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 pro-
visions. 
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 state-
ments. 
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 remain-
der of this Act, or an amendment made by this Act, or 
the application of such provision to other persons or cir-
cumstances, 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U.S.C. 515–515k), is repealed.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 ‘‘to-
bacco,’’. 
(c) PROCESSING TAX.—Section 9(b) of the Agricul-
tural 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 Ag-
ricultural 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–Sep-
tember 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 to-
bacco’’;
(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 para-
graph (15). 
(g) PARITY PAYMENTS.—Section 303 of the Agricul-
tural 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 Ag-
ricultural Adjustment Act of 1938 (7 U.S.C. 1373) is 
amended—
(1) in subsection (a)—
(A) by striking the first sentence and in-
serting the following new sentence: ‘‘This sub-
section shall apply to warehousemen, proc-
essors, 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 to-
bacco’’ and inserting ‘‘or rice’’.
(l) REGULATIONS.—Section 375(a) of the Agricul-
tural 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 Agricul-
tural Adjustment Act of 1938 (7 U.S.C. 1378) is amend-
ed—
(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 re-
pealed. 
(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 sec-
tion shall not affect the liability of any person under any 
provision of law in effect before the amendments take ef-
fect as provided under subsection (u). 
(u) APPLICATION OF AMENDMENTS.—The amend-
ments 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 Ag-
ricultural 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 here-
in), 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 COM-
MODITY.—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.—Sec-
tion 3 of Public Law 98–59 (7 U.S.C. 625) is repealed. 
(e) POWERS
OF COMMODITY CREDIT CORPORA-
TION.—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 re-
spect 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 Sec-
retary of Agriculture shall issue regulations that re-
quire—
(A) the orderly disposition of quota to-
bacco 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 sup-
port loans or surrender of collateral by such as-
sociations not later than one year after this sec-
tion becomes effective. 
(3) SPECIAL RULES FOR TERMINATION OF NO 
NET COST FUNDS AND ACCOUNTS.—Notwithstanding 
any other provision of law, upon the repeal by sub-
section (b) of the authorities in section 106A and 
106B of the Agricultural Act of 1949 for the estab-
lishment 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 ac-
count shall be disposed of in the manner pre-
scribed 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 Sec-
retary 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 pro-
vide an orderly economic transition away from the mar-
keting 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 commu-
nities. 
(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 IN-
SURANCE. 
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 
TO-
BACCO QUOTA HOLDERS AND 
PRODUCERS 
SEC. 201. DEFINITIONS. 
In this title: 
(1) The term ‘‘active producer of quota to-
bacco’’ means a person that was the actual pro-
ducer, as determined by the Secretary, of tobacco 
marketed under a marketing quota for the 2001 to-
bacco 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 mar-
keting 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 allot-
ment for quota tobacco was established with respect 
to the 2002 tobacco marketing year under a mar-
keting 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 ter-
mination 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 Sec-
retary 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 to-
bacco 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 POUND-
AGE 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 ob-
tained 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 lo-
cated for the kind of tobacco for the 1998 mar-
keting 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 ob-
tained 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 regard-
ing the eligibility of a person to receive a payment under 
this section, or the amount of the payment, shall be re-
solved 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 Sec-
retary 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 Sec-
retary shall make transition payments under this section 
to eligible active producers of quota tobacco. 
(b) ELIGIBILITY.—To be eligible to receive a transi-
tion 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 satis-
faction of the Secretary that the person satisfies the defi-
nition 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 estab-
lish 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 deter-
mined 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 ac-
tive producer under subsection (c). 
(e) TIME FOR PAYMENT.—The payments to eligible 
active producers of quota tobacco required under this sec-
tion shall be made in five equal installments during fiscal 
years 2004, 2005, 2006, 2007, and 2008. 
