In the Senate of the United States, 

June 11, 2009. 

Resolved, That the bill from the House of Representatives (H.R. 1256) entitled ‘‘An Act to protect the public 

health by providing the Food and Drug Administration with 

certain authority to regulate tobacco products, to amend title 

5, United States Code, to make certain modifications in the 

Thrift Savings Plan, the Civil Service Retirement System, 

and the Federal Employees’ Retirement System, and for 

other purposes.’’, do pass with the following 

AMENDMENT: 

Strike all after the enacting clause and insert the 

following: 

1 DIVISION A—FAMILY SMOKING 

2 PREVENTION AND TOBACCO 

3 CONTROL ACT 

4 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

6 ‘‘Family Smoking Prevention and Tobacco Control Act’’. 
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1 (b) TABLE OF CONTENTS.—The table of contents of this 

2 division is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 

Sec. 3. Purpose. 

Sec. 4. Scope and effect. 

Sec. 5. Severability. 

Sec. 6. Modification of deadlines for Secretarial action. 

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. 

Sec. 106. Studies of progress and effectiveness. 

TITLE II—TOBACCO PRODUCT WARNINGS; CONSTITUENT AND 

SMOKE CONSTITUENT DISCLOSURE 

Sec. 201. Cigarette label and advertising warnings. 

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

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

Sec. 204. Smokeless tobacco labels and advertising warnings. 

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

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

TITLE III—PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS 

Sec. 301. Labeling, recordkeeping, records inspection. 

Sec. 302. Study and report. 

3 SEC. 2. FINDINGS. 

4 The Congress finds the following: 

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

6 children is a pediatric disease of considerable propor7 tions that results in new generations of tobacco-de8 pendent children and adults. 

9 (2) A consensus exists within the scientific and 

10 medical communities that tobacco products are inher11 ently dangerous and cause cancer, heart disease, and 

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

2 (4) Virtually all new users of tobacco products 

3 are under the minimum legal age to purchase such 

4 products. 

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

7 tobacco products by adolescents. 

8 (6) Because past efforts to restrict advertising 

9 and marketing of tobacco products have failed ade10 quately to curb tobacco use by adolescents, comprehen11 sive restrictions on the sale, promotion, and distribu12 tion of such products are needed. 

13 (7) Federal and State governments have lacked 

14 the legal and regulatory authority and resources they 

15 need to address comprehensively the public health and 

16 societal problems caused by the use of tobacco prod17 ucts. 

18 (8) Federal and State public health officials, the 

19 public health community, and the public at large rec20 ognize that the tobacco industry should be subject to 

21 ongoing oversight. 

22 (9) Under article I, section 8 of the Constitution, 

23 the Congress is vested with the responsibility for regu24 lating interstate commerce and commerce with Indian 

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

3 and substantially affecting interstate commerce be4 cause they are sold, marketed, advertised, and distrib5 uted in interstate commerce on a nationwide basis, 

6 and have a substantial effect on the Nation’s economy. 

7 (11) The sale, distribution, marketing, adver8 tising, and use of such products substantially affect 

9 interstate commerce through the health care and other 

10 costs attributable to the use of tobacco products. 

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

12 enact legislation that provides the Food and Drug Ad13 ministration with the authority to regulate tobacco 

14 products and the advertising and promotion of such 

15 products. The benefits to the American people from 

16 enacting such legislation would be significant in 

17 human and economic terms. 

18 (13) Tobacco use is the foremost preventable 

19 cause of premature death in America. It causes over 

20 400,000 deaths in the United States each year, and 

21 approximately 8,600,000 Americans have chronic ill22 nesses related to smoking. 

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

24 50 percent would prevent well over 10,000,000 of to25 day’s children from becoming regular, daily smokers, 
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1 saving over 3,000,000 of them from premature death 

2 due to tobacco-induced disease. Such a reduction in 

3 youth smoking would also result in approximately 

4 $75,000,000,000 in savings attributable to reduced 

5 health care costs. 

