I 

111TH CONGRESS 

1ST SESSION H. R. 1256 

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

with certain authority to regulate tobacco products. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 3, 2009 

Mr. WAXMAN (for himself, Mr. PLATTS, Mr. TOWNS, Mr. LYNCH, Mr. 

PALLONE, Mr. DINGELL, Mr. RANGEL, Mr. ABERCROMBIE, Mr. ACKERMAN, Ms. BALDWIN, Mr. BARROW, Mr. BERRY, Mr. BILBRAY, Mr. 

BLUMENAUER, Mrs. BONO MACK, Ms. BORDALLO, Mr. BOUCHER, Mr. 

BRADY of Pennsylvania, Mr. BRALEY of Iowa, Mrs. CAPPS, Mr. CARNEY, 

Mr. CARSON of Indiana, Mr. CASTLE, Ms. CASTOR of Florida, Mrs. 

CHRISTENSEN, Mr. COHEN, Mr. CONNOLLY of Virginia, Mr. CONYERS, 

Mr. COURTNEY, Mr. CUMMINGS, Mrs. DAHLKEMPER, Mrs. DAVIS of California, Mr. DEFAZIO, Ms. DEGETTE, Mr. DELAHUNT, Ms. DELAURO, 

Mr. DOYLE, Mr. EDWARDS of Texas, Mr. ELLISON, Mrs. EMERSON, Mr. 

ENGEL, Ms. ESHOO, Mr. FILNER, Mr. FRELINGHUYSEN, Mr. GONZALEZ, 

Mr. GENE GREEN of Texas, Mr. GRIJALVA, Mr. GUTIERREZ, Mr. HALL

of New York, Ms. HARMAN, Mr. HEINRICH, Mr. HIGGINS, Mr. HIMES, 

Mr. HINCHEY, Ms. HIRONO, Mr. HOLT, Mr. INSLEE, Mr. ISRAEL, Ms. 

JACKSON-LEE of Texas, Mr. JACKSON of Illinois, Mr. KILDEE, Ms. KILROY, Mr. KIND, Mr. KIRK, Mr. LARSEN of Washington, Mr. LARSON of 

Connecticut, Ms. LEE of California, Mr. LEWIS of Georgia, Mr. LIPINSKI, 

Mr. LOBIONDO, Mr. LOEBSACK, Mrs. LOWEY, Mr. LUJA ́N, Mr. MAFFEI, 

Mrs. MALONEY, Ms. MARKEY of Colorado, Mr. MARKEY of Massachusetts, Mr. MATHESON, Ms. MATSUI, Mrs. MCCARTHY of New York, Ms. 

MCCOLLUM, Mr. MCDERMOTT, Mr. MCGOVERN, Mr. MCMAHON, Mr. 

MCNERNEY, Mr. MICHAUD, Mr. GEORGE MILLER of California, Mr. 

MITCHELL, Mr. MORAN of Virginia, Mr. MURPHY of Connecticut, Mr. 

NADLER of New York, Mrs. NAPOLITANO, Ms. NORTON, Mr. OBERSTAR, 

Mr. OLVER, Mr. PASCRELL, Ms. PINGREE of Maine, Mr. REICHERT, Mr. 

REYES, Mr. ROTHMAN of New Jersey, Ms. ROYBAL-ALLARD, Mr. RUSH, 

Mr. RYAN of Ohio, Ms. LORETTA SANCHEZ of California, Mr. SARBANES, 

Ms. SCHAKOWSKY, Mr. SCHIFF, Ms. SCHWARTZ, Mr. SCOTT of Virginia, 

Mr. SERRANO, Mr. SHERMAN, Ms. SLAUGHTER, Mr. SMITH of New Jersey, Mr. SNYDER, Mr. STARK, Ms. SUTTON, Mr. TIERNEY, Mr. TONKO, 

Mr. VAN HOLLEN, Ms. WATSON, Mr. WEINER, Mr. WELCH, Mr. 

WEXLER, Mr. WU, and Mr. YARMUTH) introduced the following bill; 

which was referred to the Committee on Energy and Commerce, and in 


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addition to the Committee on Oversight and Government Reform, for a 

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

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

A BILL 

To protect the public health by providing the Food and 

Drug Administration with certain authority to regulate 

tobacco products. 

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

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

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

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

7 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 

Sec. 3. Purpose. 

Sec. 4. Scope and effect. 

Sec. 5. Severability. 

TITLE I—AUTHORITY OF THE FOOD AND DRUG 

ADMINISTRATION 

Sec. 101. Amendment of Federal Food, Drug, and Cosmetic Act. 

Sec. 102. Final rule. 

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

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. 


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Sec. 205. Authority to revise smokeless tobacco product warning label statements. 

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

TITLE III—PREVENTION OF ILLICIT TRADE IN TOBACCO 

PRODUCTS 

Sec. 301. Labeling, recordkeeping, records inspection. 

Sec. 302. Study and report. 

TITLE IV—THRIFT SAVINGS PLAN ENHANCEMENT 

Sec. 401. Short title. 

Sec. 402. Automatic enrollments. 

Sec. 403. Qualified Roth contribution program. 

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

Sec. 405. Reporting requirements. 

Sec. 406. Acknowledgement of risk. 

Sec. 407. Credit for unused sick leave. 

1 SEC. 2. FINDINGS. 

2 The Congress finds the following: 

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

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

7 (2) A consensus exists within the scientific and 

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

10 and other serious adverse health effects. 

11 (3) Nicotine is an addictive drug. 

12 (4) Virtually all new users of tobacco products 

13 are under the minimum legal age to purchase such 

14 products. 

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

17 tobacco products by adolescents. 


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1 (6) Because past efforts to restrict advertising 

2 and marketing of tobacco products have failed ade3 quately to curb tobacco use by adolescents, com4 prehensive restrictions on the sale, promotion, and 

5 distribution of such products are needed. 

6 (7) Federal and State governments have lacked 

7 the legal and regulatory authority and resources 

8 they need to address comprehensively the public 

9 health and societal problems caused by the use of to10 bacco products. 

11 (8) Federal and State public health officials, 

12 the public health community, and the public at large 

13 recognize that the tobacco industry should be subject 

14 to ongoing oversight. 

15 (9) Under article I, section 8 of the Constitu16 tion, the Congress is vested with the responsibility 

17 for regulating interstate commerce and commerce 

18 with Indian tribes. 

19 (10) The sale, distribution, marketing, adver20 tising, and use of tobacco products are activities in 

21 and substantially affecting interstate commerce be22 cause they are sold, marketed, advertised, and dis23 tributed in interstate commerce on a nationwide 

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

25 economy. 


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1 (11) The sale, distribution, marketing, adver2 tising, and use of such products substantially affect 

3 interstate commerce through the health care and 

4 other costs attributable to the use of tobacco prod5 ucts. 

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

7 enact legislation that provides the Food and Drug 

8 Administration with the authority to regulate to9 bacco products and the advertising and promotion of 

10 such products. The benefits to the American people 

11 from enacting such legislation would be significant 

12 in human and economic terms. 

13 (13) Tobacco use is the foremost preventable 

14 cause of premature death in America. It causes over 

15 400,000 deaths in the United States each year, and 

16 approximately 8,600,000 Americans have chronic ill17 nesses related to smoking. 

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

19 50 percent would prevent well over 10,000,000 of to20 day’s children from becoming regular, daily smokers, 

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

22 death due to tobacco-induced disease. Such a reduc23 tion in youth smoking would also result in approxi24 mately $75,000,000,000 in savings attributable to 

25 reduced health care costs. 


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1 (15) Advertising, marketing, and promotion of 

2 tobacco products have been especially directed to at3 tract young persons to use tobacco products, and 

4 these efforts have resulted in increased use of such 

5 products by youth. Past efforts to oversee these ac6 tivities have not been successful in adequately pre7 venting such increased use. 

8 (16) In 2005, the cigarette manufacturers 

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

10 users, retain current users, increase current con11 sumption, and generate favorable long-term atti12 tudes toward smoking and tobacco use. 

13 (17) Tobacco product advertising often 

14 misleadingly portrays the use of tobacco as socially 

15 acceptable and healthful to minors. 

16 (18) Tobacco product advertising is regularly 

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

18 under the age of 18 are regularly exposed to tobacco 

19 product promotional efforts. 

20 (19) Through advertisements during and spon21 sorship of sporting events, tobacco has become 

22 strongly associated with sports and has become por23 trayed as an integral part of sports and the healthy 

24 lifestyle associated with rigorous sporting activity. 


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1 (20) Children are exposed to substantial and 

2 unavoidable tobacco advertising that leads to favor3 able beliefs about tobacco use, plays a role in leading 

4 young people to overestimate the prevalence of to5 bacco use, and increases the number of young people 

6 who begin to use tobacco. 

7 (21) The use of tobacco products in motion pic8 tures and other mass media glamorizes its use for 

9 young people and encourages them to use tobacco 

10 products. 

11 (22) Tobacco advertising expands the size of 

12 the tobacco market by increasing consumption of to13 bacco products including tobacco use by young peo14 ple. 

15 (23) Children are more influenced by tobacco 

16 marketing than adults: more than 80 percent of 

17 youth smoke three heavily marketed brands, while 

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

19 same brands. 

20 (24) Tobacco company documents indicate that 

21 young people are an important and often crucial seg22 ment of the tobacco market. Children, who tend to 

23 be more price sensitive than adults, are influenced 

24 by advertising and promotion practices that result in 

25 drastically reduced cigarette prices. 


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1 (25) Comprehensive advertising restrictions will 

2 have a positive effect on the smoking rates of young 

3 people. 

4 (26) Restrictions on advertising are necessary 

5 to prevent unrestricted tobacco advertising from un6 dermining legislation prohibiting access to young 

7 people and providing for education about tobacco 

8 use. 

9 (27) International experience shows that adver10 tising regulations that are stringent and comprehen11 sive have a greater impact on overall tobacco use 

12 and young people’s use than weaker or less com13 prehensive ones. 

14 (28) Text only requirements, although not as 

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

16 tobacco products while preserving the informational 

17 function of advertising. 

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

19 adopt legislation to address the public health crisis 

20 created by actions of the tobacco industry. 

21 (30) The final regulations promulgated by the 

22 Secretary of Health and Human Services in the Au23 gust 28, 1996, issue of the Federal Register (61 

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

25 of title 21, Code of Federal Regulations, are conVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 sistent with the first amendment to the United 

2 States Constitution and with the standards set forth 

3 in the amendments made by this subtitle for the reg4 ulation of tobacco products by the Food and Drug 

5 Administration, and the restriction on the sale and 

6 distribution of, including access to and the adver7 tising and promotion of, tobacco products contained 

8 in such regulations are substantially related to ac9 complishing the public health goals of this Act. 

10 (31) The regulations described in paragraph 

11 (30) will directly and materially advance the Federal 

12 Government’s substantial interest in reducing the 

13 number of children and adolescents who use ciga14 rettes and smokeless tobacco and in preventing the 

15 life-threatening health consequences associated with 

16 tobacco use. An overwhelming majority of Americans 

17 who use tobacco products begin using such products 

18 while they are minors and become addicted to the 

19 nicotine in those products before reaching the age of 

20 18. Tobacco advertising and promotion play a cru21 cial role in the decision of these minors to begin 

22 using tobacco products. Less restrictive and less 

23 comprehensive approaches have not and will not be 

24 effective in reducing the problems addressed by such 

25 regulations. The reasonable restrictions on the adVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 vertising and promotion of tobacco products con2 tained in such regulations will lead to a significant 

3 decrease in the number of minors using and becom4 ing addicted to those products. 

5 (32) The regulations described in paragraph 

6 (30) impose no more extensive restrictions on com7 munication by tobacco manufacturers and sellers 

8 than are necessary to reduce the number of children 

9 and adolescents who use cigarettes and smokeless to10 bacco and to prevent the life-threatening health con11 sequences associated with tobacco use. Such regula12 tions are narrowly tailored to restrict those adver13 tising and promotional practices which are most like14 ly to be seen or heard by youth and most likely to 

15 entice them into tobacco use, while affording tobacco 

16 manufacturers and sellers ample opportunity to con17 vey information about their products to adult con18 sumers. 

19 (33) Tobacco dependence is a chronic disease, 

20 one that typically requires repeated interventions to 

21 achieve long-term or permanent abstinence. 

22 (34) Because the only known safe alternative to 

23 smoking is cessation, interventions should target all 

24 smokers to help them quit completely. 


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1 (35) Tobacco products have been used to facili2 tate and finance criminal activities both domestically 

3 and internationally. Illicit trade of tobacco products 

4 has been linked to organized crime and terrorist 

5 groups. 

6 (36) It is essential that the Food and Drug Ad7 ministration review products sold or distributed for 

8 use to reduce risks or exposures associated with to9 bacco products and that it be empowered to review 

10 any advertising and labeling for such products. It is 

11 also essential that manufacturers, prior to marketing 

12 such products, be required to demonstrate that such 

13 products will meet a series of rigorous criteria, and 

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

15 taking into account both users of tobacco products 

16 and persons who do not currently use tobacco prod17 ucts. 

18 (37) Unless tobacco products that purport to 

19 reduce the risks to the public of tobacco use actually 

20 reduce such risks, those products can cause substan21 tial harm to the public health to the extent that the 

22 individuals, who would otherwise not consume to23 bacco products or would consume such products less, 

24 use tobacco products purporting to reduce risk. 

25 Those who use products sold or distributed as modiVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 fied risk products that do not in fact reduce risk, 

2 rather than quitting or reducing their use of tobacco 

3 products, have a substantially increased likelihood of 

4 suffering disability and premature death. The costs 

5 to society of the widespread use of products sold or 

6 distributed as modified risk products that do not in 

7 fact reduce risk or that increase risk include thou8 sands of unnecessary deaths and injuries and huge 

9 costs to our health care system. 

10 (38) As the National Cancer Institute has 

11 found, many smokers mistakenly believe that ‘‘low 

12 tar’’ and ‘‘light’’ cigarettes cause fewer health prob13 lems than other cigarettes. As the National Cancer 

14 Institute has also found, mistaken beliefs about the 

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

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

17 smoking entirely and thereby lead to disease and 

18 death. 

19 (39) Recent studies have demonstrated that 

20 there has been no reduction in risk on a population21 wide basis from ‘‘low tar’’ and ‘‘light’’ cigarettes, 

22 and such products may actually increase the risk of 

23 tobacco use. 

24 (40) The dangers of products sold or distrib25 uted as modified risk tobacco products that do not 


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1 in fact reduce risk are so high that there is a com2 pelling governmental interest in ensuring that state3 ments about modified risk tobacco products are com4 plete, accurate, and relate to the overall disease risk 

5 of the product. 

6 (41) As the Federal Trade Commission has 

7 found, consumers have misinterpreted advertise8 ments in which one product is claimed to be less 

9 harmful than a comparable product, even in the 

10 presence of disclosures and advisories intended to 

11 provide clarification. 

12 (42) Permitting manufacturers to make unsub13 stantiated statements concerning modified risk to14 bacco products, whether express or implied, even if 

15 accompanied by disclaimers would be detrimental to 

16 the public health. 

17 (43) The only way to effectively protect the 

18 public health from the dangers of unsubstantiated 

19 modified risk tobacco products is to empower the 

20 Food and Drug Administration to require that prod21 ucts that tobacco manufacturers sold or distributed 

22 for risk reduction be reviewed in advance of mar23 keting, and to require that the evidence relied on to 

24 support claims be fully verified. 


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1 (44) The Food and Drug Administration is a 

2 regulatory agency with the scientific expertise to 

3 identify harmful substances in products to which 

4 consumers are exposed, to design standards to limit 

5 exposure to those substances, to evaluate scientific 

6 studies supporting claims about the safety of prod7 ucts, and to evaluate the impact of labels, labeling, 

8 and advertising on consumer behavior in order to re9 duce the risk of harm and promote understanding of 

10 the impact of the product on health. In connection 

11 with its mandate to promote health and reduce the 

12 risk of harm, the Food and Drug Administration 

13 routinely makes decisions about whether and how 

14 products may be marketed in the United States. 

15 (45) The Federal Trade Commission was cre16 ated to protect consumers from unfair or deceptive 

17 acts or practices, and to regulate unfair methods of 

18 competition. Its focus is on those marketplace prac19 tices that deceive or mislead consumers, and those 

20 that give some competitors an unfair advantage. Its 

21 mission is to regulate activities in the marketplace. 

22 Neither the Federal Trade Commission nor any 

23 other Federal agency except the Food and Drug Ad24 ministration possesses the scientific expertise needed 


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1 to implement effectively all provisions of the Family 

2 Smoking Prevention and Tobacco Control Act. 

3 (46) If manufacturers state or imply in commu4 nications directed to consumers through the media 

5 or through a label, labeling, or advertising, that a to6 bacco product is approved or inspected by the Food 

7 and Drug Administration or complies with Food and 

8 Drug Administration standards, consumers are like9 ly to be confused and misled. Depending upon the 

10 particular language used and its context, such a 

11 statement could result in consumers being misled 

12 into believing that the product is endorsed by the 

13 Food and Drug Administration for use or in con14 sumers being misled about the harmfulness of the 

15 product because of such regulation, inspection, ap16 proval, or compliance. 

17 (47) In August 2006 a United States district 

18 court judge found that the major United States cig19 arette companies continue to target and market to 

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

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

22 (48) In August 2006 a United States district 

23 court judge found that the major United States cig24 arette companies dramatically increased their adver25 tising and promotional spending in ways that enVerDate Nov 24 2008 03:25 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 courage youth to start smoking subsequent to the 

2 signing of the Master Settlement Agreement in 

3 1998. USA v. Philip Morris, USA, Inc., et al. (Civil 

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

5 (49) In August 2006 a United States district 

6 court judge found that the major United States cig7 arette companies have designed their cigarettes to 

8 precisely control nicotine delivery levels and provide 

9 doses of nicotine sufficient to create and sustain ad10 diction while also concealing much of their nicotine11 related research. USA v. Philip Morris, USA, Inc., 

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

13 2006). 

14 SEC. 3. PURPOSE. 

15 The purposes of this Act are— 

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

17 Administration to regulate tobacco products under 

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

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

20 Federal regulatory authority with respect to the 

21 manufacture, marketing, and distribution of tobacco 

22 products as provided for in this Act; 

23 (2) to ensure that the Food and Drug Adminis24 tration has the authority to address issues of par25 ticular concern to public health officials, especially 


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1 the use of tobacco by young people and dependence 

2 on tobacco; 

3 (3) to authorize the Food and Drug Adminis4 tration to set national standards controlling the 

5 manufacture of tobacco products and the identity, 

6 public disclosure, and amount of ingredients used in 

7 such products; 

8 (4) to provide new and flexible enforcement au9 thority to ensure that there is effective oversight of 

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

11 and promote less harmful tobacco products; 

12 (5) to vest the Food and Drug Administration 

13 with the authority to regulate the levels of tar, nico14 tine, and other harmful components of tobacco prod15 ucts; 

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

17 informed, to require tobacco product manufacturers 

18 to disclose research which has not previously been 

19 made available, as well as research generated in the 

20 future, relating to the health and dependency effects 

21 or safety of tobacco products; 

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

23 products to adults in conjunction with measures to 

24 ensure that they are not sold or accessible to under25 age purchasers; 


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1 (8) to impose appropriate regulatory controls on 

2 the tobacco industry; 

3 (9) to promote cessation to reduce disease risk 

4 and the social costs associated with tobacco-related 

5 diseases; and 

6 (10) to strengthen legislation against illicit 

7 trade in tobacco products. 

8 SEC. 4. SCOPE AND EFFECT. 

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

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

11 (1) establish a precedent with regard to any 

12 other industry, situation, circumstance, or legal ac13 tion; or 

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

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

16 contract of any kind. 

17 (b) AGRICULTURAL ACTIVITIES.—The provisions of 

18 this Act (or an amendment made by this Act) which au19 thorize the Secretary to take certain actions with regard 

20 to tobacco and tobacco products shall not be construed to 

21 affect any authority of the Secretary of Agriculture under 

22 existing law regarding the growing, cultivation, or curing 

23 of raw tobacco. 

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

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


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1 the Secretary to take certain actions with regard to to2 bacco products shall not be construed to affect any author3 ity of the Secretary of the Treasury under chapter 52 of 

4 the Internal Revenue Code of 1986. 

5 SEC. 5. SEVERABILITY. 

6 If any provision of this Act, the amendments made 

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

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

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

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

11 other person or circumstance shall not be affected and 

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

13 TITLE I—AUTHORITY OF THE 

14 FOOD AND DRUG ADMINIS15 TRATION 

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

17 COSMETIC ACT. 

18 (a) DEFINITION OF TOBACCO PRODUCTS.—Section 

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

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

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

24 human consumption, including any component, part, or 

25 accessory of a tobacco product (except for raw materials 


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1 other than tobacco used in manufacturing a component, 

2 part, or accessory of a tobacco product). 

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

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

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

6 in section 503(g). 

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

8 be subject to chapter V of this Act. 

9 ‘‘(4) A tobacco product shall not be marketed in com10 bination with any other article or product regulated under 

11 this Act (including a drug, biologic, food, cosmetic, med12 ical device, or a dietary supplement).’’. 

13 (b) FDA AUTHORITY OVER TOBACCO PRODUCTS.— 

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

15 301 et seq.) is amended— 

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

17 (2) by redesignating sections 901 through 910 

18 as sections 1001 through 1010; and 

19 (3) by inserting after chapter VIII the fol20 lowing: 

21 ‘‘CHAPTER IX—TOBACCO PRODUCTS 

22 ‘‘SEC. 900. DEFINITIONS. 

23 ‘‘In this chapter: 

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

25 any substance the intended use of which results or 


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1 may reasonably be expected to result, directly or in2 directly, in its becoming a component or otherwise 

3 affecting the characteristic of any tobacco product 

4 (including any substances intended for use as a fla5 voring or coloring or in producing, manufacturing, 

6 packing, processing, preparing, treating, packaging, 

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

8 not include tobacco or a pesticide chemical residue 

9 in or on raw tobacco or a pesticide chemical. 

10 ‘‘(2) BRAND.—The term ‘brand’ means a vari11 ety of tobacco product distinguished by the tobacco 

12 used, tar content, nicotine content, flavoring used, 

13 size, filtration, packaging, logo, registered trade14 mark, brand name, identifiable pattern of colors, or 

15 any combination of such attributes. 

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

17 ‘‘(A) means a product that— 

18 ‘‘(i) is a tobacco product; and 

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

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

21 Cigarette Labeling and Advertising Act; 

22 and 

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

24 functional in the product, which, because of its 

25 appearance, the type of tobacco used in the 


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

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

3 cigarette or as roll-your-own tobacco. 

4 ‘‘(4) CIGARETTE TOBACCO.—The term ‘ciga5 rette tobacco’ means any product that consists of 

6 loose tobacco that is intended for use by consumers 

7 in a cigarette. Unless otherwise stated, the require8 ments applicable to cigarettes under this chapter 

9 shall also apply to cigarette tobacco. 

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

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

12 Federal Cigarette Labeling and Advertising Act. 

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

14 term ‘counterfeit tobacco product’ means a tobacco 

15 product (or the container or labeling of such a prod16 uct) that, without authorization, bears the trade17 mark, trade name, or other identifying mark, im18 print, or device, or any likeness thereof, of a tobacco 

19 product listed in a registration under section 

20 905(i)(1). 

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

22 regards a tobacco product means any person who 

23 furthers the distribution of a tobacco product, 

24 whether domestic or imported, at any point from the 

25 original place of manufacture to the person who sells 


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1 or distributes the product to individuals for personal 

2 consumption. Common carriers are not considered 

3 distributors for purposes of this chapter. 

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

5 means any practice or conduct prohibited by law 

6 which relates to production, shipment, receipt, pos7 session, distribution, sale, or purchase of tobacco 

8 products including any practice or conduct intended 

9 to facilitate such activity. 

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

11 country’ has the meaning given such term in section 

12 1151 of title 18, United States Code. 

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

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

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

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

18 means a product that— 

19 ‘‘(A) is a tobacco product; and 

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

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

22 Labeling and Advertising Act. 

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

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


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

2 any salt or complex of nicotine. 

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

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

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

7 sale, sold, or otherwise distributed to consumers. 

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

9 any person, government, or entity who sells tobacco 

10 products to individuals for personal consumption, or 

11 who operates a facility where self-service displays of 

12 tobacco products are permitted. 

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

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

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

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

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

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

22 employs fewer than 350 employees. For purposes of 

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

25 a manufacturer are deemed to include the employees 


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

2 under common control with such manufacturer. 

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

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

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

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

11 ‘smokeless tobacco’ means any tobacco product that 

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

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

14 cavity. 

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

16 and ‘Territory’ shall have the meanings given to 

17 such terms in section 201. 

18 ‘‘(20) TOBACCO PRODUCT MANUFACTURER.— 

19 The term ‘tobacco product manufacturer’ means any 

20 person, including any repacker or relabeler, who— 

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

22 processes, or labels a tobacco product; or 

23 ‘‘(B) imports a finished tobacco product 

24 for sale or distribution in the United States. 

