(j), the 
        Secretary may by order suspend the distribution of the tobacco 
        product that is the subject of the report if the Secretary 
        determines that there is a reasonable likelihood that the 
        tobacco product is not substantially equivalent to a tobacco 
        product that is--
                    ``(A) commercially marketed in the United States as 
                of the date of the Tobacco Livelihood and Economic 
                Assistance for Our Farmers Act of 2002; and
                    ``(B) in compliance with the requirements of this 
                Act.
            ``(3) Failure to issue order.--If the Secretary fails to 
        issue an order within the 90-day period described in paragraph 
        (2), the tobacco product that is the subject of the report 
        shall be deemed to be substantially equivalent to a predicate 
        tobacco product.
            ``(4) Final agency action.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                issuance of an order under this paragraph shall 
                constitute final agency action for purposes of section 
                702 of title 5, United States Code.
                    ``(B) Rescission or modification.--The Secretary 
                may rescind or modify an order issued under this 
                subsection at any time.
    ``(c) Health Information.--
            ``(1) In general.--As part of a submission under section 
        906(j) with respect to a tobacco product, the person required 
        to file a premarket notification under section 906(j) shall 
        provide an adequate summary of any health information relating 
        to the tobacco product or state that the information will be 
        made available on request by any person.
            ``(2) Administration.--Any summary under paragraph (1) 
        respecting a tobacco product shall--
                    ``(A) contain detailed information regarding data 
                concerning adverse health effects; and
                    ``(B) be made available to the public by the 
                Secretary not later than 30 days after the date of 
                issuance of a determination that the tobacco product is 
                substantially equivalent to another tobacco product.
            ``(3) Requirements.--The communication that the product is 
        a reduced exposure tobacco product or a reduced risk tobacco 
        product shall comply with requirements prescribed by the 
        Secretary relating to the communication.
            ``(4) Prior approval.--The Secretary may require prior 
        approval of the communication in each case in accordance with 
        section 913.
    ``(d) Application.--
            ``(1) Contents.--An application for premarket approval 
        shall contain--
                    ``(A) full reports of all information, published or 
                known to, or that should reasonably be known to, the 
                applicant, concerning investigations that have been 
                made to show the health risks of the tobacco product 
                and whether the tobacco product presents greater risk 
                than other tobacco products;
                    ``(B) a full statement of the components, 
                ingredients, and properties, and of the principle or 
                principles of operation, of the 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, the tobacco product;
                    ``(D) an identifying reference to any performance 
                standard under section 908 that would be applicable to 
                any aspect of the tobacco product, and either adequate 
                information to show that the aspect of the tobacco 
                product fully meets the performance standard or 
                adequate information to justify any deviation from the 
                standard;
                    ``(E) such samples of the tobacco product and of 
                components of the tobacco product as the Secretary may 
                reasonably require;
                    ``(F) specimens of the labeling proposed to be used 
                for the 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.--On receipt of an 
        application meeting the requirements set forth in paragraph 
        (1), the Secretary--
                    ``(A) on the Secretary's own initiative, may refer 
                the application to an advisory committee 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; or
                    ``(B) on the request of an applicant, shall refer 
                the application to an advisory committee in accordance 
                with subparagraph (A).
    ``(e) Action on Application.--
            ``(1) Deadline.--
                    ``(A) In general.--As promptly as practicable, but 
                not later than 180 days, after the date of receipt of 
                an application under subsection (d), the Secretary, 
                after considering the report and recommendation 
                submitted under subsection (d)(2), shall--
                            ``(i) issue an order approving the 
                        application, if the Secretary finds that none 
                        of the grounds for denying approval specified 
                        in paragraph (2) applies; or
                            ``(ii) deny approval of the application, if 
                        the Secretary finds (and sets forth the basis 
                        for the finding as part of or accompanying the 
                        denial) that 1 or more grounds for denial 
                        specified in paragraph (2) apply.
                    ``(B) Sales restrictions.--An order approving an 
                application for a tobacco product may require as a 
                condition to the 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 
                promulgated under section 907(d).
            ``(2) Denial of approval.--The Secretary shall deny 
        approval of an application for a tobacco product if, on the 
        basis of the information submitted to the Secretary as part of 
        the application and any other information before the Secretary 
        with respect to the tobacco product, the Secretary finds that--
                    ``(A) there is a lack of a showing that permitting 
                the 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 the tobacco product do not conform to the 
                requirements of section 907(e);
                    ``(C) based on a fair evaluation of all material 
                facts, the proposed labeling is false or misleading; or
                    ``(D)(i) the tobacco product is not shown to 
                conform in all respects to a performance standard in 
                effect under section 908, compliance with which is a 
                condition to approval of the application; and
                    ``(ii) there is a lack of adequate information to 
                justify the deviation from the standard.
            ``(3) Denial information.--Any denial of an application 
        shall, to the extent that the Secretary determines to be 
        practicable, be accompanied by a statement informing the 
        applicant of the measures required to make the application 
        approvable (which measures may include further research by the 
        applicant in accordance with 1 or more protocols prescribed by 
        the Secretary).
            ``(4) Basis for action.--
                    ``(A) In general.--For purposes of paragraph 
                (2)(A), whether permitting a tobacco product to be 
                marketed would be appropriate for the protection of the 
                public health shall, when appropriate, be determined on 
                the basis of well-controlled investigations, which may 
                include 1 or more clinical investigations by experts 
                qualified by training and experience to evaluate the 
                tobacco product.
                    ``(B) Evidence.--If the Secretary determines that 
                there exists valid scientific evidence (other than 
                evidence derived from investigations described in 
                subparagraph (A)) that is sufficient to evaluate the 
                tobacco product, the Secretary may authorize that the 
                determination under paragraph (2)(A) be made on the 
                basis of the evidence.
    ``(f) Withdrawal and Temporary Suspension.--
            ``(1) In general.--The Secretary shall, on 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 that--
                    ``(A) the continued marketing of the tobacco 
                product poses greater risks to the public health than 
                other available products;
                    ``(B) the application contained or was accompanied 
                by a false or misleading statement of a material fact;
                    ``(C) 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 910;
                            ``(ii) has refused to permit access to, or 
                        copying or verification of, the records as 
                        required by section 704; or
                            ``(iii) has not complied with the 
                        requirements of section 906;
                    ``(D) on the basis of new information before the 
                Secretary with respect to the tobacco product, 
                evaluated, together with the evidence  before the 
Secretary when the application was approved, whether the methods used 
in, or the facilities and controls used for, the manufacture, 
processing, packing, or installation of the tobacco product do not 
conform with the requirements of section 907(e) and were not brought 
into conformity with the 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, 
                whether the labeling of the tobacco product, based on a 
                fair evaluation of all material facts, is false or 
                misleading and was not corrected within a reasonable 
                time after receipt of written notice from the Secretary 
                of the 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, 
                whether the tobacco product is shown to conform in all 
                respects to a performance standard that is in effect 
                under section 908, compliance with which was a 
                condition to approval of the application, and whether 
                there is a lack of adequate information to justify the 
                deviation from the standard.
            ``(2) Appeal.--The holder of an application subject to an 
        order issued under paragraph (1) withdrawing approval of the 
        application may, by petition filed on or before the 30th day 
        after the date on which the holder receives notice of the 
        withdrawal, obtain review of the order in accordance with 
        subsection (e).
            ``(3) Temporary suspension.--
                    ``(A) In general.--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.
                    ``(B) Withdrawal of application.--If the Secretary 
                issues such an order, the Secretary shall proceed 
                expeditiously under paragraph (1) to withdraw the 
                application.
    ``(g) 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. 912. JUDICIAL REVIEW.