6 (15) Advertising, marketing, and promotion of 

7 tobacco products have been especially directed to at8 tract young persons to use tobacco products, and these 

9 efforts have resulted in increased use of such products 

10 by youth. Past efforts to oversee these activities have 

11 not been successful in adequately preventing such in12 creased use. 

13 (16) In 2005, the cigarette manufacturers spent 

14 more than $13,000,000,000 to attract new users, re15 tain current users, increase current consumption, and 

16 generate favorable long-term attitudes toward smoking 

17 and tobacco use. 

18 (17) Tobacco product advertising often 

19 misleadingly portrays the use of tobacco as socially 

20 acceptable and healthful to minors. 

21 (18) Tobacco product advertising is regularly 

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

23 under the age of 18 are regularly exposed to tobacco 

24 product promotional efforts. 
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1 (19) Through advertisements during and spon2 sorship of sporting events, tobacco has become strongly 

3 associated with sports and has become portrayed as 

4 an integral part of sports and the healthy lifestyle as5 sociated with rigorous sporting activity. 

6 (20) Children are exposed to substantial and un7 avoidable tobacco advertising that leads to favorable 

8 beliefs about tobacco use, plays a role in leading 

9 young people to overestimate the prevalence of tobacco 

10 use, and increases the number of young people who 

11 begin to use tobacco. 

12 (21) The use of tobacco products in motion pic13 tures and other mass media glamorizes its use for 

14 young people and encourages them to use tobacco 

15 products. 

16 (22) Tobacco advertising expands the size of the 

17 tobacco market by increasing consumption of tobacco 

18 products including tobacco use by young people. 

19 (23) Children are more influenced by tobacco 

20 marketing than adults: more than 80 percent of youth 

21 smoke three heavily marketed brands, while only 54 

22 percent of adults, 26 and older, smoke these same 

23 brands. 

24 (24) Tobacco company documents indicate that 

25 young people are an important and often crucial seg-
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1 ment of the tobacco market. Children, who tend to be 

2 more price sensitive than adults, are influenced by 

3 advertising and promotion practices that result in 

4 drastically reduced cigarette prices. 

5 (25) Comprehensive advertising restrictions will 

6 have a positive effect on the smoking rates of young 

7 people. 

8 (26) Restrictions on advertising are necessary to 

9 prevent unrestricted tobacco advertising from under10 mining legislation prohibiting access to young people 

11 and providing for education about tobacco use. 

12 (27) International experience shows that adver13 tising regulations that are stringent and comprehen14 sive have a greater impact on overall tobacco use and 

15 young people’s use than weaker or less comprehensive 

16 ones. 

17 (28) Text only requirements, although not as 

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

19 tobacco products while preserving the informational 

20 function of advertising. 

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

22 adopt legislation to address the public health crisis 

23 created by actions of the tobacco industry. 

24 (30) The final regulations promulgated by the 

25 Secretary of Health and Human Services in the Au-
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1 gust 28, 1996, issue of the Federal Register (61 Fed. 

2 Reg. 44615–44618) for inclusion as part 897 of title 

3 21, Code of Federal Regulations, are consistent with 

4 the first amendment to the United States Constitution 

5 and with the standards set forth in the amendments 

6 made by this subtitle for the regulation of tobacco 

7 products by the Food and Drug Administration, and 

8 the restriction on the sale and distribution of, includ9 ing access to and the advertising and promotion of, 

10 tobacco products contained in such regulations are 

11 substantially related to accomplishing the public 

12 health goals of this division. 

13 (31) The regulations described in paragraph (30) 

14 will directly and materially advance the Federal Gov15 ernment’s substantial interest in reducing the number 

16 of children and adolescents who use cigarettes and 

17 smokeless tobacco and in preventing the life-threat18 ening health consequences associated with tobacco use. 

