I 

108TH CONGRESS 

1ST SESSION H. R. 140

To eliminate the Federal quota and price support programs for tobacco, 

to compensate quota holders and active producers for the loss of tobacco 

quota asset value, to establish a permanent advisory board to determine 

and describe the physical characteristics of United States farm-produced 

tobacco and unmanufactured imported tobacco, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 7, 2003

Mr. MCINTYRE (for himself, Mr. BOYD, and Mr. TOM DAVIS of Virginia) introduced the following bill; which was referred to the Committee on Agriculture, and in addition to the Committee on Energy and Commerce, for 

a period to be subsequently determined by the Speaker, in each case for 

consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL

To eliminate the Federal quota and price support programs 

for tobacco, to compensate quota holders and active producers for the loss of tobacco quota asset value, to establish a permanent advisory board to determine and describe the physical characteristics of United States farmproduced tobacco and unmanufactured imported tobacco, 

and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

2 (a) SHORT TITLE.—This Act may be cited as the 

3 ‘‘Tobacco Livelihood and Economic Assistance for our 

4 Farmers Act’’. 

5 (b) TABLE OF CONTENTS.—The table of contents for 

6 this Act is as follows:

Sec. 1. Short title; table of contents. 

Sec. 2. Severability. 

TITLE I—TERMINATION OF CURRENT TOBACCO PROGRAMS 

Sec. 101. Termination of marketing quota programs and repeal of related provisions. 

Sec. 102. Termination of tobacco price support loan and no net cost provisions 

and repeal of related provisions. 

Sec. 103. Geographical restrictions on expansion of tobacco production. 

Sec. 104. Continued availability of Federal crop insurance. 

TITLE II—PAYMENTS TO TOBACCO QUOTA HOLDERS AND 

PRODUCERS 

Sec. 201. Definitions. 

Sec. 202. Payments to tobacco quota holders. 

Sec. 203. Transition payments for active producers of quota tobacco. 

TITLE III—TOBACCO QUALITY BOARD 

Sec. 301. Establishment of Board. 

Sec. 302. Membership. 

Sec. 303. Duties. 

Sec. 304. Administrative provisions. 

TITLE IV—TOBACCO PRODUCT MANUFACTURER AND IMPORTER 

USER FEES 

Sec. 401. User fee. 

Sec. 402. Allocation of user fees. 

TITLE V—FDA REGULATION OF TOBACCO PRODUCTS 

Sec. 501. Findings. 

Sec. 502. Definitions. 

Sec. 503. Amendment of Federal Food, Drug, and Cosmetic Act. 

Sec. 504. Regulatory record. 

Sec. 505. Conforming and other amendments to general provisions. 

Sec. 506. Cigarette label and advertising warnings. 

Sec. 507. Authority to revise cigarette warning label statements. 

Sec. 508. Smokeless tobacco labels and advertising warnings. 

Sec. 509. Authority to revise smokeless tobacco product warning label statements. 

Sec. 510. Tar, nicotine, and other smoke constituent disclosure to the public. 
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Sec. 511. Regulation requirement. 

Sec. 512. FTC jurisdiction not affected.

1 SEC. 2. SEVERABILITY. 

2 If any provision of this Act, or an amendment made 

3 by this Act, or the application of such provision to any 

4 person or circumstance, is held to be invalid, the remain5 der of this Act, or an amendment made by this Act, or 

6 the application of such provision to other persons or cir7 cumstances, shall not be affected. 

8 TITLE I—TERMINATION OF 

9 CURRENT TOBACCO PROGRAMS 

10 SEC. 101. TERMINATION OF MARKETING QUOTA PROGRAMS 

11 AND REPEAL OF RELATED PROVISIONS. 

12 (a) TOBACCO CONTROL ACT.—The Act of April 25, 

13 1936 (commonly known as the Tobacco Control Act; 7 

14 U.S.C. 515–515k), is repealed. 

15 (b) COMMODITY HANDLING ORDERS.—Section 8c(2) 

16 of the Agricultural Adjustment Act (7 U.S.C. 608c(2)), 

17 reenacted with amendments by the Agricultural Marketing 

18 Agreement Act of 1937, is amended by striking ‘‘to19 bacco,’’. 

20 (c) PROCESSING TAX.—Section 9(b) of the Agricul21 tural Adjustment Act (7 U.S.C. 609(b)), reenacted with 

22 amendments by the Agricultural Marketing Agreement 

23 Act of 1937, is amended—

24 (1) in paragraph (2), by striking ‘‘tobacco,’’
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1 (2) in paragraph (6)(B)(i), by striking ‘‘, or, in 

2 the case of tobacco, is less than the fair exchange 

3 value by not more than 10 per centum,’’. 

4 (d) BURLEY TOBACCO IMPORT REVIEW.—Section 3 

5 of Public Law 98–59 (7 U.S.C. 625) is repealed. 

6 (e) DECLARATION OF POLICY.—Section 2 of the Ag7 ricultural Adjustment Act of 1938 (7 U.S.C. 1282) is 

8 amended by striking ‘‘tobacco,’’. 

9 (f) DEFINITIONS.—Section 301(b) of the Agricultural 

10 Adjustment Act of 1938 (7 U.S.C. 1301(b)) is amended—

11 (1) in paragraph (3)—

12 (A) by striking subparagraph (C); and 

13 (B) by redesignating subparagraph (D) as 

14 subparagraph (C); 

15 (2) in paragraph (6)(A), by striking ‘‘tobacco,’’; 

16 (3) in paragraph (7), by striking the following: 

17 ‘‘Tobacco (flue-cured), July 1–June 30; 

18 Tobacco (other than flue-cured), October 1–Sep19 tember 30;’’

20 (4) in paragraph (10)—

21 (A) by striking subparagraph (B); and 

22 (B) by redesignating subparagraph (C) as 

23 subparagraph (B); 

24 (5) in paragraph (11)(B), by striking ‘‘and to25 bacco’’; 
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1 (6) in paragraph (12), by striking ‘‘tobacco,’’; 

2 (7) in paragraph (14)—

3 (A) by striking ‘‘(A)’’ in subparagraph (A); 

4 and 

5 (B) by striking subparagraphs (B), (C), 

6 and (D); 

7 (8) by striking paragraph (15); 

8 (9) in paragraph (16)—

9 (A) by striking subparagraph (B); and 

10 (B) by redesignating subparagraph (C) as 

11 subparagraph (B); 

12 (10) by striking paragraph (17); and 

13 (11) by redesignating paragraph (16) as para14 graph (15). 

15 (g) PARITY PAYMENTS.—Section 303 of the Agricul16 tural Adjustment Act of 1938 (7 U.S.C. 1303) is amended 

17 in the first sentence by striking ‘‘rice, or tobacco’’ and 

18 inserting ‘‘or rice’’. 

19 (h) MARKETING QUOTAS.—Part I of subtitle B of 

20 title III of the Agricultural Adjustment Act of 1938 (7 

21 U.S.C. 1311 et seq.) is repealed. 

22 (i) ADMINISTRATIVE PROVISIONS.—Section 361 of 

23 the Agricultural Adjustment Act of 1938 (7 U.S.C. 1361) 

24 is amended by striking ‘‘tobacco,’’.
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1 (j) ADJUSTMENT OF QUOTAS.—Section 371 of the 

2 Agricultural Adjustment Act of 1938 (7 U.S.C. 1371) is 

3 amended—

4 (1) in the first sentence of subsection (a) by 

5 striking ‘‘, rice, or tobacco’’ and inserting ‘‘or rice’’; 

6 and 

7 (2) in the first sentence of subsection (b), by 

8 striking ‘‘, rice, or tobacco’’ and inserting ‘‘or rice’’. 

9 (k) REPORTS AND RECORDS.—Section 373 of the Ag10 ricultural Adjustment Act of 1938 (7 U.S.C. 1373) is 

11 amended—

12 (1) in subsection (a)—

13 (A) by striking the first sentence and in14 serting the following new sentence: ‘‘This sub15 section shall apply to warehousemen, proc16 essors, and common carriers of corn, wheat, 

17 cotton, or rice, all ginners of cotton, and all 

18 persons engaged in the business of purchasing 

19 corn, wheat, cotton, or rice from producers.’’; 

20 and 

21 (B) in the last sentence by striking ‘‘$500’’ 

22 and all that follows through the period at the 

23 end of the sentence and inserting ‘‘$500.’’. 

24 (2) in subsection (b), by striking ‘‘rice, or to25 bacco’’ and inserting ‘‘or rice’’. 
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1 (l) REGULATIONS.—Section 375(a) of the Agricul2 tural Adjustment Act of 1938 (7 U.S.C. 1375(a)) is 

3 amended by striking ‘‘peanuts, or tobacco’’ and inserting 

4 ‘‘or peanuts’’. 

5 (m) EMINENT DOMAIN.—Section 378 of the Agricul6 tural Adjustment Act of 1938 (7 U.S.C. 1378) is amend7 ed—

8 (1) in the first sentence of subsection (c) by 

9 striking ‘‘and tobacco’’; and 

10 (2) by striking subsection (f). 

11 (n) BURLEY TOBACCO FARM RECONSTITUTION.—

12 Section 379 of the Agricultural Adjustment Act of 1938 

13 (7 U.S.C. 1379) is amended—

14 (1) in subsection (a)—

15 (A) by striking ‘‘(a)’’; and 

16 (B) in paragraph (6) by striking ‘‘, but 

17 this clause (6) shall not be applicable in the 

18 case of burley tobacco’’; and 

19 (2) by striking subsections (b) and (c). 

20 (o) ACREAGE-POUNDAGE QUOTAS.—Section 4 of the 

21 Act of April 16, 1955 (Public Law 89–12; 7 U.S.C. 1314c 

22 note), is repealed. 

23 (p) BURLEY TOBACCO ACREAGE ALLOTMENTS.—

24 The Act of July 12, 1952 (7 U.S.C. 1315), is repealed. 
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1 (q) TRANSFER OF ALLOTMENTS.—Section 703 of the 

2 Food and Agriculture Act of 1965 (7 U.S.C. 1316) is re3 pealed. 

4 (r) ADVANCE RECOURSE LOANS.—Section 

5 13(a)(2)(B) of the Food Security Improvements Act of 

6 1986 (7 U.S.C. 1433c–1(a)(2)(B)) is amended by striking 

7 ‘‘tobacco and’’. 

8 (s) TOBACCO FIELD MEASUREMENT.—Section 1112 

9 of the Omnibus Budget Reconciliation Act of 1987 (Public 

10 Law 100–203) is amended by striking subsection (c). 

11 (t) LIABILITY.—The amendments made by this sec12 tion shall not affect the liability of any person under any 

13 provision of law in effect before the amendments take ef14 fect as provided under subsection (u). 

15 (u) APPLICATION OF AMENDMENTS.—The amend16 ments made by this section shall apply with respect to the 

17 2004 and subsequent tobacco crops. 

18 SEC. 102. TERMINATION OF TOBACCO PRICE SUPPORT 

19 LOAN AND NO NET COST PROVISIONS AND 

20 REPEAL OF RELATED PROVISIONS. 

21 (a) PARITY PRICE SUPPORT.—Section 101 of the Ag22 ricultural Act of 1949 (7 U.S.C. 1441) is amended—

23 (1) in the first sentence of subsection (a), by 

24 striking ‘‘tobacco (except as otherwise provided here25 in), corn,’’ and inserting ‘‘corn’’; 
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1 (2) by striking subsection (c); 

2 (3) in subsection (d)(3)—

3 (A) by striking ‘‘, except tobacco,’’; and 

4 (B) by striking ‘‘and no price support shall 

5 be made available for any crop of tobacco for 

6 which marketing quotas have been disapproved 

7 by producers;’’; and 

8 (4) by redesignating subsections (d) and (e) as 

9 subsections (c) and (d), respectively. 

10 (b) TERMINATION OF TOBACCO PRICE SUPPORT AND

11 NO NET COST PROVISIONS.—Sections 106, 106A, and 

12 106B of the Agricultural Act of 1949 (7 U.S.C. 1445, 

13 1445–1, 1445–2) are repealed. 

14 (c) DEFINITION OF BASIC AGRICULTURAL COM15 MODITY.—Section 408(c) of the Agricultural Act of 1949 

16 (7 U.S.C. 1428(c)) is amended by striking ‘‘tobacco,’’. 

17 (d) REVIEW OF BURLEY TOBACCO IMPORTS.—Sec18 tion 3 of Public Law 98–59 (7 U.S.C. 625) is repealed. 

19 (e) POWERS OF COMMODITY CREDIT CORPORA20 TION.—Section 5 of the Commodity Credit Corporation 

21 Charter Act (15 U.S.C. 714c) is amended by inserting 

22 ‘‘(other than tobacco)’’ after ‘‘agricultural commodities’’ 

23 each place it appears. 

24 (f) TRANSITION PROVISIONS.—
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1 (1) PRICE SUPPORT LOAN OBLIGATIONS.—The 

2 amendments made by this section shall not affect 

3 any person’s obligations that arise under or with re4 spect to the price support loan program or loans 

5 issued through such program under any provision of 

6 law in effect before the amendments take effect as 

7 provided under subsection (g). 

8 (2) TOBACCO STOCKS AND LOANS.—The Sec9 retary of Agriculture shall issue regulations that re10 quire—

11 (A) the orderly disposition of quota to12 bacco held by any producer-owned cooperative 

13 marketing association that has entered into a 

14 loan agreement with the Commodity Credit 

15 Corporation to make price support available to 

16 producers of quota tobacco; 

17 (B) the repayment of all tobacco price sup18 port loans or surrender of collateral by such as19 sociations not later than one year after this sec20 tion becomes effective. 

21 (3) SPECIAL RULES FOR TERMINATION OF NO

22 NET COST FUNDS AND ACCOUNTS.—Notwithstanding 

23 any other provision of law, upon the repeal by sub24 section (b) of the authorities in section 106A and 

25 106B of the Agricultural Act of 1949 for the estab-
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1 lishment of tobacco no net cost funds and accounts, 

2 respectively—

3 (A) any obligation of a tobacco producer, 

4 purchaser, or importer to make payments into 

5 any such fund or account also shall terminate; 

6 and 

7 (B) any monies in any such fund or ac8 count shall be disposed of in the manner pre9 scribed by the Secretary of Agriculture, except 

10 that—

11 (i) to the extent needed, such monies 

12 shall be applied or used for the purposes 

13 therefor prescribed by such sections; and 

14 (ii) if any monies remain, the Sec15 retary shall transfer such monies to the 

16 Secretary of Health and Human Services 

17 for use in accordance with section 402. 

18 (g) APPLICATION OF AMENDMENTS.—This section 

19 and the amendments made by this section shall apply with 

20 respect to the 2004 and subsequent tobacco crops. 

21 SEC. 103. GEOGRAPHICAL RESTRICTIONS ON EXPANSION 

22 OF TOBACCO PRODUCTION. 

23 (a) PURPOSE.—The purpose of this section is to pro24 vide an orderly economic transition away from the mar25 keting of tobacco based on quotas and price support while 
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1 also addressing the economic dislocation, and the resulting 

2 impact on interstate commerce, that the termination of the 

3 current tobacco program might cause in certain commu4 nities. 

5 (b) PENALTY APPLICABLE TO TOBACCO GROWN IN

6 NONQUOTA COUNTIES AND STATES.—The marketing of 

7 tobacco in the 2004 or subsequent marketing years, of a 

8 kind of tobacco that was subject to a marketing quota in 

9 the 2003 marketing year, shall be subject to a penalty 

10 equal to 100 percent of the total amount received on the 

11 marketing of the tobacco unless the tobacco was grown 

12 in any county in which such kind of tobacco was grown 

13 pursuant to a marketing quota in the 2003 marketing 

14 year. 

15 (c) DEFINITIONS.—In this section: 

16 (1) The term ‘‘marketing year’’ means July 1 

17 to June 30 for flue-cured tobacco and October 1 to 

18 September 30 for all other kinds of tobacco. 

19 (2) The term ‘‘marketing quota in the 2003 

20 marketing year’’ means a quota established for that 

21 year pursuant to part I of subtitle B of title III of 

22 the Agricultural Adjustment Act of 1938 (7 U.S.C. 

23 1311 et seq.) and related provisions, as in effect for 

24 that marketing year. 
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1 SEC. 104. CONTINUED AVAILABILITY OF FEDERAL CROP IN2 SURANCE. 

3 Nothing in this title shall be construed to affect the 

4 eligibility of tobacco producers to obtain crop insurance 

5 for their crops pursuant to the Federal Crop Insurance 

6 Act (7 U.S.C. 1501 et seq.) under the terms of such Act. 

7 TITLE II—PAYMENTS TO TO8 BACCO QUOTA HOLDERS AND 

9 PRODUCERS 

10 SEC. 201. DEFINITIONS. 

11 In this title: 

12 (1) The term ‘‘active producer of quota to13 bacco’’ means a person that was the actual pro14 ducer, as determined by the Secretary, of tobacco 

15 marketed under a marketing quota for the 2001 to16 bacco marketing year. 

17 (2) The term ‘‘quota tobacco’’ means a kind of 

18 tobacco that is subject to farm marketing quotas or 

19 farm acreage allotments for the 1999, 2000, 2001, 

20 and 2002 tobacco marketing years under a mar21 keting quota or allotment program established under 

22 part I of subtitle B of title III of the Agricultural 

23 Adjustment Act of 1938 (7 U.S.C. 1281 et seq.). 

24 (3) The term ‘‘Secretary’’ means the Secretary 

25 of Agriculture. 
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1 (4) The term ‘‘tobacco quota holder’’ means an 

2 owner of a farm on January 1, 2002, for which a 

3 tobacco farm marketing quota or farm acreage allot4 ment for quota tobacco was established with respect 

5 to the 2002 tobacco marketing year under a mar6 keting quota program established under part I of 

7 subtitle B of title III of the Agricultural Adjustment 

8 Act of 1938. 

9 SEC. 202. PAYMENTS TO TOBACCO QUOTA HOLDERS. 

10 (a) PAYMENT REQUIRED.—The Secretary shall make 

11 payments to each eligible tobacco quota holder for the ter12 mination of tobacco marketing quotas and related price 

13 support under title I, which shall constitute full and fair 

14 compensation for any losses relating to such termination. 

15 (b) ELIGIBILITY.—To be eligible to receive a payment 

16 under this section, a person shall submit to the Secretary 

17 an application containing such information as the Sec18 retary may require to demonstrate to the satisfaction of 

19 the Secretary that the person satisfies the definition of 

20 tobacco quota holder. The application shall be submitted 

21 within such time, in such form, and in such manner as 

22 the Secretary may require. 

23 (c) BASE QUOTA LEVEL.—
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1 (1) IN GENERAL.—The Secretary shall establish 

2 a base quota level applicable to each eligible tobacco 

3 quota holder, as determined under subsection (b). 

4 (2) POUNDAGE QUOTAS.—For each kind of to5 bacco for which the marketing quota is expressed in 

6 pounds, the base quota level for each tobacco quota 

7 holder shall be equal to the basic tobacco marketing 

8 quota under the Agriculture Adjustment Act of 1938 

9 for the 1998 marketing year for quota tobacco on 

10 the farm owned by the tobacco quota holder. 

11 (3) MARKETING QUOTAS OTHER THAN POUND12 AGE QUOTAS.—For each kind of tobacco for which 

13 there is marketing quota or allotment on an acreage 

14 basis, the base quota level for each tobacco quota 

15 holder shall be the amount equal to the product ob16 tained by multiplying—

17 (A) the basic tobacco farm marketing 

18 quota or allotment for the 1998 marketing year 

19 established by the Secretary for quota tobacco 

20 on the farm owned by the tobacco quota holder; 

21 by 

22 (B) the average county production yield 

23 per acre for the county in which the farm is lo24 cated for the kind of tobacco for the 1998 mar25 keting year. 
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1 (d) PAYMENT.—The Secretary shall make payments 

2 to each eligible tobacco quota holder, as determined under 

3 subsection (b), in a total amount equal to the product ob4 tained by multiplying—

5 (1) $8 per pound; by 

6 (2) the base quota level established for the 

7 quota holder under subsection (c). 