    ``(a) Definition of Record.--In this section, the term `record' 
means--
            ``(1) all notices and other matter published in the Federal 
        Register with respect to a regulation or order reviewed;
            ``(2) all information submitted to the Secretary with 
        respect to--
                    ``(A) a regulation or order;
                    ``(B) proceedings of any panel or advisory 
                committee with respect to the regulation or order; and
                    ``(C) any hearing held with respect to the 
                regulation or order; and
            ``(3) any other information identified by the Secretary, in 
        the administrative proceeding held with respect to the 
        regulation or order, as being relevant to the regulation or 
        order.
    ``(b) Petition.--
            ``(1) In general.--Not later than 30 days after the date of 
        promulgation of a regulation under section 908 establishing, 
        amending, or revoking a performance standard for a tobacco 
        product, or a denial of an application for approval under 
        section 911(c), any person adversely affected by the regulation 
        or order may file a petition with the United States Court of 
        Appeals for the District of Columbia, or for the circuit in 
        which the person resides or has the person's principal place of 
        business, for judicial review of the regulation or order.
            ``(2) Copy of petition.--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.
            ``(3) Record of proceedings.--
                    ``(A) Filing.--The Secretary shall file in the 
                court the record of the proceedings on which the 
                Secretary based the Secretary's regulation or order.
                    ``(B) Rationale.--Each record or order shall 
                contain a statement of the reasons for the issuance of 
                the order and the basis, on the record, for the 
                issuance of the order.
    ``(c) Additional Findings by Secretary.--
            ``(1) In general.--The court may order the Secretary to 
        provide additional opportunity for the oral presentation of 
        data, views, or arguments and for written submissions if the 
        petitioner--
                    ``(A) applies to the court for leave to adduce 
                additional data, views, or arguments respecting the 
                regulation or order being reviewed; and
                    ``(B) demonstrates to the satisfaction of the court 
                that--
                            ``(i) the additional data, views, or 
                        arguments are material; and
                            ``(ii) there were reasonable grounds for 
                        the petitioner's failure to adduce the data, 
                        views, or arguments in the proceedings before 
                        the Secretary.
            ``(2) Modification.--The Secretary--
                    ``(A) may modify the Secretary's findings, or make 
                new findings by reason of the additional data, views, 
                or arguments so taken; and
                    ``(B) shall file with the court--
                            ``(i) the modified or new findings;
                            ``(ii) the Secretary's recommendation, if 
                        any, for the modification or setting aside of 
                        the regulation or order being reviewed; and
                            ``(iii) the return of the additional data, 
                        views, or arguments.
    ``(d) Standard of Review.--
            ``(1) In general.--On the filing of the petition under 
        subsection (a) for judicial review of a regulation or order, 
        the court shall have jurisdiction--
                    ``(A) to review the regulation or order in 
                accordance with chapter 7 of title 5, United States 
                Code; and
                    ``(B) to grant appropriate relief, including 
                interim relief, as provided in that chapter.
            ``(2) Standard.--A regulation or order described in 
        paragraph (1) or (2) of subsection (a) shall not be affirmed if 
        the regulation or order is found to be unsupported by 
        substantial evidence on the record taken as a whole.
    ``(e) 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 on 
certiorari or certification, as provided in section 1254 of title 28, 
United States Code.
    ``(f) Other Remedies.--The remedies provided for in this section 
shall be in addition to and not in lieu of any other remedy provided by 
law.
    ``(g) Regulations and Orders Must Recite Basis in Record.--To 
facilitate judicial review under this section or under any other 
provision of law or a regulation or order issued under section 907, 
908, 909, 910, 911, or 914, each such regulation or order shall contain 
a statement of--
            ``(1) the reasons for the issuance of the regulation or 
        order; and
            ``(2) the basis, in the record of the proceedings held in 
        connection with the issuance of the regulation or order, for 
        the issuance of the regulation or order.

``SEC. 913. REDUCED EXPOSURE AND REDUCED RISK TOBACCO PRODUCTS.

    ``(a) Definitions of Reduced Exposure and Reduced Risk Tobacco 
Products.--In this section, the terms `reduced exposure tobacco 
product' and `reduced risk tobacco product' mean a tobacco product 
designated by the Secretary as a reduced exposure tobacco product or a 
reduced risk tobacco product, respectively, under subsection (b).
    ``(b) Designation.--
            ``(1) In general.--A product may be designated by the 
        Secretary as a reduced exposure tobacco product or a reduced 
        risk tobacco product if the Secretary finds that the product is 
        demonstrated to significantly reduce harm to individuals caused 
        by a tobacco product in accordance with the standards provided 
        under subparagraph (B), based on an application submitted by 
        the manufacturer of the product (or other responsible person) 
        that--
                    ``(A)(i) demonstrates, through appropriate chemical 
                and biological testing (including testing on animals 
                and short-term human testing), that use of the product 
                results in ingestion or inhalation of a substantially 
                lower yield of toxic substances than use of another 
                tobacco product in the same or different category as 
                the subject tobacco product; or
                    ``(ii) contains scientific evidence showing that 
                use of the product results in a substantially lower 
                potential risk to health in 1 or more specific respects 
                than use of another tobacco product in the same or 
                different category as the proposed reduced exposure 
                tobacco product or the reduced risk product; and
                    ``(B) if required by the Secretary, includes 
                studies of the long-term health effects of the product.
            ``(2) Consultation on protocols.--If studies are required 
        under paragraph (1), the manufacturer may consult with the 
        Secretary regarding protocols for conducting the studies.
            ``(3) Basis for finding.--
                    ``(A) Reduced exposure tobacco products.--The 
                Secretary shall designate a tobacco product as a 
                reduced exposure tobacco product if the Secretary 
                determines, based on such information as may be 
                submitted by the applicant and other available 
                information, that--
                            ``(i) the product substantially reduces 
                        exposure to 1 or more tobacco toxicants; and
                            ``(ii) independent scientific experts have 
                        found or predict, through clinical or 
                        epidemiological studies, a measurable reduction 
                        in the morbidity or mortality associated with 
                        the use of the product compared with the use of 
                        other tobacco products (whether in the same or 
                        a different category) commercially marketed in 
                        the United States.
                    ``(B) Reduced risk tobacco products.--The Secretary 
                shall designate a tobacco product as a reduced risk 
                tobacco product only if the Secretary determines, based 
                on such information as may be submitted by the 
                applicant and other available information, that--
                            ``(i) the product meets the criteria 
                        established under subparagraph (A); and
                            ``(ii) there is sufficient evidence that 
                        the product can reasonably be expected to 
                        reduce the risk of 1 or more specific diseases 
                        or other adverse health effects, as compared 
                        with the use of other tobacco products (whether 
                        in the same or a different category) 
                        commercially marketed in the United States.
            ``(4) Marketing requirements.--A tobacco product may be 
        marketed and labeled as a reduced exposure tobacco product or a 
        reduced risk tobacco product if the tobacco product--
                    ``(A) has been designated by the Secretary under 
                paragraph (1);
                    ``(B) bears a label statement prescribed by the 
                Secretary concerning the product's contribution to 
                reducing harm to health; and
                    ``(C) complies with--
                            ``(i) requirements prescribed by the 
                        Secretary relating to marketing and advertising 
                        of the product to ensure that neither the 
                        marketing nor the labeling is false or 
                        misleading; and
                            ``(ii) other provisions of this chapter, as 
                        prescribed by the Secretary.
    ``(c) Revocation of Designation.--At any time after the date on 
which a tobacco product is designated as a reduced exposure tobacco 
product or a reduced risk tobacco product under this section, the 
Secretary may, after providing an opportunity for an informal hearing, 
revoke the designation if the Secretary determines, based on 
information not available at the time of the designation, that--
            ``(1) the finding made under subsection (b)(1) is no longer 
        valid; or
            ``(2) the product is being marketed in violation of 
        subsection (b)(3).
    ``(d) Limitation.--A tobacco product that is designated as a 
reduced exposure tobacco product or a reduced risk tobacco product that 
is in compliance with subsection (b) shall not be regulated as a drug 
or device.
    ``(e) Development of Reduced Exposure and Risk Tobacco Product 
Technology.--A tobacco product manufacturer shall provide written 
notice to the Secretary on the development or acquisition by the 
manufacturer of any technology that would reduce exposure to 1 or more 
tobacco toxicants, or the risk of a tobacco product to the health of 
the user, for which the manufacturer is not seeking designation as a 
reduced exposure tobacco product or a reduced risk tobacco product 
under this section.
    ``(f) Postmarket Surveillance.--
            ``(1) Discretionary surveillance.--The Secretary may 
        require a tobacco product manufacturer to conduct postmarket 
        surveillance for a reduced exposure tobacco product or a 
        reduced risk 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.--
                    ``(A) In general.--Each tobacco product 
                manufacturer required to conduct a surveillance of a 
                reduced exposure tobacco product or a reduced risk 
                tobacco product under paragraph (1) shall, not later 
                than 30 days after receiving notice that the 
                manufacturer is required to conduct the surveillance, 
                submit, for the approval of the Secretary, a protocol 
                for the required surveillance.
                    ``(B) Basis.--The Secretary, not later than 60 days 
                after the receipt of the protocol, shall determine if--
                            ``(i) the principal investigator proposed 
                        to be used in the surveillance has sufficient 
                        qualifications and experience to conduct the 
                        surveillance; and
                            ``(ii) the protocol will result in 
                        collection of useful data or other information 
                        necessary to protect the public health.
                    ``(C) Review.--The Secretary may not approve such a 
                protocol until the protocol has been reviewed by an 
                appropriately qualified scientific and technical review 
                committee established by the Secretary.

