110TH CONGRESS 

2D SESSION H. R. 1108 

AN ACT 

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, 
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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

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

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

5 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. 

Sec. 104. Study on raising the minimum age to purchase tobacco products. 

Sec. 105. Tobacco industry concentration. 

Sec. 106. Enforcement action plan for advertising and promotion restrictions. 

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. 

TITLE IV—THRIFT SAVINGS PLAN ENHANCEMENT 

Sec. 401. Short title. 

Sec. 402. Automatic enrollments. 

Sec. 403. Qualified Roth contribution program. 

Sec. 404. Authority to establish self-directed investment window. 

Sec. 405. Reporting requirements. 

Sec. 406. Acknowledgement of risk. 

Sec. 407. Credit for unused sick leave. 

6 SEC. 2. FINDINGS. 

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

2 children is a pediatric disease of considerable pro3 portions that results in new generations of tobacco4 dependent children and adults. 

5 (2) A consensus exists within the scientific and 

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

8 and other serious adverse health effects. 

9 (3) Nicotine is an addictive drug. 

10 (4) Virtually all new users of tobacco products 

11 are under the minimum legal age to purchase such 

12 products. 

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

15 tobacco products by adolescents. 

16 (6) Because past efforts to restrict advertising 

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

20 distribution of such products are needed. 

21 (7) Federal and State governments have lacked 

22 the legal and regulatory authority and resources 

23 they need to address comprehensively the public 

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

2 the public health community, and the public at large 

3 recognize that the tobacco industry should be subject 

4 to ongoing oversight. 

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

7 for regulating interstate commerce and commerce 

8 with Indian tribes. 

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

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

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

15 economy. 

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

18 interstate commerce through the health care and 

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

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

22 enact legislation that provides the Food and Drug 

23 Administration with the authority to regulate to24 bacco products and the advertising and promotion of 

25 such products. The benefits to the American people 
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1 from enacting such legislation would be significant 

2 in human and economic terms. 

3 (13) Tobacco use is the foremost preventable 

4 cause of premature death in America. It causes over 

5 400,000 deaths in the United States each year, and 

6 approximately 8,600,000 Americans have chronic ill7 nesses related to smoking. 

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

9 50 percent would prevent well over 10,000,000 of to10 day’s children from becoming regular, daily smokers, 

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

12 death due to tobacco-induced disease. Such a reduc13 tion in youth smoking would also result in approxi14 mately $75,000,000,000 in savings attributable to 

15 reduced health care costs. 

16 (15) Advertising, marketing, and promotion of 

17 tobacco products have been especially directed to at18 tract young persons to use tobacco products, and 

19 these efforts have resulted in increased use of such 

20 products by youth. Past efforts to oversee these ac21 tivities have not been successful in adequately pre22 venting such increased use. 

23 (16) In 2005, the cigarette manufacturers 

24 spent more than $13,000,000,000 to attract new 

25 users, retain current users, increase current con-
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1 sumption, and generate favorable long-term atti2 tudes toward smoking and tobacco use. 

3 (17) Tobacco product advertising often 

4 misleadingly portrays the use of tobacco as socially 

5 acceptable and healthful to minors. 

6 (18) Tobacco product advertising is regularly 

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

8 under the age of 18 are regularly exposed to tobacco 

9 product promotional efforts. 

10 (19) Through advertisements during and spon11 sorship of sporting events, tobacco has become 

12 strongly associated with sports and has become por13 trayed as an integral part of sports and the healthy 

14 lifestyle associated with rigorous sporting activity. 

15 (20) Children are exposed to substantial and 

16 unavoidable tobacco advertising that leads to favor17 able beliefs about tobacco use, plays a role in leading 

18 young people to overestimate the prevalence of to19 bacco use, and increases the number of young people 

20 who begin to use tobacco. 

21 (21) The use of tobacco products in motion pic22 tures and other mass media glamorizes its use for 

23 young people and encourages them to use tobacco 

24 products. 
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1 (22) Tobacco advertising expands the size of 

2 the tobacco market by increasing consumption of to3 bacco products including tobacco use by young peo4 ple. 

5 (23) Children are more influenced by tobacco 

6 marketing than adults: more than 80 percent of 

7 youth smoke three heavily marketed brands, while 

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

9 same brands. 

10 (24) Tobacco company documents indicate that 

11 young people are an important and often crucial seg12 ment of the tobacco market. Children, who tend to 

13 be more price sensitive than adults, are influenced 

14 by advertising and promotion practices that result in 

15 drastically reduced cigarette prices. 

16 (25) Comprehensive advertising restrictions will 

17 have a positive effect on the smoking rates of young 

18 people. 

19 (26) Restrictions on advertising are necessary 

20 to prevent unrestricted tobacco advertising from un21 dermining legislation prohibiting access to young 

22 people and providing for education about tobacco 

23 use. 

24 (27) International experience shows that adver25 tising regulations that are stringent and comprehen-
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1 sive have a greater impact on overall tobacco use 

2 and young people’s use than weaker or less com3 prehensive ones. 

4 (28) Text only requirements, although not as 

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

6 tobacco products while preserving the informational 

7 function of advertising. 

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

9 adopt legislation to address the public health crisis 

10 created by actions of the tobacco industry. 

11 (30) The final regulations promulgated by the 

12 Secretary of Health and Human Services in the Au13 gust 28, 1996, issue of the Federal Register (61 

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

15 of title 21, Code of Federal Regulations, are con16 sistent with the first amendment to the United 

17 States Constitution and with the standards set forth 

18 in the amendments made by this subtitle for the reg19 ulation of tobacco products by the Food and Drug 

20 Administration, and the restriction on the sale and 

21 distribution of, including access to and the adver22 tising and promotion of, tobacco products contained 

23 in such regulations are substantially related to ac24 complishing the public health goals of this Act. 
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1 (31) The regulations described in paragraph 

2 (30) will directly and materially advance the Federal 

3 Government’s substantial interest in reducing the 

4 number of children and adolescents who use ciga5 rettes and smokeless tobacco and in preventing the 

6 life-threatening health consequences associated with 

7 tobacco use. An overwhelming majority of Americans 

8 who use tobacco products begin using such products 

9 while they are minors and become addicted to the 

10 nicotine in those products before reaching the age of 

11 18. Tobacco advertising and promotion play a cru12 cial role in the decision of these minors to begin 

13 using tobacco products. Less restrictive and less 

14 comprehensive approaches have not and will not be 

15 effective in reducing the problems addressed by such 

16 regulations. The reasonable restrictions on the ad17 vertising and promotion of tobacco products con18 tained in such regulations will lead to a significant 

19 decrease in the number of minors using and becom20 ing addicted to those products. 

21 (32) The regulations described in paragraph 

22 (30) impose no more extensive restrictions on com23 munication by tobacco manufacturers and sellers 

24 than are necessary to reduce the number of children 

25 and adolescents who use cigarettes and smokeless to-
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1 bacco and to prevent the life-threatening health con2 sequences associated with tobacco use. Such regula3 tions are narrowly tailored to restrict those adver4 tising and promotional practices which are most like5 ly to be seen or heard by youth and most likely to 

6 entice them into tobacco use, while affording tobacco 

7 manufacturers and sellers ample opportunity to con8 vey information about their products to adult con9 sumers. 

10 (33) Tobacco dependence is a chronic disease, 

11 one that typically requires repeated interventions to 

12 achieve long-term or permanent abstinence. 

13 (34) Because the only known safe alternative to 

14 smoking is cessation, interventions should target all 

15 smokers to help them quit completely. 

16 (35) Tobacco products have been used to facili17 tate and finance criminal activities both domestically 

18 and internationally. Illicit trade of tobacco products 

19 has been linked to organized crime and terrorist 

20 groups. 

21 (36) It is essential that the Food and Drug Ad22 ministration review products sold or distributed for 

23 use to reduce risks or exposures associated with to24 bacco products and that it be empowered to review 

25 any advertising and labeling for such products. It is 
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1 also essential that manufacturers, prior to marketing 

2 such products, be required to demonstrate that such 

3 products will meet a series of rigorous criteria, and 

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

5 taking into account both users of tobacco products 

6 and persons who do not currently use tobacco prod7 ucts. 

8 (37) Unless tobacco products that purport to 

9 reduce the risks to the public of tobacco use actually 

10 reduce such risks, those products can cause substan11 tial harm to the public health to the extent that the 

12 individuals, who would otherwise not consume to13 bacco products or would consume such products less, 

14 use tobacco products purporting to reduce risk. 

15 Those who use products sold or distributed as modi16 fied risk products that do not in fact reduce risk, 

17 rather than quitting or reducing their use of tobacco 

18 products, have a substantially increased likelihood of 

19 suffering disability and premature death. The costs 

20 to society of the widespread use of products sold or 

21 distributed as modified risk products that do not in 

22 fact reduce risk or that increase risk include thou23 sands of unnecessary deaths and injuries and huge 

24 costs to our health care system. 
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1 (38) As the National Cancer Institute has 

2 found, many smokers mistakenly believe that ‘‘low 

3 tar’’ and ‘‘light’’ cigarettes cause fewer health prob4 lems than other cigarettes. As the National Cancer 

5 Institute has also found, mistaken beliefs about the 

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

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

8 smoking entirely and thereby lead to disease and 

9 death. 

10 (39) Recent studies have demonstrated that 

11 there has been no reduction in risk on a population12 wide basis from ‘‘low tar’’ and ‘‘light’’ cigarettes, 

13 and such products may actually increase the risk of 

14 tobacco use. 

15 (40) The dangers of products sold or distrib16 uted as modified risk tobacco products that do not 

17 in fact reduce risk are so high that there is a com18 pelling governmental interest in ensuring that state19 ments about modified risk tobacco products are com20 plete, accurate, and relate to the overall disease risk 

21 of the product. 

22 (41) As the Federal Trade Commission has 

23 found, consumers have misinterpreted advertise24 ments in which one product is claimed to be less 

25 harmful than a comparable product, even in the 
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1 presence of disclosures and advisories intended to 

2 provide clarification. 

3 (42) Permitting manufacturers to make unsub4 stantiated statements concerning modified risk to5 bacco products, whether express or implied, even if 

6 accompanied by disclaimers would be detrimental to 

7 the public health. 

8 (43) The only way to effectively protect the 

9 public health from the dangers of unsubstantiated 

10 modified risk tobacco products is to empower the 

11 Food and Drug Administration to require that prod12 ucts that tobacco manufacturers sold or distributed 

13 for risk reduction be reviewed in advance of mar14 keting, and to require that the evidence relied on to 

15 support claims be fully verified. 

16 (44) The Food and Drug Administration is a 

17 regulatory agency with the scientific expertise to 

18 identify harmful substances in products to which 

19 consumers are exposed, to design standards to limit 

20 exposure to those substances, to evaluate scientific 

21 studies supporting claims about the safety of prod22 ucts, and to evaluate the impact of labels, labeling, 

23 and advertising on consumer behavior in order to re24 duce the risk of harm and promote understanding of 

25 the impact of the product on health. In connection 
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1 with its mandate to promote health and reduce the 

2 risk of harm, the Food and Drug Administration 

3 routinely makes decisions about whether and how 

4 products may be marketed in the United States. 

5 (45) The Federal Trade Commission was cre6 ated to protect consumers from unfair or deceptive 

7 acts or practices, and to regulate unfair methods of 

8 competition. Its focus is on those marketplace prac9 tices that deceive or mislead consumers, and those 

10 that give some competitors an unfair advantage. Its 

11 mission is to regulate activities in the marketplace. 

12 Neither the Federal Trade Commission nor any 

13 other Federal agency except the Food and Drug Ad14 ministration possesses the scientific expertise needed 

15 to implement effectively all provisions of the Family 

16 Smoking Prevention and Tobacco Control Act. 

17 (46) If manufacturers state or imply in commu18 nications directed to consumers through the media 

19 or through a label, labeling, or advertising, that a to20 bacco product is approved or inspected by the Food 

21 and Drug Administration or complies with Food and 

22 Drug Administration standards, consumers are like23 ly to be confused and misled. Depending upon the 

24 particular language used and its context, such a 

25 statement could result in consumers being misled 
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1 into believing that the product is endorsed by the 

2 Food and Drug Administration for use or in con3 sumers being misled about the harmfulness of the 

4 product because of such regulation, inspection, ap5 proval, or compliance. 

6 (47) If manufacturers are permitted to state or 

7 imply in communications directed to consumers that 

8 a tobacco product is approved or inspected by the 

9 Food and Drug Administration or complies with 

10 Food and Drug Administration standards, con11 sumers are likely to be confused and misled. Such a 

12 statement could result in consumers being misled 

13 into believing that the product is endorsed by the 

14 Food and Drug Administration for use or in con15 sumers being misled about the harmfulness of the 

16 product because of such regulation, inspection, or 

17 compliance. 

18 (48) In August 2006 a United States district 

19 court judge found that the major United States cig20 arette companies continue to target and market to 

21 youth. USA v Philip Morris, USA, Inc., et al. (Civil 

22 Action No. 99–2496 (GK), August 17, 2006). 

23 (49) In August 2006 a United States district 

24 court judge found that the major United States cig25 arette companies dramatically increased their adver-
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1 tising and promotional spending in ways that en2 courage youth to start smoking subsequent to the 

3 signing of the Master Settlement Agreement in 

4 1998. USA v Philip Morris, USA, Inc., et al. (Civil 

5 Action No. 99–2496 (GK), August 17, 2006). 

6 (50) In August 2006 a United States district 

7 court judge found that the major United States cig8 arette companies have designed their cigarettes to 

9 precisely control nicotine delivery levels and provide 

10 doses of nicotine sufficient to create and sustain ad11 diction while also concealing much of their nicotine12 related research. USA v Philip Morris, USA, Inc., et 

13 al. (Civil Action No. 99–2496 (GK), August 17, 

14 2006). 

15 SEC. 3. PURPOSE. 

16 The purposes of this Act are— 

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

18 Administration to regulate tobacco products under 

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

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

21 Federal regulatory authority with respect to the 

22 manufacture, marketing, and distribution of tobacco 

23 products as provided for in this Act; 

24 (2) to ensure that the Food and Drug Adminis25 tration has the authority to address issues of par-
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1 ticular concern to public health officials, especially 

2 the use of tobacco by young people and dependence 

3 on tobacco; 

4 (3) to authorize the Food and Drug Adminis5 tration to set national standards controlling the 

6 manufacture of tobacco products and the identity, 

7 public disclosure, and amount of ingredients used in 

8 such products; 

9 (4) to provide new and flexible enforcement au10 thority to ensure that there is effective oversight of 

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

12 and promote less harmful tobacco products; 

13 (5) to vest the Food and Drug Administration 

14 with the authority to regulate the levels of tar, nico15 tine, and other harmful components of tobacco prod16 ucts; 

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

18 informed, to require tobacco product manufacturers 

19 to disclose research which has not previously been 

20 made available, as well as research generated in the 

21 future, relating to the health and dependency effects 

22 or safety of tobacco products; 

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

24 products to adults in conjunction with measures to 
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1 ensure that they are not sold or accessible to under2 age purchasers; 

3 (8) to impose appropriate regulatory controls on 

4 the tobacco industry; 

5 (9) to promote cessation to reduce disease risk 

6 and the social costs associated with tobacco-related 

7 diseases; and 

8 (10) to strengthen legislation against illicit 

9 trade in tobacco products. 

10 SEC. 4. SCOPE AND EFFECT. 

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

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

13 (1) establish a precedent with regard to any 

14 other industry, situation, circumstance, or legal ac15 tion; or 

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

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

18 contract of any kind. 

19 (b) AGRICULTURAL ACTIVITIES.—The provisions of 

20 this Act (or an amendment made by this Act) which au21 thorize the Secretary to take certain actions with regard 

22 to tobacco and tobacco products shall not be construed to 

23 affect any authority of the Secretary of Agriculture under 

24 existing law regarding the growing, cultivation, or curing 

25 of raw tobacco. 
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1 (c) REVENUE ACTIVITIES.—The provisions of this 

2 Act (or an amendment made by this Act) which authorize 

3 the Secretary to take certain actions with regard to to4 bacco products shall not be construed to affect any author5 ity of the Secretary of the Treasury under chapter 52 of 

6 the Internal Revenue Code of 1986. 

7 SEC. 5. SEVERABILITY. 

8 If any provision of this Act, the amendments made 

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

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

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

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

13 other person or circumstance shall not be affected and 

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

15 TITLE I—AUTHORITY OF THE 

16 FOOD AND DRUG ADMINIS17 TRATION 

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

19 COSMETIC ACT. 

20 (a) DEFINITION OF TOBACCO PRODUCTS.—Section 

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

22 U.S.C. 321) is amended by adding at the end the fol23 lowing: 

24 ‘‘(rr)(1) The term ‘tobacco product’ means any prod25 uct made or derived from tobacco that is intended for 
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1 human consumption, including any component, part, or 

2 accessory of a tobacco product (except for raw materials 

3 other than tobacco used in manufacturing a component, 

4 part, or accessory of a tobacco product). 

5 ‘‘(2) The term ‘tobacco product’ does not mean an 

6 article that is a drug under subsection (g)(1), a device 

7 under subsection (h), or a combination product described 

8 in section 503(g). 

9 ‘‘(3) The products described in paragraph (2) shall 

10 be subject to chapter V of this Act. 

11 ‘‘(4) A tobacco product may not be marketed in com12 bination with any other article or product regulated under 

13 this Act (including a drug, biologic, food, cosmetic, med14 ical device, or a dietary supplement).’’. 

15 (b) FDA AUTHORITY OVER TOBACCO PRODUCTS.— 

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

17 301 et seq.) is amended— 

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

19 (2) by redesignating sections 901 through 910 

20 as sections 1001 through 1010; and 

21 (3) by inserting after chapter VIII the fol22 lowing: 

23 ‘‘CHAPTER IX—TOBACCO PRODUCTS 

24 ‘‘SEC. 900. DEFINITIONS. 

25 ‘‘In this chapter: 
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1 ‘‘(1) ADDITIVE.—The term ‘additive’ means 

2 any substance the intended use of which results or 

3 may reasonably be expected to result, directly or in4 directly, in its becoming a component or otherwise 

5 affecting the characteristic of any tobacco product 

6 (including any substances intended for use as a fla7 voring or coloring or in producing, manufacturing, 

8 packing, processing, preparing, treating, packaging, 

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

10 not include tobacco or a pesticide chemical residue 

11 in or on raw tobacco or a pesticide chemical. 

12 ‘‘(2) BRAND.—The term ‘brand’ means a vari13 ety of tobacco product distinguished by the tobacco 

14 used, tar content, nicotine content, flavoring used, 

15 size, filtration, packaging, logo, registered trade16 mark, brand name, identifiable pattern of colors, or 

17 any combination of such attributes. 

18 ‘‘(3) CIGARETTE.—The term ‘cigarette’— 

19 ‘‘(A) means a product that— 

20 ‘‘(i) is a tobacco product; and 

21 ‘‘(ii) meets the definition of the term 

22 ‘cigarette’ in section 3(1) of the Federal 

23 Cigarette Labeling and Advertising Act; 

24 and 
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1 ‘‘(B) includes tobacco, in any form, that is 

2 functional in the product, which, because of its 

3 appearance, the type of tobacco used in the 

4 filler, or its packaging and labeling, is likely to 

5 be offered to, or purchased by, consumers as a 

6 cigarette or as roll-your-own tobacco. 

7 ‘‘(4) CIGARETTE TOBACCO.—The term ‘ciga8 rette tobacco’ means any product that consists of 

9 loose tobacco that is intended for use by consumers 

10 in a cigarette. Unless otherwise stated, the require11 ments applicable to cigarettes under this chapter 

12 shall also apply to cigarette tobacco. 

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

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

15 Federal Cigarette Labeling and Advertising Act. 

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

17 term ‘counterfeit tobacco product’ means a tobacco 

18 product (or the container or labeling of such a prod19 uct) that, without authorization, bears the trade20 mark, trade name, or other identifying mark, im21 print, or device, or any likeness thereof, of a tobacco 

22 product listed in a registration under section 

23 905(i)(1). 

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

25 regards a tobacco product means any person who 
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1 furthers the distribution of a tobacco product, 

2 whether domestic or imported, at any point from the 

3 original place of manufacture to the person who sells 

4 or distributes the product to individuals for personal 

5 consumption. Common carriers are not considered 

6 distributors for purposes of this chapter. 

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

8 means any practice or conduct prohibited by law 

9 which relates to production, shipment, receipt, pos10 session, distribution, sale, or purchase of tobacco 

11 products including any practice or conduct intended 

12 to facilitate such activity. 

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

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

15 the Indian Self-Determination and Education Assist16 ance Act. 

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

18 means a product that— 

19 ‘‘(A) is a tobacco product; and 

20 ‘‘(B) meets the definition of the term ‘little 

21 cigar’ in section 3(7) of the Federal Cigarette 

22 Labeling and Advertising Act. 

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

24 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, government, or entity who sells tobacco 

10 products to individuals for personal consumption, or 

11 who operates a facility where self-service displays of 

12 tobacco products are permitted. 

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

14 ‘roll-your-own tobacco’ means any tobacco product 

15 which, because of its appearance, type, packaging, or 

16 labeling, is suitable for use and likely to be offered 

17 to, or purchased by, consumers as tobacco for mak18 ing cigarettes. 

19 ‘‘(15) SMALL TOBACCO PRODUCT MANUFAC20 TURER.—The term ‘small tobacco product manufac21 turer’ means a tobacco product manufacturer that 

22 employs fewer than 350 employees. For purposes of 

23 determining the number of employees of a manufac24 turer under the preceding sentence, the employees of 

25 a manufacturer are deemed to include the employees 
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1 of each entity that controls, is controlled by, or is 

2 under common control with such manufacturer. 

3 ‘‘(16) SMOKE CONSTITUENT.—The term ‘smoke 

4 constituent’ means any chemical or chemical com5 pound in mainstream or sidestream tobacco smoke 

6 that either transfers from any component of the cig7 arette to the smoke or that is formed by the combus8 tion or heating of tobacco, additives, or other compo9 nent of the tobacco product. 

10 ‘‘(17) SMOKELESS TOBACCO.—The term 

11 ‘smokeless tobacco’ means any tobacco product that 

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

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

14 cavity. 

15 ‘‘(18) STATE; TERRITORY.—The terms ‘State’ 

16 and ‘Territory’ shall have the meanings given to 

17 such terms in section 201. 

18 ‘‘(19) TOBACCO PRODUCT MANUFACTURER.— 

19 The term ‘tobacco product manufacturer’ means any 

20 person, including any repacker or relabeler, who— 

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

22 processes, or labels a tobacco product; or 

23 ‘‘(B) imports a finished tobacco product 

24 for sale or distribution in the United States. 

25 ‘‘(20) TOBACCO WAREHOUSE.— 
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1 ‘‘(A) Subject to subparagraphs (B) and 

2 (C), the term ‘tobacco warehouse’ includes any 

3 person— 

4 ‘‘(i) who— 

5 ‘‘(I) removes foreign material 

6 from tobacco leaf through nothing 

7 other than a mechanical process; 

8 ‘‘(II) humidifies tobacco leaf with 

9 nothing other than potable water in 

10 the form of steam or mist; or 

11 ‘‘(III) de-stems, dries, and packs 

12 tobacco leaf for storage and shipment; 

13 ‘‘(ii) who performs no other actions 

14 with respect to tobacco leaf; and 

15 ‘‘(iii) who provides to any manufac16 turer to whom the person sells tobacco all 

17 information related to the person’s actions 

18 described in clause (i) that is necessary for 

19 compliance with this Act. 

20 ‘‘(B) The term ‘tobacco warehouse’ ex21 cludes any person who— 

22 ‘‘(i) reconstitutes tobacco leaf; 

23 ‘‘(ii) is a manufacturer, distributor, or 

24 retailer of a tobacco product; or 
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1 ‘‘(iii) applies any chemical, additive, 

2 or substance to the tobacco leaf other than 

3 potable water in the form of steam or mist. 

4 ‘‘(C) The definition of the term ‘tobacco 

5 warehouse’ in subparagraph (A) shall not apply 

6 to the extent to which the Secretary determines, 

7 through rulemaking, that regulation under this 

8 chapter of the actions described in such sub9 paragraph is appropriate for the protection of 

10 the public health. 

11 ‘‘(21) UNITED STATES.—The term ‘United 

12 States’ means the 50 States of the United States of 

13 America and the District of Columbia, the Common14 wealth of Puerto Rico, Guam, the Virgin Islands, 

15 American Samoa, Wake Island, Midway Islands, 

16 Kingman Reef, Johnston Atoll, the Northern Mar17 iana Islands, and any other trust territory or posses18 sion of the United States. 

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

20 ‘‘(a) IN GENERAL.—Tobacco products, including 

21 modified risk tobacco products for which an order has 

22 been issued in accordance with section 911, shall be regu23 lated by the Secretary under this chapter and shall not 

24 be subject to the provisions of chapter V. 
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1 ‘‘(b) APPLICABILITY.—This chapter shall apply to all 

2 cigarettes, cigarette tobacco, roll-your-own tobacco, and 

3 smokeless tobacco and to any other tobacco products that 

4 the Secretary by regulation deems to be subject to this 

5 chapter. 

6 ‘‘(c) SCOPE.— 

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

8 any policy issued or regulation promulgated there9 under, or in sections 101(a), 102, or 103 of title I, 

10 title II, or title III of the Family Smoking Preven11 tion and Tobacco Control Act, shall be construed to 

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

13 over (including the authority to determine whether 

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

15 products under this Act that are not tobacco prod16 ucts under chapter V or any other chapter. 

17 ‘‘(2) LIMITATION OF AUTHORITY.— 

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

19 chapter shall not apply to tobacco leaf that is 

20 not in the possession of a manufacturer of to21 bacco products, or to the producers of tobacco 

22 leaf, including tobacco growers, tobacco ware23 houses, and tobacco grower cooperatives, nor 

24 shall any employee of the Food and Drug Ad25 ministration have any authority to enter onto a 
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•HR 1108 EH

1 farm owned by a producer of tobacco leaf with2 out the written consent of such producer. 

3 ‘‘(B) EXCEPTION.—Notwithstanding sub4 paragraph (A), if a producer of tobacco leaf is 

5 also a tobacco product manufacturer or con6 trolled by a tobacco product manufacturer, the 

7 producer shall be subject to this chapter in the 

8 producer’s capacity as a manufacturer. The ex9 ception in this subparagraph shall not apply to 

10 a producer of tobacco leaf who grows tobacco 

11 under a contract with a tobacco product manu12 facturer and who is not otherwise engaged in 

13 the manufacturing process. 

