Directs: (1) the Secretary of Agriculture to establish in the Department of Agriculture the Tobacco Quality Board; and (2) the Secretary of Health and Human Services (Secretary) to assess fees on tobacco product manufacturers and importers that sell tobacco products in U.S. domestic commerce.
Amends the Federal Food, Drug, and Cosmetic Act to extend Food and Drug Administration regulatory authority to tobacco products, with exceptions for certain health-or disease treatment-related uses. Sets forth provisions respecting: (1) adulterated and misbranded tobacco products; (2) required health information; (3) registration and recordkeeping; (4) control of tobacco products; (5) performance standards; (6) remedies; (7) premarket review; (8) judicial review; (9) reduced risk tobacco products; (10) access and marketing restrictions; (11) mandatory disclosures; (12) testing; and (13) examinations and investigations.
Amends the Federal Cigarette Labeling and Advertising Act and the Comprehensive Smokeless Tobacco Health Education Act of 1986, respectively, to revise cigarette and smokeless tobacco labeling and advertising warning provisions.
Amends the Federal Cigarette Labeling and Advertising Act to: (1) revise the definition of "cigarette"; and (2) direct the Secretary to determine whether cigarette labeling and advertising shall be required to provide tar, nicotine, and other smoke constituent information.
[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>
Introduced in Senate
Read twice and referred to the Committee on Finance. (text of measure as introduced: CR S7109-7126)
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