``SEC. 914. PRESERVATION OF STATE AND LOCAL AUTHORITY.

    ``(a) Additional Requirements.--
            ``(1) In general.--Except as provided in paragraph (2), 
        nothing in this Act prohibits a State or political subdivision 
        of a State 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) In general.--Except as provided in 
                subparagraph (B), no State or political subdivision of 
                a State may establish or continue in effect with 
                respect to a tobacco product any requirement that 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 exposure tobacco 
                products or reduced risk tobacco products.
                    ``(B) Sale, distribution, or use.--Subparagraph (A) 
                does not apply to requirements relating to the sale, 
                use, or distribution of a tobacco product, including 
                requirements relating to the access to, and the 
                advertising and promotion of, a tobacco product.
    ``(b) Product Liability.--No provision of this chapter relating to 
a tobacco product modifies or otherwise affects any action or the 
liability of any person under the product liability law of any State.

``SEC. 915. EQUAL TREATMENT OF RETAIL OUTLETS.

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

``SEC. 916. ACCESS AND MARKETING RESTRICTIONS.

    ``(a) Definitions.--In this section:
            ``(1) Adult.--The term `adult' means any person who is 
        older than the minimum age at which it is legal to purchase or 
        possess (whichever minimum age is older) tobacco products.
            ``(2) Adult-only facility.--
                    ``(A) In general.--The term `adult-only facility' 
                means a facility or restricted area (whether open-air 
                or enclosed) where the operator ensures or has a 
                reasonable basis to believe (such as by checking 
                identification as required under State law, or by 
checking the identification of any person appearing to be under the age 
of 27) that only adults are present.
                    ``(B) Temporary adult-only facility.--A facility or 
                restricted area need not be permanently restricted to 
                adults in order to constitute an adult-only facility, 
                if the operator ensures or has a reasonable basis to 
                believe that only adults are present during the event 
                or time period in question.
            ``(3) Brand name.--
                    ``(A) In general.--The term `brand name' means a 
                brand name (alone or in conjunction with any other 
                word), trademark, logo, symbol, motto, selling message, 
                recognizable pattern of colors, or any other indicia of 
                product identification identical or similar to, or 
                identifiable with, those used for any domestic brand of 
                tobacco products.
                    ``(B) Exclusion.--The term `brand name' shall not 
                include the corporate name of any tobacco product 
                manufacturer that does not, after the date of enactment 
                of the Tobacco Livelihood and Economic Assistance for 
                Our Farmers Act of 2002, sell a brand of tobacco 
                products in the United States that includes the 
                corporate name.
    ``(b) Cigarette and Smokeless Tobacco Product Requirements.--
            ``(1) Minimum sales age.--No retailer may sell a tobacco 
        product to any person younger than 18 years of age.
            ``(2) Proof of age.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), each retailer shall verify by means 
                of photographic identification containing the bearer's 
                date of birth that no person purchasing the product is 
                younger than 18 years of age.
                    ``(B) Maximum age.--No such verification is 
                required for any person over the age of 26.
            ``(3) Enforcement by states.--
                    ``(A) In general.--The Secretary may enter into an 
                agreement with a State if--
                            ``(i) the State has in effect a State law 
                        that is at least as restrictive as this 
                        subsection under which the State agrees to 
                        enforce the State law in a manner reasonably 
                        designed to prevent the violation of the State 
                        law; and
                            ``(ii) the Secretary provides a grant to 
                        the State for the purpose of enforcing the 
                        State law.
                    ``(B) Authority of secretary.--No action taken by 
                the Secretary under subparagraph (A) limits the 
                authority of the Secretary under this subsection.
            ``(4) Mail order sales.--Not later than 2 years after the 
        date of enactment of the Tobacco Livelihood and Economic 
        Assistance for Our Farmers Act of 2002, the Secretary shall 
        submit to Congress a report describing the extent, if any, to 
        which individuals younger than 18 years of age are obtaining 
        tobacco products through the mail.
    ``(c) Minimum Package Size Requirements.--
            ``(1) Minimum number of cigarettes.--No manufacturer, 
        distributor, or retailer may sell or cause to be sold, or 
        distribute or cause to be distributed, any cigarette package 
        that contains fewer than 20 cigarettes.
            ``(2) Opening tobacco product packages.--No retailer may 
        break or otherwise open any tobacco product package to sell or 
        distribute individual cigarettes or a number of unpackaged 
        cigarettes that is smaller than--
                    ``(A) the quantity in the minimum cigarette package 
                size provided under paragraph (1); or
                    ``(B) any quantity of another tobacco product that 
                is smaller than the smallest package distributed by the 
                manufacturer for individual consumer use.
    ``(d) Prohibition on Youth Access to Free Samples.--
            ``(1) Definition of free sample.--In this subsection, the 
        term `free sample' does not include a tobacco product that is 
        provided to an adult in connection with--
                    ``(A) the purchase, exchange or redemption for 
                proof of purchase of any tobacco product (including a 
                free offer in connection with the purchase of a tobacco 
                product, such as a 2-for-1 offer); or
                    ``(B) the conducting of consumer testing or 
                evaluation of a tobacco product with persons who 
                certify that they are adults.
            ``(2) Prohibition.--No manufacturer, distributor, or 
        retailer may distribute or cause to be distributed any free 
        sample of a tobacco product, except in an adult-only facility.
    ``(e) Vending Machines, Self-Service Displays, Mail-Order Sales, 
and Other Impersonal Modes of Sale.--
            ``(1) Definition of self-service display.--In this 
        subsection, the term `self-service display' means any display 
        located in an area in which the customer has access to the 
        tobacco products without the aid of a sales clerk.
            ``(2) Requirement.--Except as provided in paragraph (3), a 
        retailer may sell a tobacco product--
                    ``(A) only in a direct, face-to-face exchange 
                between the retailer and the consumer; and
                    ``(B) not through a method of sale such as a 
                vending machine or self-service display.
            ``(3) Permitted methods.--The following methods of sale of 
        tobacco products shall be permitted under this subsection:
                    ``(A) Mail-order sales, excluding mail-order 
                redemption of coupons and distribution of free samples 
                through the mail.
                    ``(B) Vending machines that are located in an 
                adult-only facility.
    ``(f) Prohibition on Youth Targeting.
            ``(1) Definition of youth.--In this subsection, the term 
        `youth' means any person or persons under 18 years of age.
            ``(2) Prohibition.--No manufacturer, distributor, or 
        retailer may take--
                    ``(A) any action, directly or indirectly, to target 
                youth in the advertising, promotion, or marketing of 
                tobacco products; or
                    ``(B) any action the primary purpose of which is to 
                initiate, maintain, or increase the incidence of youth 
                smoking.
    ``(g) Prohibition on Use of Cartoons.--
            ``(1) Definition of cartoon.--In this subsection:
                    ``(A) In general.--The term `cartoon' means any 
                drawing or other depiction of an object, person, 
                animal, or creature, or any similar caricature, that 
                satisfies any of the following criteria:
                            ``(i) The use of comically exaggerated 
                        features.
                            ``(ii) The attribution of human 
                        characteristics to animals, plants, or other 
                        objects, or the similar use of anthropomorphic 
                        technique.
                            ``(iii) The attribution of unnatural or 
                        extrahuman abilities, such as imperviousness to 
                        pain or injury, X-ray vision, tunneling at very 
                        high speeds, or transformation.
                    ``(B) Inclusion.--The term `cartoon' includes a 
                drawing or other depiction of the character popularly 
                known as `Joe Camel'.
                    ``(C) Exclusions.--The term `cartoon' does not 
                include any drawing or other depiction that, on July 1, 
                1998, was in use in the United States in any 
                manufacturer's corporate logo or in any manufacturer's 
                tobacco product packaging.
            ``(2) Prohibition.--No manufacturer, distributor, or 
        retailer may use or cause to be used any cartoon in the 
        advertising, promoting, packaging, or labeling of tobacco 
        products.
    ``(h) Prohibition on Outdoor Advertising.--
            ``(1) Definitions.--In this subsection:
                    ``(A) Outdoor advertising.--
                            ``(i) In general.--The term `outdoor 
                        advertising' means advertising through--
                                    ``(I) billboards;
                                    ``(II) signs and placards in 
                                arenas, stadiums, shopping malls, and 
                                video game arcades (regardless of 
                                whether located in the open air or 
                                enclosed); and
                                    ``(III) any other advertisements 
                                placed--
                                            ``(aa) outdoors; or
                                            ``(bb) on the inside 
                                        surface of a window facing 
                                        outward.
                            ``(ii) Exclusions.--The term `outdoor 
                        advertising' does not include--
                                    ``(I) an advertisement on the 
                                outside of a tobacco product 
                                manufacturing facility;
                                    ``(II) an individual advertisement 
                                that--
                                            ``(aa) does not occupy an 
                                        area larger than 14 square 
                                        feet;
                                            ``(bb) is not placed in 
                                        such proximity to any other 
                                        such advertisement so as to 
                                        create a single mosaic-type 
                                        advertisement larger than 14 
                                        square feet;
                                            ``(cc) does not function 
                                        solely as a segment of a larger 
