111TH CONGRESS 

1ST SESSION H. R. 1256 

AN ACT 

To protect the public health by providing the Food and 

Drug Administration with certain authority to regulate 

tobacco products, to amend title 5, United States Code, 

to make certain modifications in the Thrift Savings Plan, 

the Civil Service Retirement System, and the Federal 

Employees’ Retirement System, and for other purposes. 
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1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 DIVISION A—FAMILY SMOKING 

4 PREVENTION AND TOBACCO 

5 CONTROL ACT 

6 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

7 (a) SHORT TITLE.—This division may be cited as the 

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

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

10 this Act is as follows: 

DIVISION A—FAMILY SMOKING PREVENTION AND TOBACCO 

CONTROL ACT 

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. 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. 
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DIVISION B—FEDERAL RETIREMENT REFORM ACT 

Sec. 100. Short title; table of contents. 

TITLE I—PROVISIONS RELATING TO FEDERAL EMPLOYEES 

RETIREMENT 

Subtitle A—Thrift Savings Plan Enhancement 

Sec. 101. Short title. 

Sec. 102. Automatic enrollments. 

Sec. 103. Qualified Roth contribution program. 

Sec. 104. Authority to establish self-directed investment window. 

Sec. 105. Reporting requirements. 

Sec. 106. Acknowledgement of risk. 

Subtitle B—Other Retirement-Related Provisions 

Sec. 111. Credit for unused sick leave. 

Sec. 112. Exemption of certain CSRS repayments from the requirement that 

they be made with interest. 

Sec. 113. Computation of certain annuities based on part-time service. 

Sec. 114. Treatment of members of the uniformed services under the Thrift 

Savings Plan. 

Sec. 115. Authority to deposit refunds under FERS. 

Sec. 116. Retirement credit for service of certain employees transferred from 

District of Columbia service to Federal service. 

TITLE II—SPECIAL SURVIVOR INDEMNITY ALLOWANCE FOR 

SURVIVING SPOUSES OF ARMED FORCES MEMBERS 

Sec. 201. Increase in monthly amount of special survivor indemnity allowance 

for widows and widowers of deceased members of the Armed 

Forces affected by required Survivor Benefit Plan annuity offset for dependency and indemnity compensation. 

1 SEC. 2. FINDINGS. 

2 The Congress finds the following: 

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

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

7 (2) A consensus exists within the scientific and 

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

10 and other serious adverse health effects. 
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1 (3) Nicotine is an addictive drug. 

2 (4) Virtually all new users of tobacco products 

3 are under the minimum legal age to purchase such 

4 products. 

5 (5) Tobacco advertising and marketing con6 tribute significantly to the use of nicotine-containing 

7 tobacco products by adolescents. 

8 (6) Because past efforts to restrict advertising 

9 and marketing of tobacco products have failed ade10 quately to curb tobacco use by adolescents, com11 prehensive restrictions on the sale, promotion, and 

12 distribution of such products are needed. 

13 (7) Federal and State governments have lacked 

14 the legal and regulatory authority and resources 

15 they need to address comprehensively the public 

16 health and societal problems caused by the use of to17 bacco products. 

18 (8) Federal and State public health officials, 

19 the public health community, and the public at large 

20 recognize that the tobacco industry should be subject 

21 to ongoing oversight. 

22 (9) Under article I, section 8 of the Constitu23 tion, the Congress is vested with the responsibility 

24 for regulating interstate commerce and commerce 

25 with Indian tribes. 
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1 (10) The sale, distribution, marketing, adver2 tising, and use of tobacco products are activities in 

3 and substantially affecting interstate commerce be4 cause they are sold, marketed, advertised, and dis5 tributed in interstate commerce on a nationwide 

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

7 economy. 

8 (11) The sale, distribution, marketing, adver9 tising, and use of such products substantially affect 

10 interstate commerce through the health care and 

11 other costs attributable to the use of tobacco prod12 ucts. 

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

14 enact legislation that provides the Food and Drug 

15 Administration with the authority to regulate to16 bacco products and the advertising and promotion of 

17 such products. The benefits to the American people 

18 from enacting such legislation would be significant 

19 in human and economic terms. 

20 (13) Tobacco use is the foremost preventable 

21 cause of premature death in America. It causes over 

22 400,000 deaths in the United States each year, and 

23 approximately 8,600,000 Americans have chronic ill24 nesses related to smoking. 
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1 (14) Reducing the use of tobacco by minors by 

2 50 percent would prevent well over 10,000,000 of to3 day’s children from becoming regular, daily smokers, 

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

5 death due to tobacco-induced disease. Such a reduc6 tion in youth smoking would also result in approxi7 mately $75,000,000,000 in savings attributable to 

8 reduced health care costs. 

9 (15) Advertising, marketing, and promotion of 

10 tobacco products have been especially directed to at11 tract young persons to use tobacco products, and 

12 these efforts have resulted in increased use of such 

13 products by youth. Past efforts to oversee these ac14 tivities have not been successful in adequately pre15 venting such increased use. 

16 (16) In 2005, the cigarette manufacturers 

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

18 users, retain current users, increase current con19 sumption, and generate favorable long-term atti20 tudes toward smoking and tobacco use. 

21 (17) Tobacco product advertising often 

22 misleadingly portrays the use of tobacco as socially 

23 acceptable and healthful to minors. 

24 (18) Tobacco product advertising is regularly 

25 seen by persons under the age of 18, and persons 
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1 under the age of 18 are regularly exposed to tobacco 

2 product promotional efforts. 

3 (19) Through advertisements during and spon4 sorship of sporting events, tobacco has become 

5 strongly associated with sports and has become por6 trayed as an integral part of sports and the healthy 

7 lifestyle associated with rigorous sporting activity. 

8 (20) Children are exposed to substantial and 

9 unavoidable tobacco advertising that leads to favor10 able beliefs about tobacco use, plays a role in leading 

11 young people to overestimate the prevalence of to12 bacco use, and increases the number of young people 

13 who begin to use tobacco. 

14 (21) The use of tobacco products in motion pic15 tures and other mass media glamorizes its use for 

16 young people and encourages them to use tobacco 

17 products. 

18 (22) Tobacco advertising expands the size of 

19 the tobacco market by increasing consumption of to20 bacco products including tobacco use by young peo21 ple. 

22 (23) Children are more influenced by tobacco 

23 marketing than adults: more than 80 percent of 

24 youth smoke three heavily marketed brands, while 
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1 only 54 percent of adults, 26 and older, smoke these 

2 same brands. 

3 (24) Tobacco company documents indicate that 

4 young people are an important and often crucial seg5 ment of the tobacco market. Children, who tend to 

6 be more price sensitive than adults, are influenced 

7 by advertising and promotion practices that result in 

8 drastically reduced cigarette prices. 

9 (25) Comprehensive advertising restrictions will 

10 have a positive effect on the smoking rates of young 

11 people. 

12 (26) Restrictions on advertising are necessary 

13 to prevent unrestricted tobacco advertising from un14 dermining legislation prohibiting access to young 

15 people and providing for education about tobacco 

16 use. 

17 (27) International experience shows that adver18 tising regulations that are stringent and comprehen19 sive have a greater impact on overall tobacco use 

20 and young people’s use than weaker or less com21 prehensive ones. 

22 (28) Text only requirements, although not as 

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

24 tobacco products while preserving the informational 

25 function of advertising. 
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1 (29) It is in the public interest for Congress to 

2 adopt legislation to address the public health crisis 

3 created by actions of the tobacco industry. 

4 (30) The final regulations promulgated by the 

5 Secretary of Health and Human Services in the Au6 gust 28, 1996, issue of the Federal Register (61 

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

8 of title 21, Code of Federal Regulations, are con9 sistent with the first amendment to the United 

10 States Constitution and with the standards set forth 

11 in the amendments made by this subtitle for the reg12 ulation of tobacco products by the Food and Drug 

13 Administration, and the restriction on the sale and 

14 distribution of, including access to and the adver15 tising and promotion of, tobacco products contained 

16 in such regulations are substantially related to ac17 complishing the public health goals of this Act. 

18 (31) The regulations described in paragraph 

19 (30) will directly and materially advance the Federal 

20 Government’s substantial interest in reducing the 

21 number of children and adolescents who use ciga22 rettes and smokeless tobacco and in preventing the 

23 life-threatening health consequences associated with 

24 tobacco use. An overwhelming majority of Americans 

25 who use tobacco products begin using such products 
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1 while they are minors and become addicted to the 

2 nicotine in those products before reaching the age of 

3 18. Tobacco advertising and promotion play a cru4 cial role in the decision of these minors to begin 

5 using tobacco products. Less restrictive and less 

6 comprehensive approaches have not and will not be 

7 effective in reducing the problems addressed by such 

8 regulations. The reasonable restrictions on the ad9 vertising and promotion of tobacco products con10 tained in such regulations will lead to a significant 

11 decrease in the number of minors using and becom12 ing addicted to those products. 

13 (32) The regulations described in paragraph 

14 (30) impose no more extensive restrictions on com15 munication by tobacco manufacturers and sellers 

16 than are necessary to reduce the number of children 

17 and adolescents who use cigarettes and smokeless to18 bacco and to prevent the life-threatening health con19 sequences associated with tobacco use. Such regula20 tions are narrowly tailored to restrict those adver21 tising and promotional practices which are most like22 ly to be seen or heard by youth and most likely to 

23 entice them into tobacco use, while affording tobacco 

24 manufacturers and sellers ample opportunity to con-
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1 vey information about their products to adult con2 sumers. 

3 (33) Tobacco dependence is a chronic disease, 

4 one that typically requires repeated interventions to 

5 achieve long-term or permanent abstinence. 

6 (34) Because the only known safe alternative to 

7 smoking is cessation, interventions should target all 

8 smokers to help them quit completely. 

9 (35) Tobacco products have been used to facili10 tate and finance criminal activities both domestically 

11 and internationally. Illicit trade of tobacco products 

12 has been linked to organized crime and terrorist 

13 groups. 

14 (36) It is essential that the Food and Drug Ad15 ministration review products sold or distributed for 

16 use to reduce risks or exposures associated with to17 bacco products and that it be empowered to review 

18 any advertising and labeling for such products. It is 

19 also essential that manufacturers, prior to marketing 

20 such products, be required to demonstrate that such 

21 products will meet a series of rigorous criteria, and 

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

23 taking into account both users of tobacco products 

24 and persons who do not currently use tobacco prod25 ucts. 
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1 (37) Unless tobacco products that purport to 

2 reduce the risks to the public of tobacco use actually 

3 reduce such risks, those products can cause substan4 tial harm to the public health to the extent that the 

5 individuals, who would otherwise not consume to6 bacco products or would consume such products less, 

7 use tobacco products purporting to reduce risk. 

8 Those who use products sold or distributed as modi9 fied risk products that do not in fact reduce risk, 

10 rather than quitting or reducing their use of tobacco 

11 products, have a substantially increased likelihood of 

12 suffering disability and premature death. The costs 

13 to society of the widespread use of products sold or 

14 distributed as modified risk products that do not in 

15 fact reduce risk or that increase risk include thou16 sands of unnecessary deaths and injuries and huge 

17 costs to our health care system. 

18 (38) As the National Cancer Institute has 

19 found, many smokers mistakenly believe that ‘‘low 

20 tar’’ and ‘‘light’’ cigarettes cause fewer health prob21 lems than other cigarettes. As the National Cancer 

22 Institute has also found, mistaken beliefs about the 

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

24 ‘‘light’’ cigarettes can reduce the motivation to quit 
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1 smoking entirely and thereby lead to disease and 

2 death. 

3 (39) Recent studies have demonstrated that 

4 there has been no reduction in risk on a population5 wide basis from ‘‘low tar’’ and ‘‘light’’ cigarettes, 

6 and such products may actually increase the risk of 

7 tobacco use. 

8 (40) The dangers of products sold or distrib9 uted as modified risk tobacco products that do not 

10 in fact reduce risk are so high that there is a com11 pelling governmental interest in ensuring that state12 ments about modified risk tobacco products are com13 plete, accurate, and relate to the overall disease risk 

14 of the product. 

15 (41) As the Federal Trade Commission has 

16 found, consumers have misinterpreted advertise17 ments in which one product is claimed to be less 

18 harmful than a comparable product, even in the 

19 presence of disclosures and advisories intended to 

20 provide clarification. 

21 (42) Permitting manufacturers to make unsub22 stantiated statements concerning modified risk to23 bacco products, whether express or implied, even if 

24 accompanied by disclaimers would be detrimental to 

25 the public health. 
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1 (43) The only way to effectively protect the 

2 public health from the dangers of unsubstantiated 

3 modified risk tobacco products is to empower the 

4 Food and Drug Administration to require that prod5 ucts that tobacco manufacturers sold or distributed 

6 for risk reduction be reviewed in advance of mar7 keting, and to require that the evidence relied on to 

8 support claims be fully verified. 

9 (44) The Food and Drug Administration is a 

10 regulatory agency with the scientific expertise to 

11 identify harmful substances in products to which 

12 consumers are exposed, to design standards to limit 

13 exposure to those substances, to evaluate scientific 

14 studies supporting claims about the safety of prod15 ucts, and to evaluate the impact of labels, labeling, 

16 and advertising on consumer behavior in order to re17 duce the risk of harm and promote understanding of 

18 the impact of the product on health. In connection 

19 with its mandate to promote health and reduce the 

20 risk of harm, the Food and Drug Administration 

21 routinely makes decisions about whether and how 

22 products may be marketed in the United States. 

23 (45) The Federal Trade Commission was cre24 ated to protect consumers from unfair or deceptive 

25 acts or practices, and to regulate unfair methods of 
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1 competition. Its focus is on those marketplace prac2 tices that deceive or mislead consumers, and those 

3 that give some competitors an unfair advantage. Its 

4 mission is to regulate activities in the marketplace. 

5 Neither the Federal Trade Commission nor any 

6 other Federal agency except the Food and Drug Ad7 ministration possesses the scientific expertise needed 

8 to implement effectively all provisions of the Family 

9 Smoking Prevention and Tobacco Control Act. 

10 (46) If manufacturers state or imply in commu11 nications directed to consumers through the media 

12 or through a label, labeling, or advertising, that a to13 bacco product is approved or inspected by the Food 

14 and Drug Administration or complies with Food and 

15 Drug Administration standards, consumers are like16 ly to be confused and misled. Depending upon the 

17 particular language used and its context, such a 

18 statement could result in consumers being misled 

19 into believing that the product is endorsed by the 

20 Food and Drug Administration for use or in con21 sumers being misled about the harmfulness of the 

22 product because of such regulation, inspection, ap23 proval, or compliance. 

24 (47) In August 2006 a United States district 

25 court judge found that the major United States cig-
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1 arette companies continue to target and market to 

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

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

4 (48) In August 2006 a United States district 

5 court judge found that the major United States cig6 arette companies dramatically increased their adver7 tising and promotional spending in ways that en8 courage youth to start smoking subsequent to the 

9 signing of the Master Settlement Agreement in 

10 1998. USA v. Philip Morris, USA, Inc., et al. (Civil 

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

12 (49) In August 2006 a United States district 

13 court judge found that the major United States cig14 arette companies have designed their cigarettes to 

15 precisely control nicotine delivery levels and provide 

16 doses of nicotine sufficient to create and sustain ad17 diction while also concealing much of their nicotine18 related research. USA v. Philip Morris, USA, Inc., 

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

20 2006). 

21 SEC. 3. PURPOSE. 

22 The purposes of this Act are— 

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

24 Administration to regulate tobacco products under 

25 the Federal Food, Drug, and Cosmetic Act (21 
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1 U.S.C. 301 et seq.), by recognizing it as the primary 

2 Federal regulatory authority with respect to the 

3 manufacture, marketing, and distribution of tobacco 

4 products as provided for in this Act; 

5 (2) to ensure that the Food and Drug Adminis6 tration has the authority to address issues of par7 ticular concern to public health officials, especially 

8 the use of tobacco by young people and dependence 

9 on tobacco; 

10 (3) to authorize the Food and Drug Adminis11 tration to set national standards controlling the 

12 manufacture of tobacco products and the identity, 

13 public disclosure, and amount of ingredients used in 

14 such products; 

15 (4) to provide new and flexible enforcement au16 thority to ensure that there is effective oversight of 

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

18 and promote less harmful tobacco products; 

19 (5) to vest the Food and Drug Administration 

20 with the authority to regulate the levels of tar, nico21 tine, and other harmful components of tobacco prod22 ucts; 

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

24 informed, to require tobacco product manufacturers 

25 to disclose research which has not previously been 
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1 made available, as well as research generated in the 

2 future, relating to the health and dependency effects 

3 or safety of tobacco products; 

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

5 products to adults in conjunction with measures to 

6 ensure that they are not sold or accessible to under7 age purchasers; 

8 (8) to impose appropriate regulatory controls on 

9 the tobacco industry; 

10 (9) to promote cessation to reduce disease risk 

11 and the social costs associated with tobacco-related 

12 diseases; and 

13 (10) to strengthen legislation against illicit 

14 trade in tobacco products. 

15 SEC. 4. SCOPE AND EFFECT. 

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

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

18 (1) establish a precedent with regard to any 

19 other industry, situation, circumstance, or legal ac20 tion; or 

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

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

23 contract of any kind. 

24 (b) AGRICULTURAL ACTIVITIES.—The provisions of 

25 this Act (or an amendment made by this Act) which au-
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1 thorize the Secretary to take certain actions with regard 

2 to tobacco and tobacco products shall not be construed to 

3 affect any authority of the Secretary of Agriculture under 

4 existing law regarding the growing, cultivation, or curing 

5 of raw tobacco. 

6 (c) REVENUE ACTIVITIES.—The provisions of this 

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

8 the Secretary to take certain actions with regard to to9 bacco products shall not be construed to affect any author10 ity of the Secretary of the Treasury under chapter 52 of 

11 the Internal Revenue Code of 1986. 

12 SEC. 5. SEVERABILITY. 

13 If any provision of this Act, the amendments made 

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

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

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

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

18 other person or circumstance shall not be affected and 

19 shall continue to be enforced to the fullest extent possible. 
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1 TITLE I—AUTHORITY OF THE 

2 FOOD AND DRUG ADMINIS3 TRATION 

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

5 COSMETIC ACT. 

6 (a) DEFINITION OF TOBACCO PRODUCTS.—Section 

7 201 of the Federal Food, Drug, and Cosmetic Act (21 

8 U.S.C. 321) is amended by adding at the end the fol9 lowing: 

10 ‘‘(rr)(1) The term ‘tobacco product’ means any prod11 uct made or derived from tobacco that is intended for 

12 human consumption, including any component, part, or 

13 accessory of a tobacco product (except for raw materials 

14 other than tobacco used in manufacturing a component, 

15 part, or accessory of a tobacco product). 

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

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

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

19 in section 503(g). 

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

21 be subject to chapter V of this Act. 

22 ‘‘(4) A tobacco product shall not be marketed in com23 bination with any other article or product regulated under 

24 this Act (including a drug, biologic, food, cosmetic, med25 ical device, or a dietary supplement).’’. 
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1 (b) FDA AUTHORITY OVER TOBACCO PRODUCTS.— 

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

3 301 et seq.) is amended— 

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

5 (2) by redesignating sections 901 through 910 

6 as sections 1001 through 1010; and 

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

9 ‘‘CHAPTER IX—TOBACCO PRODUCTS 

10 ‘‘SEC. 900. DEFINITIONS. 

11 ‘‘In this chapter: 

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

13 any substance the intended use of which results or 

14 may reasonably be expected to result, directly or in15 directly, in its becoming a component or otherwise 

16 affecting the characteristic of any tobacco product 

17 (including any substances intended for use as a fla18 voring or coloring or in producing, manufacturing, 

19 packing, processing, preparing, treating, packaging, 

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

21 not include tobacco or a pesticide chemical residue 

22 in or on raw tobacco or a pesticide chemical. 

23 ‘‘(2) BRAND.—The term ‘brand’ means a vari24 ety of tobacco product distinguished by the tobacco 

25 used, tar content, nicotine content, flavoring used, 
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1 size, filtration, packaging, logo, registered trade2 mark, brand name, identifiable pattern of colors, or 

3 any combination of such attributes. 

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

5 ‘‘(A) means a product that— 

6 ‘‘(i) is a tobacco product; and 

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

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

9 Cigarette Labeling and Advertising Act; 

10 and 

11 ‘‘(B) includes tobacco, in any form, that is 

12 functional in the product, which, because of its 

13 appearance, the type of tobacco used in the 

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

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

16 cigarette or as roll-your-own tobacco. 

17 ‘‘(4) CIGARETTE TOBACCO.—The term ‘ciga18 rette tobacco’ means any product that consists of 

19 loose tobacco that is intended for use by consumers 

20 in a cigarette. Unless otherwise stated, the require21 ments applicable to cigarettes under this chapter 

22 shall also apply to cigarette tobacco. 

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

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

25 Federal Cigarette Labeling and Advertising Act. 
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1 ‘‘(6) COUNTERFEIT TOBACCO PRODUCT.—The 

2 term ‘counterfeit tobacco product’ means a tobacco 

3 product (or the container or labeling of such a prod4 uct) that, without authorization, bears the trade5 mark, trade name, or other identifying mark, im6 print, or device, or any likeness thereof, of a tobacco 

7 product listed in a registration under section 

8 905(i)(1). 

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

10 regards a tobacco product means any person who 

11 furthers the distribution of a tobacco product, 

12 whether domestic or imported, at any point from the 

13 original place of manufacture to the person who sells 

14 or distributes the product to individuals for personal 

15 consumption. Common carriers are not considered 

16 distributors for purposes of this chapter. 

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

18 means any practice or conduct prohibited by law 

19 which relates to production, shipment, receipt, pos20 session, distribution, sale, or purchase of tobacco 

21 products including any practice or conduct intended 

22 to facilitate such activity. 

23 ‘‘(9) INDIAN COUNTRY.—The term ‘Indian 

24 country’ has the meaning given such term in section 

25 1151 of title 18, United States Code. 
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1 ‘‘(10) INDIAN TRIBE.—The term ‘Indian tribe’ 

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

3 the Indian Self-Determination and Education Assist4 ance Act. 

5 ‘‘(11) LITTLE CIGAR.—The term ‘little cigar’ 

6 means a product that— 

7 ‘‘(A) is a tobacco product; and 

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

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

10 Labeling and Advertising Act. 

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

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

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

14 any salt or complex of nicotine. 

15 ‘‘(13) PACKAGE.—The term ‘package’ means a 

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

17 other container, any wrapping (including cello18 phane), in which a tobacco product is offered for 

19 sale, sold, or otherwise distributed to consumers. 

20 ‘‘(14) RETAILER.—The term ‘retailer’ means 

21 any person, government, or entity who sells tobacco 

22 products to individuals for personal consumption, or 

23 who operates a facility where self-service displays of 

24 tobacco products are permitted. 
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1 ‘‘(15) ROLL-YOUR-OWN TOBACCO.—The term 

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

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

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

5 to, or purchased by, consumers as tobacco for mak6 ing cigarettes. 

7 ‘‘(16) SMALL TOBACCO PRODUCT MANUFAC8 TURER.—The term ‘small tobacco product manufac9 turer’ means a tobacco product manufacturer that 

10 employs fewer than 350 employees. For purposes of 

11 determining the number of employees of a manufac12 turer under the preceding sentence, the employees of 

13 a manufacturer are deemed to include the employees 

14 of each entity that controls, is controlled by, or is 

15 under common control with such manufacturer. 

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

17 constituent’ means any chemical or chemical com18 pound in mainstream or sidestream tobacco smoke 

19 that either transfers from any component of the cig20 arette to the smoke or that is formed by the combus21 tion or heating of tobacco, additives, or other compo22 nent of the tobacco product. 

23 ‘‘(18) SMOKELESS TOBACCO.—The term 

24 ‘smokeless tobacco’ means any tobacco product that 

25 consists of cut, ground, powdered, or leaf tobacco 
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1 and that is intended to be placed in the oral or nasal 

2 cavity. 

3 ‘‘(19) STATE; TERRITORY.—The terms ‘State’ 

4 and ‘Territory’ shall have the meanings given to 

5 such terms in section 201. 

6 ‘‘(20) TOBACCO PRODUCT MANUFACTURER.— 

7 The term ‘tobacco product manufacturer’ means any 

8 person, including any repacker or relabeler, who— 

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

10 processes, or labels a tobacco product; or 

11 ‘‘(B) imports a finished tobacco product 

12 for sale or distribution in the United States. 

13 ‘‘(21) TOBACCO WAREHOUSE.— 

14 ‘‘(A) Subject to subparagraphs (B) and 

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

16 person— 

17 ‘‘(i) who— 

18 ‘‘(I) removes foreign material 

19 from tobacco leaf through nothing 

20 other than a mechanical process; 

21 ‘‘(II) humidifies tobacco leaf with 

22 nothing other than potable water in 

23 the form of steam or mist; or 

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

25 tobacco leaf for storage and shipment; 
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1 ‘‘(ii) who performs no other actions 

2 with respect to tobacco leaf; and 

3 ‘‘(iii) who provides to any manufac4 turer to whom the person sells tobacco all 

5 information related to the person’s actions 

6 described in clause (i) that is necessary for 

7 compliance with this Act. 

8 ‘‘(B) The term ‘tobacco warehouse’ ex9 cludes any person who— 

10 ‘‘(i) reconstitutes tobacco leaf; 

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

12 retailer of a tobacco product; or 

13 ‘‘(iii) applies any chemical, additive, 

14 or substance to the tobacco leaf other than 

15 potable water in the form of steam or mist. 

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

17 warehouse’ in subparagraph (A) shall not apply 

18 to the extent to which the Secretary determines, 

19 through rulemaking, that regulation under this 

20 chapter of the actions described in such sub21 paragraph is appropriate for the protection of 

22 the public health. 

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

24 States’ means the 50 States of the United States of 

25 America and the District of Columbia, the Common-
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1 wealth of Puerto Rico, Guam, the Virgin Islands, 

2 American Samoa, Wake Island, Midway Islands, 

3 Kingman Reef, Johnston Atoll, the Northern Mar4 iana Islands, and any other trust territory or posses5 sion of the United States. 