25 ‘‘(21) TOBACCO WAREHOUSE.— 


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

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

3 person— 

4 ‘‘(i) who— 

5 ‘‘(I) removes foreign material 

6 from tobacco leaf through nothing 

7 other than a mechanical process; 

8 ‘‘(II) humidifies tobacco leaf with 

9 nothing other than potable water in 

10 the form of steam or mist; or 

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

12 tobacco leaf for storage and shipment; 

13 ‘‘(ii) who performs no other actions 

14 with respect to tobacco leaf; and 

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

17 information related to the person’s actions 

18 described in clause (i) that is necessary for 

19 compliance with this Act. 

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

22 ‘‘(i) reconstitutes tobacco leaf; 

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

24 retailer of a tobacco product; or 


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

2 or substance to the tobacco leaf other than 

3 potable water in the form of steam or mist. 

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

5 warehouse’ in subparagraph (A) shall not apply 

6 to the extent to which the Secretary determines, 

7 through rulemaking, that regulation under this 

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

10 the public health. 

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

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

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

15 American Samoa, Wake Island, Midway Islands, 

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

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

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

21 modified risk tobacco products for which an order has 

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

24 be subject to the provisions of chapter V. 


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

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

3 smokeless tobacco and to any other tobacco products that 

4 the Secretary by regulation deems to be subject to this 

5 chapter. 

6 ‘‘(c) SCOPE.— 

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

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

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

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

13 over (including the authority to determine whether 

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

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

17 ‘‘(2) LIMITATION OF AUTHORITY.— 

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

19 chapter shall not apply to tobacco leaf that is 

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

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

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


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

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

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

7 producer shall be subject to this chapter in the 

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

10 a producer of tobacco leaf who grows tobacco 

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

13 the manufacturing process. 

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

15 in this chapter shall be construed to grant the 

16 Secretary authority to promulgate regulations 

17 on any matter that involves the production of 

18 tobacco leaf or a producer thereof, other than 

19 activities by a manufacturer affecting produc20 tion. 

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

22 under this chapter shall be in accordance with chapter 5 

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

24 be construed to affect the rulemaking provisions of section 


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

2 Control Act. 

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

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

5 Smoking Prevention and Tobacco Control Act, the Sec6 retary shall establish within the Food and Drug Adminis7 tration the Center for Tobacco Products, which shall re8 port to the Commissioner of Food and Drugs in the same 

9 manner as the other agency centers within the Food and 

10 Drug Administration. The Center shall be responsible for 

11 the implementation of this chapter and related matters as12 signed by the Commissioner. 

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

14 MANUFACTURERS.—The Secretary shall establish within 

15 the Food and Drug Administration an identifiable office 

16 to provide technical and other nonfinancial assistance to 

17 small tobacco product manufacturers to assist them in 

18 complying with the requirements of this Act. 

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

20 to promulgating rules under this chapter, the Secretary 

21 shall endeavor to consult with other Federal agencies as 

22 appropriate. 

23 ‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS. 

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

25 if— 


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

2 putrid, or decomposed substance, or is otherwise 

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

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

7 under insanitary conditions whereby it may have 

8 been contaminated with filth, or whereby it may 

9 have been rendered injurious to health; 

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

11 part, of any poisonous or deleterious substance 

12 which may render the contents injurious to health; 

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

15 such manufacturer or importer pursuant to section 

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

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

18 any dispute as to the amount of such fee; 

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

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

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


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

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

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

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

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

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

11 906(e)(2); or 

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

13 ‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS. 

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

15 deemed to be misbranded— 

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

17 particular; 

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

19 containing— 

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

21 tobacco product manufacturer, packer, or dis22 tributor; 

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

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

25 numerical count; 


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

3 domestically grown tobacco and the percentage 

4 that is foreign grown tobacco; and 

5 ‘‘(D) the statement required under section 

6 920(a), 

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

9 small packages shall be established, by regulations 

10 prescribed by the Secretary; 

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

13 to appear on the label or labeling is not prominently 

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

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

17 to be read and understood by the ordinary individual 

18 under customary conditions of purchase and use; 

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

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

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


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1 use, or adequate warnings against use by children, 

2 that are necessary for the protection of users unless 

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

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

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

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

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

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

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

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

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

18 in any particular; or 

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

20 regulations prescribed under section 906(d); 

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

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

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

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

6 ‘‘(B) a brief statement of— 

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

8 and relevant warnings, precautions, side 

9 effects, and contraindications; and 

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

11 products made subject to a finding by the 

12 Secretary after notice and opportunity for 

13 comment that such action is appropriate to 

14 protect the public health, a full description 

15 of the components of such tobacco product 

16 or the formula showing quantitatively each 

17 ingredient of such tobacco product to the 

18 extent required in regulations which shall 

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

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

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

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


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

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

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

6 The Secretary may, by regulation, require prior approval 

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

8 regulation issued under this subsection may require prior 

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

13 Smoking Prevention and Tobacco Control Act shall, with 

14 respect to the language of label statements as prescribed 

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

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

22 SECRETARY. 

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

25 the Secretary the following information: 


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

2 enactment of the Family Smoking Prevention and 

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

7 of each tobacco product by brand and by quantity in 

8 each brand and subbrand. 

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

10 form of nicotine in each tobacco product measured 

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

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

14 and Advertising Act. 

15 ‘‘(3) Beginning 3 years after the date of enact16 ment of the Family Smoking Prevention and To17 bacco Control Act, a listing of all constituents, in18 cluding smoke constituents as applicable, identified 

19 by the Secretary as harmful or potentially harmful 

20 to health in each tobacco product, and as applicable 

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

22 by quantity in each brand and subbrand. Effective 

23 beginning 3 years after such date of enactment, the 

24 manufacturer, importer, or agent shall comply with 

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1 porting information under this paragraph, where ap2 plicable. 

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

6 such date of enactment that relate to health, toxi7 cological, behavioral, or physiologic effects of current 

8 or future tobacco products, their constituents (in9 cluding smoke constituents), ingredients, compo10 nents, and additives. 

11 ‘‘(b) DATA SUBMISSION.—At the request of the Sec12 retary, each tobacco product manufacturer or importer of 

13 tobacco products, or agents thereof, shall submit the fol14 lowing: 

15 ‘‘(1) Any or all documents (including under16 lying scientific information) relating to research ac17 tivities, and research findings, conducted, supported, 

18 or possessed by the manufacturer (or agents thereof) 

19 on the health, toxicological, behavioral, or physio20 logic effects of tobacco products and their constitu21 ents (including smoke constituents), ingredients, 

22 components, and additives. 

23 ‘‘(2) Any or all documents (including under24 lying scientific information) relating to research ac25 tivities, and research findings, conducted, supported, 


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1 or possessed by the manufacturer (or agents thereof) 

2 that relate to the issue of whether a reduction in 

3 risk to health from tobacco products can occur upon 

4 the employment of technology available or known to 

5 the manufacturer. 

6 ‘‘(3) Any or all documents (including under7 lying scientific or financial information) relating to 

8 marketing research involving the use of tobacco 

9 products or marketing practices and the effective10 ness of such practices used by tobacco manufactur11 ers and distributors. 

12 An importer of a tobacco product not manufactured in the 

13 United States shall supply the information required of a 

14 tobacco product manufacturer under this subsection. 

15 ‘‘(c) TIME FOR SUBMISSION.— 

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

17 the delivery for introduction into interstate com18 merce of a tobacco product not on the market on the 

19 date of enactment of the Family Smoking Preven20 tion and Tobacco Control Act, the manufacturer of 

21 such product shall provide the information required 

22 under subsection (a). 

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

24 time a tobacco product manufacturer adds to its to25 bacco products a new tobacco additive or increases 


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1 the quantity of an existing tobacco additive, the 

2 manufacturer shall, except as provided in paragraph 

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

4 the Secretary in writing. 

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

6 any time a tobacco product manufacturer eliminates 

7 or decreases an existing additive, or adds or in8 creases an additive that has by regulation been des9 ignated by the Secretary as an additive that is not 

10 a human or animal carcinogen, or otherwise harmful 

11 to health under intended conditions of use, the man12 ufacturer shall within 60 days of such action so ad13 vise the Secretary in writing. 

14 ‘‘(d) DATA LIST.— 

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

16 after the date of enactment of the Family Smoking 

17 Prevention and Tobacco Control Act, and annually 

18 thereafter, the Secretary shall publish in a format 

19 that is understandable and not misleading to a lay 

20 person, and place on public display (in a manner de21 termined by the Secretary) the list established under 

22 subsection (e). 

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

24 shall conduct periodic consumer research to ensure 

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


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1 misleading to lay persons. Not later than 5 years 

2 after the date of enactment of the Family Smoking 

3 Prevention and Tobacco Control Act, the Secretary 

4 shall submit to the appropriate committees of Con5 gress a report on the results of such research, to6 gether with recommendations on whether such publi7 cation should be continued or modified. 

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

9 after the date of enactment of the Family Smoking Pre10 vention and Tobacco Control Act, the Secretary shall es11 tablish, and periodically revise as appropriate, a list of 

12 harmful and potentially harmful constituents, including 

13 smoke constituents, to health in each tobacco product by 

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

15 Secretary shall publish a public notice requesting the sub16 mission by interested persons of scientific and other infor17 mation concerning the harmful and potentially harmful 

18 constituents in tobacco products and tobacco smoke. 

19 ‘‘SEC. 905. ANNUAL REGISTRATION. 

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

21 ‘‘(1) MANUFACTURE, PREPARATION, 

22 COMPOUNDING, OR PROCESSING.—The term 

23 ‘manufacture, preparation, compounding, or proc24 essing’ shall include repackaging or otherwise chang25 ing the container, wrapper, or labeling of any toVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00041 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 bacco product package in furtherance of the dis2 tribution of the tobacco product from the original 

3 place of manufacture to the person who makes final 

4 delivery or sale to the ultimate consumer or user. 

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

6 the case of a partnership the name of each partner 

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

8 corporate officer and director, and the State of in9 corporation. 

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

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

12 owns or operates any establishment in any State engaged 

13 in the manufacture, preparation, compounding, or proc14 essing of a tobacco product or tobacco products shall reg15 ister with the Secretary the name, places of business, and 

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

17 Family Smoking Prevention and Tobacco Control Act oc18 curs in the second half of the calendar year, the Secretary 

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

20 subsequent calendar year by which registration pursuant 

21 to this subsection shall occur. 

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

25 product or tobacco products in any establishment owned 


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1 or operated in any State by that person shall immediately 

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

3 business, and such establishment. 

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

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

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

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

10 product or tobacco products. 

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

14 may require that persons who are required to list such 

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

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

19 to any person so requesting, any registration filed under 

20 this section. 

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

23 Secretary under this section shall be subject to inspection 

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


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1 processing of a tobacco product or tobacco products shall 

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

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

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

6 successive 2-year period thereafter. 

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

9 engaged in the manufacture, preparation, compounding, 

10 or processing of a tobacco product or tobacco products, 

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

13 such establishment to provide the information required by 

14 subsection (i) and shall include provisions for registration 

15 of any such establishment upon condition that adequate 

16 and effective means are available, by arrangement with the 

17 government of such foreign country or otherwise, to enable 

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

20 processed in such establishment, if imported or offered for 

21 import into the United States, shall be refused admission 

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

23 ‘‘(i) REGISTRATION INFORMATION.— 

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


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

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

3 all tobacco products which are being manufactured, 

4 prepared, compounded, or processed by that person 

5 for commercial distribution and which have not been 

6 included in any list of tobacco products filed by that 

7 person with the Secretary under this paragraph or 

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

9 list shall be prepared in such form and manner as 

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

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

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

16 to section 910, a reference to the authority for 

17 the marketing of such tobacco product and a 

18 copy of all labeling for such tobacco product; 

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

21 consumer information and other labeling for 

22 such tobacco product, a representative sampling 

23 of advertisements for such tobacco product, 

24 and, upon request made by the Secretary for 


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1 good cause, a copy of all advertisements for a 

2 particular tobacco product; and 

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

5 such list is not subject to a tobacco product 

6 standard established under section 907, a brief 

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

10 to that particular tobacco product. 

11 ‘‘(2) CONSULTATION WITH RESPECT TO

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

14 used for registration under this section to minimize 

15 the burden on those persons required to register 

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

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

19 PRODUCT LIST.—Each person who registers with the 

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

22 and once during the month of December of each 

23 year the following: 

24 ‘‘(A) A list of each tobacco product intro25 duced by the registrant for commercial distribuVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00046 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 tion which has not been included in any list 

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

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

5 tobacco product by its established name and 

6 shall be accompanied by the other information 

7 required by paragraph (1). 

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

9 made a report under this paragraph that person 

10 has discontinued the manufacture, preparation, 

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

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

14 notice of such discontinuance, the date of such 

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

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

23 of discontinuance was reported, notice of such 

24 resumption, the date of such resumption, the 

25 identity of such tobacco product by established 


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1 name, and other information required by para2 graph (1), unless the registrant has previously 

3 reported such resumption to the Secretary 

4 under this subparagraph. 

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

7 or paragraph (1). 

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

10 INTERSTATE COMMERCE.— 

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

16 use that was not commercially marketed (other than 

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

21 shall prescribe)— 

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

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


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

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

7 section 910, is substantially equivalent and 

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

10 ‘‘(ii) the tobacco product is modified 

11 within the meaning of paragraph (3), the 

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

14 the requirements of this Act, and all of the 

15 modifications are covered by exemptions 

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

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

20 that are applicable to the tobacco product. 

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

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

25 commerce for commercial distribution in the United 


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

2 date that is 21 months after the date of enactment 

3 of the Family Smoking Prevention and Tobacco 

4 Control Act shall be submitted to the Secretary not 

5 later than 21 months after such date of enactment. 

6 ‘‘(3) EXEMPTIONS.— 

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

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

11 the meaning of section 910, tobacco products 

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

14 quantity of an existing tobacco additive, if the 

15 Secretary determines that— 

16 ‘‘(i) such modification would be a 

17 minor modification of a tobacco product 

18 that can be sold under this Act; 

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

20 not necessary to ensure that permitting the 

21 tobacco product to be marketed would be 

22 appropriate for protection of the public 

23 health; and 

24 ‘‘(iii) an exemption is otherwise appro25 priate. 


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

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

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

6 ‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL 

7 OF TOBACCO PRODUCTS. 

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

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

10 tobacco product shall apply to such tobacco product until 

11 the applicability of the requirement to the tobacco product 

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

14 and any requirement established by or under section 902, 

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

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

18 shall not apply to such tobacco product. 

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

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

23 Federal Register with respect to any other action taken 

24 under any such section and which states the reasons for 

25 such action, and each publication of findings required to 


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1 be made in connection with rulemaking under any such 

2 section shall set forth— 

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

4 may examine data and other information on which 

5 the notice or findings is based; and 

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

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

10 not exceed 90 days unless the time is extended by 

11 the Secretary by a notice published in the Federal 

12 Register stating good cause therefore. 

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

15 by the Secretary or the Secretary’s representative under 

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

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

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

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

20 that section shall be considered confidential and shall not 

21 be disclosed, except that the information may be disclosed 

22 to other officers or employees concerned with carrying out 

23 this chapter, or when relevant in any proceeding under 

24 this chapter. 

25 ‘‘(d) RESTRICTIONS.— 


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

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

5 the tobacco product, if the Secretary determines that 

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

9 promotion of a tobacco product consistent with and 

10 to full extent permitted by the first amendment to 

11 the Constitution. The finding as to whether such 

12 regulation would be appropriate for the protection of 

13 the public health shall be determined with respect to 

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

15 including users and nonusers of the tobacco product, 

16 and taking into account— 

17 ‘‘(A) the increased or decreased likelihood 

18 that existing users of tobacco products will stop 

19 using such products; and 

20 ‘‘(B) the increased or decreased likelihood 

21 that those who do not use tobacco products will 

22 start using such products. 

23 No such regulation may require that the sale or dis24 tribution of a tobacco product be limited to the writVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00053 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 ten or oral authorization of a practitioner licensed 

2 by law to prescribe medical products. 

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

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

7 regulation prescribe. 

8 ‘‘(3) LIMITATIONS.— 

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

10 paragraph (1) may— 

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

12 product in face-to-face transactions by a 

13 specific category of retail outlets; or 

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

15 of tobacco products to any person older 

16 than 18 years of age. 

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

18 regulations issued by the Secretary, matchbooks 

19 of conventional size containing not more than 

20 20 paper matches, and which are customarily 

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

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


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1 treatment of matchbooks is not appropriate for 

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

6 ‘‘(4) REMOTE SALES.— 

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

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

9 of enactment of the Family Smoking Pre10 vention and Tobacco Control Act, promul11 gate regulations regarding the sale and 

12 distribution of tobacco products that occur 

13 through means other than a direct, face-to14 face exchange between a retailer and a 

15 consumer in order to prevent the sale and 

16 distribution of tobacco products to individ17 uals who have not attained the minimum 

18 age established by applicable law for the 

19 purchase of such products, including re20 quirements for age verification; and 

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

22 enactment, issue regulations to address the 

23 promotion and marketing of tobacco prod24 ucts that are sold or distributed through 

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1 change between a retailer and a consumer 

2 in order to protect individuals who have 

3 not attained the minimum age established 

4 by applicable law for the purchase of such 

5 products. 

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

7 Nothing in this paragraph limits the authority 

8 of the Secretary to take additional actions 

9 under the other paragraphs of this subsection. 

10 ‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE11 MENTS.— 

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

13 CONFORM.— 

14 ‘‘(A) IN GENERAL.—In applying manufac15 turing restrictions to tobacco, the Secretary 

16 shall, in accordance with subparagraph (B), 

17 prescribe regulations (which may differ based 

18 on the type of tobacco product involved) requir19 ing that the methods used in, and the facilities 

20 and controls used for, the manufacture, 

21 preproduction design validation (including a 

22 process to assess the performance of a tobacco 

23 product), packing, and storage of a tobacco 

24 product conform to current good manufacturing 

25 practice, or hazard analysis and critical control 


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1 point methodology, as prescribed in such regu2 lations to assure that the public health is pro3 tected and that the tobacco product is in com4 pliance with this chapter. Such regulations may 

5 provide for the testing of raw tobacco for pes6 ticide chemical residues regardless of whether a 

7 tolerance for such chemical residues has been 

8 established. 

9 ‘‘(B) REQUIREMENTS.—The Secretary 

10 shall— 

11 ‘‘(i) before promulgating any regula12 tion under subparagraph (A), afford the 

13 Tobacco Products Scientific Advisory Com14 mittee an opportunity to submit rec15 ommendations with respect to the regula16 tion proposed to be promulgated; 

17 ‘‘(ii) before promulgating any regula18 tion under subparagraph (A), afford oppor19 tunity for an oral hearing; 

20 ‘‘(iii) provide the Tobacco Products 

21 Scientific Advisory Committee a reasonable 

22 time to make its recommendation with re23 spect to proposed regulations under sub24 paragraph (A); 


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1 ‘‘(iv) in establishing the effective date 

2 of a regulation promulgated under this 

3 subsection, take into account the dif4 ferences in the manner in which the dif5 ferent types of tobacco products have his6 torically been produced, the financial re7 sources of the different tobacco product 

8 manufacturers, and the state of their exist9 ing manufacturing facilities, and shall pro10 vide for a reasonable period of time for 

11 such manufacturers to conform to good 

12 manufacturing practices; and 

13 ‘‘(v) not require any small tobacco 

14 product manufacturer to comply with a 

15 regulation under subparagraph (A) for at 

16 least 4 years following the effective date 

17 established by the Secretary for such regu18 lation. 

19 ‘‘(2) EXEMPTIONS; VARIANCES.— 

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

21 any requirement prescribed under paragraph 

22 (1) may petition the Secretary for a permanent 

23 or temporary exemption or variance from such 

24 requirement. Such a petition shall be submitted 


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1 to the Secretary in such form and manner as 

2 the Secretary shall prescribe and shall— 

3 ‘‘(i) in the case of a petition for an ex4 emption from a requirement, set forth the 

5 basis for the petitioner’s determination 

6 that compliance with the requirement is 

7 not required to assure that the tobacco 

8 product will be in compliance with this 

9 chapter; 

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

11 variance from a requirement, set forth the 

12 methods proposed to be used in, and the 

13 facilities and controls proposed to be used 

14 for, the manufacture, packing, and storage 

15 of the tobacco product in lieu of the meth16 ods, facilities, and controls prescribed by 

17 the requirement; and 

18 ‘‘(iii) contain such other information 

19 as the Secretary shall prescribe. 

20 ‘‘(B) REFERRAL TO THE TOBACCO PROD21 UCTS SCIENTIFIC ADVISORY COMMITTEE.—The 

22 Secretary may refer to the Tobacco Products 

23 Scientific Advisory Committee any petition sub24 mitted under subparagraph (A). The Tobacco 

25 Products Scientific Advisory Committee shall 


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1 report its recommendations to the Secretary 

2 with respect to a petition referred to it within 

3 60 days after the date of the petition’s referral. 

4 Within 60 days after— 

5 ‘‘(i) the date the petition was sub6 mitted to the Secretary under subpara7 graph (A); or 

8 ‘‘(ii) the day after the petition was re9 ferred to the Tobacco Products Scientific 

10 Advisory Committee, 

11 whichever occurs later, the Secretary shall by 

12 order either deny the petition or approve it. 

13 ‘‘(C) APPROVAL.—The Secretary may ap14 prove— 

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

16 tobacco product from a requirement if the 

17 Secretary determines that compliance with 

18 such requirement is not required to assure 

19 that the tobacco product will be in compli20 ance with this chapter; and 

21 ‘‘(ii) a petition for a variance for a to22 bacco product from a requirement if the 

23 Secretary determines that the methods to 

24 be used in, and the facilities and controls 

25 to be used for, the manufacture, packing, 


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1 and storage of the tobacco product in lieu 

2 of the methods, facilities, and controls pre3 scribed by the requirement are sufficient to 

4 assure that the tobacco product will be in 

5 compliance with this chapter. 

6 ‘‘(D) CONDITIONS.—An order of the Sec7 retary approving a petition for a variance shall 

8 prescribe such conditions respecting the meth9 ods used in, and the facilities and controls used 

10 for, the manufacture, packing, and storage of 

11 the tobacco product to be granted the variance 

12 under the petition as may be necessary to as13 sure that the tobacco product will be in compli14 ance with this chapter. 

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

16 order under subparagraph (B) respecting a pe17 tition, the petitioner shall have an opportunity 

18 for an informal hearing on such order. 

19 ‘‘(3) COMPLIANCE.—Compliance with require20 ments under this subsection shall not be required be21 fore the end of the 3-year period following the date 

22 of enactment of the Family Smoking Prevention and 

23 Tobacco Control Act. 

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

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1 onstrations respecting tobacco products and may obtain 

2 tobacco products for research, testing, and demonstration 

3 purposes. 

4 ‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 

5 ‘‘(a) IN GENERAL.— 

6 ‘‘(1) SPECIAL RULES.— 

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

8 Beginning 3 months after the date of enact9 ment of the Family Smoking Prevention and 

10 Tobacco Control Act, a cigarette or any of its 

11 component parts (including the tobacco, filter, 

12 or paper) shall not contain, as a constituent (in13 cluding a smoke constituent) or additive, an ar14 tificial or natural flavor (other than tobacco or 

15 menthol) or an herb or spice, including straw16 berry, grape, orange, clove, cinnamon, pine17 apple, vanilla, coconut, licorice, cocoa, chocolate, 

18 cherry, or coffee, that is a characterizing flavor 

19 of the tobacco product or tobacco smoke. Noth20 ing in this subparagraph shall be construed to 

21 limit the Secretary’s authority to take action 

22 under this section or other sections of this Act 

23 applicable to menthol or any artificial or nat24 ural flavor, herb, or spice not specified in this 

25 subparagraph. 


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1 ‘‘(B) ADDITIONAL SPECIAL RULE.—Begin2 ning 2 years after the date of enactment of the 

3 Family Smoking Prevention and Tobacco Con4 trol Act, a tobacco product manufacturer shall 

5 not use tobacco, including foreign grown to6 bacco, that contains a pesticide chemical res7 idue that is at a level greater than is specified 

8 by any tolerance applicable under Federal law 

9 to domestically grown tobacco. 

10 ‘‘(2) REVISION OF TOBACCO PRODUCT STAND11 ARDS.—The Secretary may revise the tobacco prod12 uct standards in paragraph (1) in accordance with 

13 subsection (c). 

14 ‘‘(3) TOBACCO PRODUCT STANDARDS.— 

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

16 adopt tobacco product standards in addition to 

17 those in paragraph (1) if the Secretary finds 

18 that a tobacco product standard is appropriate 

19 for the protection of the public health. 

20 ‘‘(B) DETERMINATIONS.— 

21 ‘‘(i) CONSIDERATIONS.—In making a 

22 finding described in subparagraph (A), the 

23 Secretary shall consider scientific evidence 

24 concerning— 


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

2 population as a whole, including users 

3 and nonusers of tobacco products, of 

4 the proposed standard; 

5 ‘‘(II) the increased or decreased 

6 likelihood that existing users of to7 bacco products will stop using such 

8 products; and 

9 ‘‘(III) the increased or decreased 

10 likelihood that those who do not use 

11 tobacco products will start using such 

12 products. 