                                        advertising unit or series; and
                                            ``(dd) is placed on the 
                                        outside of any retail 
                                        establishment that sells 
                                        tobacco products (other than 
                                        solely through a vending 
                                        machine), on the outside (but 
                                        on the property of) any such 
                                        establishment, or on the inside 
                                        surface of a window facing 
                                        outward in any such 
                                        establishment; or
                                    ``(III) an advertisement inside a 
                                retail establishment that sells tobacco 
                                products (other than solely through a 
                                vending machine) that is not placed on 
                                the inside surface of a window facing 
                                outward.
                    ``(B) Video game arcade.--The term `video game 
                arcade' means an entertainment establishment primarily 
                consisting of video games (other than video games 
                intended primarily for use by persons 18 years of age 
                or older) or pinball machines.
            ``(2) Prohibition.--No manufacturer, distributor, or 
        retailer may place or cause to be placed any outdoor 
        advertisement for tobacco products.
    ``(i) Prohibition on Transit Advertisements.--
            ``(1) Definition of transit advertisement.--In this 
        subsection:
                    ``(A) In general.--The term `transit advertisement' 
                means--
                            ``(i) advertising on or within a private or 
                        public vehicle; and
                            ``(ii) an advertisement placed at, on, or 
                        within any bus stop, taxi stand, transportation 
                        waiting area, train station, airport, or any 
                        similar location.
                    ``(B) Exclusion.--The term `transit advertisement' 
                does not include any advertisement placed in, on, or 
                outside the premises of any retail establishment that 
                sells tobacco products (other than solely through a 
                vending machine), unless the individual advertisement--
                            ``(i) occupies an area larger than 14 
                        square feet;
                            ``(ii) is placed in such proximity to any 
                        other such advertisement so as to create a 
                        single mosaic-type advertisement larger than 14 
                        square feet; or
                            ``(iii) functions solely as a segment of a 
                        larger advertising unit or series.
            ``(2) Prohibition.--No manufacturer, distributor, or 
        retailer may place or cause to be placed any transit 
        advertisement advertising tobacco products.
    ``(j) Prohibition on Advertising in Youth-Oriented Publications.--
            ``(1) Definition of youth-oriented publication.--In this 
        subsection, the term `youth-oriented publication' means a 
        newspaper, magazine, periodical, or other publication--
                    ``(A) at least 15 percent of the total readership 
                of which is comprised of readers younger than 18 years 
                of age, as measured by competent and reliable survey 
                evidence; or
                    ``(B) that is read by 2,000,000 or more persons 
                younger than 18 years of age, as measured by competent 
                and reliable survey evidence.
            ``(2) Prohibition.--No manufacturer, distributor, or 
        retailer shall advertise a tobacco product in any youth-
        oriented publication, regardless of whether the publication has 
periodic or limited distribution.
    ``(k) Prohibition on Tobacco Product Brand Name Sponsorships.--
            ``(1) In general.--No manufacturer, distributor, or 
        retailer may sponsor or cause to be sponsored any athletic, 
        musical, artistic, or other social or cultural event, or any 
        entry or team in any event, using the brand name (alone or in 
        conjunction with any other word), logo, symbol, motto, selling 
        message, recognizable color or pattern of colors, or any other 
        indicia of product identification identical or similar to, or 
        identifiable with, that used for any brand of cigarettes or 
        smokeless tobacco.
            ``(2) Exceptions.--Nothing in this subsection prevents a 
        manufacturer, distributor, or retailer from sponsoring or 
        causing to be sponsored any athletic, musical, artistic, or 
        other social or cultural event, or team or entry, in the name 
        of the corporation that manufactures the tobacco product, if--
                    ``(A) both the corporate name and the corporation 
                were registered and in use in the United States before 
                January 1, 2001; and
                    ``(B) the corporate name does not include any brand 
                name (alone or in conjunction with any other word), 
                logo, symbol, motto, selling message, recognizable 
                color or pattern of colors, or any other indicia of 
                product identification identical or similar to, or 
                identifiable with, that used for any brand of 
                cigarettes or smokeless tobacco.
            ``(3) Adult-only facilities.--This subsection shall not 
        apply to any event sponsored in an adult-only facility.
    ``(l) Prohibition on Tobacco Brand Name Merchandise.--
            ``(1) In general.--No manufacturer may market, distribute, 
        offer, sell, license or cause to be marketed, distributed, 
        offered, sold, or licensed (including by catalog or direct 
        mail), any apparel or other merchandise that bears the brand 
        name of a tobacco product, other than items the sole function 
        of which is to advertise tobacco products or written or 
        electronic publications.
            ``(2) Exceptions.--Nothing in this subsection shall--
                    ``(A) prohibit the distribution to any 
                manufacturer's employee who is an adult of any item 
                described in paragraph (1) that is intended for the 
                personal use of the employee;
                    ``(B) require any manufacturer to retrieve, 
                collect, or otherwise recover any item that, before the 
                date of enactment of the Tobacco Livelihood and 
                Economic Assistance for Our Farmers Act of 2002, was 
                marketed, distributed, offered, sold, licensed, or 
                caused to be marketed, distributed, offered, sold, or 
                licensed by the manufacturer;
                    ``(C) apply to coupons or other items used by 
                adults solely in connection with the purchase of 
                tobacco products; or
                    ``(D) apply to apparel or other merchandise used 
                within an adult-only facility that is not distributed 
                (by sale or otherwise) to any member of the general 
                public.
    ``(m) Prohibition on Gifts to Underage Persons Based on Proofs of 
Purchase.--
            ``(1) In general.--No manufacturer, distributor, or 
        retailer may provide or cause to be provided to any person, 
        without sufficient proof that the person is an adult, any item 
        in exchange for the purchase of tobacco products, or the 
        furnishing of credits, proofs-of-purchase, or coupons with 
        respect to such a purchase.
            ``(2) Proof of age.--
                    ``(A) In general.--For purposes of paragraph (1), a 
                driver's license or other government-issued 
                identification (or legible photocopy of the license or 
                identification), the validity of which is certified by 
                the person to whom the item is provided, shall by 
                itself be deemed to be a sufficient form of proof of 
                age.
                    ``(B) Retailers.--In the case of items provided (or 
                to be redeemed) at retail establishments, a 
                manufacturer shall be entitled to rely on verification 
                of proof of age by the retailer, if the retailer is 
                required to obtain verification under applicable 
                Federal, State, or local law.
    ``(n) Prohibition on Non-Tobacco Product Brand Names.--
            ``(1) Definition of other valuable consideration.--In this 
        subsection, the term `other valuable consideration' does not 
        include an agreement between 2 entities that enter into an 
        agreement for the sole purpose of avoiding infringement claims.
            ``(2) Prohibition.--Except as provided in paragraph (3), no 
        manufacturer may, pursuant to any agreement requiring the 
        payment of money or other valuable consideration, use or cause 
        to be used as a brand name of any tobacco product--
                    ``(A) any nationally recognized or nationally 
                established brand name or trade name of any non-tobacco 
                item or service; or
                    ``(B) any nationally recognized or nationally 
                established sports team, entertainment group, or 
                individual celebrity.
            ``(3) Nonapplicability.--Paragraph (2) shall not apply to 
        any tobacco product brand name in existence as of July 1, 1998.
    ``(o) Limitation on Third Party Use of Tobacco Brand Names.--
            ``(1) In general.--No manufacturer may license or otherwise 
        expressly authorize any third party to use or advertise any 
        brand name of a tobacco product in a manner prohibited by this 
        chapter if used or advertised by the manufacturer itself.
            ``(2) Exceptions.--Nothing in this subsection requires any 
        manufacturer to retrieve, collect, or otherwise recover any 
        item that, before the date of enactment of the Tobacco 
        Livelihood and Economic Assistance for Our Farmers Act of 2002, 
        was marketed, distributed, offered, sold, licensed, or 
caused to be marketed, distributed, offered, sold, or licensed by the 
manufacturer.
    ``(p) Prohibition on Product Placement in Certain Media.--
            ``(1) In general.--Except as provided in paragraph (2), no 
        manufacturer may make, or cause to be made, any payment or 
        other consideration to any other person or entity to use, 
        display, make reference to, or use as a prop any tobacco 
        product, tobacco product package, advertisement for a tobacco 
        product, or any other item bearing a brand name in any motion 
        picture, television show, theatrical production or other live 
        performance, live or recorded performance of music, commercial 
        film or video, or video game (collectively referred to in this 
        subsection as `media').
            ``(2) Exceptions.--Paragraph (1) shall not apply to--
                    ``(A) media the audience or viewers of which are 
                within an adult-only facility, if the media are not 
                visible to persons outside the adult-only facility;
                    ``(B) media not intended for distribution or 
                display to the public; or
                    ``(C) instructional media concerning non-
                conventional tobacco products or tobacco products 
                designated as reduced exposure tobacco products or 
                reduced risk tobacco products viewed only by or 
                provided only to consumers who are adults.
    ``(q) Effective Dates.--
            ``(1) In general.--Except as provided in paragraph (2), 
        this section shall apply beginning on the date that is 180 days 
        after the date of enactment of the Tobacco Livelihood and 
        Economic Assistance for Our Farmers Act of 2002.
            ``(2) Vending machines; sponsorships.--Subsections (e) and 
        (k) shall apply beginning on the date that is 1 year after the 
        date of enactment of that Act.