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

15 in this chapter shall be construed to grant the 

16 Secretary authority to promulgate regulations 

17 on any matter that involves the production of 

18 tobacco leaf or a producer thereof, other than 

19 activities by a manufacturer affecting produc20 tion. 

21 ‘‘(d) RULEMAKING PROCEDURES.—Each rulemaking 

22 under this chapter shall be in accordance with chapter 5 

23 of title 5, United States Code. This subsection shall not 

24 be construed to affect the rulemaking provisions of section 
30 

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1 102(a) of the Family Smoking Prevention and Tobacco 

2 Control Act. 

3 ‘‘(e) CENTER FOR TOBACCO PRODUCTS.—Not later 

4 than 90 days after the date of enactment of this chapter, 

5 the Secretary shall establish within the Food and Drug 

6 Administration the Center for Tobacco Products, which 

7 shall report to the Commissioner of Food and Drugs in 

8 the same manner as the other agency centers within the 

9 Food and Drug Administration. The Center shall be re10 sponsible for the implementation of this chapter and re11 lated matters assigned by the Commissioner. 

12 ‘‘(f) OFFICE TO ASSIST SMALL TOBACCO PRODUCT

13 MANUFACTURERS.—The Secretary shall establish within 

14 the Food and Drug Administration an identifiable office 

15 to provide technical and other nonfinancial assistance to 

16 small tobacco product manufacturers to assist them in 

17 complying with the requirements of this Act. 

18 ‘‘(g) CONSULTATION PRIOR TO RULEMAKING.—Prior 

19 to promulgating rules under this chapter, the Secretary 

20 shall endeavor to consult with other Federal agencies as 

21 appropriate. 

22 ‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS. 

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

24 if— 
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1 ‘‘(1) it consists in whole or in part of any filthy, 

2 putrid, or decomposed substance, or is otherwise 

3 contaminated by any added poisonous or added dele4 terious substance that may render the product inju5 rious to health; 

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

7 under insanitary conditions whereby it may have 

8 been contaminated with filth, or whereby it may 

9 have been rendered injurious to health; 

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

11 part, of any poisonous or deleterious substance 

12 which may render the contents injurious to health; 

13 ‘‘(4) the manufacturer or importer of the to14 bacco product fails to pay a user fee assessed to 

15 such manufacturer or importer pursuant to section 

16 919 by the date specified in section 919 or by the 

17 30th day after final agency action on a resolution of 

18 any dispute as to the amount of such fee; 

19 ‘‘(5) it is, or purports to be or is represented 

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

21 product standard established under section 907 un22 less such tobacco product is in all respects in con23 formity with such standard; 
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•HR 1108 EH

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

2 premarket review and does not have an order in ef3 fect under section 910(c)(1)(A)(i); or 

4 ‘‘(B) it is in violation of an order under section 

5 910(c)(1)(A); 

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

7 controls used for, its manufacture, packing, or stor8 age are not in conformity with applicable require9 ments under section 906(e)(1) or an applicable con10 dition prescribed by an order under section 

11 906(e)(2); or 

12 ‘‘(8) it is in violation of section 911. 

13 ‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS. 

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

15 deemed to be misbranded— 

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

17 particular; 

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

19 containing— 

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

21 tobacco product manufacturer, packer, or dis22 tributor; 

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

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

25 numerical count; 
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•HR 1108 EH

1 ‘‘(C) an accurate statement of the percent2 age of the tobacco used in the product that is 

3 domestically grown tobacco and the percentage 

4 that is foreign grown tobacco; and 

5 ‘‘(D) the statement required under section 

6 920(a), 

7 except that under subparagraph (B) reasonable vari8 ations shall be permitted, and exemptions as to 

9 small packages shall be established, by regulations 

10 prescribed by the Secretary; 

11 ‘‘(3) if any word, statement, or other informa12 tion required by or under authority of this chapter 

13 to appear on the label or labeling is not prominently 

14 placed thereon with such conspicuousness (as com15 pared with other words, statements, or designs in 

16 the labeling) and in such terms as to render it likely 

17 to be read and understood by the ordinary individual 

18 under customary conditions of purchase and use; 

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

20 label bears, to the exclusion of any other nonpropri21 etary name, its established name prominently print22 ed in type as required by the Secretary by regula23 tion; 

24 ‘‘(5) if the Secretary has issued regulations re25 quiring that its labeling bear adequate directions for 
34 

•HR 1108 EH

1 use, or adequate warnings against use by children, 

2 that are necessary for the protection of users unless 

3 its labeling conforms in all respects to such regula4 tions; 

5 ‘‘(6) if it was manufactured, prepared, propa6 gated, compounded, or processed in an establishment 

7 not duly registered under section 905(b), 905(c), 

8 905(d), or 905(h), if it was not included in a list re9 quired by section 905(i), if a notice or other infor10 mation respecting it was not provided as required by 

11 such section or section 905(j), or if it does not bear 

12 such symbols from the uniform system for identifica13 tion of tobacco products prescribed under section 

14 905(e) as the Secretary by regulation requires; 

15 ‘‘(7) if, in the case of any tobacco product dis16 tributed or offered for sale in any State— 

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

18 in any particular; or 

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

20 regulations prescribed under section 906(d); 

21 ‘‘(8) unless, in the case of any tobacco product 

22 distributed or offered for sale in any State, the man23 ufacturer, packer, or distributor thereof includes in 

24 all advertisements and other descriptive printed mat25 ter issued or caused to be issued by the manufac-
35 

•HR 1108 EH

1 turer, packer, or distributor with respect to that to2 bacco product— 

3 ‘‘(A) a true statement of the tobacco prod4 uct’s established name as described in para5 graph (4), printed prominently; and 

6 ‘‘(B) a brief statement of— 

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

8 and relevant warnings, precautions, side 

9 effects, and contraindications; and 

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

11 products made subject to a finding by the 

12 Secretary after notice and opportunity for 

13 comment that such action is appropriate to 

14 protect the public health, a full description 

15 of the components of such tobacco product 

16 or the formula showing quantitatively each 

17 ingredient of such tobacco product to the 

18 extent required in regulations which shall 

19 be issued by the Secretary after an oppor20 tunity for a hearing; 

21 ‘‘(9) if it is a tobacco product subject to a to22 bacco product standard established under section 

23 907, unless it bears such labeling as may be pre24 scribed in such tobacco product standard; or 

25 ‘‘(10) if there was a failure or refusal— 
36 

•HR 1108 EH

1 ‘‘(A) to comply with any requirement pre2 scribed under section 904 or 908; or 

3 ‘‘(B) to furnish any material or informa4 tion required under section 909. 

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

6 The Secretary may, by regulation, require prior approval 

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

8 regulation issued under this subsection may require prior 

9 approval by the Secretary of the content of any advertise10 ment, except for modified risk tobacco products as pro11 vided in section 911. No advertisement of a tobacco prod12 uct published after the date of enactment of the Family 

13 Smoking Prevention and Tobacco Control Act shall, with 

14 respect to the language of label statements as prescribed 

15 under section 4 of the Federal Cigarette Labeling and Ad16 vertising Act and section 3 of the Comprehensive Smoke17 less Tobacco Health Education Act of 1986 or the regula18 tions issued under such sections, be subject to the provi19 sions of sections 12 through 15 of the Federal Trade Com20 mission Act. 

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

22 SECRETARY. 

23 ‘‘(a) REQUIREMENT.—Each tobacco product manu24 facturer or importer, or agents thereof, shall submit to 

25 the Secretary the following information: 
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1 ‘‘(1) Not later than 6 months after the date of 

2 enactment of the Family Smoking Prevention and 

3 Tobacco Control Act, a listing of all ingredients, in4 cluding tobacco, substances, compounds, and addi5 tives that are, as of such date, added by the manu6 facturer to the tobacco, paper, filter, or other part 

7 of each tobacco product by brand and by quantity in 

8 each brand and subbrand. 

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

10 form of nicotine in each tobacco product measured 

11 in milligrams of nicotine in accordance with regula12 tions promulgated by the Secretary in accordance 

13 with section 4(e) of the Federal Cigarette Labeling 

14 and Advertising Act. 

15 ‘‘(3) Beginning 3 years after the date of enact16 ment of this Act, a listing of all constituents, includ17 ing smoke constituents as applicable, identified by 

18 the Secretary as harmful or potentially harmful to 

19 health in each tobacco product, and as applicable in 

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

21 quantity in each brand and subbrand. Effective be22 ginning 3 years after the date of enactment of this 

23 chapter, the manufacturer, importer, or agent shall 

24 comply with regulations promulgated under section 
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•HR 1108 EH

1 915 in reporting information under this paragraph, 

2 where applicable. 

3 ‘‘(4) Beginning 6 months after the date of en4 actment of the Family Smoking Prevention and To5 bacco Control Act, all documents developed after the 

6 date of enactment of the Family Smoking Preven7 tion and Tobacco Control Act that relate to health, 

8 toxicological, behavioral, or physiologic effects of 

9 current or future tobacco products, their constitu10 ents (including smoke constituents), ingredients, 

11 components, 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 ac-
39 

•HR 1108 EH

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 

25 time a tobacco product manufacturer adds to its to-
40 

•HR 1108 EH

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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•HR 1108 EH

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 24 months 

10 after the date of enactment of the Family Smoking Pre11 vention and Tobacco Control Act, the Secretary shall es12 tablish, and periodically revise as appropriate, a list of 

13 harmful and potentially harmful constituents, including 

14 smoke constituents, to health in each tobacco product by 

15 brand and by quantity in each brand and subbrand. The 

16 Secretary shall publish a public notice requesting the sub17 mission by interested persons of scientific and other infor18 mation concerning the harmful and potentially harmful 

19 constituents in tobacco products and 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 
42 

•HR 1108 EH

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. If the enactment 

18 of this Act occurs in the second half of the calendar year, 

19 the Secretary shall designate a date no later than 6 

20 months into the subsequent calendar year by which reg21 istration pursuant to this subsection shall occur. 

22 ‘‘(c) REGISTRATION BY NEW OWNERS AND OPERA23 TORS.—Every person upon first engaging in the manufac24 ture, preparation, compounding, or processing of a tobacco 

25 product or tobacco products in any establishment owned 
43 

•HR 1108 EH

1 or operated in any State by that person shall immediately 

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

3 business, and such establishment. 

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

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

6 (c) shall immediately register with the Secretary any addi7 tional establishment which that person owns or operates 

8 in any State and in which that person begins the manufac9 ture, preparation, compounding, or processing of a tobacco 

10 product or tobacco products. 

11 ‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYS12 TEM.—The Secretary may by regulation prescribe a uni13 form system for the identification of tobacco products and 

14 may require that persons who are required to list such 

15 tobacco products under subsection (i) shall list such to16 bacco products in accordance with such system. 

17 ‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA18 TION.—The Secretary shall make available for inspection, 

19 to any person so requesting, any registration filed under 

20 this section. 

21 ‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB22 LISHMENTS.—Every establishment registered with the 

23 Secretary under this section shall be subject to inspection 

24 under section 704 or subsection (h), and every such estab25 lishment engaged in the manufacture, compounding, or 
44 

•HR 1108 EH

1 processing of a tobacco product or tobacco products shall 

2 be so inspected by 1 or more officers or employees duly 

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

4 period beginning with the date of registration of such es5 tablishment under this section and at least once in every 

6 successive 2-year period thereafter. 

7 ‘‘(h) REGISTRATION BY FOREIGN ESTABLISH8 MENTS.—Any establishment within any foreign country 

9 engaged in the manufacture, preparation, compounding, 

10 or processing of a tobacco product or tobacco products, 

11 shall register under this section under regulations promul12 gated by the Secretary. Such regulations shall require 

13 such establishment to provide the information required by 

14 subsection (i) and shall include provisions for registration 

15 of any such establishment upon condition that adequate 

16 and effective means are available, by arrangement with the 

17 government of such foreign country or otherwise, to enable 

18 the Secretary to determine from time to time whether to19 bacco products manufactured, prepared, compounded, or 

20 processed in such establishment, if imported or offered for 

21 import into the United States, shall be refused admission 

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

23 ‘‘(i) REGISTRATION INFORMATION.— 

24 ‘‘(1) PRODUCT LIST.—Every person who reg25 isters with the Secretary under subsection (b), (c), 
45 

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

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

3 all tobacco products which are being manufactured, 

4 prepared, compounded, or processed by that person 

5 for commercial distribution and which have not been 

6 included in any list of tobacco products filed by that 

7 person with the Secretary under this paragraph or 

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

9 list shall be prepared in such form and manner as 

10 the Secretary may prescribe and shall be accom11 panied by— 

12 ‘‘(A) in the case of a tobacco product con13 tained in the applicable list with respect to 

14 which a tobacco product standard has been es15 tablished under section 907 or which is subject 

16 to section 910, a reference to the authority for 

17 the marketing of such tobacco product and a 

18 copy of all labeling for such tobacco product; 

19 ‘‘(B) in the case of any other tobacco prod20 uct contained in an applicable list, a copy of all 

21 consumer information and other labeling for 

22 such tobacco product, a representative sampling 

23 of advertisements for such tobacco product, 

24 and, upon request made by the Secretary for 
46 

•HR 1108 EH

1 good cause, a copy of all advertisements for a 

2 particular tobacco product; and 

3 ‘‘(C) if the registrant filing a list has de4 termined that a tobacco product contained in 

5 such list is not subject to a tobacco product 

6 standard established under section 907, a brief 

7 statement of the basis upon which the reg8 istrant made such determination if the Sec9 retary requests such a statement with respect 

10 to that particular tobacco product. 

11 ‘‘(2) CONSULTATION WITH RESPECT TO

12 FORMS.—The Secretary shall consult with the Sec13 retary of the Treasury in developing the forms to be 

14 used for registration under this section to minimize 

15 the burden on those persons required to register 

16 with both the Secretary and the Tax and Trade Bu17 reau of the Department of the Treasury. 

18 ‘‘(3) BIANNUAL REPORT OF ANY CHANGE IN

19 PRODUCT LIST.—Each person who registers with the 

20 Secretary under this section shall report to the Sec21 retary once during the month of June of each year 

22 and once during the month of December of each 

23 year the following: 

24 ‘‘(A) A list of each tobacco product intro25 duced by the registrant for commercial distribu-
47 

•HR 1108 EH

1 tion which has not been included in any list 

2 previously filed by that person with the Sec3 retary under this subparagraph or paragraph 

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

5 tobacco product by its established name and 

6 shall be accompanied by the other information 

7 required by paragraph (1). 

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

9 made a report under this paragraph that person 

10 has discontinued the manufacture, preparation, 

11 compounding, or processing for commercial dis12 tribution of a tobacco product included in a list 

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

14 notice of such discontinuance, the date of such 

15 discontinuance, and the identity of its estab16 lished name. 

17 ‘‘(C) If since the date the registrant re18 ported under subparagraph (B) a notice of dis19 continuance that person has resumed the manu20 facture, preparation, compounding, or proc21 essing for commercial distribution of the to22 bacco product with respect to which such notice 

23 of discontinuance was reported, notice of such 

24 resumption, the date of such resumption, the 

25 identity of such tobacco product by established 
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1 name, and other information required by para2 graph (1), unless the registrant has previously 

3 reported such resumption to the Secretary 

4 under this subparagraph. 

5 ‘‘(D) Any material change in any informa6 tion previously submitted under this paragraph 

7 or paragraph (1). 

8 ‘‘(j) REPORT PRECEDING INTRODUCTION OF CER9 TAIN SUBSTANTIALLY EQUIVALENT PRODUCTS INTO

10 INTERSTATE COMMERCE.— 

11 ‘‘(1) IN GENERAL.—Each person who is re12 quired to register under this section and who pro13 poses to begin the introduction or delivery for intro14 duction into interstate commerce for commercial dis15 tribution of a tobacco product intended for human 

16 use that was not commercially marketed (other than 

17 for test marketing) in the United States as of Feb18 ruary 15, 2007, shall, at least 90 days prior to mak19 ing such introduction or delivery, report to the Sec20 retary (in such form and manner as the Secretary 

21 shall prescribe)— 

22 ‘‘(A) the basis for such person’s determina23 tion that— 

24 ‘‘(i) the tobacco product is substan25 tially equivalent, within the meaning of 
49 

•HR 1108 EH

1 section 910, to a tobacco product commer2 cially marketed (other than for test mar3 keting) in the United States as of Feb4 ruary 15, 2007, or to a tobacco product 

5 that the Secretary has previously deter6 mined, pursuant to subsection (a)(3) of 

7 section 910, is substantially equivalent and 

8 that is in compliance with the require9 ments of this Act; or 

10 ‘‘(ii) the tobacco product is modified 

11 within the meaning of paragraph (3), the 

12 modifications are to a product that is com13 mercially marketed and in compliance with 

14 the requirements of this Act, and all of the 

15 modifications are covered by exemptions 

16 granted by the Secretary pursuant to para17 graph (3); and 

18 ‘‘(B) action taken by such person to com19 ply with the requirements under section 907 

20 that are applicable to the tobacco product. 

21 ‘‘(2) APPLICATION TO CERTAIN POST-FEB22 RUARY 15, 2007, PRODUCTS.—A report under this 

23 subsection for a tobacco product that was first intro24 duced or delivered for introduction into interstate 

25 commerce for commercial distribution in the United 
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1 States after February 15, 2007, and prior to the 

2 date that is 21 months after the date of enactment 

3 of the Family Smoking Prevention and Tobacco 

4 Control Act shall be submitted to the Secretary not 

5 later than 21 months after such date of enactment. 

6 ‘‘(3) EXEMPTIONS.— 

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

8 exempt from the requirements of this sub9 section relating to the demonstration that a to10 bacco product is substantially equivalent within 

11 the meaning of section 910, tobacco products 

12 that are modified by adding or deleting a to13 bacco additive, or increasing or decreasing the 

14 quantity of an existing tobacco additive, if the 

15 Secretary determines that— 

16 ‘‘(i) such modification would be a 

17 minor modification of a tobacco product 

18 that can be sold under this Act; 

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

20 not necessary to ensure that permitting the 

21 tobacco product to be marketed would be 

22 appropriate for protection of the public 

23 health; and 

24 ‘‘(iii) an exemption is otherwise appro25 priate. 
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1 ‘‘(B) REGULATIONS.—Not later than 15 

2 months after the date of enactment of the Fam3 ily Smoking Prevention and Tobacco Control 

4 Act, the Secretary shall issue regulations to im5 plement this paragraph. 

6 ‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL 

7 OF TOBACCO PRODUCTS. 

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

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

10 tobacco product shall apply to such tobacco product until 

11 the applicability of the requirement to the tobacco product 

12 has been changed by action taken under section 907, sec13 tion 910, section 911, or subsection (d) of this section, 

14 and any requirement established by or under section 902, 

15 903, 905, or 909 which is inconsistent with a requirement 

16 imposed on such tobacco product under section 907, sec17 tion 910, section 911, or subsection (d) of this section 

18 shall not apply to such tobacco product. 

19 ‘‘(b) INFORMATION ON PUBLIC ACCESS AND COM20 MENT.—Each notice of proposed rulemaking or other noti21 fication under section 907, 908, 909, 910, or 911 or under 

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

23 Federal Register with respect to any other action taken 

24 under any such section and which states the reasons for 

25 such action, and each publication of findings required to 
52 

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1 be made in connection with rulemaking under any such 

2 section shall set forth— 

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

4 may examine data and other information on which 

5 the notice or findings is based; and 

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

7 may present their comments on the notice or find8 ings (including the need therefore) orally or in writ9 ing, which period shall be at least 60 days but may 

10 not exceed 90 days unless the time is extended by 

11 the Secretary by a notice published in the Federal 

12 Register stating good cause therefore. 

13 ‘‘(c) LIMITED CONFIDENTIALITY OF INFORMA14 TION.—Any information reported to or otherwise obtained 

15 by the Secretary or the Secretary’s representative under 

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

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

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

19 5, United States Code, by reason of subsection (b)(4) of 

20 that section shall be considered confidential and shall not 

21 be disclosed, except that the information may be disclosed 

22 to other officers or employees concerned with carrying out 

23 this chapter, or when relevant in any proceeding under 

24 this chapter. 

25 ‘‘(d) RESTRICTIONS.— 
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1 ‘‘(1) IN GENERAL.—The Secretary may by reg2 ulation require restrictions on the sale and distribu3 tion of a tobacco product, including restrictions on 

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

5 the tobacco product, if the Secretary determines that 

6 such regulation would be appropriate for the protec7 tion of the public health. The Secretary may by reg8 ulation impose restrictions on the advertising and 

9 promotion of a tobacco product consistent with and 

10 to full extent permitted by the first amendment to 

11 the Constitution. The finding as to whether such 

12 regulation would be appropriate for the protection of 

13 the public health shall be determined with respect to 

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

15 including users and nonusers of the tobacco product, 

16 and taking into account— 

17 ‘‘(A) the increased or decreased likelihood 

18 that existing users of tobacco products will stop 

19 using such products; and 

20 ‘‘(B) the increased or decreased likelihood 

21 that those who do not use tobacco products will 

22 start using such products. 

23 No such regulation may require that the sale or dis24 tribution of a tobacco product be limited to the writ-
54 

•HR 1108 EH

1 ten or oral authorization of a practitioner licensed 

2 by law to prescribe medical products. 

3 ‘‘(2) LABEL STATEMENTS.—The label of a to4 bacco product shall bear such appropriate state5 ments of the restrictions required by a regulation 

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

7 regulation prescribe. 

8 ‘‘(3) LIMITATIONS.— 

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

10 paragraph (1) may— 

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

12 product in face-to-face transactions by a 

13 specific category of retail outlets; or 

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

15 of tobacco products to any person older 

16 than 18 years of age. 

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

18 regulations issued by the Secretary, matchbooks 

19 of conventional size containing not more than 

20 20 paper matches, and which are customarily 

21 given away for free with the purchase of to22 bacco products, shall be considered as adult23 written publications which shall be permitted to 

24 contain advertising. Notwithstanding the pre25 ceding sentence, if the Secretary finds that such 
55 

•HR 1108 EH

1 treatment of matchbooks is not appropriate for 

2 the protection of the public health, the Sec3 retary may determine by regulation that match4 books shall not be considered adult-written pub5 lications. 

6 ‘‘(4) REMOTE SALES.— 

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

8 ‘‘(i) within 18 months after the date 

9 of enactment of this chapter, promulgate 

10 regulations regarding the sale and distribu11 tion of tobacco products that occur 

12 through means other than a direct, face-to13 face exchange between a retailer and a 

14 consumer in order to prevent the sale and 

15 distribution of tobacco products to individ16 uals who have not attained the minimum 

17 age established by applicable law for the 

18 purchase of such products, including re19 quirements for age verification; and 

20 ‘‘(ii) within 2 years after such date of 

21 enactment, issue regulations to address the 

22 promotion and marketing of tobacco prod23 ucts that are sold or distributed through 

24 means other than a direct, face-to-face ex25 change between a retailer and a consumer 
56 

•HR 1108 EH

1 in order to protect individuals who have 

2 not attained the minimum age established 

3 by applicable law for the purchase of such 

4 products. 

5 ‘‘(B) RELATION TO OTHER AUTHORITY.— 

6 Nothing in this paragraph limits the authority 

7 of the Secretary to take additional actions 

8 under the other paragraphs of this subsection. 

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

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

12 CONFORM.— 

13 ‘‘(A) IN GENERAL.—In applying manufac14 turing restrictions to tobacco, the Secretary 

15 shall, in accordance with subparagraph (B), 

16 prescribe regulations (which may differ based 

17 on the type of tobacco product involved) requir18 ing that the methods used in, and the facilities 

19 and controls used for, the manufacture, 

20 preproduction design validation (including a 

21 process to assess the performance of a tobacco 

22 product), packing, and storage of a tobacco 

23 product conform to current good manufacturing 

24 practice, or hazard analysis and critical control 

25 point methodology, as prescribed in such regu-
57 

•HR 1108 EH

1 lations to assure that the public health is pro2 tected and that the tobacco product is in com3 pliance with this chapter. Such regulations may 

4 provide for the testing of raw tobacco for pes5 ticide chemical residues regardless of whether a 

6 tolerance for such chemical residues has been 

7 established. 

8 ‘‘(B) REQUIREMENTS.—The Secretary 

9 shall— 

10 ‘‘(i) before promulgating any regula11 tion under subparagraph (A), afford the 

12 Tobacco Products Scientific Advisory Com13 mittee an opportunity to submit rec14 ommendations with respect to the regula15 tion proposed to be promulgated; 

16 ‘‘(ii) before promulgating any regula17 tion under subparagraph (A), afford oppor18 tunity for an oral hearing; 

19 ‘‘(iii) provide the Tobacco Products 

20 Scientific Advisory Committee a reasonable 

21 time to make its recommendation with re22 spect to proposed regulations under sub23 paragraph (A); 

24 ‘‘(iv) in establishing the effective date 

25 of a regulation promulgated under this 
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•HR 1108 EH

1 subsection, take into account the dif2 ferences in the manner in which the dif3 ferent types of tobacco products have his4 torically been produced, the financial re5 sources of the different tobacco product 

6 manufacturers, and the state of their exist7 ing manufacturing facilities, and shall pro8 vide for a reasonable period of time for 

9 such manufacturers to conform to good 

10 manufacturing practices; and 

11 ‘‘(v) not require any small tobacco 

12 product manufacturer to comply with a 

13 regulation under subparagraph (A) for at 

14 least 4 years following the effective date 

15 established by the Secretary for such regu16 lation. 

17 ‘‘(2) EXEMPTIONS; VARIANCES.— 

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

19 any requirement prescribed under paragraph 

20 (1) may petition the Secretary for a permanent 

21 or temporary exemption or variance from such 

22 requirement. Such a petition shall be submitted 

23 to the Secretary in such form and manner as 

24 the Secretary shall prescribe and shall— 
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•HR 1108 EH

1 ‘‘(i) in the case of a petition for an ex2 emption from a requirement, set forth the 

3 basis for the petitioner’s determination 

4 that compliance with the requirement is 

5 not required to assure that the tobacco 

6 product will be in compliance with this 

7 chapter; 

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

9 variance from a requirement, set forth the 

10 methods proposed to be used in, and the 

11 facilities and controls proposed to be used 

12 for, the manufacture, packing, and storage 

13 of the tobacco product in lieu of the meth14 ods, facilities, and controls prescribed by 

15 the requirement; and 

16 ‘‘(iii) contain such other information 

17 as the Secretary shall prescribe. 