13 ‘‘(ii) ADDITIONAL CONSIDER14 ATIONS.—In the event that the Secretary 

15 makes a determination, set forth in a pro16 posed tobacco product standard in a pro17 posed rule, that it is appropriate for the 

18 protection of public health to require the 

19 reduction or elimination of an additive, 

20 constituent (including a smoke constitu21 ent), or other component of a tobacco 

22 product because the Secretary has found 

23 that the additive, constituent, or other 

24 component is or may be harmful, any 

25 party objecting to the proposed standard 


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1 on the ground that the proposed standard 

2 will not reduce or eliminate the risk of ill3 ness or injury may provide for the Sec4 retary’s consideration scientific evidence 

5 that demonstrates that the proposed stand6 ard will not reduce or eliminate the risk of 

7 illness or injury. 

8 ‘‘(4) CONTENT OF TOBACCO PRODUCT STAND9 ARDS.—A tobacco product standard established 

10 under this section for a tobacco product— 

11 ‘‘(A) shall include provisions that are ap12 propriate for the protection of the public health, 

13 including provisions, where appropriate— 

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

15 ‘‘(ii) for the reduction or elimination 

16 of other constituents, including smoke con17 stituents, or harmful components of the 

18 product; or 

19 ‘‘(iii) relating to any other require20 ment under subparagraph (B); 

21 ‘‘(B) shall, where appropriate for the pro22 tection of the public health, include— 

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1 stituents, and properties of the tobacco 

2 product; 

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

4 sample basis or, if necessary, on an indi5 vidual basis) of the tobacco product; 

6 ‘‘(iii) provisions for the measurement 

7 of the tobacco product characteristics of 

8 the tobacco product; 

9 ‘‘(iv) provisions requiring that the re10 sults of each or of certain of the tests of 

11 the tobacco product required to be made 

12 under clause (ii) show that the tobacco 

13 product is in conformity with the portions 

14 of the standard for which the test or tests 

15 were required; and 

16 ‘‘(v) a provision requiring that the 

17 sale and distribution of the tobacco prod18 uct be restricted but only to the extent 

19 that the sale and distribution of a tobacco 

20 product may be restricted under a regula21 tion under section 906(d); 

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

23 use and prescribe the form and content of label24 ing for the proper use of the tobacco product; 

25 and 


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1 ‘‘(D) shall require tobacco products con2 taining foreign-grown tobacco to meet the same 

3 standards applicable to tobacco products con4 taining domestically grown tobacco. 

5 ‘‘(5) PERIODIC REEVALUATION OF TOBACCO

6 PRODUCT STANDARDS.—The Secretary shall provide 

7 for periodic evaluation of tobacco product standards 

8 established under this section to determine whether 

9 such standards should be changed to reflect new 

10 medical, scientific, or other technological data. The 

11 Secretary may provide for testing under paragraph 

12 (4)(B) by any person. 

13 ‘‘(6) INVOLVEMENT OF OTHER AGENCIES; IN14 FORMED PERSONS.—In carrying out duties under 

15 this section, the Secretary shall endeavor to— 

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

17 technical support available in other Federal 

18 agencies; 

19 ‘‘(B) consult with other Federal agencies 

20 concerned with standard setting and other na21 tionally or internationally recognized standard22 setting entities; and 

23 ‘‘(C) invite appropriate participation, 

24 through joint or other conferences, workshops, 

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1 ative of scientific, professional, industry, agri2 cultural, or consumer organizations who in the 

3 Secretary’s judgment can make a significant 

4 contribution. 

5 ‘‘(b) CONSIDERATIONS BY SECRETARY.— 

6 ‘‘(1) TECHNICAL ACHIEVABILITY.—The Sec7 retary shall consider information submitted in con8 nection with a proposed standard regarding the tech9 nical achievability of compliance with such standard. 

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

11 shall consider all other information submitted in 

12 connection with a proposed standard, including in13 formation concerning the countervailing effects of 

14 the tobacco product standard on the health of ado15 lescent tobacco users, adult tobacco users, or non16 tobacco users, such as the creation of a significant 

17 demand for contraband or other tobacco products 

18 that do not meet the requirements of this chapter 

19 and the significance of such demand. 

20 ‘‘(c) PROPOSED STANDARDS.— 

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

22 in the Federal Register a notice of proposed rule23 making for the establishment, amendment, or rev24 ocation of any tobacco product standard. 


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

2 proposed rulemaking for the establishment or 

3 amendment of a tobacco product standard for a to4 bacco product shall— 

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

6 justification that the tobacco product standard 

7 is appropriate for the protection of the public 

8 health; 

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

10 draft or proposed tobacco product standard for 

11 consideration by the Secretary; 

12 ‘‘(C) invite interested persons to submit 

13 comments on structuring the standard so that 

14 it does not advantage foreign-grown tobacco 

15 over domestically grown tobacco; and 

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

17 provide any information or analysis which the 

18 Secretary of Agriculture believes is relevant to 

19 the proposed tobacco product standard. 

20 ‘‘(3) FINDING.—A notice of proposed rule21 making for the revocation of a tobacco product 

22 standard shall set forth a finding with supporting 

23 justification that the tobacco product standard is no 

24 longer appropriate for the protection of the public 

25 health. 


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

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

3 ‘‘(d) PROMULGATION.— 

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

5 period for comment on a notice of proposed rule6 making published under subsection (c) respecting a 

7 tobacco product standard and after consideration of 

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

9 and any report from the Tobacco Products Scientific 

10 Advisory Committee, the Secretary shall— 

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

12 standard would be appropriate for the protec13 tion of the public health, promulgate a regula14 tion establishing a tobacco product standard 

15 and publish in the Federal Register findings on 

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

17 ‘‘(B) publish a notice terminating the pro18 ceeding for the development of the standard to19 gether with the reasons for such termination. 

20 ‘‘(2) EFFECTIVE DATE.—A regulation estab21 lishing a tobacco product standard shall set forth 

22 the date or dates upon which the standard shall take 

23 effect, but no such regulation may take effect before 

24 1 year after the date of its publication unless the 

25 Secretary determines that an earlier effective date is 


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1 necessary for the protection of the public health. 

2 Such date or dates shall be established so as to min3 imize, consistent with the public health, economic 

4 loss to, and disruption or dislocation of, domestic 

5 and international trade. In establishing such effec6 tive date or dates, the Secretary shall consider infor7 mation submitted in connection with a proposed 

8 product standard by interested parties, including 

9 manufacturers and tobacco growers, regarding the 

10 technical achievability of compliance with the stand11 ard, and including information concerning the exist12 ence of patents that make it impossible to comply in 

13 the timeframe envisioned in the proposed standard. 

14 If the Secretary determines, based on the Sec15 retary’s evaluation of submitted comments, that a 

16 product standard can be met only by manufacturers 

17 requiring substantial changes to the methods of 

18 farming the domestically grown tobacco used by the 

19 manufacturer, the effective date of that product 

20 standard shall be not less than 2 years after the 

21 date of publication of the final regulation estab22 lishing the standard. 

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

24 FOOD AND DRUG ADMINISTRATION.—Because of the 


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1 importance of a decision of the Secretary to issue a 

2 regulation— 

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

4 tobacco products, all little cigars, all cigars 

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

6 roll-your-own tobacco products; or 

7 ‘‘(B) requiring the reduction of nicotine 

8 yields of a tobacco product to zero, 

9 the Secretary is prohibited from taking such actions 

10 under this Act. 

11 ‘‘(4) AMENDMENT; REVOCATION.— 

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

13 the Secretary’s own initiative or upon petition 

14 of an interested person, may by a regulation, 

15 promulgated in accordance with the require16 ments of subsection (c) and paragraph (2), 

17 amend or revoke a tobacco product standard. 

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

19 may declare a proposed amendment of a to20 bacco product standard to be effective on and 

21 after its publication in the Federal Register and 

22 until the effective date of any final action taken 

23 on such amendment if the Secretary determines 

24 that making it so effective is in the public inter25 est. 


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

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

3 refer a proposed regulation for the establish4 ment, amendment, or revocation of a tobacco 

5 product standard to the Tobacco Products Sci6 entific Advisory Committee for a report and 

7 recommendation with respect to any matter in8 volved in the proposed regulation which requires 

9 the exercise of scientific judgment. 

10 ‘‘(B) INITIATION OF REFERRAL.—The Sec11 retary may make a referral under this para12 graph— 

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

14 or 

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

16 person that— 

17 ‘‘(I) demonstrates good cause for 

18 the referral; and 

19 ‘‘(II) is made before the expira20 tion of the period for submission of 

21 comments on the proposed regulation. 

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

23 regulation is referred under this paragraph to 

24 the Tobacco Products Scientific Advisory Com25 mittee, the Secretary shall provide the Advisory 


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1 Committee with the data and information on 

2 which such proposed regulation is based. 

3 ‘‘(D) REPORT AND RECOMMENDATION.— 

4 The Tobacco Products Scientific Advisory Com5 mittee shall, within 60 days after the referral of 

6 a proposed regulation under this paragraph and 

7 after independent study of the data and infor8 mation furnished to it by the Secretary and 

9 other data and information before it, submit to 

10 the Secretary a report and recommendation re11 specting such regulation, together with all un12 derlying data and information and a statement 

13 of the reason or basis for the recommendation. 

14 ‘‘(E) PUBLIC AVAILABILITY.—The Sec15 retary shall make a copy of each report and rec16 ommendation under subparagraph (D) publicly 

17 available. 

18 ‘‘(e) MENTHOL CIGARETTES.— 

19 ‘‘(1) REFERRAL; CONSIDERATIONS.—Imme20 diately upon the establishment of the Tobacco Prod21 ucts Scientific Advisory Committee under section 

22 917(a), the Secretary shall refer to the Committee 

23 for report and recommendation, under section 

24 917(c)(4), the issue of the impact of the use of men25 thol in cigarettes on the public health, including 


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1 such use among African Americans, Hispanics, and 

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

3 Tobacco Products Scientific Advisory Committee 

4 shall address the considerations listed in subsections 

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

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

7 later than 1 year after its establishment, the To8 bacco Product Scientific Advisory Committee shall 

9 submit to the Secretary the report and recommenda10 tions required pursuant to paragraph (1). 

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

12 this subsection shall be construed to limit the Sec13 retary’s authority to take action under this section 

14 or other sections of this Act applicable to menthol. 

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

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

17 that— 

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

19 delivered for introduction into interstate commerce 

20 for commercial distribution presents an unreasonable 

21 risk of substantial harm to the public health; and 

22 ‘‘(2) notification under this subsection is nec23 essary to eliminate the unreasonable risk of such 

24 harm and no more practicable means is available 


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1 under the provisions of this chapter (other than this 

2 section) to eliminate such risk, 

3 the Secretary may issue such order as may be necessary 

4 to assure that adequate notification is provided in an ap5 propriate form, by the persons and means best suited 

6 under the circumstances involved, to all persons who 

7 should properly receive such notification in order to elimi8 nate such risk. The Secretary may order notification by 

9 any appropriate means, including public service announce10 ments. Before issuing an order under this subsection, the 

11 Secretary shall consult with the persons who are to give 

12 notice under the order. 

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

14 Compliance with an order issued under this section shall 

15 not relieve any person from liability under Federal or 

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

17 action brought for the enforcement of any such liability, 

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

19 provided under such order shall be taken into account. 

20 ‘‘(c) RECALL AUTHORITY.— 

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

22 there is a reasonable probability that a tobacco prod23 uct contains a manufacturing or other defect not or24 dinarily contained in tobacco products on the market 

25 that would cause serious, adverse health conVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00076 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 sequences or death, the Secretary shall issue an 

2 order requiring the appropriate person (including 

3 the manufacturers, importers, distributors, or retail4 ers of the tobacco product) to immediately cease dis5 tribution of such tobacco product. The order shall 

6 provide the person subject to the order with an op7 portunity for an informal hearing, to be held not 

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

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

10 on whether the order should be amended to require 

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

12 an opportunity for such a hearing, the Secretary de13 termines that inadequate grounds exist to support 

14 the actions required by the order, the Secretary shall 

15 vacate the order. 

16 ‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE17 CALL.— 

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

19 opportunity for an informal hearing under 

20 paragraph (1), the Secretary determines that 

21 the order should be amended to include a recall 

22 of the tobacco product with respect to which the 

23 order was issued, the Secretary shall, except as 

24 provided in subparagraph (B), amend the order 

25 to require a recall. The Secretary shall specify 


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1 a timetable in which the tobacco product recall 

2 will occur and shall require periodic reports to 

3 the Secretary describing the progress of the re4 call. 

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

6 subparagraph (A)— 

7 ‘‘(i) shall not include recall of a to8 bacco product from individuals; and 

9 ‘‘(ii) shall provide for notice to per10 sons subject to the risks associated with 

11 the use of such tobacco product. 

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

13 the Secretary may use the assistance of retail14 ers and other persons who distributed such to15 bacco product. If a significant number of such 

16 persons cannot be identified, the Secretary shall 

17 notify such persons under section 705(b). 

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

19 provided by this subsection shall be in addition to 

20 remedies provided by subsection (a). 

21 ‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PROD22 UCTS. 

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

24 product manufacturer or importer of a tobacco product 

25 shall establish and maintain such records, make such reVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00078 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 ports, and provide such information, as the Secretary may 

2 by regulation reasonably require to assure that such to3 bacco product is not adulterated or misbranded and to 

4 otherwise protect public health. Regulations prescribed 

5 under the preceding sentence— 

6 ‘‘(1) may require a tobacco product manufac7 turer or importer to report to the Secretary when8 ever the manufacturer or importer receives or other9 wise becomes aware of information that reasonably 

10 suggests that one of its marketed tobacco products 

11 may have caused or contributed to a serious unex12 pected adverse experience associated with the use of 

13 the product or any significant increase in the fre14 quency of a serious, expected adverse product experi15 ence; 

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

17 adverse tobacco product experiences as determined 

18 by the Secretary to be necessary to be reported; 

19 ‘‘(3) shall not impose requirements unduly bur20 densome to a tobacco product manufacturer or im21 porter, taking into account the cost of complying 

22 with such requirements and the need for the protec23 tion of the public health and the implementation of 

24 this chapter; 


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

2 requests for reports or information, shall require 

3 that each request made under such regulations for 

4 submission of a report or information to the Sec5 retary state the reason or purpose for such request 

6 and identify to the fullest extent practicable such re7 port or information; 

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

9 information to the Secretary, shall state the reason 

10 or purpose for the submission of such report or in11 formation and identify to the fullest extent prac12 ticable such report or information; and 

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

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

15 information required under this subsection unless re16 quired for the medical welfare of an individual, to 

17 determine risks to public health of a tobacco prod18 uct, or to verify a record, report, or information sub19 mitted under this chapter. 

20 In prescribing regulations under this subsection, the Sec21 retary shall have due regard for the professional ethics of 

22 the medical profession and the interests of patients. The 

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

24 reports, and information concerning any individual who 


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

2 ceases to be a patient. 

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

4 ‘‘(1) IN GENERAL.—Except as provided in para5 graph (2), the Secretary shall by regulation require 

6 a tobacco product manufacturer or importer of a to7 bacco product to report promptly to the Secretary 

8 any corrective action taken or removal from the 

9 market of a tobacco product undertaken by such 

10 manufacturer or importer if the removal or correc11 tion was undertaken— 

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

13 the tobacco product; or 

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

15 caused by the tobacco product which may 

16 present a risk to health. 

17 A tobacco product manufacturer or importer of a to18 bacco product who undertakes a corrective action or 

19 removal from the market of a tobacco product which 

20 is not required to be reported under this subsection 

21 shall keep a record of such correction or removal. 

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

23 action or removal of a tobacco product may be re24 quired under paragraph (1) if a report of the correcVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00081 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 tive action or removal is required and has been sub2 mitted under subsection (a). 

3 ‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TO4 BACCO PRODUCTS. 

5 ‘‘(a) IN GENERAL.— 

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

7 purposes of this section the term ‘new tobacco prod8 uct’ means— 

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

10 products in test markets) that was not commer11 cially marketed in the United States as of Feb12 ruary 15, 2007; or 

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

14 in design, any component, any part, or any con15 stituent, including a smoke constituent, or in 

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

17 other additive or ingredient) of a tobacco prod18 uct where the modified product was commer19 cially marketed in the United States after Feb20 ruary 15, 2007. 

21 ‘‘(2) PREMARKET REVIEW REQUIRED.— 

22 ‘‘(A) NEW PRODUCTS.—An order under 

23 subsection (c)(1)(A)(i) for a new tobacco prod24 uct is required unless— 


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1 ‘‘(i) the manufacturer has submitted a 

2 report under section 905(j); and the Sec3 retary has issued an order that the tobacco 

4 product— 

5 ‘‘(I) is substantially equivalent to 

6 a tobacco product commercially mar7 keted (other than for test marketing) 

8 in the United States as of February 

9 15, 2007; and 

10 ‘‘(II) is in compliance with the 

11 requirements of this Act; or 

12 ‘‘(ii) the tobacco product is exempt 

13 from the requirements of section 905(j) 

14 pursuant to a regulation issued under sec15 tion 905(j)(3). 

16 ‘‘(B) APPLICATION TO CERTAIN POST-FEB17 RUARY 15, 2007, PRODUCTS.—Subparagraph (A) 

18 shall not apply to a tobacco product— 

19 ‘‘(i) that was first introduced or deliv20 ered for introduction into interstate com21 merce for commercial distribution in the 

22 United States after February 15, 2007, 

23 and prior to the date that is 21 months 

24 after the date of enactment of the Family 


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1 Smoking Prevention and Tobacco Control 

2 Act; and 

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

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

5 period, 

6 except that subparagraph (A) shall apply to the 

7 tobacco product if the Secretary issues an order 

8 that the tobacco product is not substantially 

9 equivalent. 

10 ‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.— 

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

12 section 905(j), the term ‘substantially equiva13 lent’ or ‘substantial equivalence’ means, with 

14 respect to the tobacco product being compared 

15 to the predicate tobacco product, that the Sec16 retary by order has found that the tobacco 

17 product— 

18 ‘‘(i) has the same characteristics as 

19 the predicate tobacco product; or 

20 ‘‘(ii) has different characteristics and 

21 the information submitted contains infor22 mation, including clinical data if deemed 

23 necessary by the Secretary, that dem24 onstrates that it is not appropriate to reg25 ulate the product under this section beVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00084 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 cause the product does not raise different 

2 questions of public health. 

3 ‘‘(B) CHARACTERISTICS.—In subpara4 graph (A), the term ‘characteristics’ means the 

5 materials, ingredients, design, composition, 

6 heating source, or other features of a tobacco 

7 product. 

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

9 not be found to be substantially equivalent to a 

10 predicate tobacco product that has been re11 moved from the market at the initiative of the 

12 Secretary or that has been determined by a ju13 dicial order to be misbranded or adulterated. 

14 ‘‘(4) HEALTH INFORMATION.— 

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

16 under section 905(j) respecting a tobacco prod17 uct, the person required to file a premarket no18 tification under such section shall provide an 

19 adequate summary of any health information 

20 related to the tobacco product or state that 

21 such information will be made available upon 

22 request by any person. 

23 ‘‘(B) REQUIRED INFORMATION.—Any sum24 mary under subparagraph (A) respecting a to25 bacco product shall contain detailed information 


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1 regarding data concerning adverse health ef2 fects and shall be made available to the public 

3 by the Secretary within 30 days of the issuance 

4 of a determination that such tobacco product is 

5 substantially equivalent to another tobacco 

6 product. 

7 ‘‘(b) APPLICATION.— 

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

9 section shall contain— 

10 ‘‘(A) full reports of all information, pub11 lished or known to, or which should reasonably 

12 be known to, the applicant, concerning inves13 tigations which have been made to show the 

14 health risks of such tobacco product and wheth15 er such tobacco product presents less risk than 

16 other tobacco products; 

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

18 ingredients, additives, and properties, and of 

19 the principle or principles of operation, of such 

20 tobacco product; 

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

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

23 manufacture, processing, and, when relevant, 

24 packing and installation of, such tobacco prod25 uct; 


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1 ‘‘(D) an identifying reference to any to2 bacco product standard under section 907 

3 which would be applicable to any aspect of such 

4 tobacco product, and either adequate informa5 tion to show that such aspect of such tobacco 

6 product fully meets such tobacco product stand7 ard or adequate information to justify any devi8 ation from such standard; 

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

10 and of components thereof as the Secretary 

11 may reasonably require; 

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

13 be used for such tobacco product; and 

14 ‘‘(G) such other information relevant to 

15 the subject matter of the application as the Sec16 retary may require. 

17 ‘‘(2) REFERRAL TO TOBACCO PRODUCTS SCI18 ENTIFIC ADVISORY COMMITTEE.—Upon receipt of an 

19 application meeting the requirements set forth in 

20 paragraph (1), the Secretary— 

21 ‘‘(A) may, on the Secretary’s own initia22 tive; or 

23 ‘‘(B) may, upon the request of an appli24 cant, 


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1 refer such application to the Tobacco Products Sci2 entific Advisory Committee for reference and for 

3 submission (within such period as the Secretary may 

4 establish) of a report and recommendation respect5 ing the application, together with all underlying data 

6 and the reasons or basis for the recommendation. 

7 ‘‘(c) ACTION ON APPLICATION.— 

8 ‘‘(1) DEADLINE.— 

9 ‘‘(A) IN GENERAL.—As promptly as pos10 sible, but in no event later than 180 days after 

11 the receipt of an application under subsection 

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

13 and recommendation submitted under sub14 section (b)(2), shall— 

15 ‘‘(i) issue an order that the new prod16 uct may be introduced or delivered for in17 troduction into interstate commerce if the 

18 Secretary finds that none of the grounds 

19 specified in paragraph (2) of this sub20 section applies; or 

21 ‘‘(ii) issue an order that the new prod22 uct may not be introduced or delivered for 

23 introduction into interstate commerce if 

24 the Secretary finds (and sets forth the 

25 basis for such finding as part of or accomVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00088 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 panying such denial) that 1 or more 

2 grounds for denial specified in paragraph 

3 (2) of this subsection apply. 

4 ‘‘(B) RESTRICTIONS ON SALE AND DIS5 TRIBUTION.—An order under subparagraph 

6 (A)(i) may require that the sale and distribu7 tion of the tobacco product be restricted but 

8 only to the extent that the sale and distribution 

9 of a tobacco product may be restricted under a 

10 regulation under section 906(d). 

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

12 shall deny an application submitted under subsection 

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

14 to the Secretary as part of the application and any 

15 other information before the Secretary with respect 

16 to such tobacco product, the Secretary finds that— 

17 ‘‘(A) there is a lack of a showing that per18 mitting such tobacco product to be marketed 

19 would be appropriate for the protection of the 

20 public health; 

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

22 or controls used for, the manufacture, proc23 essing, or packing of such tobacco product do 

24 not conform to the requirements of section 

25 906(e); 


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

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

5 conform in all respects to a tobacco product 

6 standard in effect under section 907, and there 

7 is a lack of adequate information to justify the 

8 deviation from such standard. 

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

10 application shall, insofar as the Secretary determines 

11 to be practicable, be accompanied by a statement in12 forming the applicant of the measures required to 

13 remove such application from deniable form (which 

14 measures may include further research by the appli15 cant in accordance with 1 or more protocols pre16 scribed by the Secretary). 

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

18 this section, the finding as to whether the marketing 

19 of a tobacco product for which an application has 

20 been submitted is appropriate for the protection of 

21 the public health shall be determined with respect to 

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

23 including users and nonusers of the tobacco product, 

24 and taking into account— 


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1 ‘‘(A) the increased or decreased likelihood 

2 that existing users of tobacco products will stop 

3 using such products; and 

4 ‘‘(B) the increased or decreased likelihood 

5 that those who do not use tobacco products will 

6 start using such products. 

7 ‘‘(5) BASIS FOR ACTION.— 

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

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

10 product to be marketed would be appropriate 

11 for the protection of the public health shall, 

12 when appropriate, be determined on the basis of 

13 well-controlled investigations, which may in14 clude 1 or more clinical investigations by ex15 perts qualified by training and experience to 

16 evaluate the tobacco product. 

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

18 determines that there exists valid scientific evi19 dence (other than evidence derived from inves20 tigations described in subparagraph (A)) which 

21 is sufficient to evaluate the tobacco product, the 

22 Secretary may authorize that the determination 

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

24 the basis of such evidence. 

