Directs: (1) the Secretary of Agriculture to establish in the Department of Agriculture the Tobacco Quality Board; and (2) the Secretary of Health and Human Services (Secretary) to assess fees on tobacco product manufacturers and importers that sell tobacco products in U.S. domestic commerce.
Amends the Federal Food, Drug, and Cosmetic Act to extend Food and Drug Administration regulatory authority to tobacco products, with exceptions for certain health-or disease treatment-related uses. Sets forth provisions respecting: (1) adulterated and misbranded tobacco products; (2) required health information; (3) registration and recordkeeping; (4) control of tobacco products; (5) performance standards; (6) remedies; (7) premarket review; (8) judicial review; (9) reduced risk tobacco products; (10) access and marketing restrictions; and (11) mandatory disclosures.
Amends the Federal Cigarette Labeling and Advertising Act and the Comprehensive Smokeless Tobacco Health Education Act of 1986, respectively, to revise cigarette and smokeless tobacco labeling and advertising warning provisions.
Amends the Federal Cigarette Labeling and Advertising Act to direct the Secretary to determine whether cigarette labeling and advertising shall be required to provide tar, nicotine, and other smoke constituent information.
[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 140 Introduced in House (IH)]
108th CONGRESS
1st Session
H. R. 140
To eliminate the Federal quota and price support programs for tobacco,
to compensate quota holders and active producers for the loss of
tobacco quota asset value, to establish a permanent advisory board to
determine and describe the physical characteristics of United States
farm-produced tobacco and unmanufactured imported tobacco, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 7, 2003
Mr. McIntyre (for himself, Mr. Boyd, and Mr. Tom Davis of Virginia)
introduced the following bill; which was referred to the Committee on
Agriculture, and in addition to the Committee on Energy and Commerce,
for a period to be subsequently determined by the Speaker, in each case
for consideration of such provisions as fall within the jurisdiction of
the committee concerned
_______________________________________________________________________
A BILL
To eliminate the Federal quota and price support programs for tobacco,
to compensate quota holders and active producers for the loss of
tobacco quota asset value, to establish a permanent advisory board to
determine and describe the physical characteristics of United States
farm-produced tobacco and unmanufactured imported tobacco, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Tobacco Livelihood
and Economic Assistance for our Farmers Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Severability.
TITLE I--TERMINATION OF CURRENT TOBACCO PROGRAMS
Sec. 101. Termination of marketing quota programs and repeal of related
provisions.
Sec. 102. Termination of tobacco price support loan and no net cost
provisions and repeal of related
provisions.
Sec. 103. Geographical restrictions on expansion of tobacco production.
Sec. 104. Continued availability of Federal crop insurance.
TITLE II--PAYMENTS TO TOBACCO QUOTA HOLDERS AND PRODUCERS
Sec. 201. Definitions.
Sec. 202. Payments to tobacco quota holders.
Sec. 203. Transition payments for active producers of quota tobacco.
TITLE III--TOBACCO QUALITY BOARD
Sec. 301. Establishment of Board.
Sec. 302. Membership.
Sec. 303. Duties.
Sec. 304. Administrative provisions.
TITLE IV--TOBACCO PRODUCT MANUFACTURER AND IMPORTER USER FEES
Sec. 401. User fee.
Sec. 402. Allocation of user fees.
TITLE V--FDA REGULATION OF TOBACCO PRODUCTS
Sec. 501. Findings.
Sec. 502. Definitions.
Sec. 503. Amendment of Federal Food, Drug, and Cosmetic Act.
Sec. 504. Regulatory record.
Sec. 505. Conforming and other amendments to general provisions.
Sec. 506. Cigarette label and advertising warnings.
Sec. 507. Authority to revise cigarette warning label statements.
Sec. 508. Smokeless tobacco labels and advertising warnings.
Sec. 509. Authority to revise smokeless tobacco product warning label
statements.
Sec. 510. Tar, nicotine, and other smoke constituent disclosure to the
public.
Sec. 511. Regulation requirement.
Sec. 512. FTC jurisdiction not affected.
SEC. 2. SEVERABILITY.
If any provision of this Act, or an amendment made by this Act, or
the application of such provision to any person or circumstance, is
held to be invalid, the remainder of this Act, or an amendment made by
this Act, or the application of such provision to other persons or
circumstances, shall not be affected.
TITLE I--TERMINATION OF CURRENT TOBACCO PROGRAMS
SEC. 101. TERMINATION OF MARKETING QUOTA PROGRAMS AND REPEAL OF RELATED
PROVISIONS.
(a) Tobacco Control Act.--The Act of April 25, 1936 (commonly known
as the Tobacco Control Act; 7 U.S.C. 515-515k), is repealed.
(b) Commodity Handling Orders.--Section 8c(2) of the Agricultural
Adjustment Act (7 U.S.C. 608c(2)), reenacted with amendments by the
Agricultural Marketing Agreement Act of 1937, is amended by striking
``tobacco,''.
(c) Processing Tax.--Section 9(b) of the Agricultural Adjustment
Act (7 U.S.C. 609(b)), reenacted with amendments by the Agricultural
Marketing Agreement Act of 1937, is amended--
(1) in paragraph (2), by striking ``tobacco,''
(2) in paragraph (6)(B)(i), by striking ``, or, in the case
of tobacco, is less than the fair exchange value by not more
than 10 per centum,''.
(d) Burley Tobacco Import Review.--Section 3 of Public Law 98-59 (7
U.S.C. 625) is repealed.
(e) Declaration of Policy.--Section 2 of the Agricultural
Adjustment Act of 1938 (7 U.S.C. 1282) is amended by striking
``tobacco,''.
(f) Definitions.--Section 301(b) of the Agricultural Adjustment Act
of 1938 (7 U.S.C. 1301(b)) is amended--
(1) in paragraph (3)--
(A) by striking subparagraph (C); and
(B) by redesignating subparagraph (D) as
subparagraph (C);
(2) in paragraph (6)(A), by striking ``tobacco,'';
(3) in paragraph (7), by striking the following:
``Tobacco (flue-cured), July 1-June 30;
Tobacco (other than flue-cured), October 1-September 30;''
(4) in paragraph (10)--
(A) by striking subparagraph (B); and
(B) by redesignating subparagraph (C) as
subparagraph (B);
(5) in paragraph (11)(B), by striking ``and tobacco'';
(6) in paragraph (12), by striking ``tobacco,'';
(7) in paragraph (14)--
(A) by striking ``(A)'' in subparagraph (A); and
(B) by striking subparagraphs (B), (C), and (D);
(8) by striking paragraph (15);
(9) in paragraph (16)--
(A) by striking subparagraph (B); and
(B) by redesignating subparagraph (C) as
subparagraph (B);
(10) by striking paragraph (17); and
(11) by redesignating paragraph (16) as paragraph (15).
(g) Parity Payments.--Section 303 of the Agricultural Adjustment
Act of 1938 (7 U.S.C. 1303) is amended in the first sentence by
striking ``rice, or tobacco'' and inserting ``or rice''.
(h) Marketing Quotas.--Part I of subtitle B of title III of the
Agricultural Adjustment Act of 1938 (7 U.S.C. 1311 et seq.) is
repealed.
(i) Administrative Provisions.--Section 361 of the Agricultural
Adjustment Act of 1938 (7 U.S.C. 1361) is amended by striking
``tobacco,''.
(j) Adjustment of Quotas.--Section 371 of the Agricultural
Adjustment Act of 1938 (7 U.S.C. 1371) is amended--
(1) in the first sentence of subsection (a) by striking ``,
rice, or tobacco'' and inserting ``or rice''; and
(2) in the first sentence of subsection (b), by striking
``, rice, or tobacco'' and inserting ``or rice''.
(k) Reports and Records.--Section 373 of the Agricultural
Adjustment Act of 1938 (7 U.S.C. 1373) is amended--
(1) in subsection (a)--
(A) by striking the first sentence and inserting
the following new sentence: ``This subsection shall
apply to warehousemen, processors, and common carriers
of corn, wheat, cotton, or rice, all ginners of cotton,
and all persons engaged in the business of purchasing
corn, wheat, cotton, or rice from producers.''; and
(B) in the last sentence by striking ``$500'' and
all that follows through the period at the end of the
sentence and inserting ``$500.''.
(2) in subsection (b), by striking ``rice, or tobacco'' and
inserting ``or rice''.
(l) Regulations.--Section 375(a) of the Agricultural Adjustment Act
of 1938 (7 U.S.C. 1375(a)) is amended by striking ``peanuts, or
tobacco'' and inserting ``or peanuts''.
(m) Eminent Domain.--Section 378 of the Agricultural Adjustment Act
of 1938 (7 U.S.C. 1378) is amended--
(1) in the first sentence of subsection (c) by striking
``and tobacco''; and
(2) by striking subsection (f).
(n) Burley Tobacco Farm Reconstitution.--Section 379 of the
Agricultural Adjustment Act of 1938 (7 U.S.C. 1379) is amended--
(1) in subsection (a)--
(A) by striking ``(a)''; and
(B) in paragraph (6) by striking ``, but this
clause (6) shall not be applicable in the case of
burley tobacco''; and
(2) by striking subsections (b) and (c).
(o) Acreage-Poundage Quotas.--Section 4 of the Act of April 16,
1955 (Public Law 89-12; 7 U.S.C. 1314c note), is repealed.
(p) Burley Tobacco Acreage Allotments.--The Act of July 12, 1952 (7
U.S.C. 1315), is repealed.
(q) Transfer of Allotments.--Section 703 of the Food and
Agriculture Act of 1965 (7 U.S.C. 1316) is repealed.
(r) Advance Recourse Loans.--Section 13(a)(2)(B) of the Food
Security Improvements Act of 1986 (7 U.S.C. 1433c-1(a)(2)(B)) is
amended by striking ``tobacco and''.
(s) Tobacco Field Measurement.--Section 1112 of the Omnibus Budget
Reconciliation Act of 1987 (Public Law 100-203) is amended by striking
subsection (c).
(t) Liability.--The amendments made by this section shall not
affect the liability of any person under any provision of law in effect
before the amendments take effect as provided under subsection (u).
(u) Application of Amendments.--The amendments made by this section
shall apply with respect to the 2004 and subsequent tobacco crops.
SEC. 102. TERMINATION OF TOBACCO PRICE SUPPORT LOAN AND NO NET COST
PROVISIONS AND REPEAL OF RELATED PROVISIONS.
(a) Parity Price Support.--Section 101 of the Agricultural Act of
1949 (7 U.S.C. 1441) is amended--
(1) in the first sentence of subsection (a), by striking
``tobacco (except as otherwise provided herein), corn,'' and
inserting ``corn'';
(2) by striking subsection (c);
(3) in subsection (d)(3)--
(A) by striking ``, except tobacco,''; and
(B) by striking ``and no price support shall be
made available for any crop of tobacco for which
marketing quotas have been disapproved by producers;'';
and
(4) by redesignating subsections (d) and (e) as subsections
(c) and (d), respectively.
(b) Termination of Tobacco Price Support and No Net Cost
Provisions.--Sections 106, 106A, and 106B of the Agricultural Act of
1949 (7 U.S.C. 1445, 1445-1, 1445-2) are repealed.
(c) Definition of Basic Agricultural Commodity.--Section 408(c) of
the Agricultural Act of 1949 (7 U.S.C. 1428(c)) is amended by striking
``tobacco,''.
(d) Review of Burley Tobacco Imports.--Section 3 of Public Law 98-
59 (7 U.S.C. 625) is repealed.
(e) Powers of Commodity Credit Corporation.--Section 5 of the
Commodity Credit Corporation Charter Act (15 U.S.C. 714c) is amended by
inserting ``(other than tobacco)'' after ``agricultural commodities''
each place it appears.
(f) Transition Provisions.--
(1) Price support loan obligations.--The amendments made by
this section shall not affect any person's obligations that
arise under or with respect to the price support loan program
or loans issued through such program under any provision of law
in effect before the amendments take effect as provided under
subsection (g).
(2) Tobacco stocks and loans.--The Secretary of Agriculture
shall issue regulations that require--
(A) the orderly disposition of quota tobacco held
by any producer-owned cooperative marketing association
that has entered into a loan agreement with the
Commodity Credit Corporation to make price support
available to producers of quota tobacco;
(B) the repayment of all tobacco price support
loans or surrender of collateral by such associations
not later than one year after this section becomes
effective.
(3) Special rules for termination of no net cost funds and
accounts.--Notwithstanding any other provision of law, upon the
repeal by subsection (b) of the authorities in section 106A and
106B of the Agricultural Act of 1949 for the establishment of
tobacco no net cost funds and accounts, respectively--
(A) any obligation of a tobacco producer,
purchaser, or importer to make payments into any such
fund or account also shall terminate; and
(B) any monies in any such fund or account shall be
disposed of in the manner prescribed by the Secretary
of Agriculture, except that--
(i) to the extent needed, such monies shall
be applied or used for the purposes therefor
prescribed by such sections; and
(ii) if any monies remain, the Secretary
shall transfer such monies to the Secretary of
Health and Human Services for use in accordance
with section 402.
(g) Application of Amendments.--This section and the amendments
made by this section shall apply with respect to the 2004 and
subsequent tobacco crops.
SEC. 103. GEOGRAPHICAL RESTRICTIONS ON EXPANSION OF TOBACCO PRODUCTION.
(a) Purpose.--The purpose of this section is to provide an orderly
economic transition away from the marketing of tobacco based on quotas
and price support while also addressing the economic dislocation, and
the resulting impact on interstate commerce, that the termination of
the current tobacco program might cause in certain communities.
(b) Penalty Applicable to Tobacco Grown in Nonquota Counties and
States.--The marketing of tobacco in the 2004 or subsequent marketing
years, of a kind of tobacco that was subject to a marketing quota in
the 2003 marketing year, shall be subject to a penalty equal to 100
percent of the total amount received on the marketing of the tobacco
unless the tobacco was grown in any county in which such kind of
tobacco was grown pursuant to a marketing quota in the 2003 marketing
year.
(c) Definitions.--In this section:
(1) The term ``marketing year'' means July 1 to June 30 for
flue-cured tobacco and October 1 to September 30 for all other
kinds of tobacco.
(2) The term ``marketing quota in the 2003 marketing year''
means a quota established for that year pursuant to part I of
subtitle B of title III of the Agricultural Adjustment Act of
1938 (7 U.S.C. 1311 et seq.) and related provisions, as in
effect for that marketing year.
SEC. 104. CONTINUED AVAILABILITY OF FEDERAL CROP INSURANCE.
Nothing in this title shall be construed to affect the eligibility
of tobacco producers to obtain crop insurance for their crops pursuant
to the Federal Crop Insurance Act (7 U.S.C. 1501 et seq.) under the
terms of such Act.
TITLE II--PAYMENTS TO TOBACCO QUOTA HOLDERS AND PRODUCERS
SEC. 201. DEFINITIONS.
In this title:
(1) The term ``active producer of quota tobacco'' means a
person that was the actual producer, as determined by the
Secretary, of tobacco marketed under a marketing quota for the
2001 tobacco marketing year.
(2) The term ``quota tobacco'' means a kind of tobacco that
is subject to farm marketing quotas or farm acreage allotments
for the 1999, 2000, 2001, and 2002 tobacco marketing years
under a marketing quota or allotment program established under
part I of subtitle B of title III of the Agricultural
Adjustment Act of 1938 (7 U.S.C. 1281 et seq.).
(3) The term ``Secretary'' means the Secretary of
Agriculture.