(f) RESOLUTION OF DISPUTES.—Any dispute regard-
ing the eligibility of a person to receive a payment under 
this section, or the amount of the payment, shall be re-
solved 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 Sec-
retary 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 ap-
pointed by the Secretary from nominations submitted by 
representatives of United States tobacco producers, five 
shall be appointed by the Secretary from nominations sub-
mitted by representatives of United States tobacco prod-
uct manufacturers, and one shall be an officer or employee 
of the Department of Agriculture appointed by the Sec-
retary (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 pro-
ducer representatives and two manufacturer rep-
resentatives 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 to-
bacco 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 prod-
ucts; 
(3) reviewing data collected by Federal agencies 
on the physical and chemical integrity of United 
States produced and imported unmanufactured to-
bacco, to ensure that tobacco being used in domesti-
cally-manufactured tobacco products is of the high-
est quality and is free from prohibited physical and 
chemical agents; 
(4) investigating and communicating to the Sec-
retary—
(A) conditions with respect to the produc-
tion 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 un-
manufactured tobacco and capable of collecting data and 
monitoring tobacco production information, and such
other resources necessary for the Board to perform its du-
ties under this subtitle, as determined by the Secretary. 
(b) COMMODITY CREDIT CORPORATION.—The Sec-
retary shall use the funds, facilities and authorities of the 
Commodity Credit Corporation to carry out this title.
TITLE IV—TOBACCO PRODUCT 
MANUFACTURER 
AND 
IM-
PORTER USER FEES 
SEC. 401. USER FEE. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services shall assess an annual user fee, cal-
culated 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 ciga-
rette 
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 chew-
ing tobacco manufacturers and importers shall be 
$2,275,000. 
(6) The base amount of the user fee for pipe to-
bacco 
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 cal-
endar year; and
(2) the denominator of which is the total vol-
ume of domestic sales of that class of tobacco prod-
uct 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 sub-
section (a) shall be determined in each year by mul-
tiplying—
(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 cur-
rent calendar year, as determined under sub-
section (c), for that class of tobacco product. 
(2) MARKET
SHARE
DEFINED.—In this sub-
section, the term ‘‘market share’’ for each manufac-
turer 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 manu-
facturer’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 Sec-
retary of Health and Human Services based on cer-
tified 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 vol-
umes 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 num-
ber of cigars weighing not more than three 
pounds per thousand sold. 
(C) With respect to large cigars, the num-
ber of cigars weighing more than three pounds 
per thousand sold.
(D) With respect to other classes of to-
bacco 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 Agri-
culture pursuant to section 102(f)(3)(B)(ii) shall be avail-
able, 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 Serv-
ices shall make 15 percent of the user fee amounts col-
lected pursuant to section 401 each year available to the 
Food and Drug Administration for the regulation of to-
bacco products under chapter IX of the Federal Food, 
Drug, and Cosmetic Act. 
(c) FUNDING FOR OTHER TOBACCO-RELATED PRO-
GRAMS.—
(1) TITLE II EXPENDITURES.—The Secretary 
of Health and Human Services shall use the remain-
ing 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 Ag-
riculture pursuant to section 102(f)(3)(B)(ii), to re-
imburse 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 pro-
gram 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 in-
herently 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 con-
tribute 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 ade-
quately to curb tobacco use by adolescents, com-
prehensive 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 to-
bacco 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 Constitu-
tion, the Congress is vested with the responsibility 
for regulating interstate commerce and commerce 
with Indian tribes. 
(10) The sale, distribution, marketing, adver-
tising, and use of tobacco products are activities in 
and substantially affecting interstate commerce be-
cause they are sold, marketed, advertised, and dis-
tributed in interstate commerce on a nationwide 
basis, and have a substantial effect on the Nation’s 
economy. 
(11) The sale, distribution, marketing, adver-
tising, and use of such products substantially affect 
interstate commerce through the health care and 
other costs attributable to the use of tobacco prod-
ucts. 
(12) It is in the public interest for Congress to 
adopt comprehensive public health legislation be-
cause of tobacco’s unique position in the Nation’s 
history and economy and the need to prevent the 
sale, distribution, marketing and advertising of to-
bacco 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 pur-
chase 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 at-
tract young persons to use tobacco products and 
these efforts have resulted in increased use of such 
products by youth. Past efforts to oversee these ac-
tivities have not been successful in adequately pre-
venting such increased use.
(17) Tobacco advertising increases the size of 
the tobacco market by increasing consumption of to-
bacco products including increasing tobacco use by 
young people. 
(18) Children are more influenced by tobacco 
advertising than adults and they smoke the most ad-
vertised brands. 
(19) Tobacco company documents indicate that 
young people are an important and often crucial seg-
ment 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 un-
dermining 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 ADVER-
TISING ACT.—Section 3(1) of the Federal Cigarette La-
beling 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, in-
cluding 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 ap-
pearance, the type of tobacco used in the filler, 
or its packaging and labeling, is likely to be of-
fered to, or purchased by, consumers as a ciga-
rette or as roll-your-own tobacco.’’. 