``SEC. 917. MANDATORY DISCLOSURES.

    ``(a) Disclosure of Ingredients to the 
Public.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of the Tobacco Livelihood and Economic Assistance for 
        Our Farmers Act of 2002, except as otherwise provided in this 
        subsection, the Secretary shall promulgate regulations 
        requiring the disclosure to the public on a brand-by-brand 
        basis of the common or usual name of each ingredient of a 
        tobacco product in descending order of predominance by weight.
            ``(2) Spices, flavorings, and colorings.--A manufacturer 
        may elect to designate spices, flavorings, and colorings under 
        paragraph (1) without naming each spice, flavoring, or 
        coloring.
            ``(3) Other laws.--Any ingredient that has been disclosed 
        to the public pursuant to any other law (including regulations) 
        with respect to a particular brand may be required to be 
        disclosed for the brand pursuant to this subsection.
            ``(4) Incidental additives.--The regulations required by 
        this subsection shall provide that incidental additives that 
        are present in a tobacco product at insignificant levels and 
        that do not have any technical or functional effect in the 
        finished tobacco product shall be exempt from disclosure.
            ``(5) Small quantities.--The requirement of this subsection 
        to disclose ingredients in descending order of predominance 
        shall not apply to ingredients in quantities of 2 percent or 
        less by weight if a listing of the ingredients is placed at the 
        end of the ingredients statement following an appropriate 
        quantifying statement, such as `contains ____ percent or less 
        of ____', or `less than ____ percent of ____'.
            ``(6) Means of disclosure.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), any disclosure required pursuant to 
                this subsection may be required by appropriate means.
                    ``(B) Listing of ingredients.--Notwithstanding any 
                other provision of this Act, the Secretary shall not 
                require the listing of any ingredient of a tobacco 
                product on any package or in any advertisement.
    ``(b) Disclosure of Percentage of Domestic and Foreign Tobacco.--
Not later than 1 year after the date of enactment of the Tobacco 
Livelihood and Economic Assistance for Our Farmers Act of 2002, the 
Secretary shall promulgate regulations that require that each package 
of a tobacco product disclose, with respect to the tobacco contained in 
that brand--
            ``(1) the percentage of tobacco that is domestic tobacco; 
        and
            ``(2) the percentage of tobacco that is foreign tobacco.
    ``(c) Mandatory Disclaimer.--
            ``(1) In general.--Except as otherwise provided in this 
        subsection, any tobacco product advertising that includes a 
        term classifying a brand of tobacco product according to the 
        tar yield or the yield of the brand to consumers of any 
        substance, including terms such as `light' or `low tar', shall 
        also include the following disclaimer: `[Brand] not shown to be 
        less hazardous than other [type of tobacco product]'.
            ``(2) Filtered.--This section shall apply to the use of the 
        terms `filtered' or `filter'.
            ``(3) Tobacco product packages.--A disclaimer described in 
        paragraph (1) shall not be required on any tobacco product 
        package.
            ``(4) Use of terms.--Not later than 1 year after the date 
        of enactment of the Tobacco Livelihood and Economic Assistance 
        for Our Farmers Act of 2002, the Secretary shall promulgate 
        regulations relating to the use of the terms described in 
        paragraph (1) to ensure that the terms are not false or 
        misleading.
            ``(5) Reduced exposure and reduced risk tobacco products.--
        The Secretary may modify or waive any requirement under this 
        subsection with respect to any product that has been designated 
        by the  Secretary as a reduced exposure tobacco product or a 
reduced risk tobacco product under section 913.