(4) The term ``tobacco quota holder'' means an owner of a
farm on January 1, 2002, for which a tobacco farm marketing
quota or farm acreage allotment for quota tobacco was
established with respect to the 2002 tobacco marketing year
under a marketing quota program established under part I of
subtitle B of title III of the Agricultural Adjustment Act of
1938.
SEC. 202. PAYMENTS TO TOBACCO QUOTA HOLDERS.
(a) Payment Required.--The Secretary shall make payments to each
eligible tobacco quota holder for the termination of tobacco marketing
quotas and related price support under title I, which shall constitute
full and fair compensation for any losses relating to such termination.
(b) Eligibility.--To be eligible to receive a payment under this
section, a person shall submit to the Secretary an application
containing such information as the Secretary may require to demonstrate
to the satisfaction of the Secretary that the person satisfies the
definition of tobacco quota holder. The application shall be submitted
within such time, in such form, and in such manner as the Secretary may
require.
(c) Base Quota Level.--
(1) In general.--The Secretary shall establish a base quota
level applicable to each eligible tobacco quota holder, as
determined under subsection (b).
(2) Poundage quotas.--For each kind of tobacco for which
the marketing quota is expressed in pounds, the base quota
level for each tobacco quota holder shall be equal to the basic
tobacco marketing quota under the Agriculture Adjustment Act of
1938 for the 1998 marketing year for quota tobacco on the farm
owned by the tobacco quota holder.
(3) Marketing quotas other than poundage quotas.--For each
kind of tobacco for which there is marketing quota or allotment
on an acreage basis, the base quota level for each tobacco
quota holder shall be the amount equal to the product obtained
by multiplying--
(A) the basic tobacco farm marketing quota or
allotment for the 1998 marketing year established by
the Secretary for quota tobacco on the farm owned by
the tobacco quota holder; by
(B) the average county production yield per acre
for the county in which the farm is located for the
kind of tobacco for the 1998 marketing year.
(d) Payment.--The Secretary shall make payments to each eligible
tobacco quota holder, as determined under subsection (b), in a total
amount equal to the product obtained by multiplying--
(1) $8 per pound; by
(2) the base quota level established for the quota holder
under subsection (c).
(e) Time for Payment.--The payments to eligible tobacco quota
holders required under this section shall be made in five equal
installments during fiscal years 2004, 2005, 2006, 2007, and 2008.
(f) Resolution of Disputes.--Any dispute regarding the eligibility
of a person to receive a payment under this section, or the amount of
the payment, shall be resolved by the county committee established
under section 8 of the Soil Conservation and Domestic Allotment Act (16
U.S.C. 590h) for the county or other area in which the farm owned by
the person is located.
(g) Commodity Credit Corporation.--The Secretary shall use the
funds, facilities and authorities of the Commodity Credit Corporation
to carry out this section.
SEC. 203. TRANSITION PAYMENTS FOR ACTIVE PRODUCERS OF QUOTA TOBACCO.
(a) Transition Payments Required.--The Secretary shall make
transition payments under this section to eligible active producers of
quota tobacco.
(b) Eligibility.--To be eligible to receive a transition payment
under this section, a person shall submit to the Secretary an
application containing such information as the Secretary may require to
demonstrate to the satisfaction of the Secretary that the person
satisfies the definition of active producer of quota tobacco. The
application shall be submitted within such time, in such form, and in
such manner as the Secretary may require.
(c) Production Base.--The Secretary shall establish a production
base applicable to each eligible active producer of quota tobacco, as
determined under subsection (b). A producer's production base shall be
equal to the quantity, in pounds, of quota tobacco subject to the basic
marketing quota produced and marketed by the producer under the
Agriculture Adjustment Act of 1938 for the 2001 marketing year.
(d) Payment.--The Secretary shall make payments to each eligible
active producer of quota tobacco, as determined under subsection (b),
in a total amount equal to the product obtained by multiplying--
(1) $4 per pound; by
(2) the production base established for the active producer
under subsection (c).
(e) Time for Payment.--The payments to eligible active producers of
quota tobacco required under this section shall be made in five equal
installments during fiscal years 2004, 2005, 2006, 2007, and 2008.
(f) Resolution of Disputes.--Any dispute regarding the eligibility
of a person to receive a payment under this section, or the amount of
the payment, shall be resolved by the county committee established
under section 8 of the Soil Conservation and Domestic Allotment Act (16
U.S.C. 590h) for the county or other area in which the farming
operation of the person is located.
(g) Commodity Credit Corporation.--The Secretary shall use the
funds, facilities and authorities of the Commodity Credit Corporation
to carry out this section.
TITLE III--TOBACCO QUALITY BOARD
SEC. 301. ESTABLISHMENT OF BOARD.
The Secretary of Agriculture (in this title referred to as the
``Secretary'') shall establish a permanent advisory board within the
Department of Agriculture to be known as the Tobacco Quality Board (in
this title referred to as the ``Board'').
SEC. 302. MEMBERSHIP.
(a) Nomination and Appointment.--The Board shall consist of 11
members, of which five shall be appointed by the Secretary from
nominations submitted by representatives of United States tobacco
producers, five shall be appointed by the Secretary from nominations
submitted by representatives of United States tobacco product
manufacturers, and one shall be an officer or employee of the
Department of Agriculture appointed by the Secretary (who shall serve
as Chair of the Board).
(b) Terms.--
(1) Chair.--The Chair of the Board shall serve at the
pleasure of the Secretary.
(2) Other members.--Other members of the Board shall serve
for two-year terms, except that, for the first appointments to
the Board, two producer representatives and two manufacturer
representatives shall have initial terms of one year.
SEC. 303. DUTIES.
The Board shall be responsible for--
(1) determining and describing the physical characteristics
of United States farm-produced tobacco and unmanufactured
imported tobacco;
(2) assembling and evaluating, in a systematic manner,
concerns and problems with the quality of United States
tobacco, expressed by domestic and foreign buyers and
manufacturers of tobacco products;
(3) reviewing data collected by Federal agencies on the
physical and chemical integrity of United States produced and
imported unmanufactured tobacco, to ensure that tobacco being
used in domestically-manufactured tobacco products is of the
highest quality and is free from prohibited physical and
chemical agents;
(4) investigating and communicating to the Secretary--
(A) conditions with respect to the production of
tobacco that discourage improvements in the quality of
United States produced tobacco; and
(B) recommendations for regulatory changes that
would address tobacco quality issues; and
(5) such other related activities assigned to it by the
Secretary.
SEC. 304. ADMINISTRATIVE PROVISIONS.
(a) Staff.--The Secretary shall provide the Board with staff
experienced in the sampling and analysis of unmanufactured tobacco and
capable of collecting data and monitoring tobacco production
information, and such other resources necessary for the Board to
perform its duties under this subtitle, as determined by the Secretary.
(b) Commodity Credit Corporation.--The Secretary shall use the
funds, facilities and authorities of the Commodity Credit Corporation
to carry out this title.
TITLE IV--TOBACCO PRODUCT MANUFACTURER AND IMPORTER USER FEES
SEC. 401. USER FEE.
(a) In General.--The Secretary of Health and Human Services shall
assess an annual user fee, calculated in accordance with this section,
upon each tobacco product manufacturer and tobacco product importer
that sells tobacco products in domestic commerce in the United States.
The assessments shall commence during calendar year 2004, based on
domestic sales of tobacco products during fiscal year 2003.
(b) Base Amount of User Fee for Each Class of Tobacco Product.--
(1) The base amount of the user fee for cigarette
manufacturers and importers shall be $2,116,252,000.
(2) The base amount of the user fee for small cigar
manufacturers and importers shall be $1,051,000.
(3) The base amount of the user fee for large cigar
manufacturers and importers shall be $164,274,000.
(4) The base amount of the user fee for snuff manufacturers
and importers shall be $9,920,000.
(5) The base amount of the user fee for chewing tobacco
manufacturers and importers shall be $2,275,000.
(6) The base amount of the user fee for pipe tobacco
manufacturers and importers shall be $1,505,000.
(7) The base amount of the user fee for roll-your-own
tobacco manufacturers and importers shall be $3,231,000.
(c) Determination of Annual User Fee for Each Class of Tobacco
Product.--The total user fee to be assessed upon, and paid by, the
manufacturers and importers of each class of tobacco product in each
calendar year, as allocated pursuant to subsection (d), shall be the
base amount for that class of tobacco product provided in subsection
(b) multiplied by a fraction--
(1) the numerator of which is the total volume of domestic
sales of that class of tobacco product in the fiscal year
ending on September 30 of that calendar year; and
(2) the denominator of which is the total volume of
domestic sales of that class of tobacco product in fiscal year
2003.
(d) Allocation of Total User Fee Amounts by Market Share--
(1) Formula.--The user fee for each class of tobacco
product to be paid by each manufacturer or importer of that
class of tobacco product under subsection (a) shall be
determined in each year by multiplying--
(A) such manufacturer's or importer's market share,
as calculated with respect to the current calendar
year, of that class of tobacco product; by
(B) the total user fee amount for the current
calendar year, as determined under subsection (c), for
that class of tobacco product.
(2) Market share defined.--In this subsection, the term
``market share'' for each manufacturer or importer of a class
of tobacco product for the purpose of the assessment to be
calculated in the current calendar year shall be equal to that
manufacturer's or importer's respective share (expressed as a
decimal to the fourth place) of the total volume of domestic
sales of that class of tobacco product during the calendar year
immediately preceding the year of such assessment.
(e) Determination of Volume of Domestic Sales.--
(1) Use of certified manufacturer and importer reports.--
The calculation of the volume of domestic sales of a class of
tobacco product by a manufacturer or importer, and by all
manufacturers and importers as a group, shall be made by the
Secretary of Health and Human Services based on certified
reports submitted by such manufacturers and importers pursuant
to subsection (f).
(2) Measurement methods.--For purposes of the Secretary's
calculations under this subsection and the certifications under
subsection (f), the volumes of domestic sales shall be measured
as follows:
(A) With respect to cigarettes, in terms of the
numbers of cigarettes sold.
(B) With respect to small cigars, the number of
cigars weighing not more than three pounds per thousand
sold.
(C) With respect to large cigars, the number of
cigars weighing more than three pounds per thousand
sold.
(D) With respect to other classes of tobacco
products, in terms of the number of pounds, or fraction
thereof, of these tobacco products sold.
(f) Certification of Volume of Domestic Sales.--Every manufacturer
and importer of tobacco products shall submit each year a certified
report to the Secretary of Health and Human Services setting forth for
each class of tobacco products the total, for the prior year, of such
manufacturer's or importer's domestic sales to wholesalers and
retailers and directly to consumers. These certified reports must be
submitted to the Secretary not later than March 1 of the year after the
year for which the certified report is being made.
SEC. 402. ALLOCATION OF USER FEES.
(a) In General.--The user fees collected pursuant to section 401
and any funds transferred to the Secretary of Health and Human Services
by the Secretary of Agriculture pursuant to section 102(f)(3)(B)(ii)
shall be available, without further appropriation, in accordance with,
and for the purposes described, by this section. All such funds shall
remain available until expended.
(b) Funding for FDA Regulation of Tobacco Products.--The Secretary
of Health and Human Services shall make 15 percent of the user fee
amounts collected pursuant to section 401 each year available to the
Food and Drug Administration for the regulation of tobacco products
under chapter IX of the Federal Food, Drug, and Cosmetic Act.
(c) Funding for Other Tobacco-Related Programs.--
(1) Title ii expenditures.--The Secretary of Health and
Human Services shall use the remaining 85 percent of the user
fee amounts collected each year pursuant to section 401, and
any amounts transferred to the Secretary by the Secretary of
Agriculture pursuant to section 102(f)(3)(B)(ii), to reimburse
the Commodity Credit Corporation for the expenditures made by
that agency under title II of this Act.
(2) Other tobacco-related program.--If amounts remain
available for any year after making the reimbursement required
under paragraph (1), the Secretary of Health and Human Services
shall use the remaining amounts to fund any other program that
relates to tobacco products.
TITLE V--FDA REGULATION OF TOBACCO PRODUCTS
SEC. 501. FINDINGS.
The Congress finds the following:
(1) The use of tobacco products by the Nation's children is
a pediatric disease of epic proportions that results in new
generations of tobacco-dependent children and adults.
(2) A consensus exists within the scientific and medical
communities that tobacco products are inherently dangerous and
cause cancer, heart disease, and other serious adverse health
effects.
(3) Nicotine is addictive.
(4) Virtually all new users of tobacco products are under
the minimum legal age to purchase such products.
(5) Tobacco advertising and marketing contribute
significantly to the use of nicotine-containing tobacco
products by adolescents.
(6) Because past efforts to restrict advertising and
marketing of tobacco products have failed adequately to curb
tobacco use by adolescents, comprehensive restrictions on the
sale, promotion, and distribution of such products are needed.
(7) Federal and State governments have lacked the legal and
regulatory authority and resources they need to address
comprehensively the public health and societal problems caused
by the use of tobacco products.
(8) Federal and State public health officials, the public
health community, and the public at large recognize that the
tobacco industry should be subject to ongoing oversight.
(9) Under article I, section 8 of the Constitution, the
Congress is vested with the responsibility for regulating
interstate commerce and commerce with Indian tribes.
(10) The sale, distribution, marketing, advertising, and
use of tobacco products are activities in and substantially
affecting interstate commerce because they are sold, marketed,
advertised, and distributed in interstate commerce on a
nationwide basis, and have a substantial effect on the Nation's
economy.
(11) The sale, distribution, marketing, advertising, and
use of such products substantially affect interstate commerce
through the health care and other costs attributable to the use
of tobacco products.
(12) It is in the public interest for Congress to adopt
comprehensive public health legislation because of tobacco's
unique position in the Nation's history and economy and the
need to prevent the sale, distribution, marketing and
advertising of tobacco products to persons under the minimum
legal age to purchase such products.
(13) The public interest requires a timely, fair,
equitable, and consistent result that will serve the public
interest by restricting throughout the Nation the sale,
distribution, marketing, and advertising of tobacco products
only to persons of legal age to purchase such products.
(14) Public health authorities estimate that the benefits
to the Nation of enacting Federal legislation to accomplish
these goals would be significant in human and economic terms.
(15) Reducing the use of tobacco by minors by 50 percent
would prevent well over 60,000 early deaths each year and save
up to $43 billion each year in reduced medical costs, improved
productivity, and the avoidance of premature deaths.
(16) Advertising, marketing, and promotion of tobacco
products have been especially directed to attract young persons
to use tobacco products and these efforts have resulted in
increased use of such products by youth. Past efforts to
oversee these activities have not been successful in adequately
preventing such increased use.
(17) Tobacco advertising increases the size of the tobacco
market by increasing consumption of tobacco products including
increasing tobacco use by young people.
(18) Children are more influenced by tobacco advertising
than adults and they smoke the most advertised brands.
(19) Tobacco company documents indicate that young people
are an important and often crucial segment of the tobacco
market.
(20) Advertising restrictions will have a positive effect
on the smoking rates of young people.
(21) Restrictions on advertising are necessary to prevent
unrestricted tobacco advertising from undermining legislation
prohibiting access to young people.
(22) It is in the public interest for Congress to adopt
legislation to address the public health crisis created by
actions of the tobacco industry.
SEC. 502. DEFINITIONS.
(a) Federal Cigarette Labeling and Advertising Act.--Section 3(1)
of the Federal Cigarette Labeling and Advertising Act is amended--
(1) in subparagraph (A) by striking ``and'';
(2) in subparagraph (B) by striking the period and
inserting ``; and''; and
(3) by inserting the following new subparagraph at the end
thereof:
``(C) any tobacco product, in any form, including
bidis and kreteks, if the tobacco in the product is
heated or burned and is functional in the product, and
the product, because of its appearance, the type of
tobacco used in the filler, or its packaging and
labeling, is likely to be offered to, or purchased by,
consumers as a cigarette or as roll-your-own
tobacco.''.
