Everything For Everybody Concerned About Smoking
and Protecting the Rights of Nonsmokers
The Kennedy Comprehensive Tobacco Bill, S.1492 [long download]
105th CONGRESS
1st Session
S. 1492
To amend the Public Health Service Act and the Federal Food, Drug and
Cosmetic Act to prevent the use of tobacco products by minors, to
reduce the level of tobacco addiction, to compensate Federal and State
Governments for a portion of the health costs of tobacco-related
illnesses, to enhance the national investment in biomedical and basic
scientific research, and to expand programs to address the needs of
children, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
November 8, 1997
Mr. Kennedy (for himself, Mr. Lautenberg, Mr. Durbin, Mr. Reed, and Mr.
Kerry) introduced the following bill; which was read twice and referred
to the Committee on Labor and Human Resources
_______________________________________________________________________
A BILL
To amend the Public Health Service Act and the Federal Food, Drug and
Cosmetic Act to prevent the use of tobacco products by minors, to
reduce the level of tobacco addiction, to compensate Federal and State
Governments for a portion of the health costs of tobacco-related
illnesses, to enhance the national investment in biomedical and basic
scientific research, and to expand programs to address the needs of
children, 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 ``Healthy and Smoke
Free Children Act''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings and purposes.
TITLE I--AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT RELATING TO
TOBACCO
Sec. 101. Public health and education programs.
``TITLE XXVIII--PUBLIC HEALTH AND EDUCATION PROGRAMS AND TOBACCO
CONTROL
``Sec. 2801. Definitions.
``Subtitle A--Public Health and Education Programs
``Sec. 2811. Payments to States.
``Sec. 2812. Public health programs.
``Sec. 2813. Biomedical research and child development
investments.
``Sec. 2814. Tobacco victims compensation fund.
``Sec. 2815. Tobacco community transition assistance.
``Subtitle B--National Health Initiatives
``Part 1--National Basic and Child Development Research
``Sec. 2821. National Biomedical, Basic and Child Development
Research Board.
``Sec. 2822. Grants for biomedical and basic research.
``Sec. 2823. Investments in healthy child development and
research projects and training.
``Part 2--Public Health Programs
``Sec. 2825. Research, counter-advertising, and CDC programs.
``Sec. 2826. National tobacco usage reduction and education
block grant program.
``Subtitle C--Reduction in Underage Tobacco Use
``Sec. 2831. Purpose.
``Sec. 2832. Child tobacco use surveys.
``Sec. 2833. Reduction in underage tobacco product usage.
``Sec. 2834. Noncompliance.
``Sec. 2835. Use of amounts.
``Sec. 2836. Miscellaneous provisions.
``Subtitle D--Miscellaneous Provisions
``Sec. 2841. Whistleblower protections.
``Sec. 2842. National Tobacco Document Depository.
``Sec. 2843. Tobacco Oversight and Compliance Board.
``Sec. 2844. Preservation of State and local authority.
``Sec. 2845. Regulations.
TITLE II--FDA JURISDICTION OVER TOBACCO PRODUCTS
Subtitle A--Amendments to the Federal Food, Drug and Cosmetic Act
Sec. 201. Reference.
Sec. 202. Statement of general authority.
Sec. 203. Treatment of tobacco products as drugs and devices.
Sec. 204. General health and safety regulation of tobacco products.
``CHAPTER IX--TOBACCO PRODUCTS
``Sec. 901. Definitions.
``Sec. 902. Purpose.
``Sec. 903. Promulgation of regulations.
``Sec. 904. Minimum requirements.
``Sec. 905. Scientific Advisory Committee.
``Sec. 906. Requirements relating to nicotine and other
constituents.
``Sec. 907. Reduced risk products.
``Sec. 908. Good manufacturing practice standards.
``Sec. 909. Disclosure and reporting of nontobacco ingredients
and constituents.
``Sec. 910. Tobacco product warnings, labeling and packaging.
``Sec. 911. Statement of intended use.
``Sec. 912. Miscellaneous provisions.
TITLE III--STANDARDS TO REDUCE INVOLUNTARY EXPOSURE TO TOBACCO SMOKE
Sec. 301. Standards to reduce involuntary exposure to tobacco smoke.
TITLE IV--TOBACCO MARKET TRANSITION ASSISTANCE
Sec. 401. Definitions.
Subtitle A--Tobacco Quota Buyout Contracts and Producer Transition
Payments
Sec. 411. Quota owner buyout contracts.
Sec. 412. Producer transition payments for quota tobacco.
Sec. 413. Producer transition payments for non-quota tobacco.
Sec. 414. Elements of contracts.
Subtitle B--No Net Cost Tobacco Program
Sec. 421. Budget deficit assessment.
Subtitle C--Tobacco Community Empowerment Block Grants
Sec. 431. Tobacco community empowerment block grants.
TITLE V--MISCELLANEOUS PROVISIONS
Sec. 501. Sense of the Senate.
SEC. 2. FINDINGS AND PURPOSES.
(a) Findings.--Congress makes the following findings:
(1) Tobacco products are the foremost preventable health
problem facing America today. More than 400,000 individuals die
each year as a result of tobacco induced illnesses and
conditions.
(2) Nicotine that is contained in tobacco products is
extremely addictive.
(3) The tobacco industry has historically targeted tobacco
product marketing and promotional efforts towards minors in
order to entrap them into a lifetime of smoking.
(4) Over 90 percent of individuals who smoke began smoking
regularly while they were still minors.
(5) Approximately 3000 minors begin smoking each day. 1000
of these minors will die prematurely from a tobacco induced
illness or medical condition.
(6) Tobacco induced illnesses and medical conditions
resulting from tobacco use cost the United States over
$100,000,000,000 each year.
(7) Each year the Federal Government incurs costs in excess
of $20,000,000,000 for the medical treatment of individuals
suffering from tobacco induced illnesses and conditions.
(b) Purposes.--It is the purpose of this Act to--
(1) substantially reduce youth smoking;
(2) assist individuals who are currently addicted to
tobacco products in overcoming that addiction;
(3) educate the public concerning the health dangers
inherent in the use of tobacco products;
(4) fund medical research; and
(5) provide for the healthy development of young children
and to enhance their learning capacity and improve the quality
of their care.
TITLE I--AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT RELATING TO
TOBACCO
SEC. 101. PUBLIC HEALTH AND EDUCATION PROGRAMS.
The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by
adding at the end thereof the following new title:
``TITLE XXVIII--PUBLIC HEALTH AND EDUCATION PROGRAMS AND TOBACCO
CONTROL
``SEC. 2801. DEFINITIONS.
``In this title:
``(1) Brand.--The term `brand' means a variety of a tobacco
product distinguished by the tobacco used, tar content,
nicotine content, flavoring used, size, filtration, or
packaging.
``(2) Cigar.--The term `cigar' means any roll of tobacco
wrapped in leaf tobacco or in any substance containing tobacco
(other than any roll of tobacco which is a cigarette or
cigarillo within the meaning of paragraph (3) or (4)).
``(3) Cigarette.--The term `cigarette' means any product
which contains nicotine, is intended to be burned under
ordinary conditions of use, and consists of--
``(A) any roll of tobacco wrapped in paper or in
any substance not containing tobacco; and
``(B) any roll of tobacco wrapped in any substance
containing tobacco which, because of its appearance,
the type of tobacco used in the filler, or its
packaging and labeling, is likely to be offered to, or
purchased by, consumers as a cigarette described in
subparagraph (A).
``(4) Cigarillos.--The term `cigarillos' means any roll of
tobacco wrapped in leaf tobacco or any substance containing
tobacco (other than any roll of tobacco which is a cigarette
within the meaning of paragraph (3)) and as to which 1,000
units weigh not more than 3 pounds.
``(5) Cigarette tobacco.--The term `cigarette tobacco'
means any product that consists of loose tobacco that contains
or delivers nicotine and is intended for use by persons in a
cigarette. Unless otherwise stated, the requirements of this
title pertaining to cigarettes shall also apply to cigarette
tobacco.
``(6) Commerce.--The term `commerce' means--
``(A) commerce between any State, the District of
Columbia, the Commonwealth of Puerto Rico, Guam, the
Virgin Islands, American Samoa, the Northern Mariana
Islands or any territory or possession of the United
States;
``(B) commerce between points in any State, the
District of Columbia, the Commonwealth of Puerto Rico,
Guam, the Virgin Islands, American Samoa, the Northern
Mariana Islands or any territory or possession of the
United States; or
``(C) commerce wholly within the District of
Columbia, Guam, the Virgin Islands, American Samoa, the
Northern Mariana Islands, or any territory or
possession of the United States.
``(7) Commissioner.--The term `Commissioner' means the
Commissioner of Food and Drugs.
``(8) Distributor.--The term `distributor' means any person
who furthers the distribution of tobacco products, whether
domestic or imported, at any point from the original place of
manufacture to the person who sells or distributes the product
to individuals for personal consumption. Such term shall not
include common carriers.
``(9) Little cigar.--The term `little cigar' means any roll
of tobacco wrapped in leaf tobacco or any substance containing
tobacco (other than any roll of tobacco which is a cigarette
within the meaning of subsection (1)) and as to which 1,000
units weigh not more than 3 pounds.
``(10) Manufacturer.--The term `manufacturer' means any
person, including any repacker or relabeler, who manufactures,
fabricates, assembles, processes, or labels a finished tobacco
product.
``(11) Nicotine.--The term `nicotine' means the chemical
substance named 3-(1-Methyl-2-pyrrolidinyl)pyridine or
C10 H14 N2 , including any salt
or complex of nicotine.
``(12) Package.--The term `package' means a pack, box,
carton, or container of any kind in which tobacco products are
offered for sale, sold, or otherwise distributed to consumers.
``(13) Person.--The term `person' means an individual,
partnership, corporation, or any other business or legal
entity.
``(14) Pipe tobacco.--The term `pipe tobacco' means any
loose tobacco that, because of its appearance, type, packaging,
or labeling, is likely to be offered to, or purchased by,
consumers as a tobacco product to be smoked in a pipe.
``(15) Point of sale.--The term `point of sale' means any
location at which an individual can purchase or otherwise
obtain tobacco products for personal consumption.
``(16) Retailer.--The term `retailer' means any person who
sells tobacco products to individuals for personal consumption,
or who operates a facility where vending machines or self-
service displays are permitted under this title.
``(17) Roll-your-own tobacco.--The term `roll-your-own
tobacco'' has the meaning given such term by section 5702(p) of
the Internal Revenue Code of 1986.
``(18) Sale.--The term `sale' includes the selling,
providing samples of, or otherwise making tobacco products
available for personal consumption in any place within the
scope of this title.
``(19) Secretary.--The term `Secretary' means the Secretary
of Health and Human Services.
``(20) Smokeless tobacco.--The term `smokeless tobacco'
means any product that consists of cut, ground, powdered, or
leaf tobacco that contains nicotine and that is intended to be
placed in the oral or nasal cavity.
``(21) State.--The term `State' includes the several
States, the District of Columbia, the Commonwealth of Puerto
Rico, Guam, the Virgin Islands, American Samoa, the Northern
Mariana Islands, and any other territory or possession of the
United States. Such term includes any political division of any
State.
``(22) Tobacco.--The term `tobacco' means tobacco in its
unmanufactured form.