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


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

2 obtaining, where appropriate, advice on scientific 

3 matters from the Tobacco Products Scientific Advi4 sory Committee, and after due notice and oppor5 tunity for informal hearing for a tobacco product for 

6 which an order was issued under subsection 

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

8 the Secretary finds— 

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

10 tobacco product no longer is appropriate for the 

11 protection of the public health; 

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

13 accompanied by an untrue statement of a mate14 rial fact; 

15 ‘‘(C) that the applicant— 

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

17 for maintaining records, or has repeatedly 

18 or deliberately failed to maintain records 

19 or to make reports, required by an applica20 ble regulation under section 909; 

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

22 or copying or verification of, such records 

23 as required by section 704; or 

24 ‘‘(iii) has not complied with the re25 quirements of section 905; 


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1 ‘‘(D) on the basis of new information be2 fore the Secretary with respect to such tobacco 

3 product, evaluated together with the evidence 

4 before the Secretary when the application was 

5 reviewed, that the methods used in, or the fa6 cilities and controls used for, the manufacture, 

7 processing, packing, or installation of such to8 bacco product do not conform with the require9 ments of section 906(e) and were not brought 

10 into conformity with such requirements within a 

11 reasonable time after receipt of written notice 

12 from the Secretary of nonconformity; 

13 ‘‘(E) on the basis of new information be14 fore the Secretary, evaluated together with the 

15 evidence before the Secretary when the applica16 tion was reviewed, that the labeling of such to17 bacco product, based on a fair evaluation of all 

18 material facts, is false or misleading in any par19 ticular and was not corrected within a reason20 able time after receipt of written notice from 

21 the Secretary of such fact; or 

22 ‘‘(F) on the basis of new information be23 fore the Secretary, evaluated together with the 

24 evidence before the Secretary when such order 

25 was issued, that such tobacco product is not 


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1 shown to conform in all respects to a tobacco 

2 product standard which is in effect under sec3 tion 907, compliance with which was a condi4 tion to the issuance of an order relating to the 

5 application, and that there is a lack of adequate 

6 information to justify the deviation from such 

7 standard. 

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

9 subject to an order issued under paragraph (1) with10 drawing an order issued pursuant to subsection 

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

12 30th day after the date upon which such holder re13 ceives notice of such withdrawal, obtain review there14 of in accordance with section 912. 

15 ‘‘(3) TEMPORARY SUSPENSION.—If, after pro16 viding an opportunity for an informal hearing, the 

17 Secretary determines there is reasonable probability 

18 that the continuation of distribution of a tobacco 

19 product under an order would cause serious, adverse 

20 health consequences or death, that is greater than 

21 ordinarily caused by tobacco products on the market, 

22 the Secretary shall by order temporarily suspend the 

23 authority of the manufacturer to market the prod24 uct. If the Secretary issues such an order, the SecVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00094 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 retary shall proceed expeditiously under paragraph 

2 (1) to withdraw such application. 

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

4 Secretary under this section shall be served— 

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

6 department designated by the Secretary; or 

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

8 certified mail addressed to the applicant at the ap9 plicant’s last known address in the records of the 

10 Secretary. 

11 ‘‘(f) RECORDS.— 

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

13 of any tobacco product for which an order issued 

14 pursuant to subsection (c)(1)(A)(i) for an applica15 tion filed under subsection (b) is in effect, the appli16 cant shall establish and maintain such records, and 

17 make such reports to the Secretary, as the Secretary 

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

19 application, prescribe on the basis of a finding that 

20 such records and reports are necessary in order to 

21 enable the Secretary to determine, or facilitate a de22 termination of, whether there is or may be grounds 

23 for withdrawing or temporarily suspending such 

24 order. 


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1 ‘‘(2) ACCESS TO RECORDS.—Each person re2 quired under this section to maintain records, and 

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

4 request of an officer or employee designated by the 

5 Secretary, permit such officer or employee at all rea6 sonable times to have access to and copy and verify 

7 such records. 

8 ‘‘(g) INVESTIGATIONAL TOBACCO PRODUCT EXEMP9 TION FOR INVESTIGATIONAL USE.—The Secretary may 

10 exempt tobacco products intended for investigational use 

11 from the provisions of this chapter under such conditions 

12 as the Secretary may by regulation prescribe. 

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

14 ‘‘(a) IN GENERAL.—No person may introduce or de15 liver for introduction into interstate commerce any modi16 fied risk tobacco product unless an order issued pursuant 

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

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

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

20 term ‘modified risk tobacco product’ means any to21 bacco product that is sold or distributed for use to 

22 reduce harm or the risk of tobacco-related disease 

23 associated with commercially marketed tobacco prod24 ucts. 

25 ‘‘(2) SOLD OR DISTRIBUTED.— 


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1 ‘‘(A) IN GENERAL.—With respect to a to2 bacco product, the term ‘sold or distributed for 

3 use to reduce harm or the risk of tobacco-re4 lated disease associated with commercially mar5 keted tobacco products’ means a tobacco prod6 uct— 

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

8 of which represents explicitly or implicitly 

9 that— 

10 ‘‘(I) the tobacco product presents 

11 a lower risk of tobacco-related disease 

12 or is less harmful than one or more 

13 other commercially marketed tobacco 

14 products; 

15 ‘‘(II) the tobacco product or its 

16 smoke contains a reduced level of a 

17 substance or presents a reduced expo18 sure to a substance; or 

19 ‘‘(III) the tobacco product or its 

20 smoke does not contain or is free of a 

21 substance; 

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

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

24 or ‘low’ or similar descriptors; or 


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1 ‘‘(iii) the tobacco product manufac2 turer of which has taken any action di3 rected to consumers through the media or 

4 otherwise, other than by means of the to5 bacco product’s label, labeling, or adver6 tising, after the date of enactment of the 

7 Family Smoking Prevention and Tobacco 

8 Control Act, respecting the product that 

9 would be reasonably expected to result in 

10 consumers believing that the tobacco prod11 uct or its smoke may present a lower risk 

12 of disease or is less harmful than one or 

13 more commercially marketed tobacco prod14 ucts, or presents a reduced exposure to, or 

15 does not contain or is free of, a substance 

16 or substances. 

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

18 shall be considered to be ‘sold or distributed for 

19 use to reduce harm or the risk of tobacco-re20 lated disease associated with commercially mar21 keted tobacco products’, except as described in 

22 subparagraph (A). 

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

24 smokeless tobacco product shall be considered 

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


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1 or the risk of tobacco-related disease associated 

2 with commercially marketed tobacco products’ 

3 solely because its label, labeling, or advertising 

4 uses the following phrases to describe such 

5 product and its use: ‘smokeless tobacco’, 

6 ‘smokeless tobacco product’, ‘not consumed by 

7 smoking’, ‘does not produce smoke’, 

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

9 smoke’, or ‘not smoke’. 

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

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

12 after the date of enactment of the Family Smoking 

13 Prevention and Tobacco Control Act for those prod14 ucts whose label, labeling, or advertising contains 

15 the terms described in such paragraph on such date 

16 of enactment. The effective date shall be with re17 spect to the date of manufacture, provided that, in 

18 any case, beginning 30 days after such effective 

19 date, a manufacturer shall not introduce into the do20 mestic commerce of the United States any product, 

21 irrespective of the date of manufacture, that is not 

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

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

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

25 dependence, including smoking cessation, is not a modified 


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1 risk tobacco product under this section if it has been ap2 proved as a drug or device by the Food and Drug Adminis3 tration and is subject to the requirements of chapter V. 

4 ‘‘(d) FILING.—Any person may file with the Sec5 retary an application for a modified risk tobacco product. 

6 Such application shall include— 

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

8 any proposed advertising and labeling; 

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

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

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

12 ‘‘(5) all documents (including underlying sci13 entific information) relating to research findings 

14 conducted, supported, or possessed by the tobacco 

15 product manufacturer relating to the effect of the 

16 product on tobacco-related diseases and health-re17 lated conditions, including information both favor18 able and unfavorable to the ability of the product to 

19 reduce risk or exposure and relating to human 

20 health; 

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

22 actually use the tobacco product; and 

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

24 may require. 


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

2 make the application described in subsection (d) publicly 

3 available (except matters in the application which are 

4 trade secrets or otherwise confidential, commercial infor5 mation) and shall request comments by interested persons 

6 on the information contained in the application and on the 

7 label, labeling, and advertising accompanying such appli8 cation. 

9 ‘‘(f) ADVISORY COMMITTEE.— 

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

11 the Tobacco Products Scientific Advisory Committee 

12 any application submitted under this section. 

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

14 days after the date an application is referred to the 

15 Tobacco Products Scientific Advisory Committee 

16 under paragraph (1), the Advisory Committee shall 

17 report its recommendations on the application to the 

18 Secretary. 

19 ‘‘(g) MARKETING.— 

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

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

22 respect to an application submitted under this sec23 tion, issue an order that a modified risk product 

24 may be commercially marketed only if the Secretary 

25 determines that the applicant has demonstrated that 


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

2 will— 

3 ‘‘(A) significantly reduce harm and the 

4 risk of tobacco-related disease to individual to5 bacco users; and 

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

7 as a whole taking into account both users of to8 bacco products and persons who do not cur9 rently use tobacco products. 

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

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

12 issue an order that a tobacco product may be 

13 introduced or delivered for introduction into 

14 interstate commerce, pursuant to an application 

15 under this section, with respect to a tobacco 

16 product that may not be commercially marketed 

17 under paragraph (1) if the Secretary makes the 

18 findings required under this paragraph and de19 termines that the applicant has demonstrated 

20 that— 

21 ‘‘(i) such order would be appropriate 

22 to promote the public health; 

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

24 and advertising for such product that 

25 would cause the tobacco product to be a 


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1 modified risk tobacco product under sub2 section (b) is limited to an explicit or im3 plicit representation that such tobacco 

4 product or its smoke does not contain or is 

5 free of a substance or contains a reduced 

6 level of a substance, or presents a reduced 

7 exposure to a substance in tobacco smoke; 

8 ‘‘(iii) scientific evidence is not avail9 able and, using the best available scientific 

10 methods, cannot be made available without 

11 conducting long-term epidemiological stud12 ies for an application to meet the stand13 ards set forth in paragraph (1); and 

14 ‘‘(iv) the scientific evidence that is 

15 available without conducting long-term epi16 demiological studies demonstrates that a 

17 measurable and substantial reduction in 

18 morbidity or mortality among individual 

19 tobacco users is reasonably likely in subse20 quent studies. 

21 ‘‘(B) ADDITIONAL FINDINGS REQUIRED.— 

22 To issue an order under subparagraph (A) the 

23 Secretary must also find that the applicant has 

24 demonstrated that— 


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1 ‘‘(i) the magnitude of the overall re2 ductions in exposure to the substance or 

3 substances which are the subject of the ap4 plication is substantial, such substance or 

5 substances are harmful, and the product as 

6 actually used exposes consumers to the 

7 specified reduced level of the substance or 

8 substances; 

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

10 consumers will not expose them to higher 

11 levels of other harmful substances com12 pared to the similar types of tobacco prod13 ucts then on the market unless such in14 creases are minimal and the reasonably 

15 likely overall impact of use of the product 

16 remains a substantial and measurable re17 duction in overall morbidity and mortality 

18 among individual tobacco users; 

19 ‘‘(iii) testing of actual consumer per20 ception shows that, as the applicant pro21 poses to label and market the product, con22 sumers will not be misled into believing 

23 that the product— 

24 ‘‘(I) is or has been demonstrated 

25 to be less harmful; or 


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1 ‘‘(II) presents or has been dem2 onstrated to present less of a risk of 

3 disease than 1 or more other commer4 cially marketed tobacco products; and 

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

6 to the application is expected to benefit the 

7 health of the population as a whole taking 

8 into account both users of tobacco prod9 ucts and persons who do not currently use 

10 tobacco products. 

11 ‘‘(C) CONDITIONS OF MARKETING.— 

12 ‘‘(i) IN GENERAL.—Applications sub13 ject to an order under this paragraph shall 

14 be limited to a term of not more than 5 

15 years, but may be renewed upon a finding 

16 by the Secretary that the requirements of 

17 this paragraph continue to be satisfied 

18 based on the filing of a new application. 

19 ‘‘(ii) AGREEMENTS BY APPLICANT.— 

20 An order under this paragraph shall be 

21 conditioned on the applicant’s agreement 

22 to conduct postmarket surveillance and 

23 studies and to submit to the Secretary the 

24 results of such surveillance and studies to 

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1 sumer perception, behavior, and health and 

2 to enable the Secretary to review the accu3 racy of the determinations upon which the 

4 order was based in accordance with a pro5 tocol approved by the Secretary. 

6 ‘‘(iii) ANNUAL SUBMISSION.—The re7 sults of such postmarket surveillance and 

8 studies described in clause (ii) shall be 

9 submitted annually. 

10 ‘‘(3) BASIS.—The determinations under para11 graphs (1) and (2) shall be based on— 

12 ‘‘(A) the scientific evidence submitted by 

13 the applicant; and 

14 ‘‘(B) scientific evidence and other informa15 tion that is made available to the Secretary. 

16 ‘‘(4) BENEFIT TO HEALTH OF INDIVIDUALS

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

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

19 Secretary shall take into account— 

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

21 of the tobacco product that is the subject of the 

22 application; 

23 ‘‘(B) the increased or decreased likelihood 

24 that existing users of tobacco products who 

25 would otherwise stop using such products will 


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1 switch to the tobacco product that is the subject 

2 of the application; 

3 ‘‘(C) the increased or decreased likelihood 

4 that persons who do not use tobacco products 

5 will start using the tobacco product that is the 

6 subject of the application; 

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

8 from the use of the tobacco product that is the 

9 subject of the application as compared to the 

10 use of products for smoking cessation approved 

11 under chapter V to treat nicotine dependence; 

12 and 

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

14 submitted by interested persons. 

15 ‘‘(h) ADDITIONAL CONDITIONS FOR MARKETING.— 

16 ‘‘(1) MODIFIED RISK PRODUCTS.—The Sec17 retary shall require for the marketing of a product 

18 under this section that any advertising or labeling 

19 concerning modified risk products enable the public 

20 to comprehend the information concerning modified 

21 risk and to understand the relative significance of 

22 such information in the context of total health and 

23 in relation to all of the diseases and health-related 

24 conditions associated with the use of tobacco prod25 ucts. 


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1 ‘‘(2) COMPARATIVE CLAIMS.— 

2 ‘‘(A) IN GENERAL.—The Secretary may re3 quire for the marketing of a product under this 

4 subsection that a claim comparing a tobacco 

5 product to 1 or more other commercially mar6 keted tobacco products shall compare the to7 bacco product to a commercially marketed to8 bacco product that is representative of that type 

9 of tobacco product on the market (for example 

10 the average value of the top 3 brands of an es11 tablished regular tobacco product). 

12 ‘‘(B) QUANTITATIVE COMPARISONS.—The 

13 Secretary may also require, for purposes of sub14 paragraph (A), that the percent (or fraction) of 

15 change and identity of the reference tobacco 

16 product and a quantitative comparison of the 

17 amount of the substance claimed to be reduced 

18 shall be stated in immediate proximity to the 

19 most prominent claim. 

20 ‘‘(3) LABEL DISCLOSURE.— 

21 ‘‘(A) IN GENERAL.—The Secretary may re22 quire the disclosure on the label of other sub23 stances in the tobacco product, or substances 

24 that may be produced by the consumption of 

25 that tobacco product, that may affect a disease 


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1 or health-related condition or may increase the 

2 risk of other diseases or health-related condi3 tions associated with the use of tobacco prod4 ucts. 

5 ‘‘(B) CONDITIONS OF USE.—If the condi6 tions of use of the tobacco product may affect 

7 the risk of the product to human health, the 

8 Secretary may require the labeling of conditions 

9 of use. 

10 ‘‘(4) TIME.—An order issued under subsection 

11 (g)(1) shall be effective for a specified period of 

12 time. 

13 ‘‘(5) ADVERTISING.—The Secretary may re14 quire, with respect to a product for which an appli15 cant obtained an order under subsection (g)(1), that 

16 the product comply with requirements relating to ad17 vertising and promotion of the tobacco product. 

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

19 ‘‘(1) IN GENERAL.—The Secretary shall re20 quire, with respect to a product for which an appli21 cant obtained an order under subsection (g)(1), that 

22 the applicant conduct postmarket surveillance and 

23 studies for such a tobacco product to determine the 

24 impact of the order issuance on consumer percep25 tion, behavior, and health, to enable the Secretary to 


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1 review the accuracy of the determinations upon 

2 which the order was based, and to provide informa3 tion that the Secretary determines is otherwise nec4 essary regarding the use or health risks involving 

5 the tobacco product. The results of postmarket sur6 veillance and studies shall be submitted to the Sec7 retary on an annual basis. 

8 ‘‘(2) SURVEILLANCE PROTOCOL.—Each appli9 cant required to conduct a surveillance of a tobacco 

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

11 after receiving notice that the applicant is required 

12 to conduct such surveillance, submit, for the ap13 proval of the Secretary, a protocol for the required 

14 surveillance. The Secretary, within 60 days of the 

15 receipt of such protocol, shall determine if the prin16 cipal investigator proposed to be used in the surveil17 lance has sufficient qualifications and experience to 

18 conduct such surveillance and if such protocol will 

19 result in collection of the data or other information 

20 designated by the Secretary as necessary to protect 

21 the public health. 

22 ‘‘(j) WITHDRAWAL OF AUTHORIZATION.—The Sec23 retary, after an opportunity for an informal hearing, shall 

24 withdraw an order under subsection (g) if the Secretary 

25 determines that— 


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

2 can no longer make the demonstrations required 

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

4 make the determinations required under subsection 

5 (g); 

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

7 information or included any untrue statement of ma8 terial fact; 

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

10 the product reduces risk or exposure is no longer 

11 valid, including if— 

12 ‘‘(A) a tobacco product standard is estab13 lished pursuant to section 907; 

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

15 risks presented by other commercially marketed 

16 tobacco products that were compared to the 

17 product that is the subject of the application; or 

18 ‘‘(C) any postmarket surveillance or stud19 ies reveal that the order is no longer consistent 

20 with the protection of the public health; 

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

22 the postmarket surveillance and studies required 

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

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

25 imposed under subsection (h). 


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1 ‘‘(k) CHAPTER IV OR V.—A product for which the 

2 Secretary has issued an order pursuant to subsection (g) 

3 shall not be subject to chapter IV or V. 

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

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

6 years after the date of enactment of the Family 

7 Smoking Prevention and Tobacco Control Act, the 

8 Secretary shall issue regulations or guidance (or any 

9 combination thereof) on the scientific evidence re10 quired for assessment and ongoing review of modi11 fied risk tobacco products. Such regulations or guid12 ance shall— 

13 ‘‘(A) to the extent that adequate scientific 

14 evidence exists, establish minimum standards 

15 for scientific studies needed prior to issuing an 

16 order under subsection (g) to show that a sub17 stantial reduction in morbidity or mortality 

18 among individual tobacco users occurs for prod19 ucts described in subsection (g)(1) or is reason20 ably likely for products described in subsection 

21 (g)(2); 

22 ‘‘(B) include validated biomarkers, inter23 mediate clinical endpoints, and other feasible 

24 outcome measures, as appropriate; 


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1 ‘‘(C) establish minimum standards for 

2 postmarket studies, that shall include regular 

3 and long-term assessments of health outcomes 

4 and mortality, intermediate clinical endpoints, 

5 consumer perception of harm reduction, and the 

6 impact on quitting behavior and new use of to7 bacco products, as appropriate; 

8 ‘‘(D) establish minimum standards for re9 quired postmarket surveillance, including ongo10 ing assessments of consumer perception; 

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

12 studies and surveillance be made available to 

13 the Secretary prior to the decision on renewal 

14 of a modified risk tobacco product; and 

15 ‘‘(F) establish a reasonable timetable for 

16 the Secretary to review an application under 

17 this section. 

18 ‘‘(2) CONSULTATION.—The regulations or guid19 ance issued under paragraph (1) shall be developed 

20 in consultation with the Institute of Medicine, and 

21 with the input of other appropriate scientific and 

22 medical experts, on the design and conduct of such 

23 studies and surveillance. 

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

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


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1 basis as new scientific information becomes avail2 able. 

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

4 than 2 years after the date of enactment of the 

5 Family Smoking Prevention and Tobacco Control 

6 Act, the Secretary shall issue a regulation or guid7 ance that permits the filing of a single application 

8 for any tobacco product that is a new tobacco prod9 uct under section 910 and which the applicant seeks 

10 to commercially market under this section. 

11 ‘‘(m) DISTRIBUTORS.—Except as provided in this 

12 section, no distributor may take any action, after the date 

13 of enactment of the Family Smoking Prevention and To14 bacco Control Act, with respect to a tobacco product that 

15 would reasonably be expected to result in consumers be16 lieving that the tobacco product or its smoke may present 

17 a lower risk of disease or is less harmful than one or more 

18 commercially marketed tobacco products, or presents a re19 duced exposure to, or does not contain or is free of, a sub20 stance or substances. 

21 ‘‘SEC. 912. JUDICIAL REVIEW. 

22 ‘‘(a) RIGHT TO REVIEW.— 

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

24 after— 


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1 ‘‘(A) the promulgation of a regulation 

2 under section 907 establishing, amending, or 

3 revoking a tobacco product standard; or 

4 ‘‘(B) a denial of an application under sec5 tion 910(c), 

6 any person adversely affected by such regulation or 

7 denial may file a petition for judicial review of such 

8 regulation or denial with the United States Court of 

9 Appeals for the District of Columbia or for the cir10 cuit in which such person resides or has their prin11 cipal place of business. 

12 ‘‘(2) REQUIREMENTS.— 

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

14 petition filed under paragraph (1) shall be 

15 transmitted by the clerk of the court involved to 

16 the Secretary. 

17 ‘‘(B) RECORD OF PROCEEDINGS.—On re18 ceipt of a petition under subparagraph (A), the 

19 Secretary shall file in the court in which such 

20 petition was filed— 

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

22 which the regulation or order was based; 

23 and 

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

25 the issuance of such a regulation or order. 


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

2 section, the term ‘record’ means— 

3 ‘‘(i) all notices and other matter pub4 lished in the Federal Register with respect 

5 to the regulation or order reviewed; 

6 ‘‘(ii) all information submitted to the 

7 Secretary with respect to such regulation 

8 or order; 

9 ‘‘(iii) proceedings of any panel or ad10 visory committee with respect to such reg11 ulation or order; 

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

13 such regulation or order; and 

14 ‘‘(v) any other information identified 

15 by the Secretary, in the administrative pro16 ceeding held with respect to such regula17 tion or order, as being relevant to such 

18 regulation or order. 

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

20 petition under subsection (a) for judicial review of a regu21 lation or order, the court shall have jurisdiction to review 

22 the regulation or order in accordance with chapter 7 of 

23 title 5, United States Code, and to grant appropriate re24 lief, including interim relief, as provided for in such chap25 ter. A regulation or denial described in subsection (a) shall 


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

2 5, United States Code. 

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

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

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

6 Supreme Court of the United States upon certiorari or 

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

8 United States Code. 

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

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

11 any other remedies provided by law. 

12 ‘‘(e) REGULATIONS AND ORDERS MUST RECITE

13 BASIS IN RECORD.—To facilitate judicial review, a regula14 tion or order issued under section 906, 907, 908, 909, 

15 910, or 916 shall contain a statement of the reasons for 

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

17 the proceedings held in connection with its issuance. 

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

19 ‘‘The Secretary shall issue regulations to require that 

20 retail establishments for which the predominant business 

21 is the sale of tobacco products comply with any advertising 

22 restrictions applicable to retail establishments accessible 

23 to individuals under the age of 18. 


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1 ‘‘SEC. 914. JURISDICTION OF AND COORDINATION WITH 

2 THE FEDERAL TRADE COMMISSION. 

3 ‘‘(a) JURISDICTION.— 

4 ‘‘(1) IN GENERAL.—Except where expressly 

5 provided in this chapter, nothing in this chapter 

6 shall be construed as limiting or diminishing the au7 thority of the Federal Trade Commission to enforce 

8 the laws under its jurisdiction with respect to the 

9 advertising, sale, or distribution of tobacco products. 

10 ‘‘(2) ENFORCEMENT.—Any advertising that vio11 lates this chapter or a provision of the regulations 

12 referred to in section 102 of the Family Smoking 

13 Prevention and Tobacco Control Act, is an unfair or 

14 deceptive act or practice under section 5(a) of the 

15 Federal Trade Commission Act and shall be consid16 ered a violation of a rule promulgated under section 

17 18 of that Act. 

18 ‘‘(b) COORDINATION.—With respect to the require19 ments of section 4 of the Federal Cigarette Labeling and 

20 Advertising Act and section 3 of the Comprehensive 

21 Smokeless Tobacco Health Education Act of 1986— 

22 ‘‘(1) the Chairman of the Federal Trade Com23 mission shall coordinate with the Secretary con24 cerning the enforcement of such Act as such enforce25 ment relates to unfair or deceptive acts or practices 


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1 in the advertising of cigarettes or smokeless tobacco; 

2 and 

3 ‘‘(2) the Secretary shall consult with the Chair4 man of such Commission in revising the label state5 ments and requirements under such sections. 

6 ‘‘SEC. 915. REGULATION REQUIREMENT. 

7 ‘‘(a) TESTING, REPORTING, AND DISCLOSURE.—Not 

8 later than 36 months after the date of enactment of the 

9 Family Smoking Prevention and Tobacco Control Act, the 

10 Secretary shall promulgate regulations under this Act that 

11 meet the requirements of subsection (b). 