(b) This Title.--In this title:
(1) Brand.--The term ``brand'' means a variety of tobacco
product distinguished by the tobacco used, tar content,
nicotine content, flavoring used, size, filtration, or
packaging, logo, registered trademark or brand name,
identifiable pattern of colors, or any combination of such
attributes.
(2) Cigarette.--The term ``cigarette'' has the meaning
given that term by section 3(1) of the Federal Cigarette
Labeling and Advertising Act (15 U.S.C. 1332(1)).
(3) Cigarette tobacco.--The term ``cigarette tobacco''
means any product that consists of loose tobacco that is
intended for use by consumers in a cigarette. Unless otherwise
stated, the requirements for cigarettes shall also apply to
cigarette tobacco.
(4) Commerce.--The term ``commerce'' has the meaning given
that term by section 3(2) of the Federal Cigarette Labeling and
Advertising Act (15 U.S.C. 1332(2)).
(5) Constituent.--The term ``constituent'' in relation to
cigarettes means any element of mainstream or sidestream smoke.
(6) Distributor.--The term ``distributor'' as regards a
tobacco product means any person who furthers the distribution
of cigarette or smokeless tobacco, whether domestic or
imported, at any point from the original place of manufacture
to the person who sells or distributes the product to
individuals for personal consumption. Common carriers are not
considered distributors for purposes of this title.
(7) Ingredient.--The term ``ingredient'' in relation to
cigarettes or smokeless tobacco products means any substance,
chemical, or compound (other than tobacco, water, or
reconstituted tobacco sheet made wholly from tobacco) added, or
specified for addition, by the manufacturer to the tobacco, paper, or
filter of a cigarette, or to the tobacco of a smokeless tobacco
product, including flavorants, processing aids, casing sauces,
preservatives, and combustion modifiers.
(8) Manufacturer.--The term ``manufacturer'' means any
person who manufactures tobacco products intended to be sold in
the United States. The term ``manufacturer'' shall include an
importer or other first purchaser for resale in the United
States of tobacco products manufactured outside of the United
States or tobacco products manufactured in the United States
but not intended for sale in the United States.
(9) Nicotine.--The term ``nicotine'' means the chemical
substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or
C[10]H[14]N[2], including any salt or complex of nicotine.
(10) Package.--The term ``package'' means a pack, box,
carton, or container of any kind or, if no other container, any
wrapping (including cellophane), in which cigarettes or
smokeless tobacco are offered for sale, sold, or otherwise
distributed to consumers.
(11) Retailer.--The term ``retailer'' means any person who
sells cigarettes or smokeless tobacco to individuals for
personal consumption, or who operates a facility where self-
service displays of tobacco products are permitted.
(12) Secretary.--Except where the context otherwise
requires, the term ``Secretary'' means the Secretary of Health
and Human Services.
(13) Smokeless tobacco.--The term ``smokeless tobacco''
means any product that consists of cut, ground, powdered, or
leaf tobacco and that is intended to be placed in the oral or
nasal cavity.
SEC. 503. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) Definition.--Section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the
following:
``(nn) The term `tobacco product' means any product made or
derived from tobacco that is intended for human consumption,
including any component, part, or accessory of a tobacco
product (except for raw materials other than tobacco used in
manufacturing a component, part, or accessory of a tobacco
product).
``(ll) The definitions contained in section 502 of the
Tobacco Livelihood and Economic Assistance for our Farmers Act
of 2002 shall apply with respect to chapter IX.''.
(b) FDA Authority Over Tobacco Products.--The Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
(1) by redesignating chapter IX as chapter X;
(2) by redesignating sections 901 through 907 as sections
1001 through 1007; and
(3) by inserting after chapter VIII the following:
``CHAPTER IX--TOBACCO PRODUCTS
``SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.
``(a) In General.--Tobacco products shall be regulated by the
Secretary under this chapter and shall not be subject to the provisions
of chapter V, unless--
``(1) such products are intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease (within
the meaning of section 201(g)(1)(B) or section 201(h)(2)); or
``(2) a health claim is made for such products under
section 201(g)(1)(C) or 201(h)(3), unless the product is a
reduced risk product pursuant to section 912.
``(b) Applicability.--This chapter shall apply to all tobacco
products subject to the provisions of part 897 of title 21, Code of
Federal Regulations, and to any other tobacco products that the
Secretary by regulation deems to be subject to this chapter.
``(c) Scope.--
``(1) Nothing in this chapter shall be construed to affect
the Secretary's authority over, or the regulation of, products
under this Act that are not tobacco products under chapter V or
any other chapter of this Act.
``(2) The provisions of this chapter shall not apply to
tobacco leaf that is not in the possession of the manufacturer,
or to the producers of tobacco leaf, including tobacco growers,
tobacco warehouses, and tobacco grower cooperatives, nor shall
any employee of the Food and Drug Administration have any
authority whatsoever to enter onto a farm owned by a producer
of tobacco leaf without the written consent of such producer.
Notwithstanding any other provision of this subparagraph, if a
producer of tobacco leaf is also a tobacco product manufacturer
or controlled by a tobacco product manufacturer, the producer
shall be subject to this chapter in the producer's capacity as
a manufacturer. Nothing in this chapter shall be construed to
grant the Secretary authority to promulgate regulations on any
matter that involves the production of tobacco leaf or a
producer thereof, other than activities by a manufacturer
affecting production. For purposes of the preceding sentence,
the term `controlled by' means a member of the same controlled
group of corporations as that term is used in section 52(a) of
the Internal Revenue Code of 1986, or under common control
within the meaning of the regulations promulgated under section
52(b) of such Code.
``SEC. 902. ADULTERATED TOBACCO PRODUCTS.
``A tobacco product shall be deemed to be adulterated if--
``(1) it consists in whole or in part of any filthy,
putrid, or decomposed substance, or is otherwise contaminated
by any poisonous or deleterious substance that may render the
product more injurious to health;
``(2) it has been prepared, packed, or held under
insanitary conditions whereby it may have been contaminated
with filth, or whereby it may have been rendered more injurious
to health;
``(3) its container is composed, in whole or in part, of
any poisonous or deleterious substance which may render the
contents more injurious to health;
``(4) it is, or purports to be or is represented as, a
tobacco product which is subject to a performance standard
established under section 907 unless such tobacco product is in
all respects in conformity with such standard;
``(5) it is required by section 910(a) to have premarket
approval, is not exempt under section 906(f), and does not have
an approved application in effect;
``(6) the methods used in, or the facilities or controls
used for, its manufacture, packing or storage are not in
conformity with applicable requirements under section 906(e)(1)
or an applicable condition prescribed by an order under section
906(e)(2); or
``(7) it is a tobacco product for which an exemption has
been granted under section 906(f) for investigational use and
the person who was granted such exemption or any investigator
who uses such tobacco product under such exemption fails to
comply with a requirement prescribed by or under such section.
``SEC. 903. MISBRANDED TOBACCO PRODUCTS.
``(a) In General.--A tobacco product shall be deemed to be
misbranded--
``(1) if its labeling is false or misleading in any
particular;
``(2) if in package form unless it bears a label
containing--
``(A) the name and place of business of the tobacco
product manufacturer, packer, or distributor; and
``(B) an accurate statement of the quantity of the
contents in terms of weight, measure, or numerical
count,
except that under subparagraph (B) of this paragraph reasonable
variations shall be permitted, and exemptions as to small
packages shall be established, by regulations prescribed by the
Secretary;
``(3) if any word, statement, or other information required
by or under authority of this chapter to appear on the label or
labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements or
designs in the labeling) and in such terms as to render it
likely to be read and understood by the ordinary individual
under customary conditions of purchase and use;
``(4) if it has an established name, unless its label
bears, to the exclusion of any other nonproprietary name, its
established name prominently printed in type as required by the
Secretary by regulation;
``(5) if the Secretary has issued regulations requiring
that its labeling bear adequate directions for use, or adequate
warnings against use by children, that are necessary for the
protection of users unless its labeling conforms in all
respects to such regulations;
``(6) if it was manufactured, prepared, propagated,
compounded, or processed in any State in an establishment not
duly registered under section 905(b), if it was not included in
a list required by section 905(i), if a notice or other
information respecting it was not provided as required by such
section or section 905(j), or if it does not bear such symbols
from the uniform system for identification of tobacco products
prescribed under section 905(e) as the Secretary by regulation
requires;
``(7) if, in the case of any tobacco product distributed or
offered for sale in any State--
``(A) its advertising is false or misleading in any
particular; or
``(B) it is sold, distributed, advertised, or
promoted in violation of section 915 or regulations
prescribed under section 906(d);
``(8) unless, in the case of any tobacco product
distributed or offered for sale in any State, the manufacturer,
packer, or distributor thereof includes in all advertisements
and other descriptive printed matter issued or caused to be
issued by the manufacturer, packer, or distributor with respect
to that tobacco product--
``(A) a true statement of the tobacco product's
established name as defined in paragraph (4) of this
subsection, printed prominently; and
``(B) a brief statement of--
``(i) the uses of the tobacco product and
relevant warnings, precautions, side effects,
and contraindications; and
``(ii) in the case of specific tobacco
products made subject to a finding by the
Secretary after notice and opportunity for
comment that such action is necessary to
protect the public health, a full description
of the components of such tobacco product or
the formula showing quantitatively each
ingredient of such tobacco product to the
extent required in regulations which shall be
issued by the Secretary after an opportunity
for a hearing;
``(9) unless, in the case of any tobacco product
distributed or offered for sale in any State, the manufacturer,
packer, or distributor thereof includes in all advertisements
the information required by section 916(c);
``(10) if it is a tobacco product subject to a performance
standard established under section 907, unless it bears such
labeling as may be prescribed in such performance standard; or
``(11) if there was a failure or refusal--
``(A) to comply with any requirement prescribed
under section 904 or 908; or
``(B) to furnish any material or information
required by or under section 909.
``(b) Prior Approval of Statements on Label.--The Secretary may, by
regulation, require prior approval of statements made on the label of a
tobacco product. No regulation issued under this subsection may require
prior approval by the Secretary of the content of any advertisement and
no advertisement of a tobacco product, published after the date of
enactment of this chapter shall, with respect to the matters specified
in this section or covered by regulations issued hereunder, be subject
to the provisions of sections 12 through 15 of the Federal Trade
Commission Act (15 U.S.C. 52 through 55). This subsection does not
apply to any printed matter which the Secretary determines to be
labeling as defined in section 201(m).
``SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE SECRETARY.
``(a) Requirement.--Not later than 6 months after the date of
enactment of this chapter, each tobacco product manufacturer or
importer of tobacco products, or agents thereof, shall submit to the
Secretary the following information:
``(1) A listing of all tobacco ingredients, substances and
compounds that are, on such date, added by the manufacturer to
the tobacco, paper, filter, or other component of each tobacco
product by brand and by quantity in each brand and subbrand.
``(2) A description of the content, delivery, and form of
nicotine in each tobacco product measured in milligrams of
nicotine.
``(3) All documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the
manufacturer (or agents thereof) on the health, behavioral, or
physiologic effects of tobacco products, their constituents,
ingredients, and components, and tobacco additives, described
in paragraph (1).
``(4) All documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the
manufacturer (or agents thereof) that relate to the issue of
whether a reduction in risk to health from tobacco products can
occur upon the employment of technology available or known to
the manufacturer.
``(5) All documents (including underlying scientific
information) relating to marketing research involving the use
of tobacco products.
An importer of a tobacco product not manufactured in the United States
shall supply the information required of a tobacco product manufacturer
under this subsection.
``(b) Annual Submission.--A tobacco product manufacturer or
importer that is required to submit information under subsection (a)
shall update such information on an annual basis under a schedule
determined by the Secretary.
``(c) Time for Submission.--
``(1) New products.--At least 90 days prior to the delivery
for introduction into interstate commerce of a tobacco product
not on the market on the date of enactment of this chapter, the
manufacturer of such product shall provide the information
required under subsection (a) and such product shall be subject
to the annual submission under subsection (b).
``(2) Modification of existing products.--If at any time a
tobacco product manufacturer adds to its tobacco products a new
tobacco additive, increases or decreases the quantity of an
existing tobacco additive or the nicotine content, delivery, or
form, or eliminates a tobacco additive from any tobacco
product, the manufacturer shall within 60 days of such action
so advise the Secretary in writing and reference such
modification in submissions made under subsection (b).
``SEC. 905. ANNUAL REGISTRATION.
``(a) Definitions.--As used in this section--
``(1) consistent with the provisions of section 901(c)(2),
the term `manufacture, preparation, compounding, or processing'
shall include repackaging or otherwise changing the container, wrapper,
or labeling of any tobacco product package in furtherance of the
distribution of the tobacco product from the original place of
manufacture to the person who makes final delivery or sale to the
ultimate consumer or user; and
``(2) the term `name' shall include in the case of a
partnership the name of each partner and, in the case of a
corporation, the name of each corporate officer and director,
and the State of incorporation.
``(b) Registration by Owners and Operators.--On or before December
31 of each year every person who owns or operates any establishment in
any State engaged in the manufacture, preparation, compounding, or
processing of a tobacco product or tobacco products shall register with
the Secretary the name, places of business, and all such establishments
of that person.
``(c) Registration of New Owners and Operators.--Every person upon
first engaging in the manufacture, preparation, compounding, or
processing of a tobacco product or tobacco products in any
establishment owned or operated in any State by that person shall
immediately register with the Secretary that person's name, place of
business, and such establishment.
``(d) Registration of Added Establishments.--Every person required
to register under subsection (b) or (c) shall immediately register with
the Secretary any additional establishment which that person owns or
operates in any State and in which that person begins the manufacture,
preparation, compounding, or processing of a tobacco product or tobacco
products.
``(e) Uniform Product Identification System.--The Secretary may by
regulation prescribe a uniform system for the identification of tobacco
products and may require that persons who are required to list such
tobacco products under subsection (i) of this section shall list such
tobacco products in accordance with such system.
``(f) Public Access to Registration Information.--The Secretary
shall make available for inspection, to any person so requesting, any
registration filed under this section.
``(g) Biennial Inspection of Registered Establishments.--Every
establishment in any State registered with the Secretary under this
section shall be subject to inspection under section 704, and every
such establishment engaged in the manufacture, compounding, or
processing of a tobacco product or tobacco products shall be so
inspected by one or more officers or employees duly designated by the
Secretary at least once in the 2-year period beginning with the date of
registration of such establishment under this section and at least once
in every successive 2-year period thereafter.
``(h) Foreign Establishments May Register.--Any establishment
within any foreign country engaged in the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco products,
may register under this section under regulations promulgated by the
Secretary. Such regulations shall require such establishment to provide
the information required by subsection (i) of this section and shall
include provisions for registration of any such establishment upon
condition that adequate and effective means are available, by
arrangement with the government of such foreign country or otherwise,
to enable the Secretary to determine from time to time whether tobacco
products manufactured, prepared, compounded, or processed in such
establishment, if imported or offered for import into the United
States, shall be refused admission on any of the grounds set forth in
section 801(a).