``(23) Tobacco product.--The term `tobacco product' means
cigarettes, cigarillos, cigarette tobacco, little cigars, pipe
tobacco, and smokeless tobacco, and roll-your-own tobacco.
``Subtitle A--Public Health and Education Programs
``SEC. 2811. PAYMENTS TO STATES.
``(a) Funds.--
``(1) In general.--Subject to subsection (d), there are
hereby made available to carry out this section for each fiscal
year an amount equal to the amount necessary to reimburse
States as provided for in subsection (b).
``(2) Fiscal year limitation.--Amounts made available for a
fiscal year under paragraph (1) shall be equal to--
``(A) 43 percent of the net increase in revenues
received in the Treasury for such fiscal year
attributable to any amendments made to chapter 52 of
the Internal Revenue Code of 1986 in the fiscal year in
which this title is enacted, as estimated by the
Secretary; less
``(B) amounts made available for such fiscal year
under sections 2812 and 2814.
``(b) Reimbursement.--
``(1) In general.--The Secretary shall use amounts made
available under subsection (a) in each fiscal year to provide
funds to each State to reimburse such State for amounts
expended by the State for the treatment of individuals with
tobacco-related illnesses or conditions, and to permit States
to utilize the Federal share of such expended amounts to
provide services for children.
``(2) Amount.--The amount for which a State is eligible for
under paragraph (1) shall be based on the ratio of the
expenditures of the State under title XIX of the Social
Security Act (42 U.S.C. 1396 et seq.) for fiscal year 1996 to
the expenditures by all States under such title for such fiscal
year.
``(3) Adjustment.--With respect to a fiscal year in which
the amount determined under subsection (a)(1) exceeds the
limitation under subsection (a)(2), the Secretary shall make
pro rata reductions in the amounts provided to States under
this subsection.
``(c) Use of Funds.--
``(1) Determination.--With respect to each State, the
Secretary shall determine the proportion of the reimbursement
under subsection (b) for each fiscal year that is equal to the
amount that has been paid to the State as the Federal medical
assistance percentage (as defined in section 1905(b)) of the
Social Security Act (42 U.S.C. 1396d(b)) expenditures by the
State for the preceding fiscal year.
``(2) Required use.--With respect to the amount determined
under paragraph (1) for a State for a fiscal year, the
Secretary shall not treat such amount as an overpayment under
any joint Federal-State health program if the State certifies
to the Secretary that such amount will be used by the State to
serve the needs of children in the State under 1 or more of the
following programs:
``(A) An Even Start program under section of the
Head Start Act (42 U.S.C. 9801 et seq.).
``(B) The Head Start program under the Head Start
Act (42 U.S.C. 9801 et seq.).
``(C) A child care program under the Child Care and
Development Block Grant Act of 1990 (42 U.S.C. 658A et
seq.).
``(D) The Individuals with Disabilities Education
Act.
``(E) The child care food program and start-up and
expansion funds for school break programs and summer
food programs under section 17 of the National School
Lunch Act (42 U.S.C. 1766).
``(F) The special supplemental food program under
section 17 of the Child Nutrition Act of 1966 (42
U.S.C. 1786).
``(G) The Maternal and Child Health Services Block
Grant program under title V of the Social Security Act
(42 U.S.C. 701 et seq.).
``(H) The State Children's Health Insurance Program
of the State under title XXI of the Social Security Act
(42 U.S.C. 1397aa et seq.).
``(I) The family preservation and support services
program under section 430B of the Social Security Act.
``(J) State initiated programs that are designed to
serve the health and developmental needs of children
and are approved by the Secretary.
``(3) Coordination.--A State may use not to exceed 20
percent of the amount determined under paragraph (1) for the
State for a fiscal year to--
``(A) improve linkages and coordination among
programs serving children and families, including the
provision of funds to outpost outreach workers into
Federally funded early childhood programs to ensure
effective enrollment in child health initiatives
referred to in paragraph (2)(H);
``(B) fund local collaboratives which shall be
required to use such funds on needs assessments,
planning, and investments to maximize efforts to
improve child development; and
``(C) fund innovative demonstrations that address
the outstanding needs of children and families as
assessed by State and local entities.
``(4) State plan.--To be eligible to receive funds under
this subsection a State shall prepare and submit to the
Secretary a State plan, at such time, in such manner, and
containing such information as the Secretary may require,
including a description of the manner in which the State will
use amounts provided under this subsection. Such plan shall
demonstrate, based on standards established by the Secretary,
that the State will comply with paragraph (6).
``(5) Application of requirements.--The requirements of the
respective provisions of law described in paragraph (2) shall
apply to any funds made available under this subsection through
State programs under any such provision of law to the same
extent that such requirements would otherwise apply to such
programs under such provisions of law.
``(6) Supplement not supplant.--Amounts provided to a State
under this subsection shall be used to supplement and not
supplant other Federal, State and local funds provided for
programs that serve the health and developmental needs of
children. Amounts provided to the State under any of the
provisions of law referred to in paragraph (2) shall not be
reduced solely as a result of the availability of funds under
this section.
``(7) Overpayments.--Any amount of the reimbursement of a
State under paragraph (1) to which paragraph (2) applies that
is not used in accordance with this subsection shall be treated
by the Secretary as an overpayment under section 1903 of the
Social Security Act (42 U.S.C. 1396b). Any such overpayments
may be allotted among other States under this subsection in
proportion to the amount that the State originally received
under this section.
``SEC. 2812. PUBLIC HEALTH PROGRAMS.
``(a) Funding.--There are hereby made available to carry out this
section--
``(1) for fiscal year 1998, $2,100,000,000;
``(2) for fiscal year 1999, $2,175,000,000 increased by an
amount equal to the increase in the Consumer Price Index for
the previous fiscal year for all urban consumers (all items;
U.S. city average);
``(3) for fiscal year 2000, $2,200,000,000 increased by an
amount equal to the increase in the Consumer Price Index for
the 2 previous fiscal years for all urban consumers (all items;
U.S. city average);
``(4) for fiscal year 2001, $2,325,000,000 increased by an
amount equal to the increase in the Consumer Price Index for
the 3 previous fiscal years for all urban consumers (all items;
U.S. city average); and
``(5) for fiscal year 2002 and subsequent fiscal years, the
amount made available for fiscal year 2001 increased by an
amount equal to the increase in the Consumer Price Index for
the period encompassing the fiscal years from 1998 to the
fiscal year prior to the fiscal year involved for all urban
consumers (all items; U.S. city average).
``(b) Use of Funds.--Amounts made available for a fiscal year under
subsection (a) shall be distributed in the following manner:
``(1) Use reduction and addiction prevention research.--
``(A) In general.--The amount described in
subparagraph (B) shall be used by Secretary to carry
out Federal tobacco use reduction and addiction
prevention research under section 2825(a).
``(B) Amount.--The amount described in this
subparagraph is--
``(i) for fiscal year 1998, $100,000,000;
and
``(ii) for fiscal year 1999 and each
subsequent fiscal year, the amount described in
clause (i), increased for each such fiscal year
by an amount equal to the increase in the
Consumer Price Index for the period
encompassing the fiscal years from 1998 to the
fiscal year prior to the fiscal year involved
for all urban consumers (all items; U.S. city
average).
``(2) Counter-advertising.--
``(A) In general.--The amount described in
subparagraph (B) shall be used by Secretary to carry
out the Federal tobacco product counter-advertising
campaign under section 2825(b).
``(B) Amount.--The amount described in this
subparagraph is--
``(i) for fiscal year 1998, $500,000,000;
and
``(ii) for fiscal year 1999 and each
subsequent fiscal year, the amount described in
clause (i), increased for each such fiscal year
by an amount equal to the increase in the
Consumer Price Index for the period
encompassing the fiscal years from 1998 to the
fiscal year prior to the fiscal year involved
for all urban consumers (all items; U.S. city
average).
``(3) Centers for disease control and prevention
programs.--
``(A) In general.--The amount described in
subparagraph (B) shall be used by Secretary, acting
through the Centers for Disease Control and Prevention,
to carry programs to discourage the initiation of
tobacco use, reduce the incidence of tobacco use among
current users, and for other activities designed to
reduce the risk of dependence and injury from tobacco
products under section 2825(c).
``(B) Amount.--The amount described in this
subparagraph is--
``(i) for fiscal year 1998, $60,000,000;
``(ii) for each of the fiscal years 1998
and 2000, $60,000,000, increased for each such
fiscal year by an amount equal to the increase
in the Consumer Price Index for the period
encompassing the fiscal years from 1998 to the
fiscal year prior to the fiscal year involved
for all urban consumers (all items; U.S. city
average);
``(iii) for fiscal year 2001, $100,000,000,
increased for such fiscal year by an amount
equal to the increase in the Consumer Price
Index for fiscal years 1998 through 2000 for
all urban consumers (all items; U.S. city
average); and
``(iv) for fiscal year 2002 and subsequent
fiscal years, the amount described in clause
(iii), increased for each such fiscal year by
an amount equal to the increase in the Consumer
Price Index for the period encompassing the
fiscal years from 1998 to the fiscal year prior
to the fiscal year involved for all urban
consumers (all items; U.S. city average).
``(4) Food and drug administration.--
``(A) In general.--The amount described in
subparagraph (B) shall be used by Secretary to assist
in defraying the costs associated with the activities
of the Food and Drug Administration relating to
tobacco.
``(B) Amount.--The amount described in this
subparagraph is--
``(i) for fiscal year 1998, $300,000,000;
and
``(ii) for fiscal year 1999 and each
subsequent fiscal year, the amount described in
clause (i), increased for each such fiscal year
by an amount equal to the increase in the
Consumer Price Index for the period
encompassing the fiscal years from 1998 to the
fiscal year prior to the fiscal year involved
for all urban consumers (all items; U.S. city
average).
``(5) State block grants.--
``(A) In general.--The amount described in
subparagraph (B) shall be used by Secretary to make
block grants to States under the National Tobacco Usage
Reduction and Education Block Grant Program under
section 2826.
``(B) Amount.--The amount described in this
subparagraph is--
``(i) for fiscal year 1998, $1,144,000,000;
``(ii) for fiscal year 1999,
$1,215,000,000, increased for such fiscal year
by an amount equal to the increase in the
Consumer Price Index for the previous fiscal
year for all urban consumers (all items; U.S.
city average);
``(iii) for fiscal year 2000,
$1,240,000,000, increased for such fiscal year
by an amount equal to the increase in the
Consumer Price Index for fiscal years 1998
through 2000 for all urban consumers (all
items; U.S. city average);
``(iv) for fiscal year 2001,
$1,325,000,000, increased for such fiscal year
by an amount equal to the increase in the
Consumer Price Index for fiscal years 1998
through 2000 for all urban consumers (all
items; U.S. city average);
``(v) for each of the fiscal years 2002
through 2008, $1,825,000,000, increased for
each such fiscal year by an amount equal to the
increase in the Consumer Price Index for the
period encompassing the fiscal years from 1998
to the fiscal year prior to the fiscal year
involved for all urban consumers (all items;
U.S. city average); and
``(vi) for fiscal year 2009 and subsequent
fiscal years, $1,750,000,000, increased for
each such fiscal year by an amount equal to the
increase in the Consumer Price Index for fiscal
years 1998 through the fiscal year previous to
the fiscal year for which the determination is
being made for all urban consumers (all items;
U.S. city average).