(b) THIS TITLE.—In this title: 
(1) BRAND.—The term ‘‘brand’’ means a vari-
ety of tobacco product distinguished by the tobacco 
used, tar content, nicotine content, flavoring used, 
size, filtration, or packaging, logo, registered trade-
mark 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 Fed-
eral 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 main-
stream or sidestream smoke. 
(6) DISTRIBUTOR.—The term ‘‘distributor’’ as 
regards a tobacco product means any person who 
furthers the distribution of cigarette or smokeless to-
bacco, 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 con-
sidered 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 smoke-
less tobacco product, including flavorants, processing 
aids, casing sauces, preservatives, and combustion 
modifiers. 
(8) MANUFACTURER.—The term ‘‘manufac-
turer’’ 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 cello-
phane), in which cigarettes or smokeless tobacco are 
offered for sale, sold, or otherwise distributed to con-
sumers. 
(11) RETAILER.—The term ‘‘retailer’’ means 
any person who sells cigarettes or smokeless tobacco 
to individuals for personal consumption, or who op-
erates 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 ‘‘smoke-
less 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 in-
tended for human consumption, including any com-
ponent, part, or accessory of a tobacco product (ex-
cept 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 fol-
lowing: 
‘‘CHAPTER IX—TOBACCO 
PRODUCTS 
‘‘SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—Tobacco products shall be regu-
lated 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 sec-
tion 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 regu-
lation of, products under this Act that are not to-
bacco products under chapter V or any other chap-
ter 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 em-
ployee 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 pro-
ducer of tobacco leaf is also a tobacco product man-
ufacturer or controlled by a tobacco product manu-
facturer, the producer shall be subject to this chap-
ter 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 com-
mon 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 sub-
stance 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;
‘‘(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 dis-
tributor; 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 para-
graph 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 informa-
tion required by or under authority of this chapter 
to appear on the label or labeling is not prominently 
placed thereon with such conspicuousness (as com-
pared 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 nonpropri-
etary name, its established name prominently print-
ed in type as required by the Secretary by regula-
tion; 
‘‘(5) if the Secretary has issued regulations re-
quiring 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 regula-
tions; 
‘‘(6) if it was manufactured, prepared, propa-
gated, 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 re-
specting it was not provided as required by such sec-
tion 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 dis-
tributed 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 regula-
tions prescribed under section 906(d);
‘‘(8) unless, in the case of any tobacco product 
distributed or offered for sale in any State, the man-
ufacturer, packer, or distributor thereof includes in 
all advertisements and other descriptive printed mat-
ter issued or caused to be issued by the manufac-
turer, packer, or distributor with respect to that to-
bacco product—
‘‘(A) a true statement of the tobacco prod-
uct’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 oppor-
tunity for a hearing;
‘‘(9) unless, in the case of any tobacco product 
distributed or offered for sale in any State, the man-
ufacturer, packer, or distributor thereof includes in 
all advertisements the information required by sec-
tion 916(c); 
‘‘(10) if it is a tobacco product subject to a per-
formance 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 pre-
scribed under section 904 or 908; or 
‘‘(B) to furnish any material or informa-
tion 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 sub-
ject to the provisions of sections 12 through 15 of the Fed-
eral 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 prod-
uct manufacturer or importer of tobacco products, or 
agents thereof, shall submit to the Secretary the following 
information: 
‘‘(1) A listing of all tobacco ingredients, sub-
stances and compounds that are, on such date, 
added by the manufacturer to the tobacco, paper, fil-
ter, 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 sci-
entific information) relating to research activities, 
and research findings, conducted, supported, or pos-
sessed by the manufacturer (or agents thereof) on 
the health, behavioral, or physiologic effects of to-
bacco products, their constituents, ingredients, and
components, and tobacco additives, described in 
paragraph (1). 
‘‘(4) All documents (including underlying sci-
entific information) relating to research activities, 
and research findings, conducted, supported, or pos-
sessed 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 sci-
entific 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 man-
ufacturer or importer that is required to submit informa-
tion 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 com-
merce 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 re-
quired under subsection (a) and such product shall 
be subject to the annual submission under sub-
section (b).