``(i) Registration Information.--
``(1) Product list.--Every person who registers with the
Secretary under subsection (b), (c), or (d) of this section
shall, at the time of registration under any such subsection,
file with the Secretary a list of all tobacco products which
are being manufactured, prepared, compounded, or processed by
that person for commercial distribution and which has not been
included in any list of tobacco products filed by that person
with the Secretary under this paragraph or paragraph (2) before such
time of registration. Such list shall be prepared in such form and
manner as the Secretary may prescribe and shall be accompanied by--
``(A) in the case of a tobacco product contained in
the applicable list with respect to which a performance
standard has been established under section 907 or
which is subject to section 910, a reference to the
authority for the marketing of such tobacco product and
a copy of all labeling for such tobacco product;
``(B) in the case of any other tobacco product
contained in an applicable list, a copy of all consumer
information and other labeling for such tobacco
product, a representative sampling of advertisements
for such tobacco product, and, upon request made by the
Secretary for good cause, a copy of all advertisements
for a particular tobacco product; and
``(C) if the registrant filing a list has
determined that a tobacco product contained in such
list is not subject to a performance standard
established under section 907, a brief statement of the
basis upon which the registrant made such determination
if the Secretary requests such a statement with respect
to that particular tobacco product.
``(2) Biannual report of any change in product list.--Each
person who registers with the Secretary under this section
shall report to the Secretary once during the month of June of each
year and once during the month of December of each year the following:
``(A) A list of each tobacco product introduced by
the registrant for commercial distribution which has
not been included in any list previously filed by that
person with the Secretary under this subparagraph or
paragraph (1) of this subsection. A list under this
subparagraph shall list a tobacco product by its
established name and shall be accompanied by the other
information required by paragraph (1).
``(B) If since the date the registrant last made a
report under this paragraph that person has
discontinued the manufacture, preparation, compounding, or processing
for commercial distribution of a tobacco product included in a list
filed under subparagraph (A) or paragraph (1), notice of such
discontinuance, the date of such discontinuance, and the identity of
its established name.
``(C) If since the date the registrant reported
under subparagraph (B) a notice of discontinuance that
person has resumed the manufacture, preparation,
compounding, or processing for commercial distribution
of the tobacco product with respect to which such
notice of discontinuance was reported, notice of such
resumption, the date of such resumption, the identity
of such tobacco product by established name, and other
information required by paragraph (1), unless the
registrant has previously reported such resumption to
the Secretary under this subparagraph.
``(D) Any material change in any information
previously submitted under this paragraph or paragraph
(1).
``(j) Report Preceding Introduction of Certain Substantially
Equivalent Products Into Interstate Commerce.--Each person who is
required to register under this section and who proposes to begin the
introduction or delivery for introduction into interstate commerce for
commercial distribution of a tobacco product intended for human use
that was not commercially marketed (other than for test marketing) in
the United States as of the date of enactment of this chapter, as
defined by the Secretary by regulation shall, at least 90 days before
making such introduction or delivery, report to the Secretary (in such
form and manner as the Secretary shall by regulation prescribe)--
``(1) the basis for such person's determination that the
tobacco product is substantially equivalent, within the meaning
of section 910, to a tobacco product commercially marketed
(other than for test marketing) in the United States as of the
date of this chapter's enactment, that is in compliance with
the requirements of this Act; and
``(2) action taken by such person to comply with the
requirements under section 907 that are applicable to the
tobacco product.
``SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO PRODUCTS.
``(a) In General.--Any requirement established by or under section
902, 903, 905, or 909 applicable to a tobacco product shall apply to
such tobacco product until the applicability of the requirement to the
tobacco product has been changed by action taken under section 907,
section 910, or subsection (d) of this section, and any requirement
established by or under section 902, 903, 905, or 909 which is
inconsistent with a requirement imposed on such tobacco product under
section 907, section 910, or subsection (d) of this section shall not
apply to such tobacco product.
``(b) Information on Public Access and Comment.--Each notice of
proposed rulemaking under section 907, 908, 909, or 910, or under this
section, any other notice which is published in the Federal Register
with respect to any other action taken under any such section and which
states the reasons for such action, and each publication of findings
required to be made in connection with rulemaking under any such
section shall set forth--
``(1) the manner in which interested persons may examine
data and other information on which the notice or findings is
based; and
``(2) the period within which interested persons may
present their comments on the notice or findings (including the
need thereof) orally or in writing, which period shall be at
least 60 days but may not exceed 90 days unless the time is
extended by the Secretary by a notice published in the Federal
Register stating good cause therefor.
``(c) Limited Confidentiality of Information.--Any information
reported to or otherwise obtained by the Secretary or the Secretary's
representative under section 904, 905, 907, 908, 909, 910, 912, or 704,
or under subsection (e) or (f) of this section, which is exempt from
disclosure under subsection (a) of section 552 of title 5, United
States Code, by reason of subsection (b)(4) of that section shall be
considered confidential and shall not be disclosed, except that the
information may be disclosed to other officers or employees concerned
with carrying out this chapter, or when relevant in any proceeding
under this chapter.
``(d) Restrictions.--
``(1) The Secretary may by regulation require that a
tobacco product be restricted to sale or distribution upon such
conditions, including restrictions on the access to, and the
advertising and promotion of, the tobacco product, as the
Secretary may prescribe in such regulation if the Secretary
determines that such regulation would be appropriate for the
prevention of, or decrease in, the use of tobacco products by
children under the age at which tobacco products may be legally
purchased. No such condition may require that the sale or
distribution of a tobacco product be limited to the written or
oral authorization of a practitioner licensed by law to
prescribe medical products.
``(2) The label of a tobacco product shall bear such
appropriate statements of the restrictions required by a
regulation under subsection (a) as the Secretary may in such
regulation prescribe.
``(3) No restriction under paragraph (1) may prohibit the
sale of any tobacco product in face-to-face transactions by a
specific category of retail outlets.
``(e) Good Manufacturing Practice Requirements.--
``(1) Methods, facilities, and controls to conform.--
``(A) The Secretary may, in accordance with
subparagraph (B), prescribe regulations requiring that
the methods used in, and the facilities and controls
used for, the manufacture, pre-production design
validation (including a process to assess the
performance of a tobacco product), packing and storage
of a tobacco product, conform to current good
manufacturing practice for an agricultural product,
as prescribed in such regulations, to assure that the public health is
protected and that the tobacco product is in compliance with this
chapter.
``(B) The Secretary shall--
``(i) before promulgating any regulation
under subparagraph (A), afford an advisory
committee an opportunity to submit
recommendations with respect to the regulation
proposed to be promulgated;
``(ii) before promulgating any regulation
under subparagraph (A), afford opportunity for
an oral hearing;
``(iii) provide the advisory committee a
reasonable time to make its recommendation with
respect to proposed regulations under
subparagraph (A); and
``(iv) in establishing the effective date
of a regulation promulgated under this
subsection, take into account the differences
in the manner in which the different types of
tobacco products have historically been
produced, the financial resources of the
different tobacco product manufacturers, and
the state of their existing manufacturing
facilities; and shall provide for a reasonable
period of time for such manufacturers to
conform to good manufacturing practices.
``(2) Exemptions; variances.--
``(A) Any person subject to any requirement
prescribed under paragraph (1) may petition the
Secretary for a permanent or temporary exemption or
variance from such requirement. Such a petition shall
be submitted to the Secretary in such form and manner
as the Secretary shall prescribe and shall--
``(i) in the case of a petition for an
exemption from a requirement, set forth the
basis for the petitioner's determination that
compliance with the requirement is not required
to assure that the tobacco product will be in
compliance with this chapter;
``(ii) in the case of a petition for a
variance from a requirement, set forth the
methods proposed to be used in, and the
facilities and controls proposed to be used
for, the manufacture, packing, and storage of
the tobacco product in lieu of the methods,
facilities, and controls prescribed by the
requirement; and
``(iii) contain such other information as
the Secretary shall prescribe.
``(B) The Secretary may refer to an advisory
committee any petition submitted under subparagraph
(A). The advisory committee shall report its
recommendations to the Secretary with respect to a
petition referred to it within 60 days after the date
of the petition's referral. Within 60 days after--
``(i) the date the petition was submitted
to the Secretary under subparagraph (A); or
``(ii) the day after the petition was
referred to an advisory committee,
whichever occurs later, the Secretary shall by order
either deny the petition or approve it.
``(C) The Secretary may approve--
``(i) a petition for an exemption for a
tobacco product from a requirement if the
Secretary determines that compliance with such
requirement is not required to assure that the
tobacco product will be in compliance with this
chapter; and
``(ii) a petition for a variance for a
tobacco product from a requirement if the
Secretary determines that the methods to be
used in, and the facilities and controls to be
used for, the manufacture, packing, and storage
of the tobacco product in lieu of the methods,
controls, and facilities prescribed by the
requirement are sufficient to assure that the
tobacco product will be in compliance with this
chapter.
``(D) An order of the Secretary approving a
petition for a variance shall prescribe such conditions
respecting the methods used in, and the facilities and
controls used for, the manufacture, packing, and
storage of the tobacco product to be granted the
variance under the petition as may be necessary to
assure that the tobacco product will be in compliance
with this chapter.
``(E) After the issuance of an order under
subparagraph (B) respecting a petition, the petitioner
shall have an opportunity for an informal hearing on
such order.
``(f) Exemption for Investigational Use.--The Secretary may exempt
tobacco products intended for investigational use from this chapter
under such conditions as the Secretary may prescribe by regulation.
``(g) Research and Development.--The Secretary may enter into
contracts for research, testing, and demonstrations respecting tobacco
products and may obtain tobacco products for research, testing, and
demonstration purposes without regard to section 3324(a) and (b) of
title 31, United States Code, and section 5 of title 41, United States
Code.
``SEC. 907. PERFORMANCE STANDARDS.
``(a) In General.--
``(1) Finding required.--The Secretary may adopt
performance standards for a tobacco product if the Secretary
finds that a performance standard is appropriate for the
protection of the public health. This finding shall be
determined with respect to the risks and benefits to the
population as a whole, including users and non-users of the
tobacco product, and taking into account--
``(A) the increased or decreased likelihood that
existing users of tobacco products will stop using such
products; and
``(B) the increased or decreased likelihood that
those who do not use tobacco products will start using
such products.
``(2) Content of performance standards.--A performance
standard established under this section for a tobacco product--
``(A) shall include provisions to provide
performance that is appropriate for the protection of
the public health, including provisions, where
appropriate--
``(i) for the reduction of nicotine yields
of the product;
``(ii) for the reduction or elimination of
other harmful constituents or harmful
components of the product; or
``(iii) relating to any other requirement
under (B);
``(B) shall, where necessary to be appropriate for
the protection of the public health, include--
``(i) provisions respecting the
construction, components, ingredients, and
properties of the tobacco product;
``(ii) provisions for the testing (on a
sample basis or, if necessary, on an individual
basis) of the tobacco product;
``(iii) provisions for the measurement of
the performance characteristics of the tobacco
product; and
``(iv) provisions requiring that the
results of each or of certain of the tests of
the tobacco product required to be made under
clause (ii) show that the tobacco product is in
conformity with the portions of the standard
for which the test or tests were required; and
``(C) shall not render the tobacco product
unacceptable for adult consumption.
``(3) Periodic reevaluation of performance standards.--The
Secretary shall provide for periodic evaluation of performance
standards established under this section to determine whether
such standards should be changed to reflect new medical,
scientific, or other technological data. The Secretary may
provide for testing under paragraph (2) by any person.
``(4) Involvement of other agencies; informed persons.--In
carrying out duties under this section, the Secretary shall, to
the maximum extent practicable--
``(A) use personnel, facilities, and other
technical support available in other Federal agencies;
``(B) consult with other Federal agencies concerned
with standard-setting and other nationally or
internationally recognized standard-setting entities;
and
``(C) invite appropriate participation, through
joint or other conferences, workshops, or other means,
by informed persons representative of scientific,
professional, industry, or consumer organizations who
in the Secretary's judgment can make a significant
contribution.
``(b) Establishment of Standards.--
``(1) Notice.--
``(A) The Secretary shall publish in the Federal
Register a notice of proposed rulemaking for the
establishment, amendment, or revocation of any
performance standard for a tobacco product.
``(B) A notice of proposed rulemaking for the
establishment or amendment of a performance standard
for a tobacco product shall--
``(i) set forth a finding with supporting
justification that the performance standard is
appropriate for the protection of the public
health;
``(ii) set forth proposed findings with
respect to the risk of illness or injury that
the performance standard is intended to reduce
or eliminate; and
``(iii) invite interested persons to submit
an existing performance standard for the
tobacco product, including a draft or proposed
performance standard, for consideration by the
Secretary.
``(C) A notice of proposed rulemaking for the
revocation of a performance standard shall set forth a
finding with supporting justification that the
performance standard is no longer necessary to be
appropriate for the protection of the public health.
``(D) The Secretary shall consider all information
submitted in connection with a proposed standard,
including information concerning the countervailing
effects of the performance standard on the health of
adolescent tobacco users, adult tobacco users, or non-
tobacco users, such as the creation of a significant
demand for contraband or other tobacco products that do
not meet the requirements of this chapter and the
significance of such demand, and shall issue the
standard if the Secretary determines that the standard
would be appropriate for the protection of the public health.
``(E) The Secretary shall provide for a comment
period of not less than 60 days.
``(2) Promulgation.--
``(A) After the expiration of the period for
comment on a notice of proposed rulemaking published
under paragraph (1) respecting a performance standard
and after consideration of such comments and any report
from an advisory committee, the Secretary shall--
``(i) promulgate a regulation establishing
a performance standard and publish in the
Federal Register findings on the matters
referred to in paragraph (1); or
``(ii) publish a notice terminating the
proceeding for the development of the standard
together with the reasons for such termination.
``(B) A regulation establishing a performance
standard shall set forth the date or dates upon which
the standard shall take effect, but no such regulation
may take effect before one year after the date of its publication
unless the Secretary determines that an earlier effective date is
necessary for the protection of the public health. Such date or dates
shall be established so as to minimize, consistent with the public
health, economic loss to, and disruption or dislocation of, domestic
and international trade.
``(3) Power reserved to congress.--Because of the
importance of any decision to issue a regulation establishing a
performance standard--
``(A) eliminating all cigarettes, all smokeless
tobacco products, or any similar class of tobacco
products, or
``(B) requiring the reduction of nicotine yields of
a tobacco product to zero,
Congress expressly reserves to itself the power to make such a
decision.
``(4) Amendment; revocation.--
``(A) The Secretary, upon the Secretary's own
initiative or upon petition of an interested person may
by a regulation, promulgated in accordance with the
requirements of paragraphs (1) and (2)(B) of this
subsection, amend or revoke a performance standard.
``(B) The Secretary may declare a proposed
amendment of a performance standard to be effective on
and after its publication in the Federal Register and
until the effective date of any final action taken on
such amendment if the Secretary determines that making
it so effective is in the public interest.
``(5) Reference to advisory committee.--The Secretary--
``(A) may, on the Secretary's own initiative, refer
a proposed regulation for the establishment, amendment,
or revocation of a performance standard; or
``(B) shall, upon the request of an interested
person which demonstrates good cause for referral and
which is made before the expiration of the period for
submission of comments on such proposed regulation,
refer such proposed regulation to an advisory committee, for a
report and recommendation with respect to any matter involved
in the proposed regulation which requires the exercise of
scientific judgment. If a proposed regulation is referred under
this subparagraph to the advisory committee, the Secretary
shall provide the advisory committee with the data and information on
which such proposed regulation is based. The advisory committee shall,
within 60 days after the referral of a proposed regulation and after
independent study of the data and information furnished to it by the
Secretary and other data and information before it, submit to the
Secretary a report and recommendation respecting such regulation,
together with all underlying data and information and a statement of
the reason or basis for the recommendation. A copy of such report and
recommendation shall be made public by the Secretary.
``SEC. 908. NOTIFICATION AND OTHER REMEDIES.