12 ‘‘(b) CONTENTS OF RULES.—The regulations pro13 mulgated under subsection (a)— 

14 ‘‘(1) shall require testing and reporting of to15 bacco product constituents, ingredients, and addi16 tives, including smoke constituents, by brand and 

17 subbrand that the Secretary determines should be 

18 tested to protect the public health, provided that, for 

19 purposes of the testing requirements of this para20 graph, tobacco products manufactured and sold by a 

21 single tobacco product manufacturer that are iden22 tical in all respects except the labels, packaging de23 sign, logo, trade dress, trademark, brand name, or 

24 any combination thereof, shall be considered as a 

25 single brand; and 


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1 ‘‘(2) may require that tobacco product manu2 facturers, packagers, or importers make disclosures 

3 relating to the results of the testing of tar and nico4 tine through labels or advertising or other appro5 priate means, and make disclosures regarding the 

6 results of the testing of other constituents, including 

7 smoke constituents, ingredients, or additives, that 

8 the Secretary determines should be disclosed to the 

9 public to protect the public health and will not mis10 lead consumers about the risk of tobacco-related dis11 ease. 

12 ‘‘(c) AUTHORITY.—The Secretary shall have the au13 thority under this chapter to conduct or to require the 

14 testing, reporting, or disclosure of tobacco product con15 stituents, including smoke constituents. 

16 ‘‘(d) SMALL TOBACCO PRODUCT MANUFACTUR17 ERS.— 

18 ‘‘(1) FIRST COMPLIANCE DATE.—The initial 

19 regulations promulgated under subsection (a) shall 

20 not impose requirements on small tobacco product 

21 manufacturers before the later of— 

22 ‘‘(A) the end of the 2-year period following 

23 the final promulgation of such regulations; and 

24 ‘‘(B) the initial date set by the Secretary 

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1 facturers that are not small tobacco product 

2 manufacturers. 

3 ‘‘(2) TESTING AND REPORTING INITIAL COM4 PLIANCE PERIOD.— 

5 ‘‘(A) 4-YEAR PERIOD.—The initial regula6 tions promulgated under subsection (a) shall 

7 give each small tobacco product manufacturer a 

8 4-year period over which to conduct testing and 

9 reporting for all of its tobacco products. Subject 

10 to paragraph (1), the end of the first year of 

11 such 4-year period shall coincide with the initial 

12 date of compliance under this section set by the 

13 Secretary with respect to manufacturers that 

14 are not small tobacco product manufacturers or 

15 the end of the 2-year period following the final 

16 promulgation of such regulations, as described 

17 in paragraph (1)(A). A small tobacco product 

18 manufacturer shall be required— 

19 ‘‘(i) to conduct such testing and re20 porting for 25 percent of its tobacco prod21 ucts during each year of such 4-year pe22 riod; and 

23 ‘‘(ii) to conduct such testing and re24 porting for its largest-selling tobacco prod25 ucts (as determined by the Secretary) beVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00121 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 fore its other tobacco products, or in such 

2 other order of priority as determined by 

3 the Secretary. 

4 ‘‘(B) CASE-BY-CASE DELAY.—Notwith5 standing subparagraph (A), the Secretary may, 

6 on a case-by-case basis, delay the date by which 

7 an individual small tobacco product manufac8 turer must conduct testing and reporting for its 

9 tobacco products under this section based upon 

10 a showing of undue hardship to such manufac11 turer. Notwithstanding the preceding sentence, 

12 the Secretary shall not extend the deadline for 

13 a small tobacco product manufacturer to con14 duct testing and reporting for all of its tobacco 

15 products beyond a total of 5 years after the ini16 tial date of compliance under this section set by 

17 the Secretary with respect to manufacturers 

18 that are not small tobacco product manufactur19 ers. 

20 ‘‘(3) SUBSEQUENT AND ADDITIONAL TESTING

21 AND REPORTING.—The regulations promulgated 

22 under subsection (a) shall provide that, with respect 

23 to any subsequent or additional testing and report24 ing of tobacco products required under this section, 

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1 uct manufacturer shall be conducted in accordance 

2 with the timeframes described in paragraph (2)(A), 

3 except that, in the case of a new product, or if there 

4 has been a modification described in section 

5 910(a)(1)(B) of any product of a small tobacco 

6 product manufacturer since the last testing and re7 porting required under this section, the Secretary 

8 shall require that any subsequent or additional test9 ing and reporting be conducted in accordance with 

10 the same timeframe applicable to manufacturers 

11 that are not small tobacco product manufacturers. 

12 ‘‘(4) JOINT LABORATORY TESTING SERVICES.— 

13 The Secretary shall allow any 2 or more small to14 bacco product manufacturers to join together to pur15 chase laboratory testing services required by this 

16 section on a group basis in order to ensure that such 

17 manufacturers receive access to, and fair pricing of, 

18 such testing services. 

19 ‘‘(e) EXTENSIONS FOR LIMITED LABORATORY CA20 PACITY.— 

21 ‘‘(1) IN GENERAL.—The regulations promul22 gated under subsection (a) shall provide that a small 

23 tobacco product manufacturer shall not be consid24 ered to be in violation of this section before the 


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1 deadline applicable under paragraphs (3) and (4), 

2 if— 

3 ‘‘(A) the tobacco products of such manu4 facturer are in compliance with all other re5 quirements of this chapter; and 

6 ‘‘(B) the conditions described in paragraph 

7 (2) are met. 

8 ‘‘(2) CONDITIONS.—Notwithstanding the re9 quirements of this section, the Secretary may delay 

10 the date by which a small tobacco product manufac11 turer must be in compliance with the testing and re12 porting required by this section until such time as 

13 the testing is reported if, not later than 90 days be14 fore the deadline for reporting in accordance with 

15 this section, a small tobacco product manufacturer 

16 provides evidence to the Secretary demonstrating 

17 that— 

18 ‘‘(A) the manufacturer has submitted the 

19 required products for testing to a laboratory 

20 and has done so sufficiently in advance of the 

21 deadline to create a reasonable expectation of 

22 completion by the deadline; 

23 ‘‘(B) the products currently are awaiting 

24 testing by the laboratory; and 


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1 ‘‘(C) neither that laboratory nor any other 

2 laboratory is able to complete testing by the 

3 deadline at customary, nonexpedited testing 

4 fees. 

5 ‘‘(3) EXTENSION.—The Secretary, taking into 

6 account the laboratory testing capacity that is avail7 able to tobacco product manufacturers, shall review 

8 and verify the evidence submitted by a small tobacco 

9 product manufacturer in accordance with paragraph 

10 (2). If the Secretary finds that the conditions de11 scribed in such paragraph are met, the Secretary 

12 shall notify the small tobacco product manufacturer 

13 that the manufacturer shall not be considered to be 

14 in violation of the testing and reporting require15 ments of this section until the testing is reported or 

16 until 1 year after the reporting deadline has passed, 

17 whichever occurs sooner. If, however, the Secretary 

18 has not made a finding before the reporting dead19 line, the manufacturer shall not be considered to be 

20 in violation of such requirements until the Secretary 

21 finds that the conditions described in paragraph (2) 

22 have not been met, or until 1 year after the report23 ing deadline, whichever occurs sooner. 

24 ‘‘(4) ADDITIONAL EXTENSION.—In addition to 

25 the time that may be provided under paragraph (3), 


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1 the Secretary may provide further extensions of 

2 time, in increments of no more than 1 year, for re3 quired testing and reporting to occur if the Sec4 retary determines, based on evidence properly and 

5 timely submitted by a small tobacco product manu6 facturer in accordance with paragraph (2), that a 

7 lack of available laboratory capacity prevents the 

8 manufacturer from completing the required testing 

9 during the period described in paragraph (3). 

10 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in sub11 section (d) or (e) shall be construed to authorize the exten12 sion of any deadline, or to otherwise affect any timeframe, 

13 under any provision of this Act or the Family Smoking 

14 Prevention and Tobacco Control Act other than this sec15 tion. 

16 ‘‘SEC. 916. PRESERVATION OF STATE AND LOCAL AUTHOR17 ITY. 

18 ‘‘(a) IN GENERAL.— 

19 ‘‘(1) PRESERVATION.—Except as provided in 

20 paragraph (2)(A), nothing in this chapter, or rules 

21 promulgated under this chapter, shall be construed 

22 to limit the authority of a Federal agency (including 

23 the Armed Forces), a State or political subdivision 

24 of a State, or the government of an Indian tribe to 

25 enact, adopt, promulgate, and enforce any law, rule, 


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1 regulation, or other measure with respect to tobacco 

2 products that is in addition to, or more stringent 

3 than, requirements established under this chapter, 

4 including a law, rule, regulation, or other measure 

5 relating to or prohibiting the sale, distribution, pos6 session, exposure to, access to, advertising and pro7 motion of, or use of tobacco products by individuals 

8 of any age, information reporting to the State, or 

9 measures relating to fire safety standards for to10 bacco products. No provision of this chapter shall 

11 limit or otherwise affect any State, Tribal, or local 

12 taxation of tobacco products. 

13 ‘‘(2) PREEMPTION OF CERTAIN STATE AND

14 LOCAL REQUIREMENTS.— 

15 ‘‘(A) IN GENERAL.—No State or political 

16 subdivision of a State may establish or continue 

17 in effect with respect to a tobacco product any 

18 requirement which is different from, or in addi19 tion to, any requirement under the provisions of 

20 this chapter relating to tobacco product stand21 ards, premarket review, adulteration, mis22 branding, labeling, registration, good manufac23 turing standards, or modified risk tobacco prod24 ucts. 


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1 ‘‘(B) EXCEPTION.—Subparagraph (A) 

2 does not apply to requirements relating to the 

3 sale, distribution, possession, information re4 porting to the State, exposure to, access to, the 

5 advertising and promotion of, or use of, tobacco 

6 products by individuals of any age, or relating 

7 to fire safety standards for tobacco products. 

8 Information disclosed to a State under subpara9 graph (A) that is exempt from disclosure under 

10 section 552(b)(4) of title 5, United States Code, 

11 shall be treated as a trade secret and confiden12 tial information by the State. 

13 ‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT

14 LIABILITY.—No provision of this chapter relating to a to15 bacco product shall be construed to modify or otherwise 

16 affect any action or the liability of any person under the 

17 product liability law of any State. 

18 ‘‘SEC. 917. TOBACCO PRODUCTS SCIENTIFIC ADVISORY 

19 COMMITTEE. 

20 ‘‘(a) ESTABLISHMENT.—Not later than 6 months 

21 after the date of enactment of the Family Smoking Pre22 vention and Tobacco Control Act, the Secretary shall es23 tablish a 12-member advisory committee, to be known as 

24 the Tobacco Products Scientific Advisory Committee (in 

25 this section referred to as the ‘Advisory Committee’). 


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1 ‘‘(b) MEMBERSHIP.— 

2 ‘‘(1) IN GENERAL.— 

3 ‘‘(A) MEMBERS.—The Secretary shall ap4 point as members of the Tobacco Products Sci5 entific Advisory Committee individuals who are 

6 technically qualified by training and experience 

7 in medicine, medical ethics, science, or tech8 nology involving the manufacture, evaluation, or 

9 use of tobacco products, who are of appro10 priately diversified professional backgrounds. 

11 The committee shall be composed of— 

12 ‘‘(i) 7 individuals who are physicians, 

13 dentists, scientists, or health care profes14 sionals practicing in the area of oncology, 

15 pulmonology, cardiology, toxicology, phar16 macology, addiction, or any other relevant 

17 specialty; 

18 ‘‘(ii) 1 individual who is an officer or 

19 employee of a State or local government or 

20 of the Federal Government; 

21 ‘‘(iii) 1 individual as a representative 

22 of the general public; 

23 ‘‘(iv) 1 individual as a representative 

24 of the interests of the tobacco manufac25 turing industry; 


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1 ‘‘(v) 1 individual as a representative 

2 of the interests of the small business to3 bacco manufacturing industry, which posi4 tion may be filled on a rotating, sequential 

5 basis by representatives of different small 

6 business tobacco manufacturers based on 

7 areas of expertise relevant to the topics 

8 being considered by the Advisory Com9 mittee; and 

10 ‘‘(vi) 1 individual as a representative 

11 of the interests of the tobacco growers. 

12 ‘‘(B) NONVOTING MEMBERS.—The mem13 bers of the committee appointed under clauses 

14 (iv), (v), and (vi) of subparagraph (A) shall 

15 serve as consultants to those described in 

16 clauses (i) through (iii) of subparagraph (A) 

17 and shall be nonvoting representatives. 

18 ‘‘(C) CONFLICTS OF INTEREST.—No mem19 bers of the committee, other than members ap20 pointed pursuant to clauses (iv), (v), and (vi) of 

21 subparagraph (A) shall, during the member’s 

22 tenure on the committee or for the 18-month 

23 period prior to becoming such a member, re24 ceive any salary, grants, or other payments or 

25 support from any business that manufactures, 


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1 distributes, markets, or sells cigarettes or other 

2 tobacco products. 

3 ‘‘(2) LIMITATION.—The Secretary may not ap4 point to the Advisory Committee any individual who 

5 is in the regular full-time employ of the Food and 

6 Drug Administration or any agency responsible for 

7 the enforcement of this Act. The Secretary may ap8 point Federal officials as ex officio members. 

9 ‘‘(3) CHAIRPERSON.—The Secretary shall des10 ignate 1 of the members appointed under clauses (i), 

11 (ii), and (iii) of paragraph (1)(A) to serve as chair12 person. 

13 ‘‘(c) DUTIES.—The Tobacco Products Scientific Ad14 visory Committee shall provide advice, information, and 

15 recommendations to the Secretary— 

16 ‘‘(1) as provided in this chapter; 

17 ‘‘(2) on the effects of the alteration of the nico18 tine yields from tobacco products; 

19 ‘‘(3) on whether there is a threshold level below 

20 which nicotine yields do not produce dependence on 

21 the tobacco product involved; and 

22 ‘‘(4) on its review of other safety, dependence, 

23 or health issues relating to tobacco products as re24 quested by the Secretary. 

25 ‘‘(d) COMPENSATION; SUPPORT; FACA.— 


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1 ‘‘(1) COMPENSATION AND TRAVEL.—Members 

2 of the Advisory Committee who are not officers or 

3 employees of the United States, while attending con4 ferences or meetings of the committee or otherwise 

5 engaged in its business, shall be entitled to receive 

6 compensation at rates to be fixed by the Secretary, 

7 which may not exceed the daily equivalent of the 

8 rate in effect under the Senior Executive Schedule 

9 under section 5382 of title 5, United States Code, 

10 for each day (including travel time) they are so en11 gaged; and while so serving away from their homes 

12 or regular places of business each member may be 

13 allowed travel expenses, including per diem in lieu of 

14 subsistence, as authorized by section 5703 of title 5, 

15 United States Code, for persons in the Government 

16 service employed intermittently. 

17 ‘‘(2) ADMINISTRATIVE SUPPORT.—The Sec18 retary shall furnish the Advisory Committee clerical 

19 and other assistance. 

20 ‘‘(3) NONAPPLICATION OF FACA.—Section 14 of 

21 the Federal Advisory Committee Act does not apply 

22 to the Advisory Committee. 

23 ‘‘(e) PROCEEDINGS OF ADVISORY PANELS AND COM24 MITTEES.—The Advisory Committee shall make and 

25 maintain a transcript of any proceeding of the panel or 


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1 committee. Each such panel and committee shall delete 

2 from any transcript made under this subsection informa3 tion which is exempt from disclosure under section 552(b) 

4 of title 5, United States Code. 

5 ‘‘SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DE6 PENDENCE. 

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

8 ‘‘(1) at the request of the applicant, consider 

9 designating products for smoking cessation, includ10 ing nicotine replacement products as fast track re11 search and approval products within the meaning of 

12 section 506; 

13 ‘‘(2) consider approving the extended use of nic14 otine replacement products (such as nicotine patch15 es, nicotine gum, and nicotine lozenges) for the 

16 treatment of tobacco dependence; and 

17 ‘‘(3) review and consider the evidence for addi18 tional indications for nicotine replacement products, 

19 such as for craving relief or relapse prevention. 

20 ‘‘(b) REPORT ON INNOVATIVE PRODUCTS.— 

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

22 after the date of enactment of the Family Smoking 

23 Prevention and Tobacco Control Act, the Secretary, 

24 after consultation with recognized scientific, medical, 

25 and public health experts (including both Federal 


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1 agencies and nongovernmental entities, the Institute 

2 of Medicine of the National Academy of Sciences, 

3 and the Society for Research on Nicotine and To4 bacco), shall submit to the Congress a report that 

5 examines how best to regulate, promote, and encour6 age the development of innovative products and 

7 treatments (including nicotine-based and non-nico8 tine-based products and treatments) to better 

9 achieve, in a manner that best protects and pro10 motes the public health— 

11 ‘‘(A) total abstinence from tobacco use; 

12 ‘‘(B) reductions in consumption of tobacco; 

13 and 

14 ‘‘(C) reductions in the harm associated 

15 with continued tobacco use. 

16 ‘‘(2) RECOMMENDATIONS.—The report under 

17 paragraph (1) shall include the recommendations of 

18 the Secretary on how the Food and Drug Adminis19 tration should coordinate and facilitate the exchange 

20 of information on such innovative products and 

21 treatments among relevant offices and centers within 

22 the Administration and within the National Insti23 tutes of Health, the Centers for Disease Control and 

24 Prevention, and other relevant agencies. 


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1 ‘‘SEC. 919. USER FEES. 

2 ‘‘(a) ESTABLISHMENT OF QUARTERLY FEE.—Begin3 ning on the date of enactment of the Family Smoking Pre4 vention and Tobacco Control Act, the Secretary shall in 

5 accordance with this section assess user fees on, and col6 lect such fees from, each manufacturer and importer of 

7 tobacco products subject to this chapter. The fees shall 

8 be assessed and collected with respect to each quarter of 

9 each fiscal year, and the total amount assessed and col10 lected for a fiscal year shall be the amount specified in 

11 subsection (b)(1) for such year, subject to subsection (c). 

12 ‘‘(b) ASSESSMENT OF USER FEE.— 

13 ‘‘(1) AMOUNT OF ASSESSMENT.—The total 

14 amount of user fees authorized to be assessed and 

15 collected under subsection (a) for a fiscal year is the 

16 following, as applicable to the fiscal year involved: 

17 ‘‘(A) For fiscal year 2009, $85,000,000 

18 (subject to subsection (e)). 

19 ‘‘(B) For fiscal year 2010, $235,000,000. 

20 ‘‘(C) For fiscal year 2011, $450,000,000. 

21 ‘‘(D) For fiscal year 2012, $477,000,000. 

22 ‘‘(E) For fiscal year 2013, $505,000,000. 

23 ‘‘(F) For fiscal year 2014, $534,000,000. 

24 ‘‘(G) For fiscal year 2015, $566,000,000. 

25 ‘‘(H) For fiscal year 2016, $599,000,000. 

26 ‘‘(I) For fiscal year 2017, $635,000,000. 


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1 ‘‘(J) For fiscal year 2018, $672,000,000. 

2 ‘‘(K) For fiscal year 2019 and each subse3 quent fiscal year, $712,000,000. 

4 ‘‘(2) ALLOCATIONS OF ASSESSMENT BY CLASS

5 OF TOBACCO PRODUCTS.— 

6 ‘‘(A) IN GENERAL.—The total user fees as7 sessed and collected under subsection (a) each 

8 fiscal year with respect to each class of tobacco 

9 products shall be an amount that is equal to 

10 the applicable percentage of each class for the 

11 fiscal year multiplied by the amount specified in 

12 paragraph (1) for the fiscal year. 

13 ‘‘(B) APPLICABLE PERCENTAGE.— 

14 ‘‘(i) IN GENERAL.—For purposes of 

15 subparagraph (A), the applicable percent16 age for a fiscal year for each of the fol17 lowing classes of tobacco products shall be 

18 determined in accordance with clause (ii): 

19 ‘‘(I) Cigarettes. 

20 ‘‘(II) Cigars, including small ci21 gars and cigars other than small ci22 gars. 

23 ‘‘(III) Snuff. 

24 ‘‘(IV) Chewing tobacco. 

25 ‘‘(V) Pipe tobacco. 


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1 ‘‘(VI) Roll-your-own tobacco. 

2 ‘‘(ii) ALLOCATIONS.—The applicable 

3 percentage of each class of tobacco product 

4 described in clause (i) for a fiscal year 

5 shall be the percentage determined under 

6 section 625(c) of Public Law 108–357 for 

7 each such class of product for such fiscal 

8 year. 

9 ‘‘(iii) REQUIREMENT OF REGULA10 TIONS.—Notwithstanding clause (ii), no 

11 user fees shall be assessed on a class of to12 bacco products unless such class of tobacco 

13 products is listed in section 901(b) or is 

14 deemed by the Secretary in a regulation 

15 under section 901(b) to be subject to this 

16 chapter. 

17 ‘‘(iv) REALLOCATIONS.—In the case 

18 of a class of tobacco products that is not 

19 listed in section 901(b) or deemed by the 

20 Secretary in a regulation under section 

21 901(b) to be subject to this chapter, the 

22 amount of user fees that would otherwise 

23 be assessed to such class of tobacco prod24 ucts shall be reallocated to the classes of 

25 tobacco products that are subject to this 


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1 chapter in the same manner and based on 

2 the same relative percentages otherwise de3 termined under clause (ii). 

4 ‘‘(3) DETERMINATION OF USER FEE BY COM5 PANY.— 

6 ‘‘(A) IN GENERAL.—The total user fee to 

7 be paid by each manufacturer or importer of a 

8 particular class of tobacco products shall be de9 termined for each quarter by multiplying— 

10 ‘‘(i) such manufacturer’s or importer’s 

11 percentage share as determined under 

12 paragraph (4); by 

13 ‘‘(ii) the portion of the user fee 

14 amount for the current quarter to be as15 sessed on all manufacturers and importers 

16 of such class of tobacco products as deter17 mined under paragraph (2). 

18 ‘‘(B) NO FEE IN EXCESS OF PERCENTAGE

19 SHARE.—No manufacturer or importer of to20 bacco products shall be required to pay a user 

21 fee in excess of the percentage share of such 

22 manufacturer or importer. 

23 ‘‘(4) ALLOCATION OF ASSESSMENT WITHIN

24 EACH CLASS OF TOBACCO PRODUCT.—The percent25 age share of each manufacturer or importer of a 


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1 particular class of tobacco products of the total user 

2 fee to be paid by all manufacturers or importers of 

3 that class of tobacco products shall be the percent4 age determined for purposes of allocations under 

5 subsections (e) through (h) of section 625 of Public 

6 Law 108–357. 

7 ‘‘(5) ALLOCATION FOR CIGARS.—Notwith8 standing paragraph (4), if a user fee assessment is 

9 imposed on cigars, the percentage share of each 

10 manufacturer or importer of cigars shall be based on 

11 the excise taxes paid by such manufacturer or im12 porter during the prior fiscal year. 

13 ‘‘(6) TIMING OF ASSESSMENT.—The Secretary 

14 shall notify each manufacturer and importer of to15 bacco products subject to this section of the amount 

16 of the quarterly assessment imposed on such manu17 facturer or importer under this subsection for each 

18 quarter of each fiscal year. Such notifications shall 

19 occur not later than 30 days prior to the end of the 

20 quarter for which such assessment is made, and pay21 ments of all assessments shall be made by the last 

22 day of the quarter involved. 

23 ‘‘(7) MEMORANDUM OF UNDERSTANDING.— 

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

25 request the appropriate Federal agency to enter 


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1 into a memorandum of understanding that pro2 vides for the regular and timely transfer from 

3 the head of such agency to the Secretary of the 

4 information described in paragraphs (2)(B)(ii) 

5 and (4) and all necessary information regarding 

6 all tobacco product manufacturers and import7 ers required to pay user fees. The Secretary 

8 shall maintain all disclosure restrictions estab9 lished by the head of such agency regarding the 

10 information provided under the memorandum of 

11 understanding. 

12 ‘‘(B) ASSURANCES.—Beginning not later 

13 than fiscal year 2015, and for each subsequent 

14 fiscal year, the Secretary shall ensure that the 

15 Food and Drug Administration is able to deter16 mine the applicable percentages described in 

17 paragraph (2) and the percentage shares de18 scribed in paragraph (4). The Secretary may 

19 carry out this subparagraph by entering into a 

20 contract with the head of the Federal agency 

21 referred to in subparagraph (A) to continue to 

22 provide the necessary information. 

23 ‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 

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1 tion only to the extent and in the amount provided 

2 in advance in appropriations Acts. Such fees are au3 thorized to remain available until expended. Such 

4 sums as may be necessary may be transferred from 

5 the Food and Drug Administration salaries and ex6 penses appropriation account without fiscal year lim7 itation to such appropriation account for salaries 

8 and expenses with such fiscal year limitation. 

9 ‘‘(2) AVAILABILITY.— 

10 ‘‘(A) IN GENERAL.—Fees appropriated 

11 under paragraph (3) are available only for the 

12 purpose of paying the costs of the activities of 

13 the Food and Drug Administration related to 

14 the regulation of tobacco products under this 

15 chapter and the Family Smoking Prevention 

16 and Tobacco Control Act. No fees collected 

17 under subsection (a) may be used for any other 

18 costs. 