8 (e) TIME FOR PAYMENT.—The payments to eligible 

9 tobacco quota holders required under this section shall be 

10 made in five equal installments during fiscal years 2004, 

11 2005, 2006, 2007, and 2008. 

12 (f) RESOLUTION OF DISPUTES.—Any dispute regard13 ing the eligibility of a person to receive a payment under 

14 this section, or the amount of the payment, shall be re15 solved by the county committee established under section 

16 8 of the Soil Conservation and Domestic Allotment Act 

17 (16 U.S.C. 590h) for the county or other area in which 

18 the farm owned by the person is located. 

19 (g) COMMODITY CREDIT CORPORATION.—The Sec20 retary shall use the funds, facilities and authorities of the 

21 Commodity Credit Corporation to carry out this section. 
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1 SEC. 203. TRANSITION PAYMENTS FOR ACTIVE PRODUCERS 

2 OF QUOTA TOBACCO. 

3 (a) TRANSITION PAYMENTS REQUIRED.—The Sec4 retary shall make transition payments under this section 

5 to eligible active producers of quota tobacco. 

6 (b) ELIGIBILITY.—To be eligible to receive a transi7 tion payment under this section, a person shall submit to 

8 the Secretary an application containing such information 

9 as the Secretary may require to demonstrate to the satis10 faction of the Secretary that the person satisfies the defi11 nition of active producer of quota tobacco. The application 

12 shall be submitted within such time, in such form, and 

13 in such manner as the Secretary may require. 

14 (c) PRODUCTION BASE.—The Secretary shall estab15 lish a production base applicable to each eligible active 

16 producer of quota tobacco, as determined under subsection 

17 (b). A producer’s production base shall be equal to the 

18 quantity, in pounds, of quota tobacco subject to the basic 

19 marketing quota produced and marketed by the producer 

20 under the Agriculture Adjustment Act of 1938 for the 

21 2001 marketing year. 

22 (d) PAYMENT.—The Secretary shall make payments 

23 to each eligible active producer of quota tobacco, as deter24 mined under subsection (b), in a total amount equal to 

25 the product obtained by multiplying—

26 (1) $4 per pound; by 
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1 (2) the production base established for the ac2 tive producer under subsection (c). 

3 (e) TIME FOR PAYMENT.—The payments to eligible 

4 active producers of quota tobacco required under this sec5 tion shall be made in five equal installments during fiscal 

6 years 2004, 2005, 2006, 2007, and 2008. 

7 (f) RESOLUTION OF DISPUTES.—Any dispute regard8 ing the eligibility of a person to receive a payment under 

9 this section, or the amount of the payment, shall be re10 solved by the county committee established under section 

11 8 of the Soil Conservation and Domestic Allotment Act 

12 (16 U.S.C. 590h) for the county or other area in which 

13 the farming operation of the person is located. 

14 (g) COMMODITY CREDIT CORPORATION.—The Sec15 retary shall use the funds, facilities and authorities of the 

16 Commodity Credit Corporation to carry out this section. 

17 TITLE III—TOBACCO QUALITY 

18 BOARD 

19 SEC. 301. ESTABLISHMENT OF BOARD. 

20 The Secretary of Agriculture (in this title referred to 

21 as the ‘‘Secretary’’) shall establish a permanent advisory 

22 board within the Department of Agriculture to be known 

23 as the Tobacco Quality Board (in this title referred to as 

24 the ‘‘Board’’). 
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1 SEC. 302. MEMBERSHIP. 

2 (a) NOMINATION AND APPOINTMENT.—The Board 

3 shall consist of 11 members, of which five shall be ap4 pointed by the Secretary from nominations submitted by 

5 representatives of United States tobacco producers, five 

6 shall be appointed by the Secretary from nominations sub7 mitted by representatives of United States tobacco prod8 uct manufacturers, and one shall be an officer or employee 

9 of the Department of Agriculture appointed by the Sec10 retary (who shall serve as Chair of the Board). 

11 (b) TERMS.—

12 (1) CHAIR.—The Chair of the Board shall serve 

13 at the pleasure of the Secretary. 

14 (2) OTHER MEMBERS.—Other members of the 

15 Board shall serve for two-year terms, except that, 

16 for the first appointments to the Board, two pro17 ducer representatives and two manufacturer rep18 resentatives shall have initial terms of one year. 

19 SEC. 303. DUTIES. 

20 The Board shall be responsible for—

21 (1) determining and describing the physical 

22 characteristics of United States farm-produced to23 bacco and unmanufactured imported tobacco; 

24 (2) assembling and evaluating, in a systematic 

25 manner, concerns and problems with the quality of 

26 United States tobacco, expressed by domestic and
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1 foreign buyers and manufacturers of tobacco prod2 ucts; 

3 (3) reviewing data collected by Federal agencies 

4 on the physical and chemical integrity of United 

5 States produced and imported unmanufactured to6 bacco, to ensure that tobacco being used in domesti7 cally-manufactured tobacco products is of the high8 est quality and is free from prohibited physical and 

9 chemical agents; 

10 (4) investigating and communicating to the Sec11 retary—

12 (A) conditions with respect to the produc13 tion of tobacco that discourage improvements in 

14 the quality of United States produced tobacco; 

15 and 

16 (B) recommendations for regulatory 

17 changes that would address tobacco quality 

18 issues; and 

19 (5) such other related activities assigned to it 

20 by the Secretary. 

21 SEC. 304. ADMINISTRATIVE PROVISIONS. 

22 (a) STAFF.—The Secretary shall provide the Board 

23 with staff experienced in the sampling and analysis of un24 manufactured tobacco and capable of collecting data and 

25 monitoring tobacco production information, and such 
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1 other resources necessary for the Board to perform its du2 ties under this subtitle, as determined by the Secretary. 

3 (b) COMMODITY CREDIT CORPORATION.—The Sec4 retary shall use the funds, facilities and authorities of the 

5 Commodity Credit Corporation to carry out this title.

6 TITLE IV—TOBACCO PRODUCT 

7 MANUFACTURER AND IM8 PORTER USER FEES 

9 SEC. 401. USER FEE. 

10 (a) IN GENERAL.—The Secretary of Health and 

11 Human Services shall assess an annual user fee, cal12 culated in accordance with this section, upon each tobacco 

13 product manufacturer and tobacco product importer that 

14 sells tobacco products in domestic commerce in the United 

15 States. The assessments shall commence during calendar 

16 year 2004, based on domestic sales of tobacco products 

17 during fiscal year 2003. 

18 (b) BASE AMOUNT OF USER FEE FOR EACH CLASS

19 OF TOBACCO PRODUCT.—

20 (1) The base amount of the user fee for ciga21 rette manufacturers and importers shall be 

22 $2,116,252,000. 

23 (2) The base amount of the user fee for small 

24 cigar manufacturers and importers shall be 

25 $1,051,000. 
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1 (3) The base amount of the user fee for large 

2 cigar manufacturers and importers shall be 

3 $164,274,000. 

4 (4) The base amount of the user fee for snuff 

5 manufacturers and importers shall be $9,920,000. 

6 (5) The base amount of the user fee for chew7 ing tobacco manufacturers and importers shall be 

8 $2,275,000. 

9 (6) The base amount of the user fee for pipe to10 bacco manufacturers and importers shall be 

11 $1,505,000. 

12 (7) The base amount of the user fee for roll13 your-own tobacco manufacturers and importers shall 

14 be $3,231,000. 

15 (c) DETERMINATION OF ANNUAL USER FEE FOR

16 EACH CLASS OF TOBACCO PRODUCT.—The total user fee 

17 to be assessed upon, and paid by, the manufacturers and 

18 importers of each class of tobacco product in each calendar 

19 year, as allocated pursuant to subsection (d), shall be the 

20 base amount for that class of tobacco product provided 

21 in subsection (b) multiplied by a fraction—

22 (1) the numerator of which is the total volume 

23 of domestic sales of that class of tobacco product in 

24 the fiscal year ending on September 30 of that cal25 endar year; and 
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1 (2) the denominator of which is the total vol2 ume of domestic sales of that class of tobacco prod3 uct in fiscal year 2003. 

4 (d) ALLOCATION OF TOTAL USER FEE AMOUNTS BY

5 MARKET SHARE—

6 (1) FORMULA.—The user fee for each class of 

7 tobacco product to be paid by each manufacturer or 

8 importer of that class of tobacco product under sub9 section (a) shall be determined in each year by mul10 tiplying—

11 (A) such manufacturer’s or importer’s 

12 market share, as calculated with respect to the 

13 current calendar year, of that class of tobacco 

14 product; by 

15 (B) the total user fee amount for the cur16 rent calendar year, as determined under sub17 section (c), for that class of tobacco product. 

18 (2) MARKET SHARE DEFINED.—In this sub19 section, the term ‘‘market share’’ for each manufac20 turer or importer of a class of tobacco product for 

21 the purpose of the assessment to be calculated in the 

22 current calendar year shall be equal to that manu23 facturer’s or importer’s respective share (expressed 

24 as a decimal to the fourth place) of the total volume 

25 of domestic sales of that class of tobacco product 
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1 during the calendar year immediately preceding the 

2 year of such assessment. 

3 (e) DETERMINATION OF VOLUME OF DOMESTIC

4 SALES.—

5 (1) USE OF CERTIFIED MANUFACTURER AND

6 IMPORTER REPORTS.—The calculation of the volume 

7 of domestic sales of a class of tobacco product by a 

8 manufacturer or importer, and by all manufacturers 

9 and importers as a group, shall be made by the Sec10 retary of Health and Human Services based on cer11 tified reports submitted by such manufacturers and 

12 importers pursuant to subsection (f). 

13 (2) MEASUREMENT METHODS.—For purposes 

14 of the Secretary’s calculations under this subsection 

15 and the certifications under subsection (f), the vol16 umes of domestic sales shall be measured as follows: 

17 (A) With respect to cigarettes, in terms of 

18 the numbers of cigarettes sold. 

19 (B) With respect to small cigars, the num20 ber of cigars weighing not more than three 

21 pounds per thousand sold. 

22 (C) With respect to large cigars, the num23 ber of cigars weighing more than three pounds 

24 per thousand sold.
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1 (D) With respect to other classes of to2 bacco products, in terms of the number of 

3 pounds, or fraction thereof, of these tobacco 

4 products sold. 

5 (f) CERTIFICATION OF VOLUME OF DOMESTIC

6 SALES.—Every manufacturer and importer of tobacco 

7 products shall submit each year a certified report to the 

8 Secretary of Health and Human Services setting forth for 

9 each class of tobacco products the total, for the prior year, 

10 of such manufacturer’s or importer’s domestic sales to 

11 wholesalers and retailers and directly to consumers. These 

12 certified reports must be submitted to the Secretary not 

13 later than March 1 of the year after the year for which 

14 the certified report is being made. 

15 SEC. 402. ALLOCATION OF USER FEES. 

16 (a) IN GENERAL.—The user fees collected pursuant 

17 to section 401 and any funds transferred to the Secretary 

18 of Health and Human Services by the Secretary of Agri19 culture pursuant to section 102(f)(3)(B)(ii) shall be avail20 able, without further appropriation, in accordance with, 

21 and for the purposes described, by this section. All such 

22 funds shall remain available until expended. 

23 (b) FUNDING FOR FDA REGULATION OF TOBACCO

24 PRODUCTS.—The Secretary of Health and Human Serv25 ices shall make 15 percent of the user fee amounts col-
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1 lected pursuant to section 401 each year available to the 

2 Food and Drug Administration for the regulation of to3 bacco products under chapter IX of the Federal Food, 

4 Drug, and Cosmetic Act. 

5 (c) FUNDING FOR OTHER TOBACCO-RELATED PRO6 GRAMS.—

7 (1) TITLE II EXPENDITURES.—The Secretary 

8 of Health and Human Services shall use the remain9 ing 85 percent of the user fee amounts collected 

10 each year pursuant to section 401, and any amounts 

11 transferred to the Secretary by the Secretary of Ag12 riculture pursuant to section 102(f)(3)(B)(ii), to re13 imburse the Commodity Credit Corporation for the 

14 expenditures made by that agency under title II of 

15 this Act. 

16 (2) OTHER TOBACCO-RELATED PROGRAM.—If 

17 amounts remain available for any year after making 

18 the reimbursement required under paragraph (1), 

19 the Secretary of Health and Human Services shall 

20 use the remaining amounts to fund any other pro21 gram that relates to tobacco products.

22 TITLE V—FDA REGULATION OF 

23 TOBACCO PRODUCTS 

24 SEC. 501. FINDINGS. 

25 The Congress finds the following: 
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1 (1) The use of tobacco products by the Nation’s 

2 children is a pediatric disease of epic proportions 

3 that results in new generations of tobacco-dependent 

4 children and adults. 

5 (2) A consensus exists within the scientific and 

6 medical communities that tobacco products are in7 herently dangerous and cause cancer, heart disease, 

8 and other serious adverse health effects. 

9 (3) Nicotine is addictive. 

10 (4) Virtually all new users of tobacco products 

11 are under the minimum legal age to purchase such 

12 products. 

13 (5) Tobacco advertising and marketing con14 tribute significantly to the use of nicotine-containing 

15 tobacco products by adolescents. 

16 (6) Because past efforts to restrict advertising 

17 and marketing of tobacco products have failed ade18 quately to curb tobacco use by adolescents, com19 prehensive restrictions on the sale, promotion, and 

20 distribution of such products are needed. 

21 (7) Federal and State governments have lacked 

22 the legal and regulatory authority and resources 

23 they need to address comprehensively the public 

24 health and societal problems caused by the use of to25 bacco products. 
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1 (8) Federal and State public health officials, 

2 the public health community, and the public at large 

3 recognize that the tobacco industry should be subject 

4 to ongoing oversight. 

5 (9) Under article I, section 8 of the Constitu6 tion, the Congress is vested with the responsibility 

7 for regulating interstate commerce and commerce 

8 with Indian tribes. 

9 (10) The sale, distribution, marketing, adver10 tising, and use of tobacco products are activities in 

11 and substantially affecting interstate commerce be12 cause they are sold, marketed, advertised, and dis13 tributed in interstate commerce on a nationwide 

14 basis, and have a substantial effect on the Nation’s 

15 economy. 

16 (11) The sale, distribution, marketing, adver17 tising, and use of such products substantially affect 

18 interstate commerce through the health care and 

19 other costs attributable to the use of tobacco prod20 ucts. 

21 (12) It is in the public interest for Congress to 

22 adopt comprehensive public health legislation be23 cause of tobacco’s unique position in the Nation’s 

24 history and economy and the need to prevent the 

25 sale, distribution, marketing and advertising of to-
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1 bacco products to persons under the minimum legal 

2 age to purchase such products. 

3 (13) The public interest requires a timely, fair, 

4 equitable, and consistent result that will serve the 

5 public interest by restricting throughout the Nation 

6 the sale, distribution, marketing, and advertising of 

7 tobacco products only to persons of legal age to pur8 chase such products. 

9 (14) Public health authorities estimate that the 

10 benefits to the Nation of enacting Federal legislation 

11 to accomplish these goals would be significant in 

12 human and economic terms. 

13 (15) Reducing the use of tobacco by minors by 

14 50 percent would prevent well over 60,000 early 

15 deaths each year and save up to $43 billion each 

16 year in reduced medical costs, improved productivity, 

17 and the avoidance of premature deaths. 

18 (16) Advertising, marketing, and promotion of 

19 tobacco products have been especially directed to at20 tract young persons to use tobacco products and 

21 these efforts have resulted in increased use of such 

22 products by youth. Past efforts to oversee these ac23 tivities have not been successful in adequately pre24 venting such increased use.
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1 (17) Tobacco advertising increases the size of 

2 the tobacco market by increasing consumption of to3 bacco products including increasing tobacco use by 

4 young people. 

5 (18) Children are more influenced by tobacco 

6 advertising than adults and they smoke the most ad7 vertised brands. 

8 (19) Tobacco company documents indicate that 

9 young people are an important and often crucial seg10 ment of the tobacco market. 

11 (20) Advertising restrictions will have a positive 

12 effect on the smoking rates of young people. 

13 (21) Restrictions on advertising are necessary 

14 to prevent unrestricted tobacco advertising from un15 dermining legislation prohibiting access to young 

16 people. 

17 (22) It is in the public interest for Congress to 

18 adopt legislation to address the public health crisis 

19 created by actions of the tobacco industry.

20 SEC. 502. DEFINITIONS. 

21 (a) FEDERAL CIGARETTE LABELING AND ADVER22 TISING ACT.—Section 3(1) of the Federal Cigarette La23 beling and Advertising Act is amended—

24 (1) in subparagraph (A) by striking ‘‘and’’; 
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1 (2) in subparagraph (B) by striking the period 

2 and inserting ‘‘; and’’; and 

3 (3) by inserting the following new subparagraph 

4 at the end thereof: 

5 ‘‘(C) any tobacco product, in any form, in6 cluding bidis and kreteks, if the tobacco in the 

7 product is heated or burned and is functional in 

8 the product, and the product, because of its ap9 pearance, the type of tobacco used in the filler, 

10 or its packaging and labeling, is likely to be of11 fered to, or purchased by, consumers as a ciga12 rette or as roll-your-own tobacco.’’. 

13 (b) THIS TITLE.—In this title: 

14 (1) BRAND.—The term ‘‘brand’’ means a vari15 ety of tobacco product distinguished by the tobacco 

16 used, tar content, nicotine content, flavoring used, 

17 size, filtration, or packaging, logo, registered trade18 mark or brand name, identifiable pattern of colors, 

19 or any combination of such attributes.

20 (2) CIGARETTE.—The term ‘‘cigarette’’ has the 

21 meaning given that term by section 3(1) of the Fed22 eral Cigarette Labeling and Advertising Act (15 

23 U.S.C. 1332(1)). 

24 (3) CIGARETTE TOBACCO.—The term ‘‘cigarette 

25 tobacco’’ means any product that consists of loose 
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1 tobacco that is intended for use by consumers in a 

2 cigarette. Unless otherwise stated, the requirements 

3 for cigarettes shall also apply to cigarette tobacco. 

4 (4) COMMERCE.—The term ‘‘commerce’’ has 

5 the meaning given that term by section 3(2) of the 

6 Federal Cigarette Labeling and Advertising Act (15 

7 U.S.C. 1332(2)). 

8 (5) CONSTITUENT.—The term ‘‘constituent’’ in 

9 relation to cigarettes means any element of main10 stream or sidestream smoke. 

11 (6) DISTRIBUTOR.—The term ‘‘distributor’’ as 

12 regards a tobacco product means any person who 

13 furthers the distribution of cigarette or smokeless to14 bacco, whether domestic or imported, at any point 

15 from the original place of manufacture to the person 

16 who sells or distributes the product to individuals for 

17 personal consumption. Common carriers are not con18 sidered distributors for purposes of this title. 

19 (7) INGREDIENT.—The term ‘‘ingredient’’ in 

20 relation to cigarettes or smokeless tobacco products 

21 means any substance, chemical, or compound (other

22 than tobacco, water, or reconstituted tobacco sheet 

23 made wholly from tobacco) added, or specified for 

24 addition, by the manufacturer to the tobacco, paper, 

25 or filter of a cigarette, or to the tobacco of a smoke-
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1 less tobacco product, including flavorants, processing 

2 aids, casing sauces, preservatives, and combustion 

3 modifiers. 

4 (8) MANUFACTURER.—The term ‘‘manufac5 turer’’ means any person who manufactures tobacco 

6 products intended to be sold in the United States. 