``SEC. 918. REGULATORY RECORD.

    ``(a) In General.--Notwithstanding subchapter II of chapter 5 of 
title 5, United States Code, in promulgating regulations under this 
chapter, the record developed and used 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 the regulations), shall be deemed to have the same legal 
status as if the record had been developed under a rulemaking 
proceeding conducted pursuant to section 907(d)(1).
    ``(b) Other Respects.--In all other respects (including the issue 
of whether the regulations conform to section 907(d)(1)), the 
procedural requirements of this chapter and subchapter II of chapter 5, 
and chapter 7, of title 5, United States Code (commonly known as the 
`Administrative Procedure Act') shall apply to this chapter.

``SEC. 919. REGULATION REQUIREMENT.

    ``(a) Testing, Reporting, and Disclosure.--Not later than 2 years 
after the date of enactment of the Tobacco Livelihood and Economic 
Assistance for Our Farmers Act of 2002, the Secretary, acting through 
the Commissioner of Food and Drugs, shall promulgate regulations under 
this Act that meet the requirements of subsection (b).
    ``(b) Contents of Rules.--
            ``(1) In general.--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.
            ``(2) Constituents.--The constituents shall include tar, 
        nicotine, carbon monoxide, and such other smoke constituents or 
        ingredients as the Secretary may determine to be appropriate.
            ``(3) Administration.--The rules may require that tobacco 
        product manufacturers, packagers, or importers make--
                    ``(A) the disclosures relating to tar and nicotine 
                through labels or advertising; and
                    ``(B) the disclosures regarding other smoke 
                constituents or ingredients that the Secretary 
                determines are necessary to protect the public health.
    ``(c) Authority.--The Secretary, acting through the Commissioner of 
Food and Drugs, shall have authority to conduct or to require the 
testing, reporting, or disclosure of tobacco product smoke 
constituents.''.

SEC. 513. CONFORMING AND TECHNICAL AMENDMENTS.

    (a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended--
            (1) in subsections (a), (b), (c), (g), (h), and (k), by 
        inserting ``tobacco product,'' after ``device,'' each place it 
        appears;
            (2) in subsection (e), by striking ``515(f), or 519'' and 
        inserting ``515(f), 519, or 910'';
            (3) in subsection (j), by striking ``708, or 721'' and 
        inserting ``708, 721, 904, 905, 906, 907, 908, 909, 910, 911, 
        or 913'';
            (4) by striking subsection (p) and inserting the following:
    ``(p) The failure--
            ``(1) to register in accordance with section 510 or 906;
            ``(2) to provide any information required by section 
        510(j), 510(k), 906(i), or 906(j); or
            ``(3) to provide a notice required by section 510(j)(2) or 
        906(j)(2).'';
            (5) in subsection (q)--
                    (A) 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), 907(f), or 909;
            ``(B) to furnish any notification or other material or 
        information required by or under section 519, 520(g), 905, 
        907(f), or 910; or
            ``(C) to comply with a requirement under section 522.''; 
        and
                    (B) in paragraph (2), by striking ``device,'' and 
                inserting ``device or tobacco product,'';
            (6) in subsection (r), by inserting ``or tobacco product'' 
        after ``device'' each place it appears; and
            (7) by adding at the end the following:
    ``(bb) The sale of a tobacco product in violation of a no-tobacco-
sale order issued under section 303(g)(3).''.
    (b) Penalties.--Section 303(g) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333(g)) is amended--
            (1) by striking ``(g)(1)(A) Except'' and inserting the 
        following:
    ``(g) Civil Penalties.--
            ``(1) In general.--
                    ``(A) Penalty.--Except'';
            (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) No-tobacco-sale orders.--
                    ``(A) In general.--If the Secretary finds that a 
                person has committed repeated violations of 
                restrictions promulgated under section 906(d) at a 
                particular retail outlet, the Secretary may impose a 
                no-tobacco-sale order on the person prohibiting the 
                sale of tobacco products in the outlet.
                    ``(B) Civil penalties.--A no-tobacco-sale order may 
                be imposed with a civil penalty under paragraph (1).'';
            (5) in paragraph (4) (as redesignated by paragraph (3))--
                    (A) in subparagraph (A)--
                            (i) in the first sentence, by striking 
                        ``assessed'' the first place it appears 
and inserting ``assessed, or a no-tobacco-sale order may be imposed,''; 
and
                            (ii) in the second sentence, by striking 
                        ``penalty'' and inserting ``penalty, or on whom 
                        a no-tobacco-order is to be imposed,'';
                    (B) in subparagraph (B)--
                            (i) by striking ``(B) In'' and inserting 
                        the following:
                    ``(B) Administration.--
                            ``(i) Factors.--In''
                            (ii) by inserting after ``penalty'' the 
                        following: ``or the period to be covered by a 
                        no-tobacco-sale order,''; and
                            (iii) by adding at the end the following:
                            ``(ii) No-tobacco-sale orders.--A no-
                        tobacco-sale order permanently prohibiting an 
                        individual retail outlet from selling tobacco 
                        products shall include provisions that allow 
                        the outlet, after a specified period of time, 
                        to request that the Secretary compromise, 
                        modify, or terminate the order.''; and
                    (C) by adding at the end the following:
                    ``(D) Compromise, modification, or termination of 
                no-tobacco-sale orders.--The Secretary may compromise, 
                modify, or terminate, with or without conditions, any 
                no-tobacco-sale order.'';
            (6) in paragraph (5) (as redesignated by paragraph (3))--
                    (A) in the first sentence--
                            (i) by striking ``(3)(A)'' and inserting 
                        ``(4)(A)''; and
                            (ii) by inserting ``or the imposition of a 
                        no-tobacco-sale order'' after ``penalty'' the 
                        first 2 places it appears; and
                    (B) in the second sentence, by inserting before the 
                period at the end the following: ``, or on which the 
                no-tobacco-sale order was imposed, as the case may 
                be''; and
            (7) in paragraph (6) (as redesignated by paragraph (3)), by 
        striking ``paragraph (4)'' each place it appears and inserting 
        ``paragraph (5)''.
    (c) Seizure.--Section 304 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 334) is amended--
            (1) in subsection (a)(2)--
                    (A) by striking ``and'' before ``(D)''; and
                    (B) by inserting before the period at the end the 
                following: ``, and (E) Any adulterated or misbranded 
                tobacco product'';
            (2) in the first sentence of subsection (d)(1), by 
        inserting ``tobacco product,'' after ``device,''; and
            (3) in subsection (g), by inserting ``or tobacco product'' 
        after ``device'' each place it appears.
    (d) Examinations and Investigations.--Section 702(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 372(a)) is amended--
            (1) by striking the section heading through ``(a) The 
        Secretary'' and inserting the following:

``SEC. 702. EXAMINATIONS AND INVESTIGATIONS.