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

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

8 modified risk tobacco products for which an order has 

9 been issued in accordance with section 911, shall be regu10 lated by the Secretary under this chapter and shall not 

11 be subject to the provisions of chapter V. 

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

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

14 smokeless tobacco and to any other tobacco products that 

15 the Secretary by regulation deems to be subject to this 

16 chapter. 

17 ‘‘(c) SCOPE.— 

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

19 any policy issued or regulation promulgated there20 under, or in sections 101(a), 102, or 103 of title I, 

21 title II, or title III of the Family Smoking Preven22 tion and Tobacco Control Act, shall be construed to 

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

24 over (including the authority to determine whether 

25 products may be regulated), or the regulation of, 
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1 products under this Act that are not tobacco prod2 ucts under chapter V or any other chapter. 

3 ‘‘(2) LIMITATION OF AUTHORITY.— 

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

5 chapter shall not apply to tobacco leaf that is 

6 not in the possession of a manufacturer of to7 bacco products, or to the producers of tobacco 

8 leaf, including tobacco growers, tobacco ware9 houses, and tobacco grower cooperatives, nor 

10 shall any employee of the Food and Drug Ad11 ministration have any authority to enter onto a 

12 farm owned by a producer of tobacco leaf with13 out the written consent of such producer. 

14 ‘‘(B) EXCEPTION.—Notwithstanding sub15 paragraph (A), if a producer of tobacco leaf is 

16 also a tobacco product manufacturer or con17 trolled by a tobacco product manufacturer, the 

18 producer shall be subject to this chapter in the 

19 producer’s capacity as a manufacturer. The ex20 ception in this subparagraph shall not apply to 

21 a producer of tobacco leaf who grows tobacco 

22 under a contract with a tobacco product manu23 facturer and who is not otherwise engaged in 

24 the manufacturing process. 
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1 ‘‘(C) RULE OF CONSTRUCTION.—Nothing 

2 in this chapter shall be construed to grant the 

3 Secretary authority to promulgate regulations 

4 on any matter that involves the production of 

5 tobacco leaf or a producer thereof, other than 

6 activities by a manufacturer affecting produc7 tion. 

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

9 under this chapter shall be in accordance with chapter 5 

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

11 be construed to affect the rulemaking provisions of section 

12 102(a) of the Family Smoking Prevention and Tobacco 

13 Control Act. 

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

15 than 90 days after the date of enactment of the Family 

16 Smoking Prevention and Tobacco Control Act, the Sec17 retary shall establish within the Food and Drug Adminis18 tration the Center for Tobacco Products, which shall re19 port to the Commissioner of Food and Drugs in the same 

20 manner as the other agency centers within the Food and 

21 Drug Administration. The Center shall be responsible for 

22 the implementation of this chapter and related matters as23 signed by the Commissioner. 

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

25 MANUFACTURERS.—The Secretary shall establish within 
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1 the Food and Drug Administration an identifiable office 

2 to provide technical and other nonfinancial assistance to 

3 small tobacco product manufacturers to assist them in 

4 complying with the requirements of this Act. 

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

6 to promulgating rules under this chapter, the Secretary 

7 shall endeavor to consult with other Federal agencies as 

8 appropriate. 

9 ‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS. 

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

11 if— 

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

13 putrid, or decomposed substance, or is otherwise 

14 contaminated by any added poisonous or added dele15 terious substance that may render the product inju16 rious to health; 

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

18 under insanitary conditions whereby it may have 

19 been contaminated with filth, or whereby it may 

20 have been rendered injurious to health; 

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

22 part, of any poisonous or deleterious substance 

23 which may render the contents injurious to health; 

24 ‘‘(4) the manufacturer or importer of the to25 bacco product fails to pay a user fee assessed to 
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1 such manufacturer or importer pursuant to section 

2 919 by the date specified in section 919 or by the 

3 30th day after final agency action on a resolution of 

4 any dispute as to the amount of such fee; 

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

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

7 product standard established under section 907 un8 less such tobacco product is in all respects in con9 formity with such standard; 

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

11 premarket review and does not have an order in ef12 fect under section 910(c)(1)(A)(i); or 

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

14 910(c)(1)(A); 

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

16 controls used for, its manufacture, packing, or stor17 age are not in conformity with applicable require18 ments under section 906(e)(1) or an applicable con19 dition prescribed by an order under section 

20 906(e)(2); or 

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

22 ‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS. 

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

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

2 particular; 

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

4 containing— 

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

6 tobacco product manufacturer, packer, or dis7 tributor; 

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

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

10 numerical count; 

11 ‘‘(C) an accurate statement of the percent12 age of the tobacco used in the product that is 

13 domestically grown tobacco and the percentage 

14 that is foreign grown tobacco; and 

15 ‘‘(D) the statement required under section 

16 920(a), 

17 except that under subparagraph (B) reasonable vari18 ations shall be permitted, and exemptions as to 

19 small packages shall be established, by regulations 

20 prescribed by the Secretary; 

21 ‘‘(3) if any word, statement, or other informa22 tion required by or under authority of this chapter 

23 to appear on the label or labeling is not prominently 

24 placed thereon with such conspicuousness (as com25 pared with other words, statements, or designs in 
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1 the labeling) and in such terms as to render it likely 

2 to be read and understood by the ordinary individual 

3 under customary conditions of purchase and use; 

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

5 label bears, to the exclusion of any other nonpropri6 etary name, its established name prominently print7 ed in type as required by the Secretary by regula8 tion; 

9 ‘‘(5) if the Secretary has issued regulations re10 quiring that its labeling bear adequate directions for 

11 use, or adequate warnings against use by children, 

12 that are necessary for the protection of users unless 

13 its labeling conforms in all respects to such regula14 tions; 

15 ‘‘(6) if it was manufactured, prepared, propa16 gated, compounded, or processed in an establishment 

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

18 905(d), or 905(h), if it was not included in a list re19 quired by section 905(i), if a notice or other infor20 mation respecting it was not provided as required by 

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

22 such symbols from the uniform system for identifica23 tion of tobacco products prescribed under section 

24 905(e) as the Secretary by regulation requires; 
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1 ‘‘(7) if, in the case of any tobacco product dis2 tributed or offered for sale in any State— 

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

4 in any particular; or 

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

6 regulations prescribed under section 906(d); 

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

8 distributed or offered for sale in any State, the man9 ufacturer, packer, or distributor thereof includes in 

10 all advertisements and other descriptive printed mat11 ter issued or caused to be issued by the manufac12 turer, packer, or distributor with respect to that to13 bacco product— 

14 ‘‘(A) a true statement of the tobacco prod15 uct’s established name as described in para16 graph (4), printed prominently; and 

17 ‘‘(B) a brief statement of— 

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

19 and relevant warnings, precautions, side 

20 effects, and contraindications; and 

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

22 products made subject to a finding by the 

23 Secretary after notice and opportunity for 

24 comment that such action is appropriate to 

25 protect the public health, a full description 
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1 of the components of such tobacco product 

2 or the formula showing quantitatively each 

3 ingredient of such tobacco product to the 

4 extent required in regulations which shall 

5 be issued by the Secretary after an oppor6 tunity for a hearing; 

7 ‘‘(9) if it is a tobacco product subject to a to8 bacco product standard established under section 

9 907, unless it bears such labeling as may be pre10 scribed in such tobacco product standard; or 

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

12 ‘‘(A) to comply with any requirement pre13 scribed under section 904 or 908; or 

14 ‘‘(B) to furnish any material or informa15 tion required under section 909. 

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

17 The Secretary may, by regulation, require prior approval 

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

19 regulation issued under this subsection may require prior 

20 approval by the Secretary of the content of any advertise21 ment, except for modified risk tobacco products as pro22 vided in section 911. No advertisement of a tobacco prod23 uct published after the date of enactment of the Family 

24 Smoking Prevention and Tobacco Control Act shall, with 

25 respect to the language of label statements as prescribed 
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1 under section 4 of the Federal Cigarette Labeling and Ad2 vertising Act and section 3 of the Comprehensive Smoke3 less Tobacco Health Education Act of 1986 or the regula4 tions issued under such sections, be subject to the provi5 sions of sections 12 through 15 of the Federal Trade Com6 mission Act. 

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

8 SECRETARY. 

9 ‘‘(a) REQUIREMENT.—Each tobacco product manu10 facturer or importer, or agents thereof, shall submit to 

11 the Secretary the following information: 

12 ‘‘(1) Not later than 6 months after the date of 

13 enactment of the Family Smoking Prevention and 

14 Tobacco Control Act, a listing of all ingredients, in15 cluding tobacco, substances, compounds, and addi16 tives that are, as of such date, added by the manu17 facturer to the tobacco, paper, filter, or other part 

18 of each tobacco product by brand and by quantity in 

19 each brand and subbrand. 

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

21 form of nicotine in each tobacco product measured 

22 in milligrams of nicotine in accordance with regula23 tions promulgated by the Secretary in accordance 

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

25 and Advertising Act. 
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1 ‘‘(3) Beginning 3 years after the date of enact2 ment of the Family Smoking Prevention and To3 bacco Control Act, a listing of all constituents, in4 cluding smoke constituents as applicable, identified 

5 by the Secretary as harmful or potentially harmful 

6 to health in each tobacco product, and as applicable 

7 in the smoke of each tobacco product, by brand and 

8 by quantity in each brand and subbrand. Effective 

9 beginning 3 years after such date of enactment, the 

10 manufacturer, importer, or agent shall comply with 

11 regulations promulgated under section 915 in re12 porting information under this paragraph, where ap13 plicable. 

14 ‘‘(4) Beginning 6 months after the date of en15 actment of the Family Smoking Prevention and To16 bacco Control Act, all documents developed after 

17 such date of enactment that relate to health, toxi18 cological, behavioral, or physiologic effects of current 

19 or future tobacco products, their constituents (in20 cluding smoke constituents), ingredients, compo21 nents, and additives. 

22 ‘‘(b) DATA SUBMISSION.—At the request of the Sec23 retary, each tobacco product manufacturer or importer of 

24 tobacco products, or agents thereof, shall submit the fol25 lowing: 
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1 ‘‘(1) Any or all documents (including under2 lying scientific information) relating to research ac3 tivities, and research findings, conducted, supported, 

4 or possessed by the manufacturer (or agents thereof) 

5 on the health, toxicological, behavioral, or physio6 logic effects of tobacco products and their constitu7 ents (including smoke constituents), ingredients, 

8 components, and additives. 

9 ‘‘(2) Any or all documents (including under10 lying scientific information) relating to research ac11 tivities, and research findings, conducted, supported, 

12 or possessed by the manufacturer (or agents thereof) 

13 that relate to the issue of whether a reduction in 

14 risk to health from tobacco products can occur upon 

15 the employment of technology available or known to 

16 the manufacturer. 

17 ‘‘(3) Any or all documents (including under18 lying scientific or financial information) relating to 

19 marketing research involving the use of tobacco 

20 products or marketing practices and the effective21 ness of such practices used by tobacco manufactur22 ers and distributors. 

23 An importer of a tobacco product not manufactured in the 

24 United States shall supply the information required of a 

25 tobacco product manufacturer under this subsection. 
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1 ‘‘(c) TIME FOR SUBMISSION.— 

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

3 the delivery for introduction into interstate com4 merce of a tobacco product not on the market on the 

5 date of enactment of the Family Smoking Preven6 tion and Tobacco Control Act, the manufacturer of 

7 such product shall provide the information required 

8 under subsection (a). 

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

10 time a tobacco product manufacturer adds to its to11 bacco products a new tobacco additive or increases 

12 the quantity of an existing tobacco additive, the 

13 manufacturer shall, except as provided in paragraph 

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

15 the Secretary in writing. 

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

17 any time a tobacco product manufacturer eliminates 

18 or decreases an existing additive, or adds or in19 creases an additive that has by regulation been des20 ignated by the Secretary as an additive that is not 

21 a human or animal carcinogen, or otherwise harmful 

22 to health under intended conditions of use, the man23 ufacturer shall within 60 days of such action so ad24 vise the Secretary in writing. 

25 ‘‘(d) DATA LIST.— 
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1 ‘‘(1) IN GENERAL.—Not later than 3 years 

2 after the date of enactment of the Family Smoking 

3 Prevention and Tobacco Control Act, and annually 

4 thereafter, the Secretary shall publish in a format 

5 that is understandable and not misleading to a lay 

6 person, and place on public display (in a manner de7 termined by the Secretary) the list established under 

8 subsection (e). 

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

10 shall conduct periodic consumer research to ensure 

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

12 misleading to lay persons. Not later than 5 years 

13 after the date of enactment of the Family Smoking 

14 Prevention and Tobacco Control Act, the Secretary 

15 shall submit to the appropriate committees of Con16 gress a report on the results of such research, to17 gether with recommendations on whether such publi18 cation should be continued or modified. 

19 ‘‘(e) DATA COLLECTION.—Not later than 24 months 

20 after the date of enactment of the Family Smoking Pre21 vention and Tobacco Control Act, the Secretary shall es22 tablish, and periodically revise as appropriate, a list of 

23 harmful and potentially harmful constituents, including 

24 smoke constituents, to health in each tobacco product by 

25 brand and by quantity in each brand and subbrand. The 
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1 Secretary shall publish a public notice requesting the sub2 mission by interested persons of scientific and other infor3 mation concerning the harmful and potentially harmful 

4 constituents in tobacco products and tobacco smoke. 

5 ‘‘SEC. 905. ANNUAL REGISTRATION. 

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

7 ‘‘(1) MANUFACTURE, PREPARATION, 

8 COMPOUNDING, OR PROCESSING.—The term ‘manu9 facture, preparation, compounding, or processing’ 

10 shall include repackaging or otherwise changing the 

11 container, wrapper, or labeling of any tobacco prod12 uct package in furtherance of the distribution of the 

13 tobacco product from the original place of manufac14 ture to the person who makes final delivery or sale 

15 to the ultimate consumer or user. 

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

17 the case of a partnership the name of each partner 

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

19 corporate officer and director, and the State of in20 corporation. 

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

22 On or before December 31 of each year, every person who 

23 owns or operates any establishment in any State engaged 

24 in the manufacture, preparation, compounding, or proc25 essing of a tobacco product or tobacco products shall reg-
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1 ister with the Secretary the name, places of business, and 

2 all such establishments of that person. If enactment of the 

3 Family Smoking Prevention and Tobacco Control Act oc4 curs in the second half of the calendar year, the Secretary 

5 shall designate a date no later than 6 months into the 

6 subsequent calendar year by which registration pursuant 

7 to this subsection shall occur. 

8 ‘‘(c) REGISTRATION BY NEW OWNERS AND OPERA9 TORS.—Every person upon first engaging in the manufac10 ture, preparation, compounding, or processing of a tobacco 

11 product or tobacco products in any establishment owned 

12 or operated in any State by that person shall immediately 

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

14 business, and such establishment. 

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

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

17 (c) shall immediately register with the Secretary any addi18 tional establishment which that person owns or operates 

19 in any State and in which that person begins the manufac20 ture, preparation, compounding, or processing of a tobacco 

21 product or tobacco products. 

22 ‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYS23 TEM.—The Secretary may by regulation prescribe a uni24 form system for the identification of tobacco products and 

25 may require that persons who are required to list such 
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1 tobacco products under subsection (i) shall list such to2 bacco products in accordance with such system. 

3 ‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA4 TION.—The Secretary shall make available for inspection, 

5 to any person so requesting, any registration filed under 

6 this section. 

7 ‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB8 LISHMENTS.—Every establishment registered with the 

9 Secretary under this section shall be subject to inspection 

10 under section 704 or subsection (h), and every such estab11 lishment engaged in the manufacture, compounding, or 

12 processing of a tobacco product or tobacco products shall 

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

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

15 period beginning with the date of registration of such es16 tablishment under this section and at least once in every 

17 successive 2-year period thereafter. 

18 ‘‘(h) REGISTRATION BY FOREIGN ESTABLISH19 MENTS.—Any establishment within any foreign country 

20 engaged in the manufacture, preparation, compounding, 

21 or processing of a tobacco product or tobacco products, 

22 shall register under this section under regulations promul23 gated by the Secretary. Such regulations shall require 

24 such establishment to provide the information required by 

25 subsection (i) and shall include provisions for registration 
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1 of any such establishment upon condition that adequate 

2 and effective means are available, by arrangement with the 

3 government of such foreign country or otherwise, to enable 

4 the Secretary to determine from time to time whether to5 bacco products manufactured, prepared, compounded, or 

6 processed in such establishment, if imported or offered for 

7 import into the United States, shall be refused admission 

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

9 ‘‘(i) REGISTRATION INFORMATION.— 

10 ‘‘(1) PRODUCT LIST.—Every person who reg11 isters with the Secretary under subsection (b), (c), 

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

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

14 all tobacco products which are being manufactured, 

15 prepared, compounded, or processed by that person 

16 for commercial distribution and which have not been 

17 included in any list of tobacco products filed by that 

18 person with the Secretary under this paragraph or 

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

20 list shall be prepared in such form and manner as 

21 the Secretary may prescribe and shall be accom22 panied by— 

23 ‘‘(A) in the case of a tobacco product con24 tained in the applicable list with respect to 

25 which a tobacco product standard has been es-
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•HR 1256 EH

1 tablished under section 907 or which is subject 

2 to section 910, a reference to the authority for 

3 the marketing of such tobacco product and a 

4 copy of all labeling for such tobacco product; 

5 ‘‘(B) in the case of any other tobacco prod6 uct contained in an applicable list, a copy of all 

7 consumer information and other labeling for 

8 such tobacco product, a representative sampling 

9 of advertisements for such tobacco product, 

10 and, upon request made by the Secretary for 

11 good cause, a copy of all advertisements for a 

12 particular tobacco product; and 

13 ‘‘(C) if the registrant filing a list has de14 termined that a tobacco product contained in 

15 such list is not subject to a tobacco product 

16 standard established under section 907, a brief 

17 statement of the basis upon which the reg18 istrant made such determination if the Sec19 retary requests such a statement with respect 

20 to that particular tobacco product. 

21 ‘‘(2) CONSULTATION WITH RESPECT TO

22 FORMS.—The Secretary shall consult with the Sec23 retary of the Treasury in developing the forms to be 

24 used for registration under this section to minimize 

25 the burden on those persons required to register 
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1 with both the Secretary and the Tax and Trade Bu2 reau of the Department of the Treasury. 

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

4 PRODUCT LIST.—Each person who registers with the 

5 Secretary under this section shall report to the Sec6 retary once during the month of June of each year 

7 and once during the month of December of each 

8 year the following: 

9 ‘‘(A) A list of each tobacco product intro10 duced by the registrant for commercial distribu11 tion which has not been included in any list 

12 previously filed by that person with the Sec13 retary under this subparagraph or paragraph 

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

15 tobacco product by its established name and 

16 shall be accompanied by the other information 

17 required by paragraph (1). 

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

19 made a report under this paragraph that person 

20 has discontinued the manufacture, preparation, 

21 compounding, or processing for commercial dis22 tribution of a tobacco product included in a list 

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

24 notice of such discontinuance, the date of such 
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1 discontinuance, and the identity of its estab2 lished name. 

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

9 of discontinuance was reported, notice of such 

10 resumption, the date of such resumption, the 

11 identity of such tobacco product by established 

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

14 reported such resumption to the Secretary 

15 under this subparagraph. 

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

18 or paragraph (1). 

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

21 INTERSTATE COMMERCE.— 

22 ‘‘(1) IN GENERAL.—Each person who is re23 quired to register under this section and who pro24 poses to begin the introduction or delivery for intro25 duction into interstate commerce for commercial dis-
49 

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1 tribution of a tobacco product intended for human 

2 use that was not commercially marketed (other than 

3 for test marketing) in the United States as of Feb4 ruary 15, 2007, shall, at least 90 days prior to mak5 ing such introduction or delivery, report to the Sec6 retary (in such form and manner as the Secretary 

7 shall prescribe)— 

8 ‘‘(A) the basis for such person’s determina9 tion that— 

10 ‘‘(i) the tobacco product is substan11 tially equivalent, within the meaning of 

12 section 910, to a tobacco product commer13 cially marketed (other than for test mar14 keting) in the United States as of Feb15 ruary 15, 2007, or to a tobacco product 

16 that the Secretary has previously deter17 mined, pursuant to subsection (a)(3) of 

18 section 910, is substantially equivalent and 

19 that is in compliance with the require20 ments of this Act; or 

21 ‘‘(ii) the tobacco product is modified 

22 within the meaning of paragraph (3), the 

23 modifications are to a product that is com24 mercially marketed and in compliance with 

25 the requirements of this Act, and all of the 
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1 modifications are covered by exemptions 

2 granted by the Secretary pursuant to para3 graph (3); and 

4 ‘‘(B) action taken by such person to com5 ply with the requirements under section 907 

6 that are applicable to the tobacco product. 

7 ‘‘(2) APPLICATION TO CERTAIN POST-FEB8 RUARY 15, 2007, PRODUCTS.—A report under this 

9 subsection for a tobacco product that was first intro10 duced or delivered for introduction into interstate 

11 commerce for commercial distribution in the United 

12 States after February 15, 2007, and prior to the 

13 date that is 21 months after the date of enactment 

14 of the Family Smoking Prevention and Tobacco 

15 Control Act shall be submitted to the Secretary not 

16 later than 21 months after such date of enactment. 

17 ‘‘(3) EXEMPTIONS.— 

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

19 exempt from the requirements of this sub20 section relating to the demonstration that a to21 bacco product is substantially equivalent within 

22 the meaning of section 910, tobacco products 

23 that are modified by adding or deleting a to24 bacco additive, or increasing or decreasing the 
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1 quantity of an existing tobacco additive, if the 

2 Secretary determines that— 

3 ‘‘(i) such modification would be a 

4 minor modification of a tobacco product 

5 that can be sold under this Act; 

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

7 not necessary to ensure that permitting the 

8 tobacco product to be marketed would be 

9 appropriate for protection of the public 

10 health; and 

11 ‘‘(iii) an exemption is otherwise appro12 priate. 

13 ‘‘(B) REGULATIONS.—Not later than 15 

14 months after the date of enactment of the Fam15 ily Smoking Prevention and Tobacco Control 

16 Act, the Secretary shall issue regulations to im17 plement this paragraph. 

18 ‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL 

19 OF TOBACCO PRODUCTS. 

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

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

22 tobacco product shall apply to such tobacco product until 

23 the applicability of the requirement to the tobacco product 

24 has been changed by action taken under section 907, sec25 tion 910, section 911, or subsection (d) of this section, 
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1 and any requirement established by or under section 902, 

2 903, 905, or 909 which is inconsistent with a requirement 

3 imposed on such tobacco product under section 907, sec4 tion 910, section 911, or subsection (d) of this section 

5 shall not apply to such tobacco product. 

6 ‘‘(b) INFORMATION ON PUBLIC ACCESS AND COM7 MENT.—Each notice of proposed rulemaking or other noti8 fication under section 907, 908, 909, 910, or 911 or under 

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

10 Federal Register with respect to any other action taken 

11 under any such section and which states the reasons for 

12 such action, and each publication of findings required to 

13 be made in connection with rulemaking under any such 

14 section shall set forth— 

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

16 may examine data and other information on which 

17 the notice or findings is based; and 

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

19 may present their comments on the notice or find20 ings (including the need therefore) orally or in writ21 ing, which period shall be at least 60 days but may 

22 not exceed 90 days unless the time is extended by 

23 the Secretary by a notice published in the Federal 

24 Register stating good cause therefore. 
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1 ‘‘(c) LIMITED CONFIDENTIALITY OF INFORMA2 TION.—Any information reported to or otherwise obtained 

3 by the Secretary or the Secretary’s representative under 

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

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

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

7 5, United States Code, by reason of subsection (b)(4) of 

8 that section shall be considered confidential and shall not 

9 be disclosed, except that the information may be disclosed 

10 to other officers or employees concerned with carrying out 

11 this chapter, or when relevant in any proceeding under 

12 this chapter. 

13 ‘‘(d) RESTRICTIONS.— 

14 ‘‘(1) IN GENERAL.—The Secretary may by reg15 ulation require restrictions on the sale and distribu16 tion of a tobacco product, including restrictions on 

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

18 the tobacco product, if the Secretary determines that 

19 such regulation would be appropriate for the protec20 tion of the public health. The Secretary may by reg21 ulation impose restrictions on the advertising and 

22 promotion of a tobacco product consistent with and 

23 to full extent permitted by the first amendment to 

24 the Constitution. The finding as to whether such 

25 regulation would be appropriate for the protection of 
54 

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1 the public health shall be determined with respect to 

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

3 including users and nonusers of the tobacco product, 

4 and taking into account— 

5 ‘‘(A) the increased or decreased likelihood 

6 that existing users of tobacco products will stop 

7 using such products; and 

8 ‘‘(B) the increased or decreased likelihood 

9 that those who do not use tobacco products will 

10 start using such products. 

11 No such regulation may require that the sale or dis12 tribution of a tobacco product be limited to the writ13 ten or oral authorization of a practitioner licensed 

14 by law to prescribe medical products. 

15 ‘‘(2) LABEL STATEMENTS.—The label of a to16 bacco product shall bear such appropriate state17 ments of the restrictions required by a regulation 

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

19 regulation prescribe. 

20 ‘‘(3) LIMITATIONS.— 

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

22 paragraph (1) may— 

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

24 product in face-to-face transactions by a 

25 specific category of retail outlets; or 
55 

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

2 of tobacco products to any person older 

3 than 18 years of age. 

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

5 regulations issued by the Secretary, matchbooks 

6 of conventional size containing not more than 

7 20 paper matches, and which are customarily 

8 given away for free with the purchase of to9 bacco products, shall be considered as adult10 written publications which shall be permitted to 

11 contain advertising. Notwithstanding the pre12 ceding sentence, if the Secretary finds that such 

13 treatment of matchbooks is not appropriate for 

14 the protection of the public health, the Sec15 retary may determine by regulation that match16 books shall not be considered adult-written pub17 lications. 