‘‘(2) MODIFICATION OF EXISTING PRODUCTS.—
If at any time a tobacco product manufacturer adds 
to its tobacco products a new tobacco additive, in-
creases or decreases the quantity of an existing to-
bacco additive or the nicotine content, delivery, or 
form, or eliminates a tobacco additive from any to-
bacco product, the manufacturer shall within 60 
days of such action so advise the Secretary in writ-
ing 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 repack-
aging or otherwise changing the container, wrapper, 
or labeling of any tobacco product package in fur-
therance of the distribution of the tobacco product 
from the original place of manufacture to the person
in any State and in which that person begins the manufac-
ture, preparation, compounding, or processing of a tobacco 
product or tobacco products. 
‘‘(e) UNIFORM
PRODUCT
IDENTIFICATION
SYS-
TEM.—The Secretary may by regulation prescribe a uni-
form 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 INFORMA-
TION.—The Secretary shall make available for inspection, 
to any person so requesting, any registration filed under 
this section. 
‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB-
LISHMENTS.—Every establishment in any State registered 
with the Secretary under this section shall be subject to 
inspection under section 704, and every such establish-
ment engaged in the manufacture, compounding, or proc-
essing 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 es-
tablishment 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 establish-
ment 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 to-
bacco 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 reg-
isters with the Secretary under subsection (b), (c), 
or (d) of this section shall, at the time of registra-
tion under any such subsection, file with the Sec-
retary 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 pre-
scribe and shall be accompanied by—
‘‘(A) in the case of a tobacco product con-
tained in the applicable list with respect to 
which a performance standard has been estab-
lished 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 prod-
uct 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 de-
termined that a tobacco product contained in 
such list is not subject to a performance stand-
ard established under section 907, a brief state-
ment of the basis upon which the registrant
made such determination if the Secretary re-
quests 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 Sec-
retary 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 intro-
duced by the registrant for commercial distribu-
tion which has not been included in any list 
previously filed by that person with the Sec-
retary under this subparagraph or paragraph 
(1) of this subsection. A list under this sub-
paragraph shall list a tobacco product by its es-
tablished 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 dis-
tribution 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 estab-
lished name. 
‘‘(C) If since the date the registrant re-
ported under subparagraph (B) a notice of dis-
continuance that person has resumed the manu-
facture, preparation, compounding, or proc-
essing for commercial distribution of the to-
bacco 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 para-
graph (1), unless the registrant has previously 
reported such resumption to the Secretary 
under this subparagraph. 
‘‘(D) Any material change in any informa-
tion previously submitted under this paragraph 
or paragraph (1). 
‘‘(j) REPORT PRECEDING INTRODUCTION OF CER-
TAIN
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 mar-
keted (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 be-
fore 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, sec-
tion 910, or subsection (d) of this section, and any re-
quirement 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 COM-
MENT.—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 re-
spect 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 find-
ings (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 Reg-
ister stating good cause therefor. 
‘‘(c) LIMITED
CONFIDENTIALITY
OF
INFORMA-
TION.—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 dis-
tribution upon such conditions, including restrictions 
on the access to, and the advertising and promotion 
of, the tobacco product, as the Secretary may pre-
scribe 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 condi-
tion may require that the sale or distribution of a 
tobacco product be limited to the written or oral au-
thorization of a practitioner licensed by law to pre-
scribe medical products.
‘‘(2) The label of a tobacco product shall bear 
such appropriate statements of the restrictions re-
quired 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 out-
lets. 
‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE-
MENTS.—
‘‘(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 fa-
cilities 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 manufac-
turing practice for an agricultural product, as
prescribed in such regulations, to assure that 
the public health is protected and that the to-
bacco product is in compliance with this chap-
ter.
‘‘(B) The Secretary shall—
‘‘(i) before promulgating any regula-
tion under subparagraph (A), afford an ad-
visory committee an opportunity to submit 
recommendations with respect to the regu-
lation proposed to be promulgated; 
‘‘(ii) before promulgating any regula-
tion under subparagraph (A), afford oppor-
tunity for an oral hearing; 
‘‘(iii) provide the advisory committee a 
reasonable time to make its recommenda-
tion 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 dif-
ferences in the manner in which the dif-
ferent types of tobacco products have his-
torically been produced, the financial re-
sources of the different tobacco product 
manufacturers, and the state of their exist-
ing manufacturing facilities; and shall pro-
vide for a reasonable period of time for 
such manufacturers to conform to good 
manufacturing practices.