7 The term ‘‘manufacturer’’ shall include an importer 

8 or other first purchaser for resale in the United 

9 States of tobacco products manufactured outside of 

10 the United States or tobacco products manufactured 

11 in the United States but not intended for sale in the 

12 United States. 

13 (9) NICOTINE.—The term ‘‘nicotine’’ means the 

14 chemical substance named 3-(1-Methyl-2-

15 pyrrolidinyl) pyridine or C[10]H[14]N[2], including 

16 any salt or complex of nicotine. 

17 (10) PACKAGE.—The term ‘‘package’’ means a 

18 pack, box, carton, or container of any kind or, if no 

19 other container, any wrapping (including cello20 phane), in which cigarettes or smokeless tobacco are 

21 offered for sale, sold, or otherwise distributed to con22 sumers. 

23 (11) RETAILER.—The term ‘‘retailer’’ means 

24 any person who sells cigarettes or smokeless tobacco 

25 to individuals for personal consumption, or who op-
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1 erates a facility where self-service displays of tobacco 

2 products are permitted. 

3 (12) SECRETARY.—Except where the context 

4 otherwise requires, the term ‘‘Secretary’’ means the 

5 Secretary of Health and Human Services. 

6 (13) SMOKELESS TOBACCO.—The term ‘‘smoke7 less tobacco’’ means any product that consists of 

8 cut, ground, powdered, or leaf tobacco and that is 

9 intended to be placed in the oral or nasal cavity. 

10 SEC. 503. AMENDMENT OF FEDERAL FOOD, DRUG, AND 

11 COSMETIC ACT. 

12 (a) DEFINITION.—Section 201 of the Federal Food, 

13 Drug, and Cosmetic Act (21 U.S.C. 321) is amended by 

14 adding at the end the following: 

15 ‘‘(nn) The term ‘tobacco product’ means any 

16 product made or derived from tobacco that is in17 tended for human consumption, including any com18 ponent, part, or accessory of a tobacco product (ex19 cept for raw materials other than tobacco used in 

20 manufacturing a component, part, or accessory of a 

21 tobacco product). 

22 ‘‘(ll) The definitions contained in section 502 of 

23 the Tobacco Livelihood and Economic Assistance for 

24 our Farmers Act of 2002 shall apply with respect to 

25 chapter IX.’’.
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1 (b) FDA AUTHORITY OVER TOBACCO PRODUCTS.—

2 The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 301 et seq.) is amended—

4 (1) by redesignating chapter IX as chapter X; 

5 (2) by redesignating sections 901 through 907 

6 as sections 1001 through 1007; and 

7 (3) by inserting after chapter VIII the fol8 lowing: 

9 ‘‘CHAPTER IX—TOBACCO 

10 PRODUCTS 

11 ‘‘SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS. 

12 ‘‘(a) IN GENERAL.—Tobacco products shall be regu13 lated by the Secretary under this chapter and shall not 

14 be subject to the provisions of chapter V, unless—

15 ‘‘(1) such products are intended for use in the 

16 diagnosis, cure, mitigation, treatment, or prevention 

17 of disease (within the meaning of section 

18 201(g)(1)(B) or section 201(h)(2)); or 

19 ‘‘(2) a health claim is made for such products 

20 under section 201(g)(1)(C) or 201(h)(3), unless the 

21 product is a reduced risk product pursuant to sec22 tion 912. 

23 ‘‘(b) APPLICABILITY.—This chapter shall apply to all 

24 tobacco products subject to the provisions of part 897 of 

25 title 21, Code of Federal Regulations, and to any other 
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1 tobacco products that the Secretary by regulation deems 

2 to be subject to this chapter. 

3 ‘‘(c) SCOPE.—

4 ‘‘(1) Nothing in this chapter shall be construed 

5 to affect the Secretary’s authority over, or the regu6 lation of, products under this Act that are not to7 bacco products under chapter V or any other chap8 ter of this Act. 

9 ‘‘(2) The provisions of this chapter shall not 

10 apply to tobacco leaf that is not in the possession of 

11 the manufacturer, or to the producers of tobacco 

12 leaf, including tobacco growers, tobacco warehouses, 

13 and tobacco grower cooperatives, nor shall any em14 ployee of the Food and Drug Administration have 

15 any authority whatsoever to enter onto a farm 

16 owned by a producer of tobacco leaf without the 

17 written consent of such producer. Notwithstanding 

18 any other provision of this subparagraph, if a pro19 ducer of tobacco leaf is also a tobacco product man20 ufacturer or controlled by a tobacco product manu21 facturer, the producer shall be subject to this chap22 ter in the producer’s capacity as a manufacturer. 

23 Nothing in this chapter shall be construed to grant 

24 the Secretary authority to promulgate regulations on 

25 any matter that involves the production of tobacco 
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1 leaf or a producer thereof, other than activities by 

2 a manufacturer affecting production. For purposes 

3 of the preceding sentence, the term ‘controlled by’ 

4 means a member of the same controlled group of 

5 corporations as that term is used in section 52(a) of 

6 the Internal Revenue Code of 1986, or under com7 mon control within the meaning of the regulations 

8 promulgated under section 52(b) of such Code. 

9 ‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS. 

10 ‘‘A tobacco product shall be deemed to be adulterated 

11 if—

12 ‘‘(1) it consists in whole or in part of any filthy, 

13 putrid, or decomposed substance, or is otherwise 

14 contaminated by any poisonous or deleterious sub15 stance that may render the product more injurious 

16 to health; 

17 ‘‘(2) it has been prepared, packed, or held 

18 under insanitary conditions whereby it may have 

19 been contaminated with filth, or whereby it may 

20 have been rendered more injurious to health; 

21 ‘‘(3) its container is composed, in whole or in 

22 part, of any poisonous or deleterious substance 

23 which may render the contents more injurious to 

24 health; 
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1 ‘‘(4) it is, or purports to be or is represented 

2 as, a tobacco product which is subject to a perform3 ance standard established under section 907 unless 

4 such tobacco product is in all respects in conformity 

5 with such standard; 

6 ‘‘(5) it is required by section 910(a) to have 

7 premarket approval, is not exempt under section 

8 906(f), and does not have an approved application in 

9 effect; 

10 ‘‘(6) the methods used in, or the facilities or 

11 controls used for, its manufacture, packing or stor12 age are not in conformity with applicable require13 ments under section 906(e)(1) or an applicable con14 dition prescribed by an order under section 

15 906(e)(2); or 

16 ‘‘(7) it is a tobacco product for which an ex17 emption has been granted under section 906(f) for 

18 investigational use and the person who was granted 

19 such exemption or any investigator who uses such

20 tobacco product under such exemption fails to com21 ply with a requirement prescribed by or under such 

22 section. 

23 ‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS. 

24 ‘‘(a) IN GENERAL.—A tobacco product shall be 

25 deemed to be misbranded—
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1 ‘‘(1) if its labeling is false or misleading in any 

2 particular; 

3 ‘‘(2) if in package form unless it bears a label 

4 containing—

5 ‘‘(A) the name and place of business of the 

6 tobacco product manufacturer, packer, or dis7 tributor; and 

8 ‘‘(B) an accurate statement of the quantity 

9 of the contents in terms of weight, measure, or 

10 numerical count, 

11 except that under subparagraph (B) of this para12 graph reasonable variations shall be permitted, and 

13 exemptions as to small packages shall be established, 

14 by regulations prescribed by the Secretary; 

15 ‘‘(3) if any word, statement, or other informa16 tion required by or under authority of this chapter 

17 to appear on the label or labeling is not prominently 

18 placed thereon with such conspicuousness (as com19 pared with other words, statements or designs in the 

20 labeling) and in such terms as to render it likely to 

21 be read and understood by the ordinary individual 

22 under customary conditions of purchase and use; 

23 ‘‘(4) if it has an established name, unless its 

24 label bears, to the exclusion of any other nonpropri25 etary name, its established name prominently print-
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1 ed in type as required by the Secretary by regula2 tion; 

3 ‘‘(5) if the Secretary has issued regulations re4 quiring that its labeling bear adequate directions for 

5 use, or adequate warnings against use by children, 

6 that are necessary for the protection of users unless 

7 its labeling conforms in all respects to such regula8 tions; 

9 ‘‘(6) if it was manufactured, prepared, propa10 gated, compounded, or processed in any State in an 

11 establishment not duly registered under section 

12 905(b), if it was not included in a list required by 

13 section 905(i), if a notice or other information re14 specting it was not provided as required by such sec15 tion or section 905(j), or if it does not bear such 

16 symbols from the uniform system for identification 

17 of tobacco products prescribed under section 905(e) 

18 as the Secretary by regulation requires;

19 ‘‘(7) if, in the case of any tobacco product dis20 tributed or offered for sale in any State—

21 ‘‘(A) its advertising is false or misleading 

22 in any particular; or 

23 ‘‘(B) it is sold, distributed, advertised, or 

24 promoted in violation of section 915 or regula25 tions prescribed under section 906(d); 
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1 ‘‘(8) unless, in the case of any tobacco product 

2 distributed or offered for sale in any State, the man3 ufacturer, packer, or distributor thereof includes in 

4 all advertisements and other descriptive printed mat5 ter issued or caused to be issued by the manufac6 turer, packer, or distributor with respect to that to7 bacco product—

8 ‘‘(A) a true statement of the tobacco prod9 uct’s established name as defined in paragraph 

10 (4) of this subsection, printed prominently; and 

11 ‘‘(B) a brief statement of—

12 ‘‘(i) the uses of the tobacco product 

13 and relevant warnings, precautions, side 

14 effects, and contraindications; and 

15 ‘‘(ii) in the case of specific tobacco 

16 products made subject to a finding by the 

17 Secretary after notice and opportunity for 

18 comment that such action is necessary to 

19 protect the public health, a full description 

20 of the components of such tobacco product 

21 or the formula showing quantitatively each 

22 ingredient of such tobacco product to the 

23 extent required in regulations which shall 

24 be issued by the Secretary after an oppor25 tunity for a hearing; 
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1 ‘‘(9) unless, in the case of any tobacco product 

2 distributed or offered for sale in any State, the man3 ufacturer, packer, or distributor thereof includes in 

4 all advertisements the information required by sec5 tion 916(c); 

6 ‘‘(10) if it is a tobacco product subject to a per7 formance standard established under section 907, 

8 unless it bears such labeling as may be prescribed in 

9 such performance standard; or 

10 ‘‘(11) if there was a failure or refusal—

11 ‘‘(A) to comply with any requirement pre12 scribed under section 904 or 908; or 

13 ‘‘(B) to furnish any material or informa14 tion required by or under section 909. 

15 ‘‘(b) PRIOR APPROVAL OF STATEMENTS ON

16 LABEL.—The Secretary may, by regulation, require prior 

17 approval of statements made on the label of a tobacco 

18 product. No regulation issued under this subsection may 

19 require prior approval by the Secretary of the content of 

20 any advertisement and no advertisement of a tobacco 

21 product, published after the date of enactment of this 

22 chapter shall, with respect to the matters specified in this 

23 section or covered by regulations issued hereunder, be sub24 ject to the provisions of sections 12 through 15 of the Fed25 eral Trade Commission Act (15 U.S.C. 52 through 55). 
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1 This subsection does not apply to any printed matter 

2 which the Secretary determines to be labeling as defined 

3 in section 201(m). 

4 ‘‘SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE 

5 SECRETARY. 

6 ‘‘(a) REQUIREMENT.—Not later than 6 months after 

7 the date of enactment of this chapter, each tobacco prod8 uct manufacturer or importer of tobacco products, or 

9 agents thereof, shall submit to the Secretary the following 

10 information: 

11 ‘‘(1) A listing of all tobacco ingredients, sub12 stances and compounds that are, on such date, 

13 added by the manufacturer to the tobacco, paper, fil14 ter, or other component of each tobacco product by 

15 brand and by quantity in each brand and subbrand. 

16 ‘‘(2) A description of the content, delivery, and 

17 form of nicotine in each tobacco product measured 

18 in milligrams of nicotine. 

19 ‘‘(3) All documents (including underlying sci20 entific information) relating to research activities, 

21 and research findings, conducted, supported, or pos22 sessed by the manufacturer (or agents thereof) on 

23 the health, behavioral, or physiologic effects of to24 bacco products, their constituents, ingredients, and
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1 components, and tobacco additives, described in 

2 paragraph (1). 

3 ‘‘(4) All documents (including underlying sci4 entific information) relating to research activities, 

5 and research findings, conducted, supported, or pos6 sessed by the manufacturer (or agents thereof) that 

7 relate to the issue of whether a reduction in risk to 

8 health from tobacco products can occur upon the 

9 employment of technology available or known to the 

10 manufacturer. 

11 ‘‘(5) All documents (including underlying sci12 entific information) relating to marketing research 

13 involving the use of tobacco products. 

14 An importer of a tobacco product not manufactured in the 

15 United States shall supply the information required of a 

16 tobacco product manufacturer under this subsection. 

17 ‘‘(b) ANNUAL SUBMISSION.—A tobacco product man18 ufacturer or importer that is required to submit informa19 tion under subsection (a) shall update such information

20 on an annual basis under a schedule determined by the 

21 Secretary. 

22 ‘‘(c) TIME FOR SUBMISSION.—

23 ‘‘(1) NEW PRODUCTS.—At least 90 days prior 

24 to the delivery for introduction into interstate com25 merce of a tobacco product not on the market on the 
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1 date of enactment of this chapter, the manufacturer 

2 of such product shall provide the information re3 quired under subsection (a) and such product shall 

4 be subject to the annual submission under sub5 section (b).

6 ‘‘(2) MODIFICATION OF EXISTING PRODUCTS.—

7 If at any time a tobacco product manufacturer adds 

8 to its tobacco products a new tobacco additive, in9 creases or decreases the quantity of an existing to10 bacco additive or the nicotine content, delivery, or 

11 form, or eliminates a tobacco additive from any to12 bacco product, the manufacturer shall within 60 

13 days of such action so advise the Secretary in writ14 ing and reference such modification in submissions 

15 made under subsection (b). 

16 ‘‘SEC. 905. ANNUAL REGISTRATION. 

17 ‘‘(a) DEFINITIONS.—As used in this section—

18 ‘‘(1) consistent with the provisions of section 

19 901(c)(2), the term ‘manufacture, preparation,

20 compounding, or processing’ shall include repack21 aging or otherwise changing the container, wrapper, 

22 or labeling of any tobacco product package in fur23 therance of the distribution of the tobacco product 

24 from the original place of manufacture to the person
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1 who makes final delivery or sale to the ultimate con2 sumer or user; and 

3 ‘‘(2) the term ‘name’ shall include in the case 

4 of a partnership the name of each partner and, in 

5 the case of a corporation, the name of each cor6 porate officer and director, and the State of incorpo7 ration. 

8 ‘‘(b) REGISTRATION BY OWNERS AND OPERATORS.—

9 On or before December 31 of each year every person who 

10 owns or operates any establishment in any State engaged 

11 in the manufacture, preparation, compounding, or proc12 essing of a tobacco product or tobacco products shall reg13 ister with the Secretary the name, places of business, and 

14 all such establishments of that person. 

15 ‘‘(c) REGISTRATION OF NEW OWNERS AND OPERA16 TORS.—Every person upon first engaging in the manufac17 ture, preparation, compounding, or processing of a tobacco 

18 product or tobacco products in any establishment owned 

19 or operated in any State by that person shall immediately 

20 register with the Secretary that person’s name, place of 

21 business, and such establishment. 

22 ‘‘(d) REGISTRATION OF ADDED ESTABLISHMENTS.—

23 Every person required to register under subsection (b) or 

24 (c) shall immediately register with the Secretary any addi25 tional establishment which that person owns or operates 
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1 in any State and in which that person begins the manufac2 ture, preparation, compounding, or processing of a tobacco 

3 product or tobacco products. 

4 ‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYS5 TEM.—The Secretary may by regulation prescribe a uni6 form system for the identification of tobacco products and 

7 may require that persons who are required to list such 

8 tobacco products under subsection (i) of this section shall 

9 list such tobacco products in accordance with such system. 

10 ‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA11 TION.—The Secretary shall make available for inspection, 

12 to any person so requesting, any registration filed under 

13 this section. 

14 ‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB15 LISHMENTS.—Every establishment in any State registered 

16 with the Secretary under this section shall be subject to 

17 inspection under section 704, and every such establish18 ment engaged in the manufacture, compounding, or proc19 essing of a tobacco product or tobacco products shall be 

20 so inspected by one or more officers or employees duly 

21 designated by the Secretary at least once in the 2-year 

22 period beginning with the date of registration of such es23 tablishment under this section and at least once in every 

24 successive 2-year period thereafter. 
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1 ‘‘(h) FOREIGN ESTABLISHMENTS MAY REGISTER.—

2 Any establishment within any foreign country engaged in 

3 the manufacture, preparation, compounding, or processing 

4 of a tobacco product or tobacco products, may register 

5 under this section under regulations promulgated by the 

6 Secretary. Such regulations shall require such establish7 ment to provide the information required by subsection (i) 

8 of this section and shall include provisions for registration 

9 of any such establishment upon condition that adequate 

10 and effective means are available, by arrangement with the 

11 government of such foreign country or otherwise, to enable 

12 the Secretary to determine from time to time whether to13 bacco products manufactured, prepared, compounded, or 

14 processed in such establishment, if imported or offered for 

15 import into the United States, shall be refused admission 

16 on any of the grounds set forth in section 801(a). 

17 ‘‘(i) REGISTRATION INFORMATION.—

18 ‘‘(1) PRODUCT LIST.—Every person who reg19 isters with the Secretary under subsection (b), (c), 

20 or (d) of this section shall, at the time of registra21 tion under any such subsection, file with the Sec22 retary a list of all tobacco products which are being 

23 manufactured, prepared, compounded, or processed 

24 by that person for commercial distribution and 

25 which has not been included in any list of tobacco
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1 products filed by that person with the Secretary 

2 under this paragraph or paragraph (2) before such 

3 time of registration. Such list shall be prepared in 

4 such form and manner as the Secretary may pre5 scribe and shall be accompanied by—

6 ‘‘(A) in the case of a tobacco product con7 tained in the applicable list with respect to 

8 which a performance standard has been estab9 lished under section 907 or which is subject to 

10 section 910, a reference to the authority for the 

11 marketing of such tobacco product and a copy 

12 of all labeling for such tobacco product; 

13 ‘‘(B) in the case of any other tobacco prod14 uct contained in an applicable list, a copy of all 

15 consumer information and other labeling for 

16 such tobacco product, a representative sampling 

17 of advertisements for such tobacco product, 

18 and, upon request made by the Secretary for 

19 good cause, a copy of all advertisements for a 

20 particular tobacco product; and 

21 ‘‘(C) if the registrant filing a list has de22 termined that a tobacco product contained in 

23 such list is not subject to a performance stand24 ard established under section 907, a brief state25 ment of the basis upon which the registrant 
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1 made such determination if the Secretary re2 quests such a statement with respect to that 

3 particular tobacco product. 

4 ‘‘(2) BIANNUAL REPORT OF ANY CHANGE IN

5 PRODUCT LIST.—Each person who registers with the

6 Secretary under this section shall report to the Sec7 retary once during the month of June of each year 

8 and once during the month of December of each 

9 year the following: 

10 ‘‘(A) A list of each tobacco product intro11 duced by the registrant for commercial distribu12 tion which has not been included in any list 

13 previously filed by that person with the Sec14 retary under this subparagraph or paragraph 

15 (1) of this subsection. A list under this sub16 paragraph shall list a tobacco product by its es17 tablished name and shall be accompanied by the 

18 other information required by paragraph (1). 

19 ‘‘(B) If since the date the registrant last 

20 made a report under this paragraph that person

21 has discontinued the manufacture, preparation, 

22 compounding, or processing for commercial dis23 tribution of a tobacco product included in a list 

24 filed under subparagraph (A) or paragraph (1), 

25 notice of such discontinuance, the date of such
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•HR 140 IH 

1 discontinuance, and the identity of its estab2 lished name. 

