I 

110TH CONGRESS 

1ST SESSION H. R. 1108 

To protect the public health by providing the Food and Drug Administration 

with certain authority to regulate tobacco products. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 15, 2007 

Mr. WAXMAN (for himself, Mr. TOM DAVIS of Virginia, Mr. DINGELL, Mr. 

PALLONE, Mr. ABERCROMBIE, Mr. ACKERMAN, Mr. ALLEN, Ms. BALDWIN, Mr. BARTLETT of Maryland, Mr. BLUMENAUER, Ms. BORDALLO, 

Mrs. CAPPS, Mr. CAPUANO, Mr. CASTLE, Mrs. CHRISTENSEN, Mr. 

CUMMINGS, Mr. DAVIS of Illinois, Mrs. DAVIS of California, Ms. 

DEGETTE, Mr. DELAHUNT, Ms. DELAURO, Mr. ELLISON, Mr. EMANUEL, Mrs. EMERSON, Mr. ENGEL, Ms. ESHOO, Mr. FERGUSON, Mr. FILNER, Mr. FRANK of Massachusetts, Ms. GIFFORDS, Mr. GENE GREEN of 

Texas, Mr. GRIJALVA, Mr. GUTIERREZ, Mr. HIGGINS, Mr. HINCHEY, Ms. 

HIRONO, Mr. HOLT, Mr. HONDA, Mr. INSLEE, Mr. ISRAEL, Mr. JACKSON

of Illinois, Ms. JACKSON-LEE of Texas, Mr. KENNEDY, Mr. KILDEE, Mr. 

KING of New York, Mr. KIRK, Mr. LAHOOD, Mr. LANTOS, Mr. LARSEN

of Washington, Mr. LARSON of Connecticut, Ms. LEE, Mr. LEWIS of 

Georgia, Mr. LIPINSKI, Mr. LOBIONDO, Ms. ZOE LOFGREN of California, 

Mr. LYNCH, Mrs. MCCARTHY of New York, Ms. MCCOLLUM of Minnesota, Mr. MCDERMOTT, Mr. MCGOVERN, Mr. MCNULTY, Mrs. 

MALONEY of New York, Mr. MARKEY, Mr. MATHESON, Ms. MATSUI, Mr. 

MEEHAN, Mr. MICHAUD, Mrs. MILLER of Michigan, Mr. GEORGE MILLER of California, Mr. MOORE of Kansas, Mr. MORAN of Virginia, Mr. 

NADLER, Ms. NORTON, Mr. OBERSTAR, Mr. OLVER, Mr. PASCRELL, Mr. 

PAYNE, Mr. PLATTS, Ms. PRYCE of Ohio, Mr. RAMSTAD, Mr. REICHERT, 

Mr. ROTHMAN, Mr. RUSH, Ms. SCHAKOWSKY, Ms. SCHWARTZ, Mr. 

SHERMAN, Mr. SMITH of New Jersey, Ms. SOLIS, Mr. STARK, Mrs. 

TAUSCHER, Mr. TERRY, Mr. TIBERI, Mr. VAN HOLLEN, Mr. WALDEN of 

Oregon, Mr. WEINER, Mr. WELLER of Illinois, Mr. WEXLER, and Mr. 

WYNN) introduced the following bill; which was referred to the Committee 

on Energy and Commerce 


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A BILL 

To protect the public health by providing the Food and 

Drug Administration with certain authority to regulate 

tobacco products. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

5 ‘‘Family Smoking Prevention and Tobacco Control Act’’. 

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

7 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 

Sec. 3. Purpose. 

Sec. 4. Scope and effect. 

Sec. 5. Severability. 

TITLE I—AUTHORITY OF THE FOOD AND DRUG 

ADMINISTRATION 

Sec. 101. Amendment of Federal food, drug, and Cosmetic Act. 

Sec. 102. Final rule. 

Sec. 103. Conforming and other amendments to general provisions. 

TITLE II—TOBACCO PRODUCT WARNINGS; CONSTITUENT AND 

SMOKE CONSTITUENT DISCLOSURE 

Sec. 201. Cigarette label and advertising warnings. 

Sec. 202. Authority to revise cigarette warning label statements. 

Sec. 203. State regulation of cigarette advertising and promotion. 

Sec. 204. Smokeless Tobacco labels and advertising warnings. 

Sec. 205. Authority to revise Smokeless Tobacco product warning label statements. 

Sec. 206. Tar, Nicotine, and other smoke constituent disclosure to the public. 

TITLE III—PREVENTION OF ILLICIT TRADE IN TOBACCO 

PRODUCTS 

Sec. 301. Labeling, recordkeeping, records inspection. 

Sec. 302. Study and report. 


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1 SEC. 2. FINDINGS. 

2 The Congress finds the following: 

3 (1) The use of tobacco products by the Nation’s 

4 children is a pediatric disease of considerable pro5 portions that results in new generations of tobacco6 dependent children and adults. 

7 (2) A consensus exists within the scientific and 

8 medical communities that tobacco products are in9 herently dangerous and cause cancer, heart disease, 

10 and other serious adverse health effects. 

11 (3) Nicotine is an addictive drug. 

12 (4) Virtually all new users of tobacco products 

13 are under the minimum legal age to purchase such 

14 products. 

15 (5) Tobacco advertising and marketing con16 tribute significantly to the use of nicotine-containing 

17 tobacco products by adolescents. 

18 (6) Because past efforts to restrict advertising 

19 and marketing of tobacco products have failed ade20 quately to curb tobacco use by adolescents, com21 prehensive restrictions on the sale, promotion, and 

22 distribution of such products are needed. 

23 (7) Federal and State governments have lacked 

24 the legal and regulatory authority and resources 

25 they need to address comprehensively the public 


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1 health and societal problems caused by the use of to2 bacco products. 

3 (8) Federal and State public health officials, 

4 the public health community, and the public at large 

5 recognize that the tobacco industry should be subject 

6 to ongoing oversight. 

7 (9) Under article I, section 8 of the Constitu8 tion, the Congress is vested with the responsibility 

9 for regulating interstate commerce and commerce 

10 with Indian tribes. 

11 (10) The sale, distribution, marketing, adver12 tising, and use of tobacco products are activities in 

13 and substantially affecting interstate commerce be14 cause they are sold, marketed, advertised, and dis15 tributed in interstate commerce on a nationwide 

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

17 economy. 

18 (11) The sale, distribution, marketing, adver19 tising, and use of such products substantially affect 

20 interstate commerce through the health care and 

21 other costs attributable to the use of tobacco prod22 ucts. 

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

24 enact legislation that provides the Food and Drug 

25 Administration with the authority to regulate toVerDate Aug 31 2005 03:42 Feb 21, 2007 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1108.IH H1108

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1 bacco products and the advertising and promotion of 

2 such products. The benefits to the American people 

3 from enacting such legislation would be significant 

4 in human and economic terms. 

5 (13) Tobacco use is the foremost preventable 

6 cause of premature death in America. It causes over 

7 400,000 deaths in the United States each year and 

8 approximately 8,600,000 Americans have chronic ill9 nesses related to smoking. 

10 (14) Reducing the use of tobacco by minors by 

11 50 percent would prevent well over 10,000,000 of to12 day’s children from becoming regular, daily smokers, 

13 saving over 3,000,000 of them from premature 

14 death due to tobacco induced disease. Such a reduc15 tion in youth smoking would also result in approxi16 mately $75,000,000,000 in savings attributable to 

17 reduced health care costs. 

18 (15) 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 (16) In 2003, the cigarette manufacturers 

2 spent more than $15,000,000,000 to attract new 

3 users, retain current users, increase current con4 sumption, and generate favorable long-term atti5 tudes toward smoking and tobacco use. 

6 (17) Tobacco product advertising often 

7 misleadingly portrays the use of tobacco as socially 

8 acceptable and healthful to minors. 

9 (18) Tobacco product advertising is regularly 

10 seen by persons under the age of 18, and persons 

11 under the age of 18 are regularly exposed to tobacco 

12 product promotional efforts. 

13 (19) Through advertisements during and spon14 sorship of sporting events, tobacco has become 

15 strongly associated with sports and has become por16 trayed as an integral part of sports and the healthy 

17 lifestyle associated with rigorous sporting activity. 

18 (20) Children are exposed to substantial and 

19 unavoidable tobacco advertising that leads to favor20 able beliefs about tobacco use, plays a role in leading 

21 young people to overestimate the prevalence of to22 bacco use, and increases the number of young people 

23 who begin to use tobacco. 

24 (21) The use of tobacco products in motion pic25 tures and other mass media glamorizes its use for 


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1 young people and encourages them to use tobacco 

2 products. 

3 (22) Tobacco advertising expands the size of 

4 the tobacco market by increasing consumption of to5 bacco products including tobacco use by young peo6 ple. 

7 (23) Children are more influenced by tobacco 

8 marketing than adults: more than 80 percent of 

9 youth smoke three heavily marketed brands, while 

10 only 54 percent of adults, 26 and older, smoke these 

11 same brands. 

12 (24) Tobacco company documents indicate that 

13 young people are an important and often crucial seg14 ment of the tobacco market. Children, who tend to 

15 be more price-sensitive than adults, are influenced 

16 by advertising and promotion practices that result in 

17 drastically reduced cigarette prices. 

18 (25) Comprehensive advertising restrictions will 

19 have a positive effect on the smoking rates of young 

20 people. 

21 (26) Restrictions on advertising are necessary 

22 to prevent unrestricted tobacco advertising from un23 dermining legislation prohibiting access to young 

24 people and providing for education about tobacco 

25 use. 


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1 (27) International experience shows that adver2 tising regulations that are stringent and comprehen3 sive have a greater impact on overall tobacco use 

4 and young people’s use than weaker or less com5 prehensive ones. 

6 (28) Text only requirements, although not as 

7 stringent as a ban, will help reduce underage use of 

8 tobacco products while preserving the informational 

9 function of advertising. 

10 (29) It is in the public interest for Congress to 

11 adopt legislation to address the public health crisis 

12 created by actions of the tobacco industry. 

13 (30) The final regulations promulgated by the 

14 Secretary of Health and Human Services in the Au15 gust 28, 1996, issue of the Federal Register (61 

16 Fed. Reg. 44615–44618) for inclusion as part 897 

17 of title 21, Code of Federal Regulations, are con18 sistent with the First Amendment to the United 

19 States Constitution and with the standards set forth 

20 in the amendments made by this subtitle for the reg21 ulation of tobacco products by the Food and Drug 

22 Administration and the restriction on the sale and 

23 distribution, including access to and the advertising 

24 and promotion of, tobacco products contained in 


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1 such regulations are substantially related to accom2 plishing the public health goals of this Act. 

3 (31) The regulations described in paragraph 

4 (30) will directly and materially advance the Federal 

5 Government’s substantial interest in reducing the 

6 number of children and adolescents who use ciga7 rettes and smokeless tobacco and in preventing the 

8 life-threatening health consequences associated with 

9 tobacco use. An overwhelming majority of Americans 

10 who use tobacco products begin using such products 

11 while they are minors and become addicted to the 

12 nicotine in those products before reaching the age of 

13 18. Tobacco advertising and promotion plays a cru14 cial role in the decision of these minors to begin 

15 using tobacco products. Less restrictive and less 

16 comprehensive approaches have not and will not be 

17 effective in reducing the problems addressed by such 

18 regulations. The reasonable restrictions on the ad19 vertising and promotion of tobacco products con20 tained in such regulations will lead to a significant 

21 decrease in the number of minors using and becom22 ing addicted to those products. 

23 (32) The regulations described in paragraph 

24 (30) impose no more extensive restrictions on com25 munication by tobacco manufacturers and sellers 


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1 than are necessary to reduce the number of children 

2 and adolescents who use cigarettes and smokeless to3 bacco and to prevent the life-threatening health con4 sequences associated with tobacco use. Such regula5 tions are narrowly tailored to restrict those adver6 tising and promotional practices which are most like7 ly to be seen or heard by youth and most likely to 

8 entice them into tobacco use, while affording tobacco 

9 manufacturers and sellers ample opportunity to con10 vey information about their products to adult con11 sumers. 

12 (33) Tobacco dependence is a chronic disease, 

13 one that typically requires repeated interventions to 

14 achieve long-term or permanent abstinence. 

15 (34) Because the only known safe alternative to 

16 smoking is cessation, interventions should target all 

17 smokers to help them quit completely. 

18 (35) Tobacco products have been used to facili19 tate and finance criminal activities both domestically 

20 and internationally. Illicit trade of tobacco products 

21 has been linked to organized crime and terrorist 

22 groups. 

23 (36) It is essential that the Food and Drug Ad24 ministration review products sold or distributed for 

25 use to reduce risks or exposures associated with toVerDate Aug 31 2005 03:42 Feb 21, 2007 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H1108.IH H1108

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1 bacco products and that it be empowered to review 

2 any advertising and labeling for such products. It is 

3 also essential that manufacturers, prior to marketing 

4 such products, be required to demonstrate that such 

5 products will meet a series of rigorous criteria, and 

6 will benefit the health of the population as a whole, 

7 taking into account both users of tobacco products 

8 and persons who do not currently use tobacco prod9 ucts. 

10 (37) Unless tobacco products that purport to 

11 reduce the risks to the public of tobacco use actually 

12 reduce such risks, those products can cause substan13 tial harm to the public health to the extent that the 

14 individuals, who would otherwise not consume to15 bacco products or would consume such products less, 

16 use tobacco products purporting to reduce risk. 

17 Those who use products sold or distributed as modi18 fied risk products that do not in fact reduce risk, 

19 rather than quitting or reducing their use of tobacco 

20 products, have a substantially increased likelihood of 

21 suffering disability and premature death. The costs 

22 to society of the widespread use of products sold or 

23 distributed as modified risk products that do not in 

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1 sands of unnecessary deaths and injuries and huge 

2 costs to our health care system. 

3 (38) As the National Cancer Institute has 

4 found, many smokers mistakenly believe that ‘‘low 

5 tar’’ and ‘‘light’’ cigarettes cause fewer health prob6 lems than other cigarettes. As the National Cancer 

7 Institute has also found, mistaken beliefs about the 

8 health consequences of smoking ‘‘low tar’’ and 

9 ‘‘light’’ cigarettes can reduce the motivation to quit 

10 smoking entirely and thereby lead to disease and 

11 death. 

12 (39) Recent studies have demonstrated that 

13 there has been no reduction in risk on a population14 wide basis from ‘‘low tar’’ and ‘‘light’’ cigarettes and 

15 such products may actually increase the risk of to16 bacco use. 

17 (40) The dangers of products sold or distrib18 uted as modified risk tobacco products that do not 

19 in fact reduce risk are so high that there is a com20 pelling governmental interest in insuring that state21 ments about modified risk tobacco products are com22 plete, accurate, and relate to the overall disease risk 

23 of the product. 

24 (41) As the Federal Trade Commission has 

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1 ments in which one product is claimed to be less 

2 harmful than a comparable product, even in the 

3 presence of disclosures and advisories intended to 

4 provide clarification. 

5 (42) Permitting manufacturers to make unsub6 stantiated statements concerning modified risk to7 bacco products, whether express or implied, even if 

8 accompanied by disclaimers would be detrimental to 

9 the public health. 

10 (43) The only way to effectively protect the 

11 public health from the dangers of unsubstantiated 

12 modified risk tobacco products is to empower the 

13 Food and Drug Administration to require that prod14 ucts that tobacco manufacturers sold or distributed 

15 for risk reduction be approved in advance of mar16 keting, and to require that the evidence relied on to 

17 support approval of these products is rigorous. 

18 SEC. 3. PURPOSE. 

19 The purposes of this Act are— 

20 (1) to provide authority to the Food and Drug 

21 Administration to regulate tobacco products under 

22 the Federal Food, Drug, and Cosmetic Act (21 

23 U.S.C. 301 et seq.), by recognizing it as the primary 

24 Federal regulatory authority with respect to the 


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1 manufacture, marketing, and distribution of tobacco 

2 products; 

3 (2) to ensure that the Food and Drug Adminis4 tration has the authority to address issues of par5 ticular concern to public health officials, especially 

6 the use of tobacco by young people and dependence 

7 on tobacco; 

8 (3) to authorize the Food and Drug Adminis9 tration to set national standards controlling the 

10 manufacture of tobacco products and the identity, 

11 public disclosure, and amount of ingredients used in 

12 such products; 

13 (4) to provide new and flexible enforcement au14 thority to ensure that there is effective oversight of 

15 the tobacco industry’s efforts to develop, introduce, 

16 and promote less harmful tobacco products; 

17 (5) to vest the Food and Drug Administration 

18 with the authority to regulate the levels of tar, nico19 tine, and other harmful components of tobacco prod20 ucts; 

21 (6) in order to ensure that consumers are better 

22 informed, to require tobacco product manufacturers 

23 to disclose research which has not previously been 

24 made available, as well as research generated in the 


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1 future, relating to the health and dependency effects 

2 or safety of tobacco products; 

3 (7) to continue to permit the sale of tobacco 

4 products to adults in conjunction with measures to 

5 ensure that they are not sold or accessible to under6 age purchasers; 

7 (8) to impose appropriate regulatory controls on 

8 the tobacco industry; 

9 (9) to promote cessation to reduce disease risk 

10 and the social costs associated with tobacco related 

11 diseases; and 

12 (10) to strengthen legislation against illicit 

13 trade in tobacco products. 

14 SEC. 4. SCOPE AND EFFECT. 

15 (a) INTENDED EFFECT.—Nothing in this Act (or an 

16 amendment made by this Act) shall be construed to— 

17 (1) establish a precedent with regard to any 

18 other industry, situation, circumstance, or legal ac19 tion; or 

20 (2) affect any action pending in Federal, State, 

21 or Tribal court, or any agreement, consent decree, or 

22 contract of any kind. 

23 (b) AGRICULTURAL ACTIVITIES.—The provisions of 

24 this Act (or an amendment made by this Act) which au25 thorize the Secretary to take certain actions with regard 


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1 to tobacco and tobacco products shall not be construed to 

2 affect any authority of the Secretary of Agriculture under 

3 existing law regarding the growing, cultivation, or curing 

4 of raw tobacco. 

5 SEC. 5. SEVERABILITY. 

6 If any provision of this Act, the amendments made 

7 by this Act, or the application of any provision of this Act 

8 to any person or circumstance is held to be invalid, the 

9 remainder of this Act, the amendments made by this Act, 

10 and the application of the provisions of this Act to any 

11 other person or circumstance shall not be affected and 

12 shall continue to be enforced to the fullest extent possible. 

13 TITLE I—AUTHORITY OF THE 

14 FOOD AND DRUG ADMINIS15 TRATION 

16 SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND 

17 COSMETIC ACT. 

18 (a) DEFINITION OF TOBACCO PRODUCTS.—Section 

19 201 of the Federal Food, Drug, and Cosmetic Act (21 

20 U.S.C. 321) is amended by adding at the end the fol21 lowing: 

22 ‘‘(rr)(1) The term ‘tobacco product’ means any prod23 uct made or derived from tobacco that is intended for 

24 human consumption, including any component, part, or 

25 accessory of a tobacco product (except for raw materials 


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1 other than tobacco used in manufacturing a component, 

2 part, or accessory of a tobacco product). 

3 ‘‘(2) The term ‘tobacco product’ does not mean— 

4 ‘‘(A) a product in the form of conventional food 

5 (including water and chewing gum), a product rep6 resented for use as or for use in a conventional food, 

7 or a product that is intended for ingestion in cap8 sule, tablet, softgel, or liquid form; or 

9 ‘‘(B) an article that is approved or is regulated 

10 as a drug by the Food and Drug Administration. 

11 ‘‘(3) The products described in paragraph (2)(A) 

12 shall be subject to chapter IV or chapter V of this Act 

13 and the articles described in paragraph (2)(B) shall be 

14 subject to chapter V of this Act. 

15 ‘‘(4) A tobacco product may not be marketed in com16 bination with any other article or product regulated under 

17 this Act (including a drug, biologic, food, cosmetics, med18 ical device, or a dietary supplement).’’. 

19 (b) FDA AUTHORITY OVER TOBACCO PRODUCTS.— 

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

21 301 et seq.) is amended— 

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

23 (2) by redesignating sections 901 through 909 

24 as sections 1001 through 1009; 


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1 (3) in section 1009 (as so redesignated), by 

2 striking ‘‘section 908’’ and inserting ‘‘section 1008’’; 

3 and 

4 (4) by inserting after chapter VIII the fol5 lowing: 

6 ‘‘CHAPTER IX—TOBACCO PRODUCTS 

7 ‘‘SEC. 900. DEFINITIONS. 

8 ‘‘In this chapter: 

9 ‘‘(1) ADDITIVE.—The term ‘additive’ means 

10 any substance the intended use of which results or 

11 may reasonably be expected to result, directly or in12 directly, in its becoming a component or otherwise 

13 affecting the characteristic of any tobacco product 

14 (including any substances intended for use as a fla15 voring, coloring or in producing, manufacturing, 

16 packing, processing, preparing, treating, packaging, 

17 transporting, or holding), except that such term does 

18 not include tobacco or a pesticide chemical residue 

19 in or on raw tobacco or a pesticide chemical. 