18 ‘‘(B) REFERRAL TO THE TOBACCO PROD19 UCTS SCIENTIFIC ADVISORY COMMITTEE.—The 

20 Secretary may refer to the Tobacco Products 

21 Scientific Advisory Committee any petition sub22 mitted under subparagraph (A). The Tobacco 

23 Products Scientific Advisory Committee shall 

24 report its recommendations to the Secretary 

25 with respect to a petition referred to it within 
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•HR 1108 EH

1 60 days after the date of the petition’s referral. 

2 Within 60 days after— 

3 ‘‘(i) the date the petition was sub4 mitted to the Secretary under subpara5 graph (A); or 

6 ‘‘(ii) the day after the petition was re7 ferred to the Tobacco Products Scientific 

8 Advisory Committee, 

9 whichever occurs later, the Secretary shall by 

10 order either deny the petition or approve it. 

11 ‘‘(C) APPROVAL.—The Secretary may ap12 prove— 

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

14 tobacco product from a requirement if the 

15 Secretary determines that compliance with 

16 such requirement is not required to assure 

17 that the tobacco product will be in compli18 ance with this chapter; and 

19 ‘‘(ii) a petition for a variance for a to20 bacco product from a requirement if the 

21 Secretary determines that the methods to 

22 be used in, and the facilities and controls 

23 to be used for, the manufacture, packing, 

24 and storage of the tobacco product in lieu 

25 of the methods, facilities, and controls pre-
61 

•HR 1108 EH

1 scribed by the requirement are sufficient to 

2 assure that the tobacco product will be in 

3 compliance with this chapter. 

4 ‘‘(D) CONDITIONS.—An order of the Sec5 retary approving a petition for a variance shall 

6 prescribe such conditions respecting the meth7 ods used in, and the facilities and controls used 

8 for, the manufacture, packing, and storage of 

9 the tobacco product to be granted the variance 

10 under the petition as may be necessary to as11 sure that the tobacco product will be in compli12 ance with this chapter. 

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

14 order under subparagraph (B) respecting a pe15 tition, the petitioner shall have an opportunity 

16 for an informal hearing on such order. 

17 ‘‘(3) COMPLIANCE.—Compliance with require18 ments under this subsection shall not be required be19 fore the end of the 3-year period following the date 

20 of enactment of the Family Smoking Prevention and 

21 Tobacco Control Act. 

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

23 may enter into contracts for research, testing, and dem24 onstrations respecting tobacco products and may obtain 
62 

•HR 1108 EH

1 tobacco products for research, testing, and demonstration 

2 purposes. 

3 ‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 

4 ‘‘(a) IN GENERAL.— 

5 ‘‘(1) SPECIAL RULES.— 

6 ‘‘(A) SPECIAL RULE FOR CIGARETTES.— 

7 Beginning 3 months after the date of enact8 ment of the Family Smoking Prevention and 

9 Tobacco Control Act, a cigarette or any of its 

10 component parts (including the tobacco, filter, 

11 or paper) shall not contain, as a constituent (in12 cluding a smoke constituent) or additive, an ar13 tificial or natural flavor (other than tobacco or 

14 menthol) or an herb or spice, including straw15 berry, grape, orange, clove, cinnamon, pine16 apple, vanilla, coconut, licorice, cocoa, chocolate, 

17 cherry, or coffee, that is a characterizing flavor 

18 of the tobacco product or tobacco smoke. Noth19 ing in this subparagraph shall be construed to 

20 limit the Secretary’s authority to take action 

21 under this section or other sections of this Act 

22 applicable to menthol or any artificial or nat23 ural flavor, herb, or spice not specified in this 

24 subparagraph. 
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•HR 1108 EH

1 ‘‘(B) ADDITIONAL SPECIAL RULE.—A to2 bacco product manufactured in or imported into 

3 the United States shall not contain foreign4 grown tobacco that— 

5 ‘‘(i) was grown or processed using a 

6 pesticide chemical that is not approved 

7 under applicable Federal law for use in do8 mestic tobacco farming and processing; or 

9 ‘‘(ii) in the case of a pesticide chem10 ical that is so approved, was grown or 

11 processed using the pesticide chemical in a 

12 manner inconsistent with the approved la13 beling for use of the pesticide chemical in 

14 domestic tobacco farming and processing. 

15 ‘‘(2) REVISION OF TOBACCO PRODUCT STAND16 ARDS.—The Secretary may revise the tobacco prod17 uct standards in paragraph (1) in accordance with 

18 subsection (c). 

19 ‘‘(3) TOBACCO PRODUCT STANDARDS.— 

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

21 adopt tobacco product standards in addition to 

22 those in paragraph (1) if the Secretary finds 

23 that a tobacco product standard is appropriate 

24 for the protection of the public health. 

25 ‘‘(B) DETERMINATIONS.— 
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•HR 1108 EH

1 ‘‘(i) CONSIDERATIONS.—In making a 

2 finding described in subparagraph (A), the 

3 Secretary shall consider scientific evidence 

4 concerning— 

5 ‘‘(I) the risks and benefits to the 

6 population as a whole, including users 

7 and nonusers of tobacco products, of 

8 the proposed standard; 

9 ‘‘(II) the increased or decreased 

10 likelihood that existing users of to11 bacco products will stop using such 

12 products; and 

13 ‘‘(III) the increased or decreased 

14 likelihood that those who do not use 

15 tobacco products will start using such 

16 products. 

17 ‘‘(ii) ADDITIONAL CONSIDER18 ATIONS.—In the event that the Secretary 

19 makes a determination, set forth in a pro20 posed tobacco product standard in a pro21 posed rule, that it is appropriate for the 

22 protection of public health to require the 

23 reduction or elimination of an additive, 

24 constituent (including a smoke con25 stituent), or other component of a tobacco 
65 

•HR 1108 EH

1 product because the Secretary has found 

2 that the additive, constituent, or other 

3 component is or may be harmful, any 

4 party objecting to the proposed standard 

5 on the ground that the proposed standard 

6 will not reduce or eliminate the risk of ill7 ness or injury may provide for the Sec8 retary’s consideration scientific evidence 

9 that demonstrates that the proposed stand10 ard will not reduce or eliminate the risk of 

11 illness or injury. 

12 ‘‘(4) CONTENT OF TOBACCO PRODUCT STAND13 ARDS.—A tobacco product standard established 

14 under this section for a tobacco product— 

15 ‘‘(A) shall include provisions that are ap16 propriate for the protection of the public health, 

17 including provisions, where appropriate— 

18 ‘‘(i) for nicotine yields of the product; 

19 ‘‘(ii) for the reduction or elimination 

20 of other constituents, including smoke con21 stituents, or harmful components of the 

22 product; or 

23 ‘‘(iii) relating to any other require24 ment under subparagraph (B); 
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•HR 1108 EH

1 ‘‘(B) shall, where appropriate for the pro2 tection of the public health, include— 

3 ‘‘(i) provisions respecting the con4 struction, components, ingredients, addi5 tives, constituents, including smoke con6 stituents, and properties of the tobacco 

7 product; 

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

9 sample basis or, if necessary, on an indi10 vidual basis) of the tobacco product; 

11 ‘‘(iii) provisions for the measurement 

12 of the tobacco product characteristics of 

13 the tobacco product; 

14 ‘‘(iv) provisions requiring that the re15 sults of each or of certain of the tests of 

16 the tobacco product required to be made 

17 under clause (ii) show that the tobacco 

18 product is in conformity with the portions 

19 of the standard for which the test or tests 

20 were required; and 

21 ‘‘(v) a provision requiring that the 

22 sale and distribution of the tobacco prod23 uct be restricted but only to the extent 

24 that the sale and distribution of a tobacco 
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•HR 1108 EH

1 product may be restricted under a regula2 tion under section 906(d); 

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

4 use and prescribe the form and content of label5 ing for the proper use of the tobacco product; 

6 and 

7 ‘‘(D) shall require tobacco products con8 taining foreign-grown tobacco to meet the same 

9 standards applicable to tobacco products con10 taining domestically grown tobacco. 

11 ‘‘(5) PERIODIC REEVALUATION OF TOBACCO

12 PRODUCT STANDARDS.—The Secretary shall provide 

13 for periodic evaluation of tobacco product standards 

14 established under this section to determine whether 

15 such standards should be changed to reflect new 

16 medical, scientific, or other technological data. The 

17 Secretary may provide for testing under paragraph 

18 (4)(B) by any person. 

19 ‘‘(6) INVOLVEMENT OF OTHER AGENCIES; IN20 FORMED PERSONS.—In carrying out duties under 

21 this section, the Secretary shall endeavor to— 

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

23 technical support available in other Federal 

24 agencies; 
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•HR 1108 EH

1 ‘‘(B) consult with other Federal agencies 

2 concerned with standard setting and other na3 tionally or internationally recognized standard4 setting entities; and 

5 ‘‘(C) invite appropriate participation, 

6 through joint or other conferences, workshops, 

7 or other means, by informed persons represent8 ative of scientific, professional, industry, agri9 cultural, or consumer organizations who in the 

10 Secretary’s judgment can make a significant 

11 contribution. 

12 ‘‘(b) CONSIDERATIONS BY SECRETARY.— 

13 ‘‘(1) TECHNICAL ACHIEVABILITY.—The Sec14 retary shall consider information submitted in con15 nection with a proposed standard regarding the tech16 nical achievability of compliance with such standard. 

17 ‘‘(2) OTHER CONSIDERATIONS.—The Secretary 

18 shall consider all other information submitted in 

19 connection with a proposed standard, including in20 formation concerning the countervailing effects of 

21 the tobacco product standard on the health of ado22 lescent tobacco users, adult tobacco users, or non23 tobacco users, such as the creation of a significant 

24 demand for contraband or other tobacco products 
69 

•HR 1108 EH

1 that do not meet the requirements of this chapter 

2 and the significance of such demand. 

3 ‘‘(c) PROPOSED STANDARDS.— 

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

5 in the Federal Register a notice of proposed rule6 making for the establishment, amendment, or rev7 ocation of any tobacco product standard. 

8 ‘‘(2) REQUIREMENTS OF NOTICE.—A notice of 

9 proposed rulemaking for the establishment or 

10 amendment of a tobacco product standard for a to11 bacco product shall— 

12 ‘‘(A) set forth a finding with supporting 

13 justification that the tobacco product standard 

14 is appropriate for the protection of the public 

15 health; 

16 ‘‘(B) invite interested persons to submit a 

17 draft or proposed tobacco product standard for 

18 consideration by the Secretary; 

19 ‘‘(C) invite interested persons to submit 

20 comments on structuring the standard so that 

21 it does not advantage foreign-grown tobacco 

22 over domestically grown tobacco; and 

23 ‘‘(D) invite the Secretary of Agriculture to 

24 provide any information or analysis which the 
70 

•HR 1108 EH

1 Secretary of Agriculture believes is relevant to 

2 the proposed tobacco product standard. 

3 ‘‘(3) FINDING.—A notice of proposed rule4 making for the revocation of a tobacco product 

5 standard shall set forth a finding with supporting 

6 justification that the tobacco product standard is no 

7 longer appropriate for the protection of the public 

8 health. 

9 ‘‘(4) COMMENT.—The Secretary shall provide 

10 for a comment period of not less than 60 days. 

11 ‘‘(d) PROMULGATION.— 

12 ‘‘(1) IN GENERAL.—After the expiration of the 

13 period for comment on a notice of proposed rule14 making published under subsection (c) respecting a 

15 tobacco product standard and after consideration of 

16 comments submitted under subsections (b) and (c) 

17 and any report from the Tobacco Products Scientific 

18 Advisory Committee, if the Secretary determines 

19 that the standard would be appropriate for the pro20 tection of the public health, the Secretary shall— 

21 ‘‘(A) promulgate a regulation establishing 

22 a tobacco product standard and publish in the 

23 Federal Register findings on the matters re24 ferred to in subsection (c); or 
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•HR 1108 EH

1 ‘‘(B) publish a notice terminating the pro2 ceeding for the development of the standard to3 gether with the reasons for such termination. 

4 ‘‘(2) EFFECTIVE DATE.—A regulation estab5 lishing a tobacco product standard shall set forth 

6 the date or dates upon which the standard shall take 

7 effect, but no such regulation may take effect before 

8 1 year after the date of its publication unless the 

9 Secretary determines that an earlier effective date is 

10 necessary for the protection of the public health. 

11 Such date or dates shall be established so as to min12 imize, consistent with the public health, economic 

13 loss to, and disruption or dislocation of, domestic 

14 and international trade. In establishing such effec15 tive date or dates, the Secretary shall consider infor16 mation submitted in connection with a proposed 

17 product standard by interested parties, including 

18 manufacturers and tobacco growers, regarding the 

19 technical achievability of compliance with the stand20 ard, and including information concerning the exist21 ence of patents that make it impossible to comply in 

22 the timeframe envisioned in the proposed standard. 

23 If the Secretary determines, based on the Sec24 retary’s evaluation of submitted comments, that a 

25 product standard can be met only by manufacturers 
72 

•HR 1108 EH

1 requiring substantial changes to the methods of 

2 farming the domestically grown tobacco used by the 

3 manufacturer, the effective date of that product 

4 standard shall be not less than 2 years after the 

5 date of publication of the final regulation estab6 lishing the standard. 

7 ‘‘(3) LIMITATION ON POWER GRANTED TO THE

8 FOOD AND DRUG ADMINISTRATION.—Because of the 

9 importance of a decision of the Secretary to issue a 

10 regulation— 

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

12 tobacco products, all little cigars, all cigars 

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

14 roll-your-own tobacco products; or 

15 ‘‘(B) requiring the reduction of nicotine 

16 yields of a tobacco product to zero, 

17 the Secretary is prohibited from taking such actions 

18 under this Act. 

19 ‘‘(4) AMENDMENT; REVOCATION.— 

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

21 the Secretary’s own initiative or upon petition 

22 of an interested person, may by a regulation, 

23 promulgated in accordance with the require24 ments of subsection (c) and paragraph (2), 

25 amend or revoke a tobacco product standard. 
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•HR 1108 EH

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

2 may declare a proposed amendment of a to3 bacco product standard to be effective on and 

4 after its publication in the Federal Register and 

5 until the effective date of any final action taken 

6 on such amendment if the Secretary determines 

7 that making it so effective is in the public inter8 est. 

9 ‘‘(5) REFERRAL TO ADVISORY COMMITTEE.— 

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

11 refer a proposed regulation for the establish12 ment, amendment, or revocation of a tobacco 

13 product standard to the Tobacco Products Sci14 entific Advisory Committee for a report and 

15 recommendation with respect to any matter in16 volved in the proposed regulation which requires 

17 the exercise of scientific judgment. 

18 ‘‘(B) INITIATION OF REFERRAL.—The Sec19 retary may make a referral under this para20 graph— 

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

22 or 

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

24 person that— 
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•HR 1108 EH

1 ‘‘(I) demonstrates good cause for 

2 the referral; and 

3 ‘‘(II) is made before the expira4 tion of the period for submission of 

5 comments on the proposed regulation. 

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

7 regulation is referred under this paragraph to 

8 the Tobacco Products Scientific Advisory Com9 mittee, the Secretary shall provide the Advisory 

10 Committee with the data and information on 

11 which such proposed regulation is based. 

12 ‘‘(D) REPORT AND RECOMMENDATION.— 

13 The Tobacco Products Scientific Advisory Com14 mittee shall, within 60 days after the referral of 

15 a proposed regulation under this paragraph and 

16 after independent study of the data and infor17 mation furnished to it by the Secretary and 

18 other data and information before it, submit to 

19 the Secretary a report and recommendation re20 specting such regulation, together with all un21 derlying data and information and a statement 

22 of the reason or basis for the recommendation. 

23 ‘‘(E) PUBLIC AVAILABILITY.—The Sec24 retary shall make a copy of each report and rec-
75 

•HR 1108 EH

1 ommendation under subparagraph (D) publicly 

2 available. 

3 ‘‘(e) MENTHOL CIGARETTES.— 

4 ‘‘(1) REFERRAL; CONSIDERATIONS.—Imme5 diately upon the establishment of the Tobacco Prod6 ucts Scientific Advisory Committee under section 

7 917(a), the Secretary shall refer to the Committee 

8 for report and recommendation, under section 

9 917(c)(4), the issue of the impact of the use of men10 thol in cigarettes on the public health, including 

11 such use among African Americans, Hispanics, and 

12 other racial and ethnic minorities. In its review, the 

13 Tobacco Products Scientific Advisory Committee 

14 shall address the considerations listed in subsections 

15 (a)(3)(B)(i) and (b). 

16 ‘‘(2) REPORT AND RECOMMENDATION.—Not 

17 later than 1 year after its establishment, the To18 bacco Product Scientific Advisory Committee shall 

19 submit to the Secretary the report and recommenda20 tions required pursuant to paragraph (1). 

21 ‘‘(3) RULE OF CONSTRUCTION.—Nothing in 

22 this subsection shall be construed to limit the Sec23 retary’s authority to take action under this section 

24 or other sections of this Act applicable to menthol. 
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1 ‘‘SEC. 908. NOTIFICATION AND OTHER REMEDIES. 

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

3 that— 

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

5 delivered for introduction into interstate commerce 

6 for commercial distribution presents an unreasonable 

7 risk of substantial harm to the public health; and 

8 ‘‘(2) notification under this subsection is nec9 essary to eliminate the unreasonable risk of such 

10 harm and no more practicable means is available 

11 under the provisions of this chapter (other than this 

12 section) to eliminate such risk, 

13 the Secretary may issue such order as may be necessary 

14 to assure that adequate notification is provided in an ap15 propriate form, by the persons and means best suited 

16 under the circumstances involved, to all persons who 

17 should properly receive such notification in order to elimi18 nate such risk. The Secretary may order notification by 

19 any appropriate means, including public service announce20 ments. Before issuing an order under this subsection, the 

21 Secretary shall consult with the persons who are to give 

22 notice under the order. 

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

24 Compliance with an order issued under this section shall 

25 not relieve any person from liability under Federal or 

26 State law. In awarding damages for economic loss in an 
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•HR 1108 EH

1 action brought for the enforcement of any such liability, 

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

3 provided under such order shall be taken into account. 

4 ‘‘(c) RECALL AUTHORITY.— 

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

6 there is a reasonable probability that a tobacco prod7 uct contains a manufacturing or other defect not or8 dinarily contained in tobacco products on the market 

9 that would cause serious, adverse health con10 sequences or death, the Secretary shall issue an 

11 order requiring the appropriate person (including 

12 the manufacturers, importers, distributors, or retail13 ers of the tobacco product) to immediately cease dis14 tribution of such tobacco product. The order shall 

15 provide the person subject to the order with an op16 portunity for an informal hearing, to be held not 

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

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

19 on whether the order should be amended to require 

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

21 an opportunity for such a hearing, the Secretary de22 termines that inadequate grounds exist to support 

23 the actions required by the order, the Secretary shall 

24 vacate the order. 
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•HR 1108 EH

1 ‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE2 CALL.— 

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

4 opportunity for an informal hearing under 

5 paragraph (1), the Secretary determines that 

6 the order should be amended to include a recall 

7 of the tobacco product with respect to which the 

8 order was issued, the Secretary shall, except as 

9 provided in subparagraph (B), amend the order 

10 to require a recall. The Secretary shall specify 

11 a timetable in which the tobacco product recall 

12 will occur and shall require periodic reports to 

13 the Secretary describing the progress of the re14 call. 

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

16 subparagraph (A)— 

17 ‘‘(i) shall not include recall of a to18 bacco product from individuals; and 

19 ‘‘(ii) shall provide for notice to per20 sons subject to the risks associated with 

21 the use of such tobacco product. 

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

23 the Secretary may use the assistance of retail24 ers and other persons who distributed such to25 bacco product. If a significant number of such 
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•HR 1108 EH

1 persons cannot be identified, the Secretary shall 

2 notify such persons under section 705(b). 

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

4 provided by this subsection shall be in addition to 

5 remedies provided by subsection (a). 

6 ‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PROD7 UCTS. 

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

9 product manufacturer or importer of a tobacco product 

10 shall establish and maintain such records, make such re11 ports, and provide such information, as the Secretary may 

12 by regulation reasonably require to assure that such to13 bacco product is not adulterated or misbranded and to 

14 otherwise protect public health. Regulations prescribed 

15 under the preceding sentence— 

16 ‘‘(1) may require a tobacco product manufac17 turer or importer to report to the Secretary when18 ever the manufacturer or importer receives or other19 wise becomes aware of information that reasonably 

20 suggests that one of its marketed tobacco products 

21 may have caused or contributed to a serious unex22 pected adverse experience associated with the use of 

23 the product or any significant increase in the fre24 quency of a serious, expected adverse product experi25 ence; 
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•HR 1108 EH

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

2 adverse tobacco product experiences as determined 

3 by the Secretary to be necessary to be reported; 

4 ‘‘(3) shall not impose requirements unduly bur5 densome to a tobacco product manufacturer or im6 porter, taking into account the cost of complying 

7 with such requirements and the need for the protec8 tion of the public health and the implementation of 

9 this chapter; 

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

11 requests for reports or information, shall require 

12 that each request made under such regulations for 

13 submission of a report or information to the Sec14 retary state the reason or purpose for such request 

15 and identify to the fullest extent practicable such re16 port or information; 

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

18 information to the Secretary, shall state the reason 

19 or purpose for the submission of such report or in20 formation and identify to the fullest extent prac21 ticable such report or information; and 

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

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

24 information required under this subsection unless re25 quired for the medical welfare of an individual, to 
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1 determine risks to public health of a tobacco prod2 uct, or to verify a record, report, or information sub3 mitted under this chapter. 

4 In prescribing regulations under this subsection, the Sec5 retary shall have due regard for the professional ethics of 

6 the medical profession and the interests of patients. The 

7 prohibitions of paragraph (6) continue to apply to records, 

8 reports, and information concerning any individual who 

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

10 ceases to be a patient. 

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

12 ‘‘(1) IN GENERAL.—Except as provided in para13 graph (2), the Secretary shall by regulation require 

14 a tobacco product manufacturer or importer of a to15 bacco product to report promptly to the Secretary 

16 any corrective action taken or removal from the 

17 market of a tobacco product undertaken by such 

18 manufacturer or importer if the removal or correc19 tion was undertaken— 

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

21 the tobacco product; or 

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

23 caused by the tobacco product which may 

24 present a risk to health. 
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1 A tobacco product manufacturer or importer of a to2 bacco product who undertakes a corrective action or 

3 removal from the market of a tobacco product which 

4 is not required to be reported under this subsection 

5 shall keep a record of such correction or removal. 

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

7 action or removal of a tobacco product may be re8 quired under paragraph (1) if a report of the correc9 tive action or removal is required and has been sub10 mitted under subsection (a). 

11 ‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TO12 BACCO PRODUCTS. 

13 ‘‘(a) IN GENERAL.— 

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

15 purposes of this section the term ‘new tobacco prod16 uct’ means— 

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

18 products in test markets) that was not commer19 cially marketed in the United States as of Feb20 ruary 15, 2007; or 

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

22 in design, any component, any part, or any con23 stituent, including a smoke constituent, or in 

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

25 other additive or ingredient) of a tobacco prod-
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1 uct where the modified product was commer2 cially marketed in the United States after Feb3 ruary 15, 2007. 

4 ‘‘(2) PREMARKET REVIEW REQUIRED.— 

5 ‘‘(A) NEW PRODUCTS.—An order under 

6 subsection (c)(1)(A)(i) for a new tobacco prod7 uct is required unless— 

8 ‘‘(i) the manufacturer has submitted a 

9 report under section 905(j); and the Sec10 retary has issued an order that the tobacco 

11 product— 

12 ‘‘(I) is substantially equivalent to 

13 a tobacco product commercially mar14 keted (other than for test marketing) 

15 in the United States as of February 

16 15, 2007; and 

17 ‘‘(II) is in compliance with the 

18 requirements of this Act; or 

19 ‘‘(ii) the tobacco product is exempt 

20 from the requirements of section 905(j) 

21 pursuant to a regulation issued under sec22 tion 905(j)(3). 

23 ‘‘(B) APPLICATION TO CERTAIN POST-FEB24 RUARY 15, 2007, PRODUCTS.—Subparagraph (A) 

25 shall not apply to a tobacco product— 
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1 ‘‘(i) that was first introduced or deliv2 ered for introduction into interstate com3 merce for commercial distribution in the 

4 United States after February 15, 2007, 

5 and prior to the date that is 21 months 

6 after the date of enactment of the Family 

7 Smoking Prevention and Tobacco Control 

8 Act; and 

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

10 under section 905(j) within such 21-month 

11 period, 

12 except that subparagraph (A) shall apply to the 

13 tobacco product if the Secretary issues an order 

14 that the tobacco product is not substantially 

15 equivalent. 

16 ‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.— 

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

18 section 905(j), the term ‘substantially equiva19 lent’ or ‘substantial equivalence’ means, with 

20 respect to the tobacco product being compared 

21 to the predicate tobacco product, that the Sec22 retary by order has found that the tobacco 

23 product— 

24 ‘‘(i) has the same characteristics as 

25 the predicate tobacco product; or 
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1 ‘‘(ii) has different characteristics and 

2 the information submitted contains infor3 mation, including clinical data if deemed 

4 necessary by the Secretary, that dem5 onstrates that it is not appropriate to reg6 ulate the product under this section be7 cause the product does not raise different 

8 questions of public health. 

9 ‘‘(B) CHARACTERISTICS.—In subpara10 graph (A), the term ‘characteristics’ means the 

11 materials, ingredients, design, composition, 

12 heating source, or other features of a tobacco 

13 product. 

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

15 not be found to be substantially equivalent to a 

16 predicate tobacco product that has been re17 moved from the market at the initiative of the 

18 Secretary or that has been determined by a ju19 dicial order to be misbranded or adulterated. 

20 ‘‘(4) HEALTH INFORMATION.— 

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

22 under section 905(j) respecting a tobacco prod23 uct, the person required to file a premarket no24 tification under such section shall provide an 

25 adequate summary of any health information 
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1 related to the tobacco product or state that 

2 such information will be made available upon 

3 request by any person. 