3 ‘‘(C) If since the date the registrant re4 ported under subparagraph (B) a notice of dis5 continuance that person has resumed the manu6 facture, preparation, compounding, or proc7 essing for commercial distribution of the to8 bacco product with respect to which such notice 

9 of discontinuance was reported, notice of such 

10 resumption, the date of such resumption, the 

11 identity of such tobacco product by established 

12 name, and other information required by para13 graph (1), unless the registrant has previously 

14 reported such resumption to the Secretary 

15 under this subparagraph. 

16 ‘‘(D) Any material change in any informa17 tion previously submitted under this paragraph 

18 or paragraph (1). 

19 ‘‘(j) REPORT PRECEDING INTRODUCTION OF CER20 TAIN SUBSTANTIALLY EQUIVALENT PRODUCTS INTO

21 INTERSTATE COMMERCE.—Each person who is required 

22 to register under this section and who proposes to begin 

23 the introduction or delivery for introduction into interstate 

24 commerce for commercial distribution of a tobacco product 

25 intended for human use that was not commercially mar-
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•HR 140 IH 

1 keted (other than for test marketing) in the United States 

2 as of the date of enactment of this chapter, as defined 

3 by the Secretary by regulation shall, at least 90 days be4 fore making such introduction or delivery, report to the 

5 Secretary (in such form and manner as the Secretary shall 

6 by regulation prescribe)—

7 ‘‘(1) the basis for such person’s determination 

8 that the tobacco product is substantially equivalent, 

9 within the meaning of section 910, to a tobacco 

10 product commercially marketed (other than for test 

11 marketing) in the United States as of the date of 

12 this chapter’s enactment, that is in compliance with 

13 the requirements of this Act; and 

14 ‘‘(2) action taken by such person to comply 

15 with the requirements under section 907 that are 

16 applicable to the tobacco product. 

17 ‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL 

18 OF TOBACCO PRODUCTS. 

19 ‘‘(a) IN GENERAL.—Any requirement established by 

20 or under section 902, 903, 905, or 909 applicable to a 

21 tobacco product shall apply to such tobacco product until 

22 the applicability of the requirement to the tobacco product 

23 has been changed by action taken under section 907, sec24 tion 910, or subsection (d) of this section, and any re25 quirement established by or under section 902, 903, 905, 
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1 or 909 which is inconsistent with a requirement imposed 

2 on such tobacco product under section 907, section 910, 

3 or subsection (d) of this section shall not apply to such 

4 tobacco product. 

5 ‘‘(b) INFORMATION ON PUBLIC ACCESS AND COM6 MENT.—Each notice of proposed rulemaking under section 

7 907, 908, 909, or 910, or under this section, any other 

8 notice which is published in the Federal Register with re9 spect to any other action taken under any such section 

10 and which states the reasons for such action, and each 

11 publication of findings required to be made in connection 

12 with rulemaking under any such section shall set forth—

13 ‘‘(1) the manner in which interested persons 

14 may examine data and other information on which 

15 the notice or findings is based; and 

16 ‘‘(2) the period within which interested persons 

17 may present their comments on the notice or find18 ings (including the need thereof) orally or in writing, 

19 which period shall be at least 60 days but may not 

20 exceed 90 days unless the time is extended by the 

21 Secretary by a notice published in the Federal Reg22 ister stating good cause therefor. 

23 ‘‘(c) LIMITED CONFIDENTIALITY OF INFORMA24 TION.—Any information reported to or otherwise obtained 

25 by the Secretary or the Secretary’s representative under
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1 section 904, 905, 907, 908, 909, 910, 912, or 704, or 

2 under subsection (e) or (f) of this section, which is exempt 

3 from disclosure under subsection (a) of section 552 of title 

4 5, United States Code, by reason of subsection (b)(4) of 

5 that section shall be considered confidential and shall not 

6 be disclosed, except that the information may be disclosed 

7 to other officers or employees concerned with carrying out 

8 this chapter, or when relevant in any proceeding under 

9 this chapter. 

10 ‘‘(d) RESTRICTIONS.—

11 ‘‘(1) The Secretary may by regulation require 

12 that a tobacco product be restricted to sale or dis13 tribution upon such conditions, including restrictions 

14 on the access to, and the advertising and promotion 

15 of, the tobacco product, as the Secretary may pre16 scribe in such regulation if the Secretary determines 

17 that such regulation would be appropriate for the 

18 prevention of, or decrease in, the use of tobacco 

19 products by children under the age at which tobacco 

20 products may be legally purchased. No such condi21 tion may require that the sale or distribution of a 

22 tobacco product be limited to the written or oral au23 thorization of a practitioner licensed by law to pre24 scribe medical products. 
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1 ‘‘(2) The label of a tobacco product shall bear 

2 such appropriate statements of the restrictions re3 quired by a regulation under subsection (a) as the 

4 Secretary may in such regulation prescribe.

5 ‘‘(3) No restriction under paragraph (1) may 

6 prohibit the sale of any tobacco product in face-to7 face transactions by a specific category of retail out8 lets. 

9 ‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE10 MENTS.—

11 ‘‘(1) METHODS, FACILITIES, AND CONTROLS TO

12 CONFORM.—

13 ‘‘(A) The Secretary may, in accordance 

14 with subparagraph (B), prescribe regulations 

15 requiring that the methods used in, and the fa16 cilities and controls used for, the manufacture, 

17 pre-production design validation (including a 

18 process to assess the performance of a tobacco 

19 product), packing and storage of a tobacco 

20 product, conform to current good manufac21 turing practice for an agricultural product, as

22 prescribed in such regulations, to assure that 

23 the public health is protected and that the to24 bacco product is in compliance with this chap25 ter.
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1 ‘‘(B) The Secretary shall—

2 ‘‘(i) before promulgating any regula3 tion under subparagraph (A), afford an ad4 visory committee an opportunity to submit 

5 recommendations with respect to the regu6 lation proposed to be promulgated; 

7 ‘‘(ii) before promulgating any regula8 tion under subparagraph (A), afford oppor9 tunity for an oral hearing; 

10 ‘‘(iii) provide the advisory committee a 

11 reasonable time to make its recommenda12 tion with respect to proposed regulations 

13 under subparagraph (A); and 

14 ‘‘(iv) in establishing the effective date 

15 of a regulation promulgated under this 

16 subsection, take into account the dif17 ferences in the manner in which the dif18 ferent types of tobacco products have his19 torically been produced, the financial re20 sources of the different tobacco product 

21 manufacturers, and the state of their exist22 ing manufacturing facilities; and shall pro23 vide for a reasonable period of time for 

24 such manufacturers to conform to good 

25 manufacturing practices. 
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1 ‘‘(2) EXEMPTIONS; VARIANCES.—

2 ‘‘(A) Any person subject to any require3 ment prescribed under paragraph (1) may peti4 tion the Secretary for a permanent or tem5 porary exemption or variance from such re6 quirement. Such a petition shall be submitted 

7 to the Secretary in such form and manner as 

8 the Secretary shall prescribe and shall—

9 ‘‘(i) in the case of a petition for an ex10 emption from a requirement, set forth the 

11 basis for the petitioner’s determination 

12 that compliance with the requirement is 

13 not required to assure that the tobacco 

14 product will be in compliance with this 

15 chapter; 

16 ‘‘(ii) in the case of a petition for a 

17 variance from a requirement, set forth the 

18 methods proposed to be used in, and the 

19 facilities and controls proposed to be used 

20 for, the manufacture, packing, and storage 

21 of the tobacco product in lieu of the meth22 ods, facilities, and controls prescribed by 

23 the requirement; and 

24 ‘‘(iii) contain such other information 

25 as the Secretary shall prescribe. 
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1 ‘‘(B) The Secretary may refer to an advi2 sory committee any petition submitted under 

3 subparagraph (A). The advisory committee 

4 shall report its recommendations to the Sec5 retary with respect to a petition referred to it 

6 within 60 days after the date of the petition’s 

7 referral. Within 60 days after—

8 ‘‘(i) the date the petition was sub9 mitted to the Secretary under subpara10 graph (A); or 

11 ‘‘(ii) the day after the petition was re12 ferred to an advisory committee, 

13 whichever occurs later, the Secretary shall by 

14 order either deny the petition or approve it. 

15 ‘‘(C) The Secretary may approve—

16 ‘‘(i) a petition for an exemption for a 

17 tobacco product from a requirement if the 

18 Secretary determines that compliance with 

19 such requirement is not required to assure 

20 that the tobacco product will be in compli21 ance with this chapter; and 

22 ‘‘(ii) a petition for a variance for a to23 bacco product from a requirement if the 

24 Secretary determines that the methods to 

25 be used in, and the facilities and controls 
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•HR 140 IH 

1 to be used for, the manufacture, packing, 

2 and storage of the tobacco product in lieu 

3 of the methods, controls, and facilities pre4 scribed by the requirement are sufficient to 

5 assure that the tobacco product will be in 

6 compliance with this chapter. 

7 ‘‘(D) An order of the Secretary approving 

8 a petition for a variance shall prescribe such 

9 conditions respecting the methods used in, and 

10 the facilities and controls used for, the manu11 facture, packing, and storage of the tobacco 

12 product to be granted the variance under the 

13 petition as may be necessary to assure that the 

14 tobacco product will be in compliance with this 

15 chapter. 

16 ‘‘(E) After the issuance of an order under 

17 subparagraph (B) respecting a petition, the pe18 titioner shall have an opportunity for an infor19 mal hearing on such order. 

20 ‘‘(f) EXEMPTION FOR INVESTIGATIONAL USE.—The 

21 Secretary may exempt tobacco products intended for in22 vestigational use from this chapter under such conditions 

23 as the Secretary may prescribe by regulation. 

24 ‘‘(g) RESEARCH AND DEVELOPMENT.—The Sec25 retary may enter into contracts for research, testing, and
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•HR 140 IH 

1 demonstrations respecting tobacco products and may ob2 tain tobacco products for research, testing, and dem3 onstration purposes without regard to section 3324(a) and 

4 (b) of title 31, United States Code, and section 5 of title 

5 41, United States Code. 

6 ‘‘SEC. 907. PERFORMANCE STANDARDS. 

7 ‘‘(a) IN GENERAL.—

8 ‘‘(1) FINDING REQUIRED.—The Secretary may 

9 adopt performance standards for a tobacco product 

10 if the Secretary finds that a performance standard 

11 is appropriate for the protection of the public health. 

12 This finding shall be determined with respect to the 

13 risks and benefits to the population as a whole, in14 cluding users and non-users of the tobacco product, 

15 and taking into account—

16 ‘‘(A) the increased or decreased likelihood 

17 that existing users of tobacco products will stop 

18 using such products; and 

19 ‘‘(B) the increased or decreased likelihood 

20 that those who do not use tobacco products will 

21 start using such products.

22 ‘‘(2) CONTENT OF PERFORMANCE STAND23 ARDS.—A performance standard established under 

24 this section for a tobacco product—
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1 ‘‘(A) shall include provisions to provide 

2 performance that is appropriate for the protec3 tion of the public health, including provisions, 

4 where appropriate— 

5 ‘‘(i) for the reduction of nicotine 

6 yields of the product; 

7 ‘‘(ii) for the reduction or elimination 

8 of other harmful constituents or harmful 

9 components of the product; or 

10 ‘‘(iii) relating to any other require11 ment under (B); 

12 ‘‘(B) shall, where necessary to be appro13 priate for the protection of the public health, 

14 include—

15 ‘‘(i) provisions respecting the con16 struction, components, ingredients, and 

17 properties of the tobacco product; 

18 ‘‘(ii) provisions for the testing (on a 

19 sample basis or, if necessary, on an indi20 vidual basis) of the tobacco product;

21 ‘‘(iii) provisions for the measurement 

22 of the performance characteristics of the 

23 tobacco product; and 

24 ‘‘(iv) provisions requiring that the re25 sults of each or of certain of the tests of 
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•HR 140 IH 

1 the tobacco product required to be made 

2 under clause (ii) show that the tobacco 

3 product is in conformity with the portions 

4 of the standard for which the test or tests 

5 were required; and 

6 ‘‘(C) shall not render the tobacco product 

7 unacceptable for adult consumption. 

8 ‘‘(3) PERIODIC REEVALUATION OF PERFORM9 ANCE STANDARDS.—The Secretary shall provide for 

10 periodic evaluation of performance standards estab11 lished under this section to determine whether such 

12 standards should be changed to reflect new medical, 

13 scientific, or other technological data. The Secretary 

14 may provide for testing under paragraph (2) by any 

15 person. 

16 ‘‘(4) INVOLVEMENT OF OTHER AGENCIES; IN17 FORMED PERSONS.—In carrying out duties under 

18 this section, the Secretary shall, to the maximum ex19 tent practicable—

20 ‘‘(A) use personnel, facilities, and other 

21 technical support available in other Federal 

22 agencies; 

23 ‘‘(B) consult with other Federal agencies 

24 concerned with standard-setting and other na-
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1 tionally or internationally recognized standard2 setting entities; and 

3 ‘‘(C) invite appropriate participation, 

4 through joint or other conferences, workshops, 

5 or other means, by informed persons represent6 ative of scientific, professional, industry, or con7 sumer organizations who in the Secretary’s 

8 judgment can make a significant contribution. 

9 ‘‘(b) ESTABLISHMENT OF STANDARDS.—

10 ‘‘(1) NOTICE.—

11 ‘‘(A) The Secretary shall publish in the 

12 Federal Register a notice of proposed rule13 making for the establishment, amendment, or 

14 revocation of any performance standard for a 

15 tobacco product. 

16 ‘‘(B) A notice of proposed rulemaking for 

17 the establishment or amendment of a perform18 ance standard for a tobacco product shall—

19 ‘‘(i) set forth a finding with sup20 porting justification that the performance 

21 standard is appropriate for the protection 

22 of the public health; 

23 ‘‘(ii) set forth proposed findings with 

24 respect to the risk of illness or injury that 
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1 the performance standard is intended to 

2 reduce or eliminate; and 

3 ‘‘(iii) invite interested persons to sub4 mit an existing performance standard for 

5 the tobacco product, including a draft or 

6 proposed performance standard, for consid7 eration by the Secretary. 

8 ‘‘(C) A notice of proposed rulemaking for 

9 the revocation of a performance standard shall 

10 set forth a finding with supporting justification 

11 that the performance standard is no longer nec12 essary to be appropriate for the protection of 

13 the public health. 

14 ‘‘(D) The Secretary shall consider all infor15 mation submitted in connection with a proposed 

16 standard, including information concerning the 

17 countervailing effects of the performance stand18 ard on the health of adolescent tobacco users, 

19 adult tobacco users, or non-tobacco users, such 

20 as the creation of a significant demand for con21 traband or other tobacco products that do not 

22 meet the requirements of this chapter and the 

23 significance of such demand, and shall issue the 

24 standard if the Secretary determines that the
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1 standard would be appropriate for the protec2 tion of the public health. 

3 ‘‘(E) The Secretary shall provide for a 

4 comment period of not less than 60 days. 

5 ‘‘(2) PROMULGATION.—

6 ‘‘(A) After the expiration of the period for 

7 comment on a notice of proposed rulemaking 

8 published under paragraph (1) respecting a per9 formance standard and after consideration of 

10 such comments and any report from an advi11 sory committee, the Secretary shall—

12 ‘‘(i) promulgate a regulation estab13 lishing a performance standard and pub14 lish in the Federal Register findings on the 

15 matters referred to in paragraph (1); or 

16 ‘‘(ii) publish a notice terminating the 

17 proceeding for the development of the 

18 standard together with the reasons for 

19 such termination. 

20 ‘‘(B) A regulation establishing a perform21 ance standard shall set forth the date or dates 

22 upon which the standard shall take effect, but

23 no such regulation may take effect before one 

24 year after the date of its publication unless the 

25 Secretary determines that an earlier effective
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•HR 140 IH 

1 date is necessary for the protection of the pub2 lic health. Such date or dates shall be estab3 lished so as to minimize, consistent with the 

4 public health, economic loss to, and disruption 

5 or dislocation of, domestic and international 

6 trade. 

7 ‘‘(3) POWER RESERVED TO CONGRESS.—Be8 cause of the importance of any decision to issue a 

9 regulation establishing a performance standard—

10 ‘‘(A) eliminating all cigarettes, all smoke11 less tobacco products, or any similar class of to12 bacco products, or 

13 ‘‘(B) requiring the reduction of nicotine 

14 yields of a tobacco product to zero, 

15 Congress expressly reserves to itself the power to 

16 make such a decision. 

17 ‘‘(4) AMENDMENT; REVOCATION.—

18 ‘‘(A) The Secretary, upon the Secretary’s 

19 own initiative or upon petition of an interested 

20 person may by a regulation, promulgated in ac21 cordance with the requirements of paragraphs 

22 (1) and (2)(B) of this subsection, amend or re23 voke a performance standard. 

24 ‘‘(B) The Secretary may declare a pro25 posed amendment of a performance standard to 
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1 be effective on and after its publication in the 

2 Federal Register and until the effective date of 

3 any final action taken on such amendment if 

4 the Secretary determines that making it so ef5 fective is in the public interest. 

6 ‘‘(5) REFERENCE TO ADVISORY COMMITTEE.—

7 The Secretary—

8 ‘‘(A) may, on the Secretary’s own initia9 tive, refer a proposed regulation for the estab10 lishment, amendment, or revocation of a per11 formance standard; or 

12 ‘‘(B) shall, upon the request of an inter13 ested person which demonstrates good cause for 

14 referral and which is made before the expiration 

15 of the period for submission of comments on 

16 such proposed regulation, 

17 refer such proposed regulation to an advisory com18 mittee, for a report and recommendation with re19 spect to any matter involved in the proposed regula20 tion which requires the exercise of scientific judg21 ment. If a proposed regulation is referred under this

22 subparagraph to the advisory committee, the Sec23 retary shall provide the advisory committee with the 

24 data and information on which such proposed regu25 lation is based. The advisory committee shall, within 
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•HR 140 IH 

1 60 days after the referral of a proposed regulation 

2 and after independent study of the data and infor3 mation furnished to it by the Secretary and other 

4 data and information before it, submit to the Sec5 retary a report and recommendation respecting such 

6 regulation, together with all underlying data and in7 formation and a statement of the reason or basis 

8 for the recommendation. A copy of such report and 

9 recommendation shall be made public by the Sec10 retary. 

11 ‘‘SEC. 908. NOTIFICATION AND OTHER REMEDIES. 

12 ‘‘(a) NOTIFICATION.—If the Secretary determines 

13 that—

14 ‘‘(1) a tobacco product which is introduced or 

15 delivered for introduction into interstate commerce 

16 for commercial distribution presents a risk of sub17 stantial harm to the public health exceeding the 

18 risks posed by tobacco products marketed before the 

19 date of enactment of this chapter; and 

20 ‘‘(2) notification under this subsection is nec21 essary to eliminate the unreasonable risk of such 

22 harm and no more practicable means is available 

23 under the provisions of this chapter (other than this 

24 section) to eliminate such risk, 
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1 the Secretary may issue such order as may be necessary 

2 to assure that adequate notification is provided in an ap3 propriate form, by the persons and means best suited 

4 under the circumstances involved, to all persons who 

5 should properly receive such notification in order to elimi6 nate such risk. The Secretary may order notification by 

7 any appropriate means, including public service announce8 ments. Before issuing an order under this subsection, the 

9 Secretary shall consult with the persons who are to give 

10 notice under the order. 