20 ‘‘(2) BRAND.—The term ‘brand’ means a vari21 ety of tobacco product distinguished by the tobacco 

22 used, tar content, nicotine content, flavoring used, 

23 size, filtration, or packaging, logo, registered trade24 mark or brand name, identifiable pattern of colors, 

25 or any combination of such attributes. 


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1 ‘‘(3) CIGARETTE.—The term ‘cigarette’ has the 

2 meaning given that term by section 3(1) of the Fed3 eral Cigarette Labeling and Advertising Act, but 

4 also includes tobacco, in any form, that is functional 

5 in the product, which, because of its appearance, the 

6 type of tobacco used in the filler, or its packaging 

7 and labeling, is likely to be offered to, or purchased 

8 by, consumers as a cigarette or as roll-your-own to9 bacco. 

10 ‘‘(4) CIGARETTE TOBACCO.—The term ‘ciga11 rette tobacco’ means any product that consists of 

12 loose tobacco that is intended for use by consumers 

13 in a cigarette. Unless otherwise stated, the require14 ments for cigarettes shall also apply to cigarette to15 bacco. 

16 ‘‘(5) COMMERCE.—The term ‘commerce’ has 

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

18 Federal Cigarette Labeling and Advertising Act. 

19 ‘‘(6) COUNTERFEIT TOBACCO PRODUCT.—The 

20 term ‘counterfeit tobacco product’ means a tobacco 

21 product (or the container or labeling of such a prod22 uct) that, without authorization, bears the trade23 mark, trade name, or other identifying mark, im24 print or device, or any likeness thereof, of a tobacco 


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1 product listed in a registration under section 

2 905(i)(1). 

3 ‘‘(7) DISTRIBUTOR.—The term ‘distributor’ as 

4 regards a tobacco product means any person who 

5 furthers the distribution of a tobacco product, 

6 whether domestic or imported, at any point from the 

7 original place of manufacture to the person who sells 

8 or distributes the product to individuals for personal 

9 consumption. Common carriers are not considered 

10 distributors for purposes of this chapter. 

11 ‘‘(8) ILLICIT TRADE.—The term ‘illicit trade’ 

12 means any practice or conduct prohibited by law 

13 which relates to production, shipment, receipt, pos14 session, distribution, sale, or purchase of tobacco 

15 products including any practice or conduct intended 

16 to facilitate such activity. 

17 ‘‘(9) INDIAN TRIBE.—The term ‘Indian tribe’ 

18 has the meaning given such term in section 4(e) of 

19 the Indian Self Determination and Education Assist20 ance Act. 

21 ‘‘(10) LITTLE CIGAR.—The term ‘little cigar’ 

22 has the meaning given that term by section 3(7) of 

23 the Federal Cigarette Labeling and Advertising Act. 

24 ‘‘(11) NICOTINE.—The term ‘nicotine’ means 

25 the chemical substance named 3-(1-Methyl-2- 


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

2 any salt or complex of nicotine. 

3 ‘‘(12) PACKAGE.—The term ‘package’ means a 

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

5 other container, any wrapping (including cello6 phane), in which a tobacco product is offered for 

7 sale, sold, or otherwise distributed to consumers. 

8 ‘‘(13) RETAILER.—The term ‘retailer’ means 

9 any person who sells tobacco products to individuals 

10 for personal consumption, or who operates a facility 

11 where self-service displays of tobacco products are 

12 permitted. 

13 ‘‘(14) ROLL-YOUR-OWN TOBACCO.—The term 

14 ‘roll-your-own tobacco’ means any tobacco which, be15 cause of its appearance, type, packaging, or labeling, 

16 is suitable for use and likely to be offered to, or pur17 chased by, consumers as tobacco for making ciga18 rettes. 

19 ‘‘(15) SMOKE CONSTITUENT.—The term ‘smoke 

20 constituent’ means any chemical or chemical com21 pound in mainstream or sidestream tobacco smoke 

22 that either transfers from any component of the cig23 arette to the smoke or that is formed by the combus24 tion or heating of tobacco, additives, or other compo25 nent of the tobacco product. 


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1 ‘‘(16) SMOKELESS TOBACCO.—The term 

2 ‘smokeless tobacco’ means any tobacco product that 

3 consists of cut, ground, powdered, or leaf tobacco 

4 and that is intended to be placed in the oral or nasal 

5 cavity. 

6 ‘‘(17) STATE.—The term ‘State’ means any 

7 State of the United States and, for purposes of this 

8 chapter, includes the District of Columbia, the Com9 monwealth of Puerto Rico, Guam, the Virgin Is10 lands, American Samoa, Wake Island, Midway Is11 lands, Kingman Reef, Johnston Atoll, the Northern 

12 Mariana Islands, and any other trust territory or 

13 possession of the United States. 

14 ‘‘(18) TOBACCO PRODUCT MANUFACTURER.— 

15 The term ‘tobacco product manufacturer’ means any 

16 person, including any repacker or relabeler, who— 

17 ‘‘(A) manufactures, fabricates, assembles, 

18 processes, or labels a tobacco product; or 

19 ‘‘(B) imports a finished cigarette or 

20 smokeless tobacco product for sale or distribu21 tion in the United States. 

22 ‘‘(19) UNITED STATES.—The term ‘United 

23 States’ means the 50 States of the United States of 

24 America and the District of Columbia, the Common25 wealth of Puerto Rico, Guam, the Virgin Islands, 


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1 American Samoa, Wake Island, Midway Islands, 

2 Kingman Reef, Johnston Atoll, the Northern Mar3 iana Islands, and any other trust territory or posses4 sion of the United States. 

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

6 ‘‘(a) IN GENERAL.—Tobacco products shall be regu7 lated by the Secretary under this chapter and shall not 

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

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

10 diagnosis, cure, mitigation, treatment, or prevention 

11 of disease (within the meaning of section 

12 201(g)(1)(B) or section 201(h)(2)); or 

13 ‘‘(2) a claim is made for such products under 

14 section 201(g)(1)(C) or 201(h)(3); 

15 other than modified risk tobacco products approved 

16 in accordance with section 911. 

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

18 tobacco products subject to the regulations referred to in 

19 section 102 of the Family Smoking Prevention and To20 bacco Control Act, and to any other tobacco products that 

21 the Secretary by regulation deems to be subject to this 

22 chapter. 

23 ‘‘(c) SCOPE.— 

24 ‘‘(1) IN GENERAL.—Nothing in this chapter, or 

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1 under, or in sections 101(a), 102, or 103 of title I, 

2 title II, or title III of the Family Smoking Preven3 tion and Tobacco Control Act, shall be construed to 

4 affect, expand, or limit the Secretary’s authority 

5 over (including the authority to determine whether 

6 products may be regulated), or the regulation of, 

7 products under this Act that are not tobacco prod8 ucts under chapter V or any other chapter. 

9 ‘‘(2) LIMITATION OF AUTHORITY.— 

10 ‘‘(A) IN GENERAL.—The provisions of this 

11 chapter shall not apply to tobacco leaf that is 

12 not in the possession of a manufacturer of to13 bacco products, or to the producers of tobacco 

14 leaf, including tobacco growers, tobacco ware15 houses, and tobacco grower cooperatives, nor 

16 shall any employee of the Food and Drug Ad17 ministration have any authority to enter onto a 

18 farm owned by a producer of tobacco leaf with19 out the written consent of such producer. 

20 ‘‘(B) EXCEPTION.—Notwithstanding sub21 paragraph (A), if a producer of tobacco leaf is 

22 also a tobacco product manufacturer or con23 trolled by a tobacco product manufacturer, the 

24 producer shall be subject to this chapter in the 

25 producer’s capacity as a manufacturer. 


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1 ‘‘(C) RULE OF CONSTRUCTION.—Nothing 

2 in this chapter shall be construed to grant the 

3 Secretary authority to promulgate regulations 

4 on any matter that involves the production of 

5 tobacco leaf or a producer thereof, other than 

6 activities by a manufacturer affecting produc7 tion. 

8 ‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS. 

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

10 if— 

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

12 putrid, or decomposed substance, or is otherwise 

13 contaminated by any added poisonous or added dele14 terious substance that may render the product inju15 rious to health; 

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

17 under insanitary conditions whereby it may have 

18 been contaminated with filth, or whereby it may 

19 have been rendered injurious to health; 

20 ‘‘(3) its package is composed, in whole or in 

21 part, of any poisonous or deleterious substance 

22 which may render the contents injurious to health; 

23 ‘‘(4) it is, or purports to be or is represented 

24 as, a tobacco product which is subject to a tobacco 

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1 less such tobacco product is in all respects in con2 formity with such standard; 

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

4 premarket approval and does not have an approved 

5 application in effect; or 

6 ‘‘(B) it is in violation of the order approving 

7 such an application; 

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

9 controls used for, its manufacture, packing, or stor10 age are not in conformity with applicable require11 ments under section 906(e)(1) or an applicable con12 dition prescribed by an order under section 

13 906(e)(2); or 

14 ‘‘(7) it is in violation of section 911. 

15 ‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS. 

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

17 deemed to be misbranded— 

18 ‘‘(1) if its labeling is false or misleading in any 

19 particular; 

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

21 containing— 

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

23 tobacco product manufacturer, packer, or dis24 tributor; 


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

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

3 numerical count; 

4 ‘‘(C) an accurate statement of the percent5 age of the tobacco used in the product that is 

6 domestically grown tobacco and the percentage 

7 that is foreign grown tobacco; and 

8 ‘‘(D) the statement required under section 

9 921(a), 

10 except that under subparagraph (B) reasonable vari11 ations shall be permitted, and exemptions as to 

12 small packages shall be established, by regulations 

13 prescribed by the Secretary; 

14 ‘‘(3) if any word, statement, or other informa15 tion required by or under authority of this chapter 

16 to appear on the label or labeling is not prominently 

17 placed thereon with such conspicuousness (as com18 pared with other words, statements or designs in the 

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

20 be read and understood by the ordinary individual 

21 under customary conditions of purchase and use; 

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

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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), 905(c), 905(d), or 905(h), if it was not in13 cluded in a list required by section 905(i), if a notice 

14 or other information respecting it was not provided 

15 as required by such section or section 905(j), or if 

16 it does not bear such symbols from the uniform sys17 tem for identification of tobacco products prescribed 

18 under section 905(e) as the Secretary by regulation 

19 requires; 

20 ‘‘(7) if, in the case of any tobacco product dis21 tributed or offered for sale in any State— 

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

23 in any particular; or 

24 ‘‘(B) it is sold or distributed in violation of 

25 regulations 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 described in para10 graph (4), 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 appropriate 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) if it is a tobacco product subject to a to2 bacco product standard established under section 

3 907, unless it bears such labeling as may be pre4 scribed in such tobacco product standard; or 

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

6 ‘‘(A) to comply with any requirement pre7 scribed under section 904 or 908; or 

8 ‘‘(B) to furnish any material or informa9 tion required under section 909. 

10 ‘‘(b) PRIOR APPROVAL OF LABEL STATEMENTS.— 

11 The Secretary may, by regulation, require prior approval 

12 of statements made on the label of a tobacco product. No 

13 regulation issued under this subsection may require prior 

14 approval by the Secretary of the content of any advertise15 ment, except for modified risk tobacco products as pro16 vided in section 911. No advertisement of a tobacco prod17 uct published after the date of enactment of the Family 

18 Smoking Prevention and Tobacco Control Act shall, with 

19 respect to the language of label statements as prescribed 

20 under section 4 of the Cigarette Labeling and Advertising 

21 Act and section 3 of the Comprehensive Smokeless To22 bacco Health Education Act of 1986 or the regulations 

23 issued under such sections, be subject to the provisions 

24 of sections 12 through 15 of the Federal Trade Commis25 sion Act. 


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

2 SECRETARY. 

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

4 the date of enactment of the Family Smoking Prevention 

5 and Tobacco Control Act, each tobacco product manufac6 turer or importer, or agents thereof, shall submit to the 

7 Secretary the following information: 

8 ‘‘(1) A listing of all ingredients, including to9 bacco, substances, compounds, and additives that 

10 are, as of such date, added by the manufacturer to 

11 the tobacco, paper, filter, or other part of each to12 bacco product by brand and by quantity in each 

13 brand and subbrand. 

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

15 form of nicotine in each tobacco product measured 

16 in milligrams of nicotine in accordance with regula17 tions promulgated by the Secretary in accordance 

18 with section 4(a)(5) of the Federal Cigarette Label19 ing and Advertising Act. 

20 ‘‘(3) A listing of all constituents, including 

21 smoke constituents as applicable, identified by the 

22 Secretary as harmful or potentially harmful to 

23 health in each tobacco product, and as applicable in 

24 the smoke of each tobacco product, by brand and by 

25 quantity in each brand and subbrand. Effective be26 ginning 2 years after the date of enactment of this 


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1 chapter, the manufacturer, importer, or agent shall 

2 comply with regulations promulgated under section 

3 916 in reporting information under this paragraph, 

4 where applicable. 

5 ‘‘(4) All documents developed after the date of 

6 enactment of the Family Smoking Prevention and 

7 Tobacco Control Act that relate to health, toxi8 cological, behavioral, or physiologic effects of current 

9 or future tobacco products, their constituents (in10 cluding smoke constituents), ingredients, compo11 nents, and additives. 

12 ‘‘(b) DATA SUBMISSION.—At the request of the Sec13 retary, each tobacco product manufacturer or importer of 

14 tobacco products, or agents thereof, shall submit the fol15 lowing: 

16 ‘‘(1) Any or all documents (including under17 lying scientific information) relating to research ac18 tivities, and research findings, conducted, supported, 

19 or possessed by the manufacturer (or agents thereof) 

20 on the health, toxicological, behavioral, or physio21 logic effects of tobacco products and their constitu22 ents (including smoke constituents), ingredients, 

23 components, and additives. 

24 ‘‘(2) Any or all documents (including under25 lying scientific information) relating to research acVerDate Aug 31 2005 03:42 Feb 21, 2007 Jkt 059200 PO 00000 Frm 00032 Fmt 6652 Sfmt 6201 E:\BILLS\H1108.IH H1108

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1 tivities, and research findings, conducted, supported, 

2 or possessed by the manufacturer (or agents thereof) 

3 that relate to the issue of whether a reduction in 

4 risk to health from tobacco products can occur upon 

5 the employment of technology available or known to 

6 the manufacturer. 

7 ‘‘(3) Any or all documents (including under8 lying scientific or financial information) relating to 

9 marketing research involving the use of tobacco 

10 products or marketing practices and the effective11 ness of such practices used by tobacco manufactur12 ers and distributors. 

13 An importer of a tobacco product not manufactured in the 

14 United States shall supply the information required of a 

15 tobacco product manufacturer under this subsection. 

16 ‘‘(c) TIME FOR SUBMISSION.— 

17 ‘‘(1) IN GENERAL.—At least 90 days prior to 

18 the delivery for introduction into interstate com19 merce of a tobacco product not on the market on the 

20 date of enactment of the Family Smoking Preven21 tion and Tobacco Control Act, the manufacturer of 

22 such product shall provide the information required 

23 under subsection (a). 

24 ‘‘(2) DISCLOSURE OF ADDITIVE.—If at any 

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1 bacco products a new tobacco additive or increases 

2 the quantity of an existing tobacco additive, the 

3 manufacturer shall, except as provided in paragraph 

4 (3), at least 90 days prior to such action so advise 

5 the Secretary in writing. 

6 ‘‘(3) DISCLOSURE OF OTHER ACTIONS.—If at 

7 any time a tobacco product manufacturer eliminates 

8 or decreases an existing additive, or adds or in9 creases an additive that has by regulation been des10 ignated by the Secretary as an additive that is not 

11 a human or animal carcinogen, or otherwise harmful 

12 to health under intended conditions of use, the man13 ufacturer shall within 60 days of such action so ad14 vise the Secretary in writing. 

15 ‘‘(d) DATA LIST.— 

16 ‘‘(1) IN GENERAL.—Not later than 3 years 

17 after the date of enactment of the Family Smoking 

18 Prevention and Tobacco Control Act, and annually 

19 thereafter, the Secretary shall publish in a format 

20 that is understandable and not misleading to a lay 

21 person, and place on public display (in a manner de22 termined by the Secretary) the list established under 

23 subsection (e). 

24 ‘‘(2) CONSUMER RESEARCH.—The Secretary 

25 shall conduct periodic consumer research to ensure 


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1 that the list published under paragraph (1) is not 

2 misleading to lay persons. Not later than 5 years 

3 after the date of enactment of the Family Smoking 

4 Prevention and Tobacco Control Act, the Secretary 

5 shall submit to the appropriate committees of Con6 gress a report on the results of such research, to7 gether with recommendations on whether such publi8 cation should be continued or modified. 

9 ‘‘(e) DATA COLLECTION.—Not later than 12 months 

10 after the date of enactment of the Family Smoking Pre11 vention and Tobacco Control Act, the Secretary shall es12 tablish a list of harmful and potentially harmful constitu13 ents, including smoke constituents, to health in each to14 bacco product by brand and by quantity in each brand 

15 and subbrand. The Secretary shall publish a public notice 

16 requesting the submission by interested persons of sci17 entific and other information concerning the harmful and 

18 potentially harmful constituents in tobacco products and 

19 tobacco smoke. 

20 ‘‘SEC. 905. ANNUAL REGISTRATION. 

21 ‘‘(a) DEFINITIONS.—In this section: 

22 ‘‘(1) MANUFACTURE, PREPARATION, 

23 COMPOUNDING, OR PROCESSING.—The term ‘manu24 facture, preparation, compounding, or processing’ 

25 shall include repackaging or otherwise changing the 


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1 container, wrapper, or labeling of any tobacco prod2 uct package in furtherance of the distribution of the 

3 tobacco product from the original place of manufac4 ture to the person who makes final delivery or sale 

5 to the ultimate consumer or user. 

6 ‘‘(2) NAME.—The term ‘name’ shall include in 

7 the case of a partnership the name of each partner 

8 and, in the case of a corporation, the name of each 

9 corporate officer and director, and the State of in10 corporation. 

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

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

13 owns or operates any establishment in any State engaged 

14 in the manufacture, preparation, compounding, or proc15 essing of a tobacco product or tobacco products shall reg16 ister with the Secretary the name, places of business, and 

17 all such establishments of that person. 

18 ‘‘(c) REGISTRATION OF NEW OWNERS AND OPERA19 TORS.—Every person upon first engaging in the manufac20 ture, preparation, compounding, or processing of a tobacco 

21 product or tobacco products in any establishment owned 

22 or operated in any State by that person shall immediately 

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

24 business, and such establishment. 


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

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

3 (c) shall immediately register with the Secretary any addi4 tional establishment which that person owns or operates 

5 in any State and in which that person begins the manufac6 ture, preparation, compounding, or processing of a tobacco 

7 product or tobacco products. 

8 ‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYS9 TEM.—The Secretary may by regulation prescribe a uni10 form system for the identification of tobacco products and 

11 may require that persons who are required to list such 

12 tobacco products under subsection (i) shall list such to13 bacco products in accordance with such system. 

14 ‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA15 TION.—The Secretary shall make available for inspection, 

16 to any person so requesting, any registration filed under 

17 this section. 

18 ‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB19 LISHMENTS.—Every establishment in any State registered 

20 with the Secretary under this section shall be subject to 

21 inspection under section 704, and every such establish22 ment engaged in the manufacture, compounding, or proc23 essing of a tobacco product or tobacco products shall be 

24 so inspected by 1 or more officers or employees duly des25 ignated by the Secretary at least once in the 2-year period 


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1 beginning with the date of registration of such establish2 ment under this section and at least once in every succes3 sive 2-year period thereafter. 

4 ‘‘(h) FOREIGN ESTABLISHMENTS SHALL REG5 ISTER.—Any establishment within any foreign country en6 gaged in the manufacture, preparation, compounding, or 

7 processing of a tobacco product or tobacco products, shall 

8 register under this section under regulations promulgated 

9 by the Secretary. Such regulations shall require such es10 tablishment to provide the information required by sub11 section (i) of this section and shall include provisions for 

12 registration of any such establishment upon condition that 

13 adequate and effective means are available, by arrange14 ment with the government of such foreign country or oth15 erwise, to enable the Secretary to determine from time to 

16 time whether tobacco products manufactured, prepared, 

17 compounded, or processed in such establishment, if im18 ported or offered for import into the United States, shall 

19 be refused admission on any of the grounds set forth in 

20 section 801(a). 