``(a) Notification.--If the Secretary determines that--
``(1) a tobacco product which is introduced or delivered
for introduction into interstate commerce for commercial
distribution presents a risk of substantial harm to the public
health exceeding the risks posed by tobacco products marketed
before the date of enactment of this chapter; and
``(2) notification under this subsection is necessary to
eliminate the unreasonable risk of such harm and no more
practicable means is available under the provisions of this
chapter (other than this section) to eliminate such risk,
the Secretary may issue such order as may be necessary to assure that
adequate notification is provided in an appropriate form, by the
persons and means best suited under the circumstances involved, to all
persons who should properly receive such notification in order to
eliminate such risk. The Secretary may order notification by any
appropriate means, including public service announcements. Before
issuing an order under this subsection, the Secretary shall consult
with the persons who are to give notice under the order.
``(b) No Exemption From Other Liability.--Compliance with an order
issued under this section shall not relieve any person from liability
under Federal or State law.
``(c) Recall Authority.--
``(1) In general.--If the Secretary finds that there is a
reasonable probability that a tobacco product contains a
manufacturing or other defect not ordinarily contained in
tobacco products on the market that would cause serious,
adverse health consequences or death, the Secretary shall issue
an order requiring the appropriate person (including the
manufacturers, importers, distributors, or retailers of the
tobacco product) to immediately cease distribution of such
tobacco product. The order shall provide the person subject to
the order with an opportunity for an informal hearing, to be held not
later than 10 days after the date of the issuance of the order, on the
actions required by the order and on whether the order should be
amended to require a recall of such tobacco product. If, after
providing an opportunity for such a hearing, the Secretary determines
that inadequate grounds exist to support the actions required by the
order, the Secretary shall vacate the order.
``(2) Amendment of order to require recall.--
``(A) If, after providing an opportunity for an
informal hearing under paragraph (1), the Secretary
determines that the order should be amended to include
a recall of the tobacco product with respect to which
the order was issued, the Secretary shall, except as
provided in subparagraph (B), amend the order to
require a recall. The Secretary shall specify a
timetable in which the tobacco product recall will
occur and shall require periodic reports to the
Secretary describing the progress of the recall.
``(B) An amended order under subparagraph (A)--
``(i) shall not include recall of a tobacco
product from individuals; and
``(ii) shall provide for notice to persons
subject to the risks associated with the use of
such tobacco product.
In providing the notice required by clause (ii), the
Secretary may use the assistance of retailers and other
persons who distributed such tobacco product. If a
significant number of such persons cannot be
identified, the Secretary shall notify such persons
under section 705(b).
``(3) Remedy not exclusive.--The remedy provided by this
subsection shall be in addition to remedies provided by
subsection (a) of this section.
``SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS.
``(a) In General.--Every person who is a tobacco product
manufacturer or importer of a tobacco product shall establish and
maintain such records, make such reports, and provide such information,
as the Secretary may by regulation reasonably require to assure that
such tobacco product is not adulterated or misbranded and to otherwise
protect public health. Regulations prescribed under the preceding
sentence--
``(1) may require a tobacco product manufacturer or
importer to report to the Secretary whenever the manufacturer
or importer receives or otherwise becomes aware of information
that reasonably suggests that one of its marketed tobacco
products may have caused or contributed to a serious unexpected
adverse experience associated with the use of the product or
any significant increase in the frequency of a serious,
expected adverse product experience;
``(2) shall require reporting of other significant adverse
tobacco product experiences as determined by the Secretary to
be necessary to be reported;
``(3) shall not impose requirements unduly burdensome to a
tobacco product manufacturer or importer, taking into account
the cost of complying with such requirements and the need for
the protection of the public health and the implementation of
this chapter;
``(4) when prescribing the procedure for making requests
for reports or information, shall require that each request
made under such regulations for submission of a report or
information to the Secretary state the reason or purpose for
such request and identify to the fullest extent practicable
such report or information;
``(5) when requiring submission of a report or information
to the Secretary, shall state the reason or purpose for the
submission of such report or information and identify to the
fullest extent practicable such report or information; and
``(6) may not require that the identity of any patient or
user be disclosed in records, reports, or information required
under this subsection unless required for the medical welfare
of an individual, to determine risks to public health of a
tobacco product, or to verify a record, report, or information
submitted under this chapter.
In prescribing regulations under this subsection, the Secretary shall
have due regard for the professional ethics of the medical profession
and the interests of patients. The prohibitions of paragraph (6) of
this subsection continue to apply to records, reports, and information
concerning any individual who has been a patient, irrespective of
whether or when he ceases to be a patient.
``(b) Reports of Removals and Corrections.--
(1) Except as provided in paragraph (3), the Secretary
shall by regulation require a tobacco product manufacturer or
importer of a tobacco product to report promptly to the
Secretary any corrective action taken or removal from the market of a
tobacco product undertaken by such manufacturer or importer if the
removal or correction was undertaken--
``(A) to reduce a risk to health posed by the
tobacco product; or
``(B) to remedy a violation of this chapter caused
by the tobacco product which may present a risk to
health.
A tobacco product manufacturer or importer of a tobacco product who
undertakes a corrective action or removal from the market of a tobacco
product which is not required to be reported under this subsection
shall keep a record of such correction or removal.
``(2) No report of the corrective action or removal of a
tobacco product may be required under paragraph (1) if a report
of the corrective action or removal is required and has been
submitted under subsection (a) of this section.
``SEC. 910. PREMARKET REVIEW OF CERTAIN TOBACCO PRODUCTS.
``(a) In General.--
``(1) Premarket approval required.--Approval under this
section of an application for premarket approval for any
tobacco product, other than a reduced risk product under
section 912, that is not commercially marketed (other than for
test marketing) in the United States as of the date of this
chapter's enactment, is required unless the manufacturer has
submitted a report under section 905(j), and the Secretary has
not suspended the distribution of such product under this
paragraph. Within 90 days of the submission of a report under
section 905(j), the Secretary may by order suspend the
distribution of the tobacco product that is the subject of that
report if the Secretary determines that there is a reasonable
likelihood that the tobacco product is not substantially
equivalent to a tobacco product commercially marketed (other
than for test marketing) in the United States as of the date of
this chapter's enactment, that is in compliance with the
requirements of this Act. If the Secretary fails to issue an
order within this 90-day period, then the tobacco product that
is the subject of that report shall be deemed to be
substantially equivalent to a predicate tobacco product. The
issuance of an order under this paragraph shall constitute
final agency action for purposes of section 702 of title 5, the
United States Code; provided, that the Secretary may rescind or
modify an order issued under this paragraph at any time.
``(2) Substantially equivalent defined.--
``(A) For purposes of this section and section
905(j), the term `substantially equivalent' or
`substantial equivalence' mean, with respect to the
tobacco product being compared to the predicate tobacco
product, that the Secretary by order has found that the
tobacco product--
``(i) has the same characteristics as the
predicate tobacco product; or
``(ii) has different characteristics and
the information submitted contains information,
including clinical data if deemed necessary by
the Secretary, that demonstrates that it is not
appropriate to regulate the product under this
section because the product could not
reasonably be expected to increase the health
risks to consumers compared to a conventional
tobacco product that is commercially marketed
in the United States and that is in compliance
with the requirements of this Act.
``(B) For purposes of subparagraph (A), the term
`characteristics' means the materials, ingredients,
design, composition, heating source, or other features
of a tobacco product.
``(C) A tobacco product may not be found to be
substantially equivalent to a predicate tobacco product
that has been removed from the market at the initiative
of the Secretary or that has been determined by a
judicial order to be misbranded or adulterated.
``(3) Health information.--
``(A) As part of a submission under section 905(j)
respecting a tobacco product, the person required to
file a premarket notification under such section shall
provide an adequate summary of any health information
related to the tobacco product or state that such
information will be made available upon request by any
person.
``(B) Any summary under subparagraph (A) respecting
a tobacco product shall contain detailed information
regarding data concerning adverse health effects and
shall be made available to the public by the Secretary
within 30 days of the issuance of a determination that
such tobacco product is substantially equivalent to another tobacco
product. The communication that such product is a reduced risk product
may comply with requirements prescribed by the Secretary relating to
such communication, and the Secretary may require prior approval of the
communication, in each case in accordance with section 912.
``(b) Application.--
``(1) Contents.--An application for premarket approval
shall contain--
``(A) full reports of all information, published or
known to or which should reasonably be known to the
applicant, concerning investigations which have been
made to show the health risks of such tobacco product
and whether such tobacco product presents greater risk
than other tobacco products;
``(B) a full statement of the components,
ingredients, and properties, and of the principle or
principles of operation, of such tobacco product;
``(C) a full description of the methods used in,
and the facilities and controls used for, the
manufacture, processing, and, when relevant, packing
and installation of, such tobacco product;
``(D) an identifying reference to any performance
standard under section 907 which would be applicable to
any aspect of such tobacco product, and either adequate
information to show that such aspect of such tobacco
product fully meets such performance standard or
adequate information to justify any deviation from such
standard;
``(E) such samples of such tobacco product and of
components thereof as the Secretary may reasonably
require;
``(F) specimens of the labeling proposed to be used
for such tobacco product; and
``(G) such other information relevant to the
subject matter of the application as the Secretary may
require.
``(2) Reference to advisory committee.--Upon receipt of an
application meeting the requirements set forth in paragraph
(1), the Secretary--
``(A) may, on the Secretary's own initiative; or
``(B) shall, upon the request of an applicant,
refer such application to an advisory committee and for
submission (within such period as the Secretary may establish)
of a report and recommendation respecting approval of the
application, together with all underlying data and the reasons
or basis for the recommendation.
``(c) Action on Application.--
``(1) Deadline.--
``(A) As promptly as possible, but in no event
later than 180 days after the receipt of an application
under subsection (b) of this section, the Secretary,
after considering the report and recommendation
submitted under paragraph (2) of such subsection,
shall--
``(i) issue an order approving the
application if the Secretary finds that none of
the grounds for denying approval specified in
paragraph (2) of this subsection applies; or
``(ii) deny approval of the application if
the Secretary finds (and sets forth the basis
for such finding as part of or accompanying
such denial) that one or more grounds for
denial specified in paragraph (2) of this
subsection apply.
``(B) An order approving an application for a
tobacco product may require as a condition to such
approval that the sale and distribution of the tobacco
product be restricted but only to the extent that the
sale and distribution of a tobacco product may be restricted under a
regulation under section 906(d).
``(2) Denial of approval.--The Secretary shall deny
approval of an application for a tobacco product if, upon the
basis of the information submitted to the Secretary as part of
the application and any other information before the Secretary
with respect to such tobacco product, the Secretary finds
that--
``(A) there is a lack of a showing that permitting
such tobacco product to be marketed would pose no
greater risk to the public health than currently
marketed tobacco products;
``(B) the methods used in, or the facilities or
controls used for, the manufacture, processing, or
packing of such tobacco product do not conform to the
requirements of section 906(e);
``(C) based on a fair evaluation of all material
facts, the proposed labeling is false or misleading in
any particular; or
``(D) such tobacco product is not shown to conform
in all respects to a performance standard in effect
under section 907, compliance with which is a condition
to approval of the application, and there is a lack of
adequate information to justify the deviation from such
standard.
``(3) Denial information.--Any denial of an application
shall, insofar as the Secretary determines to be practicable,
be accompanied by a statement informing the applicant of the
measures required to place such application in approvable form
(which measures may include further research by the applicant
in accordance with one or more protocols prescribed by the
Secretary).
``(4) Basis for action.--
``(A) For purposes of paragraph (2)(A), whether
permitting a tobacco product to be marketed would be
appropriate for the protection of the public health
shall, when appropriate, be determined on the basis of
well-controlled investigations, which may include one
or more clinical investigations by experts qualified by
training and experience to evaluate the tobacco
product.
``(B) If the Secretary determines that there exists
valid scientific evidence (other than evidence derived
from investigations described in subparagraph (A))
which is sufficient to evaluate the tobacco product the
Secretary may authorize that the determination for
purposes of paragraph (2)(A) be made on the basis of
such evidence.
``(d) Withdrawal and Temporary Suspension.--
``(1) In general.--The Secretary shall, upon obtaining,
where appropriate, advice on scientific matters from an
advisory committee, and after due notice and opportunity for
informal hearing to the holder of an approved application for a
tobacco product, issue an order withdrawing approval of the
application if the Secretary finds--
``(A) that the continued marketing of such tobacco
product poses greater risks to the public health than
other available products;
``(B) that the application contained or was
accompanied by an untrue statement of a material fact;
``(C) that the applicant--
``(i) has failed to establish a system for
maintaining records, or has repeatedly or
deliberately failed to maintain records or to
make reports, required by an applicable
regulation under section 909;
``(ii) has refused to permit access to, or
copying or verification of, such records as
required by section 704; or
``(iii) has not complied with the
requirements of section 905;
``(D) on the basis of new information before the
Secretary with respect to such tobacco product,
evaluated together with the evidence before the
Secretary when the application was approved, that the
methods used in, or the facilities and controls used
for, the manufacture, processing, packing, or
installation of such tobacco product do not conform
with the requirements of section 906(e) and were not
brought into conformity with such requirements within a
reasonable time after receipt of written notice from
the Secretary of nonconformity;
``(E) on the basis of new information before the
Secretary, evaluated together with the evidence before
the Secretary when the application was approved, that
the labeling of such tobacco product, based on a fair
evaluation of all material facts, is false or
misleading in any particular and was not corrected
within a reasonable time after receipt of written
notice from the Secretary of such fact; or
``(F) on the basis of new information before the
Secretary, evaluated together with the evidence before
the Secretary when the application was approved, that
such tobacco product is not shown to conform in all
respects to a performance standard which is in effect
under section 907, compliance with which was a
condition to approval of the application, and that
there is a lack of adequate information to justify the
deviation from such standard.
``(2) Appeal.--The holder of an application subject to an
order issued under paragraph (1) withdrawing approval of the
application may, by petition filed on or before the thirtieth
day after the date upon which he receives notice of such
withdrawal, obtain review thereof in accordance with subsection
(e) of this section.
``(3) Temporary suspension.--If, after providing an
opportunity for an informal hearing, the Secretary determines
there is reasonable probability that the continuation of
distribution of a tobacco product under an approved application
would cause serious, adverse health consequences or death, that
is greater than ordinarily caused by tobacco products on the
market, the Secretary shall by order temporarily suspend the
approval of the application approved under this section. If the
Secretary issues such an order, the Secretary shall proceed
expeditiously under paragraph (1) to withdraw such application.
``(e) Service of Order.--An order issued by the Secretary under
this section shall be served--
``(1) in person by any officer or employee of the
department designated by the Secretary; or
``(2) by mailing the order by registered mail or certified
mail addressed to the applicant at the applicant's last known
address in the records of the Secretary.
``SEC. 911. JUDICIAL REVIEW.
``(a) In General.--Not later than 30 days after--
``(1) the promulgation of a regulation under section 907
establishing, amending, or revoking a performance standard for
a tobacco product; or
``(2) a denial of an application for approval under section
910(c),
any person adversely affected by such regulation or order may file a
petition with the United States Court of Appeals for the District of
Columbia or for the circuit wherein such person resides or has his
principal place of business for judicial review of such regulation or
order. A copy of the petition shall be transmitted by the clerk of the
court to the Secretary or other officer designated by the Secretary for
that purpose. The Secretary shall file in the court the record of the
proceedings on which the Secretary based the Secretary's regulation or
order and each record or order shall contain a statement of the reasons
for its issuance and the basis, on the record, for its issuance. For
purposes of this section, the term `record' means all notices and other
matter published in the Federal Register with respect to the regulation
or order reviewed, all information submitted to the Secretary with
respect to such regulation or order, proceedings of any panel or
advisory committee with respect to such regulation or order, any
hearing held with respect to such regulation or order, and any other
information identified by the Secretary, in the administrative
proceeding held with respect to such regulation or order, as being
relevant to such regulation or order.