4 ‘‘(B) REQUIRED INFORMATION.—Any sum5 mary under subparagraph (A) respecting a to6 bacco product shall contain detailed information 

7 regarding data concerning adverse health ef8 fects and shall be made available to the public 

9 by the Secretary within 30 days of the issuance 

10 of a determination that such tobacco product is 

11 substantially equivalent to another tobacco 

12 product. 

13 ‘‘(b) APPLICATION.— 

14 ‘‘(1) CONTENTS.—An application under this 

15 section shall contain— 

16 ‘‘(A) full reports of all information, pub17 lished or known to, or which should reasonably 

18 be known to, the applicant, concerning inves19 tigations which have been made to show the 

20 health risks of such tobacco product and wheth21 er such tobacco product presents less risk than 

22 other tobacco products; 

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

24 ingredients, additives, and properties, and of 
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1 the principle or principles of operation, of such 

2 tobacco product; 

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

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

5 manufacture, processing, and, when relevant, 

6 packing and installation of, such tobacco prod7 uct; 

8 ‘‘(D) an identifying reference to any to9 bacco product standard under section 907 

10 which would be applicable to any aspect of such 

11 tobacco product, and either adequate informa12 tion to show that such aspect of such tobacco 

13 product fully meets such tobacco product stand14 ard or adequate information to justify any devi15 ation from such standard; 

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

17 and of components thereof as the Secretary 

18 may reasonably require; 

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

20 be used for such tobacco product; and 

21 ‘‘(G) such other information relevant to 

22 the subject matter of the application as the Sec23 retary may require. 

24 ‘‘(2) REFERRAL TO TOBACCO PRODUCTS SCI25 ENTIFIC ADVISORY COMMITTEE.—Upon receipt of an 
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1 application meeting the requirements set forth in 

2 paragraph (1), the Secretary— 

3 ‘‘(A) may, on the Secretary’s own initia4 tive; or 

5 ‘‘(B) may, upon the request of an appli6 cant, 

7 refer such application to the Tobacco Products Sci8 entific Advisory Committee for reference and for 

9 submission (within such period as the Secretary may 

10 establish) of a report and recommendation respect11 ing the application, together with all underlying data 

12 and the reasons or basis for the recommendation. 

13 ‘‘(c) ACTION ON APPLICATION.— 

14 ‘‘(1) DEADLINE.— 

15 ‘‘(A) IN GENERAL.—As promptly as pos16 sible, but in no event later than 180 days after 

17 the receipt of an application under subsection 

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

19 and recommendation submitted under sub20 section (b)(2), shall— 

21 ‘‘(i) issue an order that the new prod22 uct may be introduced or delivered for in23 troduction into interstate commerce if the 

24 Secretary finds that none of the grounds 
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1 specified in paragraph (2) of this sub2 section applies; or 

3 ‘‘(ii) issue an order that the new prod4 uct may not be introduced or delivered for 

5 introduction into interstate commerce if 

6 the Secretary finds (and sets forth the 

7 basis for such finding as part of or accom8 panying such denial) that 1 or more 

9 grounds for denial specified in paragraph 

10 (2) of this subsection apply. 

11 ‘‘(B) RESTRICTIONS ON SALE AND DIS12 TRIBUTION.—An order under subparagraph 

13 (A)(i) may require that the sale and distribu14 tion of the tobacco product be restricted but 

15 only to the extent that the sale and distribution 

16 of a tobacco product may be restricted under a 

17 regulation under section 906(d). 

18 ‘‘(2) DENIAL OF APPLICATION.—The Secretary 

19 shall deny an application submitted under subsection 

20 (b) if, upon the basis of the information submitted 

21 to the Secretary as part of the application and any 

22 other information before the Secretary with respect 

23 to such tobacco product, the Secretary finds that— 

24 ‘‘(A) there is a lack of a showing that per25 mitting such tobacco product to be marketed 
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1 would be appropriate for the protection of the 

2 public health; 

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

4 or controls used for, the manufacture, proc5 essing, or packing of such tobacco product do 

6 not conform to the requirements of section 

7 906(e); 

8 ‘‘(C) based on a fair evaluation of all mate9 rial facts, the proposed labeling is false or mis10 leading in any particular; or 

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

12 conform in all respects to a tobacco product 

13 standard in effect under section 907, and there 

14 is a lack of adequate information to justify the 

15 deviation from such standard. 

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

17 application shall, insofar as the Secretary determines 

18 to be practicable, be accompanied by a statement in19 forming the applicant of the measures required to 

20 remove such application from deniable form (which 

21 measures may include further research by the appli22 cant in accordance with 1 or more protocols pre23 scribed by the Secretary). 

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

25 this section, the finding as to whether the marketing 
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1 of a tobacco product for which an application has 

2 been submitted is appropriate for the protection of 

3 the public health shall be determined with respect to 

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

5 including users and nonusers of the tobacco product, 

6 and taking into account— 

7 ‘‘(A) the increased or decreased likelihood 

8 that existing users of tobacco products will stop 

9 using such products; and 

10 ‘‘(B) the increased or decreased likelihood 

11 that those who do not use tobacco products will 

12 start using such products. 

13 ‘‘(5) BASIS FOR ACTION.— 

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

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

16 product to be marketed would be appropriate 

17 for the protection of the public health shall, 

18 when appropriate, be determined on the basis of 

19 well-controlled investigations, which may in20 clude 1 or more clinical investigations by ex21 perts qualified by training and experience to 

22 evaluate the tobacco product. 

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

24 determines that there exists valid scientific evi25 dence (other than evidence derived from inves-
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1 tigations described in subparagraph (A)) which 

2 is sufficient to evaluate the tobacco product, the 

3 Secretary may authorize that the determination 

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

5 the basis of such evidence. 

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

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

8 obtaining, where appropriate, advice on scientific 

9 matters from the Tobacco Products Scientific Advi10 sory Committee, and after due notice and oppor11 tunity for informal hearing for a tobacco product for 

12 which an order was issued under subsection 

13 (c)(1)(A)(i), issue an order withdrawing the order if 

14 the Secretary finds— 

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

16 tobacco product no longer is appropriate for the 

17 protection of the public health; 

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

19 accompanied by an untrue statement of a mate20 rial fact; 

21 ‘‘(C) that the applicant— 

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

23 for maintaining records, or has repeatedly 

24 or deliberately failed to maintain records 
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1 or to make reports, required by an applica2 ble regulation under section 909; 

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

4 or copying or verification of, such records 

5 as required by section 704; or 

6 ‘‘(iii) has not complied with the re7 quirements of section 905; 

8 ‘‘(D) on the basis of new information be9 fore the Secretary with respect to such tobacco 

10 product, evaluated together with the evidence 

11 before the Secretary when the application was 

12 reviewed, that the methods used in, or the fa13 cilities and controls used for, the manufacture, 

14 processing, packing, or installation of such to15 bacco product do not conform with the require16 ments of section 906(e) and were not brought 

17 into conformity with such requirements within a 

18 reasonable time after receipt of written notice 

19 from the Secretary of nonconformity; 

20 ‘‘(E) on the basis of new information be21 fore the Secretary, evaluated together with the 

22 evidence before the Secretary when the applica23 tion was reviewed, that the labeling of such to24 bacco product, based on a fair evaluation of all 

25 material facts, is false or misleading in any par-
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1 ticular and was not corrected within a reason2 able time after receipt of written notice from 

3 the Secretary of such fact; or 

4 ‘‘(F) on the basis of new information be5 fore the Secretary, evaluated together with the 

6 evidence before the Secretary when such order 

7 was issued, that such tobacco product is not 

8 shown to conform in all respects to a tobacco 

9 product standard which is in effect under sec10 tion 907, compliance with which was a condi11 tion to the issuance of an order relating to the 

12 application, and that there is a lack of adequate 

13 information to justify the deviation from such 

14 standard. 

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

16 subject to an order issued under paragraph (1) with17 drawing an order issued pursuant to subsection 

18 (c)(1)(A)(i) may, by petition filed on or before the 

19 30th day after the date upon which such holder re20 ceives notice of such withdrawal, obtain review there21 of in accordance with section 912. 

22 ‘‘(3) TEMPORARY SUSPENSION.—If, after pro23 viding an opportunity for an informal hearing, the 

24 Secretary determines there is reasonable probability 

25 that the continuation of distribution of a tobacco 
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1 product under an order would cause serious, adverse 

2 health consequences or death, that is greater than 

3 ordinarily caused by tobacco products on the market, 

4 the Secretary shall by order temporarily suspend the 

5 authority of the manufacturer to market the prod6 uct. If the Secretary issues such an order, the Sec7 retary shall proceed expeditiously under paragraph 

8 (1) to withdraw such application. 

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

10 Secretary under this section shall be served— 

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

12 department designated by the Secretary; or 

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

14 certified mail addressed to the applicant at the ap15 plicant’s last known address in the records of the 

16 Secretary. 

17 ‘‘(f) RECORDS.— 

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

19 of any tobacco product for which an order issued 

20 pursuant to subsection (c)(1)(A)(i) for an applica21 tion filed under subsection (b) is in effect, the appli22 cant shall establish and maintain such records, and 

23 make such reports to the Secretary, as the Secretary 

24 may by regulation, or by order with respect to such 

25 application, prescribe on the basis of a finding that 
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1 such records and reports are necessary in order to 

2 enable the Secretary to determine, or facilitate a de3 termination of, whether there is or may be grounds 

4 for withdrawing or temporarily suspending such 

5 order. 

6 ‘‘(2) ACCESS TO RECORDS.—Each person re7 quired under this section to maintain records, and 

8 each person in charge of custody thereof, shall, upon 

9 request of an officer or employee designated by the 

10 Secretary, permit such officer or employee at all rea11 sonable times to have access to and copy and verify 

12 such records. 

13 ‘‘(g) INVESTIGATIONAL TOBACCO PRODUCT EXEMP14 TION FOR INVESTIGATIONAL USE.—The Secretary may 

15 exempt tobacco products intended for investigational use 

16 from the provisions of this chapter under such conditions 

17 as the Secretary may by regulation prescribe. 

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

19 ‘‘(a) IN GENERAL.—No person may introduce or de20 liver for introduction into interstate commerce any modi21 fied risk tobacco product unless an order issued pursuant 

22 to subsection (g) is effective with respect to such product. 

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

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

25 term ‘modified risk tobacco product’ means any to-
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1 bacco product that is sold or distributed for use to 

2 reduce harm or the risk of tobacco-related disease 

3 associated with commercially marketed tobacco prod4 ucts. 

5 ‘‘(2) SOLD OR DISTRIBUTED.— 

6 ‘‘(A) IN GENERAL.—With respect to a to7 bacco product, the term ‘sold or distributed for 

8 use to reduce harm or the risk of tobacco-re9 lated disease associated with commercially mar10 keted tobacco products’ means a tobacco prod11 uct— 

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

13 of which represents explicitly or implicitly 

14 that— 

15 ‘‘(I) the tobacco product presents 

16 a lower risk of tobacco-related disease 

17 or is less harmful than one or more 

18 other commercially marketed tobacco 

19 products; 

20 ‘‘(II) the tobacco product or its 

21 smoke contains a reduced level of a 

22 substance or presents a reduced expo23 sure to a substance; or 
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1 ‘‘(III) the tobacco product or its 

2 smoke does not contain or is free of a 

3 substance; 

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

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

6 or ‘low’ or similar descriptors; or 

7 ‘‘(iii) the tobacco product manufac8 turer of which has taken any action di9 rected to consumers through the media or 

10 otherwise, other than by means of the to11 bacco product’s label, labeling, or adver12 tising, after the date of enactment of the 

13 Family Smoking Prevention and Tobacco 

14 Control Act, respecting the product that 

15 would be reasonably expected to result in 

16 consumers believing that the tobacco prod17 uct or its smoke may present a lower risk 

18 of disease or is less harmful than one or 

19 more commercially marketed tobacco prod20 ucts, or presents a reduced exposure to, or 

21 does not contain or is free of, a substance 

22 or substances. 

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

24 shall be considered to be ‘sold or distributed for 

25 use to reduce harm or the risk of tobacco-re-
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1 lated disease associated with commercially mar2 keted tobacco products’, except as described in 

3 subparagraph (A). 

4 ‘‘(C) SMOKELESS TOBACCO PRODUCT.—No 

5 smokeless tobacco product shall be considered 

6 to be ‘sold or distributed for use to reduce harm 

7 or the risk of tobacco-related disease associated 

8 with commercially marketed tobacco products’ 

9 solely because its label, labeling, or advertising 

10 uses the following phrases to describe such 

11 product and its use: ‘smokeless tobacco’, 

12 ‘smokeless tobacco product’, ‘not consumed by 

13 smoking’, ‘does not produce smoke’, 

14 ‘smokefree’, ‘smoke-free’, ‘without smoke’, ‘no 

15 smoke’, or ‘not smoke’. 

16 ‘‘(3) EFFECTIVE DATE.—The provisions of 

17 paragraph (2)(A)(ii) shall take effect 12 months 

18 after the date of enactment of the Family Smoking 

19 Prevention and Tobacco Control Act for those prod20 ucts whose label, labeling, or advertising contains 

21 the terms described in such paragraph on such date 

22 of enactment. The effective date shall be with re23 spect to the date of manufacture, provided that, in 

24 any case, beginning 30 days after such effective 

25 date, a manufacturer shall not introduce into the do-
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1 mestic commerce of the United States any product, 

2 irrespective of the date of manufacture, that is not 

3 in conformance with paragraph (2)(A)(ii). 

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

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

6 dependence, including smoking cessation, is not a modified 

7 risk tobacco product under this section if it has been ap8 proved as a drug or device by the Food and Drug Adminis9 tration and is subject to the requirements of chapter V. 

10 ‘‘(d) FILING.—Any person may file with the Sec11 retary an application for a modified risk tobacco product. 

12 Such application shall include— 

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

14 any proposed advertising and labeling; 

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

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

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

18 ‘‘(5) all documents (including underlying sci19 entific information) relating to research findings 

20 conducted, supported, or possessed by the tobacco 

21 product manufacturer relating to the effect of the 

22 product on tobacco-related diseases and health-re23 lated conditions, including information both favor24 able and unfavorable to the ability of the product to 
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1 reduce risk or exposure and relating to human 

2 health; 

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

4 actually use the tobacco product; and 

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

6 may require. 

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

8 make the application described in subsection (d) publicly 

9 available (except matters in the application which are 

10 trade secrets or otherwise confidential, commercial infor11 mation) and shall request comments by interested persons 

12 on the information contained in the application and on the 

13 label, labeling, and advertising accompanying such appli14 cation. 

15 ‘‘(f) ADVISORY COMMITTEE.— 

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

17 the Tobacco Products Scientific Advisory Committee 

18 any application submitted under this section. 

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

20 days after the date an application is referred to the 

21 Tobacco Products Scientific Advisory Committee 

22 under paragraph (1), the Advisory Committee shall 

23 report its recommendations on the application to the 

24 Secretary. 

25 ‘‘(g) MARKETING.— 
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1 ‘‘(1) MODIFIED RISK PRODUCTS.—Except as 

2 provided in paragraph (2), the Secretary shall, with 

3 respect to an application submitted under this sec4 tion, issue an order that a modified risk product 

5 may be commercially marketed only if the Secretary 

6 determines that the applicant has demonstrated that 

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

8 will— 

9 ‘‘(A) significantly reduce harm and the 

10 risk of tobacco-related disease to individual to11 bacco users; and 

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

13 as a whole taking into account both users of to14 bacco products and persons who do not cur15 rently use tobacco products. 

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

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

18 issue an order that a tobacco product may be 

19 introduced or delivered for introduction into 

20 interstate commerce, pursuant to an application 

21 under this section, with respect to a tobacco 

22 product that may not be commercially marketed 

23 under paragraph (1) if the Secretary makes the 

24 findings required under this paragraph and de-
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1 termines that the applicant has demonstrated 

2 that— 

3 ‘‘(i) such order would be appropriate 

4 to promote the public health; 

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

6 and advertising for such product that 

7 would cause the tobacco product to be a 

8 modified risk tobacco product under sub9 section (b) is limited to an explicit or im10 plicit representation that such tobacco 

11 product or its smoke does not contain or is 

12 free of a substance or contains a reduced 

13 level of a substance, or presents a reduced 

14 exposure to a substance in tobacco smoke; 

15 ‘‘(iii) scientific evidence is not avail16 able and, using the best available scientific 

17 methods, cannot be made available without 

18 conducting long-term epidemiological stud19 ies for an application to meet the stand20 ards set forth in paragraph (1); and 

21 ‘‘(iv) the scientific evidence that is 

22 available without conducting long-term epi23 demiological studies demonstrates that a 

24 measurable and substantial reduction in 

25 morbidity or mortality among individual 
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1 tobacco users is reasonably likely in subse2 quent studies. 

3 ‘‘(B) ADDITIONAL FINDINGS REQUIRED.— 

4 To issue an order under subparagraph (A) the 

5 Secretary must also find that the applicant has 

6 demonstrated that— 

7 ‘‘(i) the magnitude of the overall re8 ductions in exposure to the substance or 

9 substances which are the subject of the ap10 plication is substantial, such substance or 

11 substances are harmful, and the product as 

12 actually used exposes consumers to the 

13 specified reduced level of the substance or 

14 substances; 

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

16 consumers will not expose them to higher 

17 levels of other harmful substances com18 pared to the similar types of tobacco prod19 ucts then on the market unless such in20 creases are minimal and the reasonably 

21 likely overall impact of use of the product 

22 remains a substantial and measurable re23 duction in overall morbidity and mortality 

24 among individual tobacco users; 
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1 ‘‘(iii) testing of actual consumer per2 ception shows that, as the applicant pro3 poses to label and market the product, con4 sumers will not be misled into believing 

5 that the product— 

6 ‘‘(I) is or has been demonstrated 

7 to be less harmful; or 

8 ‘‘(II) presents or has been dem9 onstrated to present less of a risk of 

10 disease than 1 or more other commer11 cially marketed tobacco products; and 

12 ‘‘(iv) issuance of an order with respect 

13 to the application is expected to benefit the 

14 health of the population as a whole taking 

15 into account both users of tobacco prod16 ucts and persons who do not currently use 

17 tobacco products. 

18 ‘‘(C) CONDITIONS OF MARKETING.— 

19 ‘‘(i) IN GENERAL.—Applications sub20 ject to an order under this paragraph shall 

21 be limited to a term of not more than 5 

22 years, but may be renewed upon a finding 

23 by the Secretary that the requirements of 

24 this paragraph continue to be satisfied 

25 based on the filing of a new application. 
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1 ‘‘(ii) AGREEMENTS BY APPLICANT.— 

2 An order under this paragraph shall be 

3 conditioned on the applicant’s agreement 

4 to conduct postmarket surveillance and 

5 studies and to submit to the Secretary the 

6 results of such surveillance and studies to 

7 determine the impact of the order on con8 sumer perception, behavior, and health and 

9 to enable the Secretary to review the accu10 racy of the determinations upon which the 

11 order was based in accordance with a pro12 tocol approved by the Secretary. 

13 ‘‘(iii) ANNUAL SUBMISSION.—The re14 sults of such postmarket surveillance and 

15 studies described in clause (ii) shall be 

16 submitted annually. 

17 ‘‘(3) BASIS.—The determinations under para18 graphs (1) and (2) shall be based on— 

19 ‘‘(A) the scientific evidence submitted by 

20 the applicant; and 

21 ‘‘(B) scientific evidence and other informa22 tion that is made available to the Secretary. 

23 ‘‘(4) BENEFIT TO HEALTH OF INDIVIDUALS

24 AND OF POPULATION AS A WHOLE.—In making the 
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1 determinations under paragraphs (1) and (2), the 

2 Secretary shall take into account— 

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

4 of the tobacco product that is the subject of the 

5 application; 

6 ‘‘(B) the increased or decreased likelihood 

7 that existing users of tobacco products who 

8 would otherwise stop using such products will 

9 switch to the tobacco product that is the subject 

10 of the application; 

11 ‘‘(C) the increased or decreased likelihood 

12 that persons who do not use tobacco products 

13 will start using the tobacco product that is the 

14 subject of the application; 

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

16 from the use of the tobacco product that is the 

17 subject of the application as compared to the 

18 use of products for smoking cessation approved 

19 under chapter V to treat nicotine dependence; 

20 and 

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

22 submitted by interested persons. 

23 ‘‘(h) ADDITIONAL CONDITIONS FOR MARKETING.— 

24 ‘‘(1) MODIFIED RISK PRODUCTS.—The Sec25 retary shall require for the marketing of a product 
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1 under this section that any advertising or labeling 

2 concerning modified risk products enable the public 

3 to comprehend the information concerning modified 

4 risk and to understand the relative significance of 

5 such information in the context of total health and 

6 in relation to all of the diseases and health-related 

7 conditions associated with the use of tobacco prod8 ucts. 

9 ‘‘(2) COMPARATIVE CLAIMS.— 

10 ‘‘(A) IN GENERAL.—The Secretary may re11 quire for the marketing of a product under this 

12 subsection that a claim comparing a tobacco 

13 product to 1 or more other commercially mar14 keted tobacco products shall compare the to15 bacco product to a commercially marketed to16 bacco product that is representative of that type 

17 of tobacco product on the market (for example 

18 the average value of the top 3 brands of an es19 tablished regular tobacco product). 

20 ‘‘(B) QUANTITATIVE COMPARISONS.—The 

21 Secretary may also require, for purposes of sub22 paragraph (A), that the percent (or fraction) of 

23 change and identity of the reference tobacco 

24 product and a quantitative comparison of the 

25 amount of the substance claimed to be reduced 
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1 shall be stated in immediate proximity to the 

2 most prominent claim. 

3 ‘‘(3) LABEL DISCLOSURE.— 

4 ‘‘(A) IN GENERAL.—The Secretary may re5 quire the disclosure on the label of other sub6 stances in the tobacco product, or substances 

7 that may be produced by the consumption of 

8 that tobacco product, that may affect a disease 

9 or health-related condition or may increase the 

10 risk of other diseases or health-related condi11 tions associated with the use of tobacco prod12 ucts. 

13 ‘‘(B) CONDITIONS OF USE.—If the condi14 tions of use of the tobacco product may affect 

15 the risk of the product to human health, the 

16 Secretary may require the labeling of conditions 

17 of use. 

18 ‘‘(4) TIME.—An order issued under subsection 

19 (g)(1) shall be effective for a specified period of 

20 time. 

21 ‘‘(5) ADVERTISING.—The Secretary may re22 quire, with respect to a product for which an appli23 cant obtained an order under subsection (g)(1), that 

24 the product comply with requirements relating to ad25 vertising and promotion of the tobacco product. 
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1 ‘‘(i) POSTMARKET SURVEILLANCE AND STUDIES.— 

2 ‘‘(1) IN GENERAL.—The Secretary shall re3 quire, with respect to a product for which an appli4 cant obtained an order under subsection (g)(1), that 

5 the applicant conduct postmarket surveillance and 

6 studies for such a tobacco product to determine the 

7 impact of the order issuance on consumer percep8 tion, behavior, and health, to enable the Secretary to 

9 review the accuracy of the determinations upon 

10 which the order was based, and to provide informa11 tion that the Secretary determines is otherwise nec12 essary regarding the use or health risks involving 

13 the tobacco product. The results of postmarket sur14 veillance and studies shall be submitted to the Sec15 retary on an annual basis. 

16 ‘‘(2) SURVEILLANCE PROTOCOL.—Each appli17 cant required to conduct a surveillance of a tobacco 

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

19 after receiving notice that the applicant is required 

20 to conduct such surveillance, submit, for the ap21 proval of the Secretary, a protocol for the required 

22 surveillance. The Secretary, within 60 days of the 

23 receipt of such protocol, shall determine if the prin24 cipal investigator proposed to be used in the surveil25 lance has sufficient qualifications and experience to 
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1 conduct such surveillance and if such protocol will 

2 result in collection of the data or other information 

3 designated by the Secretary as necessary to protect 

4 the public health. 

5 ‘‘(j) WITHDRAWAL OF AUTHORIZATION.—The Sec6 retary, after an opportunity for an informal hearing, shall 

7 withdraw an order under subsection (g) if the Secretary 

8 determines that— 

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

10 can no longer make the demonstrations required 

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

12 make the determinations required under subsection 

13 (g); 

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

15 information or included any untrue statement of ma16 terial fact; 

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

18 the product reduces risk or exposure is no longer 

19 valid, including if— 

20 ‘‘(A) a tobacco product standard is estab21 lished pursuant to section 907; 

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

23 risks presented by other commercially marketed 

24 tobacco products that were compared to the 

25 product that is the subject of the application; or 
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1 ‘‘(C) any postmarket surveillance or stud2 ies reveal that the order is no longer consistent 

3 with the protection of the public health; 

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

5 the postmarket surveillance and studies required 

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

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

8 imposed under subsection (h). 

9 ‘‘(k) CHAPTER IV OR V.—A product for which the 

10 Secretary has issued an order pursuant to subsection (g) 

11 shall not be subject to chapter IV or V. 

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

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

14 years after the date of enactment of the Family 

15 Smoking Prevention and Tobacco Control Act, the 

16 Secretary shall issue regulations or guidance (or any 

17 combination thereof) on the scientific evidence re18 quired for assessment and ongoing review of modi19 fied risk tobacco products. Such regulations or guid20 ance shall— 

21 ‘‘(A) to the extent that adequate scientific 

22 evidence exists, establish minimum standards 

23 for scientific studies needed prior to issuing an 

24 order under subsection (g) to show that a sub25 stantial reduction in morbidity or mortality 
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1 among individual tobacco users occurs for prod2 ucts described in subsection (g)(1) or is reason3 ably likely for products described in subsection 

4 (g)(2); 

5 ‘‘(B) include validated biomarkers, inter6 mediate clinical endpoints, and other feasible 

7 outcome measures, as appropriate; 

8 ‘‘(C) establish minimum standards for 

9 postmarket studies, that shall include regular 

10 and long-term assessments of health outcomes 

11 and mortality, intermediate clinical endpoints, 

12 consumer perception of harm reduction, and the 

13 impact on quitting behavior and new use of to14 bacco products, as appropriate; 

15 ‘‘(D) establish minimum standards for re16 quired postmarket surveillance, including ongo17 ing assessments of consumer perception; 

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

19 studies and surveillance be made available to 

20 the Secretary prior to the decision on renewal 

21 of a modified risk tobacco product; and 

22 ‘‘(F) establish a reasonable timetable for 

23 the Secretary to review an application under 

24 this section. 
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1 ‘‘(2) CONSULTATION.—The regulations or guid2 ance issued under paragraph (1) shall be developed 

3 in consultation with the Institute of Medicine, and 

4 with the input of other appropriate scientific and 

5 medical experts, on the design and conduct of such 

6 studies and surveillance. 