21 ‘‘(i) REGISTRATION INFORMATION.— 

22 ‘‘(1) PRODUCT LIST.—Every person who reg23 isters with the Secretary under subsection (b), (c), 

24 (d), or (h) shall, at the time of registration under 

25 any such subsection, file with the Secretary a list of 


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1 all tobacco products which are being manufactured, 

2 prepared, compounded, or processed by that person 

3 for commercial distribution and which has not been 

4 included in any list of tobacco products filed by that 

5 person with the Secretary under this paragraph or 

6 paragraph (2) before such time of registration. Such 

7 list shall be prepared in such form and manner as 

8 the Secretary may prescribe and shall be accom9 panied by— 

10 ‘‘(A) in the case of a tobacco product con11 tained in the applicable list with respect to 

12 which a tobacco product standard has been es13 tablished under section 907 or which is subject 

14 to section 910, a reference to the authority for 

15 the marketing of such tobacco product and a 

16 copy of all labeling for such tobacco product; 

17 ‘‘(B) in the case of any other tobacco prod18 uct contained in an applicable list, a copy of all 

19 consumer information and other labeling for 

20 such tobacco product, a representative sampling 

21 of advertisements for such tobacco product, 

22 and, upon request made by the Secretary for 

23 good cause, a copy of all advertisements for a 

24 particular tobacco product; and 


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1 ‘‘(C) if the registrant filing a list has de2 termined that a tobacco product contained in 

3 such list is not subject to a tobacco product 

4 standard established under section 907, a brief 

5 statement of the basis upon which the reg6 istrant made such determination if the Sec7 retary requests such a statement with respect 

8 to that particular tobacco product. 

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

10 PRODUCT LIST.—Each person who registers with the 

11 Secretary under this section shall report to the Sec12 retary once during the month of June of each year 

13 and once during the month of December of each 

14 year the following: 

15 ‘‘(A) A list of each tobacco product intro16 duced by the registrant for commercial distribu17 tion which has not been included in any list 

18 previously filed by that person with the Sec19 retary under this subparagraph or paragraph 

20 (1). A list under this subparagraph shall list a 

21 tobacco product by its established name and 

22 shall be accompanied by the other information 

23 required by paragraph (1). 

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

25 made a report under this paragraph that person 


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1 has discontinued the manufacture, preparation, 

2 compounding, or processing for commercial dis3 tribution of a tobacco product included in a list 

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

5 notice of such discontinuance, the date of such 

6 discontinuance, and the identity of its estab7 lished name. 

8 ‘‘(C) If since the date the registrant re9 ported under subparagraph (B) a notice of dis10 continuance that person has resumed the manu11 facture, preparation, compounding, or proc12 essing for commercial distribution of the to13 bacco product with respect to which such notice 

14 of discontinuance was reported, notice of such 

15 resumption, the date of such resumption, the 

16 identity of such tobacco product by established 

17 name, and other information required by para18 graph (1), unless the registrant has previously 

19 reported such resumption to the Secretary 

20 under this subparagraph. 

21 ‘‘(D) Any material change in any informa22 tion previously submitted under this paragraph 

23 or paragraph (1). 


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1 ‘‘(j) REPORT PRECEDING INTRODUCTION OF CER2 TAIN SUBSTANTIALLY-EQUIVALENT PRODUCTS INTO

3 INTERSTATE COMMERCE.— 

4 ‘‘(1) IN GENERAL.—Each person who is re5 quired to register under this section and who pro6 poses to begin the introduction or delivery for intro7 duction into interstate commerce for commercial dis8 tribution of a tobacco product intended for human 

9 use that was not commercially marketed (other than 

10 for test marketing) in the United States as of June 

11 1, 2003, shall, at least 90 days prior to making such 

12 introduction or delivery, report to the Secretary (in 

13 such form and manner as the Secretary shall pre14 scribe)— 

15 ‘‘(A) the basis for such person’s determina16 tion that the tobacco product is substantially 

17 equivalent, within the meaning of section 910, 

18 to a tobacco product commercially marketed 

19 (other than for test marketing) in the United 

20 States as of June 1, 2003, that is in compliance 

21 with the requirements of this Act; and 

22 ‘‘(B) action taken by such person to com23 ply with the requirements under section 907 

24 that are applicable to the tobacco product. 


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1 ‘‘(2) APPLICATION TO CERTAIN POST JUNE 1, 

2 2003 PRODUCTS.—A report under this subsection for 

3 a tobacco product that was first introduced or deliv4 ered for introduction into interstate commerce for 

5 commercial distribution in the United States after 

6 June 1, 2003, and prior to the date that is 15 

7 months after the date of enactment of the Family 

8 Smoking Prevention and Tobacco Control Act shall 

9 be submitted to the Secretary not later than 15 

10 months after such date of enactment. 

11 ‘‘(3) EXEMPTIONS.— 

12 ‘‘(A) IN GENERAL.—The Secretary may by 

13 regulation, exempt from the requirements of 

14 this subsection tobacco products that are modi15 fied by adding or deleting a tobacco additive, or 

16 increasing or decreasing the quantity of an ex17 isting tobacco additive, if the Secretary deter18 mines that— 

19 ‘‘(i) such modification would be a 

20 minor modification of a tobacco product 

21 authorized for sale under this Act; 

22 ‘‘(ii) a report under this subsection is 

23 not necessary to ensure that permitting the 

24 tobacco product to be marketed would be 


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1 appropriate for protection of the public 

2 health; and 

3 ‘‘(iii) an exemption is otherwise appro4 priate. 

5 ‘‘(B) REGULATIONS.—Not later than 9 

6 months after the date of enactment of the Fam7 ily Smoking Prevention and Tobacco Control 

8 Act, the Secretary shall issue regulations to im9 plement this paragraph. 

10 ‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL 

11 OF TOBACCO PRODUCTS. 

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

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

14 tobacco product shall apply to such tobacco product until 

15 the applicability of the requirement to the tobacco product 

16 has been changed by action taken under section 907, sec17 tion 910, section 911, or subsection (d) of this section, 

18 and any requirement established by or under section 902, 

19 903, 905, or 909 which is inconsistent with a requirement 

20 imposed on such tobacco product under section 907, sec21 tion 910, section 911, or subsection (d) of this section 

22 shall not apply to such tobacco product. 

23 ‘‘(b) INFORMATION ON PUBLIC ACCESS AND COM24 MENT.—Each notice of proposed rulemaking or other noti25 fication under section 907, 908, 909, 910, or 911 or under 


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•HR 1108 IH

1 this section, any other notice which is published in the 

2 Federal Register with respect to any other action taken 

3 under any such section and which states the reasons for 

4 such action, and each publication of findings required to 

5 be made in connection with rulemaking under any such 

6 section shall set forth— 

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

8 may examine data and other information on which 

9 the notice or findings is based; and 

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

11 may present their comments on the notice or find12 ings (including the need therefore) orally or in writ13 ing, which period shall be at least 60 days but may 

14 not exceed 90 days unless the time is extended by 

15 the Secretary by a notice published in the Federal 

16 Register stating good cause therefore. 

17 ‘‘(c) LIMITED CONFIDENTIALITY OF INFORMA18 TION.—Any information reported to or otherwise obtained 

19 by the Secretary or the Secretary’s representative under 

20 section 903, 904, 907, 908, 909, 910, 911, or 704, or 

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

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

23 5, United States Code, by reason of subsection (b)(4) of 

24 that section shall be considered confidential and shall not 

25 be disclosed, except that the information may be disclosed 


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1 to other officers or employees concerned with carrying out 

2 this chapter, or when relevant in any proceeding under 

3 this chapter. 

4 ‘‘(d) RESTRICTIONS.— 

5 ‘‘(1) IN GENERAL.—The Secretary may by reg6 ulation require restrictions on the sale and distribu7 tion of a tobacco product, including restrictions on 

8 the access to, and the advertising and promotion of, 

9 the tobacco product, if the Secretary determines that 

10 such regulation would be appropriate for the protec11 tion of the public health. The Secretary may by reg12 ulation impose restrictions on the advertising and 

13 promotion of a tobacco product consistent with and 

14 to full extent permitted by the first amendment to 

15 the Constitution. The finding as to whether such 

16 regulation would be appropriate for the protection of 

17 the public health shall be determined with respect to 

18 the risks and benefits to the population as a whole, 

19 including users and non-users of the tobacco prod20 uct, and taking into account— 

21 ‘‘(A) the increased or decreased likelihood 

22 that existing users of tobacco products will stop 

23 using such products; and 


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1 ‘‘(B) the increased or decreased likelihood 

2 that those who do not use tobacco products will 

3 start using such products. 

4 No such regulation may require that the sale or dis5 tribution of a tobacco product be limited to the writ6 ten or oral authorization of a practitioner licensed 

7 by law to prescribe medical products. 

8 ‘‘(2) LABEL STATEMENTS.—The label of a to9 bacco product shall bear such appropriate state10 ments of the restrictions required by a regulation 

11 under subsection (a) as the Secretary may in such 

12 regulation prescribe. 

13 ‘‘(3) LIMITATIONS.— 

14 ‘‘(A) IN GENERAL.—No restrictions under 

15 paragraph (1) may— 

16 ‘‘(i) prohibit the sale of any tobacco 

17 product in face-to-face transactions by a 

18 specific category of retail outlets; or 

19 ‘‘(ii) establish a minimum age of sale 

20 of tobacco products to any person older 

21 than 18 years of age. 

22 ‘‘(B) MATCHBOOKS.—For purposes of any 

23 regulations issued by the Secretary, matchbooks 

24 of conventional size containing not more than 

25 20 paper matches, and which are customarily 


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1 given away for free with the purchase of to2 bacco products shall be considered as adult 

3 written publications which shall be permitted to 

4 contain advertising. Notwithstanding the pre5 ceding sentence, if the Secretary finds that such 

6 treatment of matchbooks is not appropriate for 

7 the protection of the public health, the Sec8 retary may determine by regulation that match9 books shall not be considered adult written pub10 lications. 

11 ‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE12 MENTS.— 

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

14 CONFORM.— 

15 ‘‘(A) IN GENERAL.—The Secretary may, in 

16 accordance with subparagraph (B), prescribe 

17 regulations (which may differ based on the type 

18 of tobacco product involved) requiring that the 

19 methods used in, and the facilities and controls 

20 used for, the manufacture, pre-production de21 sign validation (including a process to assess 

22 the performance of a tobacco product), packing 

23 and storage of a tobacco product, conform to 

24 current good manufacturing practice, as pre25 scribed in such regulations, to assure that the 


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1 public health is protected and that the tobacco 

2 product is in compliance with this chapter. 

3 Good manufacturing practices may include the 

4 testing of raw tobacco for pesticide chemical 

5 residues regardless of whether a tolerance for 

6 such chemical residues has been established. 

7 ‘‘(B) REQUIREMENTS.—The Secretary 

8 shall— 

9 ‘‘(i) before promulgating any regula10 tion under subparagraph (A), afford the 

11 Tobacco Products Scientific Advisory Com12 mittee an opportunity to submit rec13 ommendations with respect to the regula14 tion proposed to be promulgated; 

15 ‘‘(ii) before promulgating any regula16 tion under subparagraph (A), afford oppor17 tunity for an oral hearing; 

18 ‘‘(iii) provide the Tobacco Products 

19 Scientific Advisory Committee a reasonable 

20 time to make its recommendation with re21 spect to proposed regulations under sub22 paragraph (A); and 

23 ‘‘(iv) in establishing the effective date 

24 of a regulation promulgated under this 

25 subsection, take into account the difVerDate Aug 31 2005 03:42 Feb 21, 2007 Jkt 059200 PO 00000 Frm 00049 Fmt 6652 Sfmt 6201 E:\BILLS\H1108.IH H1108

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1 ferences in the manner in which the dif2 ferent types of tobacco products have his3 torically been produced, the financial re4 sources of the different tobacco product 

5 manufacturers, and the state of their exist6 ing manufacturing facilities, and shall pro7 vide for a reasonable period of time for 

8 such manufacturers to conform to good 

9 manufacturing practices. 

10 ‘‘(2) EXEMPTIONS; VARIANCES.— 

11 ‘‘(A) PETITION.—Any person subject to 

12 any requirement prescribed under paragraph 

13 (1) may petition the Secretary for a permanent 

14 or temporary exemption or variance from such 

15 requirement. Such a petition shall be submitted 

16 to the Secretary in such form and manner as 

17 the Secretary shall prescribe and shall— 

18 ‘‘(i) in the case of a petition for an ex19 emption from a requirement, set forth the 

20 basis for the petitioner’s determination 

21 that compliance with the requirement is 

22 not required to assure that the tobacco 

23 product will be in compliance with this 

24 chapter; 


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

2 variance from a requirement, set forth the 

3 methods proposed to be used in, and the 

4 facilities and controls proposed to be used 

5 for, the manufacture, packing, and storage 

6 of the tobacco product in lieu of the meth7 ods, facilities, and controls prescribed by 

8 the requirement; and 

9 ‘‘(iii) contain such other information 

10 as the Secretary shall prescribe. 

11 ‘‘(B) REFERRAL TO THE TOBACCO PROD12 UCTS SCIENTIFIC ADVISORY COMMITTEE.—The 

13 Secretary may refer to the Tobacco Products 

14 Scientific Advisory Committee any petition sub15 mitted under subparagraph (A). The Tobacco 

16 Products Scientific Advisory Committee shall 

17 report its recommendations to the Secretary 

18 with respect to a petition referred to it within 

19 60 days after the date of the petition’s referral. 

20 Within 60 days after— 

21 ‘‘(i) the date the petition was sub22 mitted to the Secretary under subpara23 graph (A); or 


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1 ‘‘(ii) the day after the petition was re2 ferred to the Tobacco Products Scientific 

3 Advisory Committee, 

4 whichever occurs later, the Secretary shall by 

5 order either deny the petition or approve it. 

6 ‘‘(C) APPROVAL.—The Secretary may ap7 prove— 

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

9 tobacco product from a requirement if the 

10 Secretary determines that compliance with 

11 such requirement is not required to assure 

12 that the tobacco product will be in compli13 ance with this chapter; and 

14 ‘‘(ii) a petition for a variance for a to15 bacco product from a requirement if the 

16 Secretary determines that the methods to 

17 be used in, and the facilities and controls 

18 to be used for, the manufacture, packing, 

19 and storage of the tobacco product in lieu 

20 of the methods, controls, and facilities pre21 scribed by the requirement are sufficient to 

22 assure that the tobacco product will be in 

23 compliance with this chapter. 

24 ‘‘(D) CONDITIONS.—An order of the Sec25 retary approving a petition for a variance shall 


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1 prescribe such conditions respecting the meth2 ods used in, and the facilities and controls used 

3 for, the manufacture, packing, and storage of 

4 the tobacco product to be granted the variance 

5 under the petition as may be necessary to as6 sure that the tobacco product will be in compli7 ance with this chapter. 

8 ‘‘(E) HEARING.—After the issuance of an 

9 order under subparagraph (B) respecting a pe10 tition, the petitioner shall have an opportunity 

11 for an informal hearing on such order. 

12 ‘‘(3) COMPLIANCE.—Compliance with require13 ments under this subsection shall not be required be14 fore the period ending 3 years after the date of en15 actment of the Family Smoking Prevention and To16 bacco Control Act. 

17 ‘‘(f) RESEARCH AND DEVELOPMENT.—The Secretary 

18 may enter into contracts for research, testing, and dem19 onstrations respecting tobacco products and may obtain 

20 tobacco products for research, testing, and demonstration 

21 purposes without regard to section 3324(a) and (b) of title 

22 31, United States Code, and section 5 of title 41, United 

23 States Code. 

24 ‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 

25 ‘‘(a) IN GENERAL.— 


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1 ‘‘(1) SPECIAL RULE FOR CIGARETTES.—A ciga2 rette or any of its component parts (including the 

3 tobacco, filter, or paper) shall not contain, as a con4 stituent (including a smoke constituent) or additive, 

5 an artificial or natural flavor (other than tobacco or 

6 menthol) or an herb or spice, including strawberry, 

7 grape, orange, clove, cinnamon, pineapple, vanilla, 

8 coconut, licorice, cocoa, chocolate, cherry, or coffee, 

9 that is a characterizing flavor of the tobacco product 

10 or tobacco smoke. Nothing in this subparagraph 

11 shall be construed to limit the Secretary’s authority 

12 to take action under this section or other sections of 

13 this Act applicable to menthol or any artificial or 

14 natural flavor, herb, or spice not specified in this 

15 paragraph. 

16 ‘‘(2) REVISION OF TOBACCO PRODUCT STAND17 ARDS.—The Secretary may revise the tobacco prod18 uct standards in paragraph (1) in accordance with 

19 subsection (b). 

20 ‘‘(3) TOBACCO PRODUCT STANDARDS.—The 

21 Secretary may adopt tobacco product standards in 

22 addition to those in paragraph (1) if the Secretary 

23 finds that a tobacco product standard is appropriate 

24 for the protection of the public health. This finding 

25 shall be determined with respect to the risks and 


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1 benefits to the population as a whole, including 

2 users and non-users of the tobacco product, and tak3 ing into account— 

4 ‘‘(A) the increased or decreased likelihood 

5 that existing users of tobacco products will stop 

6 using such products; and 

7 ‘‘(B) the increased or decreased likelihood 

8 that those who do not use tobacco products will 

9 start using such products. 

10 ‘‘(4) CONTENT OF TOBACCO PRODUCT STAND11 ARDS.—A tobacco product standard established 

12 under this section for a tobacco product— 

13 ‘‘(A) shall include provisions that are ap14 propriate for the protection of the public health, 

15 including provisions, where appropriate— 

16 ‘‘(i) for the reduction of nicotine 

17 yields of the product; 

18 ‘‘(ii) for the reduction or elimination 

19 of other constituents, including smoke con20 stituents, or harmful components of the 

21 product; or 

22 ‘‘(iii) relating to any other require23 ment under subparagraph (B); 

24 ‘‘(B) shall, where appropriate for the pro25 tection of the public health, include— 


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1 ‘‘(i) provisions respecting the con2 struction, components, ingredients, addi3 tives, constituents, including smoke con4 stituents, and properties of the tobacco 

5 product; 

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

7 sample basis or, if necessary, on an indi8 vidual basis) of the tobacco product; 

9 ‘‘(iii) provisions for the measurement 

10 of the tobacco product characteristics of 

11 the tobacco product; 

12 ‘‘(iv) provisions requiring that the re13 sults of each or of certain of the tests of 

14 the tobacco product required to be made 

15 under clause (ii) show that the tobacco 

16 product is in conformity with the portions 

17 of the standard for which the test or tests 

18 were required; and 

19 ‘‘(v) a provision requiring that the 

20 sale and distribution of the tobacco prod21 uct be restricted but only to the extent 

22 that the sale and distribution of a tobacco 

23 product may be restricted under a regula24 tion under section 906(d); and 


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1 ‘‘(C) shall, where appropriate, require the 

2 use and prescribe the form and content of label3 ing for the proper use of the tobacco product. 

4 ‘‘(5) PERIODIC RE-EVALUATION OF TOBACCO

5 PRODUCT STANDARDS.—The Secretary shall provide 

6 for periodic evaluation of tobacco product standards 

7 established under this section to determine whether 

8 such standards should be changed to reflect new 

9 medical, scientific, or other technological data. The 

10 Secretary may provide for testing under paragraph 

11 (4)(B) by any person. 

12 ‘‘(6) INVOLVEMENT OF OTHER AGENCIES; IN13 FORMED PERSONS.—In carrying out duties under 

14 this section, the Secretary shall endeavor to— 

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

16 technical support available in other Federal 

17 agencies; 

18 ‘‘(B) consult with other Federal agencies 

19 concerned with standard-setting and other na20 tionally or internationally recognized standard21 setting entities; and 

22 ‘‘(C) invite appropriate participation, 

23 through joint or other conferences, workshops, 

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1 cultural, or consumer organizations who in the 

2 Secretary’s judgment can make a significant 

3 contribution. 

4 ‘‘(b) ESTABLISHMENT OF STANDARDS.— 

5 ‘‘(1) NOTICE.— 

6 ‘‘(A) IN GENERAL.—The Secretary shall 

7 publish in the Federal Register a notice of pro8 posed rulemaking for the establishment, amend9 ment, or revocation of any tobacco product 

10 standard. 

11 ‘‘(B) REQUIREMENTS OF NOTICE.—A no12 tice of proposed rulemaking for the establish13 ment or amendment of a tobacco product stand14 ard for a tobacco product shall— 

15 ‘‘(i) set forth a finding with sup16 porting justification that the tobacco prod17 uct standard is appropriate for the protec18 tion of the public health; 

19 ‘‘(ii) set forth proposed findings with 

20 respect to the risk of illness or injury that 

21 the tobacco product standard is intended 

22 to reduce or eliminate; and 

23 ‘‘(iii) invite interested persons to sub24 mit an existing tobacco product standard 

25 for the tobacco product, including a draft 


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1 or proposed tobacco product standard, for 

2 consideration by the Secretary. 

3 ‘‘(C) STANDARD.—Upon a determination 

4 by the Secretary that an additive, constituent 

5 (including smoke constituent), or other compo6 nent of the product that is the subject of the 

7 proposed tobacco product standard is harmful, 

8 it shall be the burden of any party challenging 

9 the proposed standard to prove that the pro10 posed standard will not reduce or eliminate the 

11 risk of illness or injury. 