``(b) Court May Order Secretary To Make Additional Findings.--If
the petitioner applies to the court for leave to adduce additional
data, views, or arguments respecting the regulation or order being
reviewed and shows to the satisfaction of the court that such
additional data, views, or arguments are material and that there were
reasonable grounds for the petitioner's failure to adduce such data,
views, or arguments in the proceedings before the Secretary, the court
may order the Secretary to provide additional opportunity for the oral
presentation of data, views, or arguments and for written submissions.
The Secretary may modify the Secretary's findings, or make new findings
by reason of the additional data, views, or arguments so taken and
shall file with the court such modified or new findings, and the
Secretary's recommendation, if any, for the modification or setting
aside of the regulation or order being reviewed, with the return of
such additional data, views, or arguments.
``(c) Standard of Review.--Upon the filing of the petition under
subsection (a) of this section for judicial review of a regulation or
order, the court shall have jurisdiction to review the regulation or
order in accordance with chapter 7 of title 5, United States Code, and
to grant appropriate relief, including interim relief, as provided in
such chapter. A regulation or order described in paragraph (1) or (2)
of subsection (a) of this section shall not be affirmed if it is found
to be unsupported by substantial evidence on the record taken as a
whole.
``(d) Finality of Judgment.--The judgment of the court affirming or
setting aside, in whole or in part, any regulation or order shall be
final, subject to review by the Supreme Court of the United States upon
certiorari or certification, as provided in section 1254 of title 28,
United States Code.
``(e) Other Remedies.--The remedies provided for in this section
shall be in addition to and not in lieu of any other remedies provided
by law.
``(f) Regulations and Orders Must Recite Basis in Record.--To
facilitate judicial review under this section or under any other
provision of law of a regulation or order issued under section 906,
907, 908, 909, 910, or 913, each such regulation or order shall contain
a statement of the reasons for its issuance and the basis, in the
record of the proceedings held in connection with its issuance, for its
issuance.
``SEC. 912. REDUCED RISK TOBACCO PRODUCTS.
``(a) Requirements.--
``(1) In general.--For purposes of this section, the term
`reduced risk tobacco product' means a tobacco product
designated by the Secretary under paragraph (2).
``(2) Designation.--
``(A) In general.--A product may be designated by
the Secretary as a reduced risk tobacco product if the
Secretary finds that the product is demonstrated to
significantly reduce harm to individuals caused by a
tobacco product and is otherwise appropriate to protect
public health, based on an application submitted by the
manufacturer of the product (or other responsible
person) that--
``(i)(I) demonstrates through testing on
animals and short-term human testing that use
of such product results in ingestion or
inhalation of a substantially lower yield of
toxic substances than use of another tobacco
product in the same or different category as
the proposed reduced risk product; or
``(II) contains scientific evidence showing
that use of such product results in a
substantially lower potential risk to health in
one or more specific respects than use of
another tobacco product in the same or
different category as the proposed reduced risk
product; and
``(ii) if required by the Secretary,
includes studies of the long-term health
effects of the product.
If such studies are required, the manufacturer may
consult with the Secretary regarding protocols for
conducting the studies.
``(B) Basis for finding.--In making the finding
under subparagraph (A), the Secretary shall take into
account--
``(i) the risks and benefits to the
population as a whole, including both users of
tobacco products and non-users of tobacco
products;
``(ii) the increased or decreased
likelihood that existing users of tobacco
products will stop using such products
including reduced risk tobacco products;
``(iii) the increased or decreased
likelihood that those who do not use tobacco
products will start to use such products,
including reduced risk tobacco products; and
``(iv) the risks and benefits to consumers
from the use of a reduced risk tobacco product
as compared to the use of products approved
under chapter V to reduce exposure to tobacco.
``(3) Marketing requirements.--A tobacco product may be
marketed and labeled as a reduced risk tobacco product if it--
``(A) has been designated as a reduced risk tobacco
product by the Secretary under paragraph (2);
``(B) bears a label prescribed by the Secretary
concerning the product's contribution to reducing harm
to health; and
``(C) complies with requirements prescribed by the
Secretary relating to marketing and advertising of the
product, and other provisions of this chapter as
prescribed by the Secretary, although in no event shall
such requirements prohibit the communication that such product is a
reduced risk product. The communication that such product is a reduced
risk product may comply with requirements prescribed by the Secretary
relating to such communication, and the Secretary may require prior
approval of the communication.
``(b) Revocation of Designation.--At any time after the date on
which a tobacco product is designated as a reduced risk tobacco product
under this section the Secretary may, after providing an opportunity
for an informal hearing, revoke such designation if the Secretary
determines, based on information not available at the time of the
designation, that--
``(1) the finding made under subsection (a)(2) is no longer
valid; or
``(2) the product is being marketed in violation of
subsection (a)(3).
``(c) Limitation.--A tobacco product that is designated as a
reduced risk tobacco product that is in compliance with subsection (a)
shall not be regulated as a drug or device.
``(d) Development of Reduced Risk Tobacco Product Technology.--A
tobacco product manufacturer shall provide written notice to the
Secretary upon the development or acquisition by the manufacturer of
any technology that would reduce the risk of a tobacco product to the
health of the user for which the manufacturer is not seeking
designation as a `reduced risk tobacco product' under subsection (a).
``(e) Postmarket Surveillance.--
``(1) Discretionary surveillance.--The Secretary may
require a tobacco product manufacturer to conduct postmarket
surveillance for reduced risk a tobacco product of the
manufacturer if the Secretary determines that postmarket surveillance
of the tobacco product is necessary to protect the public health or is
necessary to provide information regarding the health risks and other
safety issues involving the tobacco product.
``(2) Surveillance approval.--Each tobacco product
manufacturer required to conduct a surveillance of a reduced
risk tobacco product under paragraph (1) shall, within 30 days
after receiving notice that the manufacturer is required to
conduct such surveillance, submit, for the approval of the
Secretary, a protocol for the required surveillance. The
Secretary, within 60 days of the receipt of such protocol,
shall determine if the principal investigator proposed to be
used in the surveillance has sufficient qualifications and
experience to conduct such surveillance and if such protocol
will result in collection of useful data or other information
necessary to protect the public health. The Secretary may not
approve such a protocol until it has been reviewed by an
appropriately qualified scientific and technical review committee
established by the Secretary.
``SEC. 913. PRESERVATION OF STATE AND LOCAL AUTHORITY.
``(a) Additional Requirements.--
``(1) In general.--Except as provided in paragraph (2),
nothing in this Act shall be construed as prohibiting a State
or political subdivision thereof from adopting or enforcing a
requirement applicable to a tobacco product that is in addition
to, or more stringent than, requirements established under this
chapter.
``(2) Preemption of certain state and local requirements.--
``(A) Except as provided in subparagraph (B), no
State or political subdivision of a State may establish
or continue in effect with respect to a tobacco product
any requirement which is different from, or in addition
to, any requirement applicable under the provisions of
this chapter relating to performance standards,
premarket approval, adulteration, misbranding,
registration, labeling, good manufacturing standards,
or reduced risk products.
``(B) Subparagraph (A) does not apply to
requirements relating to the sale, use, or distribution
of a tobacco product including requirements related to
the access to, and the advertising and promotion of, a
tobacco product.
``(b) Rule of Construction Regarding Product Liability.--No
provision of this chapter relating to a tobacco product shall be
construed to modify or otherwise affect any action or the liability of
any person under the product liability law of any State.
``SEC. 914. EQUAL TREATMENT OF RETAIL OUTLETS.
``The Secretary shall issue regulations to require that retail
establishments for which the predominant business is the sale of
tobacco products comply with any advertising restrictions applicable to
retail establishments accessible to individuals under the age of 18.
``SEC. 915. ACCESS AND MARKETING RESTRICTIONS.
``(a) Definitions.--For purposes of this section, the following
definitions apply:
``(1) Adult.--The term `adult' means any person who is
older than the minimum age at which it is legal to purchase or
possess (whichever minimum age is older) tobacco products.
``(2) Adult-only facility.--The term `adult-only facility'
means a facility or restricted area (whether open-air or
enclosed) where the operator ensures or has a reasonable basis
to believe (such as by checking identification as required
under state law, or by checking the identification of any
person appearing to be under the age of 27) that only adults
are present. A facility or restricted area need not be
permanently restricted to adults in order to constitute an
adult-only facility, provided that the operator ensures or has
a reasonable basis to believe that only adults are present
during the event or time period in question.
``(3) Brand name.--The term `brand name' means a brand name
(alone or in conjunction with any other word), trademark, logo,
symbol, motto, selling message, recognizable pattern of colors,
or any other indicia of product identification identical or
similar to, or identifiable with, those used for any domestic
brand of tobacco products. The term `brand name' shall not
include the corporate name of any tobacco product manufacturer
that does not after the date of the enactment of this chapter
sell a brand of tobacco products in the United States that
includes such corporate name.
``(b) Cigarette and Smokeless Tobacco Product Requirements.--
``(1) Minimum sales age.--No retailer may sell a tobacco
product to any person younger than 18 years of age.
``(2) Proof of age.--
``(A) Except as otherwise provided in subparagraph
(B), each retailer shall verify by means of
photographic identification containing the bearer's
date of birth that no person purchasing the product is
younger than 18 years of age.
``(B) No such verification is required for any
person over the age of 26.
``(3) Enforcement by the states.--The Secretary may enter
into an agreement with any State which has in effect a State
law that is at least as restrictive as this subsection, whereby
such State agrees to enforce such State law in a manner
reasonably designed to prevent its violation and the Secretary
provides a grant to such State for the purpose of enforcing
such State law. No action taken by the Secretary pursuant to
this paragraph shall be construed to limit the authority of the
Secretary under this subsection.
``(4) Mail order sales.--After two years from the date of
enactment of this chapter, the Secretary shall transmit to
Congress a report describing the extent, if any, to which
individuals younger than 18 years of age are obtaining tobacco
products through the mail.
``(c) Minimum Package Size Requirements.--
``(1) No manufacturer, distributor, or retailer may sell or
cause to be sold, or distribute or cause to be distributed, any
cigarette package that contains fewer than 20 cigarettes.
``(2) No retailer may break or otherwise open any tobacco
product package to sell or distribute individual cigarettes or
a number of unpackaged cigarettes that is smaller than the
quantity in the minimum cigarette package size provided in
paragraph (1), or any quantity of another tobacco product that
is smaller than the smallest package distributed by the
manufacturer for individual consumer use.
``(d) Ban on Youth Access to Free Samples.--
``(1) No manufacturer, distributor, or retailer may
distribute or cause to be distributed any free samples of
tobacco products, except in an adult-only facility.
``(2) For purposes of this subsection, a `free sample' does
not include a tobacco product that is provided to an adult in
connection with--
``(A) the purchase, exchange or redemption for
proof of purchase of any tobacco products (including,
but not limited to, a free offer in connection with the
purchase of tobacco products, such as a `two-for-one'
offer), or
``(B) the conducting of consumer testing or
evaluation of tobacco products with persons who certify
that they are adults.
``(e) Vending Machines, Self-Service Displays, Mail-Order Sales,
and Other `Impersonal' Modes of Sale.--
``(1) Except as otherwise provided in paragraph (2), a
retailer may sell a tobacco product only in a direct, face-to-
face exchange between the retailer and the consumer. Examples
of methods of sale that are not permitted include vending
machines and self-service displays.
``(2) The following methods of sale are permitted under
this subsection:
``(A) Mail-order sales, excluding mail-order
redemption of coupons and distribution of free samples
through the mail.
``(B) Vending machines that are located in an
adult-only facility.
``(3) For purposes of this section, a `self-service'
display means any display where the customer has access to the
tobacco products without the aid of a sales clerk.
``(f) Prohibition on Youth Targeting.--No manufacturer,
distributor, or retailer may take any action, directly or indirectly,
to target youth in the advertising, promotion, or marketing of tobacco
products, or take any action the primary purpose of which is to
initiate, maintain, or increase the incidence of youth smoking. For
purposes of this subsection, the term `youth' means any person or
persons under 18 years of age.
``(g) Ban on Use of Cartoons.--
``(1) No manufacturer, distributor, or retailer may use or
cause to be used any cartoon in the advertising, promoting,
packaging, or labeling of tobacco products.
``(2) For purposes of this subsection, the term `cartoon'
means any drawing or other depiction of an object, person,
animal, creature, or any similar caricature that satisfies any
of the following criteria:
``(A) The use of comically exaggerated features;
``(B) The attribution of human characteristics to
animals, plants, or other objects, or the similar use
of anthropomorphic technique.
``(C) The attribution of unnatural or extrahuman
abilities, such as imperviousness to pain or injury, X-
ray vision, tunneling at very high speeds, or
transformation.
``(3) The term `cartoon' includes `Joe Camel,' but does not
include any drawing or other depiction that, on July 1, 1998,
was in use in the United States in any manufacturer's corporate
logo or in any manufacturer's tobacco product packaging.
``(h) Elimination of Outdoor Advertising.--
``(1) No manufacturer, distributor, or retailer may place
or cause to be placed any outdoor advertising advertising
tobacco products.
``(2) For purposes of this subsection, the term `outdoor
advertising' means--
``(A) billboards;
``(B) signs and placards in arenas, stadiums,
shopping malls, and video game arcades (whether any of
the foregoing are open air or enclosed); and
``(C) any other advertisements placed--
``(i) outdoors, or
``(ii) on the inside surface of a window
facing outward.
``(D) The term `outdoor advertising' does not
mean--
``(i) an advertisement on the outside of a
tobacco product manufacturing facility;
``(ii) an individual advertisement that
does not occupy an area larger than 14 square
feet (and that neither is placed in such
proximity to any other such advertisement so as
to create a single `mosaic'-type advertisement
larger than 14 square feet, nor functions
solely as a segment of a larger advertising
unit or series), and that is placed on the
outside of any retail establishment that sells
tobacco products (other than solely through a
vending machine), on the outside (but on the
property of) any such establishment, or on the
inside surface of a window facing outward in
any such establishment; or
``(iii) an advertisement inside a retail
establishment that sells tobacco products
(other than solely through a vending machine)
that is not placed on the inside surface of a
window facing outward.
``(3) For purposes of this subsection, the term `video game
arcade' means an entertainment establishment primarily
consisting of video games (other than video games intended
primarily for use by persons 18 years of age or older) and/or
pinball machines.
``(i) Elimination of Transit Advertisements.--
``(1) No manufacturer, distributor, or retailer may place
or cause to be placed any transit advertisements advertising
tobacco products.
``(2) For purposes of this subsection, the term `transit
advertisements' means advertising on or within private or
public vehicles and all advertisements placed at, on or within
any bus stop, taxi stand, transportation waiting area, train
station, airport, or any similar location.
``(3) The term `transit advertisements' does not include
any advertisement placed in, on, or outside the premises of any
retail establishment that sells tobacco products (other than
solely through a vending machine), except if such individual
advertisement--
``(A) occupies an area larger than 14 square feet;
``(B) is placed in such proximity to any other such
advertisement so as to create a single `mosaic'-type
advertisement larger than 14 square feet; or
``(C) functions solely as a segment of a larger
advertising unit or series).
``(j) Bar on Advertising in Any Youth-Oriented Publication.--
``(1) No manufacturer, distributor, or retailer shall
advertise a tobacco product in any youth-oriented publication
(whether periodic or limited distribution).