``SEC. 2813. BIOMEDICAL RESEARCH AND CHILD DEVELOPMENT INVESTMENTS.
``(a) Funding.--There are hereby made available to carry out this
section for each fiscal year an amount equal to 57 percent of the net
increase in revenues received in the Treasury for such fiscal year
attributable to any amendments made to chapter 52 of the Internal
Revenue Code of 1986 in the fiscal year in which this title is enacted,
as estimated by the Secretary.
``(b) Use of Funds.--Amounts made available for a fiscal year under
subsection (a) shall be used to carry out national biomedical and basic
scientific research activities and child development and research
activities under part 1 of subtitle C.
``SEC. 2814. TOBACCO VICTIMS COMPENSATION FUND.
``(a) Funding.--There are hereby made available to carry out this
section for each fiscal year an amount equal to 14.2 percent of the net
increase in revenues received in the Treasury for such fiscal year
attributable to any amendments made to chapter 52 of the Internal
Revenue Code of 1986 in the fiscal year in which this title is enacted,
as estimated by the Secretary.
``(b) Use of Funds.--Amounts made available for a fiscal year under
subsection (a) shall be used to provide assistance and compensation to
individuals suffering from tobacco-related illnesses and conditions,
under a plan to be developed by the Secretary, not later than 1 year
after the date of enactment of this Act, and submitted to Congress for
approval.
``SEC. 2815. TOBACCO COMMUNITY TRANSITION ASSISTANCE.
``(a) Funding.--There are hereby made available to carry out this
section--
``(1) for buyouts of quotas under section 411--
``(A) $3,100,000,000 for each of the fiscal years
1998 and 1999; and
``(B) $3,000,000,000 for fiscal 2000; and
``(2) for block grants under section 431--
``(A) $500,000,000 for each of the fiscal years
1998 and 1999;
``(B) $800,000,000 for each of the fiscal years
2000 through 2002; and
``(C) $400,000,000 for fiscal year 2003.
``(b) Use of Funds.--Amounts made available for a fiscal year under
subsection (a) shall remain available until expended (except that with
respect to amounts under subsection (a)(1), such amounts shall only be
available until September 30, 2001) and shall be used to provide
tobacco transition assistance under title IV of the Healthy and Smoke
Free Children Act.
``Subtitle B--National Health Initiatives
``PART 1--NATIONAL BASIC AND CHILD DEVELOPMENT RESEARCH
``SEC. 2821. NATIONAL BIOMEDICAL, BASIC AND CHILD DEVELOPMENT RESEARCH
BOARD.
``(a) Establishment.--There is established a Federal board to be
known as the `National Biomedical and Basic Scientific Research Board'
(referred to in this subpart as the `Board').
``(b) Membership.--
``(1) Composition.--The board shall be composed of--
``(A) 9 voting members to be appointed by the
President from among individuals with expertise in
biomedical research, basic research, child development,
and medicine; and
``(B) 3 ex officio (nonvoting) members of which--
``(i) 1 shall be the Secretary;
``(ii) 1 shall be the Secretary of
Education; and
``(iii) 1 shall be the Assistant to the
President for Science and Technology.
``(2) Terms.--A member of the Board under paragraph (1)(A)
shall be appointed for a term of 6 years, except that of the
members first appointed--
``(A) 3 members shall be appointed for terms of 6
years;
``(B) 3 members shall be appointed for terms of 4
years; and
``(C) 3 members shall be appointed for terms of 2
years.
``(3) Vacancies.--
``(A) In general.--A vacancy on the Board shall be
filled in the same manner in which the original
appointment was made and shall be subject to any
conditions which applied with respect to the original
appointment.
``(B) Filling unexpired term.--An individual
appointed to fill a vacancy on the Board shall be
appointed for the unexpired term of the member
replaced.
``(C) Expiration of terms.--The term of any member
of the Board shall not expire before the date on which
the member's successor takes office.
``(c) Chairperson.--The President shall designate a member of the
Board appointed under subsection (b)(1)(A) as the Chairperson of the
Board.
``(d) Meetings and Quorum.--
``(1) In general.--The Commission shall meet at the call of
the Chairperson.
``(2) Initial meeting.--Not later than 30 days after the
date on which all members of the Board have been appointed, the
Board shall hold its first meeting.
``(3) Quorum.--A majority of the members of the Board
appointed under subsection (b)(1)(A) shall constitute a quorum,
but a lesser number of members may hold hearings.
``(e) Personnel Matters.--
``(1) Compensation.--Each member of the Board who is not an
officer or employee of the Federal Government shall be
compensated at a rate equal to the daily equivalent of the
annual rate of basic pay prescribed for level IV of the
Executive Schedule under section 5315 of title 5, United States
Code, for each day (including travel time) during which such
member is engaged in the performance of the duties of the
Board. All members of the Board who are officers or employees
of the United States shall serve without compensation in
addition to that received for their services as officers or employees
of the United States.
``(2) Travel expenses.--The members of the Board shall be
allowed travel expenses, including per diem in lieu of
subsistence, at rates authorized for employees of agencies
under subchapter I of chapter 57 of title 5, United States
Code, while away from their homes or regular places of business
in the performance of services for the Board.
``(3) Staff.--
``(A) In general.--The Chairperson of the Board
may, without regard to the civil service laws and
regulations, appoint and terminate an executive
director and such other additional personnel as may be
necessary to enable the Board to perform its duties.
The employment of an executive director shall be
subject to confirmation by the Board.
``(B) Compensation.--The Chairperson of the Board
may fix the compensation of the executive director and
other personnel without regard to the provisions of
chapter 51 and subchapter III of chapter 53 of title 5,
United States Code, relating to classification of
positions and General Schedule pay rates, except that
the rate of pay for the executive director and other
personnel may not exceed the rate payable for level V
of the Executive Schedule under section 5316 of such
title.
``(4) Detail of government employees.--Any Federal
Government employee may be detailed to the Board without
reimbursement, and such detail shall be without interruption or
loss of civil service status or privilege.
``(5) Procurement of temporary and intermittent services.--
The Chairperson of the Board may procure temporary and
intermittent services under section 3109(b) of title 5, United
States Code, at rates for individuals which do not exceed the
daily equivalent of the annual rate of basic pay prescribed for
level V of the Executive Schedule under section 5316 of such
title.
``(f) Powers.--The Board shall award grants to, and enter into
contracts with eligible entities under section 2822 for the expansion
of basic and biomedical research and to provide graduate training with
respect to such research.
``(g) Delegation.--The Board may delegate all or a portion of grant
making authority under subsection (f) to the Secretary, the Secretary
of Education, the Director of the National Science Foundation, or the
head of any other Federal agency determined appropriate by the Board.
``(h) Availability of Funds.--
``(1) In general.--With respect to a fiscal year, no funds
shall be made available under this part for such fiscal year
until the Secretary certifies that the amounts appropriated for
each of the entities or activities described in subparagraphs
(A) and (B) of section 2822(a)(1) or subparagraphs (A), (B) and
(F) of section 2823(a)(1) for such fiscal year has increased as
compared to the amounts appropriated for the previous fiscal
year--
``(A) by not less than the percentage increase in
the consumer price index, as determined by the
Secretary of Labor; or
``(B) by an amount equal to the percentage increase
in the level of overall discretionary spending for such
fiscal year as compared to the previous fiscal year;
whichever is greater.
``(2) Application to child development activities.--With
respect to a fiscal year, no funds shall be made available
under this part for such fiscal year until the Secretary
certifies that the amounts appropriated for each of the
entities or activities described in section 2823(a)(1)(F) for
such fiscal has increased as compared to the amounts
appropriated for the previous fiscal year--
``(A) by not less than the percentage increase in
the consumer price index, as determined by the
Secretary of Labor; or
``(B) by an amount equal to the percentage increase
in the level of overall discretionary spending for such
fiscal year as compared to the previous fiscal year;
whichever is less.
``(3) Supplement not Supplant.--Funds made available for
use under this part shall be used to supplement and not
supplant other funds appropriated to the entities described in
section 2822(a) and 2823(a). Amounts appropriated to such
entities under other provisions of law shall not be reduced
solely as a result of the availability of funds under this
section.
``SEC. 2822. GRANTS FOR BIOMEDICAL AND BASIC RESEARCH.
``(a) Eligible Entities.--To be eligible to receive a grant or
contract under section 2821(f) an entity shall be--
``(1) the National Institutes of Health (including a
subdivision or grantee of such Institutes);
``(2) the National Science Foundation (including a
subdivision or grantee of such Foundation);
``(3) nationally recognized research hospitals;
``(4) universities with recognized programs of basic and
biomedical research;
``(5) research institutes with expertise in the conduct of
basic or biomedical research;
``(6) cancer research centers that meet the standards of
section 414; and
``(7) entities conducting quality basic or biomedical
research as determined by the Board.
``(b) Graduate Training.--Support may be provided under section
2821(f) for graduate training, including the following:
``(1) Grants for portable fellowships as defined for
purposes of the National Science Foundation Act of 1950 (42
U.S.C. 1861 et seq.).
``(2) Grants to support an additional year of portable
fellowship training to enhance the teaching capabilities of
fellows seeking careers in academic teaching settings.
``(3) Programs of student loan forgiveness for students in
the sciences and biomedical sciences who pursue careers as
teachers of science or biomedical science or researchers in
such fields in nonprofit institutions. Loans may be forgiven
under this paragraph at the rate of--
``(A) 15 percent per year for the first and second
fiscal years after the date of enactment of this title;
``(B) 20 percent per year for the third and fourth
fiscal years after the date of enactment of this title;
and
``(C) 30 percent per year for the fifth fiscal year
after the date of enactment of this title.
``(4) Programs of postdoctoral fellowships for individuals
qualifying for such fellowships under the authority of the
National Science Foundation of National Institutes of Health.
``(5) Programs of grants to universities and other research
facilities to assist in the equipping of laboratories for new
researchers of exceptional promise during the first 5 years of
post-doctoral research.
``(6) Such other programs of grants and contracts as the
Board determines will contribute to increasing the supply of
high quality scientific and biomedical researchers.
``(c) Funding.--The Board shall use 50 percent of the amount made
available for a fiscal year under section 2813 to carry out this
subpart in such fiscal year.
``SEC. 2823. INVESTMENTS IN HEALTHY CHILD DEVELOPMENT AND RESEARCH
PROJECTS AND TRAINING.
``(a) Children's Research, Training and Demonstration Projects.--
``(1) In general.--The Secretary shall use not to exceed 10
percent of the funds allocated for use under this section to
award grants of contracts for the conduct and support of
research, training and demonstration projects relating to child
health and development.
``(2) Entities eligible for research projects.--To be
eligible to receive a grant or contract under paragraph (1) for
the conduct or support of research an entity shall be--
``(A) the National Institutes of Health (including
a subdivision or grantee of such Institutes);
``(B) the National Science Foundation (including a
subdivision or grantee of the Foundation);
``(C) a nationally recognized research hospital;
``(D) a university with a recognized program of
research or training on children's development and
health and childhood disabilities; and
``(E) entities conducting child development
research and training; and
``(F) a public or private nonprofit organization,
agency, or partnership with the capacity to implement
research findings on brain development in the early
years of life and for the support of continual
physical, intellectual, and social development of young
children, including infants and toddlers with
disabilities.