18 ‘‘(4) REMOTE SALES.— 

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

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

21 of enactment of the Family Smoking Pre22 vention and Tobacco Control Act, promul23 gate regulations regarding the sale and 

24 distribution of tobacco products that occur 

25 through means other than a direct, face-to- 
56 

•HR 1256 EH

1 face exchange between a retailer and a 

2 consumer in order to prevent the sale and 

3 distribution of tobacco products to individ4 uals who have not attained the minimum 

5 age established by applicable law for the 

6 purchase of such products, including re7 quirements for age verification; and 

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

9 enactment, issue regulations to address the 

10 promotion and marketing of tobacco prod11 ucts that are sold or distributed through 

12 means other than a direct, face-to-face ex13 change between a retailer and a consumer 

14 in order to protect individuals who have 

15 not attained the minimum age established 

16 by applicable law for the purchase of such 

17 products. 

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

19 Nothing in this paragraph limits the authority 

20 of the Secretary to take additional actions 

21 under the other paragraphs of this subsection. 

22 ‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE23 MENTS.— 

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

25 CONFORM.— 
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1 ‘‘(A) IN GENERAL.—In applying manufac2 turing restrictions to tobacco, the Secretary 

3 shall, in accordance with subparagraph (B), 

4 prescribe regulations (which may differ based 

5 on the type of tobacco product involved) requir6 ing that the methods used in, and the facilities 

7 and controls used for, the manufacture, 

8 preproduction design validation (including a 

9 process to assess the performance of a tobacco 

10 product), packing, and storage of a tobacco 

11 product conform to current good manufacturing 

12 practice, or hazard analysis and critical control 

13 point methodology, as prescribed in such regu14 lations to assure that the public health is pro15 tected and that the tobacco product is in com16 pliance with this chapter. Such regulations may 

17 provide for the testing of raw tobacco for pes18 ticide chemical residues regardless of whether a 

19 tolerance for such chemical residues has been 

20 established. 

21 ‘‘(B) REQUIREMENTS.—The Secretary 

22 shall— 

23 ‘‘(i) before promulgating any regula24 tion under subparagraph (A), afford the 

25 Tobacco Products Scientific Advisory Com-
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1 mittee an opportunity to submit rec2 ommendations with respect to the regula3 tion proposed to be promulgated; 

4 ‘‘(ii) before promulgating any regula5 tion under subparagraph (A), afford oppor6 tunity for an oral hearing; 

7 ‘‘(iii) provide the Tobacco Products 

8 Scientific Advisory Committee a reasonable 

9 time to make its recommendation with re10 spect to proposed regulations under sub11 paragraph (A); 

12 ‘‘(iv) in establishing the effective date 

13 of a regulation promulgated under this 

14 subsection, take into account the dif15 ferences in the manner in which the dif16 ferent types of tobacco products have his17 torically been produced, the financial re18 sources of the different tobacco product 

19 manufacturers, and the state of their exist20 ing manufacturing facilities, and shall pro21 vide for a reasonable period of time for 

22 such manufacturers to conform to good 

23 manufacturing practices; and 

24 ‘‘(v) not require any small tobacco 

25 product manufacturer to comply with a 
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1 regulation under subparagraph (A) for at 

2 least 4 years following the effective date 

3 established by the Secretary for such regu4 lation. 

5 ‘‘(2) EXEMPTIONS; VARIANCES.— 

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

7 any requirement prescribed under paragraph 

8 (1) may petition the Secretary for a permanent 

9 or temporary exemption or variance from such 

10 requirement. Such a petition shall be submitted 

11 to the Secretary in such form and manner as 

12 the Secretary shall prescribe and shall— 

13 ‘‘(i) in the case of a petition for an ex14 emption from a requirement, set forth the 

15 basis for the petitioner’s determination 

16 that compliance with the requirement is 

17 not required to assure that the tobacco 

18 product will be in compliance with this 

19 chapter; 

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

21 variance from a requirement, set forth the 

22 methods proposed to be used in, and the 

23 facilities and controls proposed to be used 

24 for, the manufacture, packing, and storage 

25 of the tobacco product in lieu of the meth-
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1 ods, facilities, and controls prescribed by 

2 the requirement; and 

3 ‘‘(iii) contain such other information 

4 as the Secretary shall prescribe. 

5 ‘‘(B) REFERRAL TO THE TOBACCO PROD6 UCTS SCIENTIFIC ADVISORY COMMITTEE.—The 

7 Secretary may refer to the Tobacco Products 

8 Scientific Advisory Committee any petition sub9 mitted under subparagraph (A). The Tobacco 

10 Products Scientific Advisory Committee shall 

11 report its recommendations to the Secretary 

12 with respect to a petition referred to it within 

13 60 days after the date of the petition’s referral. 

14 Within 60 days after— 

15 ‘‘(i) the date the petition was sub16 mitted to the Secretary under subpara17 graph (A); or 

18 ‘‘(ii) the day after the petition was re19 ferred to the Tobacco Products Scientific 

20 Advisory Committee, 

21 whichever occurs later, the Secretary shall by 

22 order either deny the petition or approve it. 

23 ‘‘(C) APPROVAL.—The Secretary may ap24 prove— 
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1 ‘‘(i) a petition for an exemption for a 

2 tobacco product from a requirement if the 

3 Secretary determines that compliance with 

4 such requirement is not required to assure 

5 that the tobacco product will be in compli6 ance with this chapter; and 

7 ‘‘(ii) a petition for a variance for a to8 bacco product from a requirement if the 

9 Secretary determines that the methods to 

10 be used in, and the facilities and controls 

11 to be used for, the manufacture, packing, 

12 and storage of the tobacco product in lieu 

13 of the methods, facilities, and controls pre14 scribed by the requirement are sufficient to 

15 assure that the tobacco product will be in 

16 compliance with this chapter. 

17 ‘‘(D) CONDITIONS.—An order of the Sec18 retary approving a petition for a variance shall 

19 prescribe such conditions respecting the meth20 ods used in, and the facilities and controls used 

21 for, the manufacture, packing, and storage of 

22 the tobacco product to be granted the variance 

23 under the petition as may be necessary to as24 sure that the tobacco product will be in compli25 ance with this chapter. 
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1 ‘‘(E) HEARING.—After the issuance of an 

2 order under subparagraph (B) respecting a pe3 tition, the petitioner shall have an opportunity 

4 for an informal hearing on such order. 

5 ‘‘(3) COMPLIANCE.—Compliance with require6 ments under this subsection shall not be required be7 fore the end of the 3-year period following the date 

8 of enactment of the Family Smoking Prevention and 

9 Tobacco Control Act. 

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

11 may enter into contracts for research, testing, and dem12 onstrations respecting tobacco products and may obtain 

13 tobacco products for research, testing, and demonstration 

14 purposes. 

15 ‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 

16 ‘‘(a) IN GENERAL.— 

17 ‘‘(1) SPECIAL RULES.— 

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

19 Beginning 3 months after the date of enact20 ment of the Family Smoking Prevention and 

21 Tobacco Control Act, a cigarette or any of its 

22 component parts (including the tobacco, filter, 

23 or paper) shall not contain, as a constituent (in24 cluding a smoke constituent) or additive, an ar25 tificial or natural flavor (other than tobacco or 
63 

•HR 1256 EH

1 menthol) or an herb or spice, including straw2 berry, grape, orange, clove, cinnamon, pine3 apple, vanilla, coconut, licorice, cocoa, chocolate, 

4 cherry, or coffee, that is a characterizing flavor 

5 of the tobacco product or tobacco smoke. Noth6 ing in this subparagraph shall be construed to 

7 limit the Secretary’s authority to take action 

8 under this section or other sections of this Act 

9 applicable to menthol or any artificial or nat10 ural flavor, herb, or spice not specified in this 

11 subparagraph. 

12 ‘‘(B) ADDITIONAL SPECIAL RULE.—Begin13 ning 2 years after the date of enactment of the 

14 Family Smoking Prevention and Tobacco Con15 trol Act, a tobacco product manufacturer shall 

16 not use tobacco, including foreign grown to17 bacco, that contains a pesticide chemical res18 idue that is at a level greater than is specified 

19 by any tolerance applicable under Federal law 

20 to domestically grown tobacco. 

21 ‘‘(2) REVISION OF TOBACCO PRODUCT STAND22 ARDS.—The Secretary may revise the tobacco prod23 uct standards in paragraph (1) in accordance with 

24 subsection (c). 

25 ‘‘(3) TOBACCO PRODUCT STANDARDS.— 
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1 ‘‘(A) IN GENERAL.—The Secretary may 

2 adopt tobacco product standards in addition to 

3 those in paragraph (1) if the Secretary finds 

4 that a tobacco product standard is appropriate 

5 for the protection of the public health. 

6 ‘‘(B) DETERMINATIONS.— 

7 ‘‘(i) CONSIDERATIONS.—In making a 

8 finding described in subparagraph (A), the 

9 Secretary shall consider scientific evidence 

10 concerning— 

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

12 population as a whole, including users 

13 and nonusers of tobacco products, of 

14 the proposed standard; 

15 ‘‘(II) the increased or decreased 

16 likelihood that existing users of to17 bacco products will stop using such 

18 products; and 

19 ‘‘(III) the increased or decreased 

20 likelihood that those who do not use 

21 tobacco products will start using such 

22 products. 

23 ‘‘(ii) ADDITIONAL CONSIDER24 ATIONS.—In the event that the Secretary 

25 makes a determination, set forth in a pro-
65 

•HR 1256 EH

1 posed tobacco product standard in a pro2 posed rule, that it is appropriate for the 

3 protection of public health to require the 

4 reduction or elimination of an additive, 

5 constituent (including a smoke constitu6 ent), or other component of a tobacco 

7 product because the Secretary has found 

8 that the additive, constituent, or other 

9 component is or may be harmful, any 

10 party objecting to the proposed standard 

11 on the ground that the proposed standard 

12 will not reduce or eliminate the risk of ill13 ness or injury may provide for the Sec14 retary’s consideration scientific evidence 

15 that demonstrates that the proposed stand16 ard will not reduce or eliminate the risk of 

17 illness or injury. 

18 ‘‘(4) CONTENT OF TOBACCO PRODUCT STAND19 ARDS.—A tobacco product standard established 

20 under this section for a tobacco product— 

21 ‘‘(A) shall include provisions that are ap22 propriate for the protection of the public health, 

23 including provisions, where appropriate— 

24 ‘‘(i) for nicotine yields of the product; 
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•HR 1256 EH

1 ‘‘(ii) for the reduction or elimination 

2 of other constituents, including smoke con3 stituents, or harmful components of the 

4 product; or 

5 ‘‘(iii) relating to any other require6 ment under subparagraph (B); 

7 ‘‘(B) shall, where appropriate for the pro8 tection of the public health, include— 

9 ‘‘(i) provisions respecting the con10 struction, components, ingredients, addi11 tives, constituents, including smoke con12 stituents, and properties of the tobacco 

13 product; 

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

15 sample basis or, if necessary, on an indi16 vidual basis) of the tobacco product; 

17 ‘‘(iii) provisions for the measurement 

18 of the tobacco product characteristics of 

19 the tobacco product; 

20 ‘‘(iv) provisions requiring that the re21 sults of each or of certain of the tests of 

22 the tobacco product required to be made 

23 under clause (ii) show that the tobacco 

24 product is in conformity with the portions 
67 

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1 of the standard for which the test or tests 

2 were required; and 

3 ‘‘(v) a provision requiring that the 

4 sale and distribution of the tobacco prod5 uct be restricted but only to the extent 

6 that the sale and distribution of a tobacco 

7 product may be restricted under a regula8 tion under section 906(d); 

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

10 use and prescribe the form and content of label11 ing for the proper use of the tobacco product; 

12 and 

13 ‘‘(D) shall require tobacco products con14 taining foreign-grown tobacco to meet the same 

15 standards applicable to tobacco products con16 taining domestically grown tobacco. 

17 ‘‘(5) PERIODIC REEVALUATION OF TOBACCO

18 PRODUCT STANDARDS.—The Secretary shall provide 

19 for periodic evaluation of tobacco product standards 

20 established under this section to determine whether 

21 such standards should be changed to reflect new 

22 medical, scientific, or other technological data. The 

23 Secretary may provide for testing under paragraph 

24 (4)(B) by any person. 
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1 ‘‘(6) INVOLVEMENT OF OTHER AGENCIES; IN2 FORMED PERSONS.—In carrying out duties under 

3 this section, the Secretary shall endeavor to— 

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

5 technical support available in other Federal 

6 agencies; 

7 ‘‘(B) consult with other Federal agencies 

8 concerned with standard setting and other na9 tionally or internationally recognized standard10 setting entities; and 

11 ‘‘(C) invite appropriate participation, 

12 through joint or other conferences, workshops, 

13 or other means, by informed persons represent14 ative of scientific, professional, industry, agri15 cultural, or consumer organizations who in the 

16 Secretary’s judgment can make a significant 

17 contribution. 

18 ‘‘(b) CONSIDERATIONS BY SECRETARY.— 

19 ‘‘(1) TECHNICAL ACHIEVABILITY.—The Sec20 retary shall consider information submitted in con21 nection with a proposed standard regarding the tech22 nical achievability of compliance with such standard. 

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

24 shall consider all other information submitted in 

25 connection with a proposed standard, including in-
69 

•HR 1256 EH

1 formation concerning the countervailing effects of 

2 the tobacco product standard on the health of ado3 lescent tobacco users, adult tobacco users, or non4 tobacco users, such as the creation of a significant 

5 demand for contraband or other tobacco products 

6 that do not meet the requirements of this chapter 

7 and the significance of such demand. 

8 ‘‘(c) PROPOSED STANDARDS.— 

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

10 in the Federal Register a notice of proposed rule11 making for the establishment, amendment, or rev12 ocation of any tobacco product standard. 

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

14 proposed rulemaking for the establishment or 

15 amendment of a tobacco product standard for a to16 bacco product shall— 

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

18 justification that the tobacco product standard 

19 is appropriate for the protection of the public 

20 health; 

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

22 draft or proposed tobacco product standard for 

23 consideration by the Secretary; 

24 ‘‘(C) invite interested persons to submit 

25 comments on structuring the standard so that 
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1 it does not advantage foreign-grown tobacco 

2 over domestically grown tobacco; and 

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

4 provide any information or analysis which the 

5 Secretary of Agriculture believes is relevant to 

6 the proposed tobacco product standard. 

7 ‘‘(3) FINDING.—A notice of proposed rule8 making for the revocation of a tobacco product 

9 standard shall set forth a finding with supporting 

10 justification that the tobacco product standard is no 

11 longer appropriate for the protection of the public 

12 health. 

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

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

15 ‘‘(d) PROMULGATION.— 

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

17 period for comment on a notice of proposed rule18 making published under subsection (c) respecting a 

19 tobacco product standard and after consideration of 

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

21 and any report from the Tobacco Products Scientific 

22 Advisory Committee, the Secretary shall— 

23 ‘‘(A) if the Secretary determines that the 

24 standard would be appropriate for the protec25 tion of the public health, promulgate a regula-
71 

•HR 1256 EH

1 tion establishing a tobacco product standard 

2 and publish in the Federal Register findings on 

3 the matters referred to in subsection (c); or 

4 ‘‘(B) publish a notice terminating the pro5 ceeding for the development of the standard to6 gether with the reasons for such termination. 

7 ‘‘(2) EFFECTIVE DATE.—A regulation estab8 lishing a tobacco product standard shall set forth 

9 the date or dates upon which the standard shall take 

10 effect, but no such regulation may take effect before 

11 1 year after the date of its publication unless the 

12 Secretary determines that an earlier effective date is 

13 necessary for the protection of the public health. 

14 Such date or dates shall be established so as to min15 imize, consistent with the public health, economic 

16 loss to, and disruption or dislocation of, domestic 

17 and international trade. In establishing such effec18 tive date or dates, the Secretary shall consider infor19 mation submitted in connection with a proposed 

20 product standard by interested parties, including 

21 manufacturers and tobacco growers, regarding the 

22 technical achievability of compliance with the stand23 ard, and including information concerning the exist24 ence of patents that make it impossible to comply in 

25 the timeframe envisioned in the proposed standard. 
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1 If the Secretary determines, based on the Sec2 retary’s evaluation of submitted comments, that a 

3 product standard can be met only by manufacturers 

4 requiring substantial changes to the methods of 

5 farming the domestically grown tobacco used by the 

6 manufacturer, the effective date of that product 

7 standard shall be not less than 2 years after the 

8 date of publication of the final regulation estab9 lishing the standard. 

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

11 FOOD AND DRUG ADMINISTRATION.—Because of the 

12 importance of a decision of the Secretary to issue a 

13 regulation— 

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

15 tobacco products, all little cigars, all cigars 

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

17 roll-your-own tobacco products; or 

18 ‘‘(B) requiring the reduction of nicotine 

19 yields of a tobacco product to zero, 

20 the Secretary is prohibited from taking such actions 

21 under this Act. 

22 ‘‘(4) AMENDMENT; REVOCATION.— 

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

24 the Secretary’s own initiative or upon petition 

25 of an interested person, may by a regulation, 
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•HR 1256 EH

1 promulgated in accordance with the require2 ments of subsection (c) and paragraph (2), 

3 amend or revoke a tobacco product standard. 

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

5 may declare a proposed amendment of a to6 bacco product standard to be effective on and 

7 after its publication in the Federal Register and 

8 until the effective date of any final action taken 

9 on such amendment if the Secretary determines 

10 that making it so effective is in the public inter11 est. 

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

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

14 refer a proposed regulation for the establish15 ment, amendment, or revocation of a tobacco 

16 product standard to the Tobacco Products Sci17 entific Advisory Committee for a report and 

18 recommendation with respect to any matter in19 volved in the proposed regulation which requires 

20 the exercise of scientific judgment. 

21 ‘‘(B) INITIATION OF REFERRAL.—The Sec22 retary may make a referral under this para23 graph— 

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

25 or 
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1 ‘‘(ii) upon the request of an interested 

2 person that— 

3 ‘‘(I) demonstrates good cause for 

4 the referral; and 

5 ‘‘(II) is made before the expira6 tion of the period for submission of 

7 comments on the proposed regulation. 

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

9 regulation is referred under this paragraph to 

10 the Tobacco Products Scientific Advisory Com11 mittee, the Secretary shall provide the Advisory 

12 Committee with the data and information on 

13 which such proposed regulation is based. 

14 ‘‘(D) REPORT AND RECOMMENDATION.— 

15 The Tobacco Products Scientific Advisory Com16 mittee shall, within 60 days after the referral of 

17 a proposed regulation under this paragraph and 

18 after independent study of the data and infor19 mation furnished to it by the Secretary and 

20 other data and information before it, submit to 

21 the Secretary a report and recommendation re22 specting such regulation, together with all un23 derlying data and information and a statement 

24 of the reason or basis for the recommendation. 
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1 ‘‘(E) PUBLIC AVAILABILITY.—The Sec2 retary shall make a copy of each report and rec3 ommendation under subparagraph (D) publicly 

4 available. 

5 ‘‘(e) MENTHOL CIGARETTES.— 

6 ‘‘(1) REFERRAL; CONSIDERATIONS.—Imme7 diately upon the establishment of the Tobacco Prod8 ucts Scientific Advisory Committee under section 

9 917(a), the Secretary shall refer to the Committee 

10 for report and recommendation, under section 

11 917(c)(4), the issue of the impact of the use of men12 thol in cigarettes on the public health, including 

13 such use among children, African Americans, His14 panics, and other racial and ethnic minorities. In its 

15 review, the Tobacco Products Scientific Advisory 

16 Committee shall address the considerations listed in 

17 subsections (a)(3)(B)(i) and (b). 

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

19 later than 1 year after its establishment, the To20 bacco Product Scientific Advisory Committee shall 

21 submit to the Secretary the report and recommenda22 tions required pursuant to paragraph (1). 

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

24 this subsection shall be construed to limit the Sec-
76 

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1 retary’s authority to take action under this section 

2 or other sections of this Act applicable to menthol. 

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

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

5 that— 

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

7 delivered for introduction into interstate commerce 

8 for commercial distribution presents an unreasonable 

9 risk of substantial harm to the public health; and 

10 ‘‘(2) notification under this subsection is nec11 essary to eliminate the unreasonable risk of such 

12 harm and no more practicable means is available 

13 under the provisions of this chapter (other than this 

14 section) to eliminate such risk, 

15 the Secretary may issue such order as may be necessary 

16 to assure that adequate notification is provided in an ap17 propriate form, by the persons and means best suited 

18 under the circumstances involved, to all persons who 

19 should properly receive such notification in order to elimi20 nate such risk. The Secretary may order notification by 

21 any appropriate means, including public service announce22 ments. Before issuing an order under this subsection, the 

23 Secretary shall consult with the persons who are to give 

24 notice under the order. 
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1 ‘‘(b) NO EXEMPTION FROM OTHER LIABILITY.— 

2 Compliance with an order issued under this section shall 

3 not relieve any person from liability under Federal or 

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

5 action brought for the enforcement of any such liability, 

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

7 provided under such order shall be taken into account. 

8 ‘‘(c) RECALL AUTHORITY.— 

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

10 there is a reasonable probability that a tobacco prod11 uct contains a manufacturing or other defect not or12 dinarily contained in tobacco products on the market 

13 that would cause serious, adverse health con14 sequences or death, the Secretary shall issue an 

15 order requiring the appropriate person (including 

16 the manufacturers, importers, distributors, or retail17 ers of the tobacco product) to immediately cease dis18 tribution of such tobacco product. The order shall 

19 provide the person subject to the order with an op20 portunity for an informal hearing, to be held not 

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

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

23 on whether the order should be amended to require 

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

25 an opportunity for such a hearing, the Secretary de-
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1 termines that inadequate grounds exist to support 

2 the actions required by the order, the Secretary shall 

3 vacate the order. 

4 ‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE5 CALL.— 

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

7 opportunity for an informal hearing under 

8 paragraph (1), the Secretary determines that 

9 the order should be amended to include a recall 

10 of the tobacco product with respect to which the 

11 order was issued, the Secretary shall, except as 

12 provided in subparagraph (B), amend the order 

13 to require a recall. The Secretary shall specify 

14 a timetable in which the tobacco product recall 

15 will occur and shall require periodic reports to 

16 the Secretary describing the progress of the re17 call. 

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

19 subparagraph (A)— 

20 ‘‘(i) shall not include recall of a to21 bacco product from individuals; and 

22 ‘‘(ii) shall provide for notice to per23 sons subject to the risks associated with 

24 the use of such tobacco product. 
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1 In providing the notice required by clause (ii), 

2 the Secretary may use the assistance of retail3 ers and other persons who distributed such to4 bacco product. If a significant number of such 

5 persons cannot be identified, the Secretary shall 

6 notify such persons under section 705(b). 

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

8 provided by this subsection shall be in addition to 

9 remedies provided by subsection (a). 

10 ‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PROD11 UCTS. 

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

13 product manufacturer or importer of a tobacco product 

14 shall establish and maintain such records, make such re15 ports, and provide such information, as the Secretary may 

16 by regulation reasonably require to assure that such to17 bacco product is not adulterated or misbranded and to 

18 otherwise protect public health. Regulations prescribed 

19 under the preceding sentence— 

20 ‘‘(1) may require a tobacco product manufac21 turer or importer to report to the Secretary when22 ever the manufacturer or importer receives or other23 wise becomes aware of information that reasonably 

24 suggests that one of its marketed tobacco products 

25 may have caused or contributed to a serious unex-
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1 pected adverse experience associated with the use of 

2 the product or any significant increase in the fre3 quency of a serious, expected adverse product experi4 ence; 

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

6 adverse tobacco product experiences as determined 

7 by the Secretary to be necessary to be reported; 

8 ‘‘(3) shall not impose requirements unduly bur9 densome to a tobacco product manufacturer or im10 porter, taking into account the cost of complying 

11 with such requirements and the need for the protec12 tion of the public health and the implementation of 

13 this chapter; 

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

15 requests for reports or information, shall require 

16 that each request made under such regulations for 

17 submission of a report or information to the Sec18 retary state the reason or purpose for such request 

19 and identify to the fullest extent practicable such re20 port or information; 

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

22 information to the Secretary, shall state the reason 

23 or purpose for the submission of such report or in24 formation and identify to the fullest extent prac25 ticable such report or information; and 
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1 ‘‘(6) may not require that the identity of any 

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

3 information required under this subsection unless re4 quired for the medical welfare of an individual, to 

5 determine risks to public health of a tobacco prod6 uct, or to verify a record, report, or information sub7 mitted under this chapter. 

8 In prescribing regulations under this subsection, the Sec9 retary shall have due regard for the professional ethics of 

10 the medical profession and the interests of patients. The 

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

12 reports, and information concerning any individual who 

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

14 ceases to be a patient. 

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

16 ‘‘(1) IN GENERAL.—Except as provided in para17 graph (2), the Secretary shall by regulation require 

18 a tobacco product manufacturer or importer of a to19 bacco product to report promptly to the Secretary 

20 any corrective action taken or removal from the 

21 market of a tobacco product undertaken by such 

22 manufacturer or importer if the removal or correc23 tion was undertaken— 

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

25 the tobacco product; or 
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1 ‘‘(B) to remedy a violation of this chapter 

2 caused by the tobacco product which may 

3 present a risk to health. 

4 A tobacco product manufacturer or importer of a to5 bacco product who undertakes a corrective action or 

6 removal from the market of a tobacco product which 

7 is not required to be reported under this subsection 

8 shall keep a record of such correction or removal. 

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

10 action or removal of a tobacco product may be re11 quired under paragraph (1) if a report of the correc12 tive action or removal is required and has been sub13 mitted under subsection (a). 

14 ‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TO15 BACCO PRODUCTS. 

16 ‘‘(a) IN GENERAL.— 

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

18 purposes of this section the term ‘new tobacco prod19 uct’ means— 

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

21 products in test markets) that was not commer22 cially marketed in the United States as of Feb23 ruary 15, 2007; or 

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

25 in design, any component, any part, or any con-
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1 stituent, including a smoke constituent, or in 

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

3 other additive or ingredient) of a tobacco prod4 uct where the modified product was commer5 cially marketed in the United States after Feb6 ruary 15, 2007. 