19 An overwhelming majority of Americans who use to20 bacco products begin using such products while they 

21 are minors and become addicted to the nicotine in 

22 those products before reaching the age of 18. Tobacco 

23 advertising and promotion play a crucial role in the 

24 decision of these minors to begin using tobacco prod25 ucts. Less restrictive and less comprehensive ap-
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1 proaches have not and will not be effective in reduc2 ing the problems addressed by such regulations. The 

3 reasonable restrictions on the advertising and pro4 motion of tobacco products contained in such regula5 tions will lead to a significant decrease in the number 

6 of minors using and becoming addicted to those prod7 ucts. 

8 (32) The regulations described in paragraph (30) 

9 impose no more extensive restrictions on communica10 tion by tobacco manufacturers and sellers than are 

11 necessary to reduce the number of children and ado12 lescents who use cigarettes and smokeless tobacco and 

13 to prevent the life-threatening health consequences as14 sociated with tobacco use. Such regulations are nar15 rowly tailored to restrict those advertising and pro16 motional practices which are most likely to be seen or 

17 heard by youth and most likely to entice them into 

18 tobacco use, while affording tobacco manufacturers 

19 and sellers ample opportunity to convey information 

20 about their products to adult consumers. 

21 (33) Tobacco dependence is a chronic disease, one 

22 that typically requires repeated interventions to 

23 achieve long-term or permanent abstinence. 
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1 (34) Because the only known safe alternative to 

2 smoking is cessation, interventions should target all 

3 smokers to help them quit completely. 

4 (35) Tobacco products have been used to facili5 tate and finance criminal activities both domestically 

6 and internationally. Illicit trade of tobacco products 

7 has been linked to organized crime and terrorist 

8 groups. 

9 (36) It is essential that the Food and Drug Ad10 ministration review products sold or distributed for 

11 use to reduce risks or exposures associated with to12 bacco products and that it be empowered to review 

13 any advertising and labeling for such products. It is 

14 also essential that manufacturers, prior to marketing 

15 such products, be required to demonstrate that such 

16 products will meet a series of rigorous criteria, and 

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

18 taking into account both users of tobacco products 

19 and persons who do not currently use tobacco prod20 ucts. 

21 (37) Unless tobacco products that purport to re22 duce the risks to the public of tobacco use actually re23 duce such risks, those products can cause substantial 

24 harm to the public health to the extent that the indi25 viduals, who would otherwise not consume tobacco 
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1 products or would consume such products less, use to2 bacco products purporting to reduce risk. Those who 

3 use products sold or distributed as modified risk prod4 ucts that do not in fact reduce risk, rather than quit5 ting or reducing their use of tobacco products, have 

6 a substantially increased likelihood of suffering dis7 ability and premature death. The costs to society of 

8 the widespread use of products sold or distributed as 

9 modified risk products that do not in fact reduce risk 

10 or that increase risk include thousands of unnecessary 

11 deaths and injuries and huge costs to our health care 

12 system. 

13 (38) As the National Cancer Institute has found, 

14 many smokers mistakenly believe that ‘‘low tar’’ and 

15 ‘‘light’’ cigarettes cause fewer health problems than 

16 other cigarettes. As the National Cancer Institute has 

17 also found, mistaken beliefs about the health con18 sequences of smoking ‘‘low tar’’ and ‘‘light’’ cigarettes 

19 can reduce the motivation to quit smoking entirely 

20 and thereby lead to disease and death. 

21 (39) Recent studies have demonstrated that there 

22 has been no reduction in risk on a population-wide 

23 basis from ‘‘low tar’’ and ‘‘light’’ cigarettes, and such 

24 products may actually increase the risk of tobacco 

25 use. 
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1 (40) The dangers of products sold or distributed 

2 as modified risk tobacco products that do not in fact 

3 reduce risk are so high that there is a compelling gov4 ernmental interest in ensuring that statements about 

5 modified risk tobacco products are complete, accurate, 

6 and relate to the overall disease risk of the product. 

7 (41) As the Federal Trade Commission has 

8 found, consumers have misinterpreted advertisements 

9 in which one product is claimed to be less harmful 

10 than a comparable product, even in the presence of 

11 disclosures and advisories intended to provide clari12 fication. 