``(3) Training projects.--Support may be provided under
subparagraphs (D), (E) and (F) of paragraph (1) for training,
including programs to support undergraduate and graduate
training programs to expand the early childhood development
workforce by recruiting; training students for careers in early
childhood development and care, which may include grants to
institutions, scholarships, and programs of loan work forgiveness; and
preservice and inservice training programs to enhance the quality of
the existing child care workforce.
``(4) Demonstration projects.--Support may be provided
under subparagraphs (D), (E) and (F) of paragraph (1) for
demonstration projects including public-private partnerships
for paid leave to enable mothers with infants to choose to stay
at home.
``(5) Evaluations.--Each project under this subsection
shall include an evaluation component to assess the
effectiveness of the project in achieving its goals.
``(b) Child Development Projects.--
``(1) In general.--The Secretary shall use not less than 90
percent of the funds allocated for use under this section as
follows:
``(A) Investments for early childhood
development.--60 percent of such funds will be used for
investments in early childhood development as follows:
``(i) 10 percent to expand the Early Head
Start program under section 645A of the Head
Start Act (42 U.S.C. 9841).
``(ii) 20 percent to the Child Care and
Development Block Grant Act of 1990 (42 U.S.C.
658A et seq.) to provide certificates and
grants to increase the availability and
affordability of quality child care for
children of working families from birth through
school age, including children with
disabilities.
``(iii) 25 percent to expand the Head Start
program under the Head Start Act (42 U.S.C.
9801) to increase enrollment and responsiveness
of such program.
``(iv) 5 percent to early childhood
development programs under part C and section
619 of the Individuals with Disabilities
Education Act.
Not less than 30 percent of amounts made available
under clause (ii) shall be set-aside for innovative
programs for babies and toddlers, including the
development of family child care networks, start-up for
infant care programs, the training of providers, or the
provision of parent education and support.
``(B) Improvement of the quality of child care.--20
percent to establish a health and safety fund through
the Child Care and Development Block Grant Act of 1990
(42 U.S.C. 658A et seq.), 50 percent of which shall be
used to provide incentives to reward States that
improve the quality of child care programs in the State
by adopting the essential components of the child care
program of the armed services or the essential
components of other proven child care models. Such
components include the provision of training linked to
increased wages, improved standards and enforcement,
lower child to staff ratios, higher rates for
accredited programs, and consumer education including
resources referral services.
``(C) Programs to promote healthy behavior.--20
percent to the Child Care and Development Block Grant
Act of 1990 (42 U.S.C. 658A et seq.) to expand the
availability and affordability of quality before- and
after-school care, and summer and weekend activities
for school age (through 15 years of age) children,
including children with disabilities, to promote good
health and academic achievement and to help in avoiding
high risk behaviors. Eligible entities for grants under
this clause shall include elementary and secondary
schools, community-based organizations, child care
centers, family child care homes, youth centers, or
partnerships and should be targeted to communities with
high rates of poverty or at-risk children.
``(c) Supplement not Supplant.--Amounts provided to a State under
this section shall be used to supplement and not supplant other
Federal, State and local funds provided for programs that serve the
health and developmental needs of children. Amounts provided to the
State under any of the provisions of law referred to in this section
shall not be reduced solely as a result of the availability of funds
under this section.
``(d) Funding.--The Board shall use 50 percent of the amount made
available for a fiscal year under section 2813 to carry out this
subpart in such fiscal year.
``PART 2--PUBLIC HEALTH PROGRAMS
``SEC. 2825. RESEARCH, COUNTER-ADVERTISING, AND CDC PROGRAMS.
``(a) Reduction and Addiction Prevention Research.--The Secretary
shall provide for the conduct of research concerning the development of
methods, drugs, and devices to discourage individuals from using
tobacco products and to assist individuals who use such products in
quitting such use.
``(b) Counter-Advertising.--The Secretary shall carry out programs
to reduce tobacco usage through media-based (such as counter-
advertising campaigns) and nonmedia-based education, prevention and
cessation campaigns designed to discourage the use of tobacco products
by individuals and to encourage those who use such products to quit.
``(c) Centers for Disease Control and Prevention Programs.--The
Secretary, acting through the Centers for Disease Control and
Prevention, shall carry programs to discourage the initiation of
tobacco use, reduce the incidence of tobacco use among current users,
and for other activities designed to reduce the risk of dependence and
injury from tobacco products.
``(d) Funding.--
``(1) Research.--The Secretary shall use amounts available
under section 2812(b)(1) to carry out subsection (a).
``(2) Counter-Advertising.--The Secretary shall use amounts
available under section 2812(b)(2) to carry out subsection (b).
``(3) CDC programs.--The Secretary shall use amounts
available under section 2812(b)(3) to carry out subsection (c).
``SEC. 2826. NATIONAL TOBACCO USAGE REDUCTION AND EDUCATION BLOCK GRANT
PROGRAM.
``(a) Block Grants.--The Secretary shall award block grants to
States to enable such States to carry out activities for the purpose of
planning, carrying out, and evaluating tobacco use reduction and
education activities described in subsection (c).
``(b) Application.--
``(1) In general.--A State that desires to receive a grant
under subsection (a) shall prepare and submit to the Secretary
an application, at such time, in such manner, and accompanied
by such information as the Secretary may require.
``(2) Contents.--An application submitted under paragraph
(1) shall--
``(A) describe the activities that will be carried
out using assistance under this section; and
``(B) provide such assurances as the Secretary
determines to be necessary to carry out this section.
``(c) Use of Funds.--A State shall use amounts received under this
section to carry out the following activities:
``(1) Tobacco use cessation.--
``(A) In general.--Activities to assist individuals
in quitting the use of cigarettes or other tobacco
products.
``(B) Model state program.--The Secretary shall
establish a model smoking cessation program that may be
used by States in the design of State-based smoking
cessation programs. Such model program shall provide
for the provision of grants and other assistance by
such States to eligible entities and individuals in the
State for the establishment or administration of
tobacco product use cessation programs that are
approved in accordance with subparagraph (D).
``(C) Use of assistance.--Under a State smoking
cessation program under this paragraph an entity that
receives assistance shall use such amounts to establish
or administer tobacco product use cessation programs
that are approved in accordance with subparagraph (D).
``(D) Approval of cessation program or devices.--
Using the best available scientific information, the
Secretary shall promulgate regulations to provide for
the approval of tobacco product use cessation programs
and devices. Such regulations shall be designed to
ensure that tobacco product users, if requested, are
provided with reasonable access to safe and effective
cessation programs and devices. Such regulations shall
ensure that such individuals have access to a broad
range of cessation options that are tailored to the
needs of the individual tobacco user.
``(2) Tobacco usage reduction and education program.--
Activities--
``(A) to reduce tobacco usage through media-based
(such as counter-advertising campaigns) and nonmedia-
based education, prevention and cessation campaigns
designed to discourage the use of tobacco products by
individuals who are under 18 years of age and to
encourage those who use such products to quit;
``(B) to carry out informational campaigns that are
designed to discourage and de-glamorize the use of
tobacco products;
``(C) for tobacco use reduction in elementary and
secondary schools; or
``(D) for community-based tobacco control efforts
that are designed to encourage community involvement in
reducing tobacco product use.
``(3) Event transitional sponsorship program.--
``(A) In general.--Activities for the transitional
sponsorship of certain activities, including grants
to--
``(i)(I) pay the costs associated with the
transitional sponsorship of an event or
activity;
``(II) provide for the transitional
sponsorship of an individual or team;
``(III) pay the required entry fees
associated with the participation of an
individual or team in an event or activity;
``(IV) provide financial or technical
support to an individual or team in connection
with the participation of that individual or
team in an activity described in subparagraph
(C)(iii); or
``(V) for any other purposes determined
appropriate by the State; and
``(ii) promote images or activities to
discourage individuals from using
tobacco products or encourage individuals who use such products to
quit.
``(B) Eligibility.--A State program funded under
this paragraph shall ensure that to be eligible to
receive assistance under this paragraph an entity or
individual shall prepare and submit to the State an
application at such time, in such manner, and
containing such information as the State may require,
including--
``(i) a description of the event, activity,
team, or entry for which the grant is to be
provided;
``(ii) documentation that the event,
activity, team, or entry involved was sponsored
or otherwise funded by a tobacco manufacturer
or distributor prior to the date of the
application; and
``(iii) a certification that the applicant
is unable to secure funding for the event,
activity, team, or entry involved from sources
other than those described in clause (ii).
``(C) Permissible Sponsorship Activities.--Events,
activities, teams, or entries for which a grant may be
provided under this paragraph include--
``(i) an athletic, musical, artistic, or
other social or cultural event or activity that
was sponsored in whole or in part by a tobacco
manufacturer or distributor prior to the date
of enactment of this title;
``(ii) the participation of a team that was
sponsored in whole or in part by a tobacco
manufacturer or distributor prior to the date
of enactment of this title, in an athletic
event or activity; and
``(iii) the payment of a portion or all of
the entry fees of, or other financial or
technical support provided to, an individual or
team by a tobacco manufacturer or distributor
prior to the date of enactment of this title,
for participation of the individual in an
athletic, musical, artistic, or other social or
cultural event.
``(d) Allocation of Funds.--A State shall ensure that amounts
received under a block grant under subsection (a) are used to carry out
each of the activities described in subsection (c).
``(e) Funding.--The Secretary shall use amounts available under
section 2812(b)(4) to carry out this section.
``Subtitle C--Reduction in Underage Tobacco Use
``SEC. 2831. PURPOSE.
``It is the purpose of this subtitle to encourage the achievement
of reductions in the number of underage consumers of tobacco products
through the imposition of additional financial deterrents relating to
tobacco products if certain underage tobacco-use reduction targets are
not met.
``SEC. 2832. CHILD TOBACCO USE SURVEYS.
``(a) Annual Performance Survey.--Not later than 1 year after the
date of the enactment of this Act and annually thereafter the Secretary
shall conduct a survey to determine the number of children who used
each manufacturer's tobacco products within the past 30 days.
``(b) Exclusion of Certain Ages.--The Secretary may exclude from
the survey conducted under subsection (a), children under the age of 12
years (or such other lesser age as the Secretary may establish) to
strengthen the validity of the survey.
``(c) Baseline Level.--The baseline level of the child tobacco
product use of a manufacturer (referred to in this subtitle as the
`baseline level') is the number of children determined to have used the
tobacco products of such manufacturer in the first annual performance
survey for 1998.
``(d) Additional Measures.--In order to increase the understanding
of youth tobacco product use, the Secretary may, for informational
purposes only, add additional measures to the survey under subsection
(a), conduct periodic or occasional surveys at other times, and conduct
surveys of other populations such as young adults. The results of such
surveys shall be made available to manufacturers and the public to
assist in efforts to reduce youth tobacco use.
``(e) Definition.--As used in this subtitle, the term `tobacco
product' means cigarettes, smokeless tobacco products, and roll-your-
own tobacco products.
``SEC. 2833. REDUCTION IN UNDERAGE TOBACCO PRODUCT USAGE.