11 ‘‘(b) NO EXEMPTION FROM OTHER LIABILITY.—

12 Compliance with an order issued under this section shall 

13 not relieve any person from liability under Federal or 

14 State law. 

15 ‘‘(c) RECALL AUTHORITY.—

16 ‘‘(1) IN GENERAL.—If the Secretary finds that 

17 there is a reasonable probability that a tobacco prod18 uct contains a manufacturing or other defect not or19 dinarily contained in tobacco products on the market 

20 that would cause serious, adverse health con21 sequences or death, the Secretary shall issue an 

22 order requiring the appropriate person (including 

23 the manufacturers, importers, distributors, or retail24 ers of the tobacco product) to immediately cease dis25 tribution of such tobacco product. The order shall
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1 provide the person subject to the order with an op2 portunity for an informal hearing, to be held not 

3 later than 10 days after the date of the issuance 

4 of the order, on the actions required by the order 

5 and on whether the order should be amended to re6 quire a recall of such tobacco product. If, after pro7 viding an opportunity for such a hearing, the Sec8 retary determines that inadequate grounds exist to 

9 support the actions required by the order, the Sec10 retary shall vacate the order. 

11 ‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE12 CALL.—

13 ‘‘(A) If, after providing an opportunity for 

14 an informal hearing under paragraph (1), the 

15 Secretary determines that the order should be 

16 amended to include a recall of the tobacco prod17 uct with respect to which the order was issued, 

18 the Secretary shall, except as provided in sub19 paragraph (B), amend the order to require a 

20 recall. The Secretary shall specify a timetable in 

21 which the tobacco product recall will occur and 

22 shall require periodic reports to the Secretary 

23 describing the progress of the recall.

24 ‘‘(B) An amended order under subpara25 graph (A)—
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•HR 140 IH 

1 ‘‘(i) shall not include recall of a to2 bacco product from individuals; and

3 ‘‘(ii) shall provide for notice to per4 sons subject to the risks associated with 

5 the use of such tobacco product. 

6 In providing the notice required by clause (ii), 

7 the Secretary may use the assistance of retail8 ers and other persons who distributed such to9 bacco product. If a significant number of such 

10 persons cannot be identified, the Secretary shall 

11 notify such persons under section 705(b). 

12 ‘‘(3) REMEDY NOT EXCLUSIVE.—The remedy 

13 provided by this subsection shall be in addition to 

14 remedies provided by subsection (a) of this section. 

15 ‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PROD16 UCTS. 

17 ‘‘(a) IN GENERAL.—Every person who is a tobacco 

18 product manufacturer or importer of a tobacco product 

19 shall establish and maintain such records, make such re20 ports, and provide such information, as the Secretary may 

21 by regulation reasonably require to assure that such to22 bacco product is not adulterated or misbranded and to

23 otherwise protect public health. Regulations prescribed 

24 under the preceding sentence—
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1 ‘‘(1) may require a tobacco product manufac2 turer or importer to report to the Secretary when3 ever the manufacturer or importer receives or other4 wise becomes aware of information that reasonably 

5 suggests that one of its marketed tobacco products 

6 may have caused or contributed to a serious unex7 pected adverse experience associated with the use of 

8 the product or any significant increase in the fre9 quency of a serious, expected adverse product experi10 ence; 

11 ‘‘(2) shall require reporting of other significant 

12 adverse tobacco product experiences as determined 

13 by the Secretary to be necessary to be reported; 

14 ‘‘(3) shall not impose requirements unduly bur15 densome to a tobacco product manufacturer or im16 porter, taking into account the cost of complying 

17 with such requirements and the need for the protec18 tion of the public health and the implementation of 

19 this chapter; 

20 ‘‘(4) when prescribing the procedure for making 

21 requests for reports or information, shall require 

22 that each request made under such regulations for 

23 submission of a report or information to the Sec24 retary state the reason or purpose for such request 
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1 and identify to the fullest extent practicable such re2 port or information; 

3 ‘‘(5) when requiring submission of a report or 

4 information to the Secretary, shall state the reason 

5 or purpose for the submission of such report or in6 formation and identify to the fullest extent prac7 ticable such report or information; and 

8 ‘‘(6) may not require that the identity of any 

9 patient or user be disclosed in records, reports, or 

10 information required under this subsection unless re11 quired for the medical welfare of an individual, to 

12 determine risks to public health of a tobacco prod13 uct, or to verify a record, report, or information sub14 mitted under this chapter. 

15 In prescribing regulations under this subsection, the Sec16 retary shall have due regard for the professional ethics of 

17 the medical profession and the interests of patients. The 

18 prohibitions of paragraph (6) of this subsection continue 

19 to apply to records, reports, and information concerning 

20 any individual who has been a patient, irrespective of 

21 whether or when he ceases to be a patient. 

22 ‘‘(b) REPORTS OF REMOVALS AND CORRECTIONS.—

23 (1) Except as provided in paragraph (3), the 

24 Secretary shall by regulation require a tobacco prod25 uct manufacturer or importer of a tobacco product
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1 to report promptly to the Secretary any corrective 

2 action taken or removal from the market of a to3 bacco product undertaken by such manufacturer or 

4 importer if the removal or correction was under5 taken—

6 ‘‘(A) to reduce a risk to health posed by 

7 the tobacco product; or 

8 ‘‘(B) to remedy a violation of this chapter 

9 caused by the tobacco product which may 

10 present a risk to health. 

11 A tobacco product manufacturer or importer of a tobacco 

12 product who undertakes a corrective action or removal 

13 from the market of a tobacco product which is not re14 quired to be reported under this subsection shall keep a 

15 record of such correction or removal. 

16 ‘‘(2) No report of the corrective action or re17 moval of a tobacco product may be required under 

18 paragraph (1) if a report of the corrective action or 

19 removal is required and has been submitted under 

20 subsection (a) of this section. 

21 ‘‘SEC. 910. PREMARKET REVIEW OF CERTAIN TOBACCO 

22 PRODUCTS. 

23 ‘‘(a) IN GENERAL.—

24 ‘‘(1) PREMARKET APPROVAL REQUIRED.—Ap25 proval under this section of an application for pre-
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1 market approval for any tobacco product, other than 

2 a reduced risk product under section 912, that is not 

3 commercially marketed (other than for test mar4 keting) in the United States as of the date of this 

5 chapter’s enactment, is required unless the manufac6 turer has submitted a report under section 905(j), 

7 and the Secretary has not suspended the distribution 

8 of such product under this paragraph. Within 90 

9 days of the submission of a report under section 

10 905(j), the Secretary may by order suspend the dis11 tribution of the tobacco product that is the subject 

12 of that report if the Secretary determines that there 

13 is a reasonable likelihood that the tobacco product is 

14 not substantially equivalent to a tobacco product 

15 commercially marketed (other than for test mar16 keting) in the United States as of the date of this 

17 chapter’s enactment, that is in compliance with the 

18 requirements of this Act. If the Secretary fails to 

19 issue an order within this 90-day period, then the 

20 tobacco product that is the subject of that report 

21 shall be deemed to be substantially equivalent to a 

22 predicate tobacco product. The issuance of an order 

23 under this paragraph shall constitute final agency 

24 action for purposes of section 702 of title 5, the 

25 United States Code; provided, that the Secretary 
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1 may rescind or modify an order issued under this 

2 paragraph at any time. 

3 ‘‘(2) SUBSTANTIALLY EQUIVALENT DEFINED.—

4 ‘‘(A) For purposes of this section and sec5 tion 905(j), the term ‘substantially equivalent’ 

6 or ‘substantial equivalence’ mean, with respect 

7 to the tobacco product being compared to the 

8 predicate tobacco product, that the Secretary by 

9 order has found that the tobacco product—

10 ‘‘(i) has the same characteristics as 

11 the predicate tobacco product; or 

12 ‘‘(ii) has different characteristics and 

13 the information submitted contains infor14 mation, including clinical data if deemed 

15 necessary by the Secretary, that dem16 onstrates that it is not appropriate to reg17 ulate the product under this section be18 cause the product could not reasonably be 

19 expected to increase the health risks to 

20 consumers compared to a conventional to21 bacco product that is commercially mar22 keted in the United States and that is in 

23 compliance with the requirements of this 

24 Act. 
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1 ‘‘(B) For purposes of subparagraph (A), 

2 the term ‘characteristics’ means the materials, 

3 ingredients, design, composition, heating source, 

4 or other features of a tobacco product. 

5 ‘‘(C) A tobacco product may not be found 

6 to be substantially equivalent to a predicate to7 bacco product that has been removed from the 

8 market at the initiative of the Secretary or that 

9 has been determined by a judicial order to be 

10 misbranded or adulterated. 

11 ‘‘(3) HEALTH INFORMATION.—

12 ‘‘(A) As part of a submission under section 

13 905(j) respecting a tobacco product, the person 

14 required to file a premarket notification under 

15 such section shall provide an adequate summary 

16 of any health information related to the tobacco 

17 product or state that such information will be 

18 made available upon request by any person. 

19 ‘‘(B) Any summary under subparagraph 

20 (A) respecting a tobacco product shall contain 

21 detailed information regarding data concerning 

22 adverse health effects and shall be made avail23 able to the public by the Secretary within 30

24 days of the issuance of a determination that 

25 such tobacco product is substantially equivalent 
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1 to another tobacco product. The communication 

2 that such product is a reduced risk product 

3 may comply with requirements prescribed by 

4 the Secretary relating to such communication, 

5 and the Secretary may require prior approval 

6 of the communication, in each case in accord7 ance with section 912. 

8 ‘‘(b) APPLICATION.—

9 ‘‘(1) CONTENTS.—An application for premarket 

10 approval shall contain—

11 ‘‘(A) full reports of all information, pub12 lished or known to or which should reasonably 

13 be known to the applicant, concerning investiga14 tions which have been made to show the health 

15 risks of such tobacco product and whether such 

16 tobacco product presents greater risk than 

17 other tobacco products; 

18 ‘‘(B) a full statement of the components, 

19 ingredients, and properties, and of the principle 

20 or principles of operation, of such tobacco prod21 uct; 

22 ‘‘(C) a full description of the methods used 

23 in, and the facilities and controls used for, the 

24 manufacture, processing, and, when relevant,
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1 packing and installation of, such tobacco prod2 uct; 

3 ‘‘(D) an identifying reference to any per4 formance standard under section 907 which 

5 would be applicable to any aspect of such to6 bacco product, and either adequate information 

7 to show that such aspect of such tobacco prod8 uct fully meets such performance standard or 

9 adequate information to justify any deviation 

10 from such standard; 

11 ‘‘(E) such samples of such tobacco product 

12 and of components thereof as the Secretary 

13 may reasonably require; 

14 ‘‘(F) specimens of the labeling proposed to 

15 be used for such tobacco product; and 

16 ‘‘(G) such other information relevant to 

17 the subject matter of the application as the Sec18 retary may require. 

19 ‘‘(2) REFERENCE TO ADVISORY COMMITTEE.—

20 Upon receipt of an application meeting the require21 ments set forth in paragraph (1), the Secretary—

22 ‘‘(A) may, on the Secretary’s own initia23 tive; or

24 ‘‘(B) shall, upon the request of an appli25 cant, 
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1 refer such application to an advisory committee and 

2 for submission (within such period as the Secretary 

3 may establish) of a report and recommendation re4 specting approval of the application, together with 

5 all underlying data and the reasons or basis for the 

6 recommendation. 

7 ‘‘(c) ACTION ON APPLICATION.—

8 ‘‘(1) DEADLINE.—

9 ‘‘(A) As promptly as possible, but in no 

10 event later than 180 days after the receipt of 

11 an application under subsection (b) of this sec12 tion, the Secretary, after considering the report 

13 and recommendation submitted under para14 graph (2) of such subsection, shall—

15 ‘‘(i) issue an order approving the ap16 plication if the Secretary finds that none of 

17 the grounds for denying approval specified 

18 in paragraph (2) of this subsection applies; 

19 or 

20 ‘‘(ii) deny approval of the application 

21 if the Secretary finds (and sets forth the 

22 basis for such finding as part of or accom23 panying such denial) that one or more 

24 grounds for denial specified in paragraph 

25 (2) of this subsection apply. 
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1 ‘‘(B) An order approving an application for 

2 a tobacco product may require as a condition to 

3 such approval that the sale and distribution of 

4 the tobacco product be restricted but only to

5 the extent that the sale and distribution of a 

6 tobacco product may be restricted under a regu7 lation under section 906(d). 

8 ‘‘(2) DENIAL OF APPROVAL.—The Secretary 

9 shall deny approval of an application for a tobacco 

10 product if, upon the basis of the information sub11 mitted to the Secretary as part of the application 

12 and any other information before the Secretary with 

13 respect to such tobacco product, the Secretary finds 

14 that—

15 ‘‘(A) there is a lack of a showing that per16 mitting such tobacco product to be marketed 

17 would pose no greater risk to the public health 

18 than currently marketed tobacco products; 

19 ‘‘(B) the methods used in, or the facilities 

20 or controls used for, the manufacture, proc21 essing, or packing of such tobacco product do 

22 not conform to the requirements of section 

23 906(e); 
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1 ‘‘(C) based on a fair evaluation of all mate2 rial facts, the proposed labeling is false or mis3 leading in any particular; or 

4 ‘‘(D) such tobacco product is not shown to 

5 conform in all respects to a performance stand6 ard in effect under section 907, compliance with 

7 which is a condition to approval of the applica8 tion, and there is a lack of adequate informa9 tion to justify the deviation from such standard. 

10 ‘‘(3) DENIAL INFORMATION.—Any denial of an 

11 application shall, insofar as the Secretary determines 

12 to be practicable, be accompanied by a statement in13 forming the applicant of the measures required to 

14 place such application in approvable form (which 

15 measures may include further research by the appli16 cant in accordance with one or more protocols pre17 scribed by the Secretary). 

18 ‘‘(4) BASIS FOR ACTION.—

19 ‘‘(A) For purposes of paragraph (2)(A), 

20 whether permitting a tobacco product to be 

21 marketed would be appropriate for the protec22 tion of the public health shall, when appro23 priate, be determined on the basis of well-con24 trolled investigations, which may include one or 

25 more clinical investigations by experts qualified 
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1 by training and experience to evaluate the to2 bacco product. 

3 ‘‘(B) If the Secretary determines that 

4 there exists valid scientific evidence (other than 

5 evidence derived from investigations described 

6 in subparagraph (A)) which is sufficient to 

7 evaluate the tobacco product the Secretary may 

8 authorize that the determination for purposes 

9 of paragraph (2)(A) be made on the basis of 

10 such evidence. 

11 ‘‘(d) WITHDRAWAL AND TEMPORARY SUSPENSION.—

12 ‘‘(1) IN GENERAL.—The Secretary shall, upon 

13 obtaining, where appropriate, advice on scientific 

14 matters from an advisory committee, and after due 

15 notice and opportunity for informal hearing to the 

16 holder of an approved application for a tobacco 

17 product, issue an order withdrawing approval of the 

18 application if the Secretary finds—

19 ‘‘(A) that the continued marketing of such 

20 tobacco product poses greater risks to the pub21 lic health than other available products; 

22 ‘‘(B) that the application contained or was 

23 accompanied by an untrue statement of a mate24 rial fact; 

25 ‘‘(C) that the applicant—
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1 ‘‘(i) has failed to establish a system 

2 for maintaining records, or has repeatedly 

3 or deliberately failed to maintain records 

4 or to make reports, required by an applica5 ble regulation under section 909; 

6 ‘‘(ii) has refused to permit access to, 

7 or copying or verification of, such records 

8 as required by section 704; or 

9 ‘‘(iii) has not complied with the re10 quirements of section 905; 

11 ‘‘(D) on the basis of new information be12 fore the Secretary with respect to such tobacco 

13 product, evaluated together with the evidence 

14 before the Secretary when the application was 

15 approved, that the methods used in, or the fa16 cilities and controls used for, the manufacture, 

17 processing, packing, or installation of such to18 bacco product do not conform with the require19 ments of section 906(e) and were not brought 

20 into conformity with such requirements within a 

21 reasonable time after receipt of written notice 

22 from the Secretary of nonconformity; 

23 ‘‘(E) on the basis of new information be24 fore the Secretary, evaluated together with the 

25 evidence before the Secretary when the applica-
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1 tion was approved, that the labeling of such to2 bacco product, based on a fair evaluation of all 

3 material facts, is false or misleading in any par4 ticular and was not corrected within a reason5 able time after receipt of written notice from 

6 the Secretary of such fact; or 

7 ‘‘(F) on the basis of new information be8 fore the Secretary, evaluated together with the 

9 evidence before the Secretary when the applica10 tion was approved, that such tobacco product is 

11 not shown to conform in all respects to a per12 formance standard which is in effect under sec13 tion 907, compliance with which was a condi14 tion to approval of the application, and that 

15 there is a lack of adequate information to jus16 tify the deviation from such standard. 

17 ‘‘(2) APPEAL.—The holder of an application 

18 subject to an order issued under paragraph (1) with19 drawing approval of the application may, by petition 

20 filed on or before the thirtieth day after the date 

21 upon which he receives notice of such withdrawal, 

22 obtain review thereof in accordance with subsection 

23 (e) of this section. 

24 ‘‘(3) TEMPORARY SUSPENSION.—If, after pro25 viding an opportunity for an informal hearing, the 
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1 Secretary determines there is reasonable probability 

2 that the continuation of distribution of a tobacco 

3 product under an approved application would cause 

4 serious, adverse health consequences or death, that 

5 is greater than ordinarily caused by tobacco prod6 ucts on the market, the Secretary shall by order 

7 temporarily suspend the approval of the application 

8 approved under this section. If the Secretary issues 

9 such an order, the Secretary shall proceed expedi10 tiously under paragraph (1) to withdraw such appli11 cation. 

12 ‘‘(e) SERVICE OF ORDER.—An order issued by the 

13 Secretary under this section shall be served— 

14 ‘‘(1) in person by any officer or employee of the 

15 department designated by the Secretary; or 

16 ‘‘(2) by mailing the order by registered mail or 

17 certified mail addressed to the applicant at the ap18 plicant’s last known address in the records of the 

19 Secretary. 

20 ‘‘SEC. 911. JUDICIAL REVIEW. 

21 ‘‘(a) IN GENERAL.—Not later than 30 days after—

22 ‘‘(1) the promulgation of a regulation under 

23 section 907 establishing, amending, or revoking a 

24 performance standard for a tobacco product; or 
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1 ‘‘(2) a denial of an application for approval 

2 under section 910(c), 

3 any person adversely affected by such regulation or order 

4 may file a petition with the United States Court of Ap5 peals for the District of Columbia or for the circuit where6 in such person resides or has his principal place of busi7 ness for judicial review of such regulation or order. A copy 

8 of the petition shall be transmitted by the clerk of the 

9 court to the Secretary or other officer designated by the 

10 Secretary for that purpose. The Secretary shall file in the

11 court the record of the proceedings on which the Secretary 

12 based the Secretary’s regulation or order and each record 

13 or order shall contain a statement of the reasons for its 

14 issuance and the basis, on the record, for its issuance. For 

15 purposes of this section, the term ‘record’ means all no16 tices and other matter published in the Federal Register 

17 with respect to the regulation or order reviewed, all infor18 mation submitted to the Secretary with respect to such 

19 regulation or order, proceedings of any panel or advisory 

20 committee with respect to such regulation or order, any 

21 hearing held with respect to such regulation or order, and 

22 any other information identified by the Secretary, in the 

23 administrative proceeding held with respect to such regu24 lation or order, as being relevant to such regulation or 

25 order. 
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1 ‘‘(b) COURT MAY ORDER SECRETARY TO MAKE AD2 DITIONAL FINDINGS.—If the petitioner applies to the 

3 court for leave to adduce additional data, views, or argu4 ments respecting the regulation or order being reviewed 

5 and shows to the satisfaction of the court that such addi6 tional data, views, or arguments are material and that 

7 there were reasonable grounds for the petitioner’s failure 

8 to adduce such data, views, or arguments in the pro9 ceedings before the Secretary, the court may order the 

10 Secretary to provide additional opportunity for the oral 

11 presentation of data, views, or arguments and for written 

12 submissions. The Secretary may modify the Secretary’s 

13 findings, or make new findings by reason of the additional 

14 data, views, or arguments so taken and shall file with the 

15 court such modified or new findings, and the Secretary’s 

16 recommendation, if any, for the modification or setting 

17 aside of the regulation or order being reviewed, with the 

18 return of such additional data, views, or arguments.