7 ‘‘(2) PREMARKET REVIEW REQUIRED.— 

8 ‘‘(A) NEW PRODUCTS.—An order under 

9 subsection (c)(1)(A)(i) for a new tobacco prod10 uct is required unless— 

11 ‘‘(i) the manufacturer has submitted a 

12 report under section 905(j); and the Sec13 retary has issued an order that the tobacco 

14 product— 

15 ‘‘(I) is substantially equivalent to 

16 a tobacco product commercially mar17 keted (other than for test marketing) 

18 in the United States as of February 

19 15, 2007; and 

20 ‘‘(II) is in compliance with the 

21 requirements of this Act; or 

22 ‘‘(ii) the tobacco product is exempt 

23 from the requirements of section 905(j) 

24 pursuant to a regulation issued under sec25 tion 905(j)(3). 
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1 ‘‘(B) APPLICATION TO CERTAIN POST-FEB2 RUARY 15, 2007, PRODUCTS.—Subparagraph (A) 

3 shall not apply to a tobacco product— 

4 ‘‘(i) that was first introduced or deliv5 ered for introduction into interstate com6 merce for commercial distribution in the 

7 United States after February 15, 2007, 

8 and prior to the date that is 21 months 

9 after the date of enactment of the Family 

10 Smoking Prevention and Tobacco Control 

11 Act; and 

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

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

14 period, 

15 except that subparagraph (A) shall apply to the 

16 tobacco product if the Secretary issues an order 

17 that the tobacco product is not substantially 

18 equivalent. 

19 ‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.— 

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

21 section 905(j), the term ‘substantially equiva22 lent’ or ‘substantial equivalence’ means, with 

23 respect to the tobacco product being compared 

24 to the predicate tobacco product, that the Sec-
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1 retary by order has found that the tobacco 

2 product— 

3 ‘‘(i) has the same characteristics as 

4 the predicate tobacco product; or 

5 ‘‘(ii) has different characteristics and 

6 the information submitted contains infor7 mation, including clinical data if deemed 

8 necessary by the Secretary, that dem9 onstrates that it is not appropriate to reg10 ulate the product under this section be11 cause the product does not raise different 

12 questions of public health. 

13 ‘‘(B) CHARACTERISTICS.—In subpara14 graph (A), the term ‘characteristics’ means the 

15 materials, ingredients, design, composition, 

16 heating source, or other features of a tobacco 

17 product. 

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

19 not be found to be substantially equivalent to a 

20 predicate tobacco product that has been re21 moved from the market at the initiative of the 

22 Secretary or that has been determined by a ju23 dicial order to be misbranded or adulterated. 

24 ‘‘(4) HEALTH INFORMATION.— 
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1 ‘‘(A) SUMMARY.—As part of a submission 

2 under section 905(j) respecting a tobacco prod3 uct, the person required to file a premarket no4 tification under such section shall provide an 

5 adequate summary of any health information 

6 related to the tobacco product or state that 

7 such information will be made available upon 

8 request by any person. 

9 ‘‘(B) REQUIRED INFORMATION.—Any sum10 mary under subparagraph (A) respecting a to11 bacco product shall contain detailed information 

12 regarding data concerning adverse health ef13 fects and shall be made available to the public 

14 by the Secretary within 30 days of the issuance 

15 of a determination that such tobacco product is 

16 substantially equivalent to another tobacco 

17 product. 

18 ‘‘(b) APPLICATION.— 

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

20 section shall contain— 

21 ‘‘(A) full reports of all information, pub22 lished or known to, or which should reasonably 

23 be known to, the applicant, concerning inves24 tigations which have been made to show the 

25 health risks of such tobacco product and wheth-
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1 er such tobacco product presents less risk than 

2 other tobacco products; 

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

4 ingredients, additives, and properties, and of 

5 the principle or principles of operation, of such 

6 tobacco product; 

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

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

9 manufacture, processing, and, when relevant, 

10 packing and installation of, such tobacco prod11 uct; 

12 ‘‘(D) an identifying reference to any to13 bacco product standard under section 907 

14 which would be applicable to any aspect of such 

15 tobacco product, and either adequate informa16 tion to show that such aspect of such tobacco 

17 product fully meets such tobacco product stand18 ard or adequate information to justify any devi19 ation from such standard; 

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

21 and of components thereof as the Secretary 

22 may reasonably require; 

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

24 be used for such tobacco product; and 
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1 ‘‘(G) such other information relevant to 

2 the subject matter of the application as the Sec3 retary may require. 

4 ‘‘(2) REFERRAL TO TOBACCO PRODUCTS SCI5 ENTIFIC ADVISORY COMMITTEE.—Upon receipt of an 

6 application meeting the requirements set forth in 

7 paragraph (1), the Secretary— 

8 ‘‘(A) may, on the Secretary’s own initia9 tive; or 

10 ‘‘(B) may, upon the request of an appli11 cant, 

12 refer such application to the Tobacco Products Sci13 entific Advisory Committee for reference and for 

14 submission (within such period as the Secretary may 

15 establish) of a report and recommendation respect16 ing the application, together with all underlying data 

17 and the reasons or basis for the recommendation. 

18 ‘‘(c) ACTION ON APPLICATION.— 

19 ‘‘(1) DEADLINE.— 

20 ‘‘(A) IN GENERAL.—As promptly as pos21 sible, but in no event later than 180 days after 

22 the receipt of an application under subsection 

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

24 and recommendation submitted under sub25 section (b)(2), shall— 
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1 ‘‘(i) issue an order that the new prod2 uct may be introduced or delivered for in3 troduction into interstate commerce if the 

4 Secretary finds that none of the grounds 

5 specified in paragraph (2) of this sub6 section applies; or 

7 ‘‘(ii) issue an order that the new prod8 uct may not be introduced or delivered for 

9 introduction into interstate commerce if 

10 the Secretary finds (and sets forth the 

11 basis for such finding as part of or accom12 panying such denial) that 1 or more 

13 grounds for denial specified in paragraph 

14 (2) of this subsection apply. 

15 ‘‘(B) RESTRICTIONS ON SALE AND DIS16 TRIBUTION.—An order under subparagraph 

17 (A)(i) may require that the sale and distribu18 tion of the tobacco product be restricted but 

19 only to the extent that the sale and distribution 

20 of a tobacco product may be restricted under a 

21 regulation under section 906(d). 

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

23 shall deny an application submitted under subsection 

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

25 to the Secretary as part of the application and any 
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1 other information before the Secretary with respect 

2 to such tobacco product, the Secretary finds that— 

3 ‘‘(A) there is a lack of a showing that per4 mitting such tobacco product to be marketed 

5 would be appropriate for the protection of the 

6 public health; 

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

8 or controls used for, the manufacture, proc9 essing, or packing of such tobacco product do 

10 not conform to the requirements of section 

11 906(e); 

12 ‘‘(C) based on a fair evaluation of all mate13 rial facts, the proposed labeling is false or mis14 leading in any particular; or 

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

16 conform in all respects to a tobacco product 

17 standard in effect under section 907, and there 

18 is a lack of adequate information to justify the 

19 deviation from such standard. 

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

21 application shall, insofar as the Secretary determines 

22 to be practicable, be accompanied by a statement in23 forming the applicant of the measures required to 

24 remove such application from deniable form (which 

25 measures may include further research by the appli-
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1 cant in accordance with 1 or more protocols pre2 scribed by the Secretary). 

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

4 this section, the finding as to whether the marketing 

5 of a tobacco product for which an application has 

6 been submitted is appropriate for the protection of 

7 the public health shall be determined with respect to 

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

9 including users and nonusers of the tobacco product, 

10 and taking into account— 

11 ‘‘(A) the increased or decreased likelihood 

12 that existing users of tobacco products will stop 

13 using such products; and 

14 ‘‘(B) the increased or decreased likelihood 

15 that those who do not use tobacco products will 

16 start using such products. 

17 ‘‘(5) BASIS FOR ACTION.— 

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

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

20 product to be marketed would be appropriate 

21 for the protection of the public health shall, 

22 when appropriate, be determined on the basis of 

23 well-controlled investigations, which may in24 clude 1 or more clinical investigations by ex-
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1 perts qualified by training and experience to 

2 evaluate the tobacco product. 

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

4 determines that there exists valid scientific evi5 dence (other than evidence derived from inves6 tigations described in subparagraph (A)) which 

7 is sufficient to evaluate the tobacco product, the 

8 Secretary may authorize that the determination 

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

10 the basis of such evidence. 

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

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

13 obtaining, where appropriate, advice on scientific 

14 matters from the Tobacco Products Scientific Advi15 sory Committee, and after due notice and oppor16 tunity for informal hearing for a tobacco product for 

17 which an order was issued under subsection 

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

19 the Secretary finds— 

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

21 tobacco product no longer is appropriate for the 

22 protection of the public health; 

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

24 accompanied by an untrue statement of a mate25 rial fact; 
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1 ‘‘(C) that the applicant— 

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

3 for maintaining records, or has repeatedly 

4 or deliberately failed to maintain records 

5 or to make reports, required by an applica6 ble regulation under section 909; 

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

8 or copying or verification of, such records 

9 as required by section 704; or 

10 ‘‘(iii) has not complied with the re11 quirements of section 905; 

12 ‘‘(D) on the basis of new information be13 fore the Secretary with respect to such tobacco 

14 product, evaluated together with the evidence 

15 before the Secretary when the application was 

16 reviewed, that the methods used in, or the fa17 cilities and controls used for, the manufacture, 

18 processing, packing, or installation of such to19 bacco product do not conform with the require20 ments of section 906(e) and were not brought 

21 into conformity with such requirements within a 

22 reasonable time after receipt of written notice 

23 from the Secretary of nonconformity; 

24 ‘‘(E) on the basis of new information be25 fore the Secretary, evaluated together with the 
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1 evidence before the Secretary when the applica2 tion was reviewed, that the labeling of such to3 bacco product, based on a fair evaluation of all 

4 material facts, is false or misleading in any par5 ticular and was not corrected within a reason6 able time after receipt of written notice from 

7 the Secretary of such fact; or 

8 ‘‘(F) on the basis of new information be9 fore the Secretary, evaluated together with the 

10 evidence before the Secretary when such order 

11 was issued, that such tobacco product is not 

12 shown to conform in all respects to a tobacco 

13 product standard which is in effect under sec14 tion 907, compliance with which was a condi15 tion to the issuance of an order relating to the 

16 application, and that there is a lack of adequate 

17 information to justify the deviation from such 

18 standard. 

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

20 subject to an order issued under paragraph (1) with21 drawing an order issued pursuant to subsection 

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

23 30th day after the date upon which such holder re24 ceives notice of such withdrawal, obtain review there25 of in accordance with section 912. 
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1 ‘‘(3) TEMPORARY SUSPENSION.—If, after pro2 viding an opportunity for an informal hearing, the 

3 Secretary determines there is reasonable probability 

4 that the continuation of distribution of a tobacco 

5 product under an order would cause serious, adverse 

6 health consequences or death, that is greater than 

7 ordinarily caused by tobacco products on the market, 

8 the Secretary shall by order temporarily suspend the 

9 authority of the manufacturer to market the prod10 uct. If the Secretary issues such an order, the Sec11 retary shall proceed expeditiously under paragraph 

12 (1) to withdraw such application. 

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

14 Secretary under this section shall be served— 

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

16 department designated by the Secretary; or 

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

18 certified mail addressed to the applicant at the ap19 plicant’s last known address in the records of the 

20 Secretary. 

21 ‘‘(f) RECORDS.— 

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

23 of any tobacco product for which an order issued 

24 pursuant to subsection (c)(1)(A)(i) for an applica25 tion filed under subsection (b) is in effect, the appli-
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1 cant shall establish and maintain such records, and 

2 make such reports to the Secretary, as the Secretary 

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

4 application, prescribe on the basis of a finding that 

5 such records and reports are necessary in order to 

6 enable the Secretary to determine, or facilitate a de7 termination of, whether there is or may be grounds 

8 for withdrawing or temporarily suspending such 

9 order. 

10 ‘‘(2) ACCESS TO RECORDS.—Each person re11 quired under this section to maintain records, and 

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

13 request of an officer or employee designated by the 

14 Secretary, permit such officer or employee at all rea15 sonable times to have access to and copy and verify 

16 such records. 

17 ‘‘(g) INVESTIGATIONAL TOBACCO PRODUCT EXEMP18 TION FOR INVESTIGATIONAL USE.—The Secretary may 

19 exempt tobacco products intended for investigational use 

20 from the provisions of this chapter under such conditions 

21 as the Secretary may by regulation prescribe. 

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

23 ‘‘(a) IN GENERAL.—No person may introduce or de24 liver for introduction into interstate commerce any modi-
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1 fied risk tobacco product unless an order issued pursuant 

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

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

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

5 term ‘modified risk tobacco product’ means any to6 bacco product that is sold or distributed for use to 

7 reduce harm or the risk of tobacco-related disease 

8 associated with commercially marketed tobacco prod9 ucts. 

10 ‘‘(2) SOLD OR DISTRIBUTED.— 

11 ‘‘(A) IN GENERAL.—With respect to a to12 bacco product, the term ‘sold or distributed for 

13 use to reduce harm or the risk of tobacco-re14 lated disease associated with commercially mar15 keted tobacco products’ means a tobacco prod16 uct— 

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

18 of which represents explicitly or implicitly 

19 that— 

20 ‘‘(I) the tobacco product presents 

21 a lower risk of tobacco-related disease 

22 or is less harmful than one or more 

23 other commercially marketed tobacco 

24 products; 
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1 ‘‘(II) the tobacco product or its 

2 smoke contains a reduced level of a 

3 substance or presents a reduced expo4 sure to a substance; or 

5 ‘‘(III) the tobacco product or its 

6 smoke does not contain or is free of a 

7 substance; 

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

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

10 or ‘low’ or similar descriptors; or 

11 ‘‘(iii) the tobacco product manufac12 turer of which has taken any action di13 rected to consumers through the media or 

14 otherwise, other than by means of the to15 bacco product’s label, labeling, or adver16 tising, after the date of enactment of the 

17 Family Smoking Prevention and Tobacco 

18 Control Act, respecting the product that 

19 would be reasonably expected to result in 

20 consumers believing that the tobacco prod21 uct or its smoke may present a lower risk 

22 of disease or is less harmful than one or 

23 more commercially marketed tobacco prod24 ucts, or presents a reduced exposure to, or 
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1 does not contain or is free of, a substance 

2 or substances. 

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

4 shall be considered to be ‘sold or distributed for 

5 use to reduce harm or the risk of tobacco-re6 lated disease associated with commercially mar7 keted tobacco products’, except as described in 

8 subparagraph (A). 

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

10 smokeless tobacco product shall be considered 

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

12 or the risk of tobacco-related disease associated 

13 with commercially marketed tobacco products’ 

14 solely because its label, labeling, or advertising 

15 uses the following phrases to describe such 

16 product and its use: ‘smokeless tobacco’, 

17 ‘smokeless tobacco product’, ‘not consumed by 

18 smoking’, ‘does not produce smoke’, 

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

20 smoke’, or ‘not smoke’. 

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

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

23 after the date of enactment of the Family Smoking 

24 Prevention and Tobacco Control Act for those prod25 ucts whose label, labeling, or advertising contains 
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1 the terms described in such paragraph on such date 

2 of enactment. The effective date shall be with re3 spect to the date of manufacture, provided that, in 

4 any case, beginning 30 days after such effective 

5 date, a manufacturer shall not introduce into the do6 mestic commerce of the United States any product, 

7 irrespective of the date of manufacture, that is not 

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

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

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

11 dependence, including smoking cessation, is not a modified 

12 risk tobacco product under this section if it has been ap13 proved as a drug or device by the Food and Drug Adminis14 tration and is subject to the requirements of chapter V. 

15 ‘‘(d) FILING.—Any person may file with the Sec16 retary an application for a modified risk tobacco product. 

17 Such application shall include— 

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

19 any proposed advertising and labeling; 

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

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

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

23 ‘‘(5) all documents (including underlying sci24 entific information) relating to research findings 

25 conducted, supported, or possessed by the tobacco 
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1 product manufacturer relating to the effect of the 

2 product on tobacco-related diseases and health-re3 lated conditions, including information both favor4 able and unfavorable to the ability of the product to 

5 reduce risk or exposure and relating to human 

6 health; 

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

8 actually use the tobacco product; and 

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

10 may require. 

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

12 make the application described in subsection (d) publicly 

13 available (except matters in the application which are 

14 trade secrets or otherwise confidential, commercial infor15 mation) and shall request comments by interested persons 

16 on the information contained in the application and on the 

17 label, labeling, and advertising accompanying such appli18 cation. 

19 ‘‘(f) ADVISORY COMMITTEE.— 

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

21 the Tobacco Products Scientific Advisory Committee 

22 any application submitted under this section. 

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

24 days after the date an application is referred to the 

25 Tobacco Products Scientific Advisory Committee 
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1 under paragraph (1), the Advisory Committee shall 

2 report its recommendations on the application to the 

3 Secretary. 

4 ‘‘(g) MARKETING.— 

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

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

7 respect to an application submitted under this sec8 tion, issue an order that a modified risk product 

9 may be commercially marketed only if the Secretary 

10 determines that the applicant has demonstrated that 

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

12 will— 

13 ‘‘(A) significantly reduce harm and the 

14 risk of tobacco-related disease to individual to15 bacco users; and 

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

17 as a whole taking into account both users of to18 bacco products and persons who do not cur19 rently use tobacco products. 

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

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

22 issue an order that a tobacco product may be 

23 introduced or delivered for introduction into 

24 interstate commerce, pursuant to an application 

25 under this section, with respect to a tobacco 
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1 product that may not be commercially marketed 

2 under paragraph (1) if the Secretary makes the 

3 findings required under this paragraph and de4 termines that the applicant has demonstrated 

5 that— 

6 ‘‘(i) such order would be appropriate 

7 to promote the public health; 

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

9 and advertising for such product that 

10 would cause the tobacco product to be a 

11 modified risk tobacco product under sub12 section (b) is limited to an explicit or im13 plicit representation that such tobacco 

14 product or its smoke does not contain or is 

15 free of a substance or contains a reduced 

16 level of a substance, or presents a reduced 

17 exposure to a substance in tobacco smoke; 

18 ‘‘(iii) scientific evidence is not avail19 able and, using the best available scientific 

20 methods, cannot be made available without 

21 conducting long-term epidemiological stud22 ies for an application to meet the stand23 ards set forth in paragraph (1); and 

24 ‘‘(iv) the scientific evidence that is 

25 available without conducting long-term epi-
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1 demiological studies demonstrates that a 

2 measurable and substantial reduction in 

3 morbidity or mortality among individual 

4 tobacco users is reasonably likely in subse5 quent studies. 

6 ‘‘(B) ADDITIONAL FINDINGS REQUIRED.— 

7 To issue an order under subparagraph (A) the 

8 Secretary must also find that the applicant has 

9 demonstrated that— 

10 ‘‘(i) the magnitude of the overall re11 ductions in exposure to the substance or 

12 substances which are the subject of the ap13 plication is substantial, such substance or 

14 substances are harmful, and the product as 

15 actually used exposes consumers to the 

16 specified reduced level of the substance or 

17 substances; 

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

19 consumers will not expose them to higher 

20 levels of other harmful substances com21 pared to the similar types of tobacco prod22 ucts then on the market unless such in23 creases are minimal and the reasonably 

24 likely overall impact of use of the product 

25 remains a substantial and measurable re-
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1 duction in overall morbidity and mortality 

2 among individual tobacco users; 

3 ‘‘(iii) testing of actual consumer per4 ception shows that, as the applicant pro5 poses to label and market the product, con6 sumers will not be misled into believing 

7 that the product— 

8 ‘‘(I) is or has been demonstrated 

9 to be less harmful; or 

10 ‘‘(II) presents or has been dem11 onstrated to present less of a risk of 

12 disease than 1 or more other commer13 cially marketed tobacco products; and 

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

15 to the application is expected to benefit the 

16 health of the population as a whole taking 

17 into account both users of tobacco prod18 ucts and persons who do not currently use 

19 tobacco products. 

20 ‘‘(C) CONDITIONS OF MARKETING.— 

21 ‘‘(i) IN GENERAL.—Applications sub22 ject to an order under this paragraph shall 

23 be limited to a term of not more than 5 

24 years, but may be renewed upon a finding 

25 by the Secretary that the requirements of 
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1 this paragraph continue to be satisfied 

2 based on the filing of a new application. 

3 ‘‘(ii) AGREEMENTS BY APPLICANT.— 

4 An order under this paragraph shall be 

5 conditioned on the applicant’s agreement 

6 to conduct postmarket surveillance and 

7 studies and to submit to the Secretary the 

8 results of such surveillance and studies to 

9 determine the impact of the order on con10 sumer perception, behavior, and health and 

11 to enable the Secretary to review the accu12 racy of the determinations upon which the 

13 order was based in accordance with a pro14 tocol approved by the Secretary. 

15 ‘‘(iii) ANNUAL SUBMISSION.—The re16 sults of such postmarket surveillance and 

17 studies described in clause (ii) shall be 

18 submitted annually. 

19 ‘‘(3) BASIS.—The determinations under para20 graphs (1) and (2) shall be based on— 

21 ‘‘(A) the scientific evidence submitted by 

22 the applicant; and 

23 ‘‘(B) scientific evidence and other informa24 tion that is made available to the Secretary. 
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1 ‘‘(4) BENEFIT TO HEALTH OF INDIVIDUALS

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

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

4 Secretary shall take into account— 

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

6 of the tobacco product that is the subject of the 

7 application; 

8 ‘‘(B) the increased or decreased likelihood 

9 that existing users of tobacco products who 

10 would otherwise stop using such products will 

11 switch to the tobacco product that is the subject 

12 of the application; 

13 ‘‘(C) the increased or decreased likelihood 

14 that persons who do not use tobacco products 

15 will start using the tobacco product that is the 

16 subject of the application; 

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

18 from the use of the tobacco product that is the 

19 subject of the application as compared to the 

20 use of products for smoking cessation approved 

21 under chapter V to treat nicotine dependence; 

22 and 

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

24 submitted by interested persons. 

25 ‘‘(h) ADDITIONAL CONDITIONS FOR MARKETING.— 
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1 ‘‘(1) MODIFIED RISK PRODUCTS.—The Sec2 retary shall require for the marketing of a product 

3 under this section that any advertising or labeling 

4 concerning modified risk products enable the public 

5 to comprehend the information concerning modified 

6 risk and to understand the relative significance of 

7 such information in the context of total health and 

8 in relation to all of the diseases and health-related 

9 conditions associated with the use of tobacco prod10 ucts. 

11 ‘‘(2) COMPARATIVE CLAIMS.— 

12 ‘‘(A) IN GENERAL.—The Secretary may re13 quire for the marketing of a product under this 

14 subsection that a claim comparing a tobacco 

15 product to 1 or more other commercially mar16 keted tobacco products shall compare the to17 bacco product to a commercially marketed to18 bacco product that is representative of that type 

19 of tobacco product on the market (for example 

20 the average value of the top 3 brands of an es21 tablished regular tobacco product). 

22 ‘‘(B) QUANTITATIVE COMPARISONS.—The 

23 Secretary may also require, for purposes of sub24 paragraph (A), that the percent (or fraction) of 

25 change and identity of the reference tobacco 
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1 product and a quantitative comparison of the 

2 amount of the substance claimed to be reduced 

3 shall be stated in immediate proximity to the 

4 most prominent claim. 

5 ‘‘(3) LABEL DISCLOSURE.— 

6 ‘‘(A) IN GENERAL.—The Secretary may re7 quire the disclosure on the label of other sub8 stances in the tobacco product, or substances 

9 that may be produced by the consumption of 

10 that tobacco product, that may affect a disease 

11 or health-related condition or may increase the 

12 risk of other diseases or health-related condi13 tions associated with the use of tobacco prod14 ucts. 

15 ‘‘(B) CONDITIONS OF USE.—If the condi16 tions of use of the tobacco product may affect 

17 the risk of the product to human health, the 

18 Secretary may require the labeling of conditions 

19 of use. 

20 ‘‘(4) TIME.—An order issued under subsection 

21 (g)(1) shall be effective for a specified period of 

22 time. 

23 ‘‘(5) ADVERTISING.—The Secretary may re24 quire, with respect to a product for which an appli25 cant obtained an order under subsection (g)(1), that 
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1 the product comply with requirements relating to ad2 vertising and promotion of the tobacco product. 

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

4 ‘‘(1) IN GENERAL.—The Secretary shall re5 quire, with respect to a product for which an appli6 cant obtained an order under subsection (g)(1), that 

7 the applicant conduct postmarket surveillance and 

8 studies for such a tobacco product to determine the 

9 impact of the order issuance on consumer percep10 tion, behavior, and health, to enable the Secretary to 

11 review the accuracy of the determinations upon 

12 which the order was based, and to provide informa13 tion that the Secretary determines is otherwise nec14 essary regarding the use or health risks involving 

15 the tobacco product. The results of postmarket sur16 veillance and studies shall be submitted to the Sec17 retary on an annual basis. 

18 ‘‘(2) SURVEILLANCE PROTOCOL.—Each appli19 cant required to conduct a surveillance of a tobacco 

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

21 after receiving notice that the applicant is required 

22 to conduct such surveillance, submit, for the ap23 proval of the Secretary, a protocol for the required 

24 surveillance. The Secretary, within 60 days of the 

25 receipt of such protocol, shall determine if the prin-
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1 cipal investigator proposed to be used in the surveil2 lance has sufficient qualifications and experience to 

3 conduct such surveillance and if such protocol will 

4 result in collection of the data or other information 

5 designated by the Secretary as necessary to protect 

6 the public health. 

7 ‘‘(j) WITHDRAWAL OF AUTHORIZATION.—The Sec8 retary, after an opportunity for an informal hearing, shall 

9 withdraw an order under subsection (g) if the Secretary 

10 determines that— 

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

12 can no longer make the demonstrations required 

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

14 make the determinations required under subsection 

15 (g); 

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

17 information or included any untrue statement of ma18 terial fact; 

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

20 the product reduces risk or exposure is no longer 

21 valid, including if— 

22 ‘‘(A) a tobacco product standard is estab23 lished pursuant to section 907; 

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

25 risks presented by other commercially marketed 
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1 tobacco products that were compared to the 

2 product that is the subject of the application; or 

3 ‘‘(C) any postmarket surveillance or stud4 ies reveal that the order is no longer consistent 

5 with the protection of the public health; 

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

7 the postmarket surveillance and studies required 

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

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

10 imposed under subsection (h). 