``(2) For purposes of this subsection, a `youth oriented
publication' is a newspaper, magazine, periodical, or other
publication--
``(A) whose readers younger than 18 years of age
constitute more than 15 percent of the total readership
as measured by competent and reliable survey evidence;
or
``(B) that is read by 2,000,000 or more persons
younger than 18 years of age as measured by competent
and reliable survey evidence.
``(k) Ban on Tobacco Product Brand Name Sponsorships.--
``(1) No manufacturer, distributor, or retailer may sponsor
or cause to be sponsored any athletic, musical, artistic, or
other social or cultural event, or any entry or team in any
event, in the brand name (alone or in conjunction with any
other word), logo, symbol, motto, selling message, recognizable
color or pattern of colors, or any other indicia of product
identification identical or similar to, or identifiable with,
those used for any brand of cigarettes or smokeless tobacco.
``(2) Nothing in this subsection shall be construed to
prevent a manufacturer, distributor, or retailer from
sponsoring or causing to be sponsored any athletic, musical,
artistic, or other social or cultural event, or team or entry,
in the name of the corporation which manufactures the tobacco
product, provided that both the corporate name and the
corporation were registered and in use in the United States
prior to January 1, 2001, and that the corporate name does not
include any brand name (alone or in conjunction with any other
word), logo, symbol, motto, selling message, recognizable color
or pattern of colors, or any other indicia of product
identification identical or similar to, or identifiable with,
those used for any brand of cigarettes or smokeless tobacco.
``(3) This subsection shall not apply to any event
sponsored in an adult-only facility.
``(l) Ban on Tobacco Brand Name Merchandise.--
``(1) No manufacturer may market, distribute, offer, sell,
license or cause to be marketed, distributed, offered, sold, or
licensed (including, without limitation, by catalogue or direct
mail), any apparel or other merchandise (other than tobacco
products, items the sole function of which is to advertise
tobacco products, or written or electronic publications) which
bears a brand name.
``(2) Nothing in this subsection shall--
``(A) prohibit the distribution to any
manufacturer's employee who is an adult of any item
described above that is intended for the personal use
of such an employee;
``(B) require any manufacturer to retrieve, collect
or otherwise recover any item that prior to the
enactment of this chapter was marketed, distributed,
offered, sold, licensed, or caused to be marketed,
distributed, offered, sold, or licensed by such manufacturer;
``(C) apply to coupons or other items used by
adults solely in connection with the purchase of
tobacco products; or
``(D) apply to apparel or other merchandise used
within an adult-only facility that is not distributed
(by sale or otherwise) to any member of the general
public.
``(m) Ban on Gifts to Underage Persons Based on Proofs of
Purchase.--
``(1) No manufacturer, distributor, or retailer may provide
or cause to be provided to any person, without sufficient proof
that such person is an adult, any item in exchange for the
purchase of tobacco products, or the furnishing of credits,
proofs-of-purchase, or coupons with respect to such a purchase.
``(2)(A) For purposes of paragraph (1), a driver's license
or other government-issued identification (or legible photocopy
thereof), the validity of which is certified by the person to
whom the item is provided, shall by itself be deemed to be a
sufficient form of proof of age; and
``(B) In the case of items provided (or to be redeemed) at
retail establishments, a manufacturer shall be entitled to rely
on verification of proof of age by the retailer, where such
retailer is required to obtain verification under applicable
Federal, State or local law.
``(n) Ban on Non-Tobacco Product Brand Names.--
``(1) Except as provided in paragraph (2), no manufacturer
may, pursuant to any agreement requiring the payment of money
or other valuable consideration, use or cause to be used as a
brand name of any tobacco product any nationally recognized or
nationally established brand name or trade name of any non-
tobacco item or service or any nationally recognized or
nationally established sports team, entertainment group, or
individual celebrity.
``(2) Paragraph (1) shall not apply to any tobacco product
brand name in existence as of July 1, 1998.
``(3) For the purposes of this section, the term `other
valuable consideration' shall not include an agreement between
two entities who enter into such agreement for the sole purpose
of avoiding infringement claims.
``(o) Limitation on Third Party Use of Tobacco Brand Names.--
``(1) No manufacturer may license or otherwise expressly
authorize any third party to use or advertise any brand name in
a manner prohibited by this Act if done by such manufacturer
itself.
``(2) Nothing in this subsection shall require any
manufacturer to retrieve, collect, or otherwise recover any
item that prior to the enactment of this chapter was marketed,
distributed, offered, sold, licensed, or caused to be marketed,
distributed, offered, sold, or licensed by such manufacturer.
``(p) Bar on Product Placement in Certain Media.--
``(1) Except as provided in paragraph (2), no manufacturer
may make, or cause to be made, any payment or other
consideration to any other person or entity to use, display,
make reference to, or use as a prop any tobacco product,
tobacco product package, advertisement for a tobacco product,
or any other item bearing a brand name in any motion picture,
television show, theatrical production or other live
performance, live or recorded performance of music, commercial
film or video, or video game (`media').
``(2) Paragraph (1) shall not apply to--
``(A) media where the audience or viewers are
within an adult-only facility (provided such media are
not visible to persons outside such adult-only
facility);
``(B) media not intended for distribution or
display to the public; or
``(C) instructional media concerning non-
conventional tobacco products or tobacco products
designated as reduced risk viewed only by or provided
only to consumers who are adults.
``(q) Severability.--If any provision of this section is held
invalid, those subsections, and paragraphs which are not so held shall
continue to be in effect.
``(r) Effective Dates.--The provisions of this section shall take
effect on the date that is six months after the date of enactment of
this section, except for the provisions of subsections (e) and (k),
which shall take effect on the date that is one year after the
effective date of this section.
``SEC. 916. MANDATORY DISCLOSURES.
``(a) Disclosure of Ingredients to the Public.--
``(1) Not later than 12 months after the effective date of
this section, the Secretary shall promulgate regulations
requiring the disclosure to the public on a brand-by-brand
basis of the common or usual name of each ingredient of a
tobacco product in descending order of predominance by weight,
except that spices, flavorings, and colorings may at the
manufacturer's election be designated as spices, flavorings,
and colorings without naming each. Any ingredient that has been
disclosed to the public pursuant to any other law or regulation
with respect to a particular brand may be required to be
disclosed for such brand pursuant to this subsection.
``(2) The regulations required by this subsection shall
provide that incidental additives that are present in a tobacco
product at insignificant levels and that do not have any
technical or functional effect in the finished tobacco product
shall be exempt from disclosure.
``(3) The requirement of this subsection to disclose
ingredients in descending order of predominance shall not apply
to ingredients in amounts of 2 percent or less by weight when a
listing of such ingredients is placed at the end of the
ingredients statement following an appropriate quantifying
statement, such as `contains ____ percent or less of ____', or
`less than ____ percent of ____'.
``(4) Any disclosure required pursuant to this subsection
may be required by appropriate means, except that,
notwithstanding any other provision of this Act, the Secretary
shall not require the listing of any ingredient on any package
or in any advertisement.
``(b) Disclosure of Percentage of Domestic and Foreign Tobacco.--
Not later than 12 months after the effective date of this section, the
Secretary shall promulgate regulations that require that each package
of a tobacco product disclose, with respect to the tobacco contained in
that brand--
``(1) the percentage of tobacco that is domestic tobacco;
and
``(2) the percentage of tobacco that is foreign tobacco.
``(c) Mandatory Disclaimer.--
``(1) Any tobacco product advertising which includes a term
classifying a brand of tobacco product according to its `tar'
yield or the yield to consumers of any substance, including but
not limited to terms such as `light', or `low tar', shall also
include the following disclaimer: `[Brand] not shown to be less
hazardous than other [type of tobacco product]'. This section
shall not be deemed to apply to the use of the terms `filtered'
or `filter'. In no event shall any such disclaimer be required
on any tobacco product package.
``(2) In addition to the provisions of paragraph (1), not
later than 12 months after the effective date of this section,
the Secretary shall promulgate regulations relating to the use
of such terms, to ensure that they are not false or misleading.
``(3) The Secretary may modify or waive any requirement
under this subsection with respect to any product that has been
designated by the Secretary as a reduced risk product under
section 912.''.
SEC. 504. REGULATORY RECORD.
Notwithstanding the provisions of subchapter II of chapter 5 of
title 5, United States Code, in promulgating regulations under this
chapter, the record developed and utilized by the Secretary for the
purposes of promulgating subparts (B) and (D) of the regulations
relating to the sale, distribution, and use of tobacco products on or
about August 28, 1996, as reflected in articles IV and VI of the
preamble to the 1996 Food and Drug Administration Tobacco Rule
(including public comments, Food and Drug Administration documents, and
any other information generated or compiled for purposes of
promulgating such regulations), shall be deemed to have the same legal
status as if such record had been developed under a rulemaking
proceeding conducted pursuant to section 906(d)(1). In all other
respects, including with respect to the issue of whether such
regulations conform to section 906(d)(1), the procedural requirements
of this chapter and the Administration Procedure Act will apply.
SEC. 505. CONFORMING AND OTHER AMENDMENTS TO GENERAL PROVISIONS.
(a) Amendment of Federal Food, Drug, and Cosmetic Act.--Except as
otherwise expressly provided, whenever in this section an amendment is
expressed in terms of an amendment to, or repeal of, a section or other
provision, the reference is to a section or other provision of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(b) Section 301.--Section 301 (21 U.S.C. 331) is amended--
(1) in subsection (a), by inserting ``tobacco product,''
after ``device,'';
(2) in subsection (b), by inserting ``tobacco product,''
after ``device,'';
(3) in subsection (c), by inserting ``tobacco product,''
after ``device,'';
(4) in subsection (e), by striking ``515(f), or 519'' and
inserting ``515(f), 519, or 909'';
(5) in subsection (g), by inserting ``tobacco product,''
after ``device,'';
(6) in subsection (h), by inserting ``tobacco product,''
after ``device,'';
(7) in subsection (j), by striking ``708, or 721'' and
inserting ``708, 721, 903, 904, 905, 906, 907, 908, 909, 910,
or 912'';
(8) in subsection (k), by inserting ``tobacco product,''
after ``device,'';
(9) by striking subsection (p) and inserting the following:
``(p) The failure to register in accordance with section 510 or
905, the failure to provide any information required by section 510(j),
510(k), 905(i), or 905(j), or the failure to provide a notice required
by section 510(j)(2) or 905(j)(2).'';
(10) in subsection (q), by striking paragraph (1) and
inserting the following:
``(1) The failure or refusal--
``(A) to comply with any requirement prescribed under
section 518, 520(g), 906(f), or 908;
``(B) to furnish any notification or other material or
information required by or under section 519, 520(g), 904,
906(f), or 909; or
``(C) to comply with a requirement under section 522.'';
(11) in subsection (q)(2), by striking ``device,'' and
inserting ``device or tobacco product,'';
(12) in subsection (r), by inserting ``or tobacco product''
after ``device'' each time that it appears; and
(13) by adding at the end the following:
``(aa) The sale of tobacco products in violation of a no-
tobacco-sale order issued under section 303(f).''.
(c) Section 303.--Section 303(f) (21 U.S.C. 333(f)) is amended--
(1) by striking the subsection heading and inserting the
following:
``(f) Civil Penalties; No-Tobacco-Sale Orders.--'';
(2) in paragraph (1)(A), by inserting ``or tobacco
products'' after ``devices'';
(3) by redesignating paragraphs (3), (4), and (5) as
paragraphs (4), (5), and (6), respectively;
(4) by inserting after paragraph (2) the following:
``(3) If the Secretary finds that a person has committed
repeated violations of restrictions promulgated under section
906(d) at a particular retail outlet then the Secretary may
impose a no-tobacco-sale order on that person prohibiting the
sale of tobacco products in that outlet. A no-tobacco-sale
order may be imposed with a civil penalty under paragraph
(1).'';
(5) in subparagraph (A) of paragraph (4), as so
redesignated--
(A) by striking ``assessed'' the first time it
appears and inserting ``assessed, or a no-tobacco-sale
order may be imposed,''; and
(B) by striking ``penalty'' and inserting
``penalty, or upon whom a no-tobacco-order is to be
imposed,'';
(6) in subparagraph (B) of paragraph (4), as so
redesignated--
(A) by inserting after ``penalty,'' the following:
``or the period to be covered by a no-tobacco-sale
order,''; and
(B) by adding at the end the following: ``A no-
tobacco-sale order permanently prohibiting an
individual retail outlet from selling tobacco products
shall include provisions that allow the outlet, after a
specified period of time, to request that the Secretary
compromise, modify, or terminate the order.'';
(7) by adding at the end of paragraph (4), as so
redesignated, the following:
``(D) The Secretary may compromise, modify, or
terminate, with or without conditions, any no-tobacco-
sale order.'';
(8) in paragraph (5), as so redesignated--
(A) by striking ``(3)(A)'' and inserting
``(4)(A)'';
(B) by inserting ``or the imposition of a no-
tobacco-sale order'' after ``penalty'' the first 2
places it appears;
(C) by striking ``issued.'' and inserting ``issued,
or on which the no-tobacco-sale order was imposed, as
the case may be.''; and
(9) in paragraph (6), as so redesignated, by striking
``paragraph (4)'' each place it appears and inserting
``paragraph (5)''.
(d) Section 304.--Section 304 (21 U.S.C. 334) is amended--
(1) in subsection (a)(2), by striking ``and'' before
``(D)'';
(2) in subsection (a)(2), by striking ``device.'' and
inserting a comma and the following:
``(E) Any adulterated or misbranded tobacco
product.'';
(3) in subsection (d)(1), by inserting ``tobacco product,''
after ``device,'';
(4) in subsection (g)(1), by inserting ``or tobacco
product'' after ``device'' each place it appears; and
(5) in subsection (g)(2)(A), by inserting ``or tobacco
product'' after ``device'' each place it appears.
(e) Section 702.--Section 702(a) (21 U.S.C. 372(a)) is amended--
(1) by inserting ``(A)'' after ``(1)''; and
(2) by adding at the end thereof the following:
``(B) For a tobacco product, to the extent feasible, the Secretary
shall contract with the States in accordance with subparagraph (A) to
carry out inspections of retailers in connection with the enforcement
of this Act.''.
(f) Section 703.--Section 703 (21 U.S.C. 373) is amended--
(1) by inserting ``tobacco product,'' after ``device,''
each place it appears; and
(2) by inserting ``tobacco products,'' after ``devices,''
each place it appears.
(g) Section 704.--Section 704 (21 U.S.C. 374) is amended--
(1) in subsection (a)(1)(A), by inserting ``tobacco
products,'' after ``devices,'' each place it appears;
(2) in subsection (a)(1)(B), by inserting ``or tobacco
products'' after ``restricted devices'' each place it appears;
and
(3) in subsection (b), by inserting ``tobacco product,''
after ``device,''.
(h) Section 705.--Section 705(b) (21 U.S.C. 375(b)) is amended by
inserting ``tobacco products,'' after ``devices,''.
(i) Section 709.--Section 709 (21 U.S. C. 379) is amended by
inserting ``or tobacco product'' after ``device''.
(j) Section 801.--Section 801 (21 U.S.C. 381) is amended--
(1) in subsection (a), by inserting ``tobacco products,''
after ``devices,'' the first time it appears;
(2) in subsection (a), by inserting ``or subsection (j) of
section 905'' after ``section 510'';
(3) in subsection (a), by striking ``drugs or devices''
each time it appears and inserting ``drugs, devices, or tobacco
products''; and
(4) in subsection (e)(1), by inserting `tobacco product'
after `device'.
(k) Section 1003.--Section 1003(d)(2)(C) (as redesignated by
section 101(a)) is amended--
(1) by striking ``and'' after ``cosmetics,''; and
(2) inserting a comma and ``and tobacco products'' after
``devices''.