13 (42) Permitting manufacturers to make unsub14 stantiated statements concerning modified risk to15 bacco products, whether express or implied, even if ac16 companied by disclaimers would be detrimental to the 

17 public health. 

18 (43) The only way to effectively protect the pub19 lic health from the dangers of unsubstantiated modi20 fied risk tobacco products is to empower the Food and 

21 Drug Administration to require that products that to22 bacco manufacturers sold or distributed for risk re23 duction be reviewed in advance of marketing, and to 

24 require that the evidence relied on to support claims 

25 be fully verified. 
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1 (44) The Food and Drug Administration is a 

2 regulatory agency with the scientific expertise to iden3 tify harmful substances in products to which con4 sumers are exposed, to design standards to limit expo5 sure to those substances, to evaluate scientific studies 

6 supporting claims about the safety of products, and to 

7 evaluate the impact of labels, labeling, and adver8 tising on consumer behavior in order to reduce the 

9 risk of harm and promote understanding of the im10 pact of the product on health. In connection with its 

11 mandate to promote health and reduce the risk of 

12 harm, the Food and Drug Administration routinely 

13 makes decisions about whether and how products may 

14 be marketed in the United States. 

15 (45) The Federal Trade Commission was created 

16 to protect consumers from unfair or deceptive acts or 

17 practices, and to regulate unfair methods of competi18 tion. Its focus is on those marketplace practices that 

19 deceive or mislead consumers, and those that give 

20 some competitors an unfair advantage. Its mission is 

21 to regulate activities in the marketplace. Neither the 

22 Federal Trade Commission nor any other Federal 

23 agency except the Food and Drug Administration 

24 possesses the scientific expertise needed to implement 
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1 effectively all provisions of the Family Smoking Pre2 vention and Tobacco Control Act. 

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

5 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 likely 

9 to be confused and misled. Depending upon the par10 ticular language used and its context, such a state11 ment could result in consumers being misled into be12 lieving that the product is endorsed by the Food and 

13 Drug Administration for use or in consumers being 

14 misled about the harmfulness of the product because 

15 of such regulation, inspection, approval, or compli16 ance. 

17 (47) In August 2006 a United States district 

18 court judge found that the major United States ciga19 rette 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 ciga24 rette companies dramatically increased their adver25 tising and promotional spending in ways that en-
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1 courage youth to start smoking subsequent to the sign2 ing of the Master Settlement Agreement in 1998. USA 

3 v. Philip Morris, USA, Inc., et al. (Civil Action No. 

4 99–2496 (GK), August 17, 2006). 

5 (49) In August 2006 a United States district 

6 court judge found that the major United States ciga7 rette companies have designed their cigarettes to pre8 cisely 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., et 

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

13 2006). 

14 SEC. 3. PURPOSE. 

15 The purposes of this division are— 

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

17 Administration to regulate tobacco products under the 

18 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 

19 et seq.), by recognizing it as the primary Federal reg20 ulatory authority with respect to the manufacture, 

21 marketing, and distribution of tobacco products as 

22 provided for in this division; 

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 on 

2 tobacco; 

3 (3) to authorize the Food and Drug Administra4 tion to set national standards controlling the manu5 facture of tobacco products and the identity, public 

6 disclosure, and amount of ingredients used in such 

7 products; 

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

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

11 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 to 

18 disclose research which has not previously been made 

19 available, as well as research generated in the future, 

20 relating to the health and dependency effects or safety 

21 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 underage 

25 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 trade 

7 in tobacco products. 

8 SEC. 4. SCOPE AND EFFECT. 

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

10 an amendment made by this division) shall be construed 

11 to— 

12 (1) establish a precedent with regard to any 

13 other industry, situation, circumstance, or legal ac14 tion; or 

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

16 or tribal court, or any agreement, consent decree, or 

17 contract of any kind. 