11 ‘‘(k) CHAPTER IV OR V.—A product for which the 

12 Secretary has issued an order pursuant to subsection (g) 

13 shall not be subject to chapter IV or V. 

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

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

16 years after the date of enactment of the Family 

17 Smoking Prevention and Tobacco Control Act, the 

18 Secretary shall issue regulations or guidance (or any 

19 combination thereof) on the scientific evidence re20 quired for assessment and ongoing review of modi21 fied risk tobacco products. Such regulations or guid22 ance shall— 

23 ‘‘(A) to the extent that adequate scientific 

24 evidence exists, establish minimum standards 

25 for scientific studies needed prior to issuing an 
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1 order under subsection (g) to show that a sub2 stantial reduction in morbidity or mortality 

3 among individual tobacco users occurs for prod4 ucts described in subsection (g)(1) or is reason5 ably likely for products described in subsection 

6 (g)(2); 

7 ‘‘(B) include validated biomarkers, inter8 mediate clinical endpoints, and other feasible 

9 outcome measures, as appropriate; 

10 ‘‘(C) establish minimum standards for 

11 postmarket studies, that shall include regular 

12 and long-term assessments of health outcomes 

13 and mortality, intermediate clinical endpoints, 

14 consumer perception of harm reduction, and the 

15 impact on quitting behavior and new use of to16 bacco products, as appropriate; 

17 ‘‘(D) establish minimum standards for re18 quired postmarket surveillance, including ongo19 ing assessments of consumer perception; 

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

21 studies and surveillance be made available to 

22 the Secretary prior to the decision on renewal 

23 of a modified risk tobacco product; and 
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1 ‘‘(F) establish a reasonable timetable for 

2 the Secretary to review an application under 

3 this section. 

4 ‘‘(2) CONSULTATION.—The regulations or guid5 ance issued under paragraph (1) shall be developed 

6 in consultation with the Institute of Medicine, and 

7 with the input of other appropriate scientific and 

8 medical experts, on the design and conduct of such 

9 studies and surveillance. 

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

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

12 basis as new scientific information becomes avail13 able. 

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

15 than 2 years after the date of enactment of the 

16 Family Smoking Prevention and Tobacco Control 

17 Act, the Secretary shall issue a regulation or guid18 ance that permits the filing of a single application 

19 for any tobacco product that is a new tobacco prod20 uct under section 910 and which the applicant seeks 

21 to commercially market under this section. 

22 ‘‘(m) DISTRIBUTORS.—Except as provided in this 

23 section, no distributor may take any action, after the date 

24 of enactment of the Family Smoking Prevention and To25 bacco Control Act, with respect to a tobacco product that 
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1 would reasonably be expected to result in consumers be2 lieving that the tobacco product or its smoke may present 

3 a lower risk of disease or is less harmful than one or more 

4 commercially marketed tobacco products, or presents a re5 duced exposure to, or does not contain or is free of, a sub6 stance or substances. 

7 ‘‘SEC. 912. JUDICIAL REVIEW. 

8 ‘‘(a) RIGHT TO REVIEW.— 

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

10 after— 

11 ‘‘(A) the promulgation of a regulation 

12 under section 907 establishing, amending, or 

13 revoking a tobacco product standard; or 

14 ‘‘(B) a denial of an application under sec15 tion 910(c), 

16 any person adversely affected by such regulation or 

17 denial may file a petition for judicial review of such 

18 regulation or denial with the United States Court of 

19 Appeals for the District of Columbia or for the cir20 cuit in which such person resides or has their prin21 cipal place of business. 

22 ‘‘(2) REQUIREMENTS.— 

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

24 petition filed under paragraph (1) shall be 
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1 transmitted by the clerk of the court involved to 

2 the Secretary. 

3 ‘‘(B) RECORD OF PROCEEDINGS.—On re4 ceipt of a petition under subparagraph (A), the 

5 Secretary shall file in the court in which such 

6 petition was filed— 

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

8 which the regulation or order was based; 

9 and 

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

11 the issuance of such a regulation or order. 

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

13 section, the term ‘record’ means— 

14 ‘‘(i) all notices and other matter pub15 lished in the Federal Register with respect 

16 to the regulation or order reviewed; 

17 ‘‘(ii) all information submitted to the 

18 Secretary with respect to such regulation 

19 or order; 

20 ‘‘(iii) proceedings of any panel or ad21 visory committee with respect to such reg22 ulation or order; 

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

24 such regulation or order; and 
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1 ‘‘(v) any other information identified 

2 by the Secretary, in the administrative pro3 ceeding held with respect to such regula4 tion or order, as being relevant to such 

5 regulation or order. 

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

7 petition under subsection (a) for judicial review of a regu8 lation or order, the court shall have jurisdiction to review 

9 the regulation or order in accordance with chapter 7 of 

10 title 5, United States Code, and to grant appropriate re11 lief, including interim relief, as provided for in such chap12 ter. A regulation or denial described in subsection (a) shall 

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

14 5, United States Code. 

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

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

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

18 Supreme Court of the United States upon certiorari or 

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

20 United States Code. 

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

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

23 any other remedies provided by law. 

24 ‘‘(e) REGULATIONS AND ORDERS MUST RECITE

25 BASIS IN RECORD.—To facilitate judicial review, a regula-
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1 tion or order issued under section 906, 907, 908, 909, 

2 910, or 916 shall contain a statement of the reasons for 

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

4 the proceedings held in connection with its issuance. 

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

6 ‘‘The Secretary shall issue regulations to require that 

7 retail establishments for which the predominant business 

8 is the sale of tobacco products comply with any advertising 

9 restrictions applicable to retail establishments accessible 

10 to individuals under the age of 18. 

11 ‘‘SEC. 914. JURISDICTION OF AND COORDINATION WITH 

12 THE FEDERAL TRADE COMMISSION. 

13 ‘‘(a) JURISDICTION.— 

14 ‘‘(1) IN GENERAL.—Except where expressly 

15 provided in this chapter, nothing in this chapter 

16 shall be construed as limiting or diminishing the au17 thority of the Federal Trade Commission to enforce 

18 the laws under its jurisdiction with respect to the 

19 advertising, sale, or distribution of tobacco products. 

20 ‘‘(2) ENFORCEMENT.—Any advertising that vio21 lates this chapter or a provision of the regulations 

22 referred to in section 102 of the Family Smoking 

23 Prevention and Tobacco Control Act, is an unfair or 

24 deceptive act or practice under section 5(a) of the 

25 Federal Trade Commission Act and shall be consid-
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1 ered a violation of a rule promulgated under section 

2 18 of that Act. 

3 ‘‘(b) COORDINATION.—With respect to the require4 ments of section 4 of the Federal Cigarette Labeling and 

5 Advertising Act and section 3 of the Comprehensive 

6 Smokeless Tobacco Health Education Act of 1986— 

7 ‘‘(1) the Chairman of the Federal Trade Com8 mission shall coordinate with the Secretary con9 cerning the enforcement of such Act as such enforce10 ment relates to unfair or deceptive acts or practices 

11 in the advertising of cigarettes or smokeless tobacco; 

12 and 

13 ‘‘(2) the Secretary shall consult with the Chair14 man of such Commission in revising the label state15 ments and requirements under such sections. 

16 ‘‘SEC. 915. REGULATION REQUIREMENT. 

17 ‘‘(a) TESTING, REPORTING, AND DISCLOSURE.—Not 

18 later than 36 months after the date of enactment of the 

19 Family Smoking Prevention and Tobacco Control Act, the 

20 Secretary shall promulgate regulations under this Act that 

21 meet the requirements of subsection (b). 

22 ‘‘(b) CONTENTS OF RULES.—The regulations pro23 mulgated under subsection (a)— 

24 ‘‘(1) shall require testing and reporting of to25 bacco product constituents, ingredients, and addi-
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1 tives, including smoke constituents, by brand and 

2 subbrand that the Secretary determines should be 

3 tested to protect the public health, provided that, for 

4 purposes of the testing requirements of this para5 graph, tobacco products manufactured and sold by a 

6 single tobacco product manufacturer that are iden7 tical in all respects except the labels, packaging de8 sign, logo, trade dress, trademark, brand name, or 

9 any combination thereof, shall be considered as a 

10 single brand; and 

11 ‘‘(2) may require that tobacco product manu12 facturers, packagers, or importers make disclosures 

13 relating to the results of the testing of tar and nico14 tine through labels or advertising or other appro15 priate means, and make disclosures regarding the 

16 results of the testing of other constituents, including 

17 smoke constituents, ingredients, or additives, that 

18 the Secretary determines should be disclosed to the 

19 public to protect the public health and will not mis20 lead consumers about the risk of tobacco-related dis21 ease. 

22 ‘‘(c) AUTHORITY.—The Secretary shall have the au23 thority under this chapter to conduct or to require the 

24 testing, reporting, or disclosure of tobacco product con25 stituents, including smoke constituents. 
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1 ‘‘(d) SMALL TOBACCO PRODUCT MANUFACTUR2 ERS.— 

3 ‘‘(1) FIRST COMPLIANCE DATE.—The initial 

4 regulations promulgated under subsection (a) shall 

5 not impose requirements on small tobacco product 

6 manufacturers before the later of— 

7 ‘‘(A) the end of the 2-year period following 

8 the final promulgation of such regulations; and 

9 ‘‘(B) the initial date set by the Secretary 

10 for compliance with such regulations by manu11 facturers that are not small tobacco product 

12 manufacturers. 

13 ‘‘(2) TESTING AND REPORTING INITIAL COM14 PLIANCE PERIOD.— 

15 ‘‘(A) 4-YEAR PERIOD.—The initial regula16 tions promulgated under subsection (a) shall 

17 give each small tobacco product manufacturer a 

18 4-year period over which to conduct testing and 

19 reporting for all of its tobacco products. Subject 

20 to paragraph (1), the end of the first year of 

21 such 4-year period shall coincide with the initial 

22 date of compliance under this section set by the 

23 Secretary with respect to manufacturers that 

24 are not small tobacco product manufacturers or 

25 the end of the 2-year period following the final 
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1 promulgation of such regulations, as described 

2 in paragraph (1)(A). A small tobacco product 

3 manufacturer shall be required— 

4 ‘‘(i) to conduct such testing and re5 porting for 25 percent of its tobacco prod6 ucts during each year of such 4-year pe7 riod; and 

8 ‘‘(ii) to conduct such testing and re9 porting for its largest-selling tobacco prod10 ucts (as determined by the Secretary) be11 fore its other tobacco products, or in such 

12 other order of priority as determined by 

13 the Secretary. 

14 ‘‘(B) CASE-BY-CASE DELAY.—Notwith15 standing subparagraph (A), the Secretary may, 

16 on a case-by-case basis, delay the date by which 

17 an individual small tobacco product manufac18 turer must conduct testing and reporting for its 

19 tobacco products under this section based upon 

20 a showing of undue hardship to such manufac21 turer. Notwithstanding the preceding sentence, 

22 the Secretary shall not extend the deadline for 

23 a small tobacco product manufacturer to con24 duct testing and reporting for all of its tobacco 

25 products beyond a total of 5 years after the ini-
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1 tial date of compliance under this section set by 

2 the Secretary with respect to manufacturers 

3 that are not small tobacco product manufactur4 ers. 

5 ‘‘(3) SUBSEQUENT AND ADDITIONAL TESTING

6 AND REPORTING.—The regulations promulgated 

7 under subsection (a) shall provide that, with respect 

8 to any subsequent or additional testing and report9 ing of tobacco products required under this section, 

10 such testing and reporting by a small tobacco prod11 uct manufacturer shall be conducted in accordance 

12 with the timeframes described in paragraph (2)(A), 

13 except that, in the case of a new product, or if there 

14 has been a modification described in section 

15 910(a)(1)(B) of any product of a small tobacco 

16 product manufacturer since the last testing and re17 porting required under this section, the Secretary 

18 shall require that any subsequent or additional test19 ing and reporting be conducted in accordance with 

20 the same timeframe applicable to manufacturers 

21 that are not small tobacco product manufacturers. 

22 ‘‘(4) JOINT LABORATORY TESTING SERVICES.— 

23 The Secretary shall allow any 2 or more small to24 bacco product manufacturers to join together to pur25 chase laboratory testing services required by this 
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1 section on a group basis in order to ensure that such 

2 manufacturers receive access to, and fair pricing of, 

3 such testing services. 

4 ‘‘(e) EXTENSIONS FOR LIMITED LABORATORY CA5 PACITY.— 

6 ‘‘(1) IN GENERAL.—The regulations promul7 gated under subsection (a) shall provide that a small 

8 tobacco product manufacturer shall not be consid9 ered to be in violation of this section before the 

10 deadline applicable under paragraphs (3) and (4), 

11 if— 

12 ‘‘(A) the tobacco products of such manu13 facturer are in compliance with all other re14 quirements of this chapter; and 

15 ‘‘(B) the conditions described in paragraph 

16 (2) are met. 

17 ‘‘(2) CONDITIONS.—Notwithstanding the re18 quirements of this section, the Secretary may delay 

19 the date by which a small tobacco product manufac20 turer must be in compliance with the testing and re21 porting required by this section until such time as 

22 the testing is reported if, not later than 90 days be23 fore the deadline for reporting in accordance with 

24 this section, a small tobacco product manufacturer 
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1 provides evidence to the Secretary demonstrating 

2 that— 

3 ‘‘(A) the manufacturer has submitted the 

4 required products for testing to a laboratory 

5 and has done so sufficiently in advance of the 

6 deadline to create a reasonable expectation of 

7 completion by the deadline; 

8 ‘‘(B) the products currently are awaiting 

9 testing by the laboratory; and 

10 ‘‘(C) neither that laboratory nor any other 

11 laboratory is able to complete testing by the 

12 deadline at customary, nonexpedited testing 

13 fees. 

14 ‘‘(3) EXTENSION.—The Secretary, taking into 

15 account the laboratory testing capacity that is avail16 able to tobacco product manufacturers, shall review 

17 and verify the evidence submitted by a small tobacco 

18 product manufacturer in accordance with paragraph 

19 (2). If the Secretary finds that the conditions de20 scribed in such paragraph are met, the Secretary 

21 shall notify the small tobacco product manufacturer 

22 that the manufacturer shall not be considered to be 

23 in violation of the testing and reporting require24 ments of this section until the testing is reported or 

25 until 1 year after the reporting deadline has passed, 
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1 whichever occurs sooner. If, however, the Secretary 

2 has not made a finding before the reporting dead3 line, the manufacturer shall not be considered to be 

4 in violation of such requirements until the Secretary 

5 finds that the conditions described in paragraph (2) 

6 have not been met, or until 1 year after the report7 ing deadline, whichever occurs sooner. 

8 ‘‘(4) ADDITIONAL EXTENSION.—In addition to 

9 the time that may be provided under paragraph (3), 

10 the Secretary may provide further extensions of 

11 time, in increments of no more than 1 year, for re12 quired testing and reporting to occur if the Sec13 retary determines, based on evidence properly and 

14 timely submitted by a small tobacco product manu15 facturer in accordance with paragraph (2), that a 

16 lack of available laboratory capacity prevents the 

17 manufacturer from completing the required testing 

18 during the period described in paragraph (3). 

19 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in sub20 section (d) or (e) shall be construed to authorize the exten21 sion of any deadline, or to otherwise affect any timeframe, 

22 under any provision of this Act or the Family Smoking 

23 Prevention and Tobacco Control Act other than this sec24 tion. 
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1 ‘‘SEC. 916. PRESERVATION OF STATE AND LOCAL AUTHOR2 ITY. 

3 ‘‘(a) IN GENERAL.— 

4 ‘‘(1) PRESERVATION.—Except as provided in 

5 paragraph (2)(A), nothing in this chapter, or rules 

6 promulgated under this chapter, shall be construed 

7 to limit the authority of a Federal agency (including 

8 the Armed Forces), a State or political subdivision 

9 of a State, or the government of an Indian tribe to 

10 enact, adopt, promulgate, and enforce any law, rule, 

11 regulation, or other measure with respect to tobacco 

12 products that is in addition to, or more stringent 

13 than, requirements established under this chapter, 

14 including a law, rule, regulation, or other measure 

15 relating to or prohibiting the sale, distribution, pos16 session, exposure to, access to, advertising and pro17 motion of, or use of tobacco products by individuals 

18 of any age, information reporting to the State, or 

19 measures relating to fire safety standards for to20 bacco products. No provision of this chapter shall 

21 limit or otherwise affect any State, Tribal, or local 

22 taxation of tobacco products. 

23 ‘‘(2) PREEMPTION OF CERTAIN STATE AND

24 LOCAL REQUIREMENTS.— 

25 ‘‘(A) IN GENERAL.—No State or political 

26 subdivision of a State may establish or continue 
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1 in effect with respect to a tobacco product any 

2 requirement which is different from, or in addi3 tion to, any requirement under the provisions of 

4 this chapter relating to tobacco product stand5 ards, premarket review, adulteration, mis6 branding, labeling, registration, good manufac7 turing standards, or modified risk tobacco prod8 ucts. 

9 ‘‘(B) EXCEPTION.—Subparagraph (A) 

10 does not apply to requirements relating to the 

11 sale, distribution, possession, information re12 porting to the State, exposure to, access to, the 

13 advertising and promotion of, or use of, tobacco 

14 products by individuals of any age, or relating 

15 to fire safety standards for tobacco products. 

16 Information disclosed to a State under subpara17 graph (A) that is exempt from disclosure under 

18 section 552(b)(4) of title 5, United States Code, 

19 shall be treated as a trade secret and confiden20 tial information by the State. 

21 ‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT

22 LIABILITY.—No provision of this chapter relating to a to23 bacco product shall be construed to modify or otherwise 

24 affect any action or the liability of any person under the 

25 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 enactment of the Family Smoking Pre13 vention and Tobacco Control Act, the Secretary shall in 

14 accordance with this section assess user fees on, and col15 lect such fees from, each manufacturer and importer of 

16 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 enactment of the Family Smoking Prevention and 

11 Tobacco Control Act occurs during fiscal year 2009, the 

12 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 SEC. 102. FINAL RULE. 

9 (a) CIGARETTES AND SMOKELESS TOBACCO.— 

10 (1) IN GENERAL.—On the first day of publica11 tion of the Federal Register that is 180 days or 

12 more after the date of enactment of this Act, the 

13 Secretary of Health and Human Services shall pub14 lish in the Federal Register a final rule regarding 

15 cigarettes and smokeless tobacco, which— 

16 (A) is deemed to be issued under chapter 

17 9 of the Federal Food, Drug, and Cosmetic 

18 Act, as added by section 101 of this Act; and 

19 (B) shall be deemed to be in compliance 

20 with all applicable provisions of chapter 5 of 

21 title 5, United States Code, and all other provi22 sions of law relating to rulemaking procedures. 

23 (2) CONTENTS OF RULE.—Except as provided 

24 in this subsection, the final rule published under 

25 paragraph (1), shall be identical in its provisions to 
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1 part 897 of the regulations promulgated by the Sec2 retary of Health and Human Services in the August 

3 28, 1996, issue of the Federal Register (61 Fed. 

4 Reg., 44615–44618). Such rule shall— 

5 (A) provide for the designation of jurisdic6 tional authority that is in accordance with this 

7 subsection in accordance with this Act and the 

8 amendments made by this Act; 

9 (B) strike Subpart C—Labels and section 

10 897.32(c); 

11 (C) strike paragraphs (a), (b), and (i) of 

12 section 897.3 and insert definitions of the terms 

13 ‘‘cigarette’’, ‘‘cigarette tobacco,’’, and ‘‘smoke14 less tobacco’’ as defined in section 900 of the 

15 Federal Food, Drug, and Cosmetic Act; 

16 (D) insert ‘‘or roll-your-own paper’’ in sec17 tion 897.34(a) after ‘‘other than cigarettes or 

18 smokeless tobacco’’; 

19 (E) become effective on the date that is 1 

20 year after the date of enactment of this Act; 

21 and 

22 (F) amend paragraph (d) of section 897.16 

23 to read as follows: 

24 ‘‘(d)(1) Except as provided in subparagraph (2), no 

25 manufacturer, distributor, or retailer may distribute or 
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1 cause to be distributed any free samples of cigarettes, 

2 smokeless tobacco, or other tobacco products (as such 

3 term is defined in section 201 of the Federal Food, Drug, 

4 and Cosmetic Act). 

5 ‘‘(2)(A) Subparagraph (1) does not prohibit a manu6 facturer, distributor, or retailer from distributing or caus7 ing to be distributed free samples of smokeless tobacco 

8 in a qualified adult-only facility. 

9 ‘‘(B) This subparagraph does not affect the authority 

10 of a State or local government to prohibit or otherwise 

11 restrict the distribution of free samples of smokeless to12 bacco. 

13 ‘‘(C) For purposes of this paragraph, the term ‘quali14 fied adult-only facility’ means a facility or restricted area 

15 that— 

16 ‘‘(i) requires each person present to provide to 

17 a law enforcement officer (whether on or off duty) 

18 or to a security guard licensed by a governmental 

19 entity government-issued identification showing a 

20 photograph and at least the minimum age estab21 lished by applicable law for the purchase of smoke22 less tobacco; 

23 ‘‘(ii) does not sell, serve, or distribute alcohol; 

24 ‘‘(iii) is not located adjacent to or immediately 

25 across from (in any direction) a space that is used 
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1 primarily for youth-oriented marketing, promotional, 

2 or other activities; 

3 ‘‘(iv) is a temporary structure constructed, des4 ignated, and operated as a distinct enclosed area for 

5 the purpose of distributing free samples of smokeless 

6 tobacco in accordance with this subparagraph; and 

7 ‘‘(v) is enclosed by a barrier that— 

8 ‘‘(I) is constructed of, or covered with, an 

9 opaque material (except for entrances and 

10 exits); 

11 ‘‘(II) extends from no more than 12 inches 

12 above the ground or floor (which area at the 

13 bottom of the barrier must be covered with ma14 terial that restricts visibility but may allow air15 flow) to at least 8 feet above the ground or 

16 floor (or to the ceiling); and 

17 ‘‘(III) prevents persons outside the quali18 fied adult-only facility from seeing into the 

19 qualified adult-only facility, unless they make 

20 unreasonable efforts to do so; and 

21 ‘‘(vi) does not display on its exterior— 

22 ‘‘(I) any tobacco product advertising; 

23 ‘‘(II) a brand name other than in conjunc24 tion with words for an area or enclosure to 

25 identify an adult-only facility; or 
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1 ‘‘(III) any combination of words that 

2 would imply to a reasonable observer that the 

3 manufacturer, distributor, or retailer has a 

4 sponsorship that would violate section 

5 897.34(c). 

6 ‘‘(D) Distribution of samples of smokeless tobacco 

7 under this subparagraph permitted to be taken out of the 

8 qualified adult-only facility shall be limited to 1 package 

9 per adult consumer containing no more than 0.53 ounces 

10 (15 grams) of smokeless tobacco. If such package of 

11 smokeless tobacco contains individual portions of smoke12 less tobacco, the individual portions of smokeless tobacco 

13 shall not exceed 8 individual portions and the collective 

14 weight of such individual portions shall not exceed 0.53 

15 ounces (15 grams). Any manufacturer, distributor, or re16 tailer who distributes or causes to be distributed free sam17 ples also shall take reasonable steps to ensure that the 

18 above amounts are limited to one such package per adult 

19 consumer per day. 

20 ‘‘(3) Notwithstanding subparagraph (2), no manufac21 turer, distributor, or retailer may distribute or cause to 

22 be distributed any free samples of smokeless tobacco— 

23 ‘‘(A) to a sports team or entertainment group; 

24 or 
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1 ‘‘(B) at any football, basketball, baseball, soc2 cer, or hockey event or any other sporting or enter3 tainment event determined by the Secretary to be 

4 covered by this subparagraph. 

5 ‘‘(4) The Secretary shall implement a program to en6 sure compliance with this paragraph and submit a report 

7 to the Congress on such compliance not later than 18 

8 months after the date of enactment of the Family Smok9 ing Prevention and Tobacco Control Act. 

10 ‘‘(5) Nothing in this paragraph shall be construed to 

11 authorize any person to distribute or cause to be distrib12 uted any sample of a tobacco product to any individual 

13 who has not attained the minimum age established by ap14 plicable law for the purchase of such product.’’. 

15 (3) AMENDMENTS TO RULE.—Prior to making 

16 amendments to the rule published under paragraph 

17 (1), the Secretary shall promulgate a proposed rule 

18 in accordance with chapter 5 of title 5, United 

19 States Code. 

20 (4) RULE OF CONSTRUCTION.—Except as pro21 vided in paragraph (3), nothing in this section shall 

22 be construed to limit the authority of the Secretary 

23 to amend, in accordance with chapter 5 of title 5, 

24 United States Code, the regulation promulgated pur25 suant to this section, including the provisions of 
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1 such regulation relating to distribution of free sam2 ples. 

3 (5) ENFORCEMENT OF RETAIL SALE PROVI4 SIONS.—The Secretary of Health and Human Serv5 ices shall ensure that the provisions of this Act, the 

6 amendments made by this Act, and the imple7 menting regulations (including such provisions, 

8 amendments, and regulations relating to the retail 

9 sale of tobacco products) are enforced with respect 

10 to the United States and Indian tribes. 

11 (6) QUALIFIED ADULT-ONLY FACILITY.—A 

12 qualified adult-only facility (as such term is defined 

13 in section 897.16(d) of the final rule published 

14 under paragraph (1)) that is also a retailer and that 

15 commits a violation as a retailer shall not be subject 

16 to the limitations in section 103(q) and shall be sub17 ject to penalties applicable to a qualified adult-only 

18 facility. 

19 (7) CONGRESSIONAL REVIEW PROVISIONS.— 

20 Section 801 of title 5, United States Code, shall not 

21 apply to the final rule published under paragraph 

22 (1). 