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

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

9 basis as new scientific information becomes avail10 able. 

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

12 than 2 years after the date of enactment of the 

13 Family Smoking Prevention and Tobacco Control 

14 Act, the Secretary shall issue a regulation or guid15 ance that permits the filing of a single application 

16 for any tobacco product that is a new tobacco prod17 uct under section 910 and which the applicant seeks 

18 to commercially market under this section. 

19 ‘‘(m) DISTRIBUTORS.—Except as provided in this 

20 section, no distributor may take any action, after the date 

21 of enactment of the Family Smoking Prevention and To22 bacco Control Act, with respect to a tobacco product that 

23 would reasonably be expected to result in consumers be24 lieving that the tobacco product or its smoke may present 

25 a lower risk of disease or is less harmful than one or more 
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1 commercially marketed tobacco products, or presents a re2 duced exposure to, or does not contain or is free of, a sub3 stance or substances. 

4 ‘‘SEC. 912. JUDICIAL REVIEW. 

5 ‘‘(a) RIGHT TO REVIEW.— 

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

7 after— 

8 ‘‘(A) the promulgation of a regulation 

9 under section 907 establishing, amending, or 

10 revoking a tobacco product standard; or 

11 ‘‘(B) a denial of an application under sec12 tion 910(c), 

13 any person adversely affected by such regulation or 

14 denial may file a petition for judicial review of such 

15 regulation or denial with the United States Court of 

16 Appeals for the District of Columbia or for the cir17 cuit in which such person resides or has their prin18 cipal place of business. 

19 ‘‘(2) REQUIREMENTS.— 

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

21 petition filed under paragraph (1) shall be 

22 transmitted by the clerk of the court involved to 

23 the Secretary. 

24 ‘‘(B) RECORD OF PROCEEDINGS.—On re25 ceipt of a petition under subparagraph (A), the 
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1 Secretary shall file in the court in which such 

2 petition was filed— 

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

4 which the regulation or order was based; 

5 and 

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

7 the issuance of such a regulation or order. 

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

9 section, the term ‘record’ means— 

10 ‘‘(i) all notices and other matter pub11 lished in the Federal Register with respect 

12 to the regulation or order reviewed; 

13 ‘‘(ii) all information submitted to the 

14 Secretary with respect to such regulation 

15 or order; 

16 ‘‘(iii) proceedings of any panel or ad17 visory committee with respect to such reg18 ulation or order; 

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

20 such regulation or order; and 

21 ‘‘(v) any other information identified 

22 by the Secretary, in the administrative pro23 ceeding held with respect to such regula24 tion or order, as being relevant to such 

25 regulation or order. 
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1 ‘‘(b) STANDARD OF REVIEW.—Upon the filing of the 

2 petition under subsection (a) for judicial review of a regu3 lation or order, the court shall have jurisdiction to review 

4 the regulation or order in accordance with chapter 7 of 

5 title 5, United States Code, and to grant appropriate re6 lief, including interim relief, as provided for in such chap7 ter. A regulation or denial described in subsection (a) shall 

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

9 5, United States Code. 

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

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

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

13 Supreme Court of the United States upon certiorari or 

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

15 United States Code. 

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

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

18 any other remedies provided by law. 

19 ‘‘(e) REGULATIONS AND ORDERS MUST RECITE

20 BASIS IN RECORD.—To facilitate judicial review, a regula21 tion or order issued under section 906, 907, 908, 909, 

22 910, or 916 shall contain a statement of the reasons for 

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

24 the proceedings held in connection with its issuance. 
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1 ‘‘SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS. 

2 ‘‘The Secretary shall issue regulations to require that 

3 retail establishments for which the predominant business 

4 is the sale of tobacco products comply with any advertising 

5 restrictions applicable to retail establishments accessible 

6 to individuals under the age of 18. 

7 ‘‘SEC. 914. JURISDICTION OF AND COORDINATION WITH 

8 THE FEDERAL TRADE COMMISSION. 

9 ‘‘(a) JURISDICTION.— 

10 ‘‘(1) IN GENERAL.—Except where expressly 

11 provided in this chapter, nothing in this chapter 

12 shall be construed as limiting or diminishing the au13 thority of the Federal Trade Commission to enforce 

14 the laws under its jurisdiction with respect to the 

15 advertising, sale, or distribution of tobacco products. 

16 ‘‘(2) ENFORCEMENT.—Any advertising that vio17 lates this chapter or a provision of the regulations 

18 referred to in section 102 of the Family Smoking 

19 Prevention and Tobacco Control Act, is an unfair or 

20 deceptive act or practice under section 5(a) of the 

21 Federal Trade Commission Act and shall be consid22 ered a violation of a rule promulgated under section 

23 18 of that Act. 

24 ‘‘(b) COORDINATION.—With respect to the require25 ments of section 4 of the Federal Cigarette Labeling and 
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1 Advertising Act and section 3 of the Comprehensive 

2 Smokeless Tobacco Health Education Act of 1986— 

3 ‘‘(1) the Chairman of the Federal Trade Com4 mission shall coordinate with the Secretary con5 cerning the enforcement of such Act as such enforce6 ment relates to unfair or deceptive acts or practices 

7 in the advertising of cigarettes or smokeless tobacco; 

8 and 

9 ‘‘(2) the Secretary shall consult with the Chair10 man of such Commission in revising the label state11 ments and requirements under such sections. 

12 ‘‘SEC. 915. REGULATION REQUIREMENT. 

13 ‘‘(a) TESTING, REPORTING, AND DISCLOSURE.—Not 

14 later than 36 months after the date of enactment of the 

15 Family Smoking Prevention and Tobacco Control Act, the 

16 Secretary shall promulgate regulations under this Act that 

17 meet the requirements of subsection (b). 

18 ‘‘(b) CONTENTS OF RULES.—The regulations pro19 mulgated under subsection (a)— 

20 ‘‘(1) shall require testing and reporting of to21 bacco product constituents, ingredients, and addi22 tives, including smoke constituents, by brand and 

23 subbrand that the Secretary determines should be 

24 tested to protect the public health, provided that, for 

25 purposes of the testing requirements of this para-
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1 graph, tobacco products manufactured and sold by a 

2 single tobacco product manufacturer that are iden3 tical in all respects except the labels, packaging de4 sign, logo, trade dress, trademark, brand name, or 

5 any combination thereof, shall be considered as a 

6 single brand; and 

7 ‘‘(2) may require that tobacco product manu8 facturers, packagers, or importers make disclosures 

9 relating to the results of the testing of tar and nico10 tine through labels or advertising or other appro11 priate means, and make disclosures regarding the 

12 results of the testing of other constituents, including 

13 smoke constituents, ingredients, or additives, that 

14 the Secretary determines should be disclosed to the 

15 public to protect the public health and will not mis16 lead consumers about the risk of tobacco-related dis17 ease. 

18 ‘‘(c) AUTHORITY.—The Secretary shall have the au19 thority under this chapter to conduct or to require the 

20 testing, reporting, or disclosure of tobacco product con21 stituents, including smoke constituents. 

22 ‘‘(d) SMALL TOBACCO PRODUCT MANUFACTUR23 ERS.— 

24 ‘‘(1) FIRST COMPLIANCE DATE.—The initial 

25 regulations promulgated under subsection (a) shall 
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1 not impose requirements on small tobacco product 

2 manufacturers before the later of— 

3 ‘‘(A) the end of the 2-year period following 

4 the final promulgation of such regulations; and 

5 ‘‘(B) the initial date set by the Secretary 

6 for compliance with such regulations by manu7 facturers that are not small tobacco product 

8 manufacturers. 

9 ‘‘(2) TESTING AND REPORTING INITIAL COM10 PLIANCE PERIOD.— 

11 ‘‘(A) 4-YEAR PERIOD.—The initial regula12 tions promulgated under subsection (a) shall 

13 give each small tobacco product manufacturer a 

14 4-year period over which to conduct testing and 

15 reporting for all of its tobacco products. Subject 

16 to paragraph (1), the end of the first year of 

17 such 4-year period shall coincide with the initial 

18 date of compliance under this section set by the 

19 Secretary with respect to manufacturers that 

20 are not small tobacco product manufacturers or 

21 the end of the 2-year period following the final 

22 promulgation of such regulations, as described 

23 in paragraph (1)(A). A small tobacco product 

24 manufacturer shall be required— 
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1 ‘‘(i) to conduct such testing and re2 porting for 25 percent of its tobacco prod3 ucts during each year of such 4-year pe4 riod; and 

5 ‘‘(ii) to conduct such testing and re6 porting for its largest-selling tobacco prod7 ucts (as determined by the Secretary) be8 fore its other tobacco products, or in such 

9 other order of priority as determined by 

10 the Secretary. 

11 ‘‘(B) CASE-BY-CASE DELAY.—Notwith12 standing subparagraph (A), the Secretary may, 

13 on a case-by-case basis, delay the date by which 

14 an individual small tobacco product manufac15 turer must conduct testing and reporting for its 

16 tobacco products under this section based upon 

17 a showing of undue hardship to such manufac18 turer. Notwithstanding the preceding sentence, 

19 the Secretary shall not extend the deadline for 

20 a small tobacco product manufacturer to con21 duct testing and reporting for all of its tobacco 

22 products beyond a total of 5 years after the ini23 tial date of compliance under this section set by 

24 the Secretary with respect to manufacturers 
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1 that are not small tobacco product manufactur2 ers. 

3 ‘‘(3) SUBSEQUENT AND ADDITIONAL TESTING

4 AND REPORTING.—The regulations promulgated 

5 under subsection (a) shall provide that, with respect 

6 to any subsequent or additional testing and report7 ing of tobacco products required under this section, 

8 such testing and reporting by a small tobacco prod9 uct manufacturer shall be conducted in accordance 

10 with the timeframes described in paragraph (2)(A), 

11 except that, in the case of a new product, or if there 

12 has been a modification described in section 

13 910(a)(1)(B) of any product of a small tobacco 

14 product manufacturer since the last testing and re15 porting required under this section, the Secretary 

16 shall require that any subsequent or additional test17 ing and reporting be conducted in accordance with 

18 the same timeframe applicable to manufacturers 

19 that are not small tobacco product manufacturers. 

20 ‘‘(4) JOINT LABORATORY TESTING SERVICES.— 

21 The Secretary shall allow any 2 or more small to22 bacco product manufacturers to join together to pur23 chase laboratory testing services required by this 

24 section on a group basis in order to ensure that such 
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1 manufacturers receive access to, and fair pricing of, 

2 such testing services. 

3 ‘‘(e) EXTENSIONS FOR LIMITED LABORATORY CA4 PACITY.— 

5 ‘‘(1) IN GENERAL.—The regulations promul6 gated under subsection (a) shall provide that a small 

7 tobacco product manufacturer shall not be consid8 ered to be in violation of this section before the 

9 deadline applicable under paragraphs (3) and (4), 

10 if— 

11 ‘‘(A) the tobacco products of such manu12 facturer are in compliance with all other re13 quirements of this chapter; and 

14 ‘‘(B) the conditions described in paragraph 

15 (2) are met. 

16 ‘‘(2) CONDITIONS.—Notwithstanding the re17 quirements of this section, the Secretary may delay 

18 the date by which a small tobacco product manufac19 turer must be in compliance with the testing and re20 porting required by this section until such time as 

21 the testing is reported if, not later than 90 days be22 fore the deadline for reporting in accordance with 

23 this section, a small tobacco product manufacturer 

24 provides evidence to the Secretary demonstrating 

25 that— 
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1 ‘‘(A) the manufacturer has submitted the 

2 required products for testing to a laboratory 

3 and has done so sufficiently in advance of the 

4 deadline to create a reasonable expectation of 

5 completion by the deadline; 

6 ‘‘(B) the products currently are awaiting 

7 testing by the laboratory; and 

8 ‘‘(C) neither that laboratory nor any other 

9 laboratory is able to complete testing by the 

10 deadline at customary, nonexpedited testing 

11 fees. 

12 ‘‘(3) EXTENSION.—The Secretary, taking into 

13 account the laboratory testing capacity that is avail14 able to tobacco product manufacturers, shall review 

15 and verify the evidence submitted by a small tobacco 

16 product manufacturer in accordance with paragraph 

17 (2). If the Secretary finds that the conditions de18 scribed in such paragraph are met, the Secretary 

19 shall notify the small tobacco product manufacturer 

20 that the manufacturer shall not be considered to be 

21 in violation of the testing and reporting require22 ments of this section until the testing is reported or 

23 until 1 year after the reporting deadline has passed, 

24 whichever occurs sooner. If, however, the Secretary 

25 has not made a finding before the reporting dead-
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1 line, the manufacturer shall not be considered to be 

2 in violation of such requirements until the Secretary 

3 finds that the conditions described in paragraph (2) 

4 have not been met, or until 1 year after the report5 ing deadline, whichever occurs sooner. 

6 ‘‘(4) ADDITIONAL EXTENSION.—In addition to 

7 the time that may be provided under paragraph (3), 

8 the Secretary may provide further extensions of 

9 time, in increments of no more than 1 year, for re10 quired testing and reporting to occur if the Sec11 retary determines, based on evidence properly and 

12 timely submitted by a small tobacco product manu13 facturer in accordance with paragraph (2), that a 

14 lack of available laboratory capacity prevents the 

15 manufacturer from completing the required testing 

16 during the period described in paragraph (3). 

17 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in sub18 section (d) or (e) shall be construed to authorize the exten19 sion of any deadline, or to otherwise affect any timeframe, 

20 under any provision of this Act or the Family Smoking 

21 Prevention and Tobacco Control Act other than this sec22 tion. 

23 ‘‘SEC. 916. 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 

25 requirement which is different from, or in addi-
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1 tion to, any requirement under the provisions of 

2 this chapter relating to tobacco product stand3 ards, premarket review, 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. 917. TOBACCO PRODUCTS SCIENTIFIC ADVISORY 

2 COMMITTEE. 

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

4 after the date of enactment of the Family Smoking Pre5 vention and Tobacco Control Act, the Secretary shall es6 tablish a 12-member advisory committee, to be known as 

7 the Tobacco Products Scientific Advisory Committee (in 

8 this 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 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 of the tobacco manufac8 turing industry; 

9 ‘‘(v) 1 individual as a representative 

10 of the interests of the small business to11 bacco manufacturing industry, which posi12 tion may be filled on a rotating, sequential 

13 basis by representatives of different small 

14 business tobacco manufacturers based on 

15 areas of expertise relevant to the topics 

16 being considered by the Advisory Com17 mittee; and 

18 ‘‘(vi) 1 individual as a representative 

19 of the interests of the tobacco growers. 

20 ‘‘(B) NONVOTING MEMBERS.—The mem21 bers of the committee appointed under clauses 

22 (iv), (v), and (vi) of subparagraph (A) shall 

23 serve as consultants to those described in 

24 clauses (i) through (iii) of subparagraph (A) 

25 and shall be nonvoting representatives. 
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1 ‘‘(C) CONFLICTS OF INTEREST.—No mem2 bers of the committee, other than members ap3 pointed pursuant to clauses (iv), (v), and (vi) of 

4 subparagraph (A) shall, during the member’s 

5 tenure on the committee or for the 18-month 

6 period prior to becoming such a member, re7 ceive any salary, grants, or other payments or 

8 support from any business that manufactures, 

9 distributes, markets, or sells cigarettes or other 

10 tobacco products. 

11 ‘‘(2) LIMITATION.—The Secretary may not ap12 point to the Advisory Committee any individual who 

13 is in the regular full-time employ of the Food and 

14 Drug Administration or any agency responsible for 

15 the enforcement of this Act. The Secretary may ap16 point Federal officials as ex officio members. 

17 ‘‘(3) CHAIRPERSON.—The Secretary shall des18 ignate 1 of the members appointed under clauses (i), 

19 (ii), and (iii) of paragraph (1)(A) to serve as chair20 person. 

21 ‘‘(c) DUTIES.—The Tobacco Products Scientific Ad22 visory Committee shall provide advice, information, and 

23 recommendations to the Secretary— 

24 ‘‘(1) as provided in this chapter; 
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1 ‘‘(2) on the effects of the alteration of the nico2 tine yields from tobacco products; 

3 ‘‘(3) on whether there is a threshold level below 

4 which nicotine yields do not produce dependence on 

5 the tobacco product involved; and 

6 ‘‘(4) on its review of other safety, dependence, 

7 or health issues relating to tobacco products as re8 quested by the Secretary. 

9 ‘‘(d) COMPENSATION; SUPPORT; FACA.— 

10 ‘‘(1) COMPENSATION AND TRAVEL.—Members 

11 of the Advisory Committee who are not officers or 

12 employees of the United States, while attending con13 ferences or meetings of the committee or otherwise 

14 engaged in its business, shall be entitled to receive 

15 compensation at rates to be fixed by the Secretary, 

16 which may not exceed the daily equivalent of the 

17 rate in effect under the Senior Executive Schedule 

18 under section 5382 of title 5, United States Code, 

19 for each day (including travel time) they are so en20 gaged; and while so serving away from their homes 

21 or regular places of business each member may be 

22 allowed travel expenses, including per diem in lieu of 

23 subsistence, as authorized by section 5703 of title 5, 

24 United States Code, for persons in the Government 

25 service employed intermittently. 
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1 ‘‘(2) ADMINISTRATIVE SUPPORT.—The Sec2 retary shall furnish the Advisory Committee clerical 

3 and other assistance. 

4 ‘‘(3) NONAPPLICATION OF FACA.—Section 14 of 

5 the Federal Advisory Committee Act does not apply 

6 to the Advisory Committee. 

7 ‘‘(e) PROCEEDINGS OF ADVISORY PANELS AND COM8 MITTEES.—The Advisory Committee shall make and 

9 maintain a transcript of any proceeding of the panel or 

10 committee. Each such panel and committee shall delete 

11 from any transcript made under this subsection informa12 tion which is exempt from disclosure under section 552(b) 

13 of title 5, United States Code. 

14 ‘‘SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DE15 PENDENCE. 

16 ‘‘(a) IN GENERAL.—The Secretary shall— 

17 ‘‘(1) at the request of the applicant, consider 

18 designating products for smoking cessation, includ19 ing nicotine replacement products as fast track re20 search and approval products within the meaning of 

21 section 506; 

22 ‘‘(2) consider approving the extended use of nic23 otine replacement products (such as nicotine patch24 es, nicotine gum, and nicotine lozenges) for the 

25 treatment of tobacco dependence; and 
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1 ‘‘(3) review and consider the evidence for addi2 tional indications for nicotine replacement products, 

3 such as for craving relief or relapse prevention. 

4 ‘‘(b) REPORT ON INNOVATIVE PRODUCTS.— 

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

6 after the date of enactment of the Family Smoking 

7 Prevention and Tobacco Control Act, the Secretary, 

8 after consultation with recognized scientific, medical, 

9 and public health experts (including both Federal 

10 agencies and nongovernmental entities, the Institute 

11 of Medicine of the National Academy of Sciences, 

12 and the Society for Research on Nicotine and To13 bacco), shall submit to the Congress a report that 

14 examines how best to regulate, promote, and encour15 age the development of innovative products and 

16 treatments (including nicotine-based and non-nico17 tine-based products and treatments) to better 

18 achieve, in a manner that best protects and pro19 motes the public health— 

20 ‘‘(A) total abstinence from tobacco use; 

21 ‘‘(B) reductions in consumption of tobacco; 

22 and 

23 ‘‘(C) reductions in the harm associated 

24 with continued tobacco use. 
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1 ‘‘(2) RECOMMENDATIONS.—The report under 

2 paragraph (1) shall include the recommendations of 

3 the Secretary on how the Food and Drug Adminis4 tration should coordinate and facilitate the exchange 

5 of information on such innovative products and 

6 treatments among relevant offices and centers within 

7 the Administration and within the National Insti8 tutes of Health, the Centers for Disease Control and 

9 Prevention, and other relevant agencies. 

10 ‘‘SEC. 919. USER FEES. 

11 ‘‘(a) ESTABLISHMENT OF QUARTERLY FEE.—Begin12 ning on the date of the enactment of the Family Smoking 

13 Prevention and Tobacco Control Act, the Secretary shall 

14 in accordance with this section assess user fees on, and 

15 collect such fees from, each manufacturer and importer 

16 of tobacco products subject to this chapter. The fees shall 

17 be assessed and collected with respect to each quarter of 

18 each fiscal year, and the total amount assessed and col19 lected for a fiscal year shall be the amount specified in 

20 subsection (b)(1) for such year, subject to subsection (c). 

21 ‘‘(b) ASSESSMENT OF USER FEE.— 

22 ‘‘(1) AMOUNT OF ASSESSMENT.—The total 

23 amount of user fees authorized to be assessed and 

24 collected under subsection (a) for a fiscal year is the 

25 following, as applicable to the fiscal year involved: 
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1 ‘‘(A) For fiscal year 2009, $85,000,000 

2 (subject to subsection (e)). 

3 ‘‘(B) For fiscal year 2010, $235,000,000. 

4 ‘‘(C) For fiscal year 2011, $450,000,000. 

5 ‘‘(D) For fiscal year 2012, $477,000,000. 

6 ‘‘(E) For fiscal year 2013, $505,000,000. 

7 ‘‘(F) For fiscal year 2014, $534,000,000. 

8 ‘‘(G) For fiscal year 2015, $566,000,000. 

9 ‘‘(H) For fiscal year 2016, $599,000,000. 

10 ‘‘(I) For fiscal year 2017, $635,000,000. 

11 ‘‘(J) For fiscal year 2018, $672,000,000. 

12 ‘‘(K) For fiscal year 2019 and each subse13 quent fiscal year, $712,000,000. 

14 ‘‘(2) ALLOCATIONS OF ASSESSMENT BY CLASS

15 OF TOBACCO PRODUCTS.— 

16 ‘‘(A) IN GENERAL.—The total user fees as17 sessed and collected under subsection (a) each 

18 fiscal year with respect to each class of tobacco 

19 products shall be an amount that is equal to 

20 the applicable percentage of each class for the 

21 fiscal year multiplied by the amount specified in 

22 paragraph (1) for the fiscal year. 

23 ‘‘(B) APPLICABLE PERCENTAGE.— 

24 ‘‘(i) IN GENERAL.—For purposes of 

25 subparagraph (A), the applicable percent-
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1 age for a fiscal year for each of the fol2 lowing classes of tobacco products shall be 

3 determined in accordance with clause (ii): 

4 ‘‘(I) Cigarettes. 

5 ‘‘(II) Cigars, including small ci6 gars and cigars other than small ci7 gars. 

8 ‘‘(III) Snuff. 

9 ‘‘(IV) Chewing tobacco. 

10 ‘‘(V) Pipe tobacco. 

11 ‘‘(VI) Roll-your-own tobacco. 

12 ‘‘(ii) ALLOCATIONS.—The applicable 

13 percentage of each class of tobacco product 

14 described in clause (i) for a fiscal year 

15 shall be the percentage determined under 

16 section 625(c) of Public Law 108-357 for 

17 each such class of product for such fiscal 

18 year. 

19 ‘‘(iii) REQUIREMENT OF REGULA20 TIONS.—Notwithstanding clause (ii), no 

21 user fees shall be assessed on a class of to22 bacco products unless such class of tobacco 

23 products is listed in section 901(b) or is 

24 deemed by the Secretary in a regulation 
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1 under section 901(b) to be subject to this 

2 chapter. 

3 ‘‘(iv) REALLOCATIONS.—In the case 

4 of a class of tobacco products that is not 

5 listed in section 901(b) or deemed by the 

6 Secretary in a regulation under section 

7 901(b) to be subject to this chapter, the 

8 amount of user fees that would otherwise 

9 be assessed to such class of tobacco prod10 ucts shall be reallocated to the classes of 

11 tobacco products that are subject to this 

12 chapter in the same manner and based on 

13 the same relative percentages otherwise de14 termined under clause (ii). 

15 ‘‘(3) DETERMINATION OF USER FEE BY COM16 PANY.— 

17 ‘‘(A) IN GENERAL.—The total user fee to 

18 be paid by each manufacturer or importer of a 

19 particular class of tobacco products shall be de20 termined for each quarter by multiplying— 

21 ‘‘(i) such manufacturer’s or importer’s 

22 percentage share as determined under 

23 paragraph (4); by 

24 ‘‘(ii) the portion of the user fee 

25 amount for the current quarter to be as-
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1 sessed on all manufacturers and importers 

2 of such class of tobacco products as deter3 mined under paragraph (2). 

4 ‘‘(B) NO FEE IN EXCESS OF PERCENTAGE

5 SHARE.—No manufacturer or importer of to6 bacco products shall be required to pay a user 

7 fee in excess of the percentage share of such 

8 manufacturer or importer. 

9 ‘‘(4) ALLOCATION OF ASSESSMENT WITHIN

10 EACH CLASS OF TOBACCO PRODUCT.—The percent11 age share of each manufacturer or importer of a 

12 particular class of tobacco products of the total user 

13 fee to be paid by all manufacturers or importers of 

14 that class of tobacco products shall be the percent15 age determined for purposes of allocations under 

16 subsections (e) through (h) of section 625 of Public 

17 Law 108–357. 

18 ‘‘(5) ALLOCATION FOR CIGARS.—Notwith19 standing paragraph (4), if a user fee assessment is 

20 imposed on cigars, the percentage share of each 

21 manufacturer or importer of cigars shall be based on 

22 the excise taxes paid by such manufacturer or im23 porter during the prior fiscal year. 

24 ‘‘(6) TIMING OF ASSESSMENT.—The Secretary 

25 shall notify each manufacturer and importer of to-
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1 bacco products subject to this section of the amount 

2 of the quarterly assessment imposed on such manu3 facturer or importer under this subsection for each 

4 quarter of each fiscal year. Such notifications shall 

5 occur not later than 30 days prior to the end of the 

6 quarter for which such assessment is made, and pay7 ments of all assessments shall be made by the last 

8 day of the quarter involved. 