``(a) Standards for Existing Manufacturers.--Each manufacturer
which manufactured a tobacco product on or before the date of the
enactment of this title shall reduce the number of children who use its
tobacco products so that the number of children determined to have used
its tobacco products on the basis of--
``(1) the fourth annual performance survey is equal to or
less than--
``(A) 60 percent of the manufacturer's baseline
level; or
``(B) the de minimis level;
whichever is greater;
``(2) the fifth annual performance survey is equal to or
less than--
``(A) 50 percent of the manufacturer's baseline
level; or
``(B) the de minimis level;
whichever is greater;
``(3) the sixth annual performance survey is equal to or
less than--
``(A) 40 percent of the manufacturer's baseline
level; or
``(B) the de minimis level;
whichever is greater;
``(4) the seventh annual performance survey is equal to or
less than--
``(A) 35 percent of the manufacturer's baseline
level; or
``(B) the de minimis level;
whichever is greater;
``(5) the eighth annual performance survey is equal to or
less than--
``(A) 30 percent of the manufacturer's baseline
level; or
``(B) the de minimis level;
whichever is greater;
``(6) the ninth annual performance survey is equal to or
less than--
``(A) 25 percent of the manufacturer's baseline
level; or
``(B) the de minimis level;
whichever is greater; and
``(7) the 10th annual performance survey and each annual
performance survey conducted thereafter is equal to or less
than--
``(A) 20 percent of the manufacturer's baseline
level; or
``(B) the de minimis level;
whichever is greater.
``(b) Standards for New Manufacturers.--Any manufacturer of a
tobacco product which begins to manufacture a tobacco product after the
date of the enactment of this title shall ensure that the number of
children determined to have used the manufacturer's tobacco products in
each annual performance survey conducted after the manufacturer begins
to manufacture tobacco products is equal to or less than the de minimis
level.
``(c) De Minimis Level.--The de minimis level shall be 0.5 percent
of the total number of children determined to have used tobacco
products in the first annual performance survey.
``SEC. 2834. NONCOMPLIANCE.
``(a) Violation of Standard.--If, with respect to a year, a
manufacturer of a tobacco product fails to comply with the required
reduction under section 2833(a), the manufacturer shall pay to the
Secretary a noncompliance fee for each unit of tobacco products
manufactured by the manufacturer which is distributed for consumer use
in the year following the year in which the noncompliance occurs, in
the amount specified in subsection (b).
``(b) Noncompliance Fee Per Unit.--
``(1) In general.--With respect to a year, a manufacturer
of a tobacco product shall be required to pay a noncompliance
fee for each unit of tobacco products manufactured by the
manufacturer if the noncompliance factor of the manufacturer
(as determined under paragraph (3)) for the year is greater
than zero.
``(2) Amount of fee.--The amount of the noncompliance fee
that is required to be paid by a manufacturer under this
section for each unit of tobacco products manufactured by the
manufacturer for the year involved shall be equal to--
``(A) 2 cents multiplied by so much of the
noncompliance factor as does not exceed 5;
``(B) 3 cents multiplied by so much of the
noncompliance factor as exceeds 5 but does not exceed
10;
``(C) 4 cents multiplied by so much of the
noncompliance factor as exceeds 10 but does not exceed
15;
``(D) 5 cents multiplied by so much of the
noncompliance factor as exceeds 15 but does not exceed
20; and
``(E) 6 cents multiplied by so much of the
noncompliance factor as exceeds 20 but does not exceed
25.
``(3) Noncompliance factor.--The noncompliance factor of a
manufacturer shall be equal to 100 multiplied by the
noncompliance percentage of the manufacturer (as determined
under paragraph (4)).
``(4) Noncompliance percentage.--The noncompliance
percentage (if any) of a manufacturer shall be equal to 1 less
the ratio of--
``(A) the actual reduction that is achieved by the
manufacturer in the number of children who use the
manufacturer's tobacco products in the year involved;
and
``(B) the reduction required under section 2833(a)
in the number of children who use the manufacturer's
tobacco products for the year.
``(c) Noncompliance Fees For Consecutive Violations.--If a
manufacturer of a tobacco product fails to comply with the required
reduction under section 2833(a) in 2 or more consecutive years, the
noncompliance fee that is required to be paid by the manufacturer under
this section for each unit of tobacco products manufactured by such
manufacturer which is distributed for consumer use in the year
following the year in which the noncompliance occurs, shall be the
amount determined under subsection (b) for the year multiplied by the
number of consecutive years in which the manufacturer has failed to
comply with such required reductions.
``(d) Prohibition on Single-Pack Sales in Cases of Repeated
Noncompliance.--Not later than 1 year after the date of enactment of
this title, the Secretary shall establish regulations to prohibit the
sale of single packs of a manufacturer's tobacco products in cases of
repeated noncompliance with the reductions required under section
2833(a). Such regulations shall require that, if a manufacturer fails
to comply with such reductions in 3 or more consecutive years, the
manufacturer's tobacco products may be sold in the following year only
in packages containing not less than 10 units of the product per
package (200 cigarettes per package in the case of cigarettes, and a
corresponding package size for other tobacco products).
``(e) Required Generic Packaging in Severe Cases of Repeated
Noncompliance.--Not later than 1 year after the date of enactment of
this title, the Secretary shall establish regulations to require units
and packages of a manufacturer's tobacco products to have generic
packaging in severe cases of repeated noncompliance with the reductions
required under section 2833(a). Such regulations shall require that, if
a manufacturer fails to comply with such reductions in 4 or more
consecutive years, the manufacturer's tobacco products may be sold in
the following year only in units and packages whose packaging contains
no external images, logos, or text (other than any required labels),
except that the brand name and the identifier `tobacco' may appear on
the packaging in block lettering in black type on a white background.
``(f) Payment.--The noncompliance fee to be paid by a manufacturer
under this section shall be paid on a quarterly basis, with payments
due not later than 30 days after the end of each calendar quarter.
``SEC. 2835. USE OF AMOUNTS.
``Of the amounts received under section 2834--
``(1) 37.5 percent of such amounts shall be made available
to the National Biomedical and Basic Scientific Research Board
for research, training and demonstration project grants under
section 2822;
``(2) 37.5 percent of such amounts shall be made available
to the Secretary for healthy child development grants under
section 2823; and
``(3) 25 percent of such amounts shall be made available to
the Secretary for reduction and addiction prevention research
grants and for grants under the national tobacco usage
reduction and education program under part 2 of subtitle C.
``SEC. 2836. MISCELLANEOUS PROVISIONS.
``(a) Judicial Review.--A manufacturer of tobacco products may seek
judicial review of any action under this subtitle only after a
noncompliance fee has been assessed and paid by the manufacturer and
only in the United States District Court for the District of Columbia.
In an action by a manufacturer seeking judicial review of an annual
performance survey, the manufacturer may prevail--
``(1) only if the manufacturer shows that the results of
the performance survey were arbitrary and capricious; and
``(2) only to the extent that the manufacturer shows that
it would have been required to pay a lesser noncompliance fee
if the results of the performance survey were not arbitrary and
capricious.
``(b) Pass-through.--Nothing in this subtitle shall be construed as
prohibiting a manufacturer from passing the costs of the amount of any
noncompliance fee assessed under this subtitle on to consumers of
tobacco products as a further economic deterrent to the use of such
products.
``(c) Prohibition.--No stay or other injunctive relief may be
granted by the Secretary or any court that has the effect of enjoining
the imposition and collection of noncompliance fees to be applied under
this section.
``(d) Child.--As used in this subtitle, the term `child' means,
except as provided in section 2832(b), an individual who is under the
age of 18.
``Subtitle D--Miscellaneous Provisions
``SEC. 2841. WHISTLEBLOWER PROTECTIONS.
``(a) Prohibition of Reprisals.--An employee of any manufacturer,
distributor, or retailer of a tobacco product may not be discharged,
demoted, or otherwise discriminated against (with respect to
compensation, terms, conditions, or privileges of employment) as a
reprisal for disclosing to an employee of the Food and Drug
Administration, the Department of Health and Human Services, the
Department of Justice, or any State or local regulatory or enforcement
authority, information relating to a substantial violation of law
related to this title or a State or local law enacted to further the
purposes of this title.
``(b) Enforcement.--Any employee or former employee who believes
that such employee has been discharged, demoted, or otherwise
discriminated against in violation of subsection (a) may file a civil
action in the appropriate United States district court before the end
of the 2-year period beginning on the date of such discharge, demotion,
or discrimination.
``(c) Remedies.--If the district court determines that a violation
has occurred, the court may order the manufacturer, distributor, or
retailer involved to--
``(1) reinstate the employee to the employee's former
position;
``(2) pay compensatory damages; or
``(3) take other appropriate actions to remedy any past
discrimination.
``(d) Limitation.--The protections of this section shall not apply
to any employee who--
``(1) deliberately causes or participates in the alleged
violation of law or regulation; or
``(2) knowingly or recklessly provides substantially false
information to the Food and Drug Administration, the Department
of Health and Human Services, the Department of Justice, or any
State or local regulatory or enforcement authority.
``SEC. 2842. NATIONAL TOBACCO DOCUMENT DEPOSITORY.
``(a) Purpose.--It is the purpose of this section to provide for
the disclosure of previously nonpublic or confidential documents by
manufacturers of tobacco products, including the results of internal
health research, and to provide for a procedure to settle claims of
attorney-client privilege, work product, or trade secrets with respect
to such documents.
``(b) Establishment.--
``(1) In general.--The Secretary shall provide for the
establishment, either within the Department of Health and Human
Services or through a private nonprofit entity, of a National
Tobacco Document Depository (in this section referred to as the
`Depository'). Such Depository shall be located in the
Washington, D.C. area and be open to the public.
``(2) Documents.--Manufacturers of tobacco products, acting
in conjunction with the Tobacco Institute and the Council for
Tobacco Research, U.S.A., shall, not later than 30 days after
the date of enactment of this title, provide documents to the
Depository in accordance with this section.
``(3) Funding.--The entities described in paragraph (2)
shall bear the sole responsibility for funding the Depository.
``(c) Use of Depository.--The Depository shall be maintained in a
manner that permits the Depository to be used as a resource for
litigants, public health groups, and any other individuals who have an
interest in the corporate records and research of the manufacturers
concerning smoking and health, addiction or nicotine dependency, safer
or less hazardous cigarettes, and underage tobacco use and marketing.
``(d) Contents.--The Depository shall include (and manufacturers
and the Tobacco Institute and the Council for Tobacco Research, U.S.A.
shall provide)--
``(1) within 90 days of the date of the establishment of
the Depository, all documents provided by such entities to
plaintiffs in--
``(A) civil or criminal actions brought by State
attorneys general (including all documents selected by
plaintiffs from the Guilford Repository of the United
Kingdom);
``(B) Philip Morris Companies Inc.'s defamation
action against Capital Cities/American Broadcasting
Company News;
``(C) the Federal Trade Commission's investigation
concerning Joe Camel and underage marketing;
``(D) Haines v. Liggett Group, Inc. (814 F. Supp.
414 (D.N.J., Jan. 26, 1993)) and Cippollone v. Liggett
Group, Inc. (822 F. 2d 335, 56 USLW 2028, 7 Fed. R.
Serv. 3d 1438 (3rd Cir. (N.J.), Jun. 8, 1987)); and
``(E) Estate of Burl Butler v. Philip Morris, Inc.