12 ‘‘(D) FINDING.—A notice of proposed rule13 making for the revocation of a tobacco product 

14 standard shall set forth a finding with sup15 porting justification that the tobacco product 

16 standard is no longer appropriate for the pro17 tection of the public health. 

18 ‘‘(E) CONSIDERATION BY SECRETARY.— 

19 The Secretary shall consider all information 

20 submitted in connection with a proposed stand21 ard, including information concerning the coun22 tervailing effects of the tobacco product stand23 ard on the health of adolescent tobacco users, 

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

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1 traband or other tobacco products that do not 

2 meet the requirements of this chapter and the 

3 significance of such demand, and shall issue the 

4 standard if the Secretary determines that the 

5 standard would be appropriate for the protec6 tion of the public health. 

7 ‘‘(F) COMMENT.—The Secretary shall pro8 vide for a comment period of not less than 60 

9 days. 

10 ‘‘(2) PROMULGATION.— 

11 ‘‘(A) IN GENERAL.—After the expiration of 

12 the period for comment on a notice of proposed 

13 rulemaking published under paragraph (1) re14 specting a tobacco product standard and after 

15 consideration of such comments and any report 

16 from the Tobacco Products Scientific Advisory 

17 Committee, the Secretary shall— 

18 ‘‘(i) promulgate a regulation estab19 lishing a tobacco product standard and 

20 publish in the Federal Register findings on 

21 the matters referred to in paragraph (1); 

22 or 

23 ‘‘(ii) publish a notice terminating the 

24 proceeding for the development of the 


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1 standard together with the reasons for 

2 such termination. 

3 ‘‘(B) EFFECTIVE DATE.—A regulation es4 tablishing a tobacco product standard shall set 

5 forth the date or dates upon which the standard 

6 shall take effect, but no such regulation may 

7 take effect before 1 year after the date of its 

8 publication unless the Secretary determines 

9 that an earlier effective date is necessary for 

10 the protection of the public health. Such date or 

11 dates shall be established so as to minimize, 

12 consistent with the public health, economic loss 

13 to, and disruption or dislocation of, domestic 

14 and international trade. 

15 ‘‘(3) POWER RESERVED TO CONGRESS.—Be16 cause of the importance of a decision of the Sec17 retary to issue a regulation establishing a tobacco 

18 product standard— 

19 ‘‘(A) banning all cigarettes, all smokeless 

20 tobacco products, all little cigars, all cigars 

21 other than little cigars, all pipe tobacco, or all 

22 roll your own tobacco products; or 

23 ‘‘(B) requiring the reduction of nicotine 

24 yields of a tobacco product to zero, 

25 Congress expressly reserves to itself such power. 


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1 ‘‘(4) AMENDMENT; REVOCATION.— 

2 ‘‘(A) AUTHORITY.—The Secretary, upon 

3 the Secretary’s own initiative or upon petition 

4 of an interested person may by a regulation, 

5 promulgated in accordance with the require6 ments of paragraphs (1) and (2)(B), amend or 

7 revoke a tobacco product standard. 

8 ‘‘(B) EFFECTIVE DATE.—The Secretary 

9 may declare a proposed amendment of a to10 bacco product standard to be effective on and 

11 after its publication in the Federal Register and 

12 until the effective date of any final action taken 

13 on such amendment if the Secretary determines 

14 that making it so effective is in the public inter15 est. 

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

17 ‘‘(A) IN GENERAL.—The Secretary may 

18 refer a proposed regulation for the establish19 ment, amendment, or revocation of a tobacco 

20 product standard to the Tobacco Products Sci21 entific Advisory Committee for a report and 

22 recommendation with respect to any matter in23 volved in the proposed regulation which requires 

24 the exercise of scientific judgment. 


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1 ‘‘(B) INITIATION OF REFERRAL.—The Sec2 retary may make a referral under this para3 graph— 

4 ‘‘(i) on the Secretary’s own initiative; 

5 or 

6 ‘‘(ii) upon the request of an interested 

7 person that— 

8 ‘‘(I) demonstrates good cause for 

9 the referral; and 

10 ‘‘(II) is made before the expira11 tion of the period for submission of 

12 comments on the proposed regulation. 

13 ‘‘(C) PROVISION OF DATA.—If a proposed 

14 regulation is referred under this paragraph to 

15 the Tobacco Products Scientific Advisory Com16 mittee, the Secretary shall provide the Advisory 

17 Committee with the data and information on 

18 which such proposed regulation is based. 

19 ‘‘(D) REPORT AND RECOMMENDATION.— 

20 The Tobacco Products Scientific Advisory Com21 mittee shall, within 60 days after the referral of 

22 a proposed regulation under this paragraph and 

23 after independent study of the data and infor24 mation furnished to it by the Secretary and 

25 other data and information before it, submit to 


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1 the Secretary a report and recommendation re2 specting such regulation, together with all un3 derlying data and information and a statement 

4 of the reason or basis for the recommendation. 

5 ‘‘(E) PUBLIC AVAILABILITY.—The Sec6 retary shall make a copy of each report and rec7 ommendation under subparagraph (D) publicly 

8 available. 

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

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

11 that— 

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

13 delivered for introduction into interstate commerce 

14 for commercial distribution presents an unreasonable 

15 risk of substantial harm to the public health; and 

16 ‘‘(2) notification under this subsection is nec17 essary to eliminate the unreasonable risk of such 

18 harm and no more practicable means is available 

19 under the provisions of this chapter (other than this 

20 section) to eliminate such risk, 

21 the Secretary may issue such order as may be necessary 

22 to assure that adequate notification is provided in an ap23 propriate form, by the persons and means best suited 

24 under the circumstances involved, to all persons who 

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1 nate such risk. The Secretary may order notification by 

2 any appropriate means, including public service announce3 ments. Before issuing an order under this subsection, the 

4 Secretary shall consult with the persons who are to give 

5 notice under the order. 

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

7 Compliance with an order issued under this section shall 

8 not relieve any person from liability under Federal or 

9 State law. In awarding damages for economic loss in an 

10 action brought for the enforcement of any such liability, 

11 the value to the plaintiff in such action of any remedy 

12 provided under such order shall be taken into account. 

13 ‘‘(c) RECALL AUTHORITY.— 

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

15 there is a reasonable probability that a tobacco prod16 uct contains a manufacturing or other defect not or17 dinarily contained in tobacco products on the market 

18 that would cause serious, adverse health con19 sequences or death, the Secretary shall issue an 

20 order requiring the appropriate person (including 

21 the manufacturers, importers, distributors, or retail22 ers of the tobacco product) to immediately cease dis23 tribution of such tobacco product. The order shall 

24 provide the person subject to the order with an op25 portunity for an informal hearing, to be held not 


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1 later than 10 days after the date of the issuance of 

2 the order, on the actions required by the order and 

3 on whether the order should be amended to require 

4 a recall of such tobacco product. If, after providing 

5 an opportunity for such a hearing, the Secretary de6 termines that inadequate grounds exist to support 

7 the actions required by the order, the Secretary shall 

8 vacate the order. 

9 ‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE10 CALL.— 

11 ‘‘(A) IN GENERAL.—If, after providing an 

12 opportunity for an informal hearing under 

13 paragraph (1), the Secretary determines that 

14 the order should be amended to include a recall 

15 of the tobacco product with respect to which the 

16 order was issued, the Secretary shall, except as 

17 provided in subparagraph (B), amend the order 

18 to require a recall. The Secretary shall specify 

19 a timetable in which the tobacco product recall 

20 will occur and shall require periodic reports to 

21 the Secretary describing the progress of the re22 call. 

23 ‘‘(B) NOTICE.—An amended order under 

24 subparagraph (A)— 


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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) continue to apply to records, 

19 reports, and information concerning any individual who 

20 has been a patient, irrespective of whether or when he 

21 ceases to be a patient. 

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

23 ‘‘(1) IN GENERAL.—Except as provided in para24 graph (2), the Secretary shall by regulation require 

25 a tobacco product manufacturer or importer of a toVerDate Aug 31 2005 03:42 Feb 21, 2007 Jkt 059200 PO 00000 Frm 00069 Fmt 6652 Sfmt 6201 E:\BILLS\H1108.IH H1108

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1 bacco product to report promptly to the Secretary 

2 any corrective action taken or removal from the 

3 market of a tobacco product undertaken by such 

4 manufacturer or importer if the removal or correc5 tion was undertaken— 

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 to12 bacco product who undertakes a corrective action or 

13 removal from the market of a tobacco product which 

14 is not required to be reported under this subsection 

15 shall keep a record of such correction or removal. 

16 ‘‘(2) EXCEPTION.—No report of the corrective 

17 action or removal of a tobacco product may be re18 quired under paragraph (1) if a report of the correc19 tive action or removal is required and has been sub20 mitted under subsection (a). 

21 ‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TO22 BACCO PRODUCTS. 

23 ‘‘(a) IN GENERAL.— 


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1 ‘‘(1) NEW TOBACCO PRODUCT DEFINED.—For 

2 purposes of this section the term ‘new tobacco prod3 uct’ means— 

4 ‘‘(A) any tobacco product (including those 

5 products in test markets) that was not commer6 cially marketed in the United States as of June 

7 1, 2003; or 

8 ‘‘(B) any modification (including a change 

9 in design, any component, any part, or any con10 stituent, including a smoke constituent, or in 

11 the content, delivery or form of nicotine, or any 

12 other additive or ingredient) of a tobacco prod13 uct where the modified product was commer14 cially marketed in the United States after June 

15 1, 2003. 

16 ‘‘(2) PREMARKET APPROVAL REQUIRED.— 

17 ‘‘(A) NEW PRODUCTS.—Approval under 

18 this section of an application for premarket ap19 proval for any new tobacco product is required 

20 unless— 

21 ‘‘(i) the manufacturer has submitted a 

22 report under section 905(j); and 

23 ‘‘(ii) the Secretary has issued an order 

24 that the tobacco product— 


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1 ‘‘(I) is substantially equivalent to 

2 a tobacco product commercially mar3 keted (other than for test marketing) 

4 in the United States as of June 1, 

5 2003; and 

6 ‘‘(II)(aa) is in compliance with 

7 the requirements of this Act; or 

8 ‘‘(bb) is exempt from the require9 ments of section 905(j) pursuant to a 

10 regulation issued under section 

11 905(j)(3). 

12 ‘‘(B) APPLICATION TO CERTAIN POST

13 JUNE 1, 2003 PRODUCTS.—Subparagraph (A) 

14 shall not apply to a tobacco product— 

15 ‘‘(i) that was first introduced or deliv16 ered for introduction into interstate com17 merce for commercial distribution in the 

18 United States after June 1, 2003, and 

19 prior to the date that is 15 months after 

20 the date of enactment of the Family Smok21 ing Prevention and Tobacco Control Act; 

22 and 

23 ‘‘(ii) for which a report was submitted 

24 under section 905(j) within such 15-month 

25 period, 


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1 except that subparagraph (A) shall apply to the 

2 tobacco product if the Secretary issues an order 

3 that the tobacco product is not substantially 

4 equivalent. 

5 ‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.— 

6 ‘‘(A) IN GENERAL.—In this section and 

7 section 905(j), the terms ‘substantially equiva8 lent’ or ‘substantial equivalence’ mean, with re9 spect to the tobacco product being compared to 

10 the predicate tobacco product, that the Sec11 retary by order has found that the tobacco 

12 product— 

13 ‘‘(i) has the same characteristics as 

14 the predicate tobacco product; or 

15 ‘‘(ii) has different characteristics and 

16 the information submitted contains infor17 mation, including clinical data if deemed 

18 necessary by the Secretary, that dem19 onstrates that it is not appropriate to reg20 ulate the product under this section be21 cause the product does not raise different 

22 questions of public health. 

23 ‘‘(B) CHARACTERISTICS.—In subpara24 graph (A), the term ‘characteristics’ means the 

25 materials, ingredients, design, composition, 


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1 heating source, or other features of a tobacco 

2 product. 

3 ‘‘(C) LIMITATION.—A tobacco product may 

4 not be found to be substantially equivalent to a 

5 predicate tobacco product that has been re6 moved from the market at the initiative of the 

7 Secretary or that has been determined by a ju8 dicial order to be misbranded or adulterated. 

9 ‘‘(4) HEALTH INFORMATION.— 

10 ‘‘(A) SUMMARY.—As part of a submission 

11 under section 905(j) respecting a tobacco prod12 uct, the person required to file a premarket no13 tification under such section shall provide an 

14 adequate summary of any health information 

15 related to the tobacco product or state that 

16 such information will be made available upon 

17 request by any person. 

18 ‘‘(B) REQUIRED INFORMATION.—Any sum19 mary under subparagraph (A) respecting a to20 bacco product shall contain detailed information 

21 regarding data concerning adverse health ef22 fects and shall be made available to the public 

23 by the Secretary within 30 days of the issuance 

24 of a determination that such tobacco product is 


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1 substantially equivalent to another tobacco 

2 product. 

3 ‘‘(b) APPLICATION.— 

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

5 approval shall contain— 

6 ‘‘(A) full reports of all information, pub7 lished or known to, or which should reasonably 

8 be known to, the applicant, concerning inves9 tigations which have been made to show the 

10 health risks of such tobacco product and wheth11 er such tobacco product presents less risk than 

12 other tobacco products; 

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

14 ingredients, additives, and properties, and of 

15 the principle or principles of operation, of such 

16 tobacco product; 

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

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

19 manufacture, processing, and, when relevant, 

20 packing and installation of, such tobacco prod21 uct; 

22 ‘‘(D) an identifying reference to any to23 bacco product standard under section 907 

24 which would be applicable to any aspect of such 

25 tobacco product, and either adequate informaVerDate Aug 31 2005 03:42 Feb 21, 2007 Jkt 059200 PO 00000 Frm 00075 Fmt 6652 Sfmt 6201 E:\BILLS\H1108.IH H1108

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1 tion to show that such aspect of such tobacco 

2 product fully meets such tobacco product stand3 ard or adequate information to justify any devi4 ation from such standard; 

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

6 and of components thereof as the Secretary 

7 may reasonably require; 

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

9 be used for such tobacco product; and 

10 ‘‘(G) such other information relevant to 

11 the subject matter of the application as the Sec12 retary may require. 

13 ‘‘(2) REFERENCE TO TOBACCO PRODUCTS SCI14 ENTIFIC ADVISORY COMMITTEE.—Upon receipt of an 

15 application meeting the requirements set forth in 

16 paragraph (1), the Secretary— 

17 ‘‘(A) may, on the Secretary’s own initia18 tive; or 

19 ‘‘(B) may, upon the request of an appli20 cant, 

21 refer such application to the Tobacco Products Sci22 entific Advisory Committee for reference and for 

23 submission (within such period as the Secretary may 

24 establish) of a report and recommendation respect25 ing approval of the application, together with all unVerDate Aug 31 2005 03:42 Feb 21, 2007 Jkt 059200 PO 00000 Frm 00076 Fmt 6652 Sfmt 6201 E:\BILLS\H1108.IH H1108

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1 derlying data and the reasons or basis for the rec2 ommendation. 

3 ‘‘(c) ACTION ON APPLICATION.— 

4 ‘‘(1) DEADLINE.— 

5 ‘‘(A) IN GENERAL.—As promptly as pos6 sible, but in no event later than 180 days after 

7 the receipt of an application under subsection 

8 (b), the Secretary, after considering the report 

9 and recommendation submitted under para10 graph (2) of such subsection, shall— 

11 ‘‘(i) issue an order approving the ap12 plication if the Secretary finds that none of 

13 the grounds for denying approval specified 

14 in paragraph (2) of this subsection applies; 

15 or 

16 ‘‘(ii) deny approval of the application 

17 if the Secretary finds (and sets forth the 

18 basis for such finding as part of or accom19 panying such denial) that 1 or more 

20 grounds for denial specified in paragraph 

21 (2) of this subsection apply. 

22 ‘‘(B) RESTRICTIONS ON SALE AND DIS23 TRIBUTION.—An order approving an application 

24 for a tobacco product may require as a condi25 tion to such approval that the sale and distribuVerDate Aug 31 2005 03:42 Feb 21, 2007 Jkt 059200 PO 00000 Frm 00077 Fmt 6652 Sfmt 6201 E:\BILLS\H1108.IH H1108

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1 tion of the tobacco product be restricted but 

2 only to the extent that the sale and distribution 

3 of a tobacco product may be restricted under a 

4 regulation under section 906(d). 

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

6 shall deny approval of an application for a tobacco 

7 product if, upon the basis of the information sub8 mitted to the Secretary as part of the application 

9 and any other information before the Secretary with 

10 respect to such tobacco product, the Secretary finds 

11 that— 

12 ‘‘(A) there is a lack of a showing that per13 mitting such tobacco product to be marketed 

14 would be appropriate for the protection of the 

15 public health; 

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

17 or controls used for, the manufacture, proc18 essing, or packing of such tobacco product do 

19 not conform to the requirements of section 

20 906(e); 

21 ‘‘(C) based on a fair evaluation of all mate22 rial facts, the proposed labeling is false or mis23 leading in any particular; or 

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

25 conform in all respects to a tobacco product 


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1 standard in effect under section 907, compli2 ance with which is a condition to approval of 

3 the application, and there is a lack of adequate 

4 information to justify the deviation from such 

5 standard. 

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

7 application shall, insofar as the Secretary determines 

8 to be practicable, be accompanied by a statement in9 forming the applicant of the measures required to 

10 place such application in approvable form (which 

11 measures may include further research by the appli12 cant in accordance with 1 or more protocols pre13 scribed by the Secretary). 

14 ‘‘(4) BASIS FOR FINDING.—For purposes of 

15 this section, the finding as to whether approval of a 

16 tobacco product is appropriate for the protection of 

17 the public health shall be determined with respect to 

18 the risks and benefits to the population as a whole, 

19 including users and nonusers of the tobacco product, 

20 and taking into account— 

21 ‘‘(A) the increased or decreased likelihood 

22 that existing users of tobacco products will stop 

23 using such products; and 


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1 ‘‘(B) the increased or decreased likelihood 

2 that those who do not use tobacco products will 

3 start using such products. 

4 ‘‘(5) BASIS FOR ACTION.— 

5 ‘‘(A) INVESTIGATIONS.—For purposes of 

6 paragraph (2)(A), whether permitting a tobacco 

7 product to be marketed would be appropriate 

8 for the protection of the public health shall, 

9 when appropriate, be determined on the basis of 

10 well-controlled investigations, which may in11 clude 1 or more clinical investigations by ex12 perts qualified by training and experience to 

13 evaluate the tobacco product. 

14 ‘‘(B) OTHER EVIDENCE.—If the Secretary 

15 determines that there exists valid scientific evi16 dence (other than evidence derived from inves17 tigations described in subparagraph (A)) which 

18 is sufficient to evaluate the tobacco product the 

19 Secretary may authorize that the determination 

20 for purposes of paragraph (2)(A) be made on 

21 the basis of such evidence. 

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

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

24 obtaining, where appropriate, advice on scientific 

25 matters from the Tobacco Products Scientific AdviVerDate Aug 31 2005 03:42 Feb 21, 2007 Jkt 059200 PO 00000 Frm 00080 Fmt 6652 Sfmt 6201 E:\BILLS\H1108.IH H1108

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1 sory Committee, and after due notice and oppor2 tunity for informal hearing to the holder of an ap3 proved application for a tobacco product, issue an 

4 order withdrawing approval of the application if the 

5 Secretary finds— 

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

7 tobacco product no longer is appropriate for the 

8 protection of the public health; 

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

10 accompanied by an untrue statement of a mate11 rial fact; 

12 ‘‘(C) that the applicant— 

13 ‘‘(i) has failed to establish a system 

14 for maintaining records, or has repeatedly 

15 or deliberately failed to maintain records 

16 or to make reports, required by an applica17 ble regulation under section 909; 

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

19 or copying or verification of, such records 

20 as required by section 704; or 

21 ‘‘(iii) has not complied with the re22 quirements of section 905; 

23 ‘‘(D) on the basis of new information be24 fore the Secretary with respect to such tobacco 

25 product, evaluated together with the evidence 


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1 before the Secretary when the application was 

2 approved, that the methods used in, or the fa3 cilities and controls used for, the manufacture, 

4 processing, packing, or installation of such to5 bacco product do not conform with the require6 ments of section 906(e) and were not brought 

7 into conformity with such requirements within a 

8 reasonable time after receipt of written notice 

9 from the Secretary of nonconformity; 

10 ‘‘(E) on the basis of new information be11 fore the Secretary, evaluated together with the 

12 evidence before the Secretary when the applica13 tion was approved, that the labeling of such to14 bacco product, based on a fair evaluation of all 

15 material facts, is false or misleading in any par16 ticular and was not corrected within a reason17 able time after receipt of written notice from 

18 the Secretary of such fact; or 

19 ‘‘(F) on the basis of new information be20 fore the Secretary, evaluated together with the 

21 evidence before the Secretary when the applica22 tion was approved, that such tobacco product is 

23 not shown to conform in all respects to a to24 bacco product standard which is in effect under 

25 section 907, compliance with which was a conVerDate Aug 31 2005 03:42 Feb 21, 2007 Jkt 059200 PO 00000 Frm 00082 Fmt 6652 Sfmt 6201 E:\BILLS\H1108.IH H1108

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1 dition to approval of the application, and that 

2 there is a lack of adequate information to jus3 tify the deviation from such standard. 