9 ‘‘(7) MEMORANDUM OF UNDERSTANDING.— 

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

11 request the appropriate Federal agency to enter 

12 into a memorandum of understanding that pro13 vides for the regular and timely transfer from 

14 the head of such agency to the Secretary of the 

15 information described in paragraphs (2)(B)(ii) 

16 and (4) and all necessary information regarding 

17 all tobacco product manufacturers and import18 ers required to pay user fees. The Secretary 

19 shall maintain all disclosure restrictions estab20 lished by the head of such agency regarding the 

21 information provided under the memorandum of 

22 understanding. 

23 ‘‘(B) ASSURANCES.—Beginning not later 

24 than fiscal year 2015, and for each subsequent 

25 fiscal year, the Secretary shall ensure that the 
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1 Food and Drug Administration is able to deter2 mine the applicable percentages described in 

3 paragraph (2) and the percentage shares de4 scribed in paragraph (4). The Secretary may 

5 carry out this subparagraph by entering into a 

6 contract with the head of the Federal agency 

7 referred to in subparagraph (A) to continue to 

8 provide the necessary information. 

9 ‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 

10 ‘‘(1) IN GENERAL.—Fees authorized under sub11 section (a) shall be collected and available for obliga12 tion only to the extent and in the amount provided 

13 in advance in appropriations Acts. Such fees are au14 thorized to remain available until expended. Such 

15 sums as may be necessary may be transferred from 

16 the Food and Drug Administration salaries and ex17 penses appropriation account without fiscal year lim18 itation to such appropriation account for salaries 

19 and expenses with such fiscal year limitation. 

20 ‘‘(2) AVAILABILITY.— 

21 ‘‘(A) IN GENERAL.—Fees appropriated 

22 under paragraph (3) are available only for the 

23 purpose of paying the costs of the activities of 

24 the Food and Drug Administration related to 

25 the regulation of tobacco products under this 
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1 chapter and the Family Smoking Prevention 

2 and Tobacco Control Act. No fees collected 

3 under subsection (a) may be used for any other 

4 costs. 

5 ‘‘(B) PROHIBITION AGAINST USE OF

6 OTHER FUNDS.— 

7 ‘‘(i) IN GENERAL.—Except as pro8 vided in clause (ii), fees collected under 

9 subsection (a) are the only funds author10 ized to be made available for the purpose 

11 described in subparagraph (A). 

12 ‘‘(ii) STARTUP COSTS.—Clause (i) 

13 does not apply until the date on which the 

14 Secretary has collected fees under sub15 section (a) for 2 fiscal year quarters. Until 

16 such date, other amounts available to the 

17 Food and Drug Administration (excluding 

18 fees collected under subsection (a)) are au19 thorized to be made available to pay the 

20 costs described in subparagraph (A), pro21 vided that such amounts are reimbursed 

22 through fees collected under subsection (a). 

23 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

24 For fiscal year 2009 and each subsequent fiscal 

25 year, there is authorized to be appropriated for fees 
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1 under this section an amount equal to the amount 

2 specified in subsection (b)(1) for the fiscal year. 

3 ‘‘(d) COLLECTION OF UNPAID FEES.—In any case 

4 where the Secretary does not receive payment of a fee as5 sessed under subsection (a) within 30 days after it is due, 

6 such fee shall be treated as a claim of the United States 

7 Government subject to subchapter II of chapter 37 of title 

8 31, United States Code. 

9 ‘‘(e) APPLICABILITY TO FISCAL YEAR 2009.—If the 

10 date of the enactment of the Family Smoking Prevention 

11 and Tobacco Control Act occurs during fiscal year 2009, 

12 the following applies, subject to subsection (c): 

13 ‘‘(1) The Secretary shall determine the fees 

14 that would apply for a single quarter of such fiscal 

15 year according to the application of subsection (b) to 

16 the amount specified in paragraph (1)(A) of such 

17 subsection (referred to in this subsection as the 

18 ‘quarterly fee amounts’). 

19 ‘‘(2) For the quarter in which such date of en20 actment occurs, the amount of fees assessed shall be 

21 a pro rata amount, determined according to the 

22 number of days remaining in the quarter (including 

23 such date of enactment) and according to the daily 

24 equivalent of the quarterly fee amounts. Fees as-
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1 sessed under the preceding sentence shall not be col2 lected until the next quarter. 

3 ‘‘(3) For the quarter following the quarter to 

4 which paragraph (2) applies, the full quarterly fee 

5 amounts shall be assessed and collected, in addition 

6 to collection of the pro rata fees assessed under 

7 paragraph (2). 

8 ‘‘(f) STUDY BY GAO.— 

9 ‘‘(1) IN GENERAL.—The Comptroller General of 

10 the United States shall conduct a study on— 

11 ‘‘(A) the prevalence of youth tobacco use 

12 and the brands and subbrands that individuals 

13 under the age of 18 consume; 

14 ‘‘(B) the feasibility of structuring the user 

15 fees or a portion of the user fees collected under 

16 this section on the youth market share of a 

17 manufacturer or year to year changes in a man18 ufacturer’s share of youth market; and 

19 ‘‘(C) the potential effects of tobacco mar20 keting to youth audiences if user fees were cal21 culated in whole or in part on youth market 

22 share. 

23 ‘‘(2) REPORT.—The Comptroller General shall 

24 submit to the Committee on Energy and Commerce 

25 of the House of Representatives and the Committee 
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1 on Health, Education, Labor, and Pensions of the 

2 Senate a report on the study conducted under para3 graph (1) by not later than 3 years after the date 

4 of enactment of the Family Smoking Prevention and 

5 Tobacco Control Act.’’. 

6 SEC. 102. FINAL RULE. 

7 (a) CIGARETTES AND SMOKELESS TOBACCO.— 

8 (1) IN GENERAL.—On the first day of publica9 tion of the Federal Register that is 180 days or 

10 more after the date of enactment of this Act, the 

11 Secretary of Health and Human Services shall pub12 lish in the Federal Register a final rule regarding 

13 cigarettes and smokeless tobacco, which— 

14 (A) is deemed to be issued under chapter 

15 9 of the Federal Food, Drug, and Cosmetic 

16 Act, as added by section 101 of this Act; and 

17 (B) shall be deemed to be in compliance 

18 with all applicable provisions of chapter 5 of 

19 title 5, United States Code, and all other provi20 sions of law relating to rulemaking procedures. 

21 (2) CONTENTS OF RULE.—Except as provided 

22 in this subsection, the final rule published under 

23 paragraph (1), shall be identical in its provisions to 

24 part 897 of the regulations promulgated by the Sec25 retary of Health and Human Services in the August 
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1 28, 1996, issue of the Federal Register (61 Fed. 

2 Reg., 44615–44618). Such rule shall— 

3 (A) provide for the designation of jurisdic4 tional authority that is in accordance with this 

5 subsection in accordance with this Act and the 

6 amendments made by this Act; 

7 (B) strike Subpart C—Labels and section 

8 897.32(c); 

9 (C) strike paragraphs (a), (b), and (i) of 

10 section 897.3 and insert definitions of the terms 

11 ‘‘cigarette’’, ‘‘cigarette tobacco,’’, and ‘‘smoke12 less tobacco’’ as defined in section 900 of the 

13 Federal Food, Drug, and Cosmetic Act; 

14 (D) insert ‘‘or roll-your-own paper’’ in sec15 tion 897.34(a) after ‘‘other than cigarettes or 

16 smokeless tobacco’’; 

17 (E) become effective on the date that is 1 

18 year after the date of enactment of this Act; 

19 and 

20 (F) amend paragraph (d) of section 897.16 

21 to read as follows: 

22 ‘‘(d)(1) Except as provided in subparagraph (2), no 

23 manufacturer, distributor, or retailer may distribute or 

24 cause to be distributed any free samples of cigarettes, 

25 smokeless tobacco, or other tobacco products (as such 
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1 term is defined in section 201 of the Federal Food, Drug, 

2 and Cosmetic Act). 

3 ‘‘(2)(A) Subparagraph (1) does not prohibit a manu4 facturer, distributor, or retailer from distributing or caus5 ing to be distributed free samples of smokeless tobacco 

6 in a qualified adult-only facility. 

7 ‘‘(B) This subparagraph does not affect the authority 

8 of a State or local government to prohibit or otherwise 

9 restrict the distribution of free samples of smokeless to10 bacco. 

11 ‘‘(C) For purposes of this paragraph, the term ‘quali12 fied adult-only facility’ means a facility or restricted area 

13 that— 

14 ‘‘(i) requires each person present to provide to 

15 a law enforcement officer (whether on or off duty) 

16 or to a security guard licensed by a governmental 

17 entity government-issued identification showing a 

18 photograph and at least the minimum age estab19 lished by applicable law for the purchase of smoke20 less tobacco; 

21 ‘‘(ii) does not sell, serve, or distribute alcohol; 

22 ‘‘(iii) is not located adjacent to or immediately 

23 across from (in any direction) a space that is used 

24 primarily for youth-oriented marketing, promotional, 

25 or other activities; 
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1 ‘‘(iv) is a temporary structure constructed, des2 ignated, and operated as a distinct enclosed area for 

3 the purpose of distributing free samples of smokeless 

4 tobacco in accordance with this subparagraph; and 

5 ‘‘(v) is enclosed by a barrier that— 

6 ‘‘(I) is constructed of, or covered with, an 

7 opaque material (except for entrances and 

8 exits); 

9 ‘‘(II) extends from no more than 12 inches 

10 above the ground or floor (which area at the 

11 bottom of the barrier must be covered with ma12 terial that restricts visibility but may allow air13 flow) to at least 8 feet above the ground or 

14 floor (or to the ceiling); and 

15 ‘‘(III) prevents persons outside the quali16 fied adult-only facility from seeing into the 

17 qualified adult-only facility, unless they make 

18 unreasonable efforts to do so; and 

19 ‘‘(vi) does not display on its exterior— 

20 ‘‘(I) any tobacco product advertising; 

21 ‘‘(II) a brand name other than in conjunc22 tion with words for an area or enclosure to 

23 identify an adult-only facility; or 

24 ‘‘(III) any combination of words that 

25 would imply to a reasonable observer that the 
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1 manufacturer, distributor, or retailer has a 

2 sponsorship that would violate section 

3 897.34(c). 

4 ‘‘(D) Distribution of samples of smokeless tobacco 

5 under this subparagraph permitted to be taken out of the 

6 qualified adult-only facility shall be limited to 1 package 

7 per adult consumer containing no more than 0.53 ounces 

8 (15 grams) of smokeless tobacco. If such package of 

9 smokeless tobacco contains individual portions of smoke10 less tobacco, the individual portions of smokeless tobacco 

11 shall not exceed 8 individual portions and the collective 

12 weight of such individual portions shall not exceed 0.53 

13 ounces (15 grams). Any manufacturer, distributor, or re14 tailer who distributes or causes to be distributed free sam15 ples also shall take reasonable steps to ensure that the 

16 above amounts are limited to one such package per adult 

17 consumer per day. 

18 ‘‘(3) Notwithstanding subparagraph (2), no manufac19 turer, distributor, or retailer may distribute or cause to 

20 be distributed any free samples of smokeless tobacco— 

21 ‘‘(A) to a sports team or entertainment group; 

22 or 

23 ‘‘(B) at any football, basketball, baseball, soc24 cer, or hockey event or any other sporting or enter-
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1 tainment event determined by the Secretary to be 

2 covered by this subparagraph. 

3 ‘‘(4) The Secretary shall implement a program to en4 sure compliance with this paragraph and submit a report 

5 to the Congress on such compliance not later than 18 

6 months after the date of enactment of the Family Smok7 ing Prevention and Tobacco Control Act. 

8 ‘‘(5) Nothing in this paragraph shall be construed to 

9 authorize any person to distribute or cause to be distrib10 uted any sample of a tobacco product to any individual 

11 who has not attained the minimum age established by ap12 plicable law for the purchase of such product.’’. 

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 chapter 5 of title 5, United 

17 States Code. 

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 chapter 5 of title 5, 

22 United States Code, the regulation promulgated pur23 suant to this section, including the provisions of 

24 such regulation relating to distribution of free sam25 ples. 
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1 (5) ENFORCEMENT OF RETAIL SALE PROVI2 SIONS.—The Secretary of Health and Human Serv3 ices shall ensure that the provisions of this Act, the 

4 amendments made by this Act, and the imple5 menting regulations (including such provisions, 

6 amendments, and regulations relating to the retail 

7 sale of tobacco products) are enforced with respect 

8 to the United States and Indian tribes. 

9 (6) QUALIFIED ADULT-ONLY FACILITY.—A 

10 qualified adult-only facility (as such term is defined 

11 in section 897.16(d) of the final rule published 

12 under paragraph (1)) that is also a retailer and that 

13 commits a violation as a retailer shall not be subject 

14 to the limitations in section 103(q) and shall be sub15 ject to penalties applicable to a qualified adult-only 

16 facility. 

17 (7) CONGRESSIONAL REVIEW PROVISIONS.— 

18 Section 801 of title 5, United States Code, shall not 

19 apply to the final rule published under paragraph 

20 (1). 

21 (b) LIMITATION ON ADVISORY OPINIONS.—As of the 

22 date of enactment of this Act, the following documents 

23 issued by the Food and Drug Administration shall not 

24 constitute advisory opinions under section 10.85(d)(1) of 

25 title 21, Code of Federal Regulations, except as they apply 
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1 to tobacco products, and shall not be cited by the Sec2 retary of Health and Human Services or the Food and 

3 Drug Administration as binding precedent: 

4 (1) The preamble to the proposed rule in the 

5 document titled ‘‘Regulations Restricting the Sale 

6 and Distribution of Cigarettes and Smokeless To7 bacco Products to Protect Children and Adoles8 cents’’ (60 Fed. Reg. 41314–41372 (August 11, 

9 1995)). 

10 (2) The document titled ‘‘Nicotine in Cigarettes 

11 and Smokeless Tobacco Products is a Drug and 

12 These Products Are Nicotine Delivery Devices 

13 Under the Federal Food, Drug, and Cosmetic Act’’ 

14 (60 Fed. Reg. 41453–41787 (August 11, 1995)). 

15 (3) The preamble to the final rule in the docu16 ment titled ‘‘Regulations Restricting the Sale and 

17 Distribution of Cigarettes and Smokeless Tobacco to 

18 Protect Children and Adolescents’’ (61 Fed. Reg. 

19 44396–44615 (August 28, 1996)). 

20 (4) The document titled ‘‘Nicotine in Cigarettes 

21 and Smokeless Tobacco is a Drug and These Prod22 ucts are Nicotine Delivery Devices Under the Fed23 eral Food, Drug, and Cosmetic Act; Jurisdictional 

24 Determination’’ (61 Fed. Reg. 44619–45318 (Au25 gust 28, 1996)). 
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1 SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GEN2 ERAL PROVISIONS. 

3 (a) AMENDMENT OF FEDERAL FOOD, DRUG, AND

4 COSMETIC ACT.—Except as otherwise expressly provided, 

5 whenever in this section an amendment is expressed in 

6 terms of an amendment to, or repeal of, a section or other 

7 provision, the reference is to a section or other provision 

8 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

9 301 et seq.). 

10 (b) SECTION 301.—Section 301 (21 U.S.C. 331) is 

11 amended— 

12 (1) in subsection (a), by inserting ‘‘tobacco 

13 product,’’ after ‘‘device,’’; 

14 (2) in subsection (b), by inserting ‘‘tobacco 

15 product,’’ after ‘‘device,’’; 

16 (3) in subsection (c), by inserting ‘‘tobacco 

17 product,’’ after ‘‘device,’’; 

18 (4) in subsection (e)— 

19 (A) by striking the period after ‘‘572(i)’’; 

20 and 

21 (B) by striking ‘‘or 761 or the refusal to 

22 permit access to’’ and inserting ‘‘761, 909, or 

23 920 or the refusal to permit access to’’; 

24 (5) in subsection (g), by inserting ‘‘tobacco 

25 product,’’ after ‘‘device,’’; 
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1 (6) in subsection (h), by inserting ‘‘tobacco 

2 product,’’ after ‘‘device,’’; 

3 (7) in subsection (j)— 

4 (A) by striking the period after ‘‘573’’; and 

5 (B) by striking ‘‘708, or 721’’ and insert6 ing ‘‘708, 721, 904, 905, 906, 907, 908, 909, 

7 or 920(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)(3).’’; 

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), 907, 908, or 916; 

22 ‘‘(B) to furnish any notification or other mate23 rial or information required by or under section 519, 

24 520(g), 904, 909, or 920; 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 the following: 

9 ‘‘(oo) The sale of tobacco products in violation of a 

10 no-tobacco-sale order issued under section 303(f). 

11 ‘‘(pp) The introduction or delivery for introduction 

12 into interstate commerce of a tobacco product in violation 

13 of section 911. 

14 ‘‘(qq)(1) Forging, counterfeiting, simulating, or false15 ly representing, or without proper authority using any 

16 mark, stamp (including tax stamp), tag, label, or other 

17 identification device upon any tobacco product or con18 tainer or labeling thereof so as to render such tobacco 

19 product a counterfeit tobacco product. 

20 ‘‘(2) Making, selling, disposing of, or keeping in pos21 session, control, or custody, or concealing any punch, die, 

22 plate, stone, or other item that is designed to print, im23 print, or reproduce the trademark, trade name, or other 

24 identifying mark, imprint, or device of another or any like25 ness of any of the foregoing upon any tobacco product or 
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1 container or labeling thereof so as to render such tobacco 

2 product a counterfeit tobacco product. 

3 ‘‘(3) The doing of any act that causes a tobacco prod4 uct to be a counterfeit tobacco product, or the sale or dis5 pensing, or the holding for sale or dispensing, of a coun6 terfeit tobacco product. 

7 ‘‘(rr) The charitable distribution of tobacco products. 

8 ‘‘(ss) The failure of a manufacturer or distributor to 

9 notify the Attorney General and the Secretary of the 

10 Treasury of their knowledge of tobacco products used in 

11 illicit trade. 

12 ‘‘(tt) With respect to a tobacco product, any state13 ment directed to consumers through the media or through 

14 the label, labeling, or advertising that would reasonably 

15 be expected to result in consumers believing that the prod16 uct is regulated, inspected or approved by the Food and 

17 Drug Administration, or that the product complies with 

18 the requirements of the Food and Drug Administration, 

19 including a statement or implication in the label, labeling, 

20 or advertising of such product, and that could result in 

21 consumers believing that the product is endorsed for use 

22 by the Food and Drug Administration or in consumers 

23 being misled about the harmfulness of the product because 

24 of such regulation, inspection, or compliance.’’. 
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1 (c) SECTION 303.—Section 303(f) (21 U.S.C. 333(f)) 

2 is amended— 

3 (1) in paragraph (1)(A), by inserting ‘‘or to4 bacco products’’ after the term ‘‘devices’’ each place 

5 such term appears; 

6 (2) in paragraph (5)— 

7 (A) in subparagraph (A)— 

8 (i) by striking ‘‘assessed’’ the first 

9 time it appears and inserting ‘‘assessed, or 

10 a no-tobacco-sale order may be imposed,’’; 

11 and 

12 (ii) by striking ‘‘penalty’’ the second 

13 time it appears and inserting ‘‘penalty, or 

14 upon whom a no-tobacco-sale order is to be 

15 imposed,’’; 

16 (B) in subparagraph (B)— 

17 (i) by inserting after ‘‘penalty,’’ the 

18 following: ‘‘or the period to be covered by 

19 a no-tobacco-sale order,’’; and 

20 (ii) by adding at the end the fol21 lowing: ‘‘A no-tobacco-sale order perma22 nently prohibiting an individual retail out23 let from selling tobacco products shall in24 clude provisions that allow the outlet, after 

25 a specified period of time, to request that 
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1 the Secretary compromise, modify, or ter2 minate the order.’’; and 

3 (C) by adding at the end the following: 

4 ‘‘(D) The Secretary may compromise, modify, or ter5 minate, with or without conditions, any no-tobacco-sale 

6 order.’’; 

7 (3) in paragraph (6)— 

8 (A) by inserting ‘‘or the imposition of a 

9 no-tobacco-sale order’’ after the term ‘‘penalty’’ 

10 each place such term appears; and 

11 (B) by striking ‘‘issued.’’ and inserting 

12 ‘‘issued, or on which the no-tobacco-sale order 

13 was imposed, as the case may be.’’; and 

14 (4) by adding at the end the following: 

15 ‘‘(8) If the Secretary finds that a person has 

16 committed repeated violations of restrictions promul17 gated under section 906(d) at a particular retail out18 let then the Secretary may impose a no-tobacco-sale 

19 order on that person prohibiting the sale of tobacco 

20 products in that outlet. A no-tobacco-sale order may 

21 be imposed with a civil penalty under paragraph (1). 

22 Prior to the entry of a no-sale order under this para23 graph, a person shall be entitled to a hearing pursu24 ant to the procedures established through regula25 tions of the Food and Drug Administration for as-
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1 sessing civil money penalties, including at a retailer’s 

2 request a hearing by telephone, or at the nearest re3 gional or field office of the Food and Drug Adminis4 tration, or at a Federal, State, or county facility 

5 within 100 miles from the location of the retail out6 let, if such a facility is available.’’. 

7 (d) SECTION 304.—Section 304 (21 U.S.C. 334) is 

8 amended— 

9 (1) in subsection (a)(2)— 

10 (A) by striking ‘‘and’’ before ‘‘(D)’’; and 

11 (B) by striking ‘‘device.’’ and inserting the 

12 following: ‘‘device, and (E) Any adulterated or 

13 misbranded tobacco product.’’; 

14 (2) in subsection (d)(1), by inserting ‘‘tobacco 

15 product,’’ after ‘‘device,’’; 

16 (3) in subsection (g)(1), by inserting ‘‘or to17 bacco product’’ after the term ‘‘device’’ each place 

18 such term appears; and 

19 (4) in subsection (g)(2)(A), by inserting ‘‘or to20 bacco product’’ after ‘‘device’’. 

21 (e) SECTION 505.—Section 505(n)(2) (21 U.S.C. 

22 355(n)(2)) is amended by striking ‘‘section 904’’ and in23 serting ‘‘section 1004’’. 
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1 (f) SECTION 523.—Section 523(b)(2)(D) (21 U.S.C. 

2 360m(b)(2)(D)) is amended by striking ‘‘section 903(g)’’ 

3 and inserting ‘‘section 1003(g)’’. 

4 (g) SECTION 702.—Section 702(a)(1) (U.S.C. 

5 372(a)(1)) is amended— 

6 (1) by striking ‘‘(a)(1)’’ and inserting 

7 ‘‘(a)(1)(A)’’; and 

8 (2) by adding at the end the following: 

9 ‘‘(B)(i) For a tobacco product, to the extent feasible, 

10 the Secretary shall contract with the States in accordance 

11 with this paragraph to carry out inspections of retailers 

12 within that State in connection with the enforcement of 

13 this Act. 

14 ‘‘(ii) The Secretary shall not enter into any contract 

15 under clause (i) with the government of any of the several 

16 States to exercise enforcement authority under this Act 

17 on Indian lands without the express written consent of the 

18 Indian tribe involved.’’. 

19 (h) SECTION 703.—Section 703 (21 U.S.C. 373) is 

20 amended— 

21 (1) by inserting ‘‘tobacco product,’’ after the 

22 term ‘‘device,’’ each place such term appears; and 

23 (2) by inserting ‘‘tobacco products,’’ after the 

24 term ‘‘devices,’’ each place such term appears. 
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1 (i) SECTION 704.—Section 704 (21 U.S.C. 374) is 

2 amended— 

3 (1) in subsection (a)(1)(A), by inserting ‘‘to4 bacco products,’’ after the term ‘‘devices,’’ each 

5 place such term appears; 

6 (2) in subsection (a)(1)(B), by inserting ‘‘or to7 bacco products’’ after the term ‘‘restricted devices’’ 

8 each place such term appears; 

9 (3) in subsection (b), by inserting ‘‘tobacco 

10 product,’’ after ‘‘device,’’; and 

11 (4) in subsection (g)(13), by striking ‘‘section 

12 903(g)’’ and inserting ‘‘section 1003(g)’’. 

13 (j) SECTION 705.—Section 705(b) (21 U.S.C. 

14 375(b)) is amended by inserting ‘‘tobacco products,’’ after 

15 ‘‘devices,’’. 

16 (k) SECTION 709.—Section 709 (21 U.S.C. 379a) is 

17 amended by inserting ‘‘tobacco product,’’ after ‘‘device,’’. 

18 (l) SECTION 801.—Section 801 (21 U.S.C. 381) is 

19 amended— 

20 (1) in subsection (a)— 

21 (A) by inserting ‘‘tobacco products,’’ after 

22 the term ‘‘devices,’’ ; 

23 (B) by inserting ‘‘or section 905(h)’’ after 

24 ‘‘section 510’’; and 
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1 (C) by striking the term ‘‘drugs or de2 vices’’ each time such term appears and insert3 ing ‘‘drugs, devices, or tobacco products’’; 

4 (2) in subsection (e)(1), by inserting ‘‘tobacco 

5 product,’’ after ‘‘device,’’; and 

6 (3) by adding at the end the following: 

7 ‘‘(p)(1) Not later than 36 months after the date of 

8 enactment of the Family Smoking Prevention and To9 bacco Control Act, and annually thereafter, the Secretary 

10 shall submit to the Committee on Health, Education, 

11 Labor, and Pensions of the Senate and the Committee on 

12 Energy and Commerce of the House of Representatives, 

13 a report regarding— 

14 ‘‘(A) the nature, extent, and destination of 

15 United States tobacco product exports that do not 

16 conform to tobacco product standards established 

17 pursuant to this Act; 

18 ‘‘(B) the public health implications of such ex19 ports, including any evidence of a negative public 

20 health impact; and 

21 ‘‘(C) recommendations or assessments of policy 

22 alternatives available to Congress and the executive 

23 branch to reduce any negative public health impact 

24 caused by such exports. 
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1 ‘‘(2) The Secretary is authorized to establish appro2 priate information disclosure requirements to carry out 

3 this subsection.’’. 

4 (m) SECTION 1003.—Section 1003(d)(2)(C) (as re5 designated by section 101(b)) is amended— 

6 (1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 

7 (2) inserting ‘‘, and tobacco products’’ after 

8 ‘‘devices’’. 

9 (n) SECTION 1009.—Section 1009(b) (as redesig10 nated by section 101(b)) is amended by striking ‘‘section 

11 908’’ and inserting ‘‘section 1008’’. 