23 (b) LIMITATION ON ADVISORY OPINIONS.—As of the 

24 date of enactment of this Act, the following documents 

25 issued by the Food and Drug Administration shall not 
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1 constitute advisory opinions under section 10.85(d)(1) of 

2 title 21, Code of Federal Regulations, except as they apply 

3 to tobacco products, and shall not be cited by the Sec4 retary of Health and Human Services or the Food and 

5 Drug Administration as binding precedent: 

6 (1) The preamble to the proposed rule in the 

7 document titled ‘‘Regulations Restricting the Sale 

8 and Distribution of Cigarettes and Smokeless To9 bacco Products to Protect Children and Adoles10 cents’’ (60 Fed. Reg. 41314–41372 (August 11, 

11 1995)). 

12 (2) The document titled ‘‘Nicotine in Cigarettes 

13 and Smokeless Tobacco Products is a Drug and 

14 These Products Are Nicotine Delivery Devices 

15 Under the Federal Food, Drug, and Cosmetic Act’’ 

16 (60 Fed. Reg. 41453–41787 (August 11, 1995)). 

17 (3) The preamble to the final rule in the docu18 ment titled ‘‘Regulations Restricting the Sale and 

19 Distribution of Cigarettes and Smokeless Tobacco to 

20 Protect Children and Adolescents’’ (61 Fed. Reg. 

21 44396–44615 (August 28, 1996)). 

22 (4) The document titled ‘‘Nicotine in Cigarettes 

23 and Smokeless Tobacco is a Drug and These Prod24 ucts are Nicotine Delivery Devices Under the Fed25 eral Food, Drug, and Cosmetic Act; Jurisdictional 
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1 Determination’’ (61 Fed. Reg. 44619–45318 (Au2 gust 28, 1996)). 

3 SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GEN4 ERAL PROVISIONS. 

5 (a) AMENDMENT OF FEDERAL FOOD, DRUG, AND

6 COSMETIC ACT.—Except as otherwise expressly provided, 

7 whenever in this section an amendment is expressed in 

8 terms of an amendment to, or repeal of, a section or other 

9 provision, the reference is to a section or other provision 

10 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

11 301 et seq.). 

12 (b) SECTION 301.—Section 301 (21 U.S.C. 331) is 

13 amended— 

14 (1) in subsection (a), by inserting ‘‘tobacco 

15 product,’’ after ‘‘device,’’; 

16 (2) in subsection (b), by inserting ‘‘tobacco 

17 product,’’ after ‘‘device,’’; 

18 (3) in subsection (c), by inserting ‘‘tobacco 

19 product,’’ after ‘‘device,’’; 

20 (4) in subsection (e)— 

21 (A) by striking the period after ‘‘572(i)’’; 

22 and 

23 (B) by striking ‘‘or 761 or the refusal to 

24 permit access to’’ and inserting ‘‘761, 909, or 

25 920 or the refusal to permit access to’’; 
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1 (5) in subsection (g), by inserting ‘‘tobacco 

2 product,’’ after ‘‘device,’’; 

3 (6) in subsection (h), by inserting ‘‘tobacco 

4 product,’’ after ‘‘device,’’; 

5 (7) in subsection (j)— 

6 (A) by striking the period after ‘‘573’’; and 

7 (B) by striking ‘‘708, or 721’’ and insert8 ing ‘‘708, 721, 904, 905, 906, 907, 908, 909, 

9 or 920(b)’’; 

10 (8) in subsection (k), by inserting ‘‘tobacco 

11 product,’’ after ‘‘device,’’; 

12 (9) by striking subsection (p) and inserting the 

13 following: 

14 ‘‘(p) The failure to register in accordance with section 

15 510 or 905, the failure to provide any information re16 quired by section 510(j), 510(k), 905(i), or 905(j), or the 

17 failure to provide a notice required by section 510(j)(2) 

18 or 905(i)(3).’’; 

19 (10) by striking subsection (q)(1) and inserting 

20 the following: 

21 ‘‘(q)(1) The failure or refusal— 

22 ‘‘(A) to comply with any requirement prescribed 

23 under section 518, 520(g), 903(b), 907, 908, or 916; 
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1 ‘‘(B) to furnish any notification or other mate2 rial or information required by or under section 519, 

3 520(g), 904, 909, or 920; or 

4 ‘‘(C) to comply with a requirement under sec5 tion 522 or 913.’’; 

6 (11) in subsection (q)(2), by striking ‘‘device,’’ 

7 and inserting ‘‘device or tobacco product,’’; 

8 (12) in subsection (r), by inserting ‘‘or tobacco 

9 product’’ after the term ‘‘device’’ each time that 

10 such term appears; and 

11 (13) by adding at the end the following: 

12 ‘‘(oo) The sale of tobacco products in violation of a 

13 no-tobacco-sale order issued under section 303(f). 

14 ‘‘(pp) The introduction or delivery for introduction 

15 into interstate commerce of a tobacco product in violation 

16 of section 911. 

17 ‘‘(qq)(1) Forging, counterfeiting, simulating, or false18 ly representing, or without proper authority using any 

19 mark, stamp (including tax stamp), tag, label, or other 

20 identification device upon any tobacco product or con21 tainer or labeling thereof so as to render such tobacco 

22 product a counterfeit tobacco product. 

23 ‘‘(2) Making, selling, disposing of, or keeping in pos24 session, control, or custody, or concealing any punch, die, 

25 plate, stone, or other item that is designed to print, im-
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1 print, or reproduce the trademark, trade name, or other 

2 identifying mark, imprint, or device of another or any like3 ness of any of the foregoing upon any tobacco product or 

4 container or labeling thereof so as to render such tobacco 

5 product a counterfeit tobacco product. 

6 ‘‘(3) The doing of any act that causes a tobacco prod7 uct to be a counterfeit tobacco product, or the sale or dis8 pensing, or the holding for sale or dispensing, of a coun9 terfeit tobacco product. 

10 ‘‘(rr) The charitable distribution of tobacco products. 

11 ‘‘(ss) The failure of a manufacturer or distributor to 

12 notify the Attorney General and the Secretary of the 

13 Treasury of their knowledge of tobacco products used in 

14 illicit trade. 

15 ‘‘(tt) With respect to a tobacco product, any state16 ment directed to consumers through the media or through 

17 the label, labeling, or advertising that would reasonably 

18 be expected to result in consumers believing that the prod19 uct is regulated, inspected or approved by the Food and 

20 Drug Administration, or that the product complies with 

21 the requirements of the Food and Drug Administration, 

22 including a statement or implication in the label, labeling, 

23 or advertising of such product, and that could result in 

24 consumers believing that the product is endorsed for use 

25 by the Food and Drug Administration or in consumers 
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1 being misled about the harmfulness of the product because 

2 of such regulation, inspection, or compliance.’’. 

3 (c) SECTION 303.—Section 303(f) (21 U.S.C. 333(f)) 

4 is amended— 

5 (1) in paragraph (1)(A), by inserting ‘‘or to6 bacco products’’ after the term ‘‘devices’’ each place 

7 such term appears; 

8 (2) in paragraph (5)— 

9 (A) in subparagraph (A)— 

10 (i) by striking ‘‘assessed’’ the first 

11 time it appears and inserting ‘‘assessed, or 

12 a no-tobacco-sale order may be imposed,’’; 

13 and 

14 (ii) by striking ‘‘penalty’’ the second 

15 time it appears and inserting ‘‘penalty, or 

16 upon whom a no-tobacco-sale order is to be 

17 imposed,’’; 

18 (B) in subparagraph (B)— 

19 (i) by inserting after ‘‘penalty,’’ the 

20 following: ‘‘or the period to be covered by 

21 a no-tobacco-sale order,’’; and 

22 (ii) by adding at the end the fol23 lowing: ‘‘A no-tobacco-sale order perma24 nently prohibiting an individual retail out25 let from selling tobacco products shall in-
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1 clude provisions that allow the outlet, after 

2 a specified period of time, to request that 

3 the Secretary compromise, modify, or ter4 minate the order.’’; and 

5 (C) by adding at the end the following: 

6 ‘‘(D) The Secretary may compromise, modify, or ter7 minate, with or without conditions, any no-tobacco-sale 

8 order.’’; 

9 (3) in paragraph (6)— 

10 (A) by inserting ‘‘or the imposition of a 

11 no-tobacco-sale order’’ after the term ‘‘penalty’’ 

12 each place such term appears; and 

13 (B) by striking ‘‘issued.’’ and inserting 

14 ‘‘issued, or on which the no-tobacco-sale order 

15 was imposed, as the case may be.’’; and 

16 (4) by adding at the end the following: 

17 ‘‘(8) If the Secretary finds that a person has com18 mitted repeated violations of restrictions promulgated 

19 under section 906(d) at a particular retail outlet then the 

20 Secretary may impose a no-tobacco-sale order on that per21 son prohibiting the sale of tobacco products in that outlet. 

22 A no-tobacco-sale order may be imposed with a civil pen23 alty under paragraph (1). Prior to the entry of a no-sale 

24 order under this paragraph, a person shall be entitled to 

25 a hearing pursuant to the procedures established through 
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1 regulations of the Food and Drug Administration for as2 sessing civil money penalties, including at a retailer’s re3 quest a hearing by telephone, or at the nearest regional 

4 or field office of the Food and Drug Administration, or 

5 at a Federal, State, or county facility within 100 miles 

6 from the location of the retail outlet, if such a facility is 

7 available.’’. 

8 (d) SECTION 304.—Section 304 (21 U.S.C. 334) is 

9 amended— 

10 (1) in subsection (a)(2)— 

11 (A) by striking ‘‘and’’ before ‘‘(D)’’; and 

12 (B) by striking ‘‘device.’’ and inserting the 

13 following: ‘‘device, and (E) Any adulterated or 

14 misbranded tobacco product.’’; 

15 (2) in subsection (d)(1), by inserting ‘‘tobacco 

16 product,’’ after ‘‘device,’’; 

17 (3) in subsection (g)(1), by inserting ‘‘or to18 bacco product’’ after the term ‘‘device’’ each place 

19 such term appears; and 

20 (4) in subsection (g)(2)(A), by inserting ‘‘or to21 bacco product’’ after ‘‘device’’. 

22 (e) SECTION 505.—Section 505(n)(2) (21 U.S.C. 

23 355(n)(2)) is amended by striking ‘‘section 904’’ and in24 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 country without the express written consent of 

18 the 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)— 

4 (A) by striking ‘‘devices, or cosmetics’’ 

5 each place it appears and inserting ‘‘devices, to6 bacco products, or cosmetics’’; 

7 (B) by striking ‘‘or restricted devices’’ each 

8 place it appears and inserting ‘‘restricted de9 vices, or tobacco products’’; 

10 (C) by striking ‘‘and devices and subject 

11 to’’ and all that follows through ‘‘other drugs or 

12 devices’’ and inserting ‘‘devices, and tobacco 

13 products and subject to reporting and inspec14 tion under regulations lawfully issued pursuant 

15 to section 505(i) or (k), section 519, section 

16 520(g), or chapter IX and data relating to 

17 other drugs, devices, or tobacco products’’; 

18 (2) in subsection (b), by inserting ‘‘tobacco 

19 product,’’ after ‘‘device,’’; and 

20 (3) in subsection (g)(13), by striking ‘‘section 

21 903(g)’’ and inserting ‘‘section 1003(g)’’. 

22 (j) SECTION 705.—Section 705(b) (21 U.S.C. 

23 375(b)) is amended by inserting ‘‘tobacco products,’’ after 

24 ‘‘devices,’’. 
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1 (k) SECTION 709.—Section 709 (21 U.S.C. 379a) is 

2 amended by inserting ‘‘tobacco product,’’ after ‘‘device,’’. 

3 (l) SECTION 801.—Section 801 (21 U.S.C. 381) is 

4 amended— 

5 (1) in subsection (a)— 

6 (A) by inserting ‘‘tobacco products,’’ after 

7 the term ‘‘devices,’’; 

8 (B) by inserting ‘‘or section 905(h)’’ after 

9 ‘‘section 510’’; and 

10 (C) by striking the term ‘‘drugs or de11 vices’’ each time such term appears and insert12 ing ‘‘drugs, devices, or tobacco products’’; 

13 (2) in subsection (e)(1)— 

14 (A) by inserting ‘‘tobacco product’’ after 

15 ‘‘drug, device,’’; and 

16 (B) by inserting ‘‘, and a tobacco product 

17 intended for export shall not be deemed to be 

18 in violation of section 906(e), 907, 911, or 

19 920(a),’’ before ‘‘if it—’’; and 

20 (3) by adding at the end the following: 

21 ‘‘(p)(1) Not later than 36 months after the date of 

22 enactment of the Family Smoking Prevention and To23 bacco Control Act, and annually thereafter, the Secretary 

24 shall submit to the Committee on Health, Education, 

25 Labor, and Pensions of the Senate and the Committee on 
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1 Energy and Commerce of the House of Representatives, 

2 a report regarding— 

3 ‘‘(A) the nature, extent, and destination of 

4 United States tobacco product exports that do not 

5 conform to tobacco product standards established 

6 pursuant to this Act; 

7 ‘‘(B) the public health implications of such ex8 ports, including any evidence of a negative public 

9 health impact; and 

10 ‘‘(C) recommendations or assessments of policy 

11 alternatives available to Congress and the executive 

12 branch to reduce any negative public health impact 

13 caused by such exports. 

14 ‘‘(2) The Secretary is authorized to establish appro15 priate information disclosure requirements to carry out 

16 this subsection.’’. 

17 (m) SECTION 1003.—Section 1003(d)(2)(C) (as re18 designated by section 101(b)) is amended— 

19 (1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 

20 (2) inserting ‘‘, and tobacco products’’ after 

21 ‘‘devices’’. 

22 (n) SECTION 1009.—Section 1009(b) (as redesig23 nated by section 101(b)) is amended by striking ‘‘section 

24 908’’ and inserting ‘‘section 1008’’. 
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1 (o) SECTION 409 OF THE FEDERAL MEAT INSPEC2 TION ACT.—Section 409(a) of the Federal Meat Inspec3 tion Act (21 U.S.C. 679(a)) is amended by striking ‘‘sec4 tion 902(b)’’ and inserting ‘‘section 1002(b)’’. 

5 (p) RULE OF CONSTRUCTION.—Nothing in this sec6 tion is intended or shall be construed to expand, contract, 

7 or otherwise modify or amend the existing limitations on 

8 State government authority over tribal restricted fee or 

9 trust lands. 

10 (q) GUIDANCE AND EFFECTIVE DATES.— 

11 (1) IN GENERAL.—The Secretary of Health and 

12 Human Services shall issue guidance— 

13 (A) defining the term ‘‘repeated violation’’, 

14 as used in section 303(f)(8) of the Federal 

15 Food, Drug, and Cosmetic Act (21 U.S.C. 

16 333(f)(8)) as amended by subsection (c), as in17 cluding at least 5 violations of particular re18 quirements over a 36-month period at a par19 ticular retail outlet that constitute a repeated 

20 violation and providing for civil penalties in ac21 cordance with paragraph (2); 

22 (B) providing for timely and effective no23 tice by certified or registered mail or personal 

24 delivery to the retailer of each alleged violation 

25 at a particular retail outlet prior to conducting 
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1 a followup compliance check, such notice to be 

2 sent to the location specified on the retailer’s 

3 registration or to the retailer’s registered agent 

4 if the retailer has provider such agent informa5 tion to the Food and Drug Administration prior 

6 to the violation; 

7 (C) providing for a hearing pursuant to the 

8 procedures established through regulations of 

9 the Food and Drug Administration for assess10 ing civil money penalties, including at a retail11 er’s request a hearing by telephone or at the 

12 nearest regional or field office of the Food and 

13 Drug Administration, and providing for an ex14 pedited procedure for the administrative appeal 

15 of an alleged violation; 

16 (D) providing that a person may not be 

17 charged with a violation at a particular retail 

18 outlet unless the Secretary has provided notice 

19 to the retailer of all previous violations at that 

20 outlet; 

21 (E) establishing that civil money penalties 

22 for multiple violations shall increase from one 

23 violation to the next violation pursuant to para24 graph (2) within the time periods provided for 

25 in such paragraph; 
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1 (F) providing that good faith reliance on 

2 the presentation of a false government-issued 

3 photographic identification that contains a date 

4 of birth does not constitute a violation of any 

5 minimum age requirement for the sale of to6 bacco products if the retailer has taken effective 

7 steps to prevent such violations, including— 

8 (i) adopting and enforcing a written 

9 policy against sales to minors; 

10 (ii) informing its employees of all ap11 plicable laws; 

12 (iii) establishing disciplinary sanctions 

13 for employee noncompliance; and 

14 (iv) requiring its employees to verify 

15 age by way of photographic identification 

16 or electronic scanning device; and 

17 (G) providing for the Secretary, in deter18 mining whether to impose a no-tobacco-sale 

19 order and in determining whether to com20 promise, modify, or terminate such an order, to 

21 consider whether the retailer has taken effective 

22 steps to prevent violations of the minimum age 

23 requirements for the sale of tobacco products, 

24 including the steps listed in subparagraph (F). 

25 (2) PENALTIES FOR VIOLATIONS.— 
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1 (A) IN GENERAL.—The amount of the civil 

2 penalty to be applied for violations of restric3 tions promulgated under section 906(d), as de4 scribed in paragraph (1), shall be as follows: 

5 (i) With respect to a retailer with an 

6 approved training program, the amount of 

7 the civil penalty shall not exceed— 

8 (I) in the case of the first viola9 tion, $0.00 together with the issuance 

10 of a warning letter to the retailer; 

11 (II) in the case of a second viola12 tion within a 12-month period, $250; 

13 (III) in the case of a third viola14 tion within a 24-month period, $500; 

15 (IV) in the case of a fourth viola16 tion within a 24-month period, 

17 $2,000; 

18 (V) in the case of a fifth violation 

19 within a 36-month period, $5,000; 

20 and 

21 (VI) in the case of a sixth or sub22 sequent violation within a 48-month 

23 period, $10,000 as determined by the 

24 Secretary on a case-by-case basis. 
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1 (ii) With respect to a retailer that 

2 does not have an approved training pro3 gram, the amount of the civil penalty shall 

4 not exceed— 

5 (I) in the case of the first viola6 tion, $250; 

7 (II) in the case of a second viola8 tion within a 12-month period, $500; 

9 (III) in the case of a third viola10 tion within a 24-month period, 

11 $1,000; 

12 (IV) in the case of a fourth viola13 tion within a 24-month period, 

14 $2,000; 

15 (V) in the case of a fifth violation 

16 within a 36-month period, $5,000; 

17 and 

18 (VI) in the case of a sixth or sub19 sequent violation within a 48-month 

20 period, $10,000 as determined by the 

21 Secretary on a case-by-case basis. 

22 (B) TRAINING PROGRAM.—For purposes of 

23 subparagraph (A), the term ‘‘approved training 

24 program’’ means a training program that com-
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1 plies with standards developed by the Food and 

2 Drug Administration for such programs. 

3 (C) CONSIDERATION OF STATE PEN4 ALTIES.—The Secretary shall coordinate with 

5 the States in enforcing the provisions of this 

6 Act and, for purposes of mitigating a civil pen7 alty to be applied for a violation by a retailer 

8 of any restriction promulgated under section 

9 906(d), shall consider the amount of any pen10 alties paid by the retailer to a State for the 

11 same violation. 

12 (3) GENERAL EFFECTIVE DATE.—The amend13 ments made by paragraphs (2), (3), and (4) of sub14 section (c) shall take effect upon the issuance of 

15 guidance described in paragraph (1) of this sub16 section. 

17 (4) SPECIAL EFFECTIVE DATE.—The amend18 ment made by subsection (c)(1) shall take effect on 

19 the date of enactment of this Act. 

20 (5) PACKAGE LABEL REQUIREMENTS.—The 

21 package label requirements of paragraphs (2), (3), 

22 and (4) of section 903(a) of the Federal Food, 

23 Drug, and Cosmetic Act (as amended by this Act) 

24 shall take effect on the date that is 12 months after 

25 the date of enactment of this Act. The effective date 
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1 shall be with respect to the date of manufacture, 

2 provided that, in any case, beginning 30 days after 

3 such effective date, a manufacturer shall not intro4 duce into the domestic commerce of the United 

5 States any product, irrespective of the date of manu6 facture, that is not in conformance with section 

7 903(a)(2), (3), and (4) and section 920(a) of the 

8 Federal Food, Drug, and Cosmetic Act. 

9 (6) ADVERTISING REQUIREMENTS.—The adver10 tising requirements of section 903(a)(8) of the Fed11 eral Food, Drug, and Cosmetic Act (as amended by 

12 this Act) shall take effect on the date that is 12 

13 months after the date of enactment of this Act. 

14 SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PUR15 CHASE TOBACCO PRODUCTS. 

16 The Secretary of Health and Human Services shall— 

17 (1) convene an expert panel to conduct a study 

18 on the public health implications of raising the min19 imum age to purchase tobacco products; and 

20 (2) not later than 5 years after the date of en21 actment of this Act, submit a report to the Congress 

22 on the results of such study. 

23 SEC. 105. ENFORCEMENT ACTION PLAN FOR ADVERTISING 

24 AND PROMOTION RESTRICTIONS. 

25 (a) ACTION PLAN.— 
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1 (1) DEVELOPMENT.—Not later than 6 months 

2 after the date of enactment of this Act, the Sec3 retary of Health and Human Services (in this sec4 tion referred to as the ‘‘Secretary’’) shall develop 

5 and publish an action plan to enforce restrictions 

6 adopted pursuant to section 906 of the Federal 

7 Food, Drug, and Cosmetic Act, as added by section 

8 101(b) of this Act, or pursuant to section 102(a) of 

9 this Act, on promotion and advertising of menthol 

10 and other cigarettes to youth. 

11 (2) CONSULTATION.—The action plan required 

12 by paragraph (1) shall be developed in consultation 

13 with public health organizations and other stake14 holders with demonstrated expertise and experience 

15 in serving minority communities. 

16 (3) PRIORITY.—The action plan required by 

17 paragraph (1) shall include provisions designed to 

18 ensure enforcement of the restrictions described in 

19 paragraph (1) in minority communities. 

20 (b) STATE AND LOCAL ACTIVITIES.— 

21 (1) INFORMATION ON AUTHORITY.—Not later 

22 than 3 months after the date of enactment of this 

23 Act, the Secretary shall inform State, local, and trib24 al governments of the authority provided to such en25 tities under section 5(c) of the Federal Cigarette La-
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1 beling and Advertising Act, as added by section 203 

2 of this Act, or preserved by such entities under sec3 tion 916 of the Federal Food, Drug, and Cosmetic 

4 Act, as added by section 101(b) of this Act. 

5 (2) COMMUNITY ASSISTANCE.—At the request 

6 of communities seeking assistance to prevent under7 age tobacco use, the Secretary shall provide such as8 sistance, including assistance with strategies to ad9 dress the prevention of underage tobacco use in com10 munities with a disproportionate use of menthol 

11 cigarettes by minors. 

12 TITLE II—TOBACCO PRODUCT 

13 WARNINGS; CONSTITUENT 

14 AND SMOKE CONSTITUENT 

15 DISCLOSURE 

16 SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS. 

17 (a) AMENDMENT.—Section 4 of the Federal Ciga18 rette Labeling and Advertising Act (15 U.S.C. 1333) is 

19 amended to read as follows: 

20 ‘‘SEC. 4. LABELING. 

21 ‘‘(a) LABEL REQUIREMENTS.— 

22 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

23 person to manufacture, package, sell, offer to sell, 

24 distribute, or import for sale or distribution within 

25 the United States any cigarettes the package of 
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1 which fails to bear, in accordance with the require2 ments of this section, one of the following labels: 

3 ‘‘WARNING: Cigarettes are addictive. 

4 ‘‘WARNING: Tobacco smoke can harm 

5 your children. 

6 ‘‘WARNING: Cigarettes cause fatal lung 

7 disease. 

8 ‘‘WARNING: Cigarettes cause cancer. 

9 ‘‘WARNING: Cigarettes cause strokes and 

10 heart disease. 

11 ‘‘WARNING: Smoking during pregnancy 

12 can harm your baby. 

13 ‘‘WARNING: Smoking can kill you. 

14 ‘‘WARNING: Tobacco smoke causes fatal 

15 lung disease in nonsmokers. 

16 ‘‘WARNING: Quitting smoking now great17 ly reduces serious risks to your health. 

18 ‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—Each 

19 label statement required by paragraph (1) shall be 

20 located in the upper portion of the front and rear 

21 panels of the package, directly on the package un22 derneath the cellophane or other clear wrapping. 

23 Each label statement shall comprise at least the top 

24 30 percent of the front and rear panels of the pack25 age. The word ‘WARNING’ shall appear in capital 
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1 letters and all text shall be in conspicuous and leg2 ible 17-point type, unless the text of the label state3 ment would occupy more than 70 percent of such 

4 area, in which case the text may be in a smaller con5 spicuous and legible type size, provided that at least 

6 60 percent of such area is occupied by required text. 

7 The text shall be black on a white background, or 

8 white on a black background, in a manner that con9 trasts, by typography, layout, or color, with all other 

10 printed material on the package, in an alternating 

11 fashion under the plan submitted under subsection 

12 (c). 

13 ‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU14 TION.—The provisions of this subsection do not 

15 apply to a tobacco product manufacturer or dis16 tributor of cigarettes which does not manufacture, 

17 package, or import cigarettes for sale or distribution 

18 within the United States. 

19 ‘‘(4) APPLICABILITY TO RETAILERS.—A retailer 

20 of cigarettes shall not be in violation of this sub21 section for packaging that— 

22 ‘‘(A) contains a warning label; 

23 ‘‘(B) is supplied to the retailer by a 

24 license- or permit-holding tobacco product man25 ufacturer, importer, or distributor; and 
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1 ‘‘(C) is not altered by the retailer in a way 

2 that is material to the requirements of this sub3 section. 

4 ‘‘(b) ADVERTISING REQUIREMENTS.— 

5 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

6 tobacco product manufacturer, importer, distributor, 

7 or retailer of cigarettes to advertise or cause to be 

8 advertised within the United States any cigarette 

9 unless its advertising bears, in accordance with the 

10 requirements of this section, one of the labels speci11 fied in subsection (a). 