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

5 subject to an order issued under paragraph (1) with6 drawing approval of the application may, by petition 

7 filed on or before the 30th day after the date upon 

8 which such holder receives notice of such with9 drawal, obtain review thereof in accordance with sec10 tion 912. 

11 ‘‘(3) TEMPORARY SUSPENSION.—If, after pro12 viding an opportunity for an informal hearing, the 

13 Secretary determines there is reasonable probability 

14 that the continuation of distribution of a tobacco 

15 product under an approved application would cause 

16 serious, adverse health consequences or death, that 

17 is greater than ordinarily caused by tobacco prod18 ucts on the market, the Secretary shall by order 

19 temporarily suspend the approval of the application 

20 approved under this section. If the Secretary issues 

21 such an order, the Secretary shall proceed expedi22 tiously under paragraph (1) to withdraw such appli23 cation. 

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

25 Secretary under this section shall be served— 


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

2 department designated by the Secretary; or 

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

4 certified mail addressed to the applicant at the ap5 plicant’s last known address in the records of the 

6 Secretary. 

7 ‘‘(f) RECORDS.— 

8 ‘‘(1) ADDITIONAL INFORMATION.—In the case 

9 of any tobacco product for which an approval of an 

10 application filed under subsection (b) is in effect, the 

11 applicant shall establish and maintain such records, 

12 and make such reports to the Secretary, as the Sec13 retary may by regulation, or by order with respect 

14 to such application, prescribe on the basis of a find15 ing that such records and reports are necessary in 

16 order to enable the Secretary to determine, or facili17 tate a determination of, whether there is or may be 

18 grounds for withdrawing or temporarily suspending 

19 such approval. 

20 ‘‘(2) ACCESS TO RECORDS.—Each person re21 quired under this section to maintain records, and 

22 each person in charge or custody thereof, shall, upon 

23 request of an officer or employee designated by the 

24 Secretary, permit such officer or employee at all reaVerDate Aug 31 2005 03:42 Feb 21, 2007 Jkt 059200 PO 00000 Frm 00084 Fmt 6652 Sfmt 6201 E:\BILLS\H1108.IH H1108

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1 sonable times to have access to and copy and verify 

2 such records. 

3 ‘‘(g) INVESTIGATIONAL TOBACCO PRODUCT EXEMP4 TION FOR INVESTIGATIONAL USE.—The Secretary may 

5 exempt tobacco products intended for investigational use 

6 from the provisions of this chapter under such conditions 

7 as the Secretary may by regulation prescribe. 

8 ‘‘SEC. 911. MODIFIED RISK TOBACCO PRODUCTS. 

9 ‘‘(a) IN GENERAL.—No person may introduce or de10 liver for introduction into interstate commerce any modi11 fied risk tobacco product unless approval of an application 

12 filed pursuant to subsection (d) is effective with respect 

13 to such product. 

14 ‘‘(b) DEFINITIONS.—In this section: 

15 ‘‘(1) MODIFIED RISK TOBACCO PRODUCT.—The 

16 term ‘modified risk tobacco product’ means any to17 bacco product that is sold or distributed for use to 

18 reduce harm or the risk of tobacco-related disease 

19 associated with commercially marketed tobacco prod20 ucts. 

21 ‘‘(2) SOLD OR DISTRIBUTED.— 

22 ‘‘(A) IN GENERAL.—With respect to a to23 bacco product, the term ‘sold or distributed for 

24 use to reduce harm or the risk of tobacco-re25 lated disease associated with commercially marVerDate Aug 31 2005 03:42 Feb 21, 2007 Jkt 059200 PO 00000 Frm 00085 Fmt 6652 Sfmt 6201 E:\BILLS\H1108.IH H1108

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1 keted tobacco products’ means a tobacco prod2 uct— 

3 ‘‘(i) the label, labeling, or advertising 

4 of which represents explicitly or implicitly 

5 that— 

6 ‘‘(I) the tobacco product presents 

7 a lower risk of tobacco-related disease 

8 or is less harmful than one or more 

9 other commercially marketed tobacco 

10 products; 

11 ‘‘(II) the tobacco product or its 

12 smoke contains a reduced level of a 

13 substance or presents a reduced expo14 sure to a substance; or 

15 ‘‘(III) the tobacco product or its 

16 smoke does not contain or is free of a 

17 substance; 

18 ‘‘(ii) the label, labeling, or advertising 

19 of which uses the descriptors ‘light’, ‘mild’, 

20 or ‘low’ or similar descriptors; or 

21 ‘‘(iii) the tobacco product manufac22 turer of which has taken any action di23 rected to consumers through the media or 

24 otherwise, other than by means of the to25 bacco product’s label, labeling, or adverVerDate Aug 31 2005 03:42 Feb 21, 2007 Jkt 059200 PO 00000 Frm 00086 Fmt 6652 Sfmt 6201 E:\BILLS\H1108.IH H1108

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1 tising, after the date of enactment of the 

2 Family Smoking Prevention and Tobacco 

3 Control Act, respecting the product that 

4 would be reasonably expected to result in 

5 consumers believing that the tobacco prod6 uct or its smoke may present a lower risk 

7 of disease or is less harmful than one or 

8 more commercially marketed tobacco prod9 ucts, or presents a reduced exposure to, or 

10 does not contain or is free of, a substance 

11 or substances. 

12 ‘‘(B) LIMITATION.—No tobacco product 

13 shall be considered to be ‘sold or distributed for 

14 use to reduce harm or the risk of tobacco-re15 lated disease associated with commercially mar16 keted tobacco products’, except as described in 

17 subparagraph (A). 

18 ‘‘(c) TOBACCO DEPENDENCE PRODUCTS.—A product 

19 that is intended to be used for the treatment of tobacco 

20 dependence, including smoking cessation, is not a modified 

21 risk tobacco product under this section and is subject to 

22 the requirements of chapter V. 

23 ‘‘(d) FILING.—Any person may file with the Sec24 retary an application for a modified risk tobacco product. 

25 Such application shall include— 


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1 ‘‘(1) a description of the proposed product and 

2 any proposed advertising and labeling; 

3 ‘‘(2) the conditions for using the product; 

4 ‘‘(3) the formulation of the product; 

5 ‘‘(4) sample product labels and labeling; 

6 ‘‘(5) all documents (including underlying sci7 entific information) relating to research findings 

8 conducted, supported, or possessed by the tobacco 

9 product manufacturer relating to the effect of the 

10 product on tobacco-related diseases and health-re11 lated conditions, including information both favor12 able and unfavorable to the ability of the product to 

13 reduce risk or exposure and relating to human 

14 health; 

15 ‘‘(6) data and information on how consumers 

16 actually use the tobacco product; and 

17 ‘‘(7) such other information as the Secretary 

18 may require. 

19 ‘‘(e) PUBLIC AVAILABILITY.—The Secretary shall 

20 make the application described in subsection (d) publicly 

21 available (except matters in the application which are 

22 trade secrets or otherwise confidential, commercial infor23 mation) and shall request comments by interested persons 

24 on the information contained in the application and on the 


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1 label, labeling, and advertising accompanying such appli2 cation. 

3 ‘‘(f) ADVISORY COMMITTEE.— 

4 ‘‘(1) IN GENERAL.—The Secretary shall refer to 

5 the Tobacco Products Scientific Advisory Committee 

6 any application submitted under this subsection. 

7 ‘‘(2) RECOMMENDATIONS.—Not later than 60 

8 days after the date an application is referred to the 

9 Tobacco Products Scientific Advisory Committee 

10 under paragraph (1), the Advisory Committee shall 

11 report its recommendations on the application to the 

12 Secretary. 

13 ‘‘(g) APPROVAL.— 

14 ‘‘(1) MODIFIED RISK PRODUCTS.—Except as 

15 provided in paragraph (2), the Secretary shall ap16 prove an application for a modified risk tobacco 

17 product filed under this section only if the Secretary 

18 determines that the applicant has demonstrated that 

19 such product, as it is actually used by consumers, 

20 will— 

21 ‘‘(A) significantly reduce harm and the 

22 risk of tobacco-related disease to individual to23 bacco users; and 

24 ‘‘(B) benefit the health of the population 

25 as a whole taking into account both users of toVerDate Aug 31 2005 03:42 Feb 21, 2007 Jkt 059200 PO 00000 Frm 00089 Fmt 6652 Sfmt 6201 E:\BILLS\H1108.IH H1108

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1 bacco products and persons who do not cur2 rently use tobacco products. 

3 ‘‘(2) SPECIAL RULE FOR CERTAIN PRODUCTS.— 

4 ‘‘(A) IN GENERAL.—The Secretary may 

5 approve an application for a tobacco product 

6 that has not been approved as a modified risk 

7 tobacco product pursuant to paragraph (1) if 

8 the Secretary makes the findings required 

9 under this paragraph and determines that the 

10 applicant has demonstrated that— 

11 ‘‘(i) the approval of the application 

12 would be appropriate to promote the public 

13 health; 

14 ‘‘(ii) any aspect of the label, labeling, 

15 and advertising for such product that 

16 would cause the tobacco product to be a 

17 modified risk tobacco product under sub18 section (b)(2) is limited to an explicit or 

19 implicit representation that such tobacco 

20 product or its smoke contains or is free of 

21 a substance or contains a reduced level of 

22 a substance, or presents a reduced expo23 sure to a substance in tobacco smoke; 

24 ‘‘(iii) scientific evidence is not avail25 able and, using the best available scientific 


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1 methods, cannot be made available without 

2 conducting long-term epidemiological stud3 ies for an application to meet the stand4 ards set forth in paragraph (1); and 

5 ‘‘(iv) the scientific evidence that is 

6 available without conducting long-term epi7 demiological studies demonstrates that a 

8 measurable and substantial reduction in 

9 morbidity or mortality among individual 

10 tobacco users is anticipated in subsequent 

11 studies. 

12 ‘‘(B) ADDITIONAL FINDINGS REQUIRED.— 

13 In order to approve an application under sub14 paragraph (A) the Secretary must also find 

15 that the applicant has demonstrated that— 

16 ‘‘(i) the magnitude of the overall re17 ductions in exposure to the substance or 

18 substances which are the subject of the ap19 plication is substantial, such substance or 

20 substances are harmful, and the product as 

21 actually used exposes consumers to the 

22 specified reduced level of the substance or 

23 substances; 

24 ‘‘(ii) the product as actually used by 

25 consumers will not expose them to higher 


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1 levels of other harmful substances com2 pared to the similar types of tobacco prod3 ucts then on the market unless such in4 creases are minimal and the anticipated 

5 overall impact of use of the product re6 mains a substantial and measurable reduc7 tion in overall morbidity and mortality 

8 among individual tobacco users; 

9 ‘‘(iii) testing of actual consumer per10 ception shows that, as the applicant pro11 poses to label and market the product, con12 sumers will not be misled into believing 

13 that the product— 

14 ‘‘(I) is or has been demonstrated 

15 to be less harmful; or 

16 ‘‘(II) presents or has been dem17 onstrated to present less of a risk of 

18 disease than 1 or more other commer19 cially marketed tobacco products; and 

20 ‘‘(iv) approval of the application is ex21 pected to benefit the health of the popu22 lation as a whole taking into account both 

23 users of tobacco products and persons who 

24 do not currently use tobacco products. 

25 ‘‘(C) CONDITIONS OF APPROVAL.— 


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1 ‘‘(i) IN GENERAL.—Applications ap2 proved under this paragraph shall be lim3 ited to a term of not more than 5 years, 

4 but may be renewed upon a finding by the 

5 Secretary that the requirements of this 

6 paragraph continue to be satisfied based 

7 on the filing of a new application. 

8 ‘‘(ii) AGREEMENTS BY APPLICANT.— 

9 Applications approved under this para10 graph shall be conditioned on the appli11 cant’s agreement to conduct post-market 

12 surveillance and studies and to submit to 

13 the Secretary the results of such surveil14 lance and studies to determine the impact 

15 of the application approval on consumer 

16 perception, behavior, and health and to en17 able the Secretary to review the accuracy 

18 of the determinations upon which the ap19 proval was based in accordance with a pro20 tocol approved by the Secretary. 

21 ‘‘(iii) ANNUAL SUBMISSION.—The re22 sults of such post-market surveillance and 

23 studies described in clause (ii) shall be 

24 submitted annually. 


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1 ‘‘(3) BASIS.—The determinations under para2 graphs (1) and (2) shall be based on— 

3 ‘‘(A) the scientific evidence submitted by 

4 the applicant; and 

5 ‘‘(B) scientific evidence and other informa6 tion that is available to the Secretary. 

7 ‘‘(4) BENEFIT TO HEALTH OF INDIVIDUALS

8 AND OF POPULATION AS A WHOLE.—In making the 

9 determinations under paragraphs (1) and (2), the 

10 Secretary shall take into account— 

11 ‘‘(A) the relative health risks to individuals 

12 of the tobacco product that is the subject of the 

13 application; 

14 ‘‘(B) the increased or decreased likelihood 

15 that existing users of tobacco products who 

16 would otherwise stop using such products will 

17 switch to the tobacco product that is the subject 

18 of the application; 

19 ‘‘(C) the increased or decreased likelihood 

20 that persons who do not use tobacco products 

21 will start using the tobacco product that is the 

22 subject of the application; 

23 ‘‘(D) the risks and benefits to persons 

24 from the use of the tobacco product that is the 

25 subject of the application as compared to the 


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1 use of products for smoking cessation approved 

2 under chapter V to treat nicotine dependence; 

3 and 

4 ‘‘(E) comments, data, and information 

5 submitted by interested persons. 

6 ‘‘(h) ADDITIONAL CONDITIONS FOR APPROVAL.— 

7 ‘‘(1) MODIFIED RISK PRODUCTS.—The Sec8 retary shall require for the approval of an applica9 tion under this section that any advertising or label10 ing concerning modified risk products enable the 

11 public to comprehend the information concerning 

12 modified risk and to understand the relative signifi13 cance of such information in the context of total 

14 health and in relation to all of the diseases and 

15 health-related conditions associated with the use of 

16 tobacco products. 

17 ‘‘(2) COMPARATIVE CLAIMS.— 

18 ‘‘(A) IN GENERAL.—The Secretary may re19 quire for the approval of an application under 

20 this subsection that a claim comparing a to21 bacco product to 1 or more other commercially 

22 marketed tobacco products shall compare the 

23 tobacco product to a commercially marketed to24 bacco product that is representative of that type 

25 of tobacco product on the market (for example 


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1 the average value of the top 3 brands of an es2 tablished regular tobacco product). 

3 ‘‘(B) QUANTITATIVE COMPARISONS.—The 

4 Secretary may also require, for purposes of sub5 paragraph (A), that the percent (or fraction) of 

6 change and identity of the reference tobacco 

7 product and a quantitative comparison of the 

8 amount of the substance claimed to be reduced 

9 shall be stated in immediate proximity to the 

10 most prominent claim. 

11 ‘‘(3) LABEL DISCLOSURE.— 

12 ‘‘(A) IN GENERAL.—The Secretary may re13 quire the disclosure on the label of other sub14 stances in the tobacco product, or substances 

15 that may be produced by the consumption of 

16 that tobacco product, that may affect a disease 

17 or health-related condition or may increase the 

18 risk of other diseases or health-related condi19 tions associated with the use of tobacco prod20 ucts. 

21 ‘‘(B) CONDITIONS OF USE.—If the condi22 tions of use of the tobacco product may affect 

23 the risk of the product to human health, the 

24 Secretary may require the labeling of conditions 

25 of use. 


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1 ‘‘(4) TIME.—The Secretary shall limit an ap2 proval under subsection (g)(1) for a specified period 

3 of time. 

4 ‘‘(5) ADVERTISING.—The Secretary may re5 quire that an applicant, whose application has been 

6 approved under this subsection, comply with require7 ments relating to advertising and promotion of the 

8 tobacco product. 

9 ‘‘(i) POSTMARKET SURVEILLANCE AND STUDIES.— 

10 ‘‘(1) IN GENERAL.—The Secretary shall require 

11 that an applicant under subsection (g)(1) conduct 

12 post market surveillance and studies for a tobacco 

13 product for which an application has been approved 

14 to determine the impact of the application approval 

15 on consumer perception, behavior, and health, to en16 able the Secretary to review the accuracy of the de17 terminations upon which the approval was based, 

18 and to provide information that the Secretary deter19 mines is otherwise necessary regarding the use or 

20 health risks involving the tobacco product. The re21 sults of post-market surveillance and studies shall be 

22 submitted to the Secretary on an annual basis. 

23 ‘‘(2) SURVEILLANCE PROTOCOL.—Each appli24 cant required to conduct a surveillance of a tobacco 

25 product under paragraph (1) shall, within 30 days 


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1 after receiving notice that the applicant is required 

2 to conduct such surveillance, submit, for the ap3 proval of the Secretary, a protocol for the required 

4 surveillance. The Secretary, within 60 days of the 

5 receipt of such protocol, shall determine if the prin6 cipal investigator proposed to be used in the surveil7 lance has sufficient qualifications and experience to 

8 conduct such surveillance and if such protocol will 

9 result in collection of the data or other information 

10 designated by the Secretary as necessary to protect 

11 the public health. 

12 ‘‘(j) WITHDRAWAL OF APPROVAL.—The Secretary, 

13 after an opportunity for an informal hearing, shall with14 draw the approval of an application under this section if 

15 the Secretary determines that— 

16 ‘‘(1) the applicant, based on new information, 

17 can no longer make the demonstrations required 

18 under subsection (g), or the Secretary can no longer 

19 make the determinations required under subsection 

20 (g); 

21 ‘‘(2) the application failed to include material 

22 information or included any untrue statement of ma23 terial fact; 


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1 ‘‘(3) any explicit or implicit representation that 

2 the product reduces risk or exposure is no longer 

3 valid, including if— 

4 ‘‘(A) a tobacco product standard is estab5 lished pursuant to section 907; 

6 ‘‘(B) an action is taken that affects the 

7 risks presented by other commercially marketed 

8 tobacco products that were compared to the 

9 product that is the subject of the application; or 

10 ‘‘(C) any postmarket surveillance or stud11 ies reveal that the approval of the application is 

12 no longer consistent with the protection of the 

13 public health; 

14 ‘‘(4) the applicant failed to conduct or submit 

15 the postmarket surveillance and studies required 

16 under subsection (g)(2)(C)(ii) or (i); or 

17 ‘‘(5) the applicant failed to meet a condition 

18 imposed under subsection (h). 

19 ‘‘(k) CHAPTER IV OR V.—A product approved in ac20 cordance with this section shall not be subject to chapter 

21 IV or V. 

22 ‘‘(l) IMPLEMENTING REGULATIONS OR GUIDANCE.— 

23 ‘‘(1) SCIENTIFIC EVIDENCE.—Not later than 2 

24 years after the date of enactment of the Family 

25 Smoking Prevention and Tobacco Control Act, the 


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1 Secretary shall issue regulations or guidance (or any 

2 combination thereof) on the scientific evidence re3 quired for assessment and ongoing review of modi4 fied risk tobacco products. Such regulations or guid5 ance shall— 

6 ‘‘(A) establish minimum standards for sci7 entific studies needed prior to approval to show 

8 that a substantial reduction in morbidity or 

9 mortality among individual tobacco users is 

10 likely; 

11 ‘‘(B) include validated biomarkers, inter12 mediate clinical endpoints, and other feasible 

13 outcome measures, as appropriate; 

14 ‘‘(C) establish minimum standards for post 

15 market studies, that shall include regular and 

16 long-term assessments of health outcomes and 

17 mortality, intermediate clinical endpoints, con18 sumer perception of harm reduction, and the 

19 impact on quitting behavior and new use of to20 bacco products, as appropriate; 

21 ‘‘(D) establish minimum standards for re22 quired postmarket surveillance, including ongo23 ing assessments of consumer perception; and 

24 ‘‘(E) require that data from the required 

25 studies and surveillance be made available to 


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1 the Secretary prior to the decision on renewal 

2 of a modified risk tobacco product. 

3 ‘‘(2) CONSULTATION.—The regulations or guid4 ance issued under paragraph (1) shall be developed 

5 in consultation with the Institute of Medicine, and 

6 with the input of other appropriate scientific and 

7 medical experts, on the design and conduct of such 

8 studies and surveillance. 

9 ‘‘(3) REVISION.—The regulations or guidance 

10 under paragraph (1) shall be revised on a regular 

11 basis as new scientific information becomes avail12 able. 