18 (b) AGRICULTURAL ACTIVITIES.—The provisions of 

19 this division (or an amendment made by this division) 

20 which authorize the Secretary to take certain actions with 

21 regard to tobacco and tobacco products shall not be con22 strued to affect any authority of the Secretary of Agri23 culture under existing law regarding the growing, cultiva24 tion, or curing of raw tobacco. 
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1 (c) REVENUE ACTIVITIES.—The provisions of this di2 vision (or an amendment made by this division) which au3 thorize the Secretary to take certain actions with regard 

4 to tobacco products shall not be construed to affect any au5 thority of the Secretary of the Treasury under chapter 52 

6 of the Internal Revenue Code of 1986. 

7 SEC. 5. SEVERABILITY. 

8 If any provision of this division, of the amendments 

9 made by this division, or of the regulations promulgated 

10 under this division (or under such amendments), or the ap11 plication of any such provision to any person or cir12 cumstance is held to be invalid, the remainder of this divi13 sion, such amendments and such regulations, and the appli14 cation of such provisions to any other person or cir15 cumstance shall not be affected and shall continue to be en16 forced to the fullest extent possible. 

17 SEC. 6. MODIFICATION OF DEADLINES FOR SECRETARIAL 

18 ACTION. 

19 (a) DELAYED COMMENCEMENT OF DATES FOR SECRE20 TARIAL ACTION.— 

21 (1) IN GENERAL.—Except as provided in sub22 section (c), with respect to any time periods specified 

23 in this division (or in an amendment made by this 

24 division) that begin on the date of enactment of this 

25 Act, within which the Secretary of Health and 
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1 Human Services is required to carry out and com2 plete specified activities, the calculation of such time 

3 periods shall commence on the date described in sub4 section (b). 

5 (2) LIMITATION.—Subsection (a) shall only 

6 apply with respect to obligations of the Secretary of 

7 Health and Human Services that must be completed 

8 within a specified time period and shall not apply to 

9 the obligations of any other person or to any other 

10 provision of this division (including the amendments 

11 made by this division) that do not create such obliga12 tions of the Secretary and are not contingent on ac13 tions by the Secretary. 

14 (b) DATE DESCRIBED.—The date described in this sub15 section is the first day of the first fiscal quarter following 

16 the initial 2 consecutive fiscal quarters of fiscal year 2010 

17 for which the Secretary of Health and Human Services has 

18 collected fees under section 919 of the Federal Food, Drug, 

19 and Cosmetic Act (as added by section 101). 

20 (c) EXCEPTION.—Subsection (a) shall not apply to 

21 any time period (or date) contained— 

22 (1) in section 102, except that the reference to 

23 ‘‘180 days’’ in subsection (a)(1) of such section shall 

24 be deemed to be ‘‘270 days’’; and 
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1 (2) in sections 201 through 204 (or the amend2 ments made by any such sections). 

3 (d) ADJUSTMENT.—The Secretary of Health and 

4 Human Services may extend or reduce the duration of one 

5 or more time periods to which subsection (a) applies if the 

6 Secretary determines appropriate, except that no such pe7 riod shall be extended for more than 90 days. 

8 TITLE I—AUTHORITY OF THE 

9 FOOD AND DRUG ADMINIS10 TRATION 

11 SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COS12 METIC ACT. 

13 (a) DEFINITION OF TOBACCO PRODUCTS.—Section 

14 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

15 321) is amended by adding at the end the following: 

16 ‘‘(rr)(1) The term ‘tobacco product’ means any product 

17 made or derived from tobacco that is intended for human 

18 consumption, including any component, part, or accessory 

19 of a tobacco product (except for raw materials other than 

20 tobacco used in manufacturing a component, part, or acces21 sory of a tobacco product). 

22 ‘‘(2) The term ‘tobacco product’ does not mean an arti23 cle that is a drug under subsection (g)(1), a device under 

24 subsection (h), or a combination product described in sec25 tion 503(g). 
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1 ‘‘(3) The products described in paragraph (2) shall be 

2 subject to chapter V of this Act. 

3 ‘‘(4) A tobacco product shall not be marketed in com4 bination with any other article or product regulated under 

5 this Act (including a drug, biologic, food, cosmetic, medical 

6 device, or a dietary supplement).’’. 