12 ‘‘(2) TYPOGRAPHY, ETC.—Each label statement 

13 required by subsection (a) in cigarette advertising 

14 shall comply with the standards set forth in this 

15 paragraph. For press and poster advertisements, 

16 each such statement and (where applicable) any re17 quired statement relating to tar, nicotine, or other 

18 constituent (including a smoke constituent) yield 

19 shall comprise at least 20 percent of the area of the 

20 advertisement and shall appear in a conspicuous and 

21 prominent format and location at the top of each ad22 vertisement within the trim area. The Secretary may 

23 revise the required type sizes in such area in such 

24 manner as the Secretary determines appropriate. 

25 The word ‘WARNING’ shall appear in capital let-
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1 ters, and each label statement shall appear in con2 spicuous and legible type. The text of the label state3 ment shall be black if the background is white and 

4 white if the background is black, under the plan sub5 mitted under subsection (c). The label statements 

6 shall be enclosed by a rectangular border that is the 

7 same color as the letters of the statements and that 

8 is the width of the first downstroke of the capital 

9 ‘W’ of the word ‘WARNING’ in the label state10 ments. The text of such label statements shall be in 

11 a typeface pro rata to the following requirements: 

12 45-point type for a whole-page broadsheet newspaper 

13 advertisement; 39-point type for a half-page 

14 broadsheet newspaper advertisement; 39-point type 

15 for a whole-page tabloid newspaper advertisement; 

16 27-point type for a half-page tabloid newspaper ad17 vertisement; 31.5-point type for a double page 

18 spread magazine or whole-page magazine advertise19 ment; 22.5-point type for a 28 centimeter by 3 col20 umn advertisement; and 15-point type for a 20 cen21 timeter by 2 column advertisement. The label state22 ments shall be in English, except that— 

23 ‘‘(A) in the case of an advertisement that 

24 appears in a newspaper, magazine, periodical, 

25 or other publication that is not in English, the 
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1 statements shall appear in the predominant lan2 guage of the publication; and 

3 ‘‘(B) in the case of any other advertise4 ment that is not in English, the statements 

5 shall appear in the same language as that prin6 cipally used in the advertisement. 

7 ‘‘(3) MATCHBOOKS.—Notwithstanding para8 graph (2), for matchbooks (defined as containing not 

9 more than 20 matches) customarily given away with 

10 the purchase of tobacco products, each label state11 ment required by subsection (a) may be printed on 

12 the inside cover of the matchbook. 

13 ‘‘(4) ADJUSTMENT BY SECRETARY.—The Sec14 retary may, through a rulemaking under section 553 

15 of title 5, United States Code, adjust the format and 

16 type sizes for the label statements required by this 

17 section; the text, format, and type sizes of any re18 quired tar, nicotine yield, or other constituent (in19 cluding smoke constituent) disclosures; or the text, 

20 format, and type sizes for any other disclosures re21 quired under the Federal Food, Drug, and Cosmetic 

22 Act. The text of any such label statements or disclo23 sures shall be required to appear only within the 20 

24 percent area of cigarette advertisements provided by 

25 paragraph (2). The Secretary shall promulgate regu-
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1 lations which provide for adjustments in the format 

2 and type sizes of any text required to appear in such 

3 area to ensure that the total text required to appear 

4 by law will fit within such area. 

5 ‘‘(c) MARKETING REQUIREMENTS.— 

6 ‘‘(1) RANDOM DISPLAY.—The label statements 

7 specified in subsection (a)(1) shall be randomly dis8 played in each 12-month period, in as equal a num9 ber of times as is possible on each brand of the 

10 product and be randomly distributed in all areas of 

11 the United States in which the product is marketed 

12 in accordance with a plan submitted by the tobacco 

13 product manufacturer, importer, distributor, or re14 tailer and approved by the Secretary. 

15 ‘‘(2) ROTATION.—The label statements speci16 fied in subsection (a)(1) shall be rotated quarterly in 

17 alternating sequence in advertisements for each 

18 brand of cigarettes in accordance with a plan sub19 mitted by the tobacco product manufacturer, im20 porter, distributor, or retailer to, and approved by, 

21 the Secretary. 

22 ‘‘(3) REVIEW.—The Secretary shall review each 

23 plan submitted under paragraph (2) and approve it 

24 if the plan— 
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1 ‘‘(A) will provide for the equal distribution 

2 and display on packaging and the rotation re3 quired in advertising under this subsection; and 

4 ‘‘(B) assures that all of the labels required 

5 under this section will be displayed by the to6 bacco product manufacturer, importer, dis7 tributor, or retailer at the same time. 

8 ‘‘(4) APPLICABILITY TO RETAILERS.—This sub9 section and subsection (b) apply to a retailer only if 

10 that retailer is responsible for or directs the label 

11 statements required under this section except that 

12 this paragraph shall not relieve a retailer of liability 

13 if the retailer displays, in a location open to the pub14 lic, an advertisement that does not contain a warn15 ing label or has been altered by the retailer in a way 

16 that is material to the requirements of this sub17 section and subsection (b).’’. 

18 (b) EFFECTIVE DATE.—The amendment made by 

19 subsection (a) shall take effect 12 months after the date 

20 of enactment of this Act. Such effective date shall be with 

21 respect to the date of manufacture, provided that, in any 

22 case, beginning 30 days after such effective date, a manu23 facturer shall not introduce into the domestic commerce 

24 of the United States any product, irrespective of the date 

25 of manufacture, that is not in conformance with section 
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1 4 of the Federal Cigarette Labeling and Advertising Act 

2 (15 U.S.C. 1333), as amended by subsection (a). 

3 SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING 

4 LABEL STATEMENTS. 

5 (a) PREEMPTION.—Section 5(a) of the Federal Ciga6 rette Labeling and Advertising Act (15 U.S.C. 1334(a)) 

7 is amended by striking ‘‘No’’ and inserting ‘‘Except to the 

8 extent the Secretary requires additional or different state9 ments on any cigarette package by a regulation, by an 

10 order, by a standard, by an authorization to market a 

11 product, or by a condition of marketing a product, pursu12 ant to the Family Smoking Prevention and Tobacco Con13 trol Act (and the amendments made by that Act), or as 

14 required under section 903(a)(2) or section 920(a) of the 

15 Federal Food, Drug, and Cosmetic Act, no’’. 

16 (b) CHANGE IN REQUIRED STATEMENTS.—Section 4 

17 of the Federal Cigarette Labeling and Advertising Act (15 

18 U.S.C. 1333), as amended by section 201, is further 

19 amended by adding at the end the following: 

20 ‘‘(d) CHANGE IN REQUIRED STATEMENTS.—The 

21 Secretary may, by a rulemaking conducted under section 

22 553 of title 5, United States Code, adjust the format, type 

23 size, and text of any of the label requirements, require 

24 color graphics to accompany the text, increase the re25 quired label area from 30 percent up to 50 percent of the 
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1 front and rear panels of the package, or establish the for2 mat, type size, and text of any other disclosures required 

3 under the Federal Food, Drug, and Cosmetic Act, if the 

4 Secretary finds that such a change would promote greater 

5 public understanding of the risks associated with the use 

6 of tobacco products.’’. 

7 SEC. 203. STATE REGULATION OF CIGARETTE ADVER8 TISING AND PROMOTION. 

9 Section 5 of the Federal Cigarette Labeling and Ad10 vertising Act (15 U.S.C. 1334) is amended by adding at 

11 the end the following: 

12 ‘‘(c) EXCEPTION.—Notwithstanding subsection (b), a 

13 State or locality may enact statutes and promulgate regu14 lations, based on smoking and health, that take effect 

15 after the effective date of the Family Smoking Prevention 

16 and Tobacco Control Act, imposing specific bans or re17 strictions on the time, place, and manner, but not content, 

18 of the advertising or promotion of any cigarettes.’’. 

19 SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING 

20 WARNINGS. 

21 (a) AMENDMENT.—Section 3 of the Comprehensive 

22 Smokeless Tobacco Health Education Act of 1986 (15 

23 U.S.C. 4402) is amended to read as follows: 

24 ‘‘SEC. 3. SMOKELESS TOBACCO WARNING. 

25 ‘‘(a) GENERAL RULE.— 
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1 ‘‘(1) It shall be unlawful for any person to man2 ufacture, package, sell, offer to sell, distribute, or 

3 import for sale or distribution within the United 

4 States any smokeless tobacco product unless the 

5 product package bears, in accordance with the re6 quirements of this Act, one of the following labels: 

7 ‘‘WARNING: This product can cause 

8 mouth cancer. 

9 ‘‘WARNING: This product can cause gum 

10 disease and tooth loss. 

11 ‘‘WARNING: This product is not a safe al12 ternative to cigarettes. 

13 ‘‘WARNING: Smokeless tobacco is addict14 ive. 

15 ‘‘(2) Each label statement required by para16 graph (1) shall be— 

17 ‘‘(A) located on the 2 principal display 

18 panels of the package, and each label statement 

19 shall comprise at least 30 percent of each such 

20 display panel; and 

21 ‘‘(B) in 17-point conspicuous and legible 

22 type and in black text on a white background, 

23 or white text on a black background, in a man24 ner that contrasts by typography, layout, or 

25 color, with all other printed material on the 
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1 package, in an alternating fashion under the 

2 plan submitted under subsection (b)(3), except 

3 that if the text of a label statement would oc4 cupy more than 70 percent of the area specified 

5 by subparagraph (A), such text may appear in 

6 a smaller type size, so long as at least 60 per7 cent of such warning area is occupied by the 

8 label statement. 

9 ‘‘(3) The label statements required by para10 graph (1) shall be introduced by each tobacco prod11 uct manufacturer, packager, importer, distributor, or 

12 retailer of smokeless tobacco products concurrently 

13 into the distribution chain of such products. 

14 ‘‘(4) The provisions of this subsection do not 

15 apply to a tobacco product manufacturer or dis16 tributor of any smokeless tobacco product that does 

17 not manufacture, package, or import smokeless to18 bacco products for sale or distribution within the 

19 United States. 

20 ‘‘(5) A retailer of smokeless tobacco products 

21 shall not be in violation of this subsection for pack22 aging that— 

23 ‘‘(A) contains a warning label; 
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1 ‘‘(B) is supplied to the retailer by a 

2 license- or permit-holding tobacco product man3 ufacturer, importer, or distributor; and 

4 ‘‘(C) is not altered by the retailer in a way 

5 that is material to the requirements of this sub6 section. 

7 ‘‘(b) REQUIRED LABELS.— 

8 ‘‘(1) It shall be unlawful for any tobacco prod9 uct manufacturer, packager, importer, distributor, or 

10 retailer of smokeless tobacco products to advertise or 

11 cause to be advertised within the United States any 

12 smokeless tobacco product unless its advertising 

13 bears, in accordance with the requirements of this 

14 section, one of the labels specified in subsection (a). 

15 ‘‘(2)(A) Each label statement required by sub16 section (a) in smokeless tobacco advertising shall 

17 comply with the standards set forth in this para18 graph. 

19 ‘‘(B) For press and poster advertisements, each 

20 such statement and (where applicable) any required 

21 statement relating to tar, nicotine, or other con22 stituent yield shall comprise at least 20 percent of 

23 the area of the advertisement. 
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1 ‘‘(C) The word ‘WARNING’ shall appear in 

2 capital letters, and each label statement shall appear 

3 in conspicuous and legible type. 

4 ‘‘(D) The text of the label statement shall be 

5 black on a white background, or white on a black 

6 background, in an alternating fashion under the 

7 plan submitted under paragraph (3). 

8 ‘‘(E) The label statements shall be enclosed by 

9 a rectangular border that is the same color as the 

10 letters of the statements and that is the width of the 

11 first downstroke of the capital ‘W’ of the word 

12 ‘WARNING’ in the label statements. 

13 ‘‘(F) The text of such label statements shall be 

14 in a typeface pro rata to the following requirements: 

15 45-point type for a whole-page broadsheet newspaper 

16 advertisement; 39-point type for a half-page 

17 broadsheet newspaper advertisement; 39-point type 

18 for a whole-page tabloid newspaper advertisement; 

19 27-point type for a half-page tabloid newspaper ad20 vertisement; 31.5-point type for a double page 

21 spread magazine or whole-page magazine advertise22 ment; 22.5-point type for a 28 centimeter by 3 col23 umn advertisement; and 15-point type for a 20 cen24 timeter by 2 column advertisement. 
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1 ‘‘(G) The label statements shall be in English, 

2 except that— 

3 ‘‘(i) in the case of an advertisement that 

4 appears in a newspaper, magazine, periodical, 

5 or other publication that is not in English, the 

6 statements shall appear in the predominant lan7 guage of the publication; and 

8 ‘‘(ii) in the case of any other advertisement 

9 that is not in English, the statements shall ap10 pear in the same language as that principally 

11 used in the advertisement. 

12 ‘‘(3)(A) The label statements specified in sub13 section (a)(1) shall be randomly displayed in each 

14 12-month period, in as equal a number of times as 

15 is possible on each brand of the product and be ran16 domly distributed in all areas of the United States 

17 in which the product is marketed in accordance with 

18 a plan submitted by the tobacco product manufac19 turer, importer, distributor, or retailer and approved 

20 by the Secretary. 

21 ‘‘(B) The label statements specified in sub22 section (a)(1) shall be rotated quarterly in alter23 nating sequence in advertisements for each brand of 

24 smokeless tobacco product in accordance with a plan 

25 submitted by the tobacco product manufacturer, im-
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1 porter, distributor, or retailer to, and approved by, 

2 the Secretary. 

3 ‘‘(C) The Secretary shall review each plan sub4 mitted under subparagraphs (A) and (B) and ap5 prove it if the plan— 

6 ‘‘(i) will provide for the equal distribution 

7 and display on packaging and the rotation re8 quired in advertising under this subsection; and 

9 ‘‘(ii) assures that all of the labels required 

10 under this section will be displayed by the to11 bacco product manufacturer, importer, dis12 tributor, or retailer at the same time. 

13 ‘‘(D) This paragraph applies to a retailer only 

14 if that retailer is responsible for or directs the label 

15 statements under this section, unless the retailer dis16 plays, in a location open to the public, an advertise17 ment that does not contain a warning label or has 

18 been altered by the retailer in a way that is material 

19 to the requirements of this subsection. 

20 ‘‘(4) The Secretary may, through a rulemaking 

21 under section 553 of title 5, United States Code, ad22 just the format and type sizes for the label state23 ments required by this section; the text, format, and 

24 type sizes of any required tar, nicotine yield, or 

25 other constituent disclosures; or the text, format, 
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1 and type sizes for any other disclosures required 

2 under the Federal Food, Drug, and Cosmetic Act. 

3 The text of any such label statements or disclosures 

4 shall be required to appear only within the 20 per5 cent area of advertisements provided by paragraph 

6 (2). The Secretary shall promulgate regulations 

7 which provide for adjustments in the format and 

8 type sizes of any text required to appear in such 

9 area to ensure that the total text required to appear 

10 by law will fit within such area. 

11 ‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is 

12 unlawful to advertise smokeless tobacco on any medium 

13 of electronic communications subject to the jurisdiction of 

14 the Federal Communications Commission.’’. 

15 (b) EFFECTIVE DATE.—The amendment made by 

16 subsection (a) shall take effect 12 months after the date 

17 of enactment of this Act. Such effective date shall be with 

18 respect to the date of manufacture, provided that, in any 

19 case, beginning 30 days after such effective date, a manu20 facturer shall not introduce into the domestic commerce 

21 of the United States any product, irrespective of the date 

22 of manufacture, that is not in conformance with section 

23 3 of the Comprehensive Smokeless Tobacco Health Edu24 cation Act of 1986 (15 U.S.C. 4402), as amended by sub25 section (a). 
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1 SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO 

2 PRODUCT WARNING LABEL STATEMENTS. 

3 (a) IN GENERAL.—Section 3 of the Comprehensive 

4 Smokeless Tobacco Health Education Act of 1986 (15 

5 U.S.C. 4402), as amended by section 204, is further 

6 amended by adding at the end the following: 

7 ‘‘(d) AUTHORITY TO REVISE WARNING LABEL

8 STATEMENTS.—The Secretary may, by a rulemaking con9 ducted under section 553 of title 5, United States Code, 

10 adjust the format, type size, and text of any of the label 

11 requirements, require color graphics to accompany the 

12 text, increase the required label area from 30 percent up 

13 to 50 percent of the front and rear panels of the package, 

14 or establish the format, type size, and text of any other 

15 disclosures required under the Federal Food, Drug, and 

16 Cosmetic Act, if the Secretary finds that such a change 

17 would promote greater public understanding of the risks 

18 associated with the use of smokeless tobacco products.’’. 

19 (b) PREEMPTION.—Section 7(a) of the Comprehen20 sive Smokeless Tobacco Health Education Act of 1986 (15 

21 U.S.C. 4406(a)) is amended by striking ‘‘No’’ and insert22 ing ‘‘Except as provided in the Family Smoking Preven23 tion and Tobacco Control Act (and the amendments made 

24 by that Act), no’’. 
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1 SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CON2 STITUENT DISCLOSURE TO THE PUBLIC. 

3 Section 4 of the Federal Cigarette Labeling and Ad4 vertising Act (15 U.S.C. 1333), as amended by sections 

5 201 and 202, is further amended by adding at the end 

6 the following: 

7 ‘‘(e) TAR, NICOTINE, AND OTHER SMOKE CON8 STITUENT DISCLOSURE.— 

9 ‘‘(1) IN GENERAL.—The Secretary shall, by a 

10 rulemaking conducted under section 553 of title 5, 

11 United States Code, determine (in the Secretary’s 

12 sole discretion) whether cigarette and other tobacco 

13 product manufacturers shall be required to include 

14 in the area of each cigarette advertisement specified 

15 by subsection (b) of this section, or on the package 

16 label, or both, the tar and nicotine yields of the ad17 vertised or packaged brand. Any such disclosure 

18 shall be in accordance with the methodology estab19 lished under such regulations, shall conform to the 

20 type size requirements of subsection (b) of this sec21 tion, and shall appear within the area specified in 

22 subsection (b) of this section. 

23 ‘‘(2) RESOLUTION OF DIFFERENCES.—Any dif24 ferences between the requirements established by the 

25 Secretary under paragraph (1) and tar and nicotine 

26 yield reporting requirements established by the Fed-
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1 eral Trade Commission shall be resolved by a memo2 randum of understanding between the Secretary and 

3 the Federal Trade Commission. 

4 ‘‘(3) CIGARETTE AND OTHER TOBACCO PROD5 UCT CONSTITUENTS.—In addition to the disclosures 

6 required by paragraph (1), the Secretary may, under 

7 a rulemaking conducted under section 553 of title 5, 

8 United States Code, prescribe disclosure require9 ments regarding the level of any cigarette or other 

10 tobacco product constituent including any smoke 

11 constituent. Any such disclosure may be required if 

12 the Secretary determines that disclosure would be of 

13 benefit to the public health, or otherwise would in14 crease consumer awareness of the health con15 sequences of the use of tobacco products, except that 

16 no such prescribed disclosure shall be required on 

17 the face of any cigarette package or advertisement. 

18 Nothing in this section shall prohibit the Secretary 

19 from requiring such prescribed disclosure through a 

20 cigarette or other tobacco product package or adver21 tisement insert, or by any other means under the 

22 Federal Food, Drug, and Cosmetic Act. 

23 ‘‘(4) RETAILERS.—This subsection applies to a 

24 retailer only if that retailer is responsible for or di-
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1 rects the label statements required under this sec2 tion.’’. 

3 TITLE III—PREVENTION OF IL4 LICIT TRADE IN TOBACCO 

5 PRODUCTS 

6 SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPEC7 TION. 

8 Chapter IX of the Federal Food, Drug, and Cosmetic 

9 Act, as added by section 101, is further amended by add10 ing at the end the following: 

11 ‘‘SEC. 920. LABELING, RECORDKEEPING, RECORDS INSPEC12 TION. 

13 ‘‘(a) ORIGIN LABELING.— 

14 ‘‘(1) REQUIREMENT.—Beginning 1 year after 

15 the date of enactment of the Family Smoking Pre16 vention and Tobacco Control Act, the label, pack17 aging, and shipping containers of tobacco products 

18 for introduction or delivery for introduction into 

19 interstate commerce in the United States shall bear 

20 the statement ‘sale only allowed in the United 

21 States’. 

22 ‘‘(2) EFFECTIVE DATE.—The effective date 

23 specified in paragraph (1) shall be with respect to 

24 the date of manufacture, provided that, in any case, 

25 beginning 30 days after such effective date, a manu-
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1 facturer shall not introduce into the domestic com2 merce of the United States any product, irrespective 

3 of the date of manufacture, that is not in conform4 ance with such paragraph. 

5 ‘‘(b) REGULATIONS CONCERNING RECORDKEEPING

6 FOR TRACKING AND TRACING.— 

7 ‘‘(1) IN GENERAL.—The Secretary shall pro8 mulgate regulations regarding the establishment and 

9 maintenance of records by any person who manufac10 tures, processes, transports, distributes, receives, 

11 packages, holds, exports, or imports tobacco prod12 ucts. 

13 ‘‘(2) INSPECTION.—In promulgating the regula14 tions described in paragraph (1), the Secretary shall 

15 consider which records are needed for inspection to 

16 monitor the movement of tobacco products from the 

17 point of manufacture through distribution to retail 

18 outlets to assist in investigating potential illicit 

19 trade, smuggling, or counterfeiting of tobacco prod20 ucts. 

21 ‘‘(3) CODES.—The Secretary may require codes 

22 on the labels of tobacco products or other designs or 

23 devices for the purpose of tracking or tracing the to24 bacco product through the distribution system. 
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1 ‘‘(4) SIZE OF BUSINESS.—The Secretary shall 

2 take into account the size of a business in promul3 gating regulations under this section. 

4 ‘‘(5) RECORDKEEPING BY RETAILERS.—The 

5 Secretary shall not require any retailer to maintain 

6 records relating to individual purchasers of tobacco 

7 products for personal consumption. 

8 ‘‘(c) RECORDS INSPECTION.—If the Secretary has a 

9 reasonable belief that a tobacco product is part of an illicit 

10 trade or smuggling or is a counterfeit product, each person 

11 who manufactures, processes, transports, distributes, re12 ceives, holds, packages, exports, or imports tobacco prod13 ucts shall, at the request of an officer or employee duly 

14 designated by the Secretary, permit such officer or em15 ployee, at reasonable times and within reasonable limits 

16 and in a reasonable manner, upon the presentation of ap17 propriate credentials and a written notice to such person, 

18 to have access to and copy all records (including financial 

19 records) relating to such article that are needed to assist 

20 the Secretary in investigating potential illicit trade, smug21 gling, or counterfeiting of tobacco products. The Secretary 

22 shall not authorize an officer or employee of the govern23 ment of any of the several States to exercise authority 

24 under the preceding sentence on Indian country without 

25 the express written consent of the Indian tribe involved. 
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1 ‘‘(d) KNOWLEDGE OF ILLEGAL TRANSACTION.— 

2 ‘‘(1) NOTIFICATION.—If the manufacturer or 

3 distributor of a tobacco product has knowledge 

4 which reasonably supports the conclusion that a to5 bacco product manufactured or distributed by such 

6 manufacturer or distributor that has left the control 

7 of such person may be or has been— 

8 ‘‘(A) imported, exported, distributed, or of9 fered for sale in interstate commerce by a per10 son without paying duties or taxes required by 

11 law; or 

12 ‘‘(B) imported, exported, distributed, or di13 verted for possible illicit marketing, 

14 the manufacturer or distributor shall promptly no15 tify the Attorney General and the Secretary of the 

16 Treasury of such knowledge. 

17 ‘‘(2) KNOWLEDGE DEFINED.—For purposes of 

18 this subsection, the term ‘knowledge’ as applied to 

19 a manufacturer or distributor means— 

20 ‘‘(A) the actual knowledge that the manu21 facturer or distributor had; or 

22 ‘‘(B) the knowledge which a reasonable 

23 person would have had under like circumstances 

24 or which would have been obtained upon the ex25 ercise of due care. 
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1 ‘‘(e) CONSULTATION.—In carrying out this section, 

2 the Secretary shall consult with the Attorney General of 

3 the United States and the Secretary of the Treasury, as 

4 appropriate.’’. 

5 SEC. 302. STUDY AND REPORT. 

6 (a) STUDY.—The Comptroller General of the United 

7 States shall conduct a study of cross-border trade in to8 bacco products to— 

9 (1) collect data on cross-border trade in tobacco 

10 products, including illicit trade and trade of counter11 feit tobacco products and make recommendations on 

12 the monitoring of such trade; 

13 (2) collect data on cross-border advertising (any 

14 advertising intended to be broadcast, transmitted, or 

15 distributed from the United States to another coun16 try) of tobacco products and make recommendations 

17 on how to prevent or eliminate, and what tech18 nologies could help facilitate the elimination of, 

19 cross-border advertising; and 

20 (3) collect data on the health effects (particu21 larly with respect to individuals under 18 years of 

22 age) resulting from cross-border trade in tobacco 

23 products, including the health effects resulting 

24 from— 
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1 (A) the illicit trade of tobacco products 

2 and the trade of counterfeit tobacco products; 

3 and 

4 (B) the differing tax rates applicable to to5 bacco products. 

6 (b) REPORT.—Not later than 18 months after the 

7 date of enactment of this Act, the Comptroller General 

8 of the United States shall submit to the Committee on 

9 Health, Education, Labor, and Pensions of the Senate and 

10 the Committee on Energy and Commerce of the House 

11 of Representatives a report on the study described in sub12 section (a). 

13 (c) DEFINITION.—In this section: 

14 (1) The term ‘‘cross-border trade’’ means trade 

15 across a border of the United States, a State or Ter16 ritory, or Indian country. 

17 (2) The term ‘‘Indian country’’ has the mean18 ing given to such term in section 1151 of title 18, 

19 United States Code. 

20 (3) The terms ‘‘State’’ and ‘‘Territory’’ have 

21 the meanings given to those terms in section 201 of 

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

23 U.S.C. 321). 
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1 DIVISION B—FEDERAL 

2 RETIREMENT REFORM ACT 

3 SEC. 100. SHORT TITLE; TABLE OF CONTENTS. 

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

5 ‘‘Federal Retirement Reform Act of 2009’’. 