19 ‘‘(c) STANDARD OF REVIEW.—Upon the filing of the 

20 petition under subsection (a) of this section for judicial 

21 review of a regulation or order, the court shall have juris22 diction to review the regulation or order in accordance 

23 with chapter 7 of title 5, United States Code, and to grant 

24 appropriate relief, including interim relief, as provided in 

25 such chapter. A regulation or order described in paragraph
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1 (1) or (2) of subsection (a) of this section shall not be 

2 affirmed if it is found to be unsupported by substantial 

3 evidence on the record taken as a whole. 

4 ‘‘(d) FINALITY OF JUDGMENT.—The judgment of the 

5 court affirming or setting aside, in whole or in part, any 

6 regulation or order shall be final, subject to review by the 

7 Supreme Court of the United States upon certiorari or 

8 certification, as provided in section 1254 of title 28, 

9 United States Code. 

10 ‘‘(e) OTHER REMEDIES.—The remedies provided for 

11 in this section shall be in addition to and not in lieu of 

12 any other remedies provided by law. 

13 ‘‘(f) REGULATIONS AND ORDERS MUST RECITE

14 BASIS IN RECORD.—To facilitate judicial review under 

15 this section or under any other provision of law of a regu16 lation or order issued under section 906, 907, 908, 909, 

17 910, or 913, each such regulation or order shall contain 

18 a statement of the reasons for its issuance and the basis, 

19 in the record of the proceedings held in connection with 

20 its issuance, for its issuance. 

21 ‘‘SEC. 912. REDUCED RISK TOBACCO PRODUCTS. 

22 ‘‘(a) REQUIREMENTS.—

23 ‘‘(1) IN GENERAL.—For purposes of this sec24 tion, the term ‘reduced risk tobacco product’ means 
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1 a tobacco product designated by the Secretary under 

2 paragraph (2). 

3 ‘‘(2) DESIGNATION.—

4 ‘‘(A) IN GENERAL.—A product may be 

5 designated by the Secretary as a reduced risk 

6 tobacco product if the Secretary finds that the 

7 product is demonstrated to significantly reduce 

8 harm to individuals caused by a tobacco prod9 uct and is otherwise appropriate to protect pub10 lic health, based on an application submitted by 

11 the manufacturer of the product (or other re12 sponsible person) that—

13 ‘‘(i)(I) demonstrates through testing 

14 on animals and short-term human testing 

15 that use of such product results in inges16 tion or inhalation of a substantially lower 

17 yield of toxic substances than use of an18 other tobacco product in the same or dif19 ferent category as the proposed reduced 

20 risk product; or 

21 ‘‘(II) contains scientific evidence 

22 showing that use of such product results in 

23 a substantially lower potential risk to 

24 health in one or more specific respects 

25 than use of another tobacco product in the 
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1 same or different category as the proposed 

2 reduced risk product; and 

3 ‘‘(ii) if required by the Secretary, in4 cludes studies of the long-term health ef5 fects of the product. 

6 If such studies are required, the manufacturer 

7 may consult with the Secretary regarding proto8 cols for conducting the studies. 

9 ‘‘(B) BASIS FOR FINDING.—In making the 

10 finding under subparagraph (A), the Secretary 

11 shall take into account—

12 ‘‘(i) the risks and benefits to the pop13 ulation as a whole, including both users of 

14 tobacco products and non-users of tobacco 

15 products; 

16 ‘‘(ii) the increased or decreased likeli17 hood that existing users of tobacco prod18 ucts will stop using such products includ19 ing reduced risk tobacco products; 

20 ‘‘(iii) the increased or decreased likeli21 hood that those who do not use tobacco 

22 products will start to use such products, 

23 including reduced risk tobacco products; 

24 and 
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1 ‘‘(iv) the risks and benefits to con2 sumers from the use of a reduced risk to3 bacco product as compared to the use of 

4 products approved under chapter V to re5 duce exposure to tobacco. 

6 ‘‘(3) MARKETING REQUIREMENTS.—A tobacco 

7 product may be marketed and labeled as a reduced 

8 risk tobacco product if it—

9 ‘‘(A) has been designated as a reduced risk 

10 tobacco product by the Secretary under para11 graph (2); 

12 ‘‘(B) bears a label prescribed by the Sec13 retary concerning the product’s contribution to 

14 reducing harm to health; and 

15 ‘‘(C) complies with requirements prescribed 

16 by the Secretary relating to marketing and ad17 vertising of the product, and other provisions of 

18 this chapter as prescribed by the Secretary, al19 though in no event shall such requirements pro20 hibit the communication that such product is a 

21 reduced risk product. The communication that 

22 such product is a reduced risk product may 

23 comply with requirements prescribed by the 

24 Secretary relating to such communication, and 
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1 the Secretary may require prior approval of the 

2 communication. 

3 ‘‘(b) REVOCATION OF DESIGNATION.—At any time 

4 after the date on which a tobacco product is designated 

5 as a reduced risk tobacco product under this section the 

6 Secretary may, after providing an opportunity for an in7 formal hearing, revoke such designation if the Secretary 

8 determines, based on information not available at the time 

9 of the designation, that—

10 ‘‘(1) the finding made under subsection (a)(2) 

11 is no longer valid; or 

12 ‘‘(2) the product is being marketed in violation 

13 of subsection (a)(3).

14 ‘‘(c) LIMITATION.—A tobacco product that is des15 ignated as a reduced risk tobacco product that is in com16 pliance with subsection (a) shall not be regulated as a 

17 drug or device. 

18 ‘‘(d) DEVELOPMENT OF REDUCED RISK TOBACCO

19 PRODUCT TECHNOLOGY.—A tobacco product manufac20 turer shall provide written notice to the Secretary upon 

21 the development or acquisition by the manufacturer of any 

22 technology that would reduce the risk of a tobacco product 

23 to the health of the user for which the manufacturer is 

24 not seeking designation as a ‘reduced risk tobacco product’ 

25 under subsection (a).
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1 ‘‘(e) POSTMARKET SURVEILLANCE.—

2 ‘‘(1) DISCRETIONARY SURVEILLANCE.—The 

3 Secretary may require a tobacco product manufac4 turer to conduct postmarket surveillance for reduced

5 risk a tobacco product of the manufacturer if the 

6 Secretary determines that postmarket surveillance of 

7 the tobacco product is necessary to protect the pub8 lic health or is necessary to provide information re9 garding the health risks and other safety issues in10 volving the tobacco product. 

11 ‘‘(2) SURVEILLANCE APPROVAL.—Each tobacco 

12 product manufacturer required to conduct a surveil13 lance of a reduced risk tobacco product under para14 graph (1) shall, within 30 days after receiving notice 

15 that the manufacturer is required to conduct such 

16 surveillance, submit, for the approval of the Sec17 retary, a protocol for the required surveillance. The 

18 Secretary, within 60 days of the receipt of such pro19 tocol, shall determine if the principal investigator 

20 proposed to be used in the surveillance has sufficient 

21 qualifications and experience to conduct such sur22 veillance and if such protocol will result in collection 

23 of useful data or other information necessary to pro24 tect the public health. The Secretary may not ap25 prove such a protocol until it has been reviewed by
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1 an appropriately qualified scientific and technical re2 view committee established by the Secretary. 

3 ‘‘SEC. 913. PRESERVATION OF STATE AND LOCAL AUTHOR4 ITY. 

5 ‘‘(a) ADDITIONAL REQUIREMENTS.—

6 ‘‘(1) IN GENERAL.—Except as provided in para7 graph (2), nothing in this Act shall be construed as 

8 prohibiting a State or political subdivision thereof 

9 from adopting or enforcing a requirement applicable 

10 to a tobacco product that is in addition to, or more 

11 stringent than, requirements established under this 

12 chapter. 

13 ‘‘(2) PREEMPTION OF CERTAIN STATE AND

14 LOCAL REQUIREMENTS.—

15 ‘‘(A) Except as provided in subparagraph 

16 (B), no State or political subdivision of a State 

17 may establish or continue in effect with respect 

18 to a tobacco product any requirement which is 

19 different from, or in addition to, any require20 ment applicable under the provisions of this 

21 chapter relating to performance standards, pre22 market approval, adulteration, misbranding, 

23 registration, labeling, good manufacturing 

24 standards, or reduced risk products. 
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1 ‘‘(B) Subparagraph (A) does not apply to 

2 requirements relating to the sale, use, or dis3 tribution of a tobacco product including require4 ments related to the access to, and the adver5 tising and promotion of, a tobacco product. 

6 ‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT

7 LIABILITY.—No provision of this chapter relating to a to8 bacco product shall be construed to modify or otherwise 

9 affect any action or the liability of any person under the 

10 product liability law of any State. 

11 ‘‘SEC. 914. EQUAL TREATMENT OF RETAIL OUTLETS. 

12 ‘‘The Secretary shall issue regulations to require that 

13 retail establishments for which the predominant business 

14 is the sale of tobacco products comply with any advertising 

15 restrictions applicable to retail establishments accessible 

16 to individuals under the age of 18. 

17 ‘‘SEC. 915. ACCESS AND MARKETING RESTRICTIONS. 

18 ‘‘(a) DEFINITIONS.—For purposes of this section, the 

19 following definitions apply: 

20 ‘‘(1) ADULT.—The term ‘adult’ means any per21 son who is older than the minimum age at which it 

22 is legal to purchase or possess (whichever minimum 

23 age is older) tobacco products. 

24 ‘‘(2) ADULT-ONLY FACILITY.—The term ‘adult25 only facility’ means a facility or restricted area 
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1 (whether open-air or enclosed) where the operator 

2 ensures or has a reasonable basis to believe (such as 

3 by checking identification as required under state 

4 law, or by checking the identification of any person 

5 appearing to be under the age of 27) that only 

6 adults are present. A facility or restricted area need 

7 not be permanently restricted to adults in order to 

8 constitute an adult-only facility, provided that the 

9 operator ensures or has a reasonable basis to believe 

10 that only adults are present during the event or time 

11 period in question. 

12 ‘‘(3) BRAND NAME.—The term ‘brand name’ 

13 means a brand name (alone or in conjunction with 

14 any other word), trademark, logo, symbol, motto, 

15 selling message, recognizable pattern of colors, or 

16 any other indicia of product identification identical 

17 or similar to, or identifiable with, those used for any 

18 domestic brand of tobacco products. The term 

19 ‘brand name’ shall not include the corporate name 

20 of any tobacco product manufacturer that does not 

21 after the date of the enactment of this chapter sell 

22 a brand of tobacco products in the United States 

23 that includes such corporate name. 

24 ‘‘(b) CIGARETTE AND SMOKELESS TOBACCO PROD25 UCT REQUIREMENTS.—
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1 ‘‘(1) MINIMUM SALES AGE.—No retailer may 

2 sell a tobacco product to any person younger than 

3 18 years of age. 

4 ‘‘(2) PROOF OF AGE.—

5 ‘‘(A) Except as otherwise provided in sub6 paragraph (B), each retailer shall verify by 

7 means of photographic identification containing 

8 the bearer’s date of birth that no person pur9 chasing the product is younger than 18 years of 

10 age. 

11 ‘‘(B) No such verification is required for 

12 any person over the age of 26. 

13 ‘‘(3) ENFORCEMENT BY THE STATES.—The 

14 Secretary may enter into an agreement with any 

15 State which has in effect a State law that is at least 

16 as restrictive as this subsection, whereby such State 

17 agrees to enforce such State law in a manner rea18 sonably designed to prevent its violation and the 

19 Secretary provides a grant to such State for the pur20 pose of enforcing such State law. No action taken by 

21 the Secretary pursuant to this paragraph shall be 

22 construed to limit the authority of the Secretary 

23 under this subsection. 

24 ‘‘(4) MAIL ORDER SALES.—After two years 

25 from the date of enactment of this chapter, the Sec-
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1 retary shall transmit to Congress a report describing 

2 the extent, if any, to which individuals younger than 

3 18 years of age are obtaining tobacco products 

4 through the mail. 

5 ‘‘(c) MINIMUM PACKAGE SIZE REQUIREMENTS.—

6 ‘‘(1) No manufacturer, distributor, or retailer 

7 may sell or cause to be sold, or distribute or cause 

8 to be distributed, any cigarette package that con9 tains fewer than 20 cigarettes. 

10 ‘‘(2) No retailer may break or otherwise open 

11 any tobacco product package to sell or distribute in12 dividual cigarettes or a number of unpackaged ciga13 rettes that is smaller than the quantity in the min14 imum cigarette package size provided in paragraph 

15 (1), or any quantity of another tobacco product that 

16 is smaller than the smallest package distributed by 

17 the manufacturer for individual consumer use. 

18 ‘‘(d) BAN ON YOUTH ACCESS TO FREE SAMPLES.—

19 ‘‘(1) No manufacturer, distributor, or retailer 

20 may distribute or cause to be distributed any free 

21 samples of tobacco products, except in an adult-only 

22 facility. 

23 ‘‘(2) For purposes of this subsection, a ‘free 

24 sample’ does not include a tobacco product that is 

25 provided to an adult in connection with—
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1 ‘‘(A) the purchase, exchange or redemption 

2 for proof of purchase of any tobacco products 

3 (including, but not limited to, a free offer in 

4 connection with the purchase of tobacco prod5 ucts, such as a ‘two-for-one’ offer), or 

6 ‘‘(B) the conducting of consumer testing or 

7 evaluation of tobacco products with persons who 

8 certify that they are adults. 

9 ‘‘(e) VENDING MACHINES, SELF-SERVICE DISPLAYS, 

10 MAIL-ORDER SALES, AND OTHER ‘IMPERSONAL’ MODES

11 OF SALE.—

12 ‘‘(1) Except as otherwise provided in paragraph 

13 (2), a retailer may sell a tobacco product only in a 

14 direct, face-to-face exchange between the retailer and 

15 the consumer. Examples of methods of sale that are 

16 not permitted include vending machines and self17 service displays. 

18 ‘‘(2) The following methods of sale are per19 mitted under this subsection: 

20 ‘‘(A) Mail-order sales, excluding mail-order 

21 redemption of coupons and distribution of free 

22 samples through the mail. 

23 ‘‘(B) Vending machines that are located in 

24 an adult-only facility.
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1 ‘‘(3) For purposes of this section, a ‘self-serv2 ice’ display means any display where the customer 

3 has access to the tobacco products without the aid 

4 of a sales clerk. 

5 ‘‘(f) PROHIBITION ON YOUTH TARGETING.—No 

6 manufacturer, distributor, or retailer may take any action, 

7 directly or indirectly, to target youth in the advertising, 

8 promotion, or marketing of tobacco products, or take any 

9 action the primary purpose of which is to initiate, main10 tain, or increase the incidence of youth smoking. For pur11 poses of this subsection, the term ‘youth’ means any per12 son or persons under 18 years of age. 

13 ‘‘(g) BAN ON USE OF CARTOONS.—

14 ‘‘(1) No manufacturer, distributor, or retailer 

15 may use or cause to be used any cartoon in the ad16 vertising, promoting, packaging, or labeling of to17 bacco products. 

18 ‘‘(2) For purposes of this subsection, the term 

19 ‘cartoon’ means any drawing or other depiction of 

20 an object, person, animal, creature, or any similar 

21 caricature that satisfies any of the following criteria: 

22 ‘‘(A) The use of comically exaggerated fea23 tures; 
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1 ‘‘(B) The attribution of human character2 istics to animals, plants, or other objects, or the 

3 similar use of anthropomorphic technique. 

4 ‘‘(C) The attribution of unnatural or 

5 extrahuman abilities, such as imperviousness to 

6 pain or injury, X-ray vision, tunneling at very 

7 high speeds, or transformation. 

8 ‘‘(3) The term ‘cartoon’ includes ‘Joe Camel,’ 

9 but does not include any drawing or other depiction 

10 that, on July 1, 1998, was in use in the United 

11 States in any manufacturer’s corporate logo or in 

12 any manufacturer’s tobacco product packaging. 

13 ‘‘(h) ELIMINATION OF OUTDOOR ADVERTISING.—

14 ‘‘(1) No manufacturer, distributor, or retailer 

15 may place or cause to be placed any outdoor adver16 tising advertising tobacco products. 

17 ‘‘(2) For purposes of this subsection, the term 

18 ‘outdoor advertising’ means—

19 ‘‘(A) billboards; 

20 ‘‘(B) signs and placards in arenas, sta21 diums, shopping malls, and video game arcades 

22 (whether any of the foregoing are open air or 

23 enclosed); and 

24 ‘‘(C) any other advertisements placed—

25 ‘‘(i) outdoors, or
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1 ‘‘(ii) on the inside surface of a window 

2 facing outward. 

3 ‘‘(D) The term ‘outdoor advertising’ does 

4 not mean—

5 ‘‘(i) an advertisement on the outside 

6 of a tobacco product manufacturing facil7 ity; 

8 ‘‘(ii) an individual advertisement that 

9 does not occupy an area larger than 14 

10 square feet (and that neither is placed in 

11 such proximity to any other such advertise12 ment so as to create a single ‘mosaic’-type 

13 advertisement larger than 14 square feet, 

14 nor functions solely as a segment of a larg15 er advertising unit or series), and that is 

16 placed on the outside of any retail estab17 lishment that sells tobacco products (other 

18 than solely through a vending machine), on 

19 the outside (but on the property of) any 

20 such establishment, or on the inside sur21 face of a window facing outward in any 

22 such establishment; or 

23 ‘‘(iii) an advertisement inside a retail 

24 establishment that sells tobacco products 

25 (other than solely through a vending ma-
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1 chine) that is not placed on the inside sur2 face of a window facing outward. 

3 ‘‘(3) For purposes of this subsection, the term 

4 ‘video game arcade’ means an entertainment estab5 lishment primarily consisting of video games (other 

6 than video games intended primarily for use by per7 sons 18 years of age or older) and/or pinball ma8 chines. 

9 ‘‘(i) ELIMINATION OF TRANSIT ADVERTISEMENTS.—

10 ‘‘(1) No manufacturer, distributor, or retailer 

11 may place or cause to be placed any transit adver12 tisements advertising tobacco products. 

13 ‘‘(2) For purposes of this subsection, the term 

14 ‘transit advertisements’ means advertising on or 

15 within private or public vehicles and all advertise16 ments placed at, on or within any bus stop, taxi 

17 stand, transportation waiting area, train station, air18 port, or any similar location. 

19 ‘‘(3) The term ‘transit advertisements’ does not 

20 include any advertisement placed in, on, or outside 

21 the premises of any retail establishment that sells 

22 tobacco products (other than solely through a vend23 ing machine), except if such individual advertise24 ment—
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1 ‘‘(A) occupies an area larger than 14 

2 square feet; 

3 ‘‘(B) is placed in such proximity to any 

4 other such advertisement so as to create a sin5 gle ‘mosaic’-type advertisement larger than 14 

6 square feet; or 

7 ‘‘(C) functions solely as a segment of a 

8 larger advertising unit or series). 

9 ‘‘(j) BAR ON ADVERTISING IN ANY YOUTH-ORI10 ENTED PUBLICATION.—

11 ‘‘(1) No manufacturer, distributor, or retailer 

12 shall advertise a tobacco product in any youth-ori13 ented publication (whether periodic or limited dis14 tribution). 