‘‘(2) EXEMPTIONS; VARIANCES.—
‘‘(A) Any person subject to any require-
ment prescribed under paragraph (1) may peti-
tion the Secretary for a permanent or tem-
porary exemption or variance from such re-
quirement. 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 ex-
emption 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 meth-
ods, 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 advi-
sory committee any petition submitted under 
subparagraph (A). The advisory committee 
shall report its recommendations to the Sec-
retary 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 sub-
mitted to the Secretary under subpara-
graph (A); or 
‘‘(ii) the day after the petition was re-
ferred 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 compli-
ance with this chapter; and 
‘‘(ii) a petition for a variance for a to-
bacco 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 pre-
scribed 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 manu-
facture, 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 pe-
titioner shall have an opportunity for an infor-
mal hearing on such order. 
‘‘(f) EXEMPTION FOR INVESTIGATIONAL USE.—The 
Secretary may exempt tobacco products intended for in-
vestigational use from this chapter under such conditions 
as the Secretary may prescribe by regulation. 
‘‘(g) RESEARCH
AND DEVELOPMENT.—The Sec-
retary may enter into contracts for research, testing, and
demonstrations respecting tobacco products and may ob-
tain tobacco products for research, testing, and dem-
onstration 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, in-
cluding 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
STAND-
ARDS.—A performance standard established under 
this section for a tobacco product—
‘‘(A) shall include provisions to provide 
performance that is appropriate for the protec-
tion 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 require-
ment under (B); 
‘‘(B) shall, where necessary to be appro-
priate for the protection of the public health, 
include—
‘‘(i) provisions respecting the con-
struction, components, ingredients, and 
properties of the tobacco product; 
‘‘(ii) provisions for the testing (on a 
sample basis or, if necessary, on an indi-
vidual basis) of the tobacco product;
‘‘(iii) provisions for the measurement 
of the performance characteristics of the 
tobacco product; and 
‘‘(iv) provisions requiring that the re-
sults 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
PERFORM-
ANCE STANDARDS.—The Secretary shall provide for 
periodic evaluation of performance standards estab-
lished 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; IN-
FORMED
PERSONS.—In carrying out duties under 
this section, the Secretary shall, to the maximum ex-
tent 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 na-
tionally or internationally recognized standard-
setting entities; and 
‘‘(C) 
invite 
appropriate 
participation, 
through joint or other conferences, workshops, 
or other means, by informed persons represent-
ative of scientific, professional, industry, or con-
sumer 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 rule-
making 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 perform-
ance standard for a tobacco product shall—
‘‘(i) set forth a finding with sup-
porting 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 sub-
mit an existing performance standard for 
the tobacco product, including a draft or 
proposed performance standard, for consid-
eration 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 nec-
essary to be appropriate for the protection of 
the public health. 
‘‘(D) The Secretary shall consider all infor-
mation submitted in connection with a proposed 
standard, including information concerning the 
countervailing effects of the performance stand-
ard on the health of adolescent tobacco users, 
adult tobacco users, or non-tobacco users, such 
as the creation of a significant demand for con-
traband 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 protec-
tion 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 per-
formance standard and after consideration of 
such comments and any report from an advi-
sory committee, the Secretary shall—
‘‘(i) promulgate a regulation estab-
lishing a performance standard and pub-
lish 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 perform-
ance 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 pub-
lic health. Such date or dates shall be estab-
lished 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.—Be-
cause of the importance of any decision to issue a 
regulation establishing a performance standard—
‘‘(A) eliminating all cigarettes, all smoke-
less tobacco products, or any similar class of to-
bacco 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 ac-
cordance with the requirements of paragraphs 
(1) and (2)(B) of this subsection, amend or re-
voke a performance standard. 
‘‘(B) The Secretary may declare a pro-
posed 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 ef-
fective is in the public interest. 