(case No. 94-4-53);
``(2) within 90 days after the date of the establishment of
the Depository, any existing documents discussing or referring
to health research, addiction or dependency, safer or less
hazardous cigarettes, studies of the smoking habits of minors,
and the relationship between advertising or promotion and youth
smoking, that the entities described in subsection (b) have not
completed producing as required in the actions described in paragraph
(1);
``(3) within 30 days of the date of the establishment of
the Depository, all documents relating to indices (as defined
by the court in State of Minnesota and Blue Cross and Blue
Shield of Minnesota v. Philip Morris, Inc., et al.) of
documents relating to smoking and health, including all indices
identified by the manufacturers in the State of Texas v.
American Tobacco Company, et al.;
``(4) upon the settlement of any action referred to in this
subsection, and after a good-faith, de novo, document-by-
document review of all documents previously withheld from
production in any actions on the grounds of attorney-client
privilege, all documents determined to be outside of the scope
of the privilege;
``(5) all existing or future documents relating to original
laboratory research concerning the health or safety of tobacco
products, including all laboratory research results relating to
methods used to make tobacco products less hazardous to
consumers;
``(6) a comprehensive new attorney-client privilege log of
all documents, itemized in sufficient detail so as to enable
any interested individual to determine whether the individual
will challenge the claim of privilege, that the entities
described in subsection (b) (based on the de novo review of
such documents by such entities) claim are protected from
disclosure under the attorney-client privilege;
``(7) all existing or future documents relating to studies
of the smoking habits of minors or documents referring to any
relationship between advertising and promotion and underage
smoking; and
``(8) all other documents determined appropriate under
regulations promulgated by the Secretary.
``(e) Dispute Resolution Panel.--
``(1) Establishment.--The Judicial Conference of the United
States shall establish a Tobacco Documents Dispute Resolution
Panel, to be composed of 3 Federal judges to be appointed by
the Conference, to resolve all disputes involving claims of
attorney-client, work product, or trade secrets privilege with
respect to documents required to be deposited into the
Depository under subsection (d) that may be brought by Federal,
State, or local governmental officials or the public or
asserted in any action by a manufacturer.
``(2) Basis for determinations.--The determinations of the
Panel established under paragraph (1) shall be based on--
``(A) the American Bar Association/American Law
Institute Model Rules or the principals of Federal law
with respect to attorney-client or work product
privilege; and
``(B) the Uniform Trade Secrets Act with respect to
trade secrecy.
``(3) Decision.--Any decision of the Panel established
under paragraph (1) shall be final and binding upon all Federal
and State courts.
``(4) Assessing of fees.--As part of a determination under
this subsection, the Panel established under paragraph (1)
shall determine whether a claimant of the privilege acted in
good faith and had a factual and legal basis for asserting the
claim. If the Panel determines that the claimant did not act in
good faith, the Panel may assess costs against the claimant,
including a reasonable attorneys' fee, and may apply such other
sanctions as the Panel determines appropriate.
``(5) Accelerated review.--The Panel established under
paragraph (1) shall establish procedures for the accelerated
review of challenges to a claim of privilege. Such procedures
shall include assurances that an individual filing a challenge
to such a claim need not make a prima facie showing of any kind
as a prerequisite to an in-camera review of the documents at
issue.
``(6) Special masters.--The Panel established under
paragraph (1) may appoint Special Masters in accordance with
Rule 53 of the Federal Rules of Civil Procedure. The cost
relating to any Special Master shall be assessed to the
manufacturers as part of a fee process to be established under
regulations promulgated by the Secretary.
``(f) Other Provisions.--
``(1) No waiver of privilege.--Compliance with this section
by the entities described in subsection (b) shall not be deemed
to be a waiver on behalf of such entities of any applicable
privilege or protection.
``(2) Avoidance of destruction.--In establishing the
Depository, procedures shall be implemented to protect against
the destruction of documents.
``(3) Deemed produced.--Any documents contained in the
Depository shall be deemed to have been produced for purposes
of any tobacco-related litigation in the United States.
``(g) Documents.--For purposes of this section, the term
`documents' shall include any paper documents that may be printed using
data that is contained in computer files.
``(h) Rule of Construction.--Nothing in this section shall be
construed to interfere in any way with the discovery rights of courts
or parties in civil or criminal actions involving tobacco products, or
the right of access to such documents under any other provision of law.
``SEC. 2843. TOBACCO OVERSIGHT AND COMPLIANCE BOARD.
``(a) Establishment.--
``(1) In general.--There is established an independent
board to be known as the Tobacco Oversight and Compliance Board
(referred to in this section as the `Board').
``(2) Membership.--The Board shall consist of 5 members
with expertise relating to tobacco and public health. The
members, including the chairperson, shall be appointed by the
Secretary. The initial members of the Board shall be appointed
by the Secretary within 30 days of the date of the enactment of
this title. A member of the Board may be removed by the
Secretary only for neglect of duty or malfeasance in office.
``(3) Terms.--The term of office of a member of the Board
shall be 6 years, except that the members first appointed shall
have terms of 2, 3, 4, and 5 years, respectively, as determined
by the Secretary.
``(b) General Duty.--The Board shall oversee and monitor the
operations of the tobacco industry to determine whether tobacco product
manufacturers are in compliance with this Act.
``(c) Disclosure of Tobacco Industry Documents.--
``(1) Submission by manufacturers.--Not later than 3 months
after the date of the enactment of this title, and as otherwise
required by the Board, each tobacco manufacturer shall submit
to the Board a copy of all documents in the manufacturer's
possession--
``(A) relating to--
``(i) any health effects, including
addiction, caused by the use of tobacco
products;
``(ii) the manipulation or control of
nicotine in tobacco products; or
``(iii) the sale or marketing of tobacco
products to children; or
``(B) produced, or ordered to be produced, by the
tobacco manufacturer in the case entitled State of
Minnesota v. Philip Morris, Inc., Civ. Action No. C1-
94-8565 (Ramsey County, Minn.) including attorney-
client and other documents produced or ordered to be
produced for in camera inspection.
``(2) Disclosure by the board.--Not later than 6 months
after the date of the enactment of this title, and otherwise as
required by the Board, the Board shall, subject to paragraph
(3), make available to the public the documents submitted under
paragraph (1).
``(3) Protection of trade secrets.--The Board, members of
the Board, and staff of the Board shall not disclose
information that is entitled to protection as a trade secret
unless the Board determines that disclosure of such information
is necessary to protect the public health. This paragraph shall
not be construed to prevent the disclosure of relevant
information to other Federal agencies or to committees of the
Congress.
``(d) Investigation and Annual Reports.--The Board shall
investigate all matters relating to the tobacco industry and public
health and report annually on the results of the investigation to
Congress. Each annual report to Congress shall, at a minimum,
disclose--
``(1) whether tobacco manufacturers are in compliance with
the provisions of this Act;
``(2) any efforts by tobacco manufacturers to conceal
research relating to the adverse health effects or addiction
caused by the use of tobacco products;
``(3) any efforts by tobacco manufacturers to mislead the
public or any Federal, State, or local elected body, agency, or
court about the adverse health effects or addiction caused by
the use of tobacco products;
``(4) any efforts by tobacco manufacturers to sell or
market tobacco products to children; and
``(5) any efforts by tobacco manufacturers to circumvent,
repeal, modify, impede the implementation of, or prevent the
adoption of any Federal, State, or local law or regulation
intended to reduce the adverse health effects or addiction
caused by the use of tobacco products.
``(e) Authority.--The Board, any member of the Board, or staff
designated by the Board may hold hearings, administer oaths, issue
subpoena, require the testimony or deposition of witnesses, the
production of documents, or the answering of interrogatories, or, upon
presentation of the proper credentials, enter and inspect facilities.
``(f) Enforcement.--Notwithstanding any other provision of law,
tobacco manufacturers shall provide any testimony, deposition,
documents, or other information, answer any interrogatories, and allow
any entry or inspection required pursuant to this section, except to
the extent that a constitutional privilege protects the tobacco
manufacturer from complying with such requirement.
``(g) Administration.--
``(1) Staff.--The Chairperson of the Board shall exercise
the executive and administrative functions of the Board and
shall have the authority to hire such staff as may be necessary
for the operation of the Board.
``(2) Salaries.--The members of the Board shall receive
such salary and benefits as the Secretary deems necessary,
except that the salary of the Chairperson shall not be less
than that provided for under level III of the Executive
Schedule in section 5314 of title 5, United States Code.
``SEC. 2844. PRESERVATION OF STATE AND LOCAL AUTHORITY.
``Except as otherwise provided for in this title or the Healthy and
Smoke Free Children Act (or an amendment made by such Act), nothing in
this title or such Act shall be construed as prohibiting a State from
imposing requirements, prohibitions, penalties or other measures to
further the purposes of this title or Act that are in addition to the
requirements, prohibitions, or penalties required under this title or
Act. To the extent not inconsistent with the purposes of this title or
Act, State and local governments may impose additional tobacco product
control measures to further restrict or limit the use of such products
by minors.
``SEC. 2845. REGULATIONS.
``The Secretary may promulgate regulations to enforce the
provisions of this title, or to modify, alter, or expand the
requirements and protections provided for in this title if the
Secretary determines that such modifications, alternations, or
expansion is necessary.''.
TITLE II--FDA JURISDICTION OVER TOBACCO PRODUCTS
Subtitle A--Amendments to the Federal Food, Drug and Cosmetic Act
SEC. 201. REFERENCE.
Whenever in this subtitle an amendment or repeal is expressed in
terms of an amendment to, or repeal of, a section or other provision,
the reference shall be considered to be made to a section or other
provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.).
SEC. 202. STATEMENT OF GENERAL AUTHORITY.
The Secretary of Health and Human Services, acting through the Food
and Drug Administration, shall have the authority under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) (above and beyond
the existing authority of the Secretary to regulate tobacco products as
of the date of enactment of this Act) to regulate the manufacture,
labeling, sale, distribution, and advertising of tobacco products.
SEC. 203. TREATMENT OF TOBACCO PRODUCTS AS DRUGS AND DEVICES.
(a) Definitions.--
(1) Drug.--Section 201(g)(1) (21 U.S.C. 321(g)(1)) is
amended by striking ``; and (D)'' and inserting ``(including
nicotine in tobacco products); and (D)''.
(2) Devices.--Section 201(h) (21 U.S.C. 321(h)) is
amended--
(A) in paragraph (3), by inserting before the comma
the following: ``(including tobacco products containing
nicotine); and
(B) by adding at the end the following: ``For
purposes of this Act a tobacco product shall be
classified as a class II device.''.
(3) Other definitions.--Section 201 (21 U.S.C. 321) is
amended by adding at the end thereof the following new
paragraphs:
``(ii)(1) The term `tobacco product' means cigarettes, cigarillos,
cigarette tobacco, little cigars, pipe tobacco, and smokeless tobacco,
and roll-your-own tobacco.
``(2) The term `cigarette' means any product which contains
nicotine, is intended to be burned under ordinary conditions of use,
and consists of--
``(A) any roll of tobacco wrapped in paper or in any
substance not containing tobacco; and
``(B) any roll of tobacco wrapped in any substance
containing tobacco which, because of its appearance, the type
of tobacco used in the filler, or its packaging and labeling,
is likely to be offered to, or purchased by, consumers as a
cigarette described in subparagraph (A).
``(3) The term `cigarette tobacco' means any product that consists
of loose tobacco that contains or delivers nicotine and is intended for
use by persons in a cigarette. Unless otherwise stated, the
requirements of this title pertaining to cigarettes shall also apply to
cigarette tobacco.