15 ‘‘(2) For purposes of this subsection, a ‘youth 

16 oriented publication’ is a newspaper, magazine, peri17 odical, or other publication—

18 ‘‘(A) whose readers younger than 18 years 

19 of age constitute more than 15 percent of the 

20 total readership as measured by competent and 

21 reliable survey evidence; or 

22 ‘‘(B) that is read by 2,000,000 or more 

23 persons younger than 18 years of age as meas24 ured by competent and reliable survey evidence.
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1 ‘‘(k) BAN ON TOBACCO PRODUCT BRAND NAME

2 SPONSORSHIPS.—

3 ‘‘(1) No manufacturer, distributor, or retailer 

4 may sponsor or cause to be sponsored any athletic, 

5 musical, artistic, or other social or cultural event, or 

6 any entry or team in any event, in the brand name 

7 (alone or in conjunction with any other word), logo, 

8 symbol, motto, selling message, recognizable color or 

9 pattern of colors, or any other indicia of product 

10 identification identical or similar to, or identifiable 

11 with, those used for any brand of cigarettes or 

12 smokeless tobacco. 

13 ‘‘(2) Nothing in this subsection shall be con14 strued to prevent a manufacturer, distributor, or re15 tailer from sponsoring or causing to be sponsored 

16 any athletic, musical, artistic, or other social or cul17 tural event, or team or entry, in the name of the 

18 corporation which manufactures the tobacco product, 

19 provided that both the corporate name and the cor20 poration were registered and in use in the United 

21 States prior to January 1, 2001, and that the cor22 porate name does not include any brand name (alone 

23 or in conjunction with any other word), logo, symbol, 

24 motto, selling message, recognizable color or pattern 

25 of colors, or any other indicia of product identifica-
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1 tion identical or similar to, or identifiable with, those 

2 used for any brand of cigarettes or smokeless to3 bacco. 

4 ‘‘(3) This subsection shall not apply to any 

5 event sponsored in an adult-only facility. 

6 ‘‘(l) BAN ON TOBACCO BRAND NAME MERCHAN7 DISE.—

8 ‘‘(1) No manufacturer may market, distribute, 

9 offer, sell, license or cause to be marketed, distrib10 uted, offered, sold, or licensed (including, without 

11 limitation, by catalogue or direct mail), any apparel 

12 or other merchandise (other than tobacco products, 

13 items the sole function of which is to advertise to14 bacco products, or written or electronic publications) 

15 which bears a brand name. 

16 ‘‘(2) Nothing in this subsection shall—

17 ‘‘(A) prohibit the distribution to any man18 ufacturer’s employee who is an adult of any 

19 item described above that is intended for the 

20 personal use of such an employee; 

21 ‘‘(B) require any manufacturer to retrieve, 

22 collect or otherwise recover any item that prior 

23 to the enactment of this chapter was marketed, 

24 distributed, offered, sold, licensed, or caused to 
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1 be marketed, distributed, offered, sold, or li2 censed by such manufacturer; 

3 ‘‘(C) apply to coupons or other items used 

4 by adults solely in connection with the purchase 

5 of tobacco products; or 

6 ‘‘(D) apply to apparel or other merchan7 dise used within an adult-only facility that is 

8 not distributed (by sale or otherwise) to any 

9 member of the general public. 

10 ‘‘(m) BAN ON GIFTS TO UNDERAGE PERSONS BASED

11 ON PROOFS OF PURCHASE.—

12 ‘‘(1) No manufacturer, distributor, or retailer 

13 may provide or cause to be provided to any person, 

14 without sufficient proof that such person is an adult, 

15 any item in exchange for the purchase of tobacco 

16 products, or the furnishing of credits, proofs-of-pur17 chase, or coupons with respect to such a purchase. 

18 ‘‘(2)(A) For purposes of paragraph (1), a driv19 er’s license or other government-issued identification 

20 (or legible photocopy thereof), the validity of which 

21 is certified by the person to whom the item is pro22 vided, shall by itself be deemed to be a sufficient 

23 form of proof of age; and 

24 ‘‘(B) In the case of items provided (or to be re25 deemed) at retail establishments, a manufacturer 
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1 shall be entitled to rely on verification of proof of 

2 age by the retailer, where such retailer is required 

3 to obtain verification under applicable Federal, State 

4 or local law. 

5 ‘‘(n) BAN ON NON-TOBACCO PRODUCT BRAND

6 NAMES.—

7 ‘‘(1) Except as provided in paragraph (2), no 

8 manufacturer may, pursuant to any agreement re9 quiring the payment of money or other valuable con10 sideration, use or cause to be used as a brand name 

11 of any tobacco product any nationally recognized or 

12 nationally established brand name or trade name of 

13 any non-tobacco item or service or any nationally 

14 recognized or nationally established sports team, en15 tertainment group, or individual celebrity. 

16 ‘‘(2) Paragraph (1) shall not apply to any to17 bacco product brand name in existence as of July 1, 

18 1998. 

19 ‘‘(3) For the purposes of this section, the term 

20 ‘other valuable consideration’ shall not include an 

21 agreement between two entities who enter into such 

22 agreement for the sole purpose of avoiding infringe23 ment claims. 

24 ‘‘(o) LIMITATION ON THIRD PARTY USE OF TO25 BACCO BRAND NAMES.—
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1 ‘‘(1) No manufacturer may license or otherwise 

2 expressly authorize any third party to use or adver3 tise any brand name in a manner prohibited by this 

4 Act if done by such manufacturer itself. 

5 ‘‘(2) Nothing in this subsection shall require 

6 any manufacturer to retrieve, collect, or otherwise 

7 recover any item that prior to the enactment of this 

8 chapter was marketed, distributed, offered, sold, li9 censed, or caused to be marketed, distributed, of10 fered, sold, or licensed by such manufacturer. 

11 ‘‘(p) BAR ON PRODUCT PLACEMENT IN CERTAIN

12 MEDIA.—

13 ‘‘(1) Except as provided in paragraph (2), no 

14 manufacturer may make, or cause to be made, any 

15 payment or other consideration to any other person 

16 or entity to use, display, make reference to, or use 

17 as a prop any tobacco product, tobacco product 

18 package, advertisement for a tobacco product, or any 

19 other item bearing a brand name in any motion pic20 ture, television show, theatrical production or other 

21 live performance, live or recorded performance of 

22 music, commercial film or video, or video game 

23 (‘media’). 

24 ‘‘(2) Paragraph (1) shall not apply to—
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1 ‘‘(A) media where the audience or viewers 

2 are within an adult-only facility (provided such 

3 media are not visible to persons outside such 

4 adult-only facility); 

5 ‘‘(B) media not intended for distribution or 

6 display to the public; or 

7 ‘‘(C) instructional media concerning non8 conventional tobacco products or tobacco prod9 ucts designated as reduced risk viewed only by 

10 or provided only to consumers who are adults. 

11 ‘‘(q) SEVERABILITY.—If any provision of this section 

12 is held invalid, those subsections, and paragraphs which 

13 are not so held shall continue to be in effect. 

14 ‘‘(r) EFFECTIVE DATES.—The provisions of this sec15 tion shall take effect on the date that is six months after 

16 the date of enactment of this section, except for the provi17 sions of subsections (e) and (k), which shall take effect 

18 on the date that is one year after the effective date of 

19 this section. 

20 ‘‘SEC. 916. MANDATORY DISCLOSURES. 

21 ‘‘(a) DISCLOSURE OF INGREDIENTS TO THE PUB22 LIC.—

23 ‘‘(1) Not later than 12 months after the effec24 tive date of this section, the Secretary shall promul25 gate regulations requiring the disclosure to the pub-
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1 lic on a brand-by-brand basis of the common or 

2 usual name of each ingredient of a tobacco product 

3 in descending order of predominance by weight, ex4 cept that spices, flavorings, and colorings may at the 

5 manufacturer’s election be designated as spices, 

6 flavorings, and colorings without naming each. Any 

7 ingredient that has been disclosed to the public pur8 suant to any other law or regulation with respect to 

9 a particular brand may be required to be disclosed 

10 for such brand pursuant to this subsection. 

11 ‘‘(2) The regulations required by this subsection 

12 shall provide that incidental additives that are 

13 present in a tobacco product at insignificant levels 

14 and that do not have any technical or functional ef15 fect in the finished tobacco product shall be exempt 

16 from disclosure. 

17 ‘‘(3) The requirement of this subsection to dis18 close ingredients in descending order of predomi19 nance shall not apply to ingredients in amounts of 

20 2 percent or less by weight when a listing of such 

21 ingredients is placed at the end of the ingredients 

22 statement following an appropriate quantifying 

23 statement, such as ‘contains ll percent or less of 

24 ll’, or ‘less than ll percent of ll’.
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1 ‘‘(4) Any disclosure required pursuant to this 

2 subsection may be required by appropriate means, 

3 except that, notwithstanding any other provision of 

4 this Act, the Secretary shall not require the listing 

5 of any ingredient on any package or in any adver6 tisement. 

7 ‘‘(b) DISCLOSURE OF PERCENTAGE OF DOMESTIC

8 AND FOREIGN TOBACCO.—Not later than 12 months after 

9 the effective date of this section, the Secretary shall pro10 mulgate regulations that require that each package of a 

11 tobacco product disclose, with respect to the tobacco con12 tained in that brand—

13 ‘‘(1) the percentage of tobacco that is domestic 

14 tobacco; and 

15 ‘‘(2) the percentage of tobacco that is foreign 

16 tobacco. 

17 ‘‘(c) MANDATORY DISCLAIMER.—

18 ‘‘(1) Any tobacco product advertising which in19 cludes a term classifying a brand of tobacco product 

20 according to its ‘tar’ yield or the yield to consumers 

21 of any substance, including but not limited to terms 

22 such as ‘light’, or ‘low tar’, shall also include the fol23 lowing disclaimer: ‘[Brand] not shown to be less 

24 hazardous than other [type of tobacco product]’. 

25 This section shall not be deemed to apply to the use 
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1 of the terms ‘filtered’ or ‘filter’. In no event shall 

2 any such disclaimer be required on any tobacco 

3 product package. 

4 ‘‘(2) In addition to the provisions of paragraph 

5 (1), not later than 12 months after the effective date 

6 of this section, the Secretary shall promulgate regu7 lations relating to the use of such terms, to ensure 

8 that they are not false or misleading. 

9 ‘‘(3) The Secretary may modify or waive any 

10 requirement under this subsection with respect to 

11 any product that has been designated by the Sec12 retary as a reduced risk product under section 

13 912.’’. 

14 SEC. 504. REGULATORY RECORD. 

15 Notwithstanding the provisions of subchapter II of 

16 chapter 5 of title 5, United States Code, in promulgating 

17 regulations under this chapter, the record developed and 

18 utilized by the Secretary for the purposes of promulgating 

19 subparts (B) and (D) of the regulations relating to the 

20 sale, distribution, and use of tobacco products on or about 

21 August 28, 1996, as reflected in articles IV and VI of the 

22 preamble to the 1996 Food and Drug Administration To23 bacco Rule (including public comments, Food and Drug 

24 Administration documents, and any other information 

25 generated or compiled for purposes of promulgating such
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1 regulations), shall be deemed to have the same legal status 

2 as if such record had been developed under a rulemaking 

3 proceeding conducted pursuant to section 906(d)(1). In all 

4 other respects, including with respect to the issue of 

5 whether such regulations conform to section 906(d)(1), 

6 the procedural requirements of this chapter and the Ad7 ministration Procedure Act will apply. 

8 SEC. 505. CONFORMING AND OTHER AMENDMENTS TO GEN9 ERAL PROVISIONS. 

10 (a) AMENDMENT OF FEDERAL FOOD, DRUG, AND

11 COSMETIC ACT.—Except as otherwise expressly provided, 

12 whenever in this section an amendment is expressed in 

13 terms of an amendment to, or repeal of, a section or other 

14 provision, the reference is to a section or other provision 

15 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

16 301 et seq.).

17 (b) SECTION 301.—Section 301 (21 U.S.C. 331) is 

18 amended—

19 (1) in subsection (a), by inserting ‘‘tobacco 

20 product,’’ after ‘‘device,’’; 

21 (2) in subsection (b), by inserting ‘‘tobacco 

22 product,’’ after ‘‘device,’’; 

23 (3) in subsection (c), by inserting ‘‘tobacco 

24 product,’’ after ‘‘device,’’; 
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1 (4) in subsection (e), by striking ‘‘515(f), or 

2 519’’ and inserting ‘‘515(f), 519, or 909’’; 

3 (5) in subsection (g), by inserting ‘‘tobacco 

4 product,’’ after ‘‘device,’’; 

5 (6) in subsection (h), by inserting ‘‘tobacco 

6 product,’’ after ‘‘device,’’; 

7 (7) in subsection (j), by striking ‘‘708, or 721’’ 

8 and inserting ‘‘708, 721, 903, 904, 905, 906, 907, 

9 908, 909, 910, or 912’’; 

10 (8) in subsection (k), by inserting ‘‘tobacco 

11 product,’’ after ‘‘device,’’; 

12 (9) by striking subsection (p) and inserting the 

13 following: 

14 ‘‘(p) The failure to register in accordance with section 

15 510 or 905, the failure to provide any information re16 quired by section 510(j), 510(k), 905(i), or 905(j), or the 

17 failure to provide a notice required by section 510(j)(2) 

18 or 905(j)(2).’’; 

19 (10) in subsection (q), by striking paragraph 

20 (1) and inserting the following: 

21 ‘‘(1) The failure or refusal—

22 ‘‘(A) to comply with any requirement prescribed 

23 under section 518, 520(g), 906(f), or 908;
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•HR 140 IH 

1 ‘‘(B) to furnish any notification or other mate2 rial or information required by or under section 519, 

3 520(g), 904, 906(f), or 909; or 

4 ‘‘(C) to comply with a requirement under sec5 tion 522.’’; 

6 (11) in subsection (q)(2), by striking ‘‘device,’’ 

7 and inserting ‘‘device or tobacco product,’’; 

8 (12) in subsection (r), by inserting ‘‘or tobacco 

9 product’’ after ‘‘device’’ each time that it appears; 

10 and 

11 (13) by adding at the end the following: 

12 ‘‘(aa) The sale of tobacco products in violation 

13 of a no-tobacco-sale order issued under section 

14 303(f).’’. 

15 (c) SECTION 303.—Section 303(f) (21 U.S.C. 333(f)) 

16 is amended—

17 (1) by striking the subsection heading and in18 serting the following: 

19 ‘‘(f) CIVIL PENALTIES; NO-TOBACCO-SALE OR20 DERS.—’’; 

21 (2) in paragraph (1)(A), by inserting ‘‘or to22 bacco products’’ after ‘‘devices’’; 

23 (3) by redesignating paragraphs (3), (4), and 

24 (5) as paragraphs (4), (5), and (6), respectively;
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1 (4) by inserting after paragraph (2) the fol2 lowing: 

3 ‘‘(3) If the Secretary finds that a person has 

4 committed repeated violations of restrictions promul5 gated under section 906(d) at a particular retail out6 let then the Secretary may impose a no-tobacco-sale 

7 order on that person prohibiting the sale of tobacco 

8 products in that outlet. A no-tobacco-sale order may 

9 be imposed with a civil penalty under paragraph 

10 (1).’’; 

11 (5) in subparagraph (A) of paragraph (4), as so 

12 redesignated—

13 (A) by striking ‘‘assessed’’ the first time it 

14 appears and inserting ‘‘assessed, or a no-to15 bacco-sale order may be imposed,’’; and 

16 (B) by striking ‘‘penalty’’ and inserting 

17 ‘‘penalty, or upon whom a no-tobacco-order is 

18 to be imposed,’’; 

19 (6) in subparagraph (B) of paragraph (4), as so 

20 redesignated—

21 (A) by inserting after ‘‘penalty,’’ the fol22 lowing: ‘‘or the period to be covered by a no-to23 bacco-sale order,’’; and 

24 (B) by adding at the end the following: ‘‘A 

25 no-tobacco-sale order permanently prohibiting 
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1 an individual retail outlet from selling tobacco 

2 products shall include provisions that allow the 

3 outlet, after a specified period of time, to re4 quest that the Secretary compromise, modify, 

5 or terminate the order.’’; 

6 (7) by adding at the end of paragraph (4), as 

7 so redesignated, the following: 

8 ‘‘(D) The Secretary may compromise, mod9 ify, or terminate, with or without conditions, 

10 any no-tobacco-sale order.’’; 

11 (8) in paragraph (5), as so redesignated—

12 (A) by striking ‘‘(3)(A)’’ and inserting 

13 ‘‘(4)(A)’’; 

14 (B) by inserting ‘‘or the imposition of a 

15 no-tobacco-sale order’’ after ‘‘penalty’’ the first 

16 2 places it appears; 

17 (C) by striking ‘‘issued.’’ and inserting 

18 ‘‘issued, or on which the no-tobacco-sale order 

19 was imposed, as the case may be.’’; and 

20 (9) in paragraph (6), as so redesignated, by 

21 striking ‘‘paragraph (4)’’ each place it appears and 

22 inserting ‘‘paragraph (5)’’. 

23 (d) SECTION 304.—Section 304 (21 U.S.C. 334) is 

24 amended—
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1 (1) in subsection (a)(2), by striking ‘‘and’’ be2 fore ‘‘(D)’’; 

3 (2) in subsection (a)(2), by striking ‘‘device.’’ 

4 and inserting a comma and the following: 

5 ‘‘(E) Any adulterated or misbranded to6 bacco product.’’; 

7 (3) in subsection (d)(1), by inserting ‘‘tobacco 

8 product,’’ after ‘‘device,’’; 

9 (4) in subsection (g)(1), by inserting ‘‘or to10 bacco product’’ after ‘‘device’’ each place it appears; 

11 and 

12 (5) in subsection (g)(2)(A), by inserting ‘‘or to13 bacco product’’ after ‘‘device’’ each place it appears. 

14 (e) SECTION 702.—Section 702(a) (21 U.S.C. 

15 372(a)) is amended—

16 (1) by inserting ‘‘(A)’’ after ‘‘(1)’’; and 

17 (2) by adding at the end thereof the following:

18 ‘‘(B) For a tobacco product, to the extent feasible, 

19 the Secretary shall contract with the States in accordance 

20 with subparagraph (A) to carry out inspections of retailers 

21 in connection with the enforcement of this Act.’’. 

22 (f) SECTION 703.—Section 703 (21 U.S.C. 373) is 

23 amended—

24 (1) by inserting ‘‘tobacco product,’’ after ‘‘de25 vice,’’ each place it appears; and 
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1 (2) by inserting ‘‘tobacco products,’’ after ‘‘de2 vices,’’ each place it appears. 

3 (g) SECTION 704.—Section 704 (21 U.S.C. 374) is 

4 amended—

5 (1) in subsection (a)(1)(A), by inserting ‘‘to6 bacco products,’’ after ‘‘devices,’’ each place it ap7 pears; 

8 (2) in subsection (a)(1)(B), by inserting ‘‘or to9 bacco products’’ after ‘‘restricted devices’’ each place 

10 it appears; and 

11 (3) in subsection (b), by inserting ‘‘tobacco 

12 product,’’ after ‘‘device,’’. 

13 (h) SECTION 705.—Section 705(b) (21 U.S.C. 

14 375(b)) is amended by inserting ‘‘tobacco products,’’ after 

15 ‘‘devices,’’. 

16 (i) SECTION 709.—Section 709 (21 U.S. C. 379) is 

17 amended by inserting ‘‘or tobacco product’’ after ‘‘device’’. 

18 (j) SECTION 801.—Section 801 (21 U.S.C. 381) is 

19 amended—

20 (1) in subsection (a), by inserting ‘‘tobacco 

21 products,’’ after ‘‘devices,’’ the first time it appears; 

22 (2) in subsection (a), by inserting ‘‘or sub23 section (j) of section 905’’ after ‘‘section 510’’;
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1 (3) in subsection (a), by striking ‘‘drugs or de2 vices’’ each time it appears and inserting ‘‘drugs, de3 vices, or tobacco products’’; and 

4 (4) in subsection (e)(1), by inserting ‘tobacco 

5 product’ after ‘device’. 