‘‘(5) REFERENCE TO ADVISORY COMMITTEE.—
The Secretary—
‘‘(A) may, on the Secretary’s own initia-
tive, refer a proposed regulation for the estab-
lishment, amendment, or revocation of a per-
formance standard; or 
‘‘(B) shall, upon the request of an inter-
ested 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 com-
mittee, for a report and recommendation with re-
spect to any matter involved in the proposed regula-
tion which requires the exercise of scientific judg-
ment. If a proposed regulation is referred under this
subparagraph to the advisory committee, the Sec-
retary shall provide the advisory committee with the 
data and information on which such proposed regu-
lation is based. The advisory committee shall, within
60 days after the referral of a proposed regulation 
and after independent study of the data and infor-
mation furnished to it by the Secretary and other 
data and information before it, submit to the Sec-
retary a report and recommendation respecting such 
regulation, together with all underlying data and in-
formation and a statement of the reason or basis 
for the recommendation. A copy of such report and 
recommendation shall be made public by the Sec-
retary. 
‘‘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 sub-
stantial 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 nec-
essary 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 ap-
propriate form, by the persons and means best suited 
under the circumstances involved, to all persons who 
should properly receive such notification in order to elimi-
nate such risk. The Secretary may order notification by 
any appropriate means, including public service announce-
ments. 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 prod-
uct contains a manufacturing or other defect not or-
dinarily contained in tobacco products on the market 
that would cause serious, adverse health con-
sequences or death, the Secretary shall issue an 
order requiring the appropriate person (including 
the manufacturers, importers, distributors, or retail-
ers of the tobacco product) to immediately cease dis-
tribution of such tobacco product. The order shall
provide the person subject to the order with an op-
portunity 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 re-
quire a recall of such tobacco product. If, after pro-
viding an opportunity for such a hearing, the Sec-
retary determines that inadequate grounds exist to 
support the actions required by the order, the Sec-
retary shall vacate the order. 
‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE-
CALL.—
‘‘(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 prod-
uct with respect to which the order was issued, 
the Secretary shall, except as provided in sub-
paragraph (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 subpara-
graph (A)—
‘‘(i) shall not include recall of a to-
bacco product from individuals; and
‘‘(ii) shall provide for notice to per-
sons 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 retail-
ers and other persons who distributed such to-
bacco 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 PROD-
UCTS. 
‘‘(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 re-
ports, and provide such information, as the Secretary may 
by regulation reasonably require to assure that such to-
bacco product is not adulterated or misbranded and to
otherwise protect public health. Regulations prescribed 
under the preceding sentence—
‘‘(1) may require a tobacco product manufac-
turer or importer to report to the Secretary when-
ever the manufacturer or importer receives or other-
wise becomes aware of information that reasonably 
suggests that one of its marketed tobacco products 
may have caused or contributed to a serious unex-
pected adverse experience associated with the use of 
the product or any significant increase in the fre-
quency of a serious, expected adverse product experi-
ence; 
‘‘(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 bur-
densome to a tobacco product manufacturer or im-
porter, taking into account the cost of complying 
with such requirements and the need for the protec-
tion 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 Sec-
retary state the reason or purpose for such request
and identify to the fullest extent practicable such re-
port 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 in-
formation and identify to the fullest extent prac-
ticable 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 re-
quired for the medical welfare of an individual, to 
determine risks to public health of a tobacco prod-
uct, or to verify a record, report, or information sub-
mitted under this chapter. 
In prescribing regulations under this subsection, the Sec-
retary 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 prod-
uct manufacturer or importer of a tobacco product
to report promptly to the Secretary any corrective 
action taken or removal from the market of a to-
bacco product undertaken by such manufacturer or 
importer if the removal or correction was under-
taken—
‘‘(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 re-
quired to be reported under this subsection shall keep a 
record of such correction or removal. 
‘‘(2) No report of the corrective action or re-
moval 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.—Ap-
proval under this section of an application for pre-
market approval for any tobacco product, other than 
a reduced risk product under section 912, that is not 
commercially marketed (other than for test mar-
keting) in the United States as of the date of this 
chapter’s enactment, is required unless the manufac-
turer 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 dis-
tribution 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 mar-
keting) 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 sec-
tion 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 infor-
mation, including clinical data if deemed 
necessary by the Secretary, that dem-
onstrates that it is not appropriate to reg-
ulate the product under this section be-
cause the product could not reasonably be 
expected to increase the health risks to 
consumers compared to a conventional to-
bacco product that is commercially mar-
keted 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 to-
bacco 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 avail-
able 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 accord-
ance with section 912. 