``(4) The term `smokeless tobacco' means any product that consists
of cut, ground, powdered, or leaf tobacco that contains nicotine and
that is intended to be placed in the oral or nasal cavity.
``(5) The term `roll-your-own tobacco' has the meaning given such
term by section 5702(p) of the Internal Revenue Code of 1986.
``(6) The term `little cigars' means any roll of tobacco wrapped in
leaf tobacco or any substance containing tobacco (other than any roll
of tobacco which is a cigarette within the meaning of this Act) and as
to which 1,000 units weigh not more than 3 pounds.
``(7) The term `cigar' means any roll of tobacco wrapped in leaf
tobacco or in any substance containing tobacco (other than any roll of
tobacco which is a cigarette or cigarillo within the meaning of
paragraph (3) or (4)).
``(8) The term `cigarillos' means any roll of tobacco wrapped in
leaf tobacco or any substance containing tobacco (other than any roll
of tobacco which is a cigarette within the meaning of paragraph (3))
and as to which 1,000 units weigh not more than 3 pounds.
``(9) The term `pipe tobacco' means any loose tobacco that, because
of its appearance, type, packaging, or labeling, is likely to be
offered to, or purchased by, consumers as a tobacco product to be
smoked in a pipe.
``(10) The term `nicotine' means the chemical substance named 3-(1-
Methyl-2-pyrrolidinyl)pyridine or
C10 H14 N2 , including any salt or
complex of nicotine.''.
``(11) The term `tobacco additive' means any substance the intended
use of which results or may reasonably be expected to result, directly
or indirectly, in the substance becoming a component of, or otherwise
affecting the characteristics of, any tobacco product, including any
substance that may have been removed from the tobacco product and then
readded in the substance's original or modified form.
``(12) The term `tar' means mainstream total articulate matter
minus nicotine and water.''.
(b) Misbranding.--Section 502(q) (21 U.S.C. 352(q)) is amended--
(1) by striking ``or (2)'' and inserting ``(2)''; and
(2) by inserting before the period the following: ``or (3)
in the case of a tobacco product, it is sold, distributed,
advertised, labeled, or used in violation of this Act or the
regulations prescribed under this Act.''.
(c) Regulatory Authority.--Section 503(g)(1) (21 U.S.C. 353(g)(1))
is amended by inserting ``(including any tobacco product)'' after
``products'' the first place such term appears.
(d) Class II Devices.--Section 513(a)(1)(B) (21 U.S.C.
360c(a)(1)(B)) is amended--
(1) by striking ``A device'' and inserting ``(i) A
device''; and
(2) by adding at the end the following: ``Tobacco products
shall be categorized as Class II devices.
``(ii) The sale of tobacco products to adults that
comply with Performance Standards established for these
products pursuant to section 514, title XXVIII of the
Public Health Service Act, and this Act, and any
regulations prescribed under this Act, shall not be
prohibited by the Secretary, notwithstanding sections
502(j), 516, and 518.''.
(e) Performance Standards.--Section 514(a) (21 U.S.C. 360d(a)) is
amended--
(1) in paragraph (2), by striking ``device--'' and
inserting ``non-tobacco product device--'';
(2) by redesignating paragraphs (3) and (4) as paragraphs
(4) and (5), respectively; and
(3) by adding at the end the following:
``(3)(A) A performance standard established under this section for
a tobacco product device--
``(i) shall include provisions to reduce the overall health
risks to the public, including the reduction in risk to
consumers thereof and the reduction in harm which will result
from those who continue to use the product, but less often and
from those who stop or do not start using the product, taking
into account all factors that the Secretary determines to be
relevant;
``(ii) shall, where necessary to provide a reduction in the
overall health risks to the public, include--
``(I) provisions regarding the construction,
components, constituents, ingredients, and properties
of the tobacco product device, including the reduction
or elimination of nicotine and the other components,
ingredients, and constituents of the tobacco product
and its components, based upon the best available
technology;
``(II) provisions for the testing of the tobacco
product device (on a sample basis or, if necessary, on
an individual basis) or, if it determined that no other
more practicable means are available to the Secretary
to assure the conformity of the tobacco product device
to the standard, provision for the testing (on a sample
basis or, if necessary, on an individual basis) by the
Secretary or by another person at the direction of the
Secretary;
``(III) provisions for the measurement of the
performance characteristics of the tobacco product
device;
``(IV) provisions requiring that the results of
each or of certain of the tests of the tobacco product
device required to be made under subclause (II) show
that the tobacco product device is in conformity with
the portions of the standard for which the test or
tests were required; and
``(V) a provision that the sale, advertising, and
distribution of the tobacco product device be
restricted but only to the extent the sale,
advertising, and distribution of a tobacco product
device may be restricted under this Act or title XXVIII
of the Public Health Service Act; and
``(iii) shall, where appropriate, require the use and
prescribe the form and content of labeling for use of the
tobacco product device.
``(B) The Secretary shall provide for the periodic evaluation of a
performance standard established under this paragraph to determine if
such standards should be changed to reflect new medical, scientific, or
other technological data.
``(C) In carrying out this paragraph, the Secretary shall, to the
maximum extent practicable--
``(i) use personnel, facilities, and other technical
support available in other Federal agencies;
``(ii) consult with the Scientific Advisory Committee
established under section 905 and other Federal agencies
concerned with standard-setting and other nationally or
internationally recognized standard-setting entities; and
``(iii) 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 judgment of the Secretary
can make a significant contribution.''.
(f) Restricted Devices.--Section 520(e) (21 U.S.C. 360j(e)) is
amended by adding at the end the following:
``(3) A tobacco product is a restricted device.''.
(g) Regulations.--Section 701(a) (21 U.S.C. 371(a)) is amended by
inserting before the period the following: ``, including the authority
to regulate the manufacture, sale, distribution, advertising and
marketing of tobacco products''.
SEC. 204. GENERAL HEALTH AND SAFETY REGULATION OF TOBACCO PRODUCTS.
The Act (21 U.S.C. 301 et seq.) is amended--
(1) by redesignating chapter IX as chapter X;
(2) by redesignating sections 901, 902, 903, 904, and 905
as sections 1001, 1002, 1003, 1004, and 1005, respectively; and
(3) by adding after chapter VIII the following new chapter:
``CHAPTER IX--TOBACCO PRODUCTS
``SEC. 901. DEFINITIONS.
``For purposes of this chapter and in addition to the definitions
contained in section 201, the definitions under section 2801 of the
Public Health Service Act shall apply.
``SEC. 902. PURPOSE.
``It is the purpose of this chapter to impose a regulatory scheme
applicable to the development and manufacturing of tobacco products.
Such scheme shall include--
``(1) with respect to ingredients contained in such
products--
``(A) the immediate and annual reporting, in
accordance with section 909(a), of all ingredients
contained in such products;
``(B) the performance, in accordance with section
909(b), of safety assessments with respect to
ingredients contained in such products; and
``(C) the approval, in accordance with section
909(b), of ingredients contained in such products; and
``(2) the imposition of standards to reduce the level of
certain constituents contained in such products, including
nicotine.
``SEC. 903. PROMULGATION OF REGULATIONS.
``The Commissioner shall promulgate regulations governing the
misbranding, adulteration, and dispensing of tobacco products that are
consistent with this chapter and with the manner in which other
products that are ingested into the body are regulated under this Act.
Such regulations shall be promulgated not later than 12 months after
the date of enactment of this chapter.
``SEC. 904. MINIMUM REQUIREMENTS.
``(a) Misbranding.--The regulations promulgated under section 903
shall at a minimum require that a tobacco product be deemed to be
misbranded if the labeling of the package of such product is not in
compliance with the provisions of this chapter, of other applicable
provisions of this Act, or of section 910 (as applicable to the type of
product involved) of the Public Health Service Act.
``(b) Adulteration.--The regulations promulgated under section 903
shall at a minimum require that a tobacco product be deemed to be
adulterated if the Commissioner determines that any tobacco additive in
such product, regardless of the amount of such tobacco additive, either
by itself or in conjunction with any other tobacco additive or
ingredient is harmful under the intended conditions of use when used in
a specified amount.
``SEC. 905. SCIENTIFIC ADVISORY COMMITTEE.
``(a) Establishment.--Not later than 1 year after the date of
enactment of this chapter, the Secretary shall establish an advisory
committee, to be known as the `Scientific Advisory Committee', to
assist the Secretary in establishing, amending, or revoking a
performance standard under section 512(a)(3).
``(b) Membership.--The Secretary shall appoint as members of the
Scientific Advisory Committee any individuals with expertise in the
medical, scientific, or other technological data involving the
manufacture and use of tobacco products, and of appropriately
diversified professional backgrounds. The Secretary may not appoint to
the Committee any individual who is in the regular full-time employ of
the Federal Government. The Secretary shall designate 1 of the members
of each advisory committee to serve as chairperson of the Committee.
``(c) Compensation and Expenses.--
``(1) Compensation.--Members of the Scientific Advisory
Committee who are not officers or employees of the United
States, while attending conferences or meetings of the
Committee or otherwise serving at the request of the Secretary,
shall be entitled to receive compensation at rates to be fixed
by the Secretary, which rates may not exceed the daily
equivalent of the rate of pay for level 4 of the
Senior Executive Schedule under section 5382 of title 5, United States
Code, for each day (including traveltime) they are so engaged.
``(2) Expenses.--While conducting the business of the
Scientific Advisory Committee away from their homes or regular
places of business, each member may be allowed travel expenses,
including per diem in lieu of subsistence, as authorized by
section 5703 of title 5 of the United States Code for persons
in the Government service employed intermittently.
``(d) Duties.--The Scientific Advisory Committee shall--
``(1) assist the Secretary in establishing, amending, or
revoking performance standards under section 514(a)(3);
``(2) examine and determine the effects of the alteration
of the nicotine yield levels in tobacco products;
``(3) examine and determine whether there is a threshold
level below which nicotine yields do not produce dependence on
the tobacco product involved, and, if so, determine what that
level is; and
``(4) review other safety, dependence or health issues
relating to tobacco products as determined appropriate by the
Secretary.
``SEC. 906. REQUIREMENTS RELATING TO NICOTINE AND OTHER CONSTITUENTS.
``(a) General Rule.--The Secretary may adopt a performance standard
under section 514(a)(3) that requires the modification of a tobacco
product in a manner that involves--
``(1) the reduction or elimination of nicotine yields of
the product; or
``(2) the reduction or elimination of other constituents or
harmful components of the product.
``(b) Tobacco Constituents.--The Secretary shall promulgate
regulations for the testing, reporting and disclosure of tobacco smoke
constituents that the Secretary determines the public should be
informed of to protect public health, including tar, nicotine, and
carbon monoxide. Such regulations may require label and advertising
disclosures relating to tar and nicotine.
``(c) Limitation on Tar.--Not later than 3 years after the date of
enactment of this chapter, the Secretary shall promulgate regulations
that limit the amount of tar in a cigarette to no more than 12
milligrams. Nothing in the preceding sentence shall be construed as
limiting the authority of the Secretary to promulgate regulations
further limiting the amount of tar that may be contained in a
cigarette.
``SEC. 907. REDUCED RISK PRODUCTS.