19 ‘‘(B) PROHIBITION AGAINST USE OF

20 OTHER FUNDS.— 

21 ‘‘(i) IN GENERAL.—Except as pro22 vided in clause (ii), fees collected under 

23 subsection (a) are the only funds author24 ized to be made available for the purpose 

25 described in subparagraph (A). 


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1 ‘‘(ii) STARTUP COSTS.—Clause (i) 

2 does not apply until the date on which the 

3 Secretary has collected fees under sub4 section (a) for 2 fiscal year quarters. Until 

5 such date, other amounts available to the 

6 Food and Drug Administration (excluding 

7 fees collected under subsection (a)) are au8 thorized to be made available to pay the 

9 costs described in subparagraph (A), pro10 vided that such amounts are reimbursed 

11 through fees collected under subsection (a). 

12 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

13 For fiscal year 2009 and each subsequent fiscal 

14 year, there is authorized to be appropriated for fees 

15 under this section an amount equal to the amount 

16 specified in subsection (b)(1) for the fiscal year. 

17 ‘‘(d) COLLECTION OF UNPAID FEES.—In any case 

18 where the Secretary does not receive payment of a fee as19 sessed under subsection (a) within 30 days after it is due, 

20 such fee shall be treated as a claim of the United States 

21 Government subject to subchapter II of chapter 37 of title 

22 31, United States Code. 

23 ‘‘(e) APPLICABILITY TO FISCAL YEAR 2009.—If the 

24 date of enactment of the Family Smoking Prevention and 


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1 Tobacco Control Act occurs during fiscal year 2009, the 

2 following applies, subject to subsection (c): 

3 ‘‘(1) The Secretary shall determine the fees 

4 that would apply for a single quarter of such fiscal 

5 year according to the application of subsection (b) to 

6 the amount specified in paragraph (1)(A) of such 

7 subsection (referred to in this subsection as the 

8 ‘quarterly fee amounts’). 

9 ‘‘(2) For the quarter in which such date of en10 actment occurs, the amount of fees assessed shall be 

11 a pro rata amount, determined according to the 

12 number of days remaining in the quarter (including 

13 such date of enactment) and according to the daily 

14 equivalent of the quarterly fee amounts. Fees as15 sessed under the preceding sentence shall not be col16 lected until the next quarter. 

17 ‘‘(3) For the quarter following the quarter to 

18 which paragraph (2) applies, the full quarterly fee 

19 amounts shall be assessed and collected, in addition 

20 to collection of the pro rata fees assessed under 

21 paragraph (2).’’. 

22 SEC. 102. FINAL RULE. 

23 (a) CIGARETTES AND SMOKELESS TOBACCO.— 

24 (1) IN GENERAL.—On the first day of publica25 tion of the Federal Register that is 180 days or 


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1 more after the date of enactment of this Act, the 

2 Secretary of Health and Human Services shall pub3 lish in the Federal Register a final rule regarding 

4 cigarettes and smokeless tobacco, which— 

5 (A) is deemed to be issued under chapter 

6 9 of the Federal Food, Drug, and Cosmetic 

7 Act, as added by section 101 of this Act; and 

8 (B) shall be deemed to be in compliance 

9 with all applicable provisions of chapter 5 of 

10 title 5, United States Code, and all other provi11 sions of law relating to rulemaking procedures. 

12 (2) CONTENTS OF RULE.—Except as provided 

13 in this subsection, the final rule published under 

14 paragraph (1), shall be identical in its provisions to 

15 part 897 of the regulations promulgated by the Sec16 retary of Health and Human Services in the August 

17 28, 1996, issue of the Federal Register (61 Fed. 

18 Reg., 44615–44618). Such rule shall— 

19 (A) provide for the designation of jurisdic20 tional authority that is in accordance with this 

21 subsection in accordance with this Act and the 

22 amendments made by this Act; 

23 (B) strike Subpart C—Labels and section 

24 897.32(c); 


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1 (C) strike paragraphs (a), (b), and (i) of 

2 section 897.3 and insert definitions of the terms 

3 ‘‘cigarette’’, ‘‘cigarette tobacco,’’, and ‘‘smoke4 less tobacco’’ as defined in section 900 of the 

5 Federal Food, Drug, and Cosmetic Act; 

6 (D) insert ‘‘or roll-your-own paper’’ in sec7 tion 897.34(a) after ‘‘other than cigarettes or 

8 smokeless tobacco’’; 

9 (E) become effective on the date that is 1 

10 year after the date of enactment of this Act; 

11 and 

12 (F) amend paragraph (d) of section 897.16 

13 to read as follows: 

14 ‘‘(d)(1) Except as provided in subparagraph (2), no 

15 manufacturer, distributor, or retailer may distribute or 

16 cause to be distributed any free samples of cigarettes, 

17 smokeless tobacco, or other tobacco products (as such 

18 term is defined in section 201 of the Federal Food, Drug, 

19 and Cosmetic Act). 

20 ‘‘(2)(A) Subparagraph (1) does not prohibit a manu21 facturer, distributor, or retailer from distributing or caus22 ing to be distributed free samples of smokeless tobacco 

23 in a qualified adult-only facility. 

24 ‘‘(B) This subparagraph does not affect the authority 

25 of a State or local government to prohibit or otherwise 


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1 restrict the distribution of free samples of smokeless to2 bacco. 

3 ‘‘(C) For purposes of this paragraph, the term ‘quali4 fied adult-only facility’ means a facility or restricted area 

5 that— 

6 ‘‘(i) requires each person present to provide to 

7 a law enforcement officer (whether on or off duty) 

8 or to a security guard licensed by a governmental 

9 entity government-issued identification showing a 

10 photograph and at least the minimum age estab11 lished by applicable law for the purchase of smoke12 less tobacco; 

13 ‘‘(ii) does not sell, serve, or distribute alcohol; 

14 ‘‘(iii) is not located adjacent to or immediately 

15 across from (in any direction) a space that is used 

16 primarily for youth-oriented marketing, promotional, 

17 or other activities; 

18 ‘‘(iv) is a temporary structure constructed, des19 ignated, and operated as a distinct enclosed area for 

20 the purpose of distributing free samples of smokeless 

21 tobacco in accordance with this subparagraph; and 

22 ‘‘(v) is enclosed by a barrier that— 

23 ‘‘(I) is constructed of, or covered with, an 

24 opaque material (except for entrances and 

25 exits); 


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1 ‘‘(II) extends from no more than 12 inches 

2 above the ground or floor (which area at the 

3 bottom of the barrier must be covered with ma4 terial that restricts visibility but may allow air5 flow) to at least 8 feet above the ground or 

6 floor (or to the ceiling); and 

7 ‘‘(III) prevents persons outside the quali8 fied adult-only facility from seeing into the 

9 qualified adult-only facility, unless they make 

10 unreasonable efforts to do so; and 

11 ‘‘(vi) does not display on its exterior— 

12 ‘‘(I) any tobacco product advertising; 

13 ‘‘(II) a brand name other than in conjunc14 tion with words for an area or enclosure to 

15 identify an adult-only facility; or 

16 ‘‘(III) any combination of words that 

17 would imply to a reasonable observer that the 

18 manufacturer, distributor, or retailer has a 

19 sponsorship that would violate section 

20 897.34(c). 

21 ‘‘(D) Distribution of samples of smokeless tobacco 

22 under this subparagraph permitted to be taken out of the 

23 qualified adult-only facility shall be limited to 1 package 

24 per adult consumer containing no more than 0.53 ounces 

25 (15 grams) of smokeless tobacco. If such package of 


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1 smokeless tobacco contains individual portions of smoke2 less tobacco, the individual portions of smokeless tobacco 

3 shall not exceed 8 individual portions and the collective 

4 weight of such individual portions shall not exceed 0.53 

5 ounces (15 grams). Any manufacturer, distributor, or re6 tailer who distributes or causes to be distributed free sam7 ples also shall take reasonable steps to ensure that the 

8 above amounts are limited to one such package per adult 

9 consumer per day. 

10 ‘‘(3) Notwithstanding subparagraph (2), no manufac11 turer, distributor, or retailer may distribute or cause to 

12 be distributed any free samples of smokeless tobacco— 

13 ‘‘(A) to a sports team or entertainment group; 

14 or 

15 ‘‘(B) at any football, basketball, baseball, soc16 cer, or hockey event or any other sporting or enter17 tainment event determined by the Secretary to be 

18 covered by this subparagraph. 

19 ‘‘(4) The Secretary shall implement a program to en20 sure compliance with this paragraph and submit a report 

21 to the Congress on such compliance not later than 18 

22 months after the date of enactment of the Family Smok23 ing Prevention and Tobacco Control Act. 

24 ‘‘(5) Nothing in this paragraph shall be construed to 

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1 uted any sample of a tobacco product to any individual 

2 who has not attained the minimum age established by ap3 plicable law for the purchase of such product.’’. 

4 (3) AMENDMENTS TO RULE.—Prior to making 

5 amendments to the rule published under paragraph 

6 (1), the Secretary shall promulgate a proposed rule 

7 in accordance with chapter 5 of title 5, United 

8 States Code. 

9 (4) RULE OF CONSTRUCTION.—Except as pro10 vided in paragraph (3), nothing in this section shall 

11 be construed to limit the authority of the Secretary 

12 to amend, in accordance with chapter 5 of title 5, 

13 United States Code, the regulation promulgated pur14 suant to this section, including the provisions of 

15 such regulation relating to distribution of free sam16 ples. 

17 (5) ENFORCEMENT OF RETAIL SALE PROVI18 SIONS.—The Secretary of Health and Human Serv19 ices shall ensure that the provisions of this Act, the 

20 amendments made by this Act, and the imple21 menting regulations (including such provisions, 

22 amendments, and regulations relating to the retail 

23 sale of tobacco products) are enforced with respect 

24 to the United States and Indian tribes. 


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1 (6) QUALIFIED ADULT-ONLY FACILITY.—A 

2 qualified adult-only facility (as such term is defined 

3 in section 897.16(d) of the final rule published 

4 under paragraph (1)) that is also a retailer and that 

5 commits a violation as a retailer shall not be subject 

6 to the limitations in section 103(q) and shall be sub7 ject to penalties applicable to a qualified adult-only 

8 facility. 

9 (7) CONGRESSIONAL REVIEW PROVISIONS.— 

10 Section 801 of title 5, United States Code, shall not 

11 apply to the final rule published under paragraph 

12 (1). 

13 (b) LIMITATION ON ADVISORY OPINIONS.—As of the 

14 date of enactment of this Act, the following documents 

15 issued by the Food and Drug Administration shall not 

16 constitute advisory opinions under section 10.85(d)(1) of 

17 title 21, Code of Federal Regulations, except as they apply 

18 to tobacco products, and shall not be cited by the Sec19 retary of Health and Human Services or the Food and 

20 Drug Administration as binding precedent: 

21 (1) The preamble to the proposed rule in the 

22 document titled ‘‘Regulations Restricting the Sale 

23 and Distribution of Cigarettes and Smokeless To24 bacco Products to Protect Children and AdolesVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00150 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 cents’’ (60 Fed. Reg. 41314–41372 (August 11, 

2 1995)). 

3 (2) The document titled ‘‘Nicotine in Cigarettes 

4 and Smokeless Tobacco Products is a Drug and 

5 These Products Are Nicotine Delivery Devices 

6 Under the Federal Food, Drug, and Cosmetic Act’’ 

7 (60 Fed. Reg. 41453–41787 (August 11, 1995)). 

8 (3) The preamble to the final rule in the docu9 ment titled ‘‘Regulations Restricting the Sale and 

10 Distribution of Cigarettes and Smokeless Tobacco to 

11 Protect Children and Adolescents’’ (61 Fed. Reg. 

12 44396–44615 (August 28, 1996)). 

13 (4) The document titled ‘‘Nicotine in Cigarettes 

14 and Smokeless Tobacco is a Drug and These Prod15 ucts are Nicotine Delivery Devices Under the Fed16 eral Food, Drug, and Cosmetic Act; Jurisdictional 

17 Determination’’ (61 Fed. Reg. 44619–45318 (Au18 gust 28, 1996)). 

19 SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GEN20 ERAL PROVISIONS. 

21 (a) AMENDMENT OF FEDERAL FOOD, DRUG, AND

22 COSMETIC ACT.—Except as otherwise expressly provided, 

23 whenever in this section an amendment is expressed in 

24 terms of an amendment to, or repeal of, a section or other 

25 provision, the reference is to a section or other provision 


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1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

2 301 et seq.). 

3 (b) SECTION 301.—Section 301 (21 U.S.C. 331) is 

4 amended— 

5 (1) in subsection (a), by inserting ‘‘tobacco 

6 product,’’ after ‘‘device,’’; 

7 (2) in subsection (b), by inserting ‘‘tobacco 

8 product,’’ after ‘‘device,’’; 

9 (3) in subsection (c), by inserting ‘‘tobacco 

10 product,’’ after ‘‘device,’’; 

11 (4) in subsection (e)— 

12 (A) by striking the period after ‘‘572(i)’’; 

13 and 

14 (B) by striking ‘‘or 761 or the refusal to 

15 permit access to’’ and inserting ‘‘761, 909, or 

16 920 or the refusal to permit access to’’; 

17 (5) in subsection (g), by inserting ‘‘tobacco 

18 product,’’ after ‘‘device,’’; 

19 (6) in subsection (h), by inserting ‘‘tobacco 

20 product,’’ after ‘‘device,’’; 

21 (7) in subsection (j)— 

22 (A) by striking the period after ‘‘573’’; and 

23 (B) by striking ‘‘708, or 721’’ and insert24 ing ‘‘708, 721, 904, 905, 906, 907, 908, 909, 

25 or 920(b)’’; 


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1 (8) in subsection (k), by inserting ‘‘tobacco 

2 product,’’ after ‘‘device,’’; 

3 (9) by striking subsection (p) and inserting the 

4 following: 

5 ‘‘(p) The failure to register in accordance with section 

6 510 or 905, the failure to provide any information re7 quired by section 510(j), 510(k), 905(i), or 905(j), or the 

8 failure to provide a notice required by section 510(j)(2) 

9 or 905(i)(3).’’; 

10 (10) by striking subsection (q)(1) and inserting 

11 the following: 

12 ‘‘(q)(1) The failure or refusal— 

13 ‘‘(A) to comply with any requirement prescribed 

14 under section 518, 520(g), 903(b), 907, 908, or 916; 

15 ‘‘(B) to furnish any notification or other mate16 rial or information required by or under section 519, 

17 520(g), 904, 909, or 920; or 

18 ‘‘(C) to comply with a requirement under sec19 tion 522 or 913.’’; 

20 (11) in subsection (q)(2), by striking ‘‘device,’’ 

21 and inserting ‘‘device or tobacco product,’’; 

22 (12) in subsection (r), by inserting ‘‘or tobacco 

23 product’’ after the term ‘‘device’’ each time that 

24 such term appears; and 

25 (13) by adding at the end the following: 


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1 ‘‘(oo) The sale of tobacco products in violation of a 

2 no-tobacco-sale order issued under section 303(f). 

3 ‘‘(pp) The introduction or delivery for introduction 

4 into interstate commerce of a tobacco product in violation 

5 of section 911. 

6 ‘‘(qq)(1) Forging, counterfeiting, simulating, or false7 ly representing, or without proper authority using any 

8 mark, stamp (including tax stamp), tag, label, or other 

9 identification device upon any tobacco product or con10 tainer or labeling thereof so as to render such tobacco 

11 product a counterfeit tobacco product. 

12 ‘‘(2) Making, selling, disposing of, or keeping in pos13 session, control, or custody, or concealing any punch, die, 

14 plate, stone, or other item that is designed to print, im15 print, or reproduce the trademark, trade name, or other 

16 identifying mark, imprint, or device of another or any like17 ness of any of the foregoing upon any tobacco product or 

18 container or labeling thereof so as to render such tobacco 

19 product a counterfeit tobacco product. 

20 ‘‘(3) The doing of any act that causes a tobacco prod21 uct to be a counterfeit tobacco product, or the sale or dis22 pensing, or the holding for sale or dispensing, of a coun23 terfeit tobacco product. 

24 ‘‘(rr) The charitable distribution of tobacco products. 


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1 ‘‘(ss) The failure of a manufacturer or distributor to 

2 notify the Attorney General and the Secretary of the 

3 Treasury of their knowledge of tobacco products used in 

4 illicit trade. 

5 ‘‘(tt) With respect to a tobacco product, any state6 ment directed to consumers through the media or through 

7 the label, labeling, or advertising that would reasonably 

8 be expected to result in consumers believing that the prod9 uct is regulated, inspected or approved by the Food and 

10 Drug Administration, or that the product complies with 

11 the requirements of the Food and Drug Administration, 

12 including a statement or implication in the label, labeling, 

13 or advertising of such product, and that could result in 

14 consumers believing that the product is endorsed for use 

15 by the Food and Drug Administration or in consumers 

16 being misled about the harmfulness of the product because 

17 of such regulation, inspection, or compliance.’’. 

18 (c) SECTION 303.—Section 303(f) (21 U.S.C. 333(f)) 

19 is amended— 

20 (1) in paragraph (1)(A), by inserting ‘‘or to21 bacco products’’ after the term ‘‘devices’’ each place 

22 such term appears; 

23 (2) in paragraph (5)— 

24 (A) in subparagraph (A)— 


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1 (i) by striking ‘‘assessed’’ the first 

2 time it appears and inserting ‘‘assessed, or 

3 a no-tobacco-sale order may be imposed,’’; 

4 and 

5 (ii) by striking ‘‘penalty’’ the second 

6 time it appears and inserting ‘‘penalty, or 

7 upon whom a no-tobacco-sale order is to be 

8 imposed,’’; 

9 (B) in subparagraph (B)— 

10 (i) by inserting after ‘‘penalty,’’ the 

11 following: ‘‘or the period to be covered by 

12 a no-tobacco-sale order,’’; and 

13 (ii) by adding at the end the fol14 lowing: ‘‘A no-tobacco-sale order perma15 nently prohibiting an individual retail out16 let from selling tobacco products shall in17 clude provisions that allow the outlet, after 

18 a specified period of time, to request that 

19 the Secretary compromise, modify, or ter20 minate the order.’’; and 

21 (C) by adding at the end the following: 

22 ‘‘(D) The Secretary may compromise, modify, or ter23 minate, with or without conditions, any no-tobacco-sale 

24 order.’’; 

25 (3) in paragraph (6)— 


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1 (A) by inserting ‘‘or the imposition of a 

2 no-tobacco-sale order’’ after the term ‘‘penalty’’ 

3 each place such term appears; and 

4 (B) by striking ‘‘issued.’’ and inserting 

5 ‘‘issued, or on which the no-tobacco-sale order 

6 was imposed, as the case may be.’’; and 

7 (4) by adding at the end the following: 

8 ‘‘(8) If the Secretary finds that a person has 

9 committed repeated violations of restrictions promul10 gated under section 906(d) at a particular retail out11 let then the Secretary may impose a no-tobacco-sale 

12 order on that person prohibiting the sale of tobacco 

13 products in that outlet. A no-tobacco-sale order may 

14 be imposed with a civil penalty under paragraph (1). 

15 Prior to the entry of a no-sale order under this para16 graph, a person shall be entitled to a hearing pursu17 ant to the procedures established through regula18 tions of the Food and Drug Administration for as19 sessing civil money penalties, including at a retailer’s 

20 request a hearing by telephone, or at the nearest re21 gional or field office of the Food and Drug Adminis22 tration, or at a Federal, State, or county facility 

23 within 100 miles from the location of the retail out24 let, if such a facility is available.’’. 


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1 (d) SECTION 304.—Section 304 (21 U.S.C. 334) is 

2 amended— 

3 (1) in subsection (a)(2)— 

4 (A) by striking ‘‘and’’ before ‘‘(D)’’; and 

5 (B) by striking ‘‘device.’’ and inserting the 

6 following: ‘‘device, and (E) Any adulterated or 

7 misbranded tobacco product.’’; 

8 (2) in subsection (d)(1), by inserting ‘‘tobacco 

9 product,’’ after ‘‘device,’’; 

10 (3) in subsection (g)(1), by inserting ‘‘or to11 bacco product’’ after the term ‘‘device’’ each place 

12 such term appears; and 

13 (4) in subsection (g)(2)(A), by inserting ‘‘or to14 bacco product’’ after ‘‘device’’. 

15 (e) SECTION 505.—Section 505(n)(2) (21 U.S.C. 

16 355(n)(2)) is amended by striking ‘‘section 904’’ and in17 serting ‘‘section 1004’’. 

18 (f) SECTION 523.—Section 523(b)(2)(D) (21 U.S.C. 

19 360m(b)(2)(D)) is amended by striking ‘‘section 903(g)’’ 

20 and inserting ‘‘section 1003(g)’’. 

21 (g) SECTION 702.—Section 702(a)(1) (U.S.C. 

22 372(a)(1)) is amended— 

23 (1) by striking ‘‘(a)(1)’’ and inserting 

24 ‘‘(a)(1)(A)’’; and 

25 (2) by adding at the end the following: 


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1 ‘‘(B)(i) For a tobacco product, to the extent feasible, 

2 the Secretary shall contract with the States in accordance 

3 with this paragraph to carry out inspections of retailers 

4 within that State in connection with the enforcement of 

5 this Act. 

6 ‘‘(ii) The Secretary shall not enter into any contract 

7 under clause (i) with the government of any of the several 

8 States to exercise enforcement authority under this Act 

9 on Indian country without the express written consent of 

10 the Indian tribe involved.’’. 

11 (h) SECTION 703.—Section 703 (21 U.S.C. 373) is 

12 amended— 

13 (1) by inserting ‘‘tobacco product,’’ after the 

14 term ‘‘device,’’ each place such term appears; and 

15 (2) by inserting ‘‘tobacco products,’’ after the 

16 term ‘‘devices,’’ each place such term appears. 

17 (i) SECTION 704.—Section 704 (21 U.S.C. 374) is 

18 amended— 

19 (1) in subsection (a)(1)(A), by inserting ‘‘to20 bacco products,’’ after the term ‘‘devices,’’ each 

21 place such term appears; 

22 (2) in subsection (a)(1)(B), by inserting ‘‘or to23 bacco products’’ after the term ‘‘restricted devices’’ 

24 each place such term appears; 


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1 (3) in subsection (b), by inserting ‘‘tobacco 

2 product,’’ after ‘‘device,’’; and 

3 (4) in subsection (g)(13), by striking ‘‘section 

4 903(g)’’ and inserting ‘‘section 1003(g)’’. 

5 (j) SECTION 705.—Section 705(b) (21 U.S.C. 

6 375(b)) is amended by inserting ‘‘tobacco products,’’ after 

7 ‘‘devices,’’. 

8 (k) SECTION 709.—Section 709 (21 U.S.C. 379a) is 

9 amended by inserting ‘‘tobacco product,’’ after ‘‘device,’’. 

10 (l) SECTION 801.—Section 801 (21 U.S.C. 381) is 

11 amended— 

12 (1) in subsection (a)— 

13 (A) by inserting ‘‘tobacco products,’’ after 

14 the term ‘‘devices,’’ ; 

15 (B) by inserting ‘‘or section 905(h)’’ after 

16 ‘‘section 510’’; and 

17 (C) by striking the term ‘‘drugs or de18 vices’’ each time such term appears and insert19 ing ‘‘drugs, devices, or tobacco products’’; 

20 (2) in subsection (e)(1), by inserting ‘‘tobacco 

21 product,’’ after ‘‘device,’’; and 

22 (3) by adding at the end the following: 

23 ‘‘(p)(1) Not later than 36 months after the date of 

24 enactment of the Family Smoking Prevention and To25 bacco Control Act, and annually thereafter, the Secretary 


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1 shall submit to the Committee on Health, Education, 

2 Labor, and Pensions of the Senate and the Committee on 

3 Energy and Commerce of the House of Representatives, 

4 a report regarding— 

5 ‘‘(A) the nature, extent, and destination of 

6 United States tobacco product exports that do not 

7 conform to tobacco product standards established 

8 pursuant to this Act; 

9 ‘‘(B) the public health implications of such ex10 ports, including any evidence of a negative public 

11 health impact; and 

12 ‘‘(C) recommendations or assessments of policy 

13 alternatives available to Congress and the executive 

14 branch to reduce any negative public health impact 

15 caused by such exports. 

16 ‘‘(2) The Secretary is authorized to establish appro17 priate information disclosure requirements to carry out 

18 this subsection.’’. 

19 (m) SECTION 1003.—Section 1003(d)(2)(C) (as re20 designated by section 101(b)) is amended— 

21 (1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 

22 (2) inserting ‘‘, and tobacco products’’ after 

23 ‘‘devices’’. 


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1 (n) SECTION 1009.—Section 1009(b) (as redesig2 nated by section 101(b)) is amended by striking ‘‘section 

3 908’’ and inserting ‘‘section 1008’’. 