12 (o) SECTION 409 OF THE FEDERAL MEAT INSPEC13 TION ACT.—Section 409(a) of the Federal Meat Inspec14 tion Act (21 U.S.C. 679(a)) is amended by striking ‘‘sec15 tion 902(b)’’ and inserting ‘‘section 1002(b)’’. 

16 (p) RULE OF CONSTRUCTION.—Nothing in this sec17 tion is intended or shall be construed to expand, contract, 

18 or otherwise modify or amend the existing limitations on 

19 State government authority over tribal restricted fee or 

20 trust lands. 

21 (q) GUIDANCE AND EFFECTIVE DATES.— 

22 (1) IN GENERAL.—The Secretary of Health and 

23 Human Services shall issue guidance— 

24 (A) defining the term ‘‘repeated violation’’, 

25 as used in section 303(f)(8) of the Federal 
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1 Food, Drug, and Cosmetic Act (21 U.S.C. 

2 333(f)(8)) as amended by subsection (c), as in3 cluding at least 5 violations of particular re4 quirements over a 36-month period at a par5 ticular retail outlet that constitute a repeated 

6 violation and providing for civil penalties in ac7 cordance with paragraph (2); 

8 (B) providing for timely and effective no9 tice by certified or registered mail or personal 

10 delivery to the retailer of each alleged violation 

11 at a particular retail outlet prior to conducting 

12 a followup compliance check, such notice to be 

13 sent to the location specified on the retailer’s 

14 registration or to the retailer’s registered agent 

15 if the retailer has provider such agent informa16 tion to the Food and Drug Administration prior 

17 to the violation; 

18 (C) providing for a hearing pursuant to the 

19 procedures established through regulations of 

20 the Food and Drug Administration for assess21 ing civil money penalties, including at a retail22 er’s request a hearing by telephone or at the 

23 nearest regional or field office of the Food and 

24 Drug Administration, and providing for an ex-
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1 pedited procedure for the administrative appeal 

2 of an alleged violation; 

3 (D) providing that a person may not be 

4 charged with a violation at a particular retail 

5 outlet unless the Secretary has provided notice 

6 to the retailer of all previous violations at that 

7 outlet; 

8 (E) establishing that civil money penalties 

9 for multiple violations shall increase from one 

10 violation to the next violation pursuant to para11 graph (2) within the time periods provided for 

12 in such paragraph; 

13 (F) providing that good faith reliance on 

14 the presentation of a false government-issued 

15 photographic identification that contains a date 

16 of birth does not constitute a violation of any 

17 minimum age requirement for the sale of to18 bacco products if the retailer has taken effective 

19 steps to prevent such violations, including— 

20 (i) adopting and enforcing a written 

21 policy against sales to minors; 

22 (ii) informing its employees of all ap23 plicable laws; 

24 (iii) establishing disciplinary sanctions 

25 for employee noncompliance; and 
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1 (iv) requiring its employees to verify 

2 age by way of photographic identification 

3 or electronic scanning device; and 

4 (G) providing for the Secretary, in deter5 mining whether to impose a no-tobacco-sale 

6 order and in determining whether to com7 promise, modify, or terminate such an order, to 

8 consider whether the retailer has taken effective 

9 steps to prevent violations of the minimum age 

10 requirements for the sale of tobacco products, 

11 including the steps listed in subparagraph (F). 

12 (2) PENALTIES FOR VIOLATIONS.— 

13 (A) IN GENERAL.—The amount of the civil 

14 penalty to be applied for violations of restric15 tions promulgated under section 906(d), as de16 scribed in paragraph (1), shall be as follows: 

17 (i) With respect to a retailer with an 

18 approved training program, the amount of 

19 the civil penalty shall not exceed— 

20 (I) in the case of the first viola21 tion, $0.00 together with the issuance 

22 of a warning letter to the retailer; 

23 (II) in the case of a second viola24 tion within a 12-month period, $250; 
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1 (III) in the case of a third viola2 tion within a 24-month period, $500; 

3 (IV) in the case of a fourth viola4 tion within a 24-month period, 

5 $2,000; 

6 (V) in the case of a fifth violation 

7 within a 36-month period, $5,000; 

8 and 

9 (VI) in the case of a sixth or sub10 sequent violation within a 48-month 

11 period, $10,000 as determined by the 

12 Secretary on a case-by-case basis. 

13 (ii) With respect to a retailer that 

14 does not have an approved training pro15 gram, the amount of the civil penalty shall 

16 not exceed— 

17 (I) in the case of the first viola18 tion, $250; 

19 (II) in the case of a second viola20 tion within a 12-month period, $500; 

21 (III) in the case of a third viola22 tion within a 24-month period, 

23 $1,000; 
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1 (IV) in the case of a fourth viola2 tion within a 24-month period, 

3 $2,000; 

4 (V) in the case of a fifth violation 

5 within a 36-month period, $5,000; 

6 and 

7 (VI) in the case of a sixth or sub8 sequent violation within a 48-month 

9 period, $10,000 as determined by the 

10 Secretary on a case-by-case basis. 

11 (B) TRAINING PROGRAM.—For purposes of 

12 subparagraph (A), the term ‘‘approved training 

13 program’’ means a training program that com14 plies with standards developed by the Food and 

15 Drug Administration for such programs. 

16 (C) CONSIDERATION OF STATE PEN17 ALTIES.—The Secretary shall coordinate with 

18 the States in enforcing the provisions of this 

19 Act and, for purposes of mitigating a civil pen20 alty to be applied for a violation by a retailer 

21 of any restriction promulgated under section 

22 906(d), shall consider the amount of any pen23 alties paid by the retailer to a State for the 

24 same violation. 
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1 (3) GENERAL EFFECTIVE DATE.—The amend2 ments made by paragraphs (2), (3), and (4) of sub3 section (c) shall take effect upon the issuance of 

4 guidance described in paragraph (1) of this sub5 section. 

6 (4) SPECIAL EFFECTIVE DATE.—The amend7 ment made by subsection (c)(1) shall take effect on 

8 the date of enactment of this Act. 

9 (5) PACKAGE LABEL REQUIREMENTS.—The 

10 package label requirements of paragraphs (2), (3), 

11 and (4) of section 903(a) of the Federal Food, 

12 Drug, and Cosmetic Act (as amended by this Act) 

13 shall take effect on the date that is 12 months after 

14 the date of enactment of this Act. The effective date 

15 shall be with respect to the date of manufacture, 

16 provided that, in any case, beginning 30 days after 

17 such effective date, a manufacturer shall not intro18 duce into the domestic commerce of the United 

19 States any product, irrespective of the date of manu20 facture, that is not in conformance with section 

21 903(a)(2), (3), and (4) and section 920(a) of the 

22 Federal Food, Drug, and Cosmetic Act. 

23 (6) ADVERTISING REQUIREMENTS.—The adver24 tising requirements of section 903(a)(8) of the Fed25 eral Food, Drug, and Cosmetic Act (as amended by 
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1 this Act) shall take effect on the date that is 12 

2 months after the date of enactment of this Act. 

3 SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PUR4 CHASE TOBACCO PRODUCTS. 

5 The Secretary of Health and Human Services shall— 

6 (1) convene an expert panel to conduct a study 

7 on the public health implications of raising the min8 imum age to purchase tobacco products; and 

9 (2) not later than 5 years after the date of the 

10 enactment of this Act, submit a report to the Con11 gress on the results of such study. 

12 SEC. 105. TOBACCO INDUSTRY CONCENTRATION. 

13 (a) STUDY.—The Federal Trade Commission shall 

14 conduct a study on the causes and effects of concentration 

15 in the tobacco industry. 

16 (b) PUBLIC REPORT.—The Federal Trade Commis17 sion shall transmit to Congress a report not later than 

18 5 years after the date of enactment of this Act, and a 

19 subsequent report on the date that is 10 years after the 

20 date of enactment of this Act. Such reports shall include— 

21 (1) an analysis of trends in the market share of 

22 any dominant tobacco product manufacturer in any 

23 class of tobacco products; or 

24 (2) an analysis of trends in competition or the 

25 emergence of a monopoly; and 
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1 (3) recommendations to Congress on any cor2 rective actions that should be taken to address to3 bacco industry concentration. 

4 SEC. 106. ENFORCEMENT ACTION PLAN FOR ADVERTISING 

5 AND PROMOTION RESTRICTIONS. 

6 (a) ACTION PLAN.— 

7 (1) DEVELOPMENT.—Not later than 6 months 

8 after the date of the enactment of this Act, the Sec9 retary of Health and Human Services (in this sec10 tion referred to as the ‘‘Secretary’’) shall develop 

11 and publish an action plan to enforce restrictions 

12 adopted pursuant to section 906 of the Federal 

13 Food, Drug, and Cosmetic Act, as added by section 

14 101(b) of this Act, or pursuant to section 102(a) of 

15 this Act, on promotion and advertising of menthol 

16 and other cigarettes to youth. 

17 (2) CONSULTATION.—The action plan required 

18 by paragraph (1) shall be developed in consultation 

19 with public health organizations and other stake20 holders with demonstrated expertise and experience 

21 in serving minority communities. 

22 (3) PRIORITY.—The action plan required by 

23 paragraph (1) shall include provisions designed to 

24 ensure enforcement of the restrictions described in 

25 paragraph (1) in minority communities. 
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1 (b) STATE AND LOCAL ACTIVITIES.— 

2 (1) INFORMATION ON AUTHORITY.—Not later 

3 than 3 months after the date of the enactment of 

4 this Act, the Secretary shall inform State, local, and 

5 tribal governments of the authority provided to such 

6 entities under section 5(c) of the Federal Cigarette 

7 Labeling and Advertising Act, as added by section 

8 203 of this Act, or preserved by such entities under 

9 section 916 of the Federal Food, Drug, and Cos10 metic Act, as added by section 101(b) of this Act. 

11 (2) COMMUNITY ASSISTANCE.—At the request 

12 of communities seeking assistance to prevent under13 age tobacco use, the Secretary shall provide such as14 sistance, including assistance with strategies to ad15 dress the prevention of underage tobacco use in com16 munities with a disproportionate use of menthol 

17 cigarettes by minors. 

18 TITLE II—TOBACCO PRODUCT 

19 WARNINGS; CONSTITUENT 

20 AND SMOKE CONSTITUENT 

21 DISCLOSURE 

22 SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS. 

23 (a) AMENDMENT.—Section 4 of the Federal Ciga24 rette Labeling and Advertising Act (15 U.S.C. 1333) is 

25 amended to read as follows: 
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1 ‘‘SEC. 4. LABELING. 

2 ‘‘(a) LABEL REQUIREMENTS.— 

3 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

4 person to manufacture, package, sell, offer to sell, 

5 distribute, or import for sale or distribution within 

6 the United States any cigarettes the package of 

7 which fails to bear, in accordance with the require8 ments of this section, one of the following labels: 

9 ‘‘WARNING: Cigarettes are addictive. 

10 ‘‘WARNING: Tobacco smoke can harm 

11 your children. 

12 ‘‘WARNING: Cigarettes cause fatal lung 

13 disease. 

14 ‘‘WARNING: Cigarettes cause cancer. 

15 ‘‘WARNING: Cigarettes cause strokes and 

16 heart disease. 

17 ‘‘WARNING: Smoking during pregnancy 

18 can harm your baby. 

19 ‘‘WARNING: Smoking can kill you. 

20 ‘‘WARNING: Tobacco smoke causes fatal 

21 lung disease in nonsmokers. 

22 ‘‘WARNING: Quitting smoking now great23 ly reduces serious risks to your health. 

24 ‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—Each 

25 label statement required by paragraph (1) shall be 

26 located in the upper portion of the front and rear 
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1 panels of the package, directly on the package un2 derneath the cellophane or other clear wrapping. 

3 Each label statement shall comprise at least the top 

4 30 percent of the front and rear panels of the pack5 age. The word ‘WARNING’ shall appear in capital 

6 letters and all text shall be in conspicuous and leg7 ible 17-point type, unless the text of the label state8 ment would occupy more than 70 percent of such 

9 area, in which case the text may be in a smaller con10 spicuous and legible type size, provided that at least 

11 60 percent of such area is occupied by required text. 

12 The text shall be black on a white background, or 

13 white on a black background, in a manner that con14 trasts, by typography, layout, or color, with all other 

15 printed material on the package, in an alternating 

16 fashion under the plan submitted under subsection 

17 (c). 

18 ‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU19 TION.—The provisions of this subsection do not 

20 apply to a tobacco product manufacturer or dis21 tributor of cigarettes which does not manufacture, 

22 package, or import cigarettes for sale or distribution 

23 within the United States. 
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1 ‘‘(4) APPLICABILITY TO RETAILERS.—A retailer 

2 of cigarettes shall not be in violation of this sub3 section for packaging that— 

4 ‘‘(A) contains a warning label; 

5 ‘‘(B) is supplied to the retailer by a 

6 license- or permit-holding tobacco product man7 ufacturer, importer, or distributor; and 

8 ‘‘(C) is not altered by the retailer in a way 

9 that is material to the requirements of this sub10 section. 

11 ‘‘(b) ADVERTISING REQUIREMENTS.— 

12 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

13 tobacco product manufacturer, importer, distributor, 

14 or retailer of cigarettes to advertise or cause to be 

15 advertised within the United States any cigarette 

16 unless its advertising bears, in accordance with the 

17 requirements of this section, one of the labels speci18 fied in subsection (a). 

19 ‘‘(2) TYPOGRAPHY, ETC.—Each label statement 

20 required by subsection (a) in cigarette advertising 

21 shall comply with the standards set forth in this 

22 paragraph. For press and poster advertisements, 

23 each such statement and (where applicable) any re24 quired statement relating to tar, nicotine, or other 

25 constituent (including a smoke constituent) yield 
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1 shall comprise at least 20 percent of the area of the 

2 advertisement and shall appear in a conspicuous and 

3 prominent format and location at the top of each ad4 vertisement within the trim area. The Secretary may 

5 revise the required type sizes in such area in such 

6 manner as the Secretary determines appropriate. 

7 The word ‘WARNING’ shall appear in capital let8 ters, and each label statement shall appear in con9 spicuous and legible type. The text of the label state10 ment shall be black if the background is white and 

11 white if the background is black, under the plan sub12 mitted under subsection (c). The label statements 

13 shall be enclosed by a rectangular border that is the 

14 same color as the letters of the statements and that 

15 is the width of the first downstroke of the capital 

16 ‘W’ of the word ‘WARNING’ in the label state17 ments. The text of such label statements shall be in 

18 a typeface pro rata to the following requirements: 

19 45-point type for a whole-page broadsheet newspaper 

20 advertisement; 39-point type for a half-page 

21 broadsheet newspaper advertisement; 39-point type 

22 for a whole-page tabloid newspaper advertisement; 

23 27-point type for a half-page tabloid newspaper ad24 vertisement; 31.5-point type for a double page 

25 spread magazine or whole-page magazine advertise-
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1 ment; 22.5-point type for a 28 centimeter by 3 col2 umn advertisement; and 15-point type for a 20 cen3 timeter by 2 column advertisement. The label state4 ments shall be in English, except that— 

5 ‘‘(A) in the case of an advertisement that 

6 appears in a newspaper, magazine, periodical, 

7 or other publication that is not in English, the 

8 statements shall appear in the predominant lan9 guage of the publication; and 

10 ‘‘(B) in the case of any other advertise11 ment that is not in English, the statements 

12 shall appear in the same language as that prin13 cipally used in the advertisement. 

14 ‘‘(3) MATCHBOOKS.—Notwithstanding para15 graph (2), for matchbooks (defined as containing not 

16 more than 20 matches) customarily given away with 

17 the purchase of tobacco products, each label state18 ment required by subsection (a) may be printed on 

19 the inside cover of the matchbook. 

20 ‘‘(4) ADJUSTMENT BY SECRETARY.—The Sec21 retary may, through a rulemaking under section 553 

22 of title 5, United States Code, adjust the format and 

23 type sizes for the label statements required by this 

24 section; the text, format, and type sizes of any re25 quired tar, nicotine yield, or other constituent (in-
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1 cluding smoke constituent) disclosures; or the text, 

2 format, and type sizes for any other disclosures re3 quired under the Federal Food, Drug, and Cosmetic 

4 Act. The text of any such label statements or disclo5 sures shall be required to appear only within the 20 

6 percent area of cigarette advertisements provided by 

7 paragraph (2). The Secretary shall promulgate regu8 lations which provide for adjustments in the format 

9 and type sizes of any text required to appear in such 

10 area to ensure that the total text required to appear 

11 by law will fit within such area. 

12 ‘‘(c) MARKETING REQUIREMENTS.— 

13 ‘‘(1) RANDOM DISPLAY.—The label statements 

14 specified in subsection (a)(1) shall be randomly dis15 played in each 12-month period, in as equal a num16 ber of times as is possible on each brand of the 

17 product and be randomly distributed in all areas of 

18 the United States in which the product is marketed 

19 in accordance with a plan submitted by the tobacco 

20 product manufacturer, importer, distributor, or re21 tailer and approved by the Secretary. 

22 ‘‘(2) ROTATION.—The label statements speci23 fied in subsection (a)(1) shall be rotated quarterly in 

24 alternating sequence in advertisements for each 

25 brand of cigarettes in accordance with a plan sub-
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1 mitted by the tobacco product manufacturer, im2 porter, distributor, or retailer to, and approved by, 

3 the Secretary. 

4 ‘‘(3) REVIEW.—The Secretary shall review each 

5 plan submitted under paragraph (2) and approve it 

6 if the plan— 

7 ‘‘(A) will provide for the equal distribution 

8 and display on packaging and the rotation re9 quired in advertising under this subsection; and 

10 ‘‘(B) assures that all of the labels required 

11 under this section will be displayed by the to12 bacco product manufacturer, importer, dis13 tributor, or retailer at the same time. 

14 ‘‘(4) APPLICABILITY TO RETAILERS.—This sub15 section and subsection (b) apply to a retailer only if 

16 that retailer is responsible for or directs the label 

17 statements required under this section except that 

18 this paragraph shall not relieve a retailer of liability 

19 if the retailer displays, in a location open to the pub20 lic, an advertisement that does not contain a warn21 ing label or has been altered by the retailer in a way 

22 that is material to the requirements of this sub23 section and subsection (b).’’. 

24 (b) EFFECTIVE DATE.—The amendment made by 

25 subsection (a) shall take effect 12 months after the date 
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1 of enactment of this Act. Such effective date shall be with 

2 respect to the date of manufacture, provided that, in any 

3 case, beginning 30 days after such effective date, a manu4 facturer shall not introduce into the domestic commerce 

5 of the United States any product, irrespective of the date 

6 of manufacture, that is not in conformance with section 

7 4 of the Federal Cigarette Labeling and Advertising Act 

8 (15 U.S.C. 1333), as amended by subsection (a). 

9 SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING 

10 LABEL STATEMENTS. 

11 (a) PREEMPTION.—Section 5(a) of the Federal Ciga12 rette Labeling and Advertising Act (15 U.S.C. 1334(a)) 

13 is amended by striking ‘‘No’’ and inserting ‘‘Except to the 

14 extent the Secretary requires additional or different state15 ments on any cigarette package by a regulation, by an 

16 order, by a standard, by an authorization to market a 

17 product, or by a condition of marketing a product, pursu18 ant to the Family Smoking Prevention and Tobacco Con19 trol Act (and the amendments made by that Act), or as 

20 required under section 903(a)(2) or section 920(a) of the 

21 Federal Food, Drug, and Cosmetic Act, no’’. 

22 (b) CHANGE IN REQUIRED STATEMENTS.—Section 4 

23 of the Federal Cigarette Labeling and Advertising Act (15 

24 U.S.C. 1333), as amended by section 201, is further 

25 amended by adding at the end the following: 
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1 ‘‘(d) CHANGE IN REQUIRED STATEMENTS.—The 

2 Secretary may, by a rulemaking conducted under section 

3 553 of title 5, United States Code, adjust the format, type 

4 size, and text of any of the label requirements, require 

5 color graphics to accompany the text, increase the re6 quired label area from 30 percent up to 50 percent of the 

7 front and rear panels of the package, or establish the for8 mat, type size, and text of any other disclosures required 

9 under the Federal Food, Drug, and Cosmetic Act, if the 

10 Secretary finds that such a change would promote greater 

11 public understanding of the risks associated with the use 

12 of tobacco products.’’. 

13 SEC. 203. STATE REGULATION OF CIGARETTE ADVER14 TISING AND PROMOTION. 

15 Section 5 of the Federal Cigarette Labeling and Ad16 vertising Act (15 U.S.C. 1334) is amended by adding at 

17 the end the following: 

18 ‘‘(c) EXCEPTION.—Notwithstanding subsection (b), a 

19 State or locality may enact statutes and promulgate regu20 lations, based on smoking and health, that take effect 

21 after the effective date of the Family Smoking Prevention 

22 and Tobacco Control Act, imposing specific bans or re23 strictions on the time, place, and manner, but not content, 

24 of the advertising or promotion of any cigarettes.’’. 
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1 SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING 

2 WARNINGS. 

3 (a) AMENDMENT.—Section 3 of the Comprehensive 

4 Smokeless Tobacco Health Education Act of 1986 (15 

5 U.S.C. 4402) is amended to read as follows: 

6 ‘‘SEC. 3. SMOKELESS TOBACCO WARNING. 

7 ‘‘(a) GENERAL RULE.— 

8 ‘‘(1) It shall be unlawful for any person to man9 ufacture, package, sell, offer to sell, distribute, or 

10 import for sale or distribution within the United 

11 States any smokeless tobacco product unless the 

12 product package bears, in accordance with the re13 quirements of this Act, one of the following labels: 

14 ‘‘WARNING: This product can cause 

15 mouth cancer. 

16 ‘‘WARNING: This product can cause gum 

17 disease and tooth loss. 

18 ‘‘WARNING: This product is not a safe al19 ternative to cigarettes. 

20 ‘‘WARNING: Smokeless tobacco is addict21 ive. 

22 ‘‘(2) Each label statement required by para23 graph (1) shall be— 

24 ‘‘(A) located on the 2 principal display 

25 panels of the package, and each label statement 
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1 shall comprise at least 30 percent of each such 

2 display panel; and 

3 ‘‘(B) in 17-point conspicuous and legible 

4 type and in black text on a white background, 

5 or white text on a black background, in a man6 ner that contrasts by typography, layout, or 

7 color, with all other printed material on the 

8 package, in an alternating fashion under the 

9 plan submitted under subsection (b)(3), except 

10 that if the text of a label statement would oc11 cupy more than 70 percent of the area specified 

12 by subparagraph (A), such text may appear in 

13 a smaller type size, so long as at least 60 per14 cent of such warning area is occupied by the 

15 label statement. 

16 ‘‘(3) The label statements required by para17 graph (1) shall be introduced by each tobacco prod18 uct manufacturer, packager, importer, distributor, or 

19 retailer of smokeless tobacco products concurrently 

20 into the distribution chain of such products. 

21 ‘‘(4) The provisions of this subsection do not 

22 apply to a tobacco product manufacturer or dis23 tributor of any smokeless tobacco product that does 

24 not manufacture, package, or import smokeless to-
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1 bacco products for sale or distribution within the 

2 United States. 

3 ‘‘(5) A retailer of smokeless tobacco products 

4 shall not be in violation of this subsection for pack5 aging that— 

6 ‘‘(A) contains a warning label; 

7 ‘‘(B) is supplied to the retailer by a 

8 license- or permit-holding tobacco product man9 ufacturer, importer, or distributor; and 

10 ‘‘(C) is not altered by the retailer in a way 

11 that is material to the requirements of this sub12 section. 

13 ‘‘(b) REQUIRED LABELS.— 

14 ‘‘(1) It shall be unlawful for any tobacco prod15 uct manufacturer, packager, importer, distributor, or 

16 retailer of smokeless tobacco products to advertise or 

17 cause to be advertised within the United States any 

18 smokeless tobacco product unless its advertising 

19 bears, in accordance with the requirements of this 

20 section, one of the labels specified in subsection (a). 

21 ‘‘(2)(A) Each label statement required by sub22 section (a) in smokeless tobacco advertising shall 

23 comply with the standards set forth in this para24 graph. 
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1 ‘‘(B) For press and poster advertisements, each 

2 such statement and (where applicable) any required 

3 statement relating to tar, nicotine, or other con4 stituent yield shall comprise at least 20 percent of 

5 the area of the advertisement. 

6 ‘‘(C) The word ‘WARNING’ shall appear in 

7 capital letters, and each label statement shall appear 

8 in conspicuous and legible type. 

9 ‘‘(D) The text of the label statement shall be 

10 black on a white background, or white on a black 

11 background, in an alternating fashion under the 

12 plan submitted under paragraph (3). 

13 ‘‘(E) The label statements shall be enclosed by 

14 a rectangular border that is the same color as the 

15 letters of the statements and that is the width of the 

16 first downstroke of the capital ‘W’ of the word 

17 ‘WARNING’ in the label statements. 

18 ‘‘(F) The text of such label statements shall be 

19 in a typeface pro rata to the following requirements: 

20 45-point type for a whole-page broadsheet newspaper 

21 advertisement; 39-point type for a half-page 

22 broadsheet newspaper advertisement; 39-point type 

23 for a whole-page tabloid newspaper advertisement; 

24 27-point type for a half-page tabloid newspaper ad25 vertisement; 31.5-point type for a double page 
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1 spread magazine or whole-page magazine advertise2 ment; 22.5-point type for a 28 centimeter by 3 col3 umn advertisement; and 15-point type for a 20 cen4 timeter by 2 column advertisement. 

5 ‘‘(G) The label statements shall be in English, 

6 except that— 

7 ‘‘(i) in the case of an advertisement that 

8 appears in a newspaper, magazine, periodical, 

9 or other publication that is not in English, the 

10 statements shall appear in the predominant lan11 guage of the publication; and 

12 ‘‘(ii) in the case of any other advertisement 

13 that is not in English, the statements shall ap14 pear in the same language as that principally 

15 used in the advertisement. 

16 ‘‘(3)(A) The label statements specified in sub17 section (a)(1) shall be randomly displayed in each 

18 12-month period, in as equal a number of times as 

19 is possible on each brand of the product and be ran20 domly distributed in all areas of the United States 

21 in which the product is marketed in accordance with 

22 a plan submitted by the tobacco product manufac23 turer, importer, distributor, or retailer and approved 

24 by the Secretary. 
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1 ‘‘(B) The label statements specified in sub2 section (a)(1) shall be rotated quarterly in alter3 nating sequence in advertisements for each brand of 

4 smokeless tobacco product in accordance with a plan 

5 submitted by the tobacco product manufacturer, im6 porter, distributor, or retailer to, and approved by, 

7 the Secretary. 