13 ‘‘(4) NEW TOBACCO PRODUCTS.—Not later 

14 than 2 years after the date of enactment of the 

15 Family Smoking Prevention and Tobacco Control 

16 Act, the Secretary shall issue a regulation or guid17 ance that permits the filing of a single application 

18 for any tobacco product that is a new tobacco prod19 uct under section 910 and for which the applicant 

20 seeks approval as a modified risk tobacco product 

21 under this section. 

22 ‘‘(m) DISTRIBUTORS.—No distributor may take any 

23 action, after the date of enactment of the Family Smoking 

24 Prevention and Tobacco Control Act, with respect to a to25 bacco product that would reasonably be expected to result 


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1 in consumers believing that the tobacco product or its 

2 smoke may present a lower risk of disease or is less harm3 ful than one or more commercially marketed tobacco prod4 ucts, or presents a reduced exposure to, or does not con5 tain or is free of, a substance or substances. 

6 ‘‘SEC. 912. JUDICIAL REVIEW. 

7 ‘‘(a) RIGHT TO REVIEW.— 

8 ‘‘(1) IN GENERAL.—Not later than 30 days 

9 after— 

10 ‘‘(A) the promulgation of a regulation 

11 under section 907 establishing, amending, or 

12 revoking a tobacco product standard; or 

13 ‘‘(B) a denial of an application for ap14 proval under section 910(c), 

15 any person adversely affected by such regulation or 

16 denial may file a petition for judicial review of such 

17 regulation or denial with the United States Court of 

18 Appeals for the District of Columbia or for the cir19 cuit in which such person resides or has their prin20 cipal place of business. 

21 ‘‘(2) REQUIREMENTS.— 

22 ‘‘(A) COPY OF PETITION.—A copy of the 

23 petition filed under paragraph (1) shall be 

24 transmitted by the clerk of the court involved to 

25 the Secretary. 


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1 ‘‘(B) RECORD OF PROCEEDINGS.—On re2 ceipt of a petition under subparagraph (A), the 

3 Secretary shall file in the court in which such 

4 petition was filed— 

5 ‘‘(i) the record of the proceedings on 

6 which the regulation or order was based; 

7 and 

8 ‘‘(ii) a statement of the reasons for 

9 the issuance of such a regulation or order. 

10 ‘‘(C) DEFINITION OF RECORD.—In this 

11 section, the term ‘record’ means— 

12 ‘‘(i) all notices and other matter pub13 lished in the Federal Register with respect 

14 to the regulation or order reviewed; 

15 ‘‘(ii) all information submitted to the 

16 Secretary with respect to such regulation 

17 or order; 

18 ‘‘(iii) proceedings of any panel or ad19 visory committee with respect to such reg20 ulation or order; 

21 ‘‘(iv) any hearing held with respect to 

22 such regulation or order; and 

23 ‘‘(v) any other information identified 

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1 tion or order, as being relevant to such 

2 regulation or order. 

3 ‘‘(b) STANDARD OF REVIEW.—Upon the filing of the 

4 petition under subsection (a) for judicial review of a regu5 lation or order, the court shall have jurisdiction to review 

6 the regulation or order in accordance with chapter 7 of 

7 title 5, United States Code, and to grant appropriate re8 lief, including interim relief, as provided for in such chap9 ter. A regulation or denial described in subsection (a) shall 

10 be reviewed in accordance with section 706(2)(A) of title 

11 5, United States Code. 

12 ‘‘(c) FINALITY OF JUDGMENT.—The judgment of the 

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

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

15 Supreme Court of the United States upon certiorari or 

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

17 United States Code. 

18 ‘‘(d) OTHER REMEDIES.—The remedies provided for 

19 in this section shall be in addition to, and not in lieu of, 

20 any other remedies provided by law. 

21 ‘‘(e) REGULATIONS AND ORDERS MUST RECITE

22 BASIS IN RECORD.—To facilitate judicial review, a regula23 tion or order issued under section 906, 907, 908, 909, 

24 910, or 916 shall contain a statement of the reasons for 


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1 the issuance of such regulation or order in the record of 

2 the proceedings held in connection with its issuance. 

3 ‘‘SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS. 

4 ‘‘The Secretary shall issue regulations to require that 

5 retail establishments for which the predominant business 

6 is the sale of tobacco products comply with any advertising 

7 restrictions applicable to retail establishments accessible 

8 to individuals under the age of 18. 

9 ‘‘SEC. 914. JURISDICTION OF AND COORDINATION WITH 

10 THE FEDERAL TRADE COMMISSION. 

11 ‘‘(a) JURISDICTION.— 

12 ‘‘(1) IN GENERAL.—Except where expressly 

13 provided in this chapter, nothing in this chapter 

14 shall be construed as limiting or diminishing the au15 thority of the Federal Trade Commission to enforce 

16 the laws under its jurisdiction with respect to the 

17 advertising, sale, or distribution of tobacco products. 

18 ‘‘(2) ENFORCEMENT.—Any advertising that vio19 lates this chapter or a provision of the regulations 

20 referred to in section 102 of the Family Smoking 

21 Prevention and Tobacco Control Act, is an unfair or 

22 deceptive act or practice under section 5(a) of the 

23 Federal Trade Commission Act and shall be consid24 ered a violation of a rule promulgated under section 

25 18 of that Act. 


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1 ‘‘(b) COORDINATION.—With respect to the require2 ments of section 4 of the Federal Cigarette Labeling and 

3 Advertising Act and section 3 of the Comprehensive 

4 Smokeless Tobacco Health Education Act of 1986— 

5 ‘‘(1) the Chairman of the Federal Trade Com6 mission shall coordinate with the Secretary con7 cerning the enforcement of such Act as such enforce8 ment relates to unfair or deceptive acts or practices 

9 in the advertising of cigarettes or smokeless tobacco; 

10 and 

11 ‘‘(2) the Secretary shall consult with the Chair12 man of such Commission in revising the label state13 ments and requirements under such sections. 

14 ‘‘SEC. 915. CONGRESSIONAL REVIEW PROVISIONS. 

15 ‘‘In accordance with section 801 of title 5, United 

16 States Code, Congress shall review, and may disapprove, 

17 any rule under this chapter that is subject to section 801. 

18 This section and section 801 do not apply to the final rule 

19 referred to in paragraphs (1) and (2) of section 102(a) 

20 of the Family Smoking Prevention and Tobacco Control 

21 Act. 

22 ‘‘SEC. 916. REGULATION REQUIREMENT. 

23 ‘‘(a) TESTING, REPORTING, AND DISCLOSURE.—Not 

24 later than 24 months after the date of enactment of the 

25 Family Smoking Prevention and Tobacco Control Act, the 


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1 Secretary, acting through the Commissioner of Food and 

2 Drugs, shall promulgate regulations under this Act that 

3 meet the requirements of subsection (b). 

4 ‘‘(b) CONTENTS OF RULES.—The regulations pro5 mulgated under subsection (a) shall require testing and 

6 reporting of tobacco product constituents, ingredients, and 

7 additives, including smoke constituents, by brand and sub8 brand that the Secretary determines should be tested to 

9 protect the public health. The regulations may require 

10 that tobacco product manufacturers, packagers, or import11 ers make disclosures relating to the results of the testing 

12 of tar and nicotine through labels or advertising or other 

13 appropriate means, and make disclosures regarding the re14 sults of the testing of other constituents, including smoke 

15 constituents, ingredients, or additives, that the Secretary 

16 determines should be disclosed to the public to protect the 

17 public health and will not mislead consumers about the 

18 risk of tobacco related disease. 

19 ‘‘(c) AUTHORITY.—The Food and Drug Administra20 tion shall have the authority under this chapter to conduct 

21 or to require the testing, reporting, or disclosure of to22 bacco product constituents, including smoke constituents. 

23 ‘‘SEC. 917. PRESERVATION OF STATE AND LOCAL AUTHOR24 ITY. 

25 ‘‘(a) IN GENERAL.— 


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1 ‘‘(1) PRESERVATION.—Except as provided in 

2 paragraph (2)(A), nothing in this chapter, or rules 

3 promulgated under this chapter, shall be construed 

4 to limit the authority of a Federal agency (including 

5 the Armed Forces), a State or political subdivision 

6 of a State, or the government of an Indian tribe to 

7 enact, adopt, promulgate, and enforce any law, rule, 

8 regulation, or other measure with respect to tobacco 

9 products that is in addition to, or more stringent 

10 than, requirements established under this chapter, 

11 including a law, rule, regulation, or other measure 

12 relating to or prohibiting the sale, distribution, pos13 session, exposure to, access to, advertising and pro14 motion of, or use of tobacco products by individuals 

15 of any age, information reporting to the State, or 

16 measures relating to fire safety standards for to17 bacco products. No provision of this chapter shall 

18 limit or otherwise affect any State, Tribal, or local 

19 taxation of tobacco products. 

20 ‘‘(2) PREEMPTION OF CERTAIN STATE AND

21 LOCAL REQUIREMENTS.— 

22 ‘‘(A) IN GENERAL.—No State or political 

23 subdivision of a State may establish or continue 

24 in effect with respect to a tobacco product any 

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1 tion to, any requirement under the provisions of 

2 this chapter relating to tobacco product stand3 ards, premarket approval, adulteration, mis4 branding, labeling, registration, good manufac5 turing standards, or modified risk tobacco prod6 ucts. 

7 ‘‘(B) EXCEPTION.—Subparagraph (A) 

8 does not apply to requirements relating to the 

9 sale, distribution, possession, information re10 porting to the State, exposure to, access to, the 

11 advertising and promotion of, or use of, tobacco 

12 products by individuals of any age, or relating 

13 to fire safety standards for tobacco products. 

14 Information disclosed to a State under subpara15 graph (A) that is exempt from disclosure under 

16 section 552(b)(4) of title 5, United States Code, 

17 shall be treated as a trade secret and confiden18 tial information by the State. 

19 ‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT

20 LIABILITY.—No provision of this chapter relating to a to21 bacco product shall be construed to modify or otherwise 

22 affect any action or the liability of any person under the 

23 product liability law of any State. 


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1 ‘‘SEC. 918. TOBACCO PRODUCTS SCIENTIFIC ADVISORY 

2 COMMITTEE. 

3 ‘‘(a) ESTABLISHMENT.—Not later than 1 year after 

4 the date of enactment of the Family Smoking Prevention 

5 and Tobacco Control Act, the Secretary shall establish an 

6 11-member advisory committee, to be known as the ‘To7 bacco Products Scientific Advisory Committee’ (in this 

8 section referred to as the ‘Advisory Committee’). 

9 ‘‘(b) MEMBERSHIP.— 

10 ‘‘(1) IN GENERAL.— 

11 ‘‘(A) MEMBERS.—The Secretary shall ap12 point as members of the Tobacco Products Sci13 entific Advisory Committee individuals who are 

14 technically qualified by training and experience 

15 in the medicine, medical ethics, science, or tech16 nology involving the manufacture, evaluation, or 

17 use of tobacco products, who are of appro18 priately diversified professional backgrounds. 

19 The committee shall be composed of— 

20 ‘‘(i) 7 individuals who are physicians, 

21 dentists, scientists, or health care profes22 sionals practicing in the area of oncology, 

23 pulmonology, cardiology, toxicology, phar24 macology, addiction, or any other relevant 

25 specialty; 


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1 ‘‘(ii) 1 individual who is an officer or 

2 employee of a State or local government or 

3 of the Federal Government; 

4 ‘‘(iii) 1 individual as a representative 

5 of the general public; 

6 ‘‘(iv) 1 individual as a representative 

7 of the interests in the tobacco manufac8 turing industry; and 

9 ‘‘(v) 1 individual as a representative 

10 of the interests of the tobacco growers. 

11 ‘‘(B) NONVOTING MEMBERS.—The mem12 bers of the committee appointed under clauses 

13 (iv) and (v) of subparagraph (A) shall serve as 

14 consultants to those described in clauses (i) 

15 through (iii) of subparagraph (A) and shall be 

16 nonvoting representatives. 

17 ‘‘(2) LIMITATION.—The Secretary may not ap18 point to the Advisory Committee any individual who 

19 is in the regular full-time employ of the Food and 

20 Drug Administration or any agency responsible for 

21 the enforcement of this Act. The Secretary may ap22 point Federal officials as ex officio members. 

23 ‘‘(3) CHAIRPERSON.—The Secretary shall des24 ignate 1 of the members of the Advisory Committee 

25 to serve as chairperson. 


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1 ‘‘(c) DUTIES.—The Tobacco Products Scientific Ad2 visory Committee shall provide advice, information, and 

3 recommendations to the Secretary— 

4 ‘‘(1) as provided in this chapter; 

5 ‘‘(2) on the effects of the alteration of the nico6 tine yields from tobacco products; 

7 ‘‘(3) on whether there is a threshold level below 

8 which nicotine yields do not produce dependence on 

9 the tobacco product involved; and 

10 ‘‘(4) on its review of other safety, dependence, 

11 or health issues relating to tobacco products as re12 quested by the Secretary. 

13 ‘‘(d) COMPENSATION; SUPPORT; FACA.— 

14 ‘‘(1) COMPENSATION AND TRAVEL.—Members 

15 of the Advisory Committee who are not officers or 

16 employees of the United States, while attending con17 ferences or meetings of the committee or otherwise 

18 engaged in its business, shall be entitled to receive 

19 compensation at rates to be fixed by the Secretary, 

20 which may not exceed the daily equivalent of the 

21 rate in effect under the Senior Executive Schedule 

22 under section 5382 of title 5, United States Code, 

23 for each day (including travel time) they are so en24 gaged; and while so serving away from their homes 

25 or regular places of business each member may be 


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1 allowed travel expenses, including per diem in lieu of 

2 subsistence, as authorized by section 5703 of title 5, 

3 United States Code, for persons in the Government 

4 service employed intermittently. 

5 ‘‘(2) ADMINISTRATIVE SUPPORT.—The Sec6 retary shall furnish the Advisory Committee clerical 

7 and other assistance. 

8 ‘‘(3) NONAPPLICATION OF FACA.—Section 14 of 

9 the Federal Advisory Committee Act does not apply 

10 to the Advisory Committee. 

11 ‘‘(e) PROCEEDINGS OF ADVISORY PANELS AND COM12 MITTEES.—The Advisory Committee shall make and 

13 maintain a transcript of any proceeding of the panel or 

14 committee. Each such panel and committee shall delete 

15 from any transcript made under this subsection informa16 tion which is exempt from disclosure under section 552(b) 

17 of title 5, United States Code. 

18 ‘‘SEC. 919. DRUG PRODUCTS USED TO TREAT TOBACCO DE19 PENDENCE. 

20 ‘‘The Secretary shall— 

21 ‘‘(1) at the request of the applicant, consider 

22 designating nicotine replacement products as fast 

23 track research and approval products within the 

24 meaning of section 506; 


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1 ‘‘(2) consider approving the extended use of nic2 otine replacement products (such as nicotine patch3 es, nicotine gum, and nicotine lozenges) for the 

4 treatment of tobacco dependence; and 

5 ‘‘(3) review and consider the evidence for addi6 tional indications for nicotine replacement products, 

7 such as for craving relief or relapse prevention. 

8 ‘‘SEC. 920. USER FEE. 

9 ‘‘(a) ESTABLISHMENT OF QUARTERLY USER FEE.— 

10 The Secretary shall assess a quarterly user fee with re11 spect to every quarter of each fiscal year commencing fis12 cal year 2008, calculated in accordance with this section, 

13 upon each manufacturer and importer of tobacco products 

14 subject to this chapter. 

15 ‘‘(b) FUNDING OF FDA REGULATION OF TOBACCO

16 PRODUCTS.—The Secretary shall make user fees collected 

17 pursuant to this section available to pay, in each fiscal 

18 year, for the costs of the activities of the Food and Drug 

19 Administration related to the regulation of tobacco prod20 ucts under this chapter. 

21 ‘‘(c) ASSESSMENT OF USER FEE.— 

22 ‘‘(1) AMOUNT OF ASSESSMENT.—Except as 

23 provided in paragraph (4), the total user fees as24 sessed each year pursuant to this section shall be 

25 sufficient, and shall not exceed what is necessary, to 


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1 pay for the costs of the activities described in sub2 section (b) for each fiscal year. 

3 ‘‘(2) ALLOCATION OF ASSESSMENT BY CLASS

4 OF TOBACCO PRODUCTS.— 

5 ‘‘(A) IN GENERAL.—Subject to paragraph 

6 (3), the total user fees assessed each fiscal year 

7 with respect to each class of importers and 

8 manufacturers shall be equal to an amount that 

9 is the applicable percentage of the total costs of 

10 activities of the Food and Drug Administration 

11 described in subsection (b). 

12 ‘‘(B) APPLICABLE PERCENTAGE.—For 

13 purposes of subparagraph (A), the applicable 

14 percentage for a fiscal year shall be the fol15 lowing: 

16 ‘‘(i) 92.07 percent shall be assessed 

17 on manufacturers and importers of ciga18 rettes; 

19 ‘‘(ii) 0.05 percent shall be assessed on 

20 manufacturers and importers of little ci21 gars; 

22 ‘‘(iii) 7.15 percent shall be assessed 

23 on manufacturers and importers of cigars 

24 other than little cigars; 


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1 ‘‘(iv) 0.43 percent shall be assessed on 

2 manufacturers and importers of snuff; 

3 ‘‘(v) 0.10 percent shall be assessed on 

4 manufacturers and importers of chewing 

5 tobacco; 

6 ‘‘(vi) 0.06 percent shall be assessed on 

7 manufacturers and importers of pipe to8 bacco; and 

9 ‘‘(vii) 0.14 percent shall be assessed 

10 on manufacturers and importers of roll11 your-own tobacco. 

12 ‘‘(3) DISTRIBUTION OF FEE SHARES OF MANU13 FACTURERS AND IMPORTERS EXEMPT FROM USER

14 FEE.—Where a class of tobacco products is not sub15 ject to a user fee under this section, the portion of 

16 the user fee assigned to such class under paragraph 

17 (2) shall be allocated by the Secretary on a pro rata 

18 basis among the classes of tobacco products that are 

19 subject to a user fee under this section. Such pro 

20 rata allocation for each class of tobacco products 

21 that is subject to a user fee under this section shall 

22 be the quotient of— 

23 ‘‘(A) the percentage assigned to such class 

24 under paragraph (2); divided by 


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1 ‘‘(B) the sum of the percentages assigned 

2 to all classes of tobacco products subject to this 

3 section. 

4 ‘‘(4) ANNUAL LIMIT ON ASSESSMENT.—The 

5 total assessment under this section— 

6 ‘‘(A) for fiscal year 2008 shall be 

7 $85,000,000; 

8 ‘‘(B) for fiscal year 2009 shall be 

9 $175,000,000; 

10 ‘‘(C) for fiscal year 2010 shall be 

11 $300,000,000; and 

12 ‘‘(D) for each subsequent fiscal year, shall 

13 not exceed the limit on the assessment imposed 

14 during the previous fiscal year, as adjusted by 

15 the Secretary (after notice, published in the 

16 Federal Register) to reflect the greater of— 

17 ‘‘(i) the total percentage change that 

18 occurred in the Consumer Price Index for 

19 all urban consumers (all items; United 

20 States city average) for the 12-month pe21 riod ending on June 30 preceding the fis22 cal year for which fees are being estab23 lished; or 

24 ‘‘(ii) the total percentage change for 

25 the previous fiscal year in basic pay under 


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1 the General Schedule in accordance with 

2 section 5332 of title 5, United States 

3 Code, as adjusted by any locality-based 

4 comparability payment pursuant to section 

5 5304 of such title for Federal employees 

6 stationed in the District of Columbia. 

7 ‘‘(5) TIMING OF USER FEE ASSESSMENT.—The 

8 Secretary shall notify each manufacturer and im9 porter of tobacco products subject to this section of 

10 the amount of the quarterly assessment imposed on 

11 such manufacturer or importer under subsection (f) 

12 during each quarter of each fiscal year. Such notifi13 cations shall occur not earlier than 3 months prior 

14 to the end of the quarter for which such assessment 

15 is made, and payments of all assessments shall be 

16 made not later than 60 days after each such notifi17 cation. 

18 ‘‘(d) DETERMINATION OF USER FEE BY COMPANY

19 MARKET SHARE.— 

20 ‘‘(1) IN GENERAL.—The user fee to be paid by 

21 each manufacturer or importer of a given class of to22 bacco products shall be determined in each quarter 

23 by multiplying— 


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1 ‘‘(A) such manufacturer’s or importer’s 

2 market share of such class of tobacco products; 

3 by 

4 ‘‘(B) the portion of the user fee amount 

5 for the current quarter to be assessed on manu6 facturers and importers of such class of tobacco 

7 products as determined under subsection (e). 

8 ‘‘(2) NO FEE IN EXCESS OF MARKET SHARE.— 

9 No manufacturer or importer of tobacco products 

10 shall be required to pay a user fee in excess of the 

11 market share of such manufacturer or importer. 