4 (o) SECTION 409 OF THE FEDERAL MEAT INSPEC5 TION ACT.—Section 409(a) of the Federal Meat Inspec6 tion Act (21 U.S.C. 679(a)) is amended by striking ‘‘sec7 tion 902(b)’’ and inserting ‘‘section 1002(b)’’. 

8 (p) RULE OF CONSTRUCTION.—Nothing in this sec9 tion is intended or shall be construed to expand, contract, 

10 or otherwise modify or amend the existing limitations on 

11 State government authority over tribal restricted fee or 

12 trust lands. 

13 (q) GUIDANCE AND EFFECTIVE DATES.— 

14 (1) IN GENERAL.—The Secretary of Health and 

15 Human Services shall issue guidance— 

16 (A) defining the term ‘‘repeated violation’’, 

17 as used in section 303(f)(8) of the Federal 

18 Food, Drug, and Cosmetic Act (21 U.S.C. 

19 333(f)(8)) as amended by subsection (c), as in20 cluding at least 5 violations of particular re21 quirements over a 36-month period at a par22 ticular retail outlet that constitute a repeated 

23 violation and providing for civil penalties in ac24 cordance with paragraph (2); 


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1 (B) providing for timely and effective no2 tice by certified or registered mail or personal 

3 delivery to the retailer of each alleged violation 

4 at a particular retail outlet prior to conducting 

5 a followup compliance check, such notice to be 

6 sent to the location specified on the retailer’s 

7 registration or to the retailer’s registered agent 

8 if the retailer has provider such agent informa9 tion to the Food and Drug Administration prior 

10 to the violation; 

11 (C) providing for a hearing pursuant to the 

12 procedures established through regulations of 

13 the Food and Drug Administration for assess14 ing civil money penalties, including at a retail15 er’s request a hearing by telephone or at the 

16 nearest regional or field office of the Food and 

17 Drug Administration, and providing for an ex18 pedited procedure for the administrative appeal 

19 of an alleged violation; 

20 (D) providing that a person may not be 

21 charged with a violation at a particular retail 

22 outlet unless the Secretary has provided notice 

23 to the retailer of all previous violations at that 

24 outlet; 


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1 (E) establishing that civil money penalties 

2 for multiple violations shall increase from one 

3 violation to the next violation pursuant to para4 graph (2) within the time periods provided for 

5 in such paragraph; 

6 (F) providing that good faith reliance on 

7 the presentation of a false government-issued 

8 photographic identification that contains a date 

9 of birth does not constitute a violation of any 

10 minimum age requirement for the sale of to11 bacco products if the retailer has taken effective 

12 steps to prevent such violations, including— 

13 (i) adopting and enforcing a written 

14 policy against sales to minors; 

15 (ii) informing its employees of all ap16 plicable laws; 

17 (iii) establishing disciplinary sanctions 

18 for employee noncompliance; and 

19 (iv) requiring its employees to verify 

20 age by way of photographic identification 

21 or electronic scanning device; and 

22 (G) providing for the Secretary, in deter23 mining whether to impose a no-tobacco-sale 

24 order and in determining whether to com25 promise, modify, or terminate such an order, to 


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1 consider whether the retailer has taken effective 

2 steps to prevent violations of the minimum age 

3 requirements for the sale of tobacco products, 

4 including the steps listed in subparagraph (F). 

5 (2) PENALTIES FOR VIOLATIONS.— 

6 (A) IN GENERAL.—The amount of the civil 

7 penalty to be applied for violations of restric8 tions promulgated under section 906(d), as de9 scribed in paragraph (1), shall be as follows: 

10 (i) With respect to a retailer with an 

11 approved training program, the amount of 

12 the civil penalty shall not exceed— 

13 (I) in the case of the first viola14 tion, $0.00 together with the issuance 

15 of a warning letter to the retailer; 

16 (II) in the case of a second viola17 tion within a 12-month period, $250; 

18 (III) in the case of a third viola19 tion within a 24-month period, $500; 

20 (IV) in the case of a fourth viola21 tion within a 24-month period, 

22 $2,000; 

23 (V) in the case of a fifth violation 

24 within a 36-month period, $5,000; 

25 and 


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1 (VI) in the case of a sixth or sub2 sequent violation within a 48-month 

3 period, $10,000 as determined by the 

4 Secretary on a case-by-case basis. 

5 (ii) With respect to a retailer that 

6 does not have an approved training pro7 gram, the amount of the civil penalty shall 

8 not exceed— 

9 (I) in the case of the first viola10 tion, $250; 

11 (II) in the case of a second viola12 tion within a 12-month period, $500; 

13 (III) in the case of a third viola14 tion within a 24-month period, 

15 $1,000; 

16 (IV) in the case of a fourth viola17 tion within a 24-month period, 

18 $2,000; 

19 (V) in the case of a fifth violation 

20 within a 36-month period, $5,000; 

21 and 

22 (VI) in the case of a sixth or sub23 sequent violation within a 48-month 

24 period, $10,000 as determined by the 

25 Secretary on a case-by-case basis. 


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1 (B) TRAINING PROGRAM.—For purposes of 

2 subparagraph (A), the term ‘‘approved training 

3 program’’ means a training program that com4 plies with standards developed by the Food and 

5 Drug Administration for such programs. 

6 (C) CONSIDERATION OF STATE PEN7 ALTIES.—The Secretary shall coordinate with 

8 the States in enforcing the provisions of this 

9 Act and, for purposes of mitigating a civil pen10 alty to be applied for a violation by a retailer 

11 of any restriction promulgated under section 

12 906(d), shall consider the amount of any pen13 alties paid by the retailer to a State for the 

14 same violation. 

15 (3) GENERAL EFFECTIVE DATE.—The amend16 ments made by paragraphs (2), (3), and (4) of sub17 section (c) shall take effect upon the issuance of 

18 guidance described in paragraph (1) of this sub19 section. 

20 (4) SPECIAL EFFECTIVE DATE.—The amend21 ment made by subsection (c)(1) shall take effect on 

22 the date of enactment of this Act. 

23 (5) PACKAGE LABEL REQUIREMENTS.—The 

24 package label requirements of paragraphs (2), (3), 

25 and (4) of section 903(a) of the Federal Food, 


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1 Drug, and Cosmetic Act (as amended by this Act) 

2 shall take effect on the date that is 12 months after 

3 the date of enactment of this Act. The effective date 

4 shall be with respect to the date of manufacture, 

5 provided that, in any case, beginning 30 days after 

6 such effective date, a manufacturer shall not intro7 duce into the domestic commerce of the United 

8 States any product, irrespective of the date of manu9 facture, that is not in conformance with section 

10 903(a)(2), (3), and (4) and section 920(a) of the 

11 Federal Food, Drug, and Cosmetic Act. 

12 (6) ADVERTISING REQUIREMENTS.—The adver13 tising requirements of section 903(a)(8) of the Fed14 eral Food, Drug, and Cosmetic Act (as amended by 

15 this Act) shall take effect on the date that is 12 

16 months after the date of enactment of this Act. 

17 SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PUR18 CHASE TOBACCO PRODUCTS. 

19 The Secretary of Health and Human Services shall— 

20 (1) convene an expert panel to conduct a study 

21 on the public health implications of raising the min22 imum age to purchase tobacco products; and 

23 (2) not later than 5 years after the date of en24 actment of this Act, submit a report to the Congress 

25 on the results of such study. 


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1 SEC. 105. ENFORCEMENT ACTION PLAN FOR ADVERTISING 

2 AND PROMOTION RESTRICTIONS. 

3 (a) ACTION PLAN.— 

4 (1) DEVELOPMENT.—Not later than 6 months 

5 after the date of enactment of this Act, the Sec6 retary of Health and Human Services (in this sec7 tion referred to as the ‘‘Secretary’’) shall develop 

8 and publish an action plan to enforce restrictions 

9 adopted pursuant to section 906 of the Federal 

10 Food, Drug, and Cosmetic Act, as added by section 

11 101(b) of this Act, or pursuant to section 102(a) of 

12 this Act, on promotion and advertising of menthol 

13 and other cigarettes to youth. 

14 (2) CONSULTATION.—The action plan required 

15 by paragraph (1) shall be developed in consultation 

16 with public health organizations and other stake17 holders with demonstrated expertise and experience 

18 in serving minority communities. 

19 (3) PRIORITY.—The action plan required by 

20 paragraph (1) shall include provisions designed to 

21 ensure enforcement of the restrictions described in 

22 paragraph (1) in minority communities. 

23 (b) STATE AND LOCAL ACTIVITIES.— 

24 (1) INFORMATION ON AUTHORITY.—Not later 

25 than 3 months after the date of enactment of this 

26 Act, the Secretary shall inform State, local, and tribVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00169 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 al governments of the authority provided to such en2 tities under section 5(c) of the Federal Cigarette La3 beling and Advertising Act, as added by section 203 

4 of this Act, or preserved by such entities under sec5 tion 916 of the Federal Food, Drug, and Cosmetic 

6 Act, as added by section 101(b) of this Act. 

7 (2) COMMUNITY ASSISTANCE.—At the request 

8 of communities seeking assistance to prevent under9 age tobacco use, the Secretary shall provide such as10 sistance, including assistance with strategies to ad11 dress the prevention of underage tobacco use in com12 munities with a disproportionate use of menthol 

13 cigarettes by minors. 

14 TITLE II—TOBACCO PRODUCT 

15 WARNINGS; CONSTITUENT 

16 AND SMOKE CONSTITUENT 

17 DISCLOSURE 

18 SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS. 

19 (a) AMENDMENT.—Section 4 of the Federal Ciga20 rette Labeling and Advertising Act (15 U.S.C. 1333) is 

21 amended to read as follows: 

22 ‘‘SEC. 4. LABELING. 

23 ‘‘(a) LABEL REQUIREMENTS.— 

24 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

25 person to manufacture, package, sell, offer to sell, 


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1 distribute, or import for sale or distribution within 

2 the United States any cigarettes the package of 

3 which fails to bear, in accordance with the require4 ments of this section, one of the following labels: 

5 ‘‘WARNING: Cigarettes are addictive. 

6 ‘‘WARNING: Tobacco smoke can harm 

7 your children. 

8 ‘‘WARNING: Cigarettes cause fatal lung 

9 disease. 

10 ‘‘WARNING: Cigarettes cause cancer. 

11 ‘‘WARNING: Cigarettes cause strokes and 

12 heart disease. 

13 ‘‘WARNING: Smoking during pregnancy 

14 can harm your baby. 

15 ‘‘WARNING: Smoking can kill you. 

16 ‘‘WARNING: Tobacco smoke causes fatal 

17 lung disease in nonsmokers. 

18 ‘‘WARNING: Quitting smoking now great19 ly reduces serious risks to your health. 

20 ‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—Each 

21 label statement required by paragraph (1) shall be 

22 located in the upper portion of the front and rear 

23 panels of the package, directly on the package un24 derneath the cellophane or other clear wrapping. 

25 Each label statement shall comprise at least the top 


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1 30 percent of the front and rear panels of the pack2 age. The word ‘WARNING’ shall appear in capital 

3 letters and all text shall be in conspicuous and leg4 ible 17-point type, unless the text of the label state5 ment would occupy more than 70 percent of such 

6 area, in which case the text may be in a smaller con7 spicuous and legible type size, provided that at least 

8 60 percent of such area is occupied by required text. 

9 The text shall be black on a white background, or 

10 white on a black background, in a manner that con11 trasts, by typography, layout, or color, with all other 

12 printed material on the package, in an alternating 

13 fashion under the plan submitted under subsection 

14 (c). 

15 ‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU16 TION.—The provisions of this subsection do not 

17 apply to a tobacco product manufacturer or dis18 tributor of cigarettes which does not manufacture, 

19 package, or import cigarettes for sale or distribution 

20 within the United States. 

21 ‘‘(4) APPLICABILITY TO RETAILERS.—A retailer 

22 of cigarettes shall not be in violation of this sub23 section for packaging that— 

24 ‘‘(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) ADVERTISING REQUIREMENTS.— 

8 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

9 tobacco product manufacturer, importer, distributor, 

10 or retailer of cigarettes to advertise or cause to be 

11 advertised within the United States any cigarette 

12 unless its advertising bears, in accordance with the 

13 requirements of this section, one of the labels speci14 fied in subsection (a). 

15 ‘‘(2) TYPOGRAPHY, ETC.—Each label statement 

16 required by subsection (a) in cigarette advertising 

17 shall comply with the standards set forth in this 

18 paragraph. For press and poster advertisements, 

19 each such statement and (where applicable) any re20 quired statement relating to tar, nicotine, or other 

21 constituent (including a smoke constituent) yield 

22 shall comprise at least 20 percent of the area of the 

23 advertisement and shall appear in a conspicuous and 

24 prominent format and location at the top of each ad25 vertisement within the trim area. The Secretary may 


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1 revise the required type sizes in such area in such 

2 manner as the Secretary determines appropriate. 

3 The word ‘WARNING’ shall appear in capital let4 ters, and each label statement shall appear in con5 spicuous and legible type. The text of the label state6 ment shall be black if the background is white and 

7 white if the background is black, under the plan sub8 mitted under subsection (c). The label statements 

9 shall be enclosed by a rectangular border that is the 

10 same color as the letters of the statements and that 

11 is the width of the first downstroke of the capital 

12 ‘W’ of the word ‘WARNING’ in the label state13 ments. The text of such label statements shall be in 

14 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. The label state25 ments shall be in English, except that— 


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1 ‘‘(A) in the case of an advertisement that 

2 appears in a newspaper, magazine, periodical, 

3 or other publication that is not in English, the 

4 statements shall appear in the predominant lan5 guage of the publication; and 

6 ‘‘(B) in the case of any other advertise7 ment that is not in English, the statements 

8 shall appear in the same language as that prin9 cipally used in the advertisement. 

10 ‘‘(3) MATCHBOOKS.—Notwithstanding para11 graph (2), for matchbooks (defined as containing not 

12 more than 20 matches) customarily given away with 

13 the purchase of tobacco products, each label state14 ment required by subsection (a) may be printed on 

15 the inside cover of the matchbook. 

16 ‘‘(4) ADJUSTMENT BY SECRETARY.—The Sec17 retary may, through a rulemaking under section 553 

18 of title 5, United States Code, adjust the format and 

19 type sizes for the label statements required by this 

20 section; the text, format, and type sizes of any re21 quired tar, nicotine yield, or other constituent (in22 cluding smoke constituent) disclosures; or the text, 

23 format, and type sizes for any other disclosures re24 quired under the Federal Food, Drug, and Cosmetic 

25 Act. The text of any such label statements or discloVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00175 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 sures shall be required to appear only within the 20 

2 percent area of cigarette advertisements provided by 

3 paragraph (2). The Secretary shall promulgate regu4 lations which provide for adjustments in the format 

5 and type sizes of any text required to appear in such 

6 area to ensure that the total text required to appear 

7 by law will fit within such area. 

8 ‘‘(c) MARKETING REQUIREMENTS.— 

9 ‘‘(1) RANDOM DISPLAY.—The label statements 

10 specified in subsection (a)(1) shall be randomly dis11 played in each 12-month period, in as equal a num12 ber of times as is possible on each brand of the 

13 product and be randomly distributed in all areas of 

14 the United States in which the product is marketed 

15 in accordance with a plan submitted by the tobacco 

16 product manufacturer, importer, distributor, or re17 tailer and approved by the Secretary. 

18 ‘‘(2) ROTATION.—The label statements speci19 fied in subsection (a)(1) shall be rotated quarterly in 

20 alternating sequence in advertisements for each 

21 brand of cigarettes in accordance with a plan sub22 mitted by the tobacco product manufacturer, im23 porter, distributor, or retailer to, and approved by, 

24 the Secretary. 


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1 ‘‘(3) REVIEW.—The Secretary shall review each 

2 plan submitted under paragraph (2) and approve it 

3 if the plan— 

4 ‘‘(A) will provide for the equal distribution 

5 and display on packaging and the rotation re6 quired in advertising under this subsection; and 

7 ‘‘(B) assures that all of the labels required 

8 under this section will be displayed by the to9 bacco product manufacturer, importer, dis10 tributor, or retailer at the same time. 

11 ‘‘(4) APPLICABILITY TO RETAILERS.—This sub12 section and subsection (b) apply to a retailer only if 

13 that retailer is responsible for or directs the label 

14 statements required under this section except that 

15 this paragraph shall not relieve a retailer of liability 

16 if the retailer displays, in a location open to the pub17 lic, an advertisement that does not contain a warn18 ing label or has been altered by the retailer in a way 

19 that is material to the requirements of this sub20 section and subsection (b).’’. 

21 (b) EFFECTIVE DATE.—The amendment made by 

22 subsection (a) shall take effect 12 months after the date 

23 of enactment of this Act. Such effective date shall be with 

24 respect to the date of manufacture, provided that, in any 

25 case, beginning 30 days after such effective date, a manuVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00177 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 facturer shall not introduce into the domestic commerce 

2 of the United States any product, irrespective of the date 

3 of manufacture, that is not in conformance with section 

4 4 of the Federal Cigarette Labeling and Advertising Act 

5 (15 U.S.C. 1333), as amended by subsection (a). 

6 SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING 

7 LABEL STATEMENTS. 

8 (a) PREEMPTION.—Section 5(a) of the Federal Ciga9 rette Labeling and Advertising Act (15 U.S.C. 1334(a)) 

10 is amended by striking ‘‘No’’ and inserting ‘‘Except to the 

11 extent the Secretary requires additional or different state12 ments on any cigarette package by a regulation, by an 

13 order, by a standard, by an authorization to market a 

14 product, or by a condition of marketing a product, pursu15 ant to the Family Smoking Prevention and Tobacco Con16 trol Act (and the amendments made by that Act), or as 

17 required under section 903(a)(2) or section 920(a) of the 

18 Federal Food, Drug, and Cosmetic Act, no’’. 

19 (b) CHANGE IN REQUIRED STATEMENTS.—Section 4 

20 of the Federal Cigarette Labeling and Advertising Act (15 

21 U.S.C. 1333), as amended by section 201, is further 

22 amended by adding at the end the following: 

23 ‘‘(d) CHANGE IN REQUIRED STATEMENTS.—The 

24 Secretary may, by a rulemaking conducted under section 

25 553 of title 5, United States Code, adjust the format, type 


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1 size, and text of any of the label requirements, require 

2 color graphics to accompany the text, increase the re3 quired label area from 30 percent up to 50 percent of the 

4 front and rear panels of the package, or establish the for5 mat, type size, and text of any other disclosures required 

6 under the Federal Food, Drug, and Cosmetic Act, if the 

7 Secretary finds that such a change would promote greater 

8 public understanding of the risks associated with the use 

9 of tobacco products.’’. 

10 SEC. 203. STATE REGULATION OF CIGARETTE ADVER11 TISING AND PROMOTION. 

12 Section 5 of the Federal Cigarette Labeling and Ad13 vertising Act (15 U.S.C. 1334) is amended by adding at 

14 the end the following: 

15 ‘‘(c) EXCEPTION.—Notwithstanding subsection (b), a 

16 State or locality may enact statutes and promulgate regu17 lations, based on smoking and health, that take effect 

18 after the effective date of the Family Smoking Prevention 

19 and Tobacco Control Act, imposing specific bans or re20 strictions on the time, place, and manner, but not content, 

21 of the advertising or promotion of any cigarettes.’’. 


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1 SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING 

2 WARNINGS. 

3 (a) AMENDMENT.—Section 3 of the Comprehensive 

4 Smokeless Tobacco Health Education Act of 1986 (15 

5 U.S.C. 4402) is amended to read as follows: 

6 ‘‘SEC. 3. SMOKELESS TOBACCO WARNING. 

7 ‘‘(a) GENERAL RULE.— 

8 ‘‘(1) It shall be unlawful for any person to man9 ufacture, package, sell, offer to sell, distribute, or 

10 import for sale or distribution within the United 

11 States any smokeless tobacco product unless the 

12 product package bears, in accordance with the re13 quirements of this Act, one of the following labels: 

14 ‘‘WARNING: This product can cause 

15 mouth cancer. 

16 ‘‘WARNING: This product can cause gum 

17 disease and tooth loss. 

18 ‘‘WARNING: This product is not a safe al19 ternative to cigarettes. 

20 ‘‘WARNING: Smokeless tobacco is addict21 ive. 

22 ‘‘(2) Each label statement required by para23 graph (1) shall be— 

24 ‘‘(A) located on the 2 principal display 

25 panels of the package, and each label statement 


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1 shall comprise at least 30 percent of each such 

2 display panel; and 

3 ‘‘(B) in 17-point conspicuous and legible 

4 type and in black text on a white background, 

5 or white text on a black background, in a man6 ner that contrasts by typography, layout, or 

7 color, with all other printed material on the 

8 package, in an alternating fashion under the 

9 plan submitted under subsection (b)(3), except 

10 that if the text of a label statement would oc11 cupy more than 70 percent of the area specified 

12 by subparagraph (A), such text may appear in 

13 a smaller type size, so long as at least 60 per14 cent of such warning area is occupied by the 

15 label statement. 

16 ‘‘(3) The label statements required by para17 graph (1) shall be introduced by each tobacco prod18 uct manufacturer, packager, importer, distributor, or 

19 retailer of smokeless tobacco products concurrently 

20 into the distribution chain of such products. 

21 ‘‘(4) The provisions of this subsection do not 

22 apply to a tobacco product manufacturer or dis23 tributor of any smokeless tobacco product that does 

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1 bacco products for sale or distribution within the 

2 United States. 

3 ‘‘(5) A retailer of smokeless tobacco products 

4 shall not be in violation of this subsection for pack5 aging that— 

6 ‘‘(A) contains a warning label; 

7 ‘‘(B) is supplied to the retailer by a 

8 license- or permit-holding tobacco product man9 ufacturer, importer, or distributor; and 

10 ‘‘(C) is not altered by the retailer in a way 

11 that is material to the requirements of this sub12 section. 

13 ‘‘(b) REQUIRED LABELS.— 

14 ‘‘(1) It shall be unlawful for any tobacco prod15 uct manufacturer, packager, importer, distributor, or 

16 retailer of smokeless tobacco products to advertise or 

17 cause to be advertised within the United States any 

18 smokeless tobacco product unless its advertising 

19 bears, in accordance with the requirements of this 

20 section, one of the labels specified in subsection (a). 

21 ‘‘(2)(A) Each label statement required by sub22 section (a) in smokeless tobacco advertising shall 

23 comply with the standards set forth in this para24 graph. 


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1 ‘‘(B) For press and poster advertisements, each 

2 such statement and (where applicable) any required 

3 statement relating to tar, nicotine, or other con4 stituent yield shall comprise at least 20 percent of 

5 the area of the advertisement. 

6 ‘‘(C) The word ‘WARNING’ shall appear in 

7 capital letters, and each label statement shall appear 

8 in conspicuous and legible type. 

9 ‘‘(D) The text of the label statement shall be 

10 black on a white background, or white on a black 

11 background, in an alternating fashion under the 

12 plan submitted under paragraph (3). 

13 ‘‘(E) The label statements shall be enclosed by 

14 a rectangular border that is the same color as the 

15 letters of the statements and that is the width of the 

16 first downstroke of the capital ‘W’ of the word 

17 ‘WARNING’ in the label statements. 

18 ‘‘(F) The text of such label statements shall be 

19 in a typeface pro rata to the following requirements: 

20 45-point type for a whole-page broadsheet newspaper 

21 advertisement; 39-point type for a half-page 

22 broadsheet newspaper advertisement; 39-point type 

23 for a whole-page tabloid newspaper advertisement; 

24 27-point type for a half-page tabloid newspaper ad25 vertisement; 31.5-point type for a double page 


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1 spread magazine or whole-page magazine advertise2 ment; 22.5-point type for a 28 centimeter by 3 col3 umn advertisement; and 15-point type for a 20 cen4 timeter by 2 column advertisement. 

5 ‘‘(G) The label statements shall be in English, 

6 except that— 

7 ‘‘(i) in the case of an advertisement that 

8 appears in a newspaper, magazine, periodical, 

9 or other publication that is not in English, the 

10 statements shall appear in the predominant lan11 guage of the publication; and 

12 ‘‘(ii) in the case of any other advertisement 

13 that is not in English, the statements shall ap14 pear in the same language as that principally 

15 used in the advertisement. 

16 ‘‘(3)(A) The label statements specified in sub17 section (a)(1) shall be randomly displayed in each 

18 12-month period, in as equal a number of times as 

19 is possible on each brand of the product and be ran20 domly distributed in all areas of the United States 

21 in which the product is marketed in accordance with 

22 a plan submitted by the tobacco product manufac23 turer, importer, distributor, or retailer and approved 

24 by the Secretary. 


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1 ‘‘(B) The label statements specified in sub2 section (a)(1) shall be rotated quarterly in alter3 nating sequence in advertisements for each brand of 

4 smokeless tobacco product in accordance with a plan 

5 submitted by the tobacco product manufacturer, im6 porter, distributor, or retailer to, and approved by, 

7 the Secretary. 