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

7 this division is as follows: 

DIVISION B—FEDERAL RETIREMENT REFORM ACT 

Sec. 100. Short title; table of contents. 

TITLE I—PROVISIONS RELATING TO FEDERAL EMPLOYEES 

RETIREMENT 

Subtitle A—Thrift Savings Plan Enhancement 

Sec. 101. Short title. 

Sec. 102. Automatic enrollments. 

Sec. 103. Qualified Roth contribution program. 

Sec. 104. Authority to establish self-directed investment window. 

Sec. 105. Reporting requirements. 

Sec. 106. Acknowledgement of risk. 

Subtitle B—Other Retirement-Related Provisions 

Sec. 111. Credit for unused sick leave. 

Sec. 112. Exemption of certain CSRS repayments from the requirement that 

they be made with interest. 

Sec. 113. Computation of certain annuities based on part-time service. 

Sec. 114. Treatment of members of the uniformed services under the Thrift 

Savings Plan. 

Sec. 115. Authority to deposit refunds under FERS. 

Sec. 116. Retirement credit for service of certain employees transferred from 

District of Columbia service to Federal service. 

TITLE II—SPECIAL SURVIVOR INDEMNITY ALLOWANCE FOR 

SURVIVING SPOUSES OF ARMED FORCES MEMBERS 

Sec. 201. Increase in monthly amount of special survivor indemnity allowance 

for widows and widowers of deceased members of the Armed 

Forces affected by required Survivor Benefit Plan annuity offset for dependency and indemnity compensation. 
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1 TITLE I—PROVISIONS RELATING 

2 TO FEDERAL EMPLOYEES RE3 TIREMENT 

4 Subtitle A—Thrift Savings Plan 

5 Enhancement 

6 SEC. 101. SHORT TITLE. 

7 This subtitle may be cited as the ‘‘Thrift Savings 

8 Plan Enhancement Act of 2009’’. 

9 SEC. 102. AUTOMATIC ENROLLMENTS. 

10 (a) IN GENERAL.—Section 8432(b) of title 5, United 

11 States Code, is amended by striking paragraphs (2) 

12 through (4) and inserting the following: 

13 ‘‘(2)(A) The Board shall by regulation provide for an 

14 eligible individual to be automatically enrolled to make 

15 contributions under subsection (a) at the default percent16 age of basic pay. 

17 ‘‘(B) For purposes of this paragraph, the default per18 centage shall be equal to 3 percent or such other percent19 age, not less than 2 percent nor more than 5 percent, as 

20 the Board may by regulation prescribe. 

21 ‘‘(C) The regulations shall include provisions under 

22 which any individual who would otherwise be automatically 

23 enrolled in accordance with subparagraph (A) may— 
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1 ‘‘(i) modify the percentage or amount to be con2 tributed pursuant to automatic enrollment, effective 

3 from the start of such enrollment; or 

4 ‘‘(ii) decline automatic enrollment altogether. 

5 ‘‘(D) For purposes of this paragraph, the term ‘eligi6 ble individual’ means any individual who, after any regula7 tions under subparagraph (A) first take effect, is ap8 pointed, transferred, or reappointed to a position in which 

9 that individual is eligible to contribute to the Thrift Sav10 ings Fund. 

11 ‘‘(E)(i) Subject to clause (ii), sections 8351(a)(1), 

12 8440a(a)(1), 8440b(a)(1), 8440c(a)(1), 8440d(a)(1), and 

13 8440e(a)(1) shall be applied in a manner consistent with 

14 the purposes of this paragraph. 

15 ‘‘(ii) The Secretary concerned may, with respect to 

16 members of the uniformed services under the authority of 

17 such Secretary, establish such special rules as such Sec18 retary considers necessary for the administration of this 

19 subparagraph, including rules in accordance with which 

20 such Secretary may— 

21 ‘‘(I) provide for delayed automatic enrollment; 

22 or 

23 ‘‘(II) preclude or suspend the application of 

24 automatic enrollment.’’. 
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1 (b) TECHNICAL AMENDMENT.—Section 8432(b)(1) 

2 of title 5, United States Code, is amended by striking the 

3 parenthetical matter in subparagraph (B). 

4 SEC. 103. QUALIFIED ROTH CONTRIBUTION PROGRAM. 

5 (a) IN GENERAL.—Subchapter III of chapter 84 of 

6 title 5, United States Code, is amended by inserting after 

7 section 8432c the following: 

8 ‘‘§ 8432d. Qualified Roth contribution program 

9 ‘‘(a) DEFINITIONS.—For purposes of this section— 

10 ‘‘(1) the term ‘qualified Roth contribution pro11 gram’ means a program described in paragraph (1) 

12 of section 402A(b) of the Internal Revenue Code of 

13 1986 which meets the requirements of paragraph (2) 

14 of such section; and 

15 ‘‘(2) the terms ‘designated Roth contribution’ 

16 and ‘elective deferral’ have the meanings given such 

17 terms in section 402A of the Internal Revenue Code 

18 of 1986. 

19 ‘‘(b) AUTHORITY TO ESTABLISH.—The Board shall 

20 by regulation provide for the inclusion in the Thrift Sav21 ings Plan of a qualified Roth contribution program, under 

22 such terms and conditions as the Board may prescribe. 

23 ‘‘(c) REQUIRED PROVISIONS.—The regulations under 

24 subsection (b) shall include— 
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1 ‘‘(1) provisions under which an election to make 

2 designated Roth contributions may be made— 

3 ‘‘(A) by any individual who is eligible to 

4 make contributions under section 8351, 

5 8432(a), 8440a, 8440b, 8440c, 8440d, or 

6 8440e; and 

7 ‘‘(B) by any individual, not described in 

8 subparagraph (A), who is otherwise eligible to 

9 make elective deferrals under the Thrift Sav10 ings Plan; 

11 ‘‘(2) any provisions which may, as a result of 

12 enactment of this section, be necessary in order to 

13 clarify the meaning of any reference to an ‘account’ 

14 made in section 8432(f), 8433, 8434(d), 8435, 

15 8437, or any other provision of law; and 

16 ‘‘(3) any other provisions which may be nec17 essary to carry out this section.’’. 

18 (b) CLERICAL AMENDMENT.—The analysis for chap19 ter 84 of title 5, United States Code, is amended by insert20 ing after the item relating to section 8432c the following: 

‘‘8432d. Qualified Roth contribution program.’’. 

21 SEC. 104. AUTHORITY TO ESTABLISH SELF-DIRECTED IN22 VESTMENT WINDOW. 

23 (a) IN GENERAL.—Section 8438(b)(1) of title 5, 

24 United States Code, is amended— 
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1 (1) in subparagraph (D), by striking ‘‘and’’ at 

2 the end; 

3 (2) in subparagraph (E), by striking the period 

4 and inserting ‘‘; and’’; and 

5 (3) by adding after subparagraph (E) the fol6 lowing: 

7 ‘‘(F) a self-directed investment window, if 

8 the Board authorizes such window under para9 graph (5).’’. 

10 (b) REQUIREMENTS.—Section 8438(b) of title 5, 

11 United States Code, is amended by adding at the end the 

12 following: 

13 ‘‘(5)(A) The Board may authorize the addition of a 

14 self-directed investment window under the Thrift Savings 

15 Plan if the Board determines that such addition would be 

16 in the best interests of participants. 

17 ‘‘(B) The self-directed investment window shall be 

18 limited to— 

19 ‘‘(i) low-cost, passively-managed index funds 

20 that offer diversification benefits; and 

21 ‘‘(ii) other investment options, if the Board de22 termines the options to be appropriate retirement in23 vestment vehicles for participants. 

24 ‘‘(C) The Board shall ensure that any administrative 

25 expenses related to use of the self-directed investment win-
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1 dow are borne solely by the participants who use such win2 dow. 

3 ‘‘(D) The Board may establish such other terms and 

4 conditions for the self-directed investment window as the 

5 Board considers appropriate to protect the interests of 

6 participants, including requirements relating to risk dis7 closure. 

8 ‘‘(E) The Board shall consult with the Employee 

9 Thrift Advisory Council (established under section 8473) 

10 before establishing any self-directed investment window.’’. 

11 SEC. 105. REPORTING REQUIREMENTS. 

12 (a) ANNUAL REPORT.—The Board shall, not later 

13 than June 30 of each year, submit to Congress an annual 

14 report on the operations of the Thrift Savings Plan. Such 

15 report shall include, for the prior calendar year, informa16 tion on the number of participants as of the last day of 

17 such prior calendar year, the median balance in partici18 pants’ accounts as of such last day, demographic informa19 tion on participants, the percentage allocation of amounts 

20 among investment funds or options, the status of the de21 velopment and implementation of the self-directed invest22 ment window, the diversity demographics of any company, 

23 investment adviser, or other entity retained to invest and 

24 manage the assets of the Thrift Savings Fund, and such 

25 other information as the Board considers appropriate. A 
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1 copy of each annual report under this subsection shall be 

2 made available to the public through an Internet website. 

3 (b) REPORTING OF FEES AND OTHER INFORMA4 TION.— 

5 (1) IN GENERAL.—The Board shall include in 

6 the periodic statements provided to participants 

7 under section 8439(c) of title 5, United States Code, 

8 the amount of the investment management fees, ad9 ministrative expenses, and any other fees or ex10 penses paid with respect to each investment fund 

11 and option under the Thrift Savings Plan. Any such 

12 statement shall also provide a statement notifying 

13 participants as to how they may access the annual 

14 report described in subsection (a), as well as any 

15 other information concerning the Thrift Savings 

16 Plan that might be useful. 

17 (2) USE OF ESTIMATES.—For purposes of pro18 viding the information required under this sub19 section, the Executive Director may provide a rea20 sonable and representative estimate of any fees or 

21 expenses described in paragraph (1) and shall indi22 cate any such estimate as being such an estimate. 

23 Any such estimate shall be based on the previous 

24 year’s experience. 

25 (c) DEFINITIONS.—For purposes of this section— 
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1 (1) the term ‘‘Board’’ has the meaning given 

2 such term by 8401(5) of title 5, United States Code; 

3 (2) the term ‘‘participant’’ has the meaning 

4 given such term by section 8471(3) of title 5, United 

5 States Code; and 

6 (3) the term ‘‘account’’ means an account es7 tablished under section 8439 of title 5, United 

8 States Code. 

9 SEC. 106. ACKNOWLEDGEMENT OF RISK. 

10 (a) IN GENERAL.—Section 8439(d) of title 5, United 

11 States Code, is amended— 

12 (1) by striking the matter after ‘‘who elects to 

13 invest in’’ and before ‘‘shall sign an acknowledge14 ment’’ and inserting ‘‘any investment fund or option 

15 under this chapter, other than the Government Se16 curities Investment Fund,’’; and 

17 (2) by striking ‘‘either such Fund’’ and insert18 ing ‘‘any such fund or option’’. 

19 (b) COORDINATION WITH PROVISIONS RELATING TO

20 FIDUCIARY RESPONSIBILITIES, LIABILITIES, AND PEN21 ALTIES.—Section 8477(e)(1)(C) of title 5, United States 

22 Code, is amended— 

23 (1) by redesignating subparagraph (C) as sub24 paragraph (C)(i); and 

25 (2) by adding at the end the following: 
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1 ‘‘(ii) A fiduciary shall not be liable under subpara2 graph (A), and no civil action may be brought against a 

3 fiduciary— 

4 ‘‘(I) for providing for the automatic enrollment 

5 of a participant in accordance with section 

6 8432(b)(2)(A); 

7 ‘‘(II) for enrolling a participant in a default in8 vestment fund in accordance with section 

9 8438(c)(2); or 

10 ‘‘(III) for allowing a participant to invest 

11 through the self-directed investment window or for 

12 establishing restrictions applicable to participants’ 

13 ability to invest through the self-directed investment 

14 window.’’. 

15 Subtitle B—Other Retirement16 Related Provisions 

17 SEC. 111. CREDIT FOR UNUSED SICK LEAVE. 

18 (a) IN GENERAL.—Section 8415 of title 5, United 

19 States Code, is amended— 

20 (1) by redesignating the second subsection (k) 

21 and subsection (l) as subsections (l) and (m), respec22 tively; and 

23 (2) in subsection (l) (as so redesignated by 

24 paragraph (1))— 
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1 (A) by striking ‘‘(l) In computing’’ and in2 serting ‘‘(l)(1) In computing’’; and 

3 (B) by adding at the end the following: 

4 ‘‘(2) Except as provided in paragraph (1), in com5 puting an annuity under this subchapter, the total service 

6 of an employee who retires on an immediate annuity or 

7 who dies leaving a survivor or survivors entitled to annuity 

8 includes the days of unused sick leave to his credit under 

9 a formal leave system, except that these days will not be 

10 counted in determining average pay or annuity eligibility 

11 under this subchapter. For purposes of this subsection, in 

12 the case of any such employee who is excepted from sub13 chapter I of chapter 63 under section 6301(2)(x)–(xiii), 

14 the days of unused sick leave to his credit include any un15 used sick leave standing to his credit when he was ex16 cepted from such subchapter.’’. 

17 (b) EXCEPTION FROM DEPOSIT REQUIREMENT.— 

18 Section 8422(d)(2) of title 5, United States Code, is 

19 amended by striking ‘‘section 8415(k)’’ and inserting 

20 ‘‘paragraph (1) or (2) of section 8415(l)’’. 

21 (c) EFFECTIVE DATE.—The amendments made by 

22 this section shall apply with respect to annuities computed 

23 based on separations occurring on or after the date of en24 actment of this Act. 
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1 SEC. 112. EXEMPTION OF CERTAIN CSRS REPAYMENTS 

2 FROM THE REQUIREMENT THAT THEY BE 

3 MADE WITH INTEREST. 

4 (a) IN GENERAL.—Section 8334(d)(1) of title 5, 

5 United States Code, is amended— 

6 (1) by striking ‘‘(d)(1)’’ and inserting 

7 ‘‘(d)(1)(A)’’; and 

8 (2) by adding at the end the following: 

9 ‘‘(B) No interest under subparagraph (A) shall be re10 quired in the case of any deposit to the extent that it rep11 resents the amount of any refund that was made to an 

12 employee or Member during the period beginning on Octo13 ber 1, 1990, and ending on February 28, 1991.’’. 

14 (b) APPLICABILITY.—The amendments made by sub15 section (a) shall be effective with respect to any annuity, 

16 entitlement to which is based on a separation from service 

17 occurring on or after the date of enactment of this Act. 

18 SEC. 113. COMPUTATION OF CERTAIN ANNUITIES BASED 

19 ON PART-TIME SERVICE. 

20 (a) IN GENERAL.—Section 8339(p) of title 5, United 

21 States Code, is amended by adding at the end the fol22 lowing: 

23 ‘‘(3) In the administration of paragraph (1)— 

24 ‘‘(A) subparagraph (A) of such paragraph shall 

25 apply with respect to service performed before, on, 

26 or after April 7, 1986; and 
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1 ‘‘(B) subparagraph (B) of such paragraph— 

2 ‘‘(i) shall apply with respect to that portion 

3 of any annuity which is attributable to service 

4 performed on or after April 7, 1986; and 

5 ‘‘(ii) shall not apply with respect to that 

6 portion of any annuity which is attributable to 

7 service performed before April 7, 1986.’’. 

8 (b) APPLICABILITY.—The amendment made by sub9 section (a) shall be effective with respect to any annuity, 

10 entitlement to which is based on a separation from service 

11 occurring on or after the date of enactment of this Act. 

12 SEC. 114. TREATMENT OF MEMBERS OF THE UNIFORMED 

13 SERVICES UNDER THE THRIFT SAVINGS 

14 PLAN. 

15 (a) SENSE OF CONGRESS.—It is the sense of Con16 gress that— 

17 (1) members of the uniformed services should 

18 have a retirement system that is at least as generous 

19 as the one which is available to Federal civilian em20 ployees; and 

21 (2) Federal civilian employees receive matching 

22 contributions from their employing agencies for their 

23 contributions to the Thrift Savings Fund, but the 

24 costs of requiring such a matching contribution from 

25 the Department of Defense could be significant. 
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1 (b) REPORTING REQUIREMENT.—Not later than 180 

2 days after the date of the enactment of this Act, the Sec3 retary of Defense shall report to Congress on— 

4 (1) the cost to the Department of Defense of 

5 providing a matching payment with respect to con6 tributions made to the Thrift Savings Fund by 

7 members of the Armed Forces; 

8 (2) the effect that requiring such a matching 

9 payment would have on recruitment and retention; 

10 and 

11 (3) any other information that the Secretary of 

12 Defense considers appropriate. 

13 SEC. 115. AUTHORITY TO DEPOSIT REFUNDS UNDER FERS. 

14 (a) DEPOSIT AUTHORITY.—Section 8422 of title 5, 

15 United States Code, is amended by adding at the end the 

16 following: 

17 ‘‘(i)(1) Each employee or Member who has received 

18 a refund of retirement deductions under this or any other 

19 retirement system established for employees of the Gov20 ernment covering service for which such employee or Mem21 ber may be allowed credit under this chapter may deposit 

22 the amount received, with interest. Credit may not be al23 lowed for the service covered by the refund until the de24 posit is made. 
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1 ‘‘(2) Interest under this subsection shall be computed 

2 in accordance with paragraphs (2) and (3) of section 

3 8334(e) and regulations prescribed by the Office. The op4 tion under the third sentence of section 8334(e)(2) to 

5 make a deposit in one or more installments shall apply 

6 to deposits under this subsection. 

7 ‘‘(3) For the purpose of survivor annuities, deposits 

8 authorized by this subsection may also be made by a sur9 vivor of an employee or Member.’’. 

10 (b) TECHNICAL AND CONFORMING AMENDMENTS.— 

11 (1) DEFINITIONAL AMENDMENT.—Section 

12 8401(19)(C) of title 5, United States Code, is 

13 amended by striking ‘‘8411(f);’’ and inserting 

14 ‘‘8411(f) or 8422(i);’’. 

15 (2) CREDITING OF DEPOSITS.—Section 8422(c) 

16 of title 5, United States Code, is amended by adding 

17 at the end the following: ‘‘Deposits made by an em18 ployee, Member, or survivor also shall be credited to 

19 the Fund.’’. 

20 (3) SECTION HEADING.—(A) The heading for 

21 section 8422 of title 5, United States Code, is 

22 amended to read as follows: 
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1 ‘‘§ 8422. Deductions from pay; contributions for other 

2 service; deposits’’. 

3 (B) The analysis for chapter 84 of title 5, 

4 United States Code, is amended by striking the item 

5 relating to section 8422 and inserting the following: 

‘‘8422. Deductions from pay; contributions for other service; deposits.’’. 

6 (4) RESTORATION OF ANNUITY RIGHTS.—The 

7 last sentence of section 8424(a) of title 5, United 

8 States Code, is amended by striking ‘‘based.’’ and 

9 inserting ‘‘based, until the employee or Member is 

10 reemployed in the service subject to this chapter.’’. 

11 SEC. 116. RETIREMENT CREDIT FOR SERVICE OF CERTAIN 

12 EMPLOYEES TRANSFERRED FROM DISTRICT 

13 OF COLUMBIA SERVICE TO FEDERAL SERV14 ICE. 

15 (a) RETIREMENT CREDIT.— 

16 (1) IN GENERAL.—Any individual who is treat17 ed as an employee of the Federal Government for 

18 purposes of chapter 83 or chapter 84 of title 5, 

19 United States Code, on or after the date of enact20 ment of this Act who performed qualifying District 

21 of Columbia service shall be entitled to have such 

22 service included in calculating the individual’s cred23 itable service under sections 8332 or 8411 of title 5, 

24 United States Code, but only for purposes of the fol25 lowing provisions of such title: 
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1 (A) Sections 8333 and 8410 (relating to 

2 eligibility for annuity). 

3 (B) Sections 8336 (other than subsections 

4 (d), (h), and (p) thereof) and 8412 (relating to 

5 immediate retirement). 

6 (C) Sections 8338 and 8413 (relating to 

7 deferred retirement). 

8 (D) Sections 8336(d), 8336(h), 8336(p), 

9 and 8414 (relating to early retirement). 

10 (E) Section 8341 and subchapter IV of 

11 chapter 84 (relating to survivor annuities). 

12 (F) Section 8337 and subchapter V of 

13 chapter 84 (relating to disability benefits). 

14 (2) TREATMENT OF DETENTION OFFICER SERV15 ICE AS LAW ENFORCEMENT OFFICER SERVICE.—Any 

16 portion of an individual’s qualifying District of Co17 lumbia service which consisted of service as a deten18 tion officer under section 2604(2) of the District of 

19 Columbia Government Comprehensive Merit Per20 sonnel Act of 1978 (sec. 1–626.04(2), D.C. Official 

21 Code) shall be treated as service as a law enforce22 ment officer under sections 8331(20) or 8401(17) of 

23 title 5, United States Code, for purposes of applying 

24 paragraph (1) with respect to the individual. 
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1 (3) SERVICE NOT INCLUDED IN COMPUTING

2 AMOUNT OF ANY ANNUITY.—Qualifying District of 

3 Columbia service shall not be taken into account for 

4 purposes of computing the amount of any benefit 

5 payable out of the Civil Service Retirement and Dis6 ability Fund. 

7 (b) QUALIFYING DISTRICT OF COLUMBIA SERVICE

8 DEFINED.—In this section, ‘‘qualifying District of Colum9 bia service’’ means any of the following: 

10 (1) Service performed by an individual as a 

11 nonjudicial employee of the District of Columbia 

12 courts— 

13 (A) which was performed prior to the ef14 fective date of the amendments made by section 

15 11246(b) of the Balanced Budget Act of 1997; 

16 and 

17 (B) for which the individual did not ever 

18 receive credit under the provisions of sub19 chapter III of chapter 83 or chapter 84 of title 

20 5, United States Code (other than by virtue of 

21 section 8331(1)(iv) of such title). 

22 (2) Service performed by an individual as an 

23 employee of an entity of the District of Columbia 

24 government whose functions were transferred to the 

25 Pretrial Services, Parole, Adult Supervision, and Of-
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1 fender Supervision Trustee under section 11232 of 

2 the Balanced Budget Act of 1997— 

3 (A) which was performed prior to the ef4 fective date of the individual’s coverage as an 

5 employee of the Federal Government under sec6 tion 11232(f) of such Act; and 

7 (B) for which the individual did not ever 

8 receive credit under the provisions of sub9 chapter III of chapter 83 or chapter 84 of title 

10 5, United States Code (other than by virtue of 

11 section 8331(1)(iv) of such title). 

12 (3) Service performed by an individual as an 

13 employee of the District of Columbia Public De14 fender Service— 

15 (A) which was performed prior to the ef16 fective date of the amendments made by section 

17 7(e) of the District of Columbia Courts and 

18 Justice Technical Corrections Act of 1998; and 

19 (B) for which the individual did not ever 

20 receive credit under the provisions of sub21 chapter III of chapter 83 or chapter 84 of title 

22 5, United States Code (other than by virtue of 

23 section 8331(1)(iv) of such title). 

24 (4) In the case of an individual who was an em25 ployee of the District of Columbia Department of 
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1 Corrections who was separated from service as a re2 sult of the closing of the Lorton Correctional Com3 plex and who was appointed to a position with the 

4 Bureau of Prisons, the District of Columbia courts, 

5 the Pretrial Services, Parole, Adult Supervision, and 

6 Offender Supervision Trustee, the United States Pa7 role Commission, or the District of Columbia Public 

8 Defender Service, service performed by the indi9 vidual as an employee of the District of Columbia 

10 Department of Corrections— 

11 (A) which was performed prior to the ef12 fective date of the individual’s coverage as an 

13 employee of the Federal Government; and 

14 (B) for which the individual did not ever 

15 receive credit under the provisions of sub16 chapter III of chapter 83 or chapter 84 of title 

17 5, United States Code (other than by virtue of 

18 section 8331(1)(iv) of such title). 

19 (c) CERTIFICATION OF SERVICE.—The Office of Per20 sonnel Management shall accept the certification of the 

21 appropriate personnel official of the government of the 

22 District of Columbia or other independent employing enti23 ty concerning whether an individual performed qualifying 

24 District of Columbia service and the length of the period 

25 of such service the individual performed. 
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1 TITLE II—SPECIAL SURVIVOR 

2 INDEMNITY ALLOWANCE FOR 

3 SURVIVING SPOUSES OF 

4 ARMED FORCES MEMBERS 

5 SEC. 201. INCREASE IN MONTHLY AMOUNT OF SPECIAL 

6 SURVIVOR INDEMNITY ALLOWANCE FOR WID7 OWS AND WIDOWERS OF DECEASED MEM8 BERS OF THE ARMED FORCES AFFECTED BY 

9 REQUIRED SURVIVOR BENEFIT PLAN ANNU10 ITY OFFSET FOR DEPENDENCY AND INDEM11 NITY COMPENSATION. 

12 Section 1450(m)(2) of title 10, United States Code, 

13 is amended— 

14 (1) in subparagraph (B), by striking ‘‘$60’’ and 

15 inserting ‘‘$95’’; 

16 (2) in subparagraph (C), by striking ‘‘$70’’ and 

17 inserting ‘‘$105’’; 

18 (3) in subparagraph (D), by striking ‘‘$80’’ and 

19 inserting ‘‘$120’’; 

20 (4) in subparagraph (E), by striking ‘‘$90; 

21 and’’ and inserting ‘‘$130;’’ and 

22 (5) by striking subparagraph (F) and inserting 

23 the following new subparagraphs: 

24 ‘‘(F) for months during fiscal year 2014, 

25 $330; 
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1 ‘‘(G) for months during fiscal year 2015, 

2 $335; and 

3 ‘‘(H) for months during fiscal year 2016 

4 ending before the termination date specified in 

5 paragraph (6), $345.’’. 

Passed the House of Representatives April 2, 2009. 

Attest: 

Clerk. 

111TH CONGRESS 

1ST SESSION H. R. 1256 

AN ACT 

To protect the public health by providing the Food 

Retirement System, and for other purposes. Retirement System, and the Federal Employees’ tions in the Thrift Savings Plan, the Civil Service United States Code, to make certain modificato regulate tobacco products, to amend title 5, and Drug Administration with certain authority