12 ‘‘(e) DETERMINATION OF VOLUME OF DOMESTIC

13 SALES.— 

14 ‘‘(1) IN GENERAL.—The calculation of gross 

15 domestic volume of a class of tobacco product by a 

16 manufacturer or importer, and by all manufacturers 

17 and importers as a group, shall be made by the Sec18 retary using information provided by manufacturers 

19 and importers pursuant to subsection (f), as well as 

20 any other relevant information provided to or ob21 tained by the Secretary. 

22 ‘‘(2) MEASUREMENT.—For purposes of the cal23 culations under this subsection and the information 

24 provided under subsection (f) by the Secretary, gross 

25 domestic volume shall be measured by— 


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1 ‘‘(A) in the case of cigarettes, the number 

2 of cigarettes sold; 

3 ‘‘(B) in the case of little cigars, the num4 ber of little cigars sold; 

5 ‘‘(C) in the case of large cigars, the num6 ber of cigars weighing more than 3 pounds per 

7 thousand sold; and 

8 ‘‘(D) in the case of other classes of tobacco 

9 products, in terms of number of pounds, or 

10 fraction thereof, of these products sold. 

11 ‘‘(f) MEASUREMENT OF GROSS DOMESTIC VOL12 UME.— 

13 ‘‘(1) IN GENERAL.—Each tobacco product man14 ufacturer and importer shall submit to the Secretary 

15 a certified copy of each of the returns or forms de16 scribed by this paragraph that are required to be 

17 filed with a Government agency on the same date 

18 that those returns or forms are required to be filed 

19 with such agency. The returns and forms described 

20 by this paragraph are those returns and forms re21 lated to the removal, as defined by section 5702(j) 

22 of the Internal Revenue Code of 1986, of tobacco 

23 products into domestic commerce or the payment of 

24 the taxes imposed under chapter 52 of such Code. 


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1 ‘‘(2) PENALTIES.—Any person that knowingly 

2 fails to provide information required under this sub3 section or that provides false information under this 

4 subsection shall be subject to the penalties described 

5 in section 1001 of title 18, United States Code. In 

6 addition, such person may be subject to a civil pen7 alty in an amount not to exceed 2 percent of the 

8 value of the kind of tobacco products manufactured 

9 or imported by such person during the applicable 

10 quarter, as determined by the Secretary. 

11 ‘‘(h) EFFECTIVE DATE.—The user fees prescribed by 

12 this section shall be assessed in fiscal year 2008, based 

13 on domestic sales of tobacco products during fiscal year 

14 2007 and shall be assessed in each fiscal year thereafter.’’. 

15 SEC. 102. FINAL RULE. 

16 (a) CIGARETTES AND SMOKELESS TOBACCO.— 

17 (1) IN GENERAL.—Not later than 30 days after 

18 the date of enactment of this Act, the Secretary of 

19 Health and Human Services shall publish in the 

20 Federal Register a final rule regarding cigarettes 

21 and smokeless tobacco, which is hereby deemed to be 

22 in compliance with the Administrative Procedures 

23 Act and other applicable law. 

24 (2) CONTENTS OF RULE.—Except as provided 

25 in this subsection, the final rule published under 


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1 paragraph (1), shall be identical in its provisions to 

2 part 897 of the regulations promulgated by the Sec3 retary of Health and Human Services in the August 

4 28, 1996, issue of the Federal Register (61 Fed. 

5 Reg., 44615–44618). Such rule shall— 

6 (A) provide for the designation of jurisdic7 tional authority that is in accordance with this 

8 subsection; 

9 (B) strike Subpart C—Labels and section 

10 897.32(c); and 

11 (C) become effective not later than 1 year 

12 after the date of enactment of this Act. 

13 (3) AMENDMENTS TO RULE.—Prior to making 

14 amendments to the rule published under paragraph 

15 (1), the Secretary shall promulgate a proposed rule 

16 in accordance with the Administrative Procedures 

17 Act. 

18 (4) RULE OF CONSTRUCTION.—Except as pro19 vided in paragraph (3), nothing in this section shall 

20 be construed to limit the authority of the Secretary 

21 to amend, in accordance with the Administrative 

22 Procedures Act, the regulation promulgated pursu23 ant to this section. 

24 (b) LIMITATION ON ADVISORY OPINIONS.—As of the 

25 date of enactment of this Act, the following documents 


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1 issued by the Food and Drug Administration shall not 

2 constitute advisory opinions under section 10.85(d)(1) of 

3 title 21, Code of Federal Regulations, except as they apply 

4 to tobacco products, and shall not be cited by the Sec5 retary of Health and Human Services or the Food and 

6 Drug Administration as binding precedent: 

7 (1) The preamble to the proposed rule in the 

8 document entitled ‘‘Regulations Restricting the Sale 

9 and Distribution of Cigarettes and Smokeless To10 bacco Products to Protect Children and Adoles11 cents’’ (60 Fed. Reg. 41314–41372 (August 11, 

12 1995)). 

13 (2) The document entitled ‘‘Nicotine in Ciga14 rettes and Smokeless Tobacco Products is a Drug 

15 and These Products Are Nicotine Delivery Devices 

16 Under the Federal Food, Drug, and Cosmetic Act’’ 

17 (60 Fed. Reg. 41453–41787 (August 11, 1995)). 

18 (3) The preamble to the final rule in the docu19 ment entitled ‘‘Regulations Restricting the Sale and 

20 Distribution of Cigarettes and Smokeless Tobacco to 

21 Protect Children and Adolescents’’ (61 Fed. Reg. 

22 44396–44615 (August 28, 1996)). 

23 (4) The document entitled ‘‘Nicotine in Ciga24 rettes and Smokeless Tobacco is a Drug and These 

25 Products are Nicotine Delivery Devices Under the 


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1 Federal Food, Drug, and Cosmetic Act; Jurisdic2 tional Determination’’ (61 Fed. Reg. 44619–45318 

3 (August 28, 1996)). 

4 SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GEN5 ERAL PROVISIONS. 

6 (a) AMENDMENT OF FEDERAL FOOD, DRUG, AND

7 COSMETIC ACT.—Except as otherwise expressly provided, 

8 whenever in this section an amendment is expressed in 

9 terms of an amendment to, or repeal of, a section or other 

10 provision, the reference is to a section or other provision 

11 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

12 301 et seq.). 

13 (b) SECTION 301.—Section 301 (21 U.S.C. 331) is 

14 amended— 

15 (1) in subsection (a), by inserting ‘‘tobacco 

16 product,’’ after ‘‘device,’’; 

17 (2) in subsection (b), by inserting ‘‘tobacco 

18 product,’’ after ‘‘device,’’; 

19 (3) in subsection (c), by inserting ‘‘tobacco 

20 product,’’ after ‘‘device,’’; 

21 (4) in subsection (e) (as amended by sections 

22 2(c) and 3(b) of the Dietary Supplement and Non23 prescription Drug Consumer Protection Act (Public 

24 Law 109–462; 120 Stat. 3472)), by inserting ‘‘, or 

25 909’’ before ‘‘or the refusal to permit access to’’; 


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1 (5) in subsection (g), by inserting ‘‘tobacco 

2 product,’’ after ‘‘device,’’; 

3 (6) in subsection (h), by inserting ‘‘tobacco 

4 product,’’ after ‘‘device,’’; 

5 (7) in subsection (j), by striking ‘‘708, or 721’’ 

6 and inserting ‘‘708, 721, 904, 905, 906, 907, 908, 

7 909, or section 921(b)’’; 

8 (8) in subsection (k), by inserting ‘‘tobacco 

9 product,’’ after ‘‘device,’’; 

10 (9) by striking subsection (p) and inserting the 

11 following: 

12 ‘‘(p) The failure to register in accordance with section 

13 510 or 905, the failure to provide any information re14 quired by section 510(j), 510(k), 905(i), or 905(j), or the 

15 failure to provide a notice required by section 510(j)(2) 

16 or 905(i)(2).’’; 

17 (10) by striking subsection (q)(1) and inserting 

18 the following: 

19 ‘‘(q)(1) The failure or refusal— 

20 ‘‘(A) to comply with any requirement prescribed 

21 under section 518, 520(g), 903(b), or 908; 

22 ‘‘(B) to furnish any notification or other mate23 rial or information required by or under section 519, 

24 520(g), 904, 909, or section 921; or 


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1 ‘‘(C) to comply with a requirement under sec2 tion 522 or 913.’’; 

3 (11) in subsection (q)(2), by striking ‘‘device,’’ 

4 and inserting ‘‘device or tobacco product,’’; 

5 (12) in subsection (r), by inserting ‘‘or tobacco 

6 product’’ after the term ‘‘device’’ each time that 

7 such term appears; and 

8 (13) by adding at the end (as amended by sec9 tion 4(a) of the Dietary Supplement and Non10 prescription Drug Consumer Protection Act (Public 

11 Law 109–462; 120 Stat. 3475)) the following: 

12 ‘‘(jj) The sale of tobacco products in violation 

13 of a no-tobacco-sale order issued under section 

14 303(f). 

15 ‘‘(kk) The introduction or delivery for introduc16 tion into interstate commerce of a tobacco product 

17 in violation of section 911. 

18 ‘‘(ll)(1) Forging, counterfeiting, simulating, or 

19 falsely representing, or without proper authority 

20 using any mark, stamp (including tax stamp), tag, 

21 label, or other identification device upon any tobacco 

22 product or container or labeling thereof so as to 

23 render such tobacco product a counterfeit tobacco 

24 product. 


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1 ‘‘(2) Making, selling, disposing of, or keeping in 

2 possession, control, or custody, or concealing any 

3 punch, die, plate, stone, or other item that is de4 signed to print, imprint, or reproduce the trade5 mark, trade name, or other identifying mark, im6 print, or device of another or any likeness of any of 

7 the foregoing upon any tobacco product or container 

8 or labeling thereof so as to render such tobacco 

9 product a counterfeit tobacco product. 

10 ‘‘(3) The doing of any act that causes a tobacco 

11 product to be a counterfeit tobacco product, or the 

12 sale or dispensing, or the holding for sale or dis13 pensing, of a counterfeit tobacco product. 

14 ‘‘(mm) The charitable distribution of tobacco 

15 products. 

16 ‘‘(nn) The failure of a manufacturer or dis17 tributor to notify the Attorney General of their 

18 knowledge of tobacco products used in illicit trade.’’. 

19 (c) SECTION 303.—Section 303 (21 U.S.C. 333(f)) 

20 is amended by redesignating the subsection that follows 

21 subsection (e) as subsection (f) and in subsection (f) (as 

22 so redesignated)— 

23 (1) in paragraph (1)(A), by inserting ‘‘or to24 bacco products’’ after ‘‘devices’’; 


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1 (2) in paragraph (2)(C), by striking ‘‘paragraph 

2 (3)(A)’’ and inserting ‘‘paragraph (4)(A)’’; 

3 (3) by redesignating paragraphs (3), (4), and 

4 (5) as paragraphs (4), (5), and (6), and inserting 

5 after paragraph (2) the following: 

6 ‘‘(3) If the Secretary finds that a person has 

7 committed repeated violations of restrictions promul8 gated under section 906(d) at a particular retail out9 let then the Secretary may impose a no-tobacco-sale 

10 order on that person prohibiting the sale of tobacco 

11 products in that outlet. A no-tobacco-sale order may 

12 be imposed with a civil penalty under paragraph 

13 (1).’’; 

14 (4) in paragraph (4) as so redesignated— 

15 (A) in subparagraph (A)— 

16 (i) by striking ‘‘assessed’’ the first 

17 time it appears and inserting ‘‘assessed, or 

18 a no-tobacco-sale order may be imposed,’’; 

19 and 

20 (ii) by striking ‘‘penalty’’ and insert21 ing ‘‘penalty, or upon whom a no-tobacco22 order is to be imposed,’’; 

23 (B) in subparagraph (B)— 


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1 (i) by inserting after ‘‘penalty,’’ the 

2 following: ‘‘or the period to be covered by 

3 a no-tobacco-sale order,’’; and 

4 (ii) by adding at the end the fol5 lowing: ‘‘A no-tobacco-sale order perma6 nently prohibiting an individual retail out7 let from selling tobacco products shall in8 clude provisions that allow the outlet, after 

9 a specified period of time, to request that 

10 the Secretary compromise, modify, or ter11 minate the order.’’; and 

12 (C) by adding at the end the following: 

13 ‘‘(D) The Secretary may compromise, mod14 ify, or terminate, with or without conditions, 

15 any no-tobacco-sale order.’’; 

16 (5) in paragraph (5) as so redesignated— 

17 (A) by striking ‘‘(3)(A)’’ as redesignated, 

18 and inserting ‘‘(4)(A)’’; 

19 (B) by inserting ‘‘or the imposition of a 

20 no-tobacco-sale order’’ after the term ‘‘penalty’’ 

21 the first 2 places such term appears; and 

22 (C) by striking ‘‘issued.’’ and inserting 

23 ‘‘issued, or on which the no-tobacco-sale order 

24 was imposed, as the case may be.’’; and 


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1 (6) in paragraph (6), as so redesignated, by 

2 striking the term ‘‘paragraph (4)’’ each place such 

3 term appears and inserting ‘‘paragraph (5)’’. 

4 (d) SECTION 304.—Section 304 (21 U.S.C. 334) is 

5 amended— 

6 (1) in subsection (a)(2)— 

7 (A) by striking ‘‘and’’ before ‘‘(D)’’; and 

8 (B) by striking ‘‘device.’’ and inserting the 

9 following: ‘‘device, and (E) Any adulterated or 

10 misbranded tobacco product.’’; 

11 (2) in subsection (d)(1), by inserting ‘‘tobacco 

12 product,’’ after ‘‘device,’’; 

13 (3) in subsection (g)(1), by inserting ‘‘or to14 bacco product’’ after the term ‘‘device’’ each place 

15 such term appears; and 

16 (4) in subsection (g)(2)(A), by inserting ‘‘or to17 bacco product’’ after the term ‘‘device’’ each place 

18 such term appears. 

19 (e) SECTION 702.—Section 702(a) (21 U.S.C. 

20 372(a)) is amended by adding at the end of paragraph 

21 (1) the following: ‘‘For a tobacco product, to the extent 

22 feasible, the Secretary shall contract with the States in 

23 accordance with this paragraph to carry out inspections 

24 of retailers within that State in connection with the en25 forcement of this Act.’’. 


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1 (f) SECTION 703.—Section 703 (21 U.S.C. 373) is 

2 amended— 

3 (1) by inserting ‘‘tobacco product,’’ after the 

4 term ‘‘device,’’ each place such term appears; and 

5 (2) by inserting ‘‘tobacco products,’’ after the 

6 term ‘‘devices,’’ each place such term appears. 

7 (g) SECTION 704.—Section 704 (21 U.S.C. 374) is 

8 amended— 

9 (1) in subsection (a)(1)(A), by inserting ‘‘to10 bacco products,’’ after the term ‘‘devices,’’ each 

11 place such term appears; 

12 (2) in subsection (a)(1)(B), by inserting ‘‘or to13 bacco product’’ after the term ‘‘restricted devices’’ 

14 each place such term appears; and 

15 (3) in subsection (b), by inserting ‘‘tobacco 

16 product,’’ after ‘‘device,’’. 

17 (h) SECTION 705.—Section 705(b) (21 U.S.C. 

18 375(b)) is amended by inserting ‘‘tobacco products,’’ after 

19 ‘‘devices,’’. 

20 (i) SECTION 709.—Section 709 (21 U.S.C. 379) is 

21 amended by inserting ‘‘tobacco product,’’ after ‘‘device,’’. 

22 (j) SECTION 801.—Section 801 (21 U.S.C. 381) is 

23 amended— 

24 (1) in subsection (a)— 


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1 (A) by inserting ‘‘tobacco products,’’ after 

2 the term ‘‘devices,’’ the first time such term ap3 pears; 

4 (B) by inserting ‘‘or section 905(j)’’ after 

5 ‘‘section 510’’; and 

6 (C) by striking the term ‘‘drugs or de7 vices’’ each time such term appears and insert8 ing ‘‘drugs, devices, or tobacco products’’; 

9 (2) in subsection (e)(1), by inserting ‘‘tobacco 

10 product,’’ after ‘‘device,’’; and 

11 (3) by adding at the end the following: 

12 ‘‘(p)(1) Not later than 2 years after the date of enact13 ment of the Family Smoking Prevention and Tobacco 

14 Control Act, and annually thereafter, the Secretary shall 

15 submit to the Committee on Health, Education, Labor, 

16 and Pensions of the Senate and the Committee on Energy 

17 and Commerce of the House of Representatives, a report 

18 regarding— 

19 ‘‘(A) the nature, extent, and destination of 

20 United States tobacco product exports that do not 

21 conform to tobacco product standards established 

22 pursuant to this Act; 

23 ‘‘(B) the public health implications of such ex24 ports, including any evidence of a negative public 

25 health impact; and 


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1 ‘‘(C) recommendations or assessments of policy 

2 alternatives available to Congress and the Executive 

3 Branch to reduce any negative public health impact 

4 caused by such exports. 

5 ‘‘(2) The Secretary is authorized to establish appro6 priate information disclosure requirements to carry out 

7 this subsection.’’. 

8 (k) SECTION 1003.—Section 1003(d)(2)(C) (as re9 designated by section 101(b)) is amended— 

10 (1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 

11 (2) inserting ‘‘, and tobacco products’’ after 

12 ‘‘devices’’. 

13 (l) GUIDANCE AND EFFECTIVE DATES.— 

14 (1) IN GENERAL.—The Secretary of Health and 

15 Human Services shall issue guidance— 

16 (A) defining the term ‘‘repeated violation’’, 

17 as used in section 303(f) of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 333(f)) as 

19 amended by subsection (c), by identifying the 

20 number of violations of particular requirements 

21 over a specified period of time at a particular 

22 retail outlet that constitute a repeated violation; 

23 (B) providing for timely and effective no24 tice to the retailer of each alleged violation at 

25 a particular retail outlet; 


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1 (C) providing for an expedited procedure 

2 for the administrative appeal of an alleged vio3 lation; 

4 (D) providing that a person may not be 

5 charged with a violation at a particular retail 

6 outlet unless the Secretary has provided notice 

7 to the retailer of all previous violations at that 

8 outlet; 

9 (E) establishing a period of time during 

10 which, if there are no violations by a particular 

11 retail outlet, that outlet will not be considered 

12 to have been the site of repeated violations 

13 when the next violation occurs; and 

14 (F) providing that good faith reliance on 

15 the presentation of a false government issued 

16 photographic identification that contains a date 

17 of birth does not constitute a violation of any 

18 minimum age requirement for the sale of to19 bacco products if the retailer has taken effective 

20 steps to prevent such violations, including— 

21 (i) adopting and enforcing a written 

22 policy against sales to minors; 

23 (ii) informing its employees of all ap24 plicable laws; 


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1 (iii) establishing disciplinary sanctions 

2 for employee noncompliance; and 

3 (iv) requiring its employees to verify 

4 age by way of photographic identification 

5 or electronic scanning device. 

6 (2) GENERAL EFFECTIVE DATE.—The amend7 ments made by subsection (c), other than the 

8 amendment made by paragraph (2) of such sub9 section, shall take effect upon the issuance of guid10 ance described in paragraph (1). 

11 (3) SPECIAL EFFECTIVE DATE.—The amend12 ments made by paragraph (2) of subsection (c) shall 

13 take effect on the date of enactment of this Act. 

14 TITLE II—TOBACCO PRODUCT 

15 WARNINGS; CONSTITUENT 

16 AND SMOKE CONSTITUENT 

17 DISCLOSURE 

18 SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS. 

19 Section 4 of the Federal Cigarette Labeling and Ad20 vertising Act (15 U.S.C. 1333) is amended to read as fol21 lows: 

22 ‘‘SEC. 4. LABELING. 

23 ‘‘(a) LABEL REQUIREMENTS.— 

24 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

25 person to manufacture, package, sell, offer to sell, 


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1 distribute, or import for sale or distribution within 

2 the United States any cigarettes the package of 

3 which fails to bear, in accordance with the require4 ments of this section, one of the following labels: 

5 ‘‘WARNING: Cigarettes are addictive’. 

6 ‘‘WARNING: Tobacco smoke can harm your 

7 children’. 

8 ‘‘WARNING: Cigarettes cause fatal lung dis9 ease’. 

10 ‘‘WARNING: Cigarettes cause cancer’. 

11 ‘‘WARNING: Cigarettes cause strokes and 

12 heart disease’. 

13 ‘‘WARNING: Smoking during pregnancy can 

14 harm your baby’. 

15 ‘‘WARNING: Smoking can kill you’. 

16 ‘‘WARNING: Tobacco smoke causes fatal lung 

17 disease in non-smokers’. 

18 ‘‘WARNING: Quitting smoking now greatly re19 duces serious risks to your health’. 

20 ‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.— 

21 ‘‘(A) IN GENERAL.—Each label statement 

22 required by paragraph (1) shall be located in 

23 the upper portion of the front and rear panels 

24 of the package, directly on the package under25 neath the cellophane or other clear wrapping. 