    ``(a) In General.--
            ``(1) Authority.--The Secretary''; and
            (2) by adding at the end the following:
            ``(2) Tobacco products.--In the case of a tobacco product, 
        to the maximum extent practicable, the Secretary shall contract 
        with States in accordance with paragraph (1) to carry out 
        inspections of retailers in connection with the enforcement of 
        this Act.''.
    (e) Records of Interstate Shipment.--Section 703 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 373) is amended--
            (1) by inserting ``tobacco products,'' after ``devices,'' 
        each place it appears; and
            (2) by inserting ``tobacco product,'' after ``device,'' 
        each place it appears.
    (f) Factory Inspection.--Section 704 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374) is amended--
            (1) in subsection (a)(1), by inserting ``tobacco 
        products,'' after ``devices,'' each place it appears; and
            (2) in subsection (b), by inserting ``tobacco product,'' 
        after ``device,''.
    (g) Publicity.--Section 705(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 375(b)) is amended in the first sentence by 
inserting ``tobacco products,'' after ``devices,''.
    (h) Presumption.--Section 709 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S. C. 379) is amended by inserting ``tobacco 
product,'' after ``device,''.
    (i) Imports and Exports.--Section 801 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 381) is amended--
            (1) in subsection (a)--
                    (A) in the first sentence, by inserting ``tobacco 
                products,'' after ``devices,'';
                    (B) in the second sentence, by striking 
                ``subsection (i) of section 510'' and inserting 
                ``section 510(i) or 906(j)''; and
                    (C) by striking ``drugs or devices'' each place it 
                appears and inserting ``drugs, devices, or tobacco 
                products''; and
            (2) in subsection (e)(1), by inserting ``tobacco product,'' 
        after ``device,''.
    (j) Food and Drug Administration.--Section 1003(d)(2)(C) of the 
Federal Food, Drug, and Cosmetic Act (as redesignated by section 
512(2)) is amended by striking ``and devices'' and inserting ``devices, 
and tobacco products''.
    (k) Effective Date for No-Tobacco-Sale Order Amendments.--The 
amendments made by subsection (a), other than the amendment to section 
301(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(b)) 
made by subsection (a)(1), shall take effect only on the promulgation 
of final regulations by the Secretary of Health and Human Services--
            (1) defining the term ``repeated violation'', as used in 
        section 303(g) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 333(g)) (as amended by subsection (b)), 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 the 
        outlet;
            (4) establishing a period of time during which, if there 
        are no violations by a particular retail outlet, the outlet 
        will not be 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.

             Subtitle B--Cigarette Labeling and Advertising

SEC. 521. DEFINITION OF CIGARETTE.

    Section 3(1) of the Federal Cigarette Labeling and Advertising Act 
(15 U.S.C. 1332) is amended--
            (1) in subparagraph (A), by striking ``and'' at the end;
            (2) in subparagraph (B), by striking the period at the end 
        and inserting ``; and''; and
            (3) by adding at the end the following:
                    ``(C) any tobacco product, in any form (including 
                Bidi and Kretek cigarettes), if--
                            ``(i) the tobacco in the product--
                                    ``(I) is heated or burned; and
                                    ``(II) is functional in the 
                                product; and
                            ``(ii) the product, because of the 
                        appearance of the product, the type of tobacco 
                        used in the filler, or the packaging and 
                        labeling of the product, is likely to be 
                        offered to, or purchased by, consumers as a 
                        cigarette or as roll-your-own tobacco.''.