``(a) Misbranding.--Except as provided in subsection (b), the
regulations promulgated in accordance with section 904(a) shall require
that a tobacco product be deemed to be misbranded if the labeling of
the package of the product, or the claims of the manufacturer in
connection with the product, can reasonably be interpreted by an
objective consumer as stating or implying that the product presents a
reduced health risk as compared to other similar products.
``(b) Exception.--
``(1) In general.--Subsection (a) shall not apply to the
labeling of a tobacco product, or the claims of the
manufacturer in connection with the product, if--
``(A) the manufacturer, based on the best available
scientific evidence, demonstrates to the Commissioner
that the product significantly reduces the risk to the
health of the user as compared to other similar tobacco
products; and
``(B) the Commissioner approves the specific claim
that will be made a part of the labeling of the
product, or the specific claims of the manufacturer in
connection with the product.
``(2) Reduction in harm.--The Commissioner shall promulgate
regulations to permit the inclusion of scientifically-based
specific health claims on the labeling of a tobacco product
package, or the making of such claims by the manufacturer in
connection with the product, where the Commissioner determines
that the inclusion or making of such claims would reduce harm
to the public and otherwise promote public health.
``(c) Development of Reduced Risk Product Technology.--
``(1) Notification of commissioner.--The manufacturer of a
tobacco product shall provide written notice to the
Commissioner upon the development or acquisition by the
manufacturer of any technology that would reduce the risk of
such products to the health of the user.
``(2) Confidentiality.--The Commissioner shall promulgate
regulations to provide a manufacturer with appropriate
confidentiality protections with respect to technology that is
the subject of a notification under paragraph (1) that contains
evidence that the technology involved is in the early developmental
stages.
``(3) Licensing.--
``(A) In general.--With respect to any technology
developed or acquired under paragraph (1), the
manufacturer shall--
``(i) use such technology in the
manufacture of its tobacco products; or
``(ii) permit the use of such technology
(for a reasonable fee) by other manufacturers
of tobacco products to which this chapter
applies.
``(B) Fees.--The Commissioner shall promulgate
regulations to provide for the payment of a
commercially reasonable fee by each manufacturer that
uses the technology described under subparagraph (A) to
the manufacturer that submits the notice under
paragraph (1) for such technology. Such regulations
shall contain procedures for the resolution of fee
disputes between manufacturers under this subparagraph.
``(d) Requirement of Manufacture and Marketing.--
``(1) Purpose.--It is the purpose of this subsection to
provide for a mechanism to ensure that tobacco products that
are designed to be less hazardous to the health of users are
developed, tested, and made available to consumers.
``(2) Determination.--Upon a determination by the
Commissioner that the manufacture of a tobacco product that is
less hazardous to the health of users is technologically
feasible, the Commissioner may, in accordance with this
subsection, require that certain manufacturers of such products
manufacture and market such less hazardous products.
``(3) Manufacturer.--
``(A) Requirement.--Except as provided in
subparagraph (B), the requirement under paragraph (2)
shall apply to any manufacturer that provides a
notification to the Commissioner under subsection
(c)(1) concerning the technology that is the subject of
the determination of the Commissioner.
``(B) Exception.--The requirement under
subparagraph (A) shall not apply to a manufacturer if--
``(i) the manufacturer elects not to
manufacture such products and provides notice
to the Commissioner of such election; and
``(ii) the manufacturer agrees to provide
the technology involved, for a commercially
reasonable fee, to other manufacturers that
enter into agreements to use such technology to
manufacture and market tobacco products that
are less hazardous to the health of users.
``SEC. 908. GOOD MANUFACTURING PRACTICE STANDARDS.
``(a) Authority.--
``(1) In general.--The Secretary may, in accordance with
paragraph (2), prescribe regulations requiring that the methods
used in, and the facilities and controls used for, the
manufacture, pre-production design validation (including a
process to assess the performance of a tobacco product),
packing, and storage of a tobacco product conform to current
good manufacturing practice, as prescribed in such regulations,
to ensure that such products will be in compliance with this
chapter.
``(2) Requirements prior to regulations.--Prior to the
Secretary promulgating any regulation under paragraph (1) the
Secretary shall--
``(A) afford the Scientific Advisory Committee
established under section 905 an opportunity (with a
reasonable time period) to submit recommendations with
respect to the regulations proposed to be promulgated;
and
``(B) afford an opportunity for an oral hearing.
``(b) Minimum Requirements.--The regulations promulgated under
subsection (a) shall at a minimum require--
``(1) the implementation of a quality control system by the
manufacturer of a tobacco product;
``(2) a process for the inspection, in accordance with this
Act, of tobacco product material prior to the packaging of such
product;
``(3) procedures for the proper handling and storage of the
packaged tobacco product;
``(4) after consultation with the Administrator of the
Environmental Protection Agency, the development and adherence
to applicable tolerances with respect to pesticide chemical
residues in or on commodities used by the manufacturer in the
manufacture of the finished tobacco product;
``(5) the inspection of facilities by officials of the Food
and Drug Administration as otherwise provided for in this Act;
and
``(6) record keeping and the reporting of certain
information.
``(c) Petitions for Exemptions and Variances.--
``(1) In general.--Any person subject to any requirement
prescribed by regulations under subsection (a) may petition the
Secretary for an exemption or variance from such requirement.
Such a petition shall be submitted to the Secretary in such
form and manner as the Secretary shall prescribe and shall--
``(A) 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 device
is in compliance with this chapter;
``(B) 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
product in lieu of the methods, facilities, and
controls prescribed by the requirement; and
``(C) contain such other information as the
Secretary shall prescribe.
``(2) Scientific advisory committee.--The Secretary may
refer to the Scientific Advisory Committee established under
section 905 any petition submitted under paragraph (1). The
Scientific Advisory Committee shall report its recommendations
to the Secretary with respect to a petition referred to it
within 60 days of the date of the petition's referral. Within
60 days after--
``(A) the date the petition was submitted to the
Secretary under paragraph (1); or
``(B) if the petition was referred to the
Scientific Advisory Committee, the expiration of the
60-day period beginning on the date the petition was
referred to such Committee;
whichever occurs later, the Secretary shall by order either
deny the petition or approve it.
``(3) Approval of petition.--
``(A) In general.--The Secretary may approve--
``(i) a petition for an exemption for a
tobacco product from a requirement if the
Secretary determines that compliance with such
requirement is not required to assure that the
product will comply 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 product in lieu of the methods,
controls, and facilities prescribed by the
requirement are sufficient to ensure that the
product will comply with this chapter.
``(B) 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 product will comply with
this chapter.
``(4) Informal hearing.--After the issuance of an order
under paragraph (2) respecting a petition, the petitioner shall
have an opportunity for an informal hearing on such order.
``(d) Agricultural Producers.--The Secretary may not promulgate any
regulation under this section that has the effect of placing regulatory
burdens on tobacco producers (as such term is used for purposes of the
Agricultural Adjustment Act of 1938 (7 U.S.C. 1281 et seq.) and the
Agricultural Act of 1949 (7 U.S.C. 1441 et seq.)) in excess of the
regulatory burdens generally placed on other agricultural commodity
producers.
``SEC. 909. DISCLOSURE AND REPORTING OF NONTOBACCO INGREDIENTS AND
CONSTITUENTS.
``(a) Disclosure of All Ingredients.--
``(1) Immediate and annual disclosure.--Not later than 30
days after the date of enactment of this chapter, and annually
thereafter, each manufacturer of a tobacco product shall submit
to the Secretary an ingredient list for all brands of tobacco
products that contains the information described in paragraph
(2).
``(2) Requirements.--The list described in paragraph (1)
shall, with respect to each brand of tobacco product of a
manufacturer, include
``(A) a list of all ingredients, constituents,
substances, and compounds that are added to the tobacco
(and the paper or filter of the product if applicable) in the
manufacture of the tobacco product, for each brand of tobacco product
so manufactured;
``(B) a description of the quantity of the
ingredients, constituents, substances, and compounds
that are listed under subparagraph (A) with respect to
each brand of tobacco product;
``(C) a description of the nicotine content of the
product, measured in milligrams of nicotine;
``(D) with respect to cigarettes a description of--
``(i) the filter ventilation percentage
(the level of air dilution in the cigarette as
provided by the ventilation holes in the
filter, described as a percentage);
``(ii) the pH level of the smoke of the
cigarette; and
``(iii) the nicotine delivery level under
average smoking conditions reported in
milligrams of nicotine per cigarette;
``(E) with respect to smokeless tobacco products a
description of--
``(i) the pH level of the tobacco;
``(ii) the moisture content of the tobacco
expressed as a percentage of the weight of the
tobacco; and
``(iii) the nicotine content--
``(I) for each gram of the product,
measured in milligrams of nicotine;
``(II) expressed as a percentage of
the dry weight of the tobacco; and
``(III) with respect to unionized
(free) nicotine, expressed as a
percentage per gram of the tobacco and
expressed in milligrams per gram of the
tobacco; and
``(F) any other information determined appropriate
by the Secretary.
``(b) Safety Assessments.--
``(1) Application to new ingredients.--
``(A) In general.--Not later than 1 year after the
date of enactment of this chapter, and annually
thereafter, each manufacturer shall submit to the
Secretary a safety assessment for each new ingredient,
constituent, substance, or compound that such
manufacturer desires to make a part of a tobacco
product. Such new ingredient, constituent, substance,
or compound shall not be included in a tobacco product
prior to approval of such a safety assessment.
``(B) Definition of new ingredient.--For purposes
of subparagraph (A), the term `new ingredient,
constituent, substance, or compound' means an
ingredient, constituent substance, or compound listed
under subsection (a)(1) that was not used in the brand
of tobacco product involved prior to the date of
enactment of this chapter.
``(2) Application to other ingredients.--With respect to
the application of this section to ingredients, constituents
substances, or compounds listed under subsection (a) to which
paragraph (1) does not apply, all such ingredients,
constituents, substances, or compounds shall be approved
through the safety assessment process within the 5-year period
beginning on the date of enactment of this chapter. The
Secretary shall develop a procedure that staggers the
percentage of such ingredients, constituents, substances, or
compounds for which safety assessments must be submitted for
approval by manufacturers in each year.
``(3) Basis of assessment.--The safety assessment of an
ingredient, constituents, substance, or compound described in
paragraphs (1) and (2) shall--
``(A) be based on the best scientific evidence
available at the time of the submission of the
assessment; and
``(B) result in a finding that there is a
reasonable certainty in the minds of competent
scientists that the ingredient, constituents,
substance, or compound is not harmful in the quantities
used under the intended conditions of use.
``(c) Prohibition.--
``(1) Regulations.--Not later than 12 months after the date
of enactment of this chapter, the Secretary shall promulgate
regulations to prohibit the use of any ingredient, constituent,
substance, or compound in the tobacco product of a
manufacturer--
``(A) if no safety assessment has been submitted by
the manufacturer for the ingredient, constituent,
substance, or compound as otherwise required under this
section;
``(B) if the Secretary disapproves of the safety of
the ingredient, constituent, substance, or compound
that was the subject of the assessment under paragraph
(2); or
``(C) if such ingredient, constituent, substance,
or compound is a new ingredient that has not been
approved for use by the Secretary.
``(2) Review of assessments.--
``(A) General review.--Not later than 180 days
after the receipt of a safety assessment under
subsecti