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1 Except as provided in subparagraph (B), each 

2 label statement shall comprise at least the top 

3 30 percent of the front and rear panels of the 

4 package. The word ‘WARNING’ shall appear in 

5 capital letters and all text shall be in con6 spicuous and legible 17-point type, unless the 

7 text of the label statement would occupy more 

8 than 70 percent of such area, in which case the 

9 text may be in a smaller conspicuous and leg10 ible type size, provided that at least 60 percent 

11 of such area is occupied by required text. The 

12 text shall be black on a white background, or 

13 white on a black background, in a manner that 

14 contrasts, by typography, layout, or color, with 

15 all other printed material on the package, in an 

16 alternating fashion under the plan submitted 

17 under subsection (b)(4). 

18 ‘‘(B) HINGED LID BOXES.—For any ciga19 rette brand package manufactured or distrib20 uted before January 1, 2000, which employs a 

21 hinged lid style (if such packaging was used for 

22 that brand in commerce prior to June 21, 

23 1997), the label statement required by para24 graph (1) shall be located on the hinged lid 

25 area of the package, even if such area is less 


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1 than 25 percent of the area of the front panel. 

2 Except as provided in this paragraph, the provi3 sions of this subsection shall apply to such 

4 packages. 

5 ‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU6 TION.—The provisions of this subsection do not 

7 apply to a tobacco product manufacturer or dis8 tributor of cigarettes which does not manufacture, 

9 package, or import cigarettes for sale or distribution 

10 within the United States. 

11 ‘‘(4) APPLICABILITY TO RETAILERS.—A retailer 

12 of cigarettes shall not be in violation of this sub13 section for packaging that is supplied to the retailer 

14 by a tobacco product manufacturer, importer, or dis15 tributor and is not altered by the retailer in a way 

16 that is material to the requirements of this sub17 section except that this paragraph shall not relieve 

18 a retailer of liability if the retailer sells or distributes 

19 tobacco products that are not labeled in accordance 

20 with this subsection. 

21 ‘‘(b) ADVERTISING REQUIREMENTS.— 

22 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

23 tobacco product manufacturer, importer, distributor, 

24 or retailer of cigarettes to advertise or cause to be 

25 advertised within the United States any cigarette 


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1 unless its advertising bears, in accordance with the 

2 requirements of this section, one of the labels speci3 fied in subsection (a) of this section. 

4 ‘‘(2) TYPOGRAPHY, ETC.—Each label statement 

5 required by subsection (a) of this section in cigarette 

6 advertising shall comply with the standards set forth 

7 in this paragraph. For press and poster advertise8 ments, each such statement and (where applicable) 

9 any required statement relating to tar, nicotine, or 

10 other constituent (including a smoke constituent) 

11 yield shall comprise at least 20 percent of the area 

12 of the advertisement and shall appear in a con13 spicuous and prominent format and location at the 

14 top of each advertisement within the trim area. The 

15 Secretary may revise the required type sizes in such 

16 area in such manner as the Secretary determines ap17 propriate. The word ‘WARNING’ shall appear in 

18 capital letters, and each label statement shall appear 

19 in conspicuous and legible type. The text of the label 

20 statement shall be black if the background is white 

21 and white if the background is black, under the plan 

22 submitted under paragraph (4) of this subsection. 

23 The label statements shall be enclosed by a rectan24 gular border that is the same color as the letters of 

25 the statements and that is the width of the first 


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1 downstroke of the capital ‘W’ of the word ‘WARN2 ING’ in the label statements. The text of such label 

3 statements shall be in a typeface pro rata to the fol4 lowing requirements: 45-point type for a whole-page 

5 broadsheet newspaper advertisement; 39-point type 

6 for a half-page broadsheet newspaper advertisement; 

7 39-point type for a whole-page tabloid newspaper ad8 vertisement; 27-point type for a half-page tabloid 

9 newspaper advertisement; 31.5-point type for a dou10 ble page spread magazine or whole-page magazine 

11 advertisement; 22.5-point type for a 28 centimeter 

12 by 3 column advertisement; and 15-point type for a 

13 20 centimeter by 2 column advertisement. The label 

14 statements shall be in English, except that in the 

15 case of— 

16 ‘‘(A) an advertisement that appears in a 

17 newspaper, magazine, periodical, or other publi18 cation that is not in English, the statements 

19 shall appear in the predominant language of the 

20 publication; and 

21 ‘‘(B) in the case of any other advertise22 ment that is not in English, the statements 

23 shall appear in the same language as that prin24 cipally used in the advertisement. 


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1 ‘‘(3) MATCHBOOKS.—Notwithstanding para2 graph (2), for matchbooks (defined as containing not 

3 more than 20 matches) customarily given away with 

4 the purchase of tobacco products, each label state5 ment required by subsection (a) may be printed on 

6 the inside cover of the matchbook. 

7 ‘‘(4) ADJUSTMENT BY SECRETARY.—The Sec8 retary may, through a rulemaking under section 553 

9 of title 5, United States Code, adjust the format and 

10 type sizes for the label statements required by this 

11 section or the text, format, and type sizes of any re12 quired tar, nicotine yield, or other constituent (in13 cluding smoke constituent) disclosures, or to estab14 lish the text, format, and type sizes for any other 

15 disclosures required under the Federal Food, Drug, 

16 and Cosmetic Act. The text of any such label state17 ments or disclosures shall be required to appear only 

18 within the 20 percent area of cigarette advertise19 ments provided by paragraph (2) of this subsection. 

20 The Secretary shall promulgate regulations which 

21 provide for adjustments in the format and type sizes 

22 of any text required to appear in such area to ensure 

23 that the total text required to appear by law will fit 

24 within such area. 

25 ‘‘(c) MARKETING REQUIREMENTS.— 


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1 ‘‘(1) RANDOM DISPLAY.—The label statements 

2 specified in subsection (a)(1) shall be randomly dis3 played in each 12-month period, in as equal a num4 ber of times as is possible on each brand of the 

5 product and be randomly distributed in all areas of 

6 the United States in which the product is marketed 

7 in accordance with a plan submitted by the tobacco 

8 product manufacturer, importer, distributor, or re9 tailer and approved by the Secretary. 

10 ‘‘(2) ROTATION.—The label statements speci11 fied in subsection (a)(1) shall be rotated quarterly in 

12 alternating sequence in advertisements for each 

13 brand of cigarettes in accordance with a plan sub14 mitted by the tobacco product manufacturer, im15 porter, distributor, or retailer to, and approved by, 

16 the Secretary. 

17 ‘‘(3) REVIEW.—The Secretary shall review each 

18 plan submitted under paragraph (2) and approve it 

19 if the plan— 

20 ‘‘(A) will provide for the equal distribution 

21 and display on packaging and the rotation re22 quired in advertising under this subsection; and 

23 ‘‘(B) assures that all of the labels required 

24 under this section will be displayed by the toVerDate Aug 31 2005 03:42 Feb 21, 2007 Jkt 059200 PO 00000 Frm 00142 Fmt 6652 Sfmt 6201 E:\BILLS\H1108.IH H1108

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1 bacco product manufacturer, importer, dis2 tributor, or retailer at the same time. 

3 ‘‘(4) APPLICABILITY TO RETAILERS.—This sub4 section and subsection (b) apply to a retailer only if 

5 that retailer is responsible for or directs the label 

6 statements required under this section except that 

7 this paragraph shall not relieve a retailer of liability 

8 if the retailer displays, in a location open to the pub9 lic, an advertisement that is not labeled in accord10 ance with the requirements of this subsection and 

11 subsection (b).’’. 

12 SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING 

13 LABEL STATEMENTS. 

14 Section 4 of the Federal Cigarette Labeling and Ad15 vertising Act (15 U.S.C. 1333), as amended by section 

16 201, is further amended by adding at the end the fol17 lowing: 

18 ‘‘(d) CHANGE IN REQUIRED STATEMENTS.—The 

19 Secretary may, by a rulemaking conducted under section 

20 553 of title 5, United States Code, adjust the format, type 

21 size, and text of any of the label requirements, require 

22 color graphics to accompany the text, increase the re23 quired label area from 30 percent up to 50 percent of the 

24 front and rear panels of the package, or establish the for25 mat, type size, and text of any other disclosures required 


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1 under the Federal Food, Drug, and Cosmetic Act, if the 

2 Secretary finds that such a change would promote greater 

3 public understanding of the risks associated with the use 

4 of tobacco products.’’. 

5 SEC. 203. STATE REGULATION OF CIGARETTE ADVER6 TISING AND PROMOTION. 

7 Section 5 of the Federal Cigarette Labeling and Ad8 vertising Act (15 U.S.C. 1334) is amended by adding at 

9 the end the following: 

10 ‘‘(c) EXCEPTION.—Notwithstanding subsection (b), a 

11 State or locality may enact statutes and promulgate regu12 lations, based on smoking and health, that take effect 

13 after the effective date of the Family Smoking Prevention 

14 and Tobacco Control Act, imposing specific bans or re15 strictions on the time, place, and manner, but not content, 

16 of the advertising or promotion of any cigarettes.’’. 

17 SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING 

18 WARNINGS. 

19 Section 3 of the Comprehensive Smokeless Tobacco 

20 Health Education Act of 1986 (15 U.S.C. 4402) is amend21 ed to read as follows: 

22 ‘‘SEC. 3. SMOKELESS TOBACCO WARNING. 

23 ‘‘(a) GENERAL RULE.— 

24 ‘‘(1) It shall be unlawful for any person to man25 ufacture, package, sell, offer to sell, distribute, or 


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1 import for sale or distribution within the United 

2 States any smokeless tobacco product unless the 

3 product package bears, in accordance with the re4 quirements of this Act, one of the following labels: 

5 ‘‘WARNING: This product can cause mouth 

6 cancer’. 

7 ‘‘WARNING: This product can cause gum dis8 ease and tooth loss’. 

9 ‘‘WARNING: This product is not a safe alter10 native to cigarettes’. 

11 ‘‘WARNING: Smokeless tobacco is addictive’. 

12 ‘‘(2) Each label statement required by para13 graph (1) shall be— 

14 ‘‘(A) located on the 2 principal display 

15 panels of the package, and each label statement 

16 shall comprise at least 30 percent of each such 

17 display panel; and 

18 ‘‘(B) in 17-point conspicuous and legible 

19 type and in black text on a white background, 

20 or white text on a black background, in a man21 ner that contrasts by typography, layout, or 

22 color, with all other printed material on the 

23 package, in an alternating fashion under the 

24 plan submitted under subsection (b)(3), except 

25 that if the text of a label statement would ocVerDate Aug 31 2005 03:42 Feb 21, 2007 Jkt 059200 PO 00000 Frm 00145 Fmt 6652 Sfmt 6201 E:\BILLS\H1108.IH H1108

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1 cupy more than 70 percent of the area specified 

2 by subparagraph (A), such text may appear in 

3 a smaller type size, so long as at least 60 per4 cent of such warning area is occupied by the 

5 label statement. 

6 ‘‘(3) The label statements required by para7 graph (1) shall be introduced by each tobacco prod8 uct manufacturer, packager, importer, distributor, or 

9 retailer of smokeless tobacco products concurrently 

10 into the distribution chain of such products. 

11 ‘‘(4) The provisions of this subsection do not 

12 apply to a tobacco product manufacturer or dis13 tributor of any smokeless tobacco product that does 

14 not manufacture, package, or import smokeless to15 bacco products for sale or distribution within the 

16 United States. 

17 ‘‘(5) A retailer of smokeless tobacco products 

18 shall not be in violation of this subsection for pack19 aging that is supplied to the retailer by a tobacco 

20 products manufacturer, importer, or distributor and 

21 that is not altered by the retailer unless the retailer 

22 offers for sale, sells, or distributes a smokeless to23 bacco product that is not labeled in accordance with 

24 this subsection. 

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 in 

20 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 toVerDate Aug 31 2005 03:42 Feb 21, 2007 Jkt 059200 PO 00000 Frm 00148 Fmt 6652 Sfmt 6201 E:\BILLS\H1108.IH H1108

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1 bacco product manufacturer, importer, dis2 tributor, or retailer at the same time. 

3 ‘‘(D) This paragraph applies to a retailer only 

4 if that retailer is responsible for or directs the label 

5 statements under this section, unless the retailer dis6 plays in a location open to the public, an advertise7 ment that is not labeled in accordance with the re8 quirements of this subsection. 

9 ‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is 

10 unlawful to advertise smokeless tobacco on any medium 

11 of electronic communications subject to the jurisdiction of 

12 the Federal Communications Commission.’’. 

13 SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO 

14 PRODUCT WARNING LABEL STATEMENTS. 

15 Section 3 of the Comprehensive Smokeless Tobacco 

16 Health Education Act of 1986 (15 U.S.C. 4402), as 

17 amended by section 204, is further amended by adding 

18 at the end the following: 

19 ‘‘(d) AUTHORITY TO REVISE WARNING LABEL

20 STATEMENTS.—The Secretary may, by a rulemaking con21 ducted under section 553 of title 5, United States Code, 

22 adjust the format, type size, and text of any of the label 

23 requirements, require color graphics to accompany the 

24 text, increase the required label area from 30 percent up 

25 to 50 percent of the front and rear panels of the package, 


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1 or establish the format, type size, and text of any other 

2 disclosures required under the Federal Food, Drug, and 

3 Cosmetic Act, if the Secretary finds that such a change 

4 would promote greater public understanding of the risks 

5 associated with the use of smokeless tobacco products.’’. 

6 SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CON7 STITUENT DISCLOSURE TO THE PUBLIC. 

8 Section 4 of the Federal Cigarette Labeling and Ad9 vertising Act (15 U.S.C. 1333), as amended by sections 

10 201 and 202, is further amended by adding at the end 

11 the following: 

12 ‘‘(e) TAR, NICOTINE, AND OTHER SMOKE CON13 STITUENT DISCLOSURE.— 

14 ‘‘(1) IN GENERAL.—The Secretary shall, by a 

15 rulemaking conducted under section 553 of title 5, 

16 United States Code, determine (in the Secretary’s 

17 sole discretion) whether cigarette and other tobacco 

18 product manufacturers shall be required to include 

19 in the area of each cigarette advertisement specified 

20 by subsection (b) of this section, or on the package 

21 label, or both, the tar and nicotine yields of the ad22 vertised or packaged brand. Any such disclosure 

23 shall be in accordance with the methodology estab24 lished under such regulations, shall conform to the 

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1 tion, and shall appear within the area specified in 

2 subsection (b) of this section. 

3 ‘‘(2) RESOLUTION OF DIFFERENCES.—Any dif4 ferences between the requirements established by the 

5 Secretary under paragraph (1) and tar and nicotine 

6 yield reporting requirements established by the Fed7 eral Trade Commission shall be resolved by a memo8 randum of understanding between the Secretary and 

9 the Federal Trade Commission. 

10 ‘‘(3) CIGARETTE AND OTHER TOBACCO PROD11 UCT CONSTITUENTS.—In addition to the disclosures 

12 required by paragraph (1), the Secretary may, under 

13 a rulemaking conducted under section 553 of title 5, 

14 United States Code, prescribe disclosure require15 ments regarding the level of any cigarette or other 

16 tobacco product constituent including any smoke 

17 constituent. Any such disclosure may be required if 

18 the Secretary determines that disclosure would be of 

19 benefit to the public health, or otherwise would in20 crease consumer awareness of the health con21 sequences of the use of tobacco products, except that 

22 no such prescribed disclosure shall be required on 

23 the face of any cigarette package or advertisement. 

24 Nothing in this section shall prohibit the Secretary 

25 from requiring such prescribed disclosure through a 


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1 cigarette or other tobacco product package or adver2 tisement insert, or by any other means under the 

3 Federal Food, Drug, and Cosmetic Act. 

4 ‘‘(4) RETAILERS.—This subsection applies to a 

5 retailer only if that retailer is responsible for or di6 rects the label statements required under this sec7 tion, except that this subsection shall not relieve a 

8 retailer of liability if the retailer sells or distributes 

9 tobacco products that are not labeled in accordance 

10 with the requirements of subsection (a).’’. 

11 TITLE III—PREVENTION OF IL12 LICIT TRADE IN TOBACCO 

13 PRODUCTS 

14 SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPEC15 TION. 

16 Chapter IX of the Federal Food, Drug, and Cosmetic 

17 Act, as added by section 101, is further amended by add18 ing at the end the following: 

19 ‘‘SEC. 921. LABELING, RECORDKEEPING, RECORDS INSPEC20 TION. 

21 ‘‘(a) ORIGIN LABELING.—The label, packaging, and 

22 shipping containers of tobacco products for introduction 

23 or delivery for introduction into interstate commerce in the 

24 United States shall bear the statement ‘sale only allowed 

25 in the United States.’ 


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1 ‘‘(b) REGULATIONS CONCERNING RECORDKEEPING

2 FOR TRACKING AND TRACING.— 

3 ‘‘(1) IN GENERAL.—Not later than 9 months 

4 after the date of enactment of the Family Smoking 

5 Prevention and Tobacco Control Act, the Secretary 

6 shall promulgate regulations regarding the establish7 ment and maintenance of records by any person who 

8 manufactures, processes, transports, distributes, re9 ceives, packages, holds, exports, or imports tobacco 

10 products. 

11 ‘‘(2) INSPECTION.—In promulgating the regula12 tions described in paragraph (1), the Secretary shall 

13 consider which records are needed for inspection to 

14 monitor the movement of tobacco products from the 

15 point of manufacture through distribution to retail 

16 outlets to assist in investigating potential illicit 

17 trade, smuggling or counterfeiting of tobacco prod18 ucts. 

19 ‘‘(3) CODES.—The Secretary may require codes 

20 on the labels of tobacco products or other designs or 

21 devices for the purpose of tracking or tracing the to22 bacco product through the distribution system. 

23 ‘‘(4) SIZE OF BUSINESS.—The Secretary shall 

24 take into account the size of a business in promul25 gating regulations under this section. 


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1 ‘‘(5) RECORDKEEPING BY RETAILERS.—The 

2 Secretary shall not require any retailer to maintain 

3 records relating to individual purchasers of tobacco 

4 products for personal consumption. 

5 ‘‘(c) RECORDS INSPECTION.—If the Secretary has a 

6 reasonable belief that a tobacco product is part of an illicit 

7 trade or smuggling or is a counterfeit product, each person 

8 who manufactures, processes, transports, distributes, re9 ceives, holds, packages, exports, or imports tobacco prod10 ucts shall, at the request of an officer or employee duly 

11 designated by the Secretary, permit such officer or em12 ployee, at reasonable times and within reasonable limits 

13 and in a reasonable manner, upon the presentation of ap14 propriate credentials and a written notice to such person, 

15 to have access to and copy all records (including financial 

16 records) relating to such article that are needed to assist 

17 the Secretary in investigating potential illicit trade, smug18 gling or counterfeiting of tobacco products. 

19 ‘‘(d) KNOWLEDGE OF ILLEGAL TRANSACTION.— 

20 ‘‘(1) NOTIFICATION.—If the manufacturer or 

21 distributor of a tobacco product has knowledge 

22 which reasonably supports the conclusion that a to23 bacco product manufactured or distributed by such 

24 manufacturer or distributor that has left the control 

25 of such person may be or has been— 


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1 ‘‘(A) imported, exported, distributed or of2 fered for sale in interstate commerce by a per3 son without paying duties or taxes required by 

4 law; or 

5 ‘‘(B) imported, exported, distributed or di6 verted for possible illicit marketing, 

7 the manufacturer or distributor shall promptly notify the 

8 Attorney General of such knowledge. 

9 ‘‘(2) KNOWLEDGE DEFINED.—For purposes of 

10 this subsection, the term ‘knowledge’ as applied to 

11 a manufacturer or distributor means— 

12 ‘‘(A) the actual knowledge that the manu13 facturer or distributor had; or 

14 ‘‘(B) the knowledge which a reasonable 

15 person would have had under like circumstances 

16 or which would have been obtained upon the ex17 ercise of due care.’’. 

18 SEC. 302. STUDY AND REPORT. 

19 (a) STUDY.—The Comptroller General of the United 

20 States shall conduct a study of cross-border trade in to21 bacco products to— 

22 (1) collect data on cross-border trade in tobacco 

23 products, including illicit trade and trade of counter24 feit tobacco products and make recommendations on 

25 the monitoring of such trade; 


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1 (2) collect data on cross-border advertising (any 

2 advertising intended to be broadcast, transmitted, or 

3 distributed from the United States to another coun4 try) of tobacco products and make recommendations 

5 on how to prevent or eliminate, and what tech6 nologies could help facilitate the elimination of, 

7 cross-border advertising. 

8 (b) REPORT.—Not later than 18 months after the 

9 date of enactment of this Act, the Comptroller General 

10 of the United States shall submit to the Committee on 

11 Health, Education, Labor, and Pensions of the Senate and 

12 the Committee on Energy and Commerce of the House 

13 of Representatives a report on the study described in sub14 section (a). 

Æ 


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