8 ‘‘(C) The Secretary shall review each plan sub9 mitted under subparagraphs (A) and (B) and ap10 prove it if the plan— 

11 ‘‘(i) will provide for the equal distribution 

12 and display on packaging and the rotation re13 quired in advertising under this subsection; and 

14 ‘‘(ii) assures that all of the labels required 

15 under this section will be displayed by the to16 bacco product manufacturer, importer, dis17 tributor, or retailer at the same time. 

18 ‘‘(D) This paragraph applies to a retailer only 

19 if that retailer is responsible for or directs the label 

20 statements under this section, unless the retailer dis21 plays, in a location open to the public, an advertise22 ment that does not contain a warning label or has 

23 been altered by the retailer in a way that is material 

24 to the requirements of this subsection. 


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1 ‘‘(4) The Secretary may, through a rulemaking 

2 under section 553 of title 5, United States Code, ad3 just the format and type sizes for the label state4 ments required by this section; the text, format, and 

5 type sizes of any required tar, nicotine yield, or 

6 other constituent disclosures; or the text, format, 

7 and type sizes for any other disclosures required 

8 under the Federal Food, Drug, and Cosmetic Act. 

9 The text of any such label statements or disclosures 

10 shall be required to appear only within the 20 per11 cent area of advertisements provided by paragraph 

12 (2). The Secretary shall promulgate regulations 

13 which provide for adjustments in the format and 

14 type sizes of any text required to appear in such 

15 area to ensure that the total text required to appear 

16 by law will fit within such area. 

17 ‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is 

18 unlawful to advertise smokeless tobacco on any medium 

19 of electronic communications subject to the jurisdiction of 

20 the Federal Communications Commission.’’. 

21 (b) EFFECTIVE DATE.—The amendment made by 

22 subsection (a) shall take effect 12 months after the date 

23 of enactment of this Act. Such effective date shall be with 

24 respect to the date of manufacture, provided that, in any 

25 case, beginning 30 days after such effective date, a manuVerDate Nov 24 2008 01:40 Mar 04, 2009 Jkt 079200 PO 00000 Frm 00186 Fmt 6652 Sfmt 6201 E:\BILLS\H1256.IH H1256

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1 facturer shall not introduce into the domestic commerce 

2 of the United States any product, irrespective of the date 

3 of manufacture, that is not in conformance with section 

4 3 of the Comprehensive Smokeless Tobacco Health Edu5 cation Act of 1986 (15 U.S.C. 4402), as amended by sub6 section (a) 

7 SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO 

8 PRODUCT WARNING LABEL STATEMENTS. 

9 (a) IN GENERAL.—Section 3 of the Comprehensive 

10 Smokeless Tobacco Health Education Act of 1986 (15 

11 U.S.C. 4402), as amended by section 204, is further 

12 amended by adding at the end the following: 

13 ‘‘(d) AUTHORITY TO REVISE WARNING LABEL

14 STATEMENTS.—The Secretary may, by a rulemaking con15 ducted under section 553 of title 5, United States Code, 

16 adjust the format, type size, and text of any of the label 

17 requirements, require color graphics to accompany the 

18 text, increase the required label area from 30 percent up 

19 to 50 percent of the front and rear panels of the package, 

20 or establish the format, type size, and text of any other 

21 disclosures required under the Federal Food, Drug, and 

22 Cosmetic Act, if the Secretary finds that such a change 

23 would promote greater public understanding of the risks 

24 associated with the use of smokeless tobacco products.’’. 


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1 (b) PREEMPTION.—Section 7(a) of the Comprehen2 sive Smokeless Tobacco Health Education Act of 1986 (15 

3 U.S.C. 4406(a)) is amended by striking ‘‘No’’ and insert4 ing ‘‘Except as provided in the Family Smoking Preven5 tion and Tobacco Control Act (and the amendments made 

6 by that Act), no’’. 

7 SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CON8 STITUENT DISCLOSURE TO THE PUBLIC. 

9 Section 4 of the Federal Cigarette Labeling and Ad10 vertising Act (15 U.S.C. 1333), as amended by sections 

11 201 and 202, is further amended by adding at the end 

12 the following: 

13 ‘‘(e) TAR, NICOTINE, AND OTHER SMOKE CON14 STITUENT DISCLOSURE.— 

15 ‘‘(1) IN GENERAL.—The Secretary shall, by a 

16 rulemaking conducted under section 553 of title 5, 

17 United States Code, determine (in the Secretary’s 

18 sole discretion) whether cigarette and other tobacco 

19 product manufacturers shall be required to include 

20 in the area of each cigarette advertisement specified 

21 by subsection (b) of this section, or on the package 

22 label, or both, the tar and nicotine yields of the ad23 vertised or packaged brand. Any such disclosure 

24 shall be in accordance with the methodology estab25 lished under such regulations, shall conform to the 


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1 type size requirements of subsection (b) of this sec2 tion, and shall appear within the area specified in 

3 subsection (b) of this section. 

4 ‘‘(2) RESOLUTION OF DIFFERENCES.—Any dif5 ferences between the requirements established by the 

6 Secretary under paragraph (1) and tar and nicotine 

7 yield reporting requirements established by the Fed8 eral Trade Commission shall be resolved by a memo9 randum of understanding between the Secretary and 

10 the Federal Trade Commission. 

11 ‘‘(3) CIGARETTE AND OTHER TOBACCO PROD12 UCT CONSTITUENTS.—In addition to the disclosures 

13 required by paragraph (1), the Secretary may, under 

14 a rulemaking conducted under section 553 of title 5, 

15 United States Code, prescribe disclosure require16 ments regarding the level of any cigarette or other 

17 tobacco product constituent including any smoke 

18 constituent. Any such disclosure may be required if 

19 the Secretary determines that disclosure would be of 

20 benefit to the public health, or otherwise would in21 crease consumer awareness of the health con22 sequences of the use of tobacco products, except that 

23 no such prescribed disclosure shall be required on 

24 the face of any cigarette package or advertisement. 

25 Nothing in this section shall prohibit the Secretary 


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1 from requiring such prescribed disclosure through a 

2 cigarette or other tobacco product package or adver3 tisement insert, or by any other means under the 

4 Federal Food, Drug, and Cosmetic Act. 

5 ‘‘(4) RETAILERS.—This subsection applies to a 

6 retailer only if that retailer is responsible for or di7 rects the label statements required under this sec8 tion.’’. 

9 TITLE III—PREVENTION OF IL10 LICIT TRADE IN TOBACCO 

11 PRODUCTS 

12 SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPEC13 TION. 

14 Chapter IX of the Federal Food, Drug, and Cosmetic 

15 Act, as added by section 101, is further amended by add16 ing at the end the following: 

17 ‘‘SEC. 920. LABELING, RECORDKEEPING, RECORDS INSPEC18 TION. 

19 ‘‘(a) ORIGIN LABELING.— 

20 ‘‘(1) REQUIREMENT.—Beginning 1 year after 

21 the date of enactment of the Family Smoking Pre22 vention and Tobacco Control Act, the label, pack23 aging, and shipping containers of tobacco products 

24 for introduction or delivery for introduction into 

25 interstate commerce in the United States shall bear 


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1 the statement ‘sale only allowed in the United 

2 States’. 

3 ‘‘(2) EFFECTIVE DATE.—The effective date 

4 specified in paragraph (1) shall be with respect to 

5 the date of manufacture, provided that, in any case, 

6 beginning 30 days after such effective date, a manu7 facturer shall not introduce into the domestic com8 merce of the United States any product, irrespective 

9 of the date of manufacture, that is not in conform10 ance with such paragraph. 

11 ‘‘(b) REGULATIONS CONCERNING RECORDKEEPING

12 FOR TRACKING AND TRACING.— 

13 ‘‘(1) IN GENERAL.—The Secretary shall pro14 mulgate regulations regarding the establishment and 

15 maintenance of records by any person who manufac16 tures, processes, transports, distributes, receives, 

17 packages, holds, exports, or imports tobacco prod18 ucts. 

19 ‘‘(2) INSPECTION.—In promulgating the regula20 tions described in paragraph (1), the Secretary shall 

21 consider which records are needed for inspection to 

22 monitor the movement of tobacco products from the 

23 point of manufacture through distribution to retail 

24 outlets to assist in investigating potential illicit 


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1 trade, smuggling, or counterfeiting of tobacco prod2 ucts. 

3 ‘‘(3) CODES.—The Secretary may require codes 

4 on the labels of tobacco products or other designs or 

5 devices for the purpose of tracking or tracing the to6 bacco product through the distribution system. 

7 ‘‘(4) SIZE OF BUSINESS.—The Secretary shall 

8 take into account the size of a business in promul9 gating regulations under this section. 

10 ‘‘(5) RECORDKEEPING BY RETAILERS.—The 

11 Secretary shall not require any retailer to maintain 

12 records relating to individual purchasers of tobacco 

13 products for personal consumption. 

14 ‘‘(c) RECORDS INSPECTION.—If the Secretary has a 

15 reasonable belief that a tobacco product is part of an illicit 

16 trade or smuggling or is a counterfeit product, each person 

17 who manufactures, processes, transports, distributes, re18 ceives, holds, packages, exports, or imports tobacco prod19 ucts shall, at the request of an officer or employee duly 

20 designated by the Secretary, permit such officer or em21 ployee, at reasonable times and within reasonable limits 

22 and in a reasonable manner, upon the presentation of ap23 propriate credentials and a written notice to such person, 

24 to have access to and copy all records (including financial 

25 records) relating to such article that are needed to assist 


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1 the Secretary in investigating potential illicit trade, smug2 gling, or counterfeiting of tobacco products. The Secretary 

3 shall not authorize an officer or employee of the govern4 ment of any of the several States to exercise authority 

5 under the preceding sentence on Indian country without 

6 the express written consent of the Indian tribe involved. 

7 ‘‘(d) KNOWLEDGE OF ILLEGAL TRANSACTION.— 

8 ‘‘(1) NOTIFICATION.—If the manufacturer or 

9 distributor of a tobacco product has knowledge 

10 which reasonably supports the conclusion that a to11 bacco product manufactured or distributed by such 

12 manufacturer or distributor that has left the control 

13 of such person may be or has been— 

14 ‘‘(A) imported, exported, distributed, or of15 fered for sale in interstate commerce by a per16 son without paying duties or taxes required by 

17 law; or 

18 ‘‘(B) imported, exported, distributed, or di19 verted for possible illicit marketing, 

20 the manufacturer or distributor shall promptly no21 tify the Attorney General and the Secretary of the 

22 Treasury of such knowledge. 

23 ‘‘(2) KNOWLEDGE DEFINED.—For purposes of 

24 this subsection, the term ‘knowledge’ as applied to 

25 a manufacturer or distributor means— 


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1 ‘‘(A) the actual knowledge that the manu2 facturer or distributor had; or 

3 ‘‘(B) the knowledge which a reasonable 

4 person would have had under like circumstances 

5 or which would have been obtained upon the ex6 ercise of due care.’’. 

7 SEC. 302. STUDY AND REPORT. 

8 (a) STUDY.—The Comptroller General of the United 

9 States shall conduct a study of cross-border trade in to10 bacco products to— 

11 (1) collect data on cross-border trade in tobacco 

12 products, including illicit trade and trade of counter13 feit tobacco products and make recommendations on 

14 the monitoring of such trade; 

15 (2) collect data on cross-border advertising (any 

16 advertising intended to be broadcast, transmitted, or 

17 distributed from the United States to another coun18 try) of tobacco products and make recommendations 

19 on how to prevent or eliminate, and what tech20 nologies could help facilitate the elimination of, 

21 cross-border advertising; and 

22 (3) collect data on the health effects (particu23 larly with respect to individuals under 18 years of 

24 age) resulting from cross-border trade in tobacco 


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1 products, including the health effects resulting 

2 from— 

3 (A) the illicit trade of tobacco products 

4 and the trade of counterfeit tobacco products; 

5 and 

6 (B) the differing tax rates applicable to to7 bacco products. 

8 (b) REPORT.—Not later than 18 months after the 

9 date of enactment of this Act, the Comptroller General 

10 of the United States shall submit to the Committee on 

11 Health, Education, Labor, and Pensions of the Senate and 

12 the Committee on Energy and Commerce of the House 

13 of Representatives a report on the study described in sub14 section (a). 

15 (c) DEFINITION.—In this section: 

16 (1) The term ‘‘cross-border trade’’ means trade 

17 across a border of the United States, a State or Ter18 ritory, or Indian country. 

19 (2) The term ‘‘Indian country’’ has the mean20 ing given to such term in section 1151 of title 18, 

21 United States Code. 

22 (3) The terms ‘‘State’’ and ‘‘Territory’’ have 

23 the meanings given to those terms in section 201 of 

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

25 U.S.C. 321). 


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1 TITLE IV—THRIFT SAVINGS 

2 PLAN ENHANCEMENT 

3 SEC. 401. SHORT TITLE. 

4 This title may be cited as the ‘‘Thrift Savings Plan 

5 Enhancement Act of 2009’’. 

6 SEC. 402. AUTOMATIC ENROLLMENTS. 

7 (a) IN GENERAL.—Section 8432(b) of title 5, United 

8 States Code, is amended by striking paragraphs (2) 

9 through (4) and inserting the following: 

10 ‘‘(2)(A) The Board shall by regulation provide for an 

11 eligible individual to be automatically enrolled to make 

12 contributions under subsection (a) at the default percent13 age of basic pay. 

14 ‘‘(B) For purposes of this paragraph, the default per15 centage shall be equal to 3 percent or such other percent16 age, not less than 2 percent nor more than 5 percent, as 

17 the Board may by regulation prescribe. 

18 ‘‘(C) The regulations shall include provisions under 

19 which any individual who would otherwise be automatically 

20 enrolled in accordance with subparagraph (A) may— 

21 ‘‘(i) modify the percentage or amount to be con22 tributed pursuant to automatic enrollment, effective 

23 from the start of such enrollment; or 

24 ‘‘(ii) decline automatic enrollment altogether. 


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1 ‘‘(D) For purposes of this paragraph, the term ‘eligi2 ble individual’ means any individual who, after any regula3 tions under subparagraph (A) first take effect, is ap4 pointed, transferred, or reappointed to a position in which 

5 that individual is eligible to contribute to the Thrift Sav6 ings Fund. 

7 ‘‘(E) Sections 8351(a)(1), 8440a(a)(1), 8440b(a)(1), 

8 8440c(a)(1), 8440d(a)(1), and 8440e(a)(1) shall be ap9 plied in a manner consistent with the purposes of this 

10 paragraph.’’. 

11 (b) TECHNICAL AMENDMENT.—Section 8432(b)(1) 

12 of title 5, United States Code, is amended by striking the 

13 parenthetical matter in subparagraph (B). 

14 SEC. 403. QUALIFIED ROTH CONTRIBUTION PROGRAM. 

15 (a) IN GENERAL.—Subchapter III of chapter 84 of 

16 title 5, United States Code, is amended by inserting after 

17 section 8432c the following: 

18 ‘‘§ 8432d. Qualified Roth contribution program 

19 ‘‘(a) DEFINITIONS.—For purposes of this section— 

20 ‘‘(1) the term ‘qualified Roth contribution pro21 gram’ means a program described in paragraph (1) 

22 of section 402A(b) of the Internal Revenue Code of 

23 1986 which meets the requirements of paragraph (2) 

24 of such section; and 


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1 ‘‘(2) the terms ‘designated Roth contribution’ 

2 and ‘elective deferral’ have the meanings given such 

3 terms in section 402A of the Internal Revenue Code 

4 of 1986. 

5 ‘‘(b) AUTHORITY TO ESTABLISH.—The Board shall 

6 by regulation provide for the inclusion in the Thrift Sav7 ings Plan of a qualified Roth contribution program, under 

8 such terms and conditions as the Board may prescribe. 

9 ‘‘(c) REQUIRED PROVISIONS.—The regulations under 

10 subsection (b) shall include— 

11 ‘‘(1) provisions under which an election to make 

12 designated Roth contributions may be made— 

13 ‘‘(A) by any individual who is eligible to 

14 make contributions under section 8351, 

15 8432(a), 8440a, 8440b, 8440c, 8440d, or 

16 8440e; and 

17 ‘‘(B) by any individual, not described in 

18 subparagraph (A), who is otherwise eligible to 

19 make elective deferrals under the Thrift Sav20 ings Plan; 

21 ‘‘(2) any provisions which may, as a result of 

22 enactment of this section, be necessary in order to 

23 clarify the meaning of any reference to an ‘account’ 

24 made in section 8432(f), 8433, 8434(d), 8435, 

25 8437, or any other provision of law; and 


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1 ‘‘(3) any other provisions which may be nec2 essary to carry out this section.’’. 

3 (b) CLERICAL AMENDMENT.—The analysis for chap4 ter 84 of title 5, United States Code, is amended by insert5 ing after the item relating to section 8432c the following: 

‘‘8432d. Qualified Roth contribution program.’’. 

6 SEC. 404. AUTHORITY TO ESTABLISH SELF-DIRECTED IN7 VESTMENT WINDOW. 

8 (a) IN GENERAL.—Section 8438(b)(1) of title 5, 

9 United States Code, is amended— 

10 (1) in subparagraph (D), by striking ‘‘and’’ at 

11 the end; 

12 (2) in subparagraph (E), by striking the period 

13 and inserting ‘‘; and’’; and 

14 (3) by adding after subparagraph (E) the fol15 lowing: 

16 ‘‘(F) a self-directed investment window, if 

17 the Board authorizes such window under para18 graph (5).’’. 

19 (b) REQUIREMENTS.—Section 8438(b) of title 5, 

20 United States Code, is amended by adding at the end the 

21 following: 

22 ‘‘(5)(A) The Board may authorize the addition of a 

23 self-directed investment window under the Thrift Savings 

24 Plan if the Board determines that such addition would be 

25 in the best interests of participants. 


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1 ‘‘(B) The self-directed investment window shall be 

2 limited to— 

3 ‘‘(i) low-cost, passively-managed index funds 

4 that offer diversification benefits; and 

5 ‘‘(ii) other investment options, if the Board de6 termines the options to be appropriate retirement in7 vestment vehicles for participants. 

8 ‘‘(C) The Board shall ensure that any administrative 

9 expenses related to use of the self-directed investment win10 dow are borne solely by the participants who use such win11 dow. 

12 ‘‘(D) The Board may establish such other terms and 

13 conditions for the self-directed investment window as the 

14 Board considers appropriate to protect the interests of 

15 participants, including requirements relating to risk dis16 closure. 

17 ‘‘(E) The Board shall consult with the Employee 

18 Thrift Advisory Council (established under section 8473) 

19 before establishing any self-directed investment window.’’. 

20 SEC. 405. REPORTING REQUIREMENTS. 

21 (a) ANNUAL REPORT.—The Board shall, not later 

22 than June 30 of each year, submit to Congress an annual 

23 report on the operations of the Thrift Savings Plan. Such 

24 report shall include, for the prior calendar year, informa25 tion on the number of participants as of the last day of 


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1 such prior calendar year, the median balance in partici2 pants’ accounts as of such last day, demographic informa3 tion on participants, the percentage allocation of amounts 

4 among investment funds or options, the status of the de5 velopment and implementation of the self-directed invest6 ment window, the diversity demographics of any company, 

7 investment adviser, or other entity retained to invest and 

8 manage the assets of the Thrift Savings Fund, and such 

9 other information as the Board considers appropriate. A 

10 copy of each annual report under this subsection shall be 

11 made available to the public through an Internet website. 

12 (b) REPORTING OF FEES AND OTHER INFORMA13 TION.— 

14 (1) IN GENERAL.—The Board shall include in 

15 the periodic statements provided to participants 

16 under section 8439(c) the amount of the investment 

17 management fees, administrative expenses, and any 

18 other fees or expenses paid with respect to each in19 vestment fund and option under the Thrift Savings 

20 Plan. Any such statement shall also provide a state21 ment notifying participants as to how they may ac22 cess the annual report described in subsection (a), as 

23 well as any other information concerning the Thrift 

24 Savings Plan that might be useful. 


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1 (2) USE OF ESTIMATES.—For purposes of pro2 viding the information required under this sub3 section, the Executive Director may provide a rea4 sonable and representative estimate of any fees or 

5 expenses described in paragraph (1) and shall indi6 cate any such estimate as being such an estimate. 

7 Any such estimate shall be based on the previous 

8 year’s experience. 

9 (c) DEFINITIONS.—For purposes of this section— 

10 (1) the term ‘‘Board’’ has the meaning given 

11 such term by 8401(5) of title 5, United States Code; 

12 (2) the term ‘‘participant’’ has the meaning 

13 given such term by section 8471(3) of title 5, United 

14 States Code; and 

15 (3) the term ‘‘account’’ means an account es16 tablished under section 8439 of title 5, United 

17 States Code. 

18 SEC. 406. ACKNOWLEDGEMENT OF RISK. 

19 (a) IN GENERAL.—Section 8439(d) of title 5, United 

20 States Code, is amended— 

21 (1) by striking the matter after ‘‘who elects to 

22 invest in’’ and before ‘‘shall sign an acknowledge23 ment’’ and inserting ‘‘any investment fund or option 

24 under this chapter, other than the Government Se25 curities Investment Fund,’’; and 


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1 (2) by striking ‘‘either such Fund’’ and insert2 ing ‘‘any such fund or option’’. 

3 (b) COORDINATION WITH PROVISIONS RELATING TO

4 INVESTMENTS IN THE ABSENCE OF AN ELECTION.—Sub5 section (d) of section 8439 of title 5, United States Code 

6 (as amended by subsection (a)) is further amended— 

7 (1) by redesignating subsection (d) as sub8 section (d)(1); and 

9 (2) by adding at the end the following: 

10 ‘‘(2)(A) In the case of an investment made under sec11 tion 8438(c)(2) in any fund or option to which paragraph 

12 (1) would otherwise apply, the participant involved shall, 

13 for purposes of this subsection, be deemed— 

14 ‘‘(i) to have elected to invest in such fund or 

15 option; and 

16 ‘‘(ii) to have executed the acknowledgement re17 quired under paragraph (1). 

18 ‘‘(B)(i) The Executive Director shall prescribe regu19 lations under which written notice shall be provided to a 

20 participant whenever an investment is made under section 

21 8438(c)(2)(B) on behalf of such participant in the absence 

22 of an affirmative election described in section 8438(c)(1). 

23 ‘‘(ii) The regulations shall ensure that any such no24 tice shall be provided to the participant within 7 calendar 

25 days after the effective date of the default election. 


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1 ‘‘(C) For purposes of this paragraph, the term ‘par2 ticipant’ has the meaning given such term by section 

3 8471(3).’’. 

4 (c) COORDINATION WITH PROVISIONS RELATING TO

5 FIDUCIARY RESPONSIBILITIES, LIABILITIES, AND PEN6 ALTIES.—Section 8477(e)(1)(C) of title 5, United States 

7 Code, is amended— 

8 (1) by redesignating subparagraph (C) as sub9 paragraph (C)(i); and 

10 (2) by adding at the end the following: 

11 ‘‘(ii) A fiduciary shall not be liable under subpara12 graph (A), and no civil action may be brought against a 

13 fiduciary— 

14 ‘‘(I) for providing for the automatic enrollment 

15 of a participant in accordance with section 

16 8432(b)(2)(A); 

17 ‘‘(II) for enrolling a participant in a default in18 vestment fund in accordance with section 

19 8438(c)(2)(B); or 

20 ‘‘(III) for allowing a participant to invest 

21 through the self-directed investment window or for 

22 establishing restrictions applicable to participants’ 

23 ability to invest through the self-directed investment 

24 window.’’. 


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1 SEC. 407. CREDIT FOR UNUSED SICK LEAVE. 

2 (a) IN GENERAL.—Section 8415 of title 5, United 

3 States Code, is amended— 

4 (1) by redesignating the second subsection (k) 

5 and subsection (l) as subsections (l) and (m), respec6 tively; and 

7 (2) in subsection (l) (as so redesignated by 

8 paragraph (1))— 

9 (A) by striking ‘‘(l) In computing’’ and in10 serting ‘‘(l)(1) In computing’’; and 

11 (B) by adding at the end the following: 

12 ‘‘(2) Except as provided in paragraph (1), in com13 puting an annuity under this subchapter, the total service 

14 of an employee who retires on an immediate annuity or 

15 who dies leaving a survivor or survivors entitled to annuity 

16 includes the days of unused sick leave to his credit under 

17 a formal leave system, except that these days will not be 

18 counted in determining average pay or annuity eligibility 

19 under this subchapter. For purposes of this subsection, in 

20 the case of any such employee who is excepted from sub21 chapter I of chapter 63 under section 6301(2)(x)-(xiii), 

22 the days of unused sick leave to his credit include any un23 used sick leave standing to his credit when he was ex24 cepted from such subchapter.’’. 

25 (b) EXCEPTION FROM DEPOSIT REQUIREMENT.— 

26 Section 8422(d)(2) of title 5, United States Code, is 


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1 amended by striking ‘‘section 8415(k)’’ and inserting 

2 ‘‘paragraph (1) or (2) of section 8415(l)’’. 

3 (c) EFFECTIVE DATE.—The amendments made by 

4 this section shall apply with respect to annuities computed 

5 based on separations occurring on or after the date of en6 actment of this Act. 

Æ 


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