6 (k) SECTION 1003.—Section 1003(d)(2)(C) (as re7 designated by section 101(a)) is amended—

8 (1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 

9 (2) inserting a comma and ‘‘and tobacco prod10 ucts’’ after ‘‘devices’’. 

11 (l) EFFECTIVE DATE FOR NO-TOBACCO-SALE

12 ORDER AMENDMENTS.—The amendments made by sub13 section (c), other than the amendment made by paragraph 

14 (2) thereof, shall take effect only upon the promulgation 

15 of final regulations by the Secretary—

16 (1) defining the term ‘‘repeated violation’’, as 

17 used in section 303(f) of the Federal Food, Drug, 

18 and Cosmetic Act (21 U.S.C. 333(f)) as amended by 

19 subsection (c), by identifying the number of viola20 tions of particular requirements over a specified pe21 riod of time that constitute a repeated violation; 

22 (2) providing for notice to the retailer of each 

23 violation at a particular retail outlet; 

24 (3) providing that a person may not be charged 

25 with repeated violations at a particular retail outlet
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1 unless the Secretary has provided notice of previous 

2 violations at that outlet; 

3 (4) establishing a period of time during which, 

4 if there are no violations by a particular retail out5 let, that outlet will not be considered to have been 

6 the site of repeated violations when the next viola7 tion occurs; and 

8 (5) providing that good faith reliance on false 

9 identification does not constitute a violation of any 

10 minimum age requirement for the sale of tobacco 

11 products. 

12 SEC. 506. CIGARETTE LABEL AND ADVERTISING WARNINGS. 

13 Section 4 of the Federal Cigarette Labeling and Ad14 vertising Act (15 U.S.C. 1333) is amended to read as fol15 lows: 

16 ‘‘SEC. 4. LABELING. 

17 ‘‘(a) LABEL REQUIREMENTS.—

18 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

19 person to manufacture, package, or import for sale 

20 or distribution within the United States any ciga21 rettes the package of which fails to bear, in accord22 ance with the requirements of this section, one of 

23 the following labels: 

24 ‘‘WARNING: Cigarettes are addictive’’
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1 ‘‘WARNING: Tobacco smoke can harm your chil2 dren’’

3 ‘‘WARNING: Cigarettes cause fatal lung disease’’

4 ‘‘WARNING: Cigarettes cause cancer’’

5 ‘‘WARNING: Cigarettes cause strokes and heart 

6 disease’’

7 ‘‘WARNING: Smoking during pregnancy can harm 

8 your baby’’

9 ‘‘WARNING: Smoking can kill you’’

10 ‘‘WARNING: Tobacco smoke causes fatal lung dis11 ease in non-smokers’’

12 ‘‘WARNING: Quitting smoking now greatly reduces 

13 serious risks to your health’’

14 ‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—

15 ‘‘(A) IN GENERAL.—Each label statement 

16 required by paragraph (1) shall be located in 

17 the upper portion of the front and rear panels 

18 of the package, directly on the package under19 neath the cellophane or other clear wrapping. 

20 Except as provided in subparagraph (B), each 

21 label statement shall comprise at least the top 

22 25 percent of the front and rear panels of the 

23 package. The word ‘‘WARNING’’ shall appear 

24 in capital letters and all text shall be in con25 spicuous and legible 17-point type, unless the
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1 text of the label statement would occupy more 

2 than 70 percent of such area, in which case the 

3 text may be in a smaller conspicuous and leg4 ible type size, provided that at least 60 percent 

5 of such area is occupied by required text. The 

6 text shall be black on a white background, or 

7 white on a black background, in a manner that 

8 contrasts, by typography, layout, or color, with 

9 all other printed material on the package, in an 

10 alternating fashion under the plan submitted 

11 under subsection (b)(4). 

12 ‘‘(B) FLIP-TOP BOXES.—For any cigarette 

13 brand package manufactured or distributed be14 fore January 1, 2000, which employs a flip-top 

15 style (if such packaging was used for that 

16 brand in commerce prior to June 21, 1997), the 

17 label statement required by paragraph (1) shall 

18 be located on the flip-top area of the package, 

19 even if such area is less than 25 percent of the 

20 area of the front panel. Except as provided in 

21 this paragraph, the provisions of this subsection 

22 shall apply to such packages.

23 ‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU24 TION.—The provisions of this subsection do not 

25 apply to a tobacco product manufacturer or dis-
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1 tributor of cigarettes which does not manufacture, 

2 package, or import cigarettes for sale or distribution 

3 within the United States. 

4 ‘‘(b) ADVERTISING REQUIREMENTS.—

5 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

6 tobacco product manufacturer, importer, distributor, 

7 or retailer of cigarettes to advertise or cause to be 

8 advertised within the United States any cigarette 

9 unless its advertising bears, in accordance with the 

10 requirements of this section, one of the labels speci11 fied in subsection (a) of this section. 

12 ‘‘(2) TYPOGRAPHY, ETC.—Each label statement 

13 required by subsection (a) of this section in cigarette 

14 advertising shall comply with the standards set forth 

15 in this paragraph. For press and poster advertise16 ments, each such statement and (where applicable) 

17 any required statement relating to tar, nicotine, or 

18 other constituent yield shall comprise at least 20 

19 percent of the area of the advertisement and shall 

20 appear in a conspicuous and prominent format and 

21 location at the top of each advertisement within the 

22 trim area. The Secretary may revise the required 

23 type sizes in such area in such manner as the Sec24 retary determines appropriate. The word ‘‘WARN25 ING’’ shall appear in capital letters, and each label
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1 statement shall appear in conspicuous and legible 

2 type. The text of the label statement shall be black 

3 if the background is white and white if the back4 ground is black, under the plan submitted under 

5 paragraph (4) of this subsection. The label state6 ments shall be enclosed by a rectangular border that 

7 is the same color as the letters of the statements 

8 and that is the width of the first downstroke of the

9 capital ‘‘W’’ of the word ‘‘WARNING’’ in the label 

10 statements. The text of such label statements shall 

11 be in a typeface pro rata to the following require12 ments: 45-point type for a whole-page broadsheet 

13 newspaper advertisement; 39-point type for a half14 page broadsheet newspaper advertisement; 39-point 

15 type for a whole-page tabloid newspaper advertise16 ment; 27-point type for a half-page tabloid news17 paper advertisement; 31.5-point type for a double 

18 page spread magazine or whole-page magazine ad19 vertisement; 22.5-point type for a 28 centimeter by 

20 3 column advertisement; and 15-point type for a 20 

21 centimeter by 2 column advertisement. The label 

22 statements shall be in English, except that in the 

23 case of—

24 ‘‘(A) an advertisement that appears in a 

25 newspaper, magazine, periodical, or other publi-
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1 cation that is not in English, the statements 

2 shall appear in the predominant language of the 

3 publication; and 

4 ‘‘(B) in the case of any other advertise5 ment that is not in English, the statements 

6 shall appear in the same language as that prin7 cipally used in the advertisement. 

8 ‘‘(3) ADJUSTMENT BY SECRETARY.—The Sec9 retary may, through a rulemaking under section 553 

10 of title 5, United States Code, adjust the format and 

11 type sizes for the label statements required by this 

12 section or the text, format, and type sizes of any re13 quired tar, nicotine yield, or other constituent disclo14 sures, or to establish the text, format, and type sizes 

15 for any other disclosures required under the Federal 

16 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

17 seq.). The text of any such label statements or dis18 closures shall be required to appear only within the 

19 20 percent area of cigarette advertisements provided 

20 by paragraph (2) of this subsection. The Secretary 

21 shall promulgate regulations which provide for ad22 justments in the format and type sizes of any text 

23 required to appear in such area to ensure that the 

24 total text required to appear by law will fit within 

25 such area. 
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1 ‘‘(4) MARKETING REQUIREMENTS.—

2 ‘‘(A) The label statements specified in sub3 section (a)(1) shall be randomly displayed in 

4 each 12-month period, in as equal a number of 

5 times as is possible on each brand of the prod6 uct and be randomly distributed in all areas of 

7 the United States in which the product is mar8 keted in accordance with a plan submitted by 

9 the tobacco product manufacturer, importer, 

10 distributor, or retailer and approved by the Sec11 retary. 

12 ‘‘(B) The label statements specified in sub13 section (a)(1) shall be rotated quarterly in al14 ternating sequence in advertisements for each 

15 brand of cigarettes in accordance with a plan 

16 submitted by the tobacco product manufacturer, 

17 importer, distributor, or retailer to, and ap18 proved by, the Secretary. 

19 ‘‘(C) The Secretary shall review each plan 

20 submitted under subparagraph (B) and approve 

21 it if the plan—

22 ‘‘(i) will provide for the equal distribu23 tion and display on packaging and the ro24 tation required in advertising under this 

25 subsection; and
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1 ‘‘(ii) assures that all of the labels re2 quired under this section will be displayed 

3 by the tobacco product manufacturer, im4 porter, distributor, or retailer at the same 

5 time.’’. 

6 SEC. 507. AUTHORITY TO REVISE CIGARETTE WARNING 

7 LABEL STATEMENTS. 

8 Section 4 of the Federal Cigarette Labeling and Ad9 vertising Act (15 U.S.C. 1333), as amended by section 

10 506, is further amended by adding at the end the fol11 lowing: 

12 ‘‘(c) CHANGE IN REQUIRED STATEMENTS.—The Sec13 retary may, by a rulemaking conducted under section 553 

14 of title 5, United States Code, adjust the format, type size, 

15 and text of any of the warning label statements required 

16 by subsection (a) of this section subject to the limitation 

17 on proportional size of the warning contained in sub18 sections (a)(2) and (b)(2), or establish the format, type 

19 size, and text of any other disclosures required under the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 

21 et seq.), if the Secretary finds that such a change would 

22 promote greater public understanding of the risks associ23 ated with the use of smokeless tobacco products.’’.
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1 SEC. 508. SMOKELESS TOBACCO LABELS AND ADVERTISING 

2 WARNINGS. 

3 Section 3 of the Comprehensive Smokeless Tobacco 

4 Health Education Act of 1986 (15 U.S.C. 4402) is amend5 ed to read as follows: 

6 ‘‘SEC. 3. SMOKELESS TOBACCO WARNING. 

7 ‘‘(a) GENERAL RULE.— 

8 ‘‘(1) It shall be unlawful for any person to man9 ufacture, package, or import for sale or distribution 

10 within the United States any smokeless tobacco 

11 product unless the product package bears, in accord12 ance with the requirements of this Act, one of the 

13 following labels: 

14 ‘‘WARNING: This product can cause mouth cancer’’

15 ‘‘WARNING: This product can cause gum disease 

16 and tooth loss’’

17 ‘‘WARNING: This product is not a safe alternative 

18 to cigarettes’’

19 ‘‘WARNING: Smokeless tobacco is addictive’’

20 ‘‘(2) Each label statement required by para21 graph (1) shall be—

22 ‘‘(A) located on the 2 principal display 

23 panels of the package, and each label statement 

24 shall comprise at least 25 percent of each such 

25 display panel; and
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1 ‘‘(B) in 17-point conspicuous and legible 

2 type and in black text on a white background, 

3 or white text on a black background, in a man4 ner that contrasts by typography, layout, or 

5 color, with all other printed material on the 

6 package, in an alternating fashion under the 

7 plan submitted under subsection (b)(3), except 

8 that if the text of a label statement would oc9 cupy more than 70 percent of the area specified

10 by subparagraph (A), such text may appear in 

11 a smaller type size, so long as at least 60 per12 cent of such warning area is occupied by the 

13 label statement. 

14 ‘‘(3) The label statements required by para15 graph (1) shall be introduced by each tobacco prod16 uct manufacturer, packager, importer, distributor, or 

17 retailer of smokeless tobacco products concurrently 

18 into the distribution chain of such products. 

19 ‘‘(4) The provisions of this subsection do not 

20 apply to a tobacco product manufacturer or dis21 tributor of any smokeless tobacco product that does 

22 not manufacture, package, or import smokeless to23 bacco products for sale or distribution within the 

24 United States. 

25 ‘‘(b) REQUIRED LABELS.—
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1 ‘‘(1) It shall be unlawful for any tobacco prod2 uct manufacturer, packager, importer, distributor, or 

3 retailer of smokeless tobacco products to advertise or 

4 cause to be advertised within the United States any 

5 smokeless tobacco product unless its advertising 

6 bears, in accordance with the requirements of this 

7 section, one of the labels specified in subsection (a). 

8 ‘‘(2) Each label statement required by sub9 section (a) in smokeless tobacco advertising shall 

10 comply with the standards set forth in this para11 graph. For press and poster advertisements, each 

12 such statement and (where applicable) any required 

13 statement relating to tar, nicotine, or other con14 stituent yield shall—

15 ‘‘(A) comprise at least 20 percent of the 

16 area of the advertisement, and the warning area 

17 shall be delineated by a dividing line of con18 trasting color from the advertisement; and 

19 ‘‘(B) the word ‘‘WARNING’’ shall appear 

20 in capital letters and each label statement shall 

21 appear in conspicuous and legible type. The text 

22 of the label statement shall be black on a white 

23 background, or white on a black background, in 

24 an alternating fashion under the plan submitted 

25 under paragraph (3).
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1 ‘‘(3)(A) The label statements specified in sub2 section (a)(1) shall be randomly displayed in each 

3 12-month period, in as equal a number of times as 

4 is possible on each brand of the product and be ran5 domly distributed in all areas of the United States 

6 in which the product is marketed in accordance with 

7 a plan submitted by the tobacco product manufac8 turer, importer, distributor, or retailer and approved 

9 by the Secretary. 

10 ‘‘(B) The label statements specified in sub11 section (a)(1) shall be rotated quarterly in alter12 nating sequence in advertisements for each brand of 

13 smokeless tobacco product in accordance with a plan 

14 submitted by the tobacco product manufacturer, im15 porter, distributor, or retailer to, and approved by, 

16 the Secretary. 

17 ‘‘(C) The Secretary shall review each plan sub18 mitted under subparagraph (B) and approve it if the 

19 plan—

20 ‘‘(i) will provide for the equal distribution 

21 and display on packaging and the rotation re22 quired in advertising under this subsection; and

23 ‘‘(ii) assures that all of the labels required 

24 under this section will be displayed by the to-
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1 bacco product manufacturer, importer, dis2 tributor, or retailer at the same time. 

3 ‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is 

4 unlawful to advertise smokeless tobacco on any medium 

5 of electronic communications subject to the jurisdiction of 

6 the Federal Communications Commission.’’. 

7 SEC. 509. AUTHORITY TO REVISE SMOKELESS TOBACCO 

8 PRODUCT WARNING LABEL STATEMENTS. 

9 Section 3 of the Comprehensive Smokeless Tobacco 

10 Health Education Act of 1986 (15 U.S.C. 4402), as 

11 amended by section 508, is further amended by adding 

12 at the end the following: 

13 ‘‘(d) AUTHORITY TO REVISE WARNING LABEL

14 STATEMENTS.—The Secretary may, by a rulemaking con15 ducted under section 553 of title 5, United States Code, 

16 adjust the format, type size, and text of any of the warn17 ing label statements required by subsection (a) of this sec18 tion, subject to the limitations on proportional size of the 

19 warning contained in paragraphs (2) and (3) of subsection 

20 (a), or establish the format, type size, and text of any 

21 other disclosures required under the Federal Food, Drug, 

22 and Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary 

23 finds that such a change would promote greater public un24 derstanding of the risks associated with the use of smoke25 less tobacco products.’’.
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1 SEC. 510. TAR, NICOTINE, AND OTHER SMOKE CON2 STITUENT DISCLOSURE TO THE PUBLIC. 

3 Section 4(a) of the Federal Cigarette Labeling and 

4 Advertising Act (15 U.S.C. 1333(a)), as amended by sec5 tion 506, is further amended by adding at the end the 

6 following: 

7 ‘‘(4)(A) The Secretary shall, by a rulemaking 

8 conducted under section 553 of title 5, United 

9 States Code, determine (in the Secretary’s sole dis10 cretion) whether cigarette and other tobacco product 

11 manufacturers shall be required to include in the 

12 area of each cigarette advertisement specified by 

13 subsection (b) of this section, or on the package 

14 label, or both, the tar and nicotine yields of the ad15 vertised or packaged brand. Any such disclosure 

16 shall be in accordance with the methodology estab17 lished under such regulations, shall conform to the 

18 type size requirements of subsection (b) of this sec19 tion, and shall appear within the area specified in 

20 subsection (b) of this section. 

21 ‘‘(B) Any differences between the requirements 

22 established by the Secretary under subparagraph (A) 

23 and tar and nicotine yield reporting requirements es24 tablished by the Federal Trade Commission shall be 

25 resolved by a memorandum of understanding be-
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1 tween the Secretary and the Federal Trade Commis2 sion. 

3 ‘‘(C) In addition to the disclosures required by 

4 subparagraph (A) of this paragraph, the Secretary 

5 may, under a rulemaking conducted under section 

6 553 of title 5, United States Code, prescribe disclo7 sure requirements regarding the level of any ciga8 rette or other tobacco product smoke constituent. 

9 Any such disclosure may be required if the Secretary 

10 determines that disclosure would be of benefit to the 

11 public health, or otherwise would increase consumer 

12 awareness of the health consequences of the use of 

13 tobacco products, except that no such prescribed dis14 closure shall be required on the face of any cigarette 

15 package or advertisement. Nothing in this section 

16 shall prohibit the Secretary from requiring such pre17 scribed disclosure through a cigarette or other to18 bacco product package or advertisement insert, or by 

19 any other means under the Federal Food, Drug, and 

20 Cosmetic Act (21 U.S.C. 301 et seq.).’’. 

21 SEC. 511. REGULATION REQUIREMENT. 

22 (a) TESTING, REPORTING, AND DISCLOSURE.—Not 

23 later than 24 months after the date of enactment of this 

24 Act, the Secretary, through the Commissioner of Food and 

25 Drugs, shall promulgate regulations under the Federal 
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1 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 

2 that meet the requirements of subsection (b) of this sec3 tion. 

4 (b) CONTENTS OF RULES.—The rules promulgated 

5 under subsection (a) shall require the testing, reporting, 

6 and disclosure of tobacco product smoke constituents and 

7 ingredients that the Secretary determines should be dis8 closed to the public in order to protect the public health. 

9 Such constituents shall include tar, nicotine, carbon mon10 oxide, and such other smoke constituents or ingredients 

11 as the Secretary may determine to be appropriate. The 

12 rule may require that tobacco product manufacturers, 

13 packagers, or importers make such disclosures relating to 

14 tar and nicotine through labels or advertising, and make 

15 such disclosures regarding other smoke constituents or in16 gredients as the Secretary determines are necessary to 

17 protect the public health. 

18 (c) AUTHORITY.—The Food and Drug Administra19 tion shall have authority to conduct or to require the test20 ing, reporting, or disclosure of tobacco product smoke con21 stituents. 

22 SEC. 512. FTC JURISDICTION NOT AFFECTED. 

23 (a) IN GENERAL.—Except where expressly provided 

24 in this Act, nothing in this Act shall be construed as lim25 iting or diminishing the authority of the Federal Trade 
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1 Commission to enforce the laws under its jurisdiction with 

2 respect to the advertising, sale, or distribution of tobacco 

3 products. 

4 (b) ENFORCEMENT BY FTC.—Any advertising that 

5 violates this Act is an unfair or deceptive act or practice 

6 under section 5(a) of the Federal Trade Commission Act 

7 (15 U.S.C. 45(a)) and shall be considered a violation of 

8 a rule promulgated under section 18 of that Act (15 

9 U.S.C. 57a).

Æ