(l) Effective Date for No-Tobacco-Sale Order Amendments.--The
amendments made by subsection (c), other than the amendment made by
paragraph (2) thereof, shall take effect only upon the promulgation of
final regulations by the Secretary--
(1) defining the term ``repeated violation'', as used in
section 303(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 333(f)) as amended by subsection (c), by identifying the
number of violations of particular requirements over a
specified period of time that constitute a repeated violation;
(2) providing for notice to the retailer of each violation
at a particular retail outlet;
(3) providing that a person may not be charged with
repeated violations at a particular retail outlet unless the
Secretary has provided notice of previous violations at that outlet;
(4) establishing a period of time during which, if there
are no violations by a particular retail outlet, that outlet
will not be considered to have been the site of repeated
violations when the next violation occurs; and
(5) providing that good faith reliance on false
identification does not constitute a violation of any minimum
age requirement for the sale of tobacco products.
SEC. 506. CIGARETTE LABEL AND ADVERTISING WARNINGS.
Section 4 of the Federal Cigarette Labeling and Advertising Act (15
U.S.C. 1333) is amended to read as follows:
``SEC. 4. LABELING.
``(a) Label Requirements.--
``(1) In general.--It shall be unlawful for any person to
manufacture, package, or import for sale or distribution within
the United States any cigarettes the package of which fails to
bear, in accordance with the requirements of this section, one
of the following labels:
``WARNING: Cigarettes are addictive''
``WARNING: Tobacco smoke can harm your children''
``WARNING: Cigarettes cause fatal lung disease''
``WARNING: Cigarettes cause cancer''
``WARNING: Cigarettes cause strokes and heart disease''
``WARNING: Smoking during pregnancy can harm your baby''
``WARNING: Smoking can kill you''
``WARNING: Tobacco smoke causes fatal lung disease in non-
smokers''
``WARNING: Quitting smoking now greatly reduces serious risks
to your health''
``(2) Placement; typography; etc.--
``(A) In general.--Each label statement required by
paragraph (1) shall be located in the upper portion of
the front and rear panels of the package, directly on
the package underneath the cellophane or other clear
wrapping. Except as provided in subparagraph (B), each
label statement shall comprise at least the top 25
percent of the front and rear panels of the package.
The word ``WARNING'' shall appear in capital letters
and all text shall be in conspicuous and legible 17-
point type, unless the text of the label statement
would occupy more than 70 percent of such area, in which case the text
may be in a smaller conspicuous and legible type size, provided that at
least 60 percent of such area is occupied by required text. The text
shall be black on a white background, or white on a black background,
in a manner that contrasts, by typography, layout, or color, with all
other printed material on the package, in an alternating fashion under
the plan submitted under subsection (b)(4).
``(B) Flip-top boxes.--For any cigarette brand
package manufactured or distributed before January 1,
2000, which employs a flip-top style (if such packaging
was used for that brand in commerce prior to June 21,
1997), the label statement required by paragraph (1)
shall be located on the flip-top area of the package,
even if such area is less than 25 percent of the area
of the front panel. Except as provided in this
paragraph, the provisions of this subsection shall
apply to such packages.
``(3) Does not apply to foreign distribution.--The
provisions of this subsection do not apply to a tobacco product
manufacturer or distributor of cigarettes which does not
manufacture, package, or import cigarettes for sale or
distribution within the United States.
``(b) Advertising Requirements.--
``(1) In general.--It shall be unlawful for any tobacco
product manufacturer, importer, distributor, or retailer of
cigarettes to advertise or cause to be advertised within the
United States any cigarette unless its advertising bears, in
accordance with the requirements of this section, one of the
labels specified in subsection (a) of this section.
``(2) Typography, etc.--Each label statement required by
subsection (a) of this section in cigarette advertising shall
comply with the standards set forth in this paragraph. For
press and poster advertisements, each such statement and (where
applicable) any required statement relating to tar, nicotine,
or other constituent yield shall comprise at least 20 percent
of the area of the advertisement and shall appear in a
conspicuous and prominent format and location at the top of
each advertisement within the trim area. The Secretary may
revise the required type sizes in such area in such manner as
the Secretary determines appropriate. The word ``WARNING''
shall appear in capital letters, and each label statement shall
appear in conspicuous and legible type. The text of the label statement
shall be black if the background is white and white if the background
is black, under the plan submitted under paragraph (4) of this
subsection. The label statements shall be enclosed by a rectangular
border that is the same color as the letters of the statements and that
is the width of the first downstroke of the capital ``W'' of the word
``WARNING'' in the label statements. The text of such label statements
shall be in a typeface pro rata to the following requirements: 45-point
type for a whole-page broadsheet newspaper advertisement; 39-point type
for a half-page broadsheet newspaper advertisement; 39-point type for a
whole-page tabloid newspaper advertisement; 27-point type for a half-
page tabloid newspaper advertisement; 31.5-point type for a double page
spread magazine or whole-page magazine advertisement; 22.5-point type
for a 28 centimeter by 3 column advertisement; and 15-point type for a
20 centimeter by 2 column advertisement. The label statements shall be
in English, except that in the case of--
``(A) an advertisement that appears in a newspaper,
magazine, periodical, or other publication that is not
in English, the statements shall appear in the
predominant language of the publication; and
``(B) in the case of any other advertisement that
is not in English, the statements shall appear in the
same language as that principally used in the
advertisement.
``(3) Adjustment by secretary.--The Secretary may, through
a rulemaking under section 553 of title 5, United States Code,
adjust the format and type sizes for the label statements
required by this section or the text, format, and type sizes of
any required tar, nicotine yield, or other constituent
disclosures, or to establish the text, format, and type sizes
for any other disclosures required under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). The text of any
such label statements or disclosures shall be required to
appear only within the 20 percent area of cigarette
advertisements provided by paragraph (2) of this subsection.
The Secretary shall promulgate regulations which provide for
adjustments in the format and type sizes of any text required
to appear in such area to ensure that the total text required
to appear by law will fit within such area.
``(4) Marketing requirements.--
``(A) The label statements specified in subsection
(a)(1) shall be randomly displayed in each 12-month
period, in as equal a number of times as is possible on
each brand of the product and be randomly distributed
in all areas of the United States in which the product
is marketed in accordance with a plan submitted by the
tobacco product manufacturer, importer, distributor, or
retailer and approved by the Secretary.
``(B) The label statements specified in subsection
(a)(1) shall be rotated quarterly in alternating
sequence in advertisements for each brand of cigarettes
in accordance with a plan submitted by the tobacco
product manufacturer, importer, distributor, or
retailer to, and approved by, the Secretary.
``(C) The Secretary shall review each plan
submitted under subparagraph (B) and approve it if the
plan--
``(i) will provide for the equal
distribution and display on packaging and the
rotation required in advertising under this
subsection; and
``(ii) assures that all of the labels
required under this section will be displayed
by the tobacco product manufacturer, importer,
distributor, or retailer at the same time.''.
SEC. 507. AUTHORITY TO REVISE CIGARETTE WARNING LABEL STATEMENTS.
Section 4 of the Federal Cigarette Labeling and Advertising Act (15
U.S.C. 1333), as amended by section 506, is further amended by adding
at the end the following:
``(c) Change in Required Statements.--The Secretary may, by a
rulemaking conducted under section 553 of title 5, United States Code,
adjust the format, type size, and text of any of the warning label
statements required by subsection (a) of this section subject to the
limitation on proportional size of the warning contained in subsections
(a)(2) and (b)(2), or establish the format, type size, and text of any
other disclosures required under the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.), if the Secretary finds that such a change
would promote greater public understanding of the risks associated with
the use of smokeless tobacco products.''.
SEC. 508. SMOKELESS TOBACCO LABELS AND ADVERTISING WARNINGS.
Section 3 of the Comprehensive Smokeless Tobacco Health Education
Act of 1986 (15 U.S.C. 4402) is amended to read as follows:
``SEC. 3. SMOKELESS TOBACCO WARNING.
``(a) General Rule.--
``(1) It shall be unlawful for any person to manufacture,
package, or import for sale or distribution within the United
States any smokeless tobacco product unless the product package
bears, in accordance with the requirements of this Act, one of
the following labels:
``WARNING: This product can cause mouth cancer''
``WARNING: This product can cause gum disease and tooth loss''
``WARNING: This product is not a safe alternative to
cigarettes''
``WARNING: Smokeless tobacco is addictive''
``(2) Each label statement required by paragraph (1) shall
be--
``(A) located on the 2 principal display panels of
the package, and each label statement shall comprise at
least 25 percent of each such display panel; and
``(B) in 17-point conspicuous and legible type and
in black text on a white background, or white text on a
black background, in a manner that contrasts by
typography, layout, or color, with all other printed
material on the package, in an alternating fashion
under the plan submitted under subsection (b)(3),
except that if the text of a label statement would
occupy more than 70 percent of the area specified by
subparagraph (A), such text may appear in a smaller type size, so long
as at least 60 percent of such warning area is occupied by the label
statement.
``(3) The label statements required by paragraph (1) shall
be introduced by each tobacco product manufacturer, packager,
importer, distributor, or retailer of smokeless tobacco
products concurrently into the distribution chain of such
products.
``(4) The provisions of this subsection do not apply to a
tobacco product manufacturer or distributor of any smokeless
tobacco product that does not manufacture, package, or import
smokeless tobacco products for sale or distribution within the
United States.
``(b) Required Labels.--
``(1) It shall be unlawful for any tobacco product
manufacturer, packager, importer, distributor, or retailer of
smokeless tobacco products to advertise or cause to be
advertised within the United States any smokeless tobacco
product unless its advertising bears, in accordance with the
requirements of this section, one of the labels specified in
subsection (a).
``(2) Each label statement required by subsection (a) in
smokeless tobacco advertising shall comply with the standards
set forth in this paragraph. For press and poster
advertisements, each such statement and (where applicable) any
required statement relating to tar, nicotine, or other
constituent yield shall--
``(A) comprise at least 20 percent of the area of
the advertisement, and the warning area shall be
delineated by a dividing line of contrasting color from
the advertisement; and
``(B) the word ``WARNING'' shall appear in capital
letters and each label statement shall appear in
conspicuous and legible type. The text of the label
statement shall be black on a white background, or
white on a black background, in an alternating fashion
under the plan submitted under paragraph (3).
``(3)(A) The label statements specified in subsection
(a)(1) shall be randomly displayed in each 12-month period, in
as equal a number of times as is possible on each brand of the
product and be randomly distributed in all areas of the United
States in which the product is marketed in accordance with a
plan submitted by the tobacco product manufacturer, importer,
distributor, or retailer and approved by the Secretary.
``(B) The label statements specified in subsection (a)(1)
shall be rotated quarterly in alternating sequence in
advertisements for each brand of smokeless tobacco product in
accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer to, and
approved by, the Secretary.
``(C) The Secretary shall review each plan submitted under
subparagraph (B) and approve it if the plan--
``(i) will provide for the equal distribution and
display on packaging and the rotation required in
advertising under this subsection; and
``(ii) assures that all of the labels required
under this section will be displayed by the tobacco
product manufacturer, importer, distributor, or
retailer at the same time.
``(c) Television and Radio Advertising.--It is unlawful to
advertise smokeless tobacco on any medium of electronic communications
subject to the jurisdiction of the Federal Communications
Commission.''.
SEC. 509. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT WARNING LABEL
STATEMENTS.
Section 3 of the Comprehensive Smokeless Tobacco Health Education
Act of 1986 (15 U.S.C. 4402), as amended by section 508, is further
amended by adding at the end the following:
``(d) Authority To Revise Warning Label Statements.--The Secretary
may, by a rulemaking conducted under section 553 of title 5, United
States Code, adjust the format, type size, and text of any of the
warning label statements required by subsection (a) of this section,
subject to the limitations on proportional size of the warning
contained in paragraphs (2) and (3) of subsection (a), or establish the
format, type size, and text of any other disclosures required under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), if the
Secretary finds that such a change would promote greater public
understanding of the risks associated with the use of smokeless tobacco
products.''.
SEC. 510. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT DISCLOSURE TO THE
PUBLIC.
Section 4(a) of the Federal Cigarette Labeling and Advertising Act
(15 U.S.C. 1333(a)), as amended by section 506, is further amended by
adding at the end the following:
``(4)(A) The Secretary shall, by a rulemaking conducted
under section 553 of title 5, United States Code, determine (in
the Secretary's sole discretion) whether cigarette and other
tobacco product manufacturers shall be required to include in
the area of each cigarette advertisement specified by
subsection (b) of this section, or on the package label, or
both, the tar and nicotine yields of the advertised or packaged
brand. Any such disclosure shall be in accordance with the
methodology established under such regulations, shall conform
to the type size requirements of subsection (b) of this
section, and shall appear within the area specified in
subsection (b) of this section.
``(B) Any differences between the requirements established
by the Secretary under subparagraph (A) and tar and nicotine
yield reporting requirements established by the Federal Trade
Commission shall be resolved by a memorandum of understanding
between the Secretary and the Federal Trade Commission.
``(C) In addition to the disclosures required by
subparagraph (A) of this paragraph, the Secretary may, under a
rulemaking conducted under section 553 of title 5, United
States Code, prescribe disclosure requirements regarding the
level of any cigarette or other tobacco product smoke
constituent. Any such disclosure may be required if the
Secretary determines that disclosure would be of benefit to the
public health, or otherwise would increase consumer awareness
of the health consequences of the use of tobacco products,
except that no such prescribed disclosure shall be required on
the face of any cigarette package or advertisement. Nothing in
this section shall prohibit the Secretary from requiring such
prescribed disclosure through a cigarette or other tobacco
product package or advertisement insert, or by any other means
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
et seq.).''.
SEC. 511. REGULATION REQUIREMENT.
(a) Testing, Reporting, and Disclosure.--Not later than 24 months
after the date of enactment of this Act, the Secretary, through the
Commissioner of Food and Drugs, shall promulgate regulations under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) that meet
the requirements of subsection (b) of this section.
(b) Contents of Rules.--The rules promulgated under subsection (a)
shall require the testing, reporting, and disclosure of tobacco product
smoke constituents and ingredients that the Secretary determines should
be disclosed to the public in order to protect the public health. Such
constituents shall include tar, nicotine, carbon monoxide, and such
other smoke constituents or ingredients as the Secretary may determine
to be appropriate. The rule may require that tobacco product
manufacturers, packagers, or importers make such disclosures relating
to tar and nicotine through labels or advertising, and make such
disclosures regarding other smoke constituents or ingredients as the
Secretary determines are necessary to protect the public health.
(c) Authority.--The Food and Drug Administration shall have
authority to conduct or to require the testing, reporting, or
disclosure of tobacco product smoke constituents.
SEC. 512. FTC JURISDICTION NOT AFFECTED.
(a) In General.--Except where expressly provided in this Act,
nothing in this Act shall be construed as limiting or diminishing the
authority of the Federal Trade Commission to enforce the laws under its
jurisdiction with respect to the advertising, sale, or distribution of
tobacco products.
(b) Enforcement by FTC.--Any advertising that violates this Act is
an unfair or deceptive act or practice under section 5(a) of the
Federal Trade Commission Act (15 U.S.C. 45(a)) and shall be considered
a violation of a rule promulgated under section 18 of that Act (15
U.S.C. 57a).
<all>
Introduced in House
Introduced in House
Referred to the Committee on Agriculture, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Agriculture, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Agriculture, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Specialty Crops and Foreign Agriculture Programs.
Executive Comment Requested from USDA.
Referred to the Subcommittee on Health, for a period to be subsequently determined by the Chairman.
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