8 ‘‘(C) The Secretary shall review each plan sub9 mitted under subparagraphs (A) and (B) and ap10 prove it if the plan— 

11 ‘‘(i) will provide for the equal distribution 

12 and display on packaging and the rotation re13 quired in advertising under this subsection; and 

14 ‘‘(ii) assures that all of the labels required 

15 under this section will be displayed by the to16 bacco product manufacturer, importer, dis17 tributor, or retailer at the same time. 

18 ‘‘(D) This paragraph applies to a retailer only 

19 if that retailer is responsible for or directs the label 

20 statements under this section, unless the retailer dis21 plays, in a location open to the public, an advertise22 ment that does not contain a warning label or has 

23 been altered by the retailer in a way that is material 

24 to the requirements of this subsection. 
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1 ‘‘(4) The Secretary may, through a rulemaking 

2 under section 553 of title 5, United States Code, ad3 just the format and type sizes for the label state4 ments required by this section; the text, format, and 

5 type sizes of any required tar, nicotine yield, or 

6 other constituent disclosures; or the text, format, 

7 and type sizes for any other disclosures required 

8 under the Federal Food, Drug, and Cosmetic Act. 

9 The text of any such label statements or disclosures 

10 shall be required to appear only within the 20 per11 cent area of advertisements provided by paragraph 

12 (2). The Secretary shall promulgate regulations 

13 which provide for adjustments in the format and 

14 type sizes of any text required to appear in such 

15 area to ensure that the total text required to appear 

16 by law will fit within such area. 

17 ‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is 

18 unlawful to advertise smokeless tobacco on any medium 

19 of electronic communications subject to the jurisdiction of 

20 the Federal Communications Commission.’’. 

21 (b) EFFECTIVE DATE.—The amendment made by 

22 subsection (a) shall take effect 12 months after the date 

23 of enactment of this Act. Such effective date shall be with 

24 respect to the date of manufacture, provided that, in any 

25 case, beginning 30 days after such effective date, a manu-
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1 facturer shall not introduce into the domestic commerce 

2 of the United States any product, irrespective of the date 

3 of manufacture, that is not in conformance with section 

4 3 of the Comprehensive Smokeless Tobacco Health Edu5 cation Act of 1986 (15 U.S.C. 4402), as amended by sub6 section (a) 

7 SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO 

8 PRODUCT WARNING LABEL STATEMENTS. 

9 (a) IN GENERAL.—Section 3 of the Comprehensive 

10 Smokeless Tobacco Health Education Act of 1986 (15 

11 U.S.C. 4402), as amended by section 204, is further 

12 amended by adding at the end the following: 

13 ‘‘(d) AUTHORITY TO REVISE WARNING LABEL

14 STATEMENTS.—The Secretary may, by a rulemaking con15 ducted under section 553 of title 5, United States Code, 

16 adjust the format, type size, and text of any of the label 

17 requirements, require color graphics to accompany the 

18 text, increase the required label area from 30 percent up 

19 to 50 percent of the front and rear panels of the package, 

20 or establish the format, type size, and text of any other 

21 disclosures required under the Federal Food, Drug, and 

22 Cosmetic Act, if the Secretary finds that such a change 

23 would promote greater public understanding of the risks 

24 associated with the use of smokeless tobacco products.’’. 
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1 (b) PREEMPTION.—Section 7(a) of the Comprehen2 sive Smokeless Tobacco Health Education Act of 1986 (15 

3 U.S.C. 4406(a)) is amended by striking ‘‘No’’ and insert4 ing ‘‘Except as provided in the Family Smoking Preven5 tion and Tobacco Control Act (and the amendments made 

6 by that Act), no’’. 

7 SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CON8 STITUENT DISCLOSURE TO THE PUBLIC. 

9 Section 4 of the Federal Cigarette Labeling and Ad10 vertising Act (15 U.S.C. 1333), as amended by sections 

11 201 and 202, is further amended by adding at the end 

12 the following: 

13 ‘‘(e) TAR, NICOTINE, AND OTHER SMOKE CON14 STITUENT DISCLOSURE.— 

15 ‘‘(1) IN GENERAL.—The Secretary shall, by a 

16 rulemaking conducted under section 553 of title 5, 

17 United States Code, determine (in the Secretary’s 

18 sole discretion) whether cigarette and other tobacco 

19 product manufacturers shall be required to include 

20 in the area of each cigarette advertisement specified 

21 by subsection (b) of this section, or on the package 

22 label, or both, the tar and nicotine yields of the ad23 vertised or packaged brand. Any such disclosure 

24 shall be in accordance with the methodology estab25 lished under such regulations, shall conform to the 
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1 type size requirements of subsection (b) of this sec2 tion, and shall appear within the area specified in 

3 subsection (b) of this section. 

4 ‘‘(2) RESOLUTION OF DIFFERENCES.—Any dif5 ferences between the requirements established by the 

6 Secretary under paragraph (1) and tar and nicotine 

7 yield reporting requirements established by the Fed8 eral Trade Commission shall be resolved by a memo9 randum of understanding between the Secretary and 

10 the Federal Trade Commission. 

11 ‘‘(3) CIGARETTE AND OTHER TOBACCO PROD12 UCT CONSTITUENTS.—In addition to the disclosures 

13 required by paragraph (1), the Secretary may, under 

14 a rulemaking conducted under section 553 of title 5, 

15 United States Code, prescribe disclosure require16 ments regarding the level of any cigarette or other 

17 tobacco product constituent including any smoke 

18 constituent. Any such disclosure may be required if 

19 the Secretary determines that disclosure would be of 

20 benefit to the public health, or otherwise would in21 crease consumer awareness of the health con22 sequences of the use of tobacco products, except that 

23 no such prescribed disclosure shall be required on 

24 the face of any cigarette package or advertisement. 

25 Nothing in this section shall prohibit the Secretary 
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1 from requiring such prescribed disclosure through a 

2 cigarette or other tobacco product package or adver3 tisement insert, or by any other means under the 

4 Federal Food, Drug, and Cosmetic Act. 

5 ‘‘(4) RETAILERS.—This subsection applies to a 

6 retailer only if that retailer is responsible for or di7 rects the label statements required under this sec8 tion.’’. 

9 TITLE III—PREVENTION OF IL10 LICIT TRADE IN TOBACCO 

11 PRODUCTS 

12 SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPEC13 TION. 

14 Chapter IX of the Federal Food, Drug, and Cosmetic 

15 Act, as added by section 101, is further amended by add16 ing at the end the following: 

17 ‘‘SEC. 920. LABELING, RECORDKEEPING, RECORDS INSPEC18 TION. 

19 ‘‘(a) ORIGIN LABELING.— 

20 ‘‘(1) REQUIREMENT.—Beginning 1 year after 

21 the date of enactment of the Family Smoking Pre22 vention and Tobacco Control Act, the label, pack23 aging, and shipping containers of tobacco products 

24 for introduction or delivery for introduction into 

25 interstate commerce in the United States shall bear 
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1 the statement ‘sale only allowed in the United 

2 States’. 

3 ‘‘(2) EFFECTIVE DATE.—The effective date 

4 specified in paragraph (1) shall be with respect to 

5 the date of manufacture, provided that, in any case, 

6 beginning 30 days after such effective date, a manu7 facturer shall not introduce into the domestic com8 merce of the United States any product, irrespective 

9 of the date of manufacture, that is not in conform10 ance with such paragraph. 

11 ‘‘(b) REGULATIONS CONCERNING RECORDKEEPING

12 FOR TRACKING AND TRACING.— 

13 ‘‘(1) IN GENERAL.—The Secretary shall pro14 mulgate regulations regarding the establishment and 

15 maintenance of records by any person who manufac16 tures, processes, transports, distributes, receives, 

17 packages, holds, exports, or imports tobacco prod18 ucts. 

19 ‘‘(2) INSPECTION.—In promulgating the regula20 tions described in paragraph (1), the Secretary shall 

21 consider which records are needed for inspection to 

22 monitor the movement of tobacco products from the 

23 point of manufacture through distribution to retail 

24 outlets to assist in investigating potential illicit 
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1 trade, smuggling, or counterfeiting of tobacco prod2 ucts. 

3 ‘‘(3) CODES.—The Secretary may require codes 

4 on the labels of tobacco products or other designs or 

5 devices for the purpose of tracking or tracing the to6 bacco product through the distribution system. 

7 ‘‘(4) SIZE OF BUSINESS.—The Secretary shall 

8 take into account the size of a business in promul9 gating regulations under this section. 

10 ‘‘(5) RECORDKEEPING BY RETAILERS.—The 

11 Secretary shall not require any retailer to maintain 

12 records relating to individual purchasers of tobacco 

13 products for personal consumption. 

14 ‘‘(c) RECORDS INSPECTION.—If the Secretary has a 

15 reasonable belief that a tobacco product is part of an illicit 

16 trade or smuggling or is a counterfeit product, each person 

17 who manufactures, processes, transports, distributes, re18 ceives, holds, packages, exports, or imports tobacco prod19 ucts shall, at the request of an officer or employee duly 

20 designated by the Secretary, permit such officer or em21 ployee, at reasonable times and within reasonable limits 

22 and in a reasonable manner, upon the presentation of ap23 propriate credentials and a written notice to such person, 

24 to have access to and copy all records (including financial 

25 records) relating to such article that are needed to assist 
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1 the Secretary in investigating potential illicit trade, smug2 gling, or counterfeiting of tobacco products. The Secretary 

3 shall not authorize an officer or employee of the govern4 ment of any of the several States to exercise authority 

5 under the preceding sentence on Indian lands without the 

6 express written consent of the Indian tribe involved. 

7 ‘‘(d) KNOWLEDGE OF ILLEGAL TRANSACTION.— 

8 ‘‘(1) NOTIFICATION.—If the manufacturer or 

9 distributor of a tobacco product has knowledge 

10 which reasonably supports the conclusion that a to11 bacco product manufactured or distributed by such 

12 manufacturer or distributor that has left the control 

13 of such person may be or has been— 

14 ‘‘(A) imported, exported, distributed, or of15 fered for sale in interstate commerce by a per16 son without paying duties or taxes required by 

17 law; or 

18 ‘‘(B) imported, exported, distributed, or di19 verted for possible illicit marketing, 

20 the manufacturer or distributor shall promptly no21 tify the Attorney General and the Secretary of the 

22 Treasury of such knowledge. 

23 ‘‘(2) KNOWLEDGE DEFINED.—For purposes of 

24 this subsection, the term ‘knowledge’ as applied to 

25 a manufacturer or distributor means— 
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1 ‘‘(A) the actual knowledge that the manu2 facturer or distributor had; or 

3 ‘‘(B) the knowledge which a reasonable 

4 person would have had under like circumstances 

5 or which would have been obtained upon the ex6 ercise of due care.’’. 

7 SEC. 302. STUDY AND REPORT. 

8 (a) STUDY.—The Comptroller General of the United 

9 States shall conduct a study of cross-border trade in to10 bacco products to— 

11 (1) collect data on cross-border trade in tobacco 

12 products, including illicit trade and trade of counter13 feit tobacco products and make recommendations on 

14 the monitoring of such trade; 

15 (2) collect data on cross-border advertising (any 

16 advertising intended to be broadcast, transmitted, or 

17 distributed from the United States to another coun18 try) of tobacco products and make recommendations 

19 on how to prevent or eliminate, and what tech20 nologies could help facilitate the elimination of, 

21 cross-border advertising; and 

22 (3) collect data on the health effects (particu23 larly with respect to individuals under 18 years of 

24 age) resulting from cross-border trade in tobacco 
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1 products, including the health effects resulting 

2 from— 

3 (A) the illicit trade of tobacco products 

4 and the trade of counterfeit tobacco products; 

5 and 

6 (B) the differing tax rates applicable to to7 bacco products. 

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). 

15 (c) DEFINITION.—In this section: 

16 (1) The term ‘‘cross-border trade’’ means trade 

17 across a border of the United States, a State or Ter18 ritory, or Indian country. 

19 (2) The term ‘‘Indian country’’ has the mean20 ing given to that term in section 1151 of title 18, 

21 United States Code. 

22 (3) The terms ‘‘State’’ and ‘‘Territory’’ have 

23 the meanings given to those terms in section 201 of 

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

25 U.S.C. 321). 
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1 TITLE IV—THRIFT SAVINGS 

2 PLAN ENHANCEMENT 

3 SEC. 401. SHORT TITLE. 

4 This title may be cited as the ‘‘Thrift Savings Plan 

5 Enhancement Act of 2008’’. 

6 SEC. 402. AUTOMATIC ENROLLMENTS. 

7 (a) AUTOMATIC ENROLLMENTS.— 

8 (1) IN GENERAL.—Section 8432(b) of title 5, 

9 United States Code, is amended by striking para10 graphs (2) through (4) and inserting the following: 

11 ‘‘(2)(A) The Board shall by regulation provide for an 

12 eligible individual to be automatically enrolled to make 

13 contributions under subsection (a) at the default percent14 age of basic pay. 

15 ‘‘(B) For purposes of this paragraph, the default per16 centage shall be equal to 3 percent or such other percent17 age, not less than 2 percent nor more than 5 percent, as 

18 the Board may by regulation prescribe. 

19 ‘‘(C) The regulations shall include provisions under 

20 which any individual who would otherwise be automatically 

21 enrolled in accordance with subparagraph (A) may— 

22 ‘‘(i) modify the percentage or amount to be con23 tributed pursuant to automatic enrollment, effective 

24 from the start of such enrollment; or 

25 ‘‘(ii) decline automatic enrollment altogether. 
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1 ‘‘(D) For purposes of this paragraph, the term ‘eligi2 ble individual’ means any individual who, after any regula3 tions under subparagraph (A) first take effect, is ap4 pointed, transferred, or reappointed to a position in which 

5 that individual is eligible to contribute to the Thrift Sav6 ings Fund. 

7 ‘‘(E) Sections 8351(a)(1), 8440a(a)(1), 8440b(a)(1), 

8 8440c(a)(1), 8440d(a)(1), and 8440e(a)(1) shall be ap9 plied in a manner consistent with the purposes of this 

10 paragraph.’’. 

11 (2) TECHNICAL AMENDMENT.—Section 

12 8432(b)(1) of title 5, United States Code, is amend13 ed by striking the parenthetical matter in subpara14 graph (B). 

15 (b) DEFAULT INVESTMENTS.—Section 8438(c)(2) of 

16 title 5, United States Code, is amended to read as follows: 

17 ‘‘(2) If an election has not been made with respect 

18 to any sums in the Thrift Savings Fund which are avail19 able for investment, the Executive Director shall invest 

20 such sums in— 

21 ‘‘(A) the Government Securities Investment 

22 Fund; or 

23 ‘‘(B) such alternative fund or funds (in lieu of 

24 the fund under subparagraph (A)) as the Board may 

25 designate in regulations. 
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1 The designation of an alternative fund by regulations 

2 under subparagraph (B) may be made only if, in the judg3 ment of the Board, such designation would be in the best 

4 interests of participants. Any decision under the preceding 

5 sentence shall be made after consultation with the Em6 ployee Thrift Advisory Council (established under section 

7 8473).’’. 

8 SEC. 403. QUALIFIED ROTH CONTRIBUTION PROGRAM. 

9 (a) IN GENERAL.—Subchapter III of chapter 84 of 

10 title 5, United States Code, is amended by inserting after 

11 section 8432c the following: 

12 ‘‘§ 8432d. Qualified Roth contribution program 

13 ‘‘(a) DEFINITIONS.—For purposes of this section— 

14 ‘‘(1) the term ‘qualified Roth contribution pro15 gram’ means a program described in paragraph (1) 

16 of section 402A(b) of the Internal Revenue Code of 

17 1986 which meets the requirements of paragraph (2) 

18 of such section; and 

19 ‘‘(2) the terms ‘designated Roth contribution’ 

20 and ‘elective deferral’ have the meanings given such 

21 terms in section 402A of the Internal Revenue Code 

22 of 1986. 

23 ‘‘(b) AUTHORITY TO ESTABLISH.—The Board shall 

24 by regulation provide for the inclusion in the Thrift Sav-
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1 ings Plan of a qualified Roth contribution program, under 

2 such terms and conditions as the Board may prescribe. 

3 ‘‘(c) REQUIRED PROVISIONS.—The regulations under 

4 subsection (b) shall include— 

5 ‘‘(1) provisions under which an election to make 

6 designated Roth contributions may be made— 

7 ‘‘(A) by any individual who is eligible to 

8 make contributions under section 8351, 

9 8432(a), 8440a, 8440b, 8440c, 8440d, or 

10 8440e; and 

11 ‘‘(B) by any individual, not described in 

12 subparagraph (A), who is otherwise eligible to 

13 make elective deferrals under the Thrift Sav14 ings Plan; 

15 ‘‘(2) any provisions which may, as a result of 

16 the enactment of this section, be necessary in order 

17 to clarify the meaning of any reference to an ‘ac18 count’ made in section 8432(f), 8433, 8434(d), 

19 8435, 8437, or any other provision of law; and 

20 ‘‘(3) any other provisions which may be nec21 essary to carry out this section.’’. 

22 (b) CLERICAL AMENDMENT.—The analysis for chap23 ter 84 of title 5, United States Code, is amended by insert24 ing after the item relating to section 8432c the following: 

‘‘8432d. Qualified Roth contribution program.’’. 
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1 SEC. 404. AUTHORITY TO ESTABLISH SELF-DIRECTED IN2 VESTMENT WINDOW. 

3 (a) IN GENERAL.—Section 8438(b)(1) of title 5, 

4 United States Code, is amended— 

5 (1) in subparagraph (D), by striking ‘‘and’’ at 

6 the end; 

7 (2) in subparagraph (E), by striking the period 

8 and inserting ‘‘; and’’; and 

9 (3) by adding after subparagraph (E) the fol10 lowing: 

11 ‘‘(F) a self-directed investment window, if 

12 the Board authorizes such window under para13 graph (5).’’. 

14 (b) REQUIREMENTS.—Section 8438(b) of title 5, 

15 United States Code, is amended by adding at the end the 

16 following: 

17 ‘‘(5)(A) The Board may authorize the addition of a 

18 self-directed investment window under the Thrift Savings 

19 Plan if the Board determines that such addition would be 

20 in the best interests of participants. 

21 ‘‘(B) The self-directed investment window shall be 

22 limited to— 

23 ‘‘(i) low-cost, passively-managed index funds 

24 that offer diversification benefits; and 
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1 ‘‘(ii) other investment options, if the Board de2 termines the options to be appropriate retirement in3 vestment vehicles for participants. 

4 ‘‘(C) The Board shall ensure that any administrative 

5 expenses related to use of the self-directed investment win6 dow are borne solely by the participants who use such win7 dow. 

8 ‘‘(D) The Board may establish such other terms and 

9 conditions for the self-directed investment window as the 

10 Board considers appropriate to protect the interests of 

11 participants, including requirements relating to risk dis12 closure. 

13 ‘‘(E) The Board shall consult with the Employee 

14 Thrift Advisory Council (established under section 8473) 

15 before establishing any self-directed investment window.’’. 

16 SEC. 405. REPORTING REQUIREMENTS. 

17 (a) ANNUAL REPORT.—The Board shall, not later 

18 than June 30 of each year, submit to Congress an annual 

19 report on the operations of the Thrift Savings Plan. Such 

20 report shall include, for the prior calendar year, informa21 tion on the number of participants as of the last day of 

22 such prior calendar year, the median balance in partici23 pants’ accounts as of such last day, demographic informa24 tion on participants, the percentage allocation of amounts 

25 among investment funds or options, the status of the de-
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1 velopment and implementation of the self-directed invest2 ment window, the diversity demographics of any company, 

3 investment adviser, or other entity retained to invest and 

4 manage the assets of the Thrift Savings Fund, and such 

5 other information as the Board considers appropriate. A 

6 copy of each annual report under this subsection shall be 

7 made available to the public through an Internet website. 

8 (b) REPORTING OF FEES AND OTHER INFORMA9 TION.— 

10 (1) IN GENERAL.—The Board shall include in 

11 the periodic statements provided to participants 

12 under section 8439(c) the amount of the investment 

13 management fees, administrative expenses, and any 

14 other fees or expenses paid with respect to each in15 vestment fund and option under the Thrift Savings 

16 Plan. Any such statement shall also provide a state17 ment notifying participants as to how they may ac18 cess the annual report described in subsection (a), as 

19 well as any other information concerning the Thrift 

20 Savings Plan that might be useful. 

21 (2) USE OF ESTIMATES.—For purposes of pro22 viding the information required under this sub23 section, the Executive Director may provide a rea24 sonable and representative estimate of any fees or 

25 expenses described in paragraph (1) and shall indi-
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1 cate any such estimate as being such an estimate. 

2 Any such estimate shall be based on the previous 

3 year’s experience. 

4 (c) DEFINITIONS.—For purposes of this section— 

5 (1) the term ‘‘Board’’ has the meaning given 

6 such term by 8401(5) of title 5, United States Code; 

7 (2) the term ‘‘participant’’ has the meaning 

8 given such term by section 8471(3) of title 5, United 

9 States Code; and 

10 (3) the term ‘‘account’’ means an account es11 tablished under section 8439 of title 5, United 

12 States Code. 

13 SEC. 406. ACKNOWLEDGEMENT OF RISK. 

14 (a) IN GENERAL.—Section 8439(d) of title 5, United 

15 States Code, is amended— 

16 (1) by striking the matter after ‘‘who elects to 

17 invest in’’ and before ‘‘shall sign an acknowledge18 ment’’ and inserting ‘‘any investment fund or option 

19 under this chapter, other than the Government Se20 curities Investment Fund,’’; and 

21 (2) by striking ‘‘either such Fund’’ and insert22 ing ‘‘any such fund or option’’. 

23 (b) COORDINATION WITH PROVISIONS RELATING TO

24 INVESTMENTS IN THE ABSENCE OF AN ELECTION.—Sub-
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1 section (d) of section 8439 of title 5, United States Code 

2 (as amended by subsection (a)) is further amended— 

3 (1) by redesignating subsection (d) as sub4 section (d)(1); and 

5 (2) by adding at the end the following: 

6 ‘‘(2)(A) In the case of an investment made under sec7 tion 8438(c)(2) in any fund or option to which paragraph 

8 (1) would otherwise apply, the participant involved shall, 

9 for purposes of this subsection, be deemed— 

10 ‘‘(i) to have elected to invest in such fund or 

11 option; and 

12 ‘‘(ii) to have executed the acknowledgement re13 quired under paragraph (1). 

14 ‘‘(B)(i) The Executive Director shall prescribe regu15 lations under which written notice shall be provided to a 

16 participant whenever an investment is made under section 

17 8438(c)(2)(B) on behalf of such participant in the absence 

18 of an affirmative election described in section 8438(c)(1). 

19 ‘‘(ii) The regulations shall ensure that any such no20 tice shall be provided to the participant within 7 calendar 

21 days after the effective date of the default election. 

22 ‘‘(C) For purposes of this paragraph, the term ‘par23 ticipant’ has the meaning given such term by section 

24 8471(3).’’. 
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1 (c) COORDINATION WITH PROVISIONS RELATING TO

2 FIDUCIARY RESPONSIBILITIES, LIABILITIES, AND PEN3 ALTIES.—Section 8477(e)(1)(C) of title 5, United States 

4 Code, is amended— 

5 (1) by redesignating subparagraph (C) as sub6 paragraph (C)(i); and 

7 (2) by adding at the end the following: 

8 ‘‘(ii) A fiduciary shall not be liable under subpara9 graph (A), and no civil action may be brought against a 

10 fiduciary— 

11 ‘‘(I) for providing for the automatic enrollment 

12 of a participant in accordance with section 

13 8432(b)(2)(A); 

14 ‘‘(II) for enrolling a participant in a default in15 vestment fund in accordance with section 

16 8438(c)(2)(B); or 

17 ‘‘(III) for allowing a participant to invest 

18 through the self-directed investment window or for 

19 establishing restrictions applicable to participants’ 

20 ability to invest through the self-directed investment 

21 window.’’. 

22 SEC. 407. CREDIT FOR UNUSED SICK LEAVE. 

23 (a) IN GENERAL.—Section 8415 of title 5, United 

24 States Code, is amended— 
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1 (1) by redesignating the second subsection (k) 

2 and subsection (l) as subsections (l) and (m), respec3 tively; and 

4 (2) in subsection (l) (as so redesignated by 

5 paragraph (1))— 

6 (A) by striking ‘‘(l) In computing’’ and in7 serting ‘‘(l)(1) In computing’’; and 

8 (B) by adding at the end the following: 

9 ‘‘(2) Except as provided in paragraph (1), in com10 puting an annuity under this subchapter, the total service 

11 of an employee who retires on an immediate annuity or 

12 who dies leaving a survivor or survivors entitled to annuity 

13 includes— 

14 ‘‘(A) for an employee who retires within 3 years 

after the date of enactment of this paragraph, 3 15 ⁄4 of 

16 the days, and 

17 ‘‘(B) for an employee who retires after 3 years 

18 after the date of enactment of this paragraph, the 

19 days 

20 of unused sick leave to his credit under a formal leave 

21 system, except that these days will not be counted in deter22 mining average pay or annuity eligibility under this sub23 chapter. For purposes of this subsection, in the case of 

24 any such employee who is excepted from subchapter I of 

25 chapter 63 under section 6301(2)(x)-(xiii), the days of un-
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1 used sick leave to his credit include any unused sick leave 

2 standing to his credit when he was excepted from such 

3 subchapter.’’. 

4 (b) EXCEPTION FROM DEPOSIT REQUIREMENT.— 

5 Section 8422(d)(2) of title 5, United States Code, is 

6 amended by striking ‘‘section 8415(k)’’ and inserting 

7 ‘‘paragraph (1) or (2) of section 8415(l)’’. 

8 (c) EFFECTIVE DATE.—The amendments made by 

9 this section shall apply with respect to annuities computed 

10 based on separations occurring on or after the date of the 

11 enactment of this Act. 

Passed the House of Representatives July 30, 2008. 

Attest: 

Clerk. 
110TH CONGRESS 

2D SESSION H. R. 1108 

AN ACT 

To protect the public health by providing the Food 

to regulate tobacco products. and Drug Administration with certain authority