‘‘(b) APPLICATION.—
‘‘(1) CONTENTS.—An application for premarket 
approval shall contain—
‘‘(A) full reports of all information, pub-
lished or known to or which should reasonably 
be known to the applicant, concerning investiga-
tions 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 prod-
uct; 
‘‘(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 prod-
uct; 
‘‘(D) an identifying reference to any per-
formance standard under section 907 which 
would be applicable to any aspect of such to-
bacco product, and either adequate information 
to show that such aspect of such tobacco prod-
uct 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 Sec-
retary may require. 
‘‘(2) REFERENCE TO ADVISORY COMMITTEE.—
Upon receipt of an application meeting the require-
ments set forth in paragraph (1), the Secretary—
‘‘(A) may, on the Secretary’s own initia-
tive; or
‘‘(B) shall, upon the request of an appli-
cant,
refer such application to an advisory committee and 
for submission (within such period as the Secretary 
may establish) of a report and recommendation re-
specting 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 sec-
tion, the Secretary, after considering the report 
and recommendation submitted under para-
graph (2) of such subsection, shall—
‘‘(i) issue an order approving the ap-
plication 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 accom-
panying 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 regu-
lation 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 sub-
mitted 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 per-
mitting 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, proc-
essing, or packing of such tobacco product do 
not conform to the requirements of section 
906(e);
‘‘(C) based on a fair evaluation of all mate-
rial facts, the proposed labeling is false or mis-
leading in any particular; or 
‘‘(D) such tobacco product is not shown to 
conform in all respects to a performance stand-
ard in effect under section 907, compliance with 
which is a condition to approval of the applica-
tion, and there is a lack of adequate informa-
tion 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 in-
forming the applicant of the measures required to 
place such application in approvable form (which 
measures may include further research by the appli-
cant in accordance with one or more protocols pre-
scribed 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 protec-
tion of the public health shall, when appro-
priate, be determined on the basis of well-con-
trolled investigations, which may include one or 
more clinical investigations by experts qualified
by training and experience to evaluate the to-
bacco 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 pub-
lic health than other available products; 
‘‘(B) that the application contained or was 
accompanied by an untrue statement of a mate-
rial 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 applica-
ble 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 re-
quirements of section 905; 
‘‘(D) on the basis of new information be-
fore 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 fa-
cilities and controls used for, the manufacture, 
processing, packing, or installation of such to-
bacco product do not conform with the require-
ments 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 be-
fore the Secretary, evaluated together with the 
evidence before the Secretary when the applica-
tion was approved, that the labeling of such to-
bacco product, based on a fair evaluation of all 
material facts, is false or misleading in any par-
ticular and was not corrected within a reason-
able time after receipt of written notice from 
the Secretary of such fact; or 
‘‘(F) on the basis of new information be-
fore the Secretary, evaluated together with the 
evidence before the Secretary when the applica-
tion was approved, that such tobacco product is 
not shown to conform in all respects to a per-
formance standard which is in effect under sec-
tion 907, compliance with which was a condi-
tion to approval of the application, and that 
there is a lack of adequate information to jus-
tify the deviation from such standard. 
‘‘(2) APPEAL.—The holder of an application 
subject to an order issued under paragraph (1) with-
drawing 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 pro-
viding 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 prod-
ucts 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 expedi-
tiously under paragraph (1) to withdraw such appli-
cation. 
‘‘(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 ap-
plicant’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 Ap-
peals for the District of Columbia or for the circuit where-
in such person resides or has his principal place of busi-
ness 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 no-
tices and other matter published in the Federal Register 
with respect to the regulation or order reviewed, all infor-
mation 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 regu-
lation or order, as being relevant to such regulation or 
order.
‘‘(b) COURT MAY ORDER SECRETARY TO MAKE AD-
DITIONAL FINDINGS.—If the petitioner applies to the 
court for leave to adduce additional data, views, or argu-
ments respecting the regulation or order being reviewed 
and shows to the satisfaction of the court that such addi-
tional 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 pro-
ceedings 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 juris-
diction 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 regu-
lation 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 sec-
tion, 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 prod-
uct and is otherwise appropriate to protect pub-
lic health, based on an application submitted by 
the manufacturer of the product (or other re-
sponsible person) that—
‘‘(i)(I) demonstrates through testing 
on animals and short-term human testing 
that use of such product results in inges-
tion or inhalation of a substantially lower 
yield of toxic substances than use of an-
other tobacco product in the same or dif-
ferent 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