SEC. 522. 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, 1 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) Format.--
                    ``(A) Location.--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.
                    ``(B) Percentage of panels.--Except as provided in 
                subparagraph (C), each label statement shall comprise 
                at least the top 25 percent of the front and rear 
                panels of the package.
                    ``(C) Text.--
                            ``(i) In general.--Except as provided in 
                        clause (ii), the word `WARNING' shall appear in 
                        capital letters and all text shall be in 
                        conspicuous and legible 17-point type.
                            ``(ii) Smaller type size.--If the text of 
                        the label statement would occupy more than 70 
                        percent of the area of a panel, the text may be 
                        in a smaller conspicuous and legible type size, 
                        if at least 60 percent of the area of the panel 
                        is occupied by required text.
                            ``(iii) Contrast.--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).
                    ``(D) Flip-top boxes.--
                            ``(i) In general.--For any cigarette brand 
                        package manufactured or distributed before 
                        January 1, 2000, that employs a flip-top style 
                        (if the packaging was used for that brand in 
                        commerce before June 21, 1997), the label 
                        statement required by paragraph (1) shall be 
                        located on the flip-top area of the package, 
                        even if the area is less than 25 percent of the 
                        area of the front panel.
                            ``(ii) Packages.--Except as provided in 
                        clause (i), the provisions of this subsection 
                        shall apply to the package.
            ``(3) Foreign distribution.--This subsection does not apply 
        to a tobacco product manufacturer or distributor of cigarettes 
        that does not manufacture, package, or import cigarettes for 
        sale or distribution within the United States.
            ``(4) Tar, nicotine, and other smoke constituent disclosure 
        to the public.--
                    ``(A) In general.--The Secretary shall, by a 
                rulemaking conducted under section 553 of title 5, 
                United States Code, determine (in the Secretary's sole 
                discretion) whether cigarette and other tobacco product 
                manufacturers shall be required to include in the area 
                of each cigarette advertisement specified by subsection 
                (b), or on the package label, or both, the tar and 
                nicotine yields of the advertised or packaged brand.
                    ``(B) Method.--Any such disclosure shall--
                            ``(i) be in accordance with the methodology 
                        established under the regulations;
                            ``(ii) conform to the type size 
                        requirements of subsection (b); and
                            ``(iii) appear within the area specified in 
                        subsection (b).
            ``(C) Consistency with ftc reporting requirements.--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.
            ``(D) Smoke constituents.--
                    ``(i) In general.--In addition to the disclosures 
                required by subparagraph (A), 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.
                    ``(ii) Conditions.--Any disclosure under this 
                subparagraph may be required if the Secretary 
                determines that disclosure would--
                            ``(I) be of benefit to the public health; 
                        or
                            ``(II) otherwise increase consumer 
                        awareness of the health consequences of the use 
                        of tobacco products.
                    ``(iii) Face of cigarette package or 
                advertisement.--No disclosure shall be required under 
                this subparagraph on the face of any cigarette package 
                or advertisement.
                    ``(iv) Other means.--Nothing in this section 
                prohibits the Secretary from requiring disclosure under 
                this subparagraph 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.).
    ``(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 the advertising for the 
        cigarette bears, in accordance with this section, 1 of the 
        labels specified in subsection (a)(1).
            ``(2) Format.--
                    ``(A) In general.--Each label statement required by 
                subsection (a) in cigarette advertising shall comply 
                with the standards set forth in this paragraph.
                    ``(B) Press and poster advertisements.--In the case 
                of a press or poster advertisement, each such statement 
                and (if applicable) any required statement relating to 
                tar, nicotine, or other constituent yield shall--
                            ``(i) comprise at least 20 percent of the 
                        area of the advertisement; and
                            ``(ii) appear in a conspicuous and 
                        prominent format and location at the top of 
                        each advertisement within the border area.
                    ``(C) Revision of type sizes.--The Secretary may 
                revise the required type sizes in the border area in 
                such manner as the Secretary determines appropriate.
                    ``(D) Text.--
                            ``(i) In general.--The word `WARNING' shall 
                        appear in capital letters, and each label 
                        statement shall appear in conspicuous and 
                        legible type.
                            ``(ii) Contrast.--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).
                    ``(E) Border.--The label statement shall be 
                enclosed by a rectangular border that is--
                            ``(i) the same color as the letters of the 
                        statement; and
                            ``(ii) the width of the first downstroke of 
                        the capital `W' of the word `WARNING' in the 
                        label statement.
                    ``(F) Typeface.--The text of the label statement 
                shall be in a typeface pro rata to the following 
                requirements:
                            ``(i) 45-point type for a whole-page 
                        broadsheet newspaper advertisement.
                            ``(ii) 39-point type for a half-page 
                        broadsheet newspaper advertisement.
                            ``(iii) 39-point type for a whole-page 
                        tabloid newspaper advertisement.
                            ``(iv) 27-point type for a half-page 
                        tabloid newspaper advertisement.
                            ``(v) 31.5-point type for a double page 
                        spread magazine or whole-page magazine 
                        advertisement.
                            ``(vi) 22.5-point type for a 28-centimeter-
                        by-3-column advertisement.
                            ``(vii) 15-point type for a 20-centimeter-
                        by-2-column advertisement.
                    ``(G) Language.--
                            ``(i) In general.--Except as provided in 
                        clauses (ii) and (iii), the label statements 
                        shall be in English.
                            ``(ii) Non-english publications.--In the 
                        case of an advertisement that appears in a 
                        newspaper, magazine, periodical, or other 
                        publication that is not in English, the 
                        statement shall appear in the predominant 
                        language of the publication.
                            ``(iii) Non-english advertisements.--In the 
                        case of any other advertisement that is not in 
                        English, the statement shall appear in the same 
                        language as that principally used in the 
                        advertisement.
            ``(3) Adjustments by secretary.--
                    ``(A) In general.--The Secretary may, through a 
                rulemaking under section 553 of title 5, United States 
                Code--
                            ``(i) adjust the format and type sizes for 
                        the label statements required by this 
                        subsection;
                            ``(ii) adjust the text, format, and type 
                        sizes of any required tar, nicotine yield, or 
                        other constituent disclosures; or
                            ``(iii) 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.).
                    ``(B) Location.--
                            ``(i) In general.--The text of any such 
                        label statements or disclosures adjusted under 
                        this paragraph shall be required to appear only 
                        within the 20 percent area of cigarette 
                        advertisements required under paragraph (2).
                            ``(ii) Regulations.--The Secretary shall 
                        promulgate regulations that provide for 
                        adjustments in the format and type sizes of any 
                        text required to appear in the 20 percent area 
                        to ensure that the total text required to 
                        appear by law will fit within the area.
            ``(4) Marketing requirements.--
                    ``(A) In general.--The label statements specified 
                in subsection (a)(1) shall be randomly displayed--
                            ``(i) in each 12-month period, in as equal 
                        a number of times as is practicable on each 
                        brand of the product; and
                            ``(ii) 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) Quarterly rotation.--The label statements 
                specified in subsection (a)(1) shall be rotated 
                quarterly in alternating sequence in advertisements for 
                each brand of cigarettes in accordance with a plan 
                submitted by the tobacco product manufacturer, 
                importer, distributor, or retailer to, and approved by, 
                the Secretary.
                    ``(C) Approval of plan.--The Secretary shall review 
                each plan submitted under subparagraph (B) and approve 
                the plan 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) ensures 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) 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 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 cigarettes or smokeless tobacco products.''.

     Subtitle C--Smokeless Tobacco Labels and Advertising Warnings

SEC. 531. 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) Labels.--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, 1 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) Format.--
                    ``(A) Location.--Each label statement required by 
                paragraph (1) shall be located on the 2 principal 
                display panels of the package.
                    ``(B) Percent of panel.--Each label statement shall 
                comprise at least 25 percent of each display panel.
                    ``(C) Text.--
                            ``(i) In general.--Except as provided in 
                        clause (ii), under the plan submitted under 
                        subsection (b)(3), each label statement shall 
                        be--
                                    ``(I) in 17-point conspicuous and 
                                legible type; and
                                    ``(II) 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.
                            ``(ii) Smaller type.--If the text of a 
                        label statement would occupy more than 70 
                        percent of the warning area of a package, the 
                        text may appear in a smaller type size, if 
                        least 60 percent of the warning area is 
                        occupied by the label statement.
            ``(3) Concurrent introduction.--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 the products.
            ``(4) Foreign distribution.--This subsection does 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) In general.--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 the advertising for the product bears, in 
        accordance with this section, 1 of the labels specified in 
        subsection (a)(1).
            ``(2) Standards.--
                    ``(A) In general.--Each label statement required by 
                subsection (a) in smokeless tobacco advertising shall 
                comply with the standards set forth in this paragraph.
                    ``(B) Press and poster advertisements.--For press 
                and poster advertisements, each such statement and 
                (where applicable) any required statement relating to 
                tar, nicotine, or other constituent yield shall--
                            ``(i) 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
                            ``(ii) the word `WARNING' shall appear in 
                        capital letters and each label statement shall 
                        appear in conspicuous and legible type.
                    ``(C) Text.--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) Marketing requirements.--
                    ``(A) In general.--The label statements specified 
                in paragraph (1) shall be randomly displayed--
                            ``(i) in each 12-month period, in as equal 
                        a number of times as is practicable on each 
                        brand of the product; and
                            ``(ii) 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) Quarterly rotation.--The label statements 
                specified in paragraph (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) Approval of plan.--The Secretary shall review 
                each plan submitted under subparagraph (B) and approve 
                the plan if the plan, as determined by the Secretary--
                            ``(i) will provide for the equal 
                        distribution and display on packaging and the 
                        rotation required in advertising under this 
                        subsection; and
                            ``(ii) ensures 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.
    ``(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 this section (subject to the 
limitations on proportional size of the warning required under this 
section), or establish the format, type size, and text of any other 
disclosures required under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.), if the Secretary finds that such a change would 
promote greater public understanding of the risks associated with the 
use of smokeless tobacco products.''.

                       Subtitle D--Administration

SEC. 541. FTC JURISDICTION NOT AFFECTED.

    (a) In General.--Except as otherwise expressly provided in this Act 
or an amendment made by this Act, nothing in this Act or an amendment 
made by this Act limits or diminishes the authority of the Federal 
Trade Commission to enforce the laws under the jurisdiction of the 
Commission with respect to the advertising, sale, or distribution of 
tobacco products.
    (b) Enforcement by FTC.--Any advertising that violates this Act or 
an amendment made by this Act shall be considered--
            (1) an unfair or deceptive act or practice under section 
        5(a) of the Federal Trade Commission Act (15 U.S.C. 45(a)); and
            (2) a violation of a rule promulgated under section 18 of 
        that Act (15 U.S.C. 57a).
                                 <all>