7 (b) FDA AUTHORITY OVER TOBACCO PRODUCTS.— 

8 The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 

9 et seq.) is amended— 

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

11 (2) by redesignating sections 901 through 910 as 

12 sections 1001 through 1010; and 

13 (3) by inserting after chapter VIII the following: 

14 ‘‘CHAPTER IX—TOBACCO PRODUCTS 

15 ‘‘SEC. 900. DEFINITIONS. 

16 ‘‘In this chapter: 

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

18 substance the intended use of which results or may 

19 reasonably be expected to result, directly or indirectly, 

20 in its becoming a component or otherwise affecting 

21 the characteristic of any tobacco product (including 

22 any substances intended for use as a flavoring or 

23 coloring or in producing, manufacturing, packing, 

24 processing, preparing, treating, packaging, trans25 porting, or holding), except that such term does not 
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1 include tobacco or a pesticide chemical residue in or 

2 on raw tobacco or a pesticide chemical. 

3 ‘‘(2) BRAND.—The term ‘brand’ means a variety 

4 of tobacco product distinguished by the tobacco used, 

5 tar content, nicotine content, flavoring used, size, fil6 tration, packaging, logo, registered trademark, brand 

7 name, identifiable pattern of colors, or any combina8 tion of such attributes. 

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

10 ‘‘(A) means a product that— 

11 ‘‘(i) is a tobacco product; and 

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

13 ‘cigarette’ in section 3(1) of the Federal Cig14 arette Labeling and Advertising Act; and 

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

16 functional in the product, which, because of its 

17 appearance, the type of tobacco used in the filler, 

18 or its packaging and labeling, is likely to be of19 fered to, or purchased by, consumers as a ciga20 rette or as roll-your-own tobacco. 

21 ‘‘(4) CIGARETTE TOBACCO.—The term ‘cigarette 

22 tobacco’ means any product that consists of loose to23 bacco that is intended for use by consumers in a ciga24 rette. Unless otherwise stated, the requirements appli-
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1 cable to cigarettes under this chapter shall also apply 

2 to cigarette tobacco. 

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

4 meaning given that term by section 3(2) of the Fed5 eral Cigarette Labeling and Advertising Act. 

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

7 term ‘counterfeit tobacco product’ means a tobacco 

8 product (or the container or labeling of such a prod9 uct) that, without authorization, bears the trademark, 

10 trade name, or other identifying mark, imprint, or 

11 device, or any likeness thereof, of a tobacco product 

12 listed in a registration under section 905(i)(1). 

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

14 regards a tobacco product means any person who fur15 thers the distribution of a tobacco product, whether 

16 domestic or imported, at any point from the original 

17 place of manufacture to the person who sells or dis18 tributes the product to individuals for personal con19 sumption. Common carriers are not considered dis20 tributors for purposes of this chapter. 

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

22 means any practice or conduct prohibited by law 

23 which relates to production, shipment, receipt, posses24 sion, distribution, sale, or purchase of tobacco prod-
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1 ucts including any practice or conduct intended to fa2 cilitate such activity. 

3 ‘‘(9) INDIAN COUNTRY.—The term ‘Indian coun4 try’ has the meaning given such term in section 1151 

5 of title 18, United States Code. 

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

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

8 Indian Self-Determination and Education Assistance 

9 Act. 

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

11 means a product that— 

12 ‘‘(A) is a tobacco product; and 

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

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

15 Labeling and Advertising Act. 

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

17 chemical substance named 3-(1-Methyl-2-pyrrolidinyl) 

18 pyridine or C[10]H[14]N[2], including any salt or 

19 complex of nicotine. 

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

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

22 other container, any wrapping (including cellophane), 

23 in which a tobacco product is offered for sale, sold, or 

24 otherwise distributed to consumers. 
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1 ‘‘(14) RETAILER.—The term ‘retailer’ means any 

2 person, government, or entity who sells tobacco prod3 ucts to individuals for personal consumption, or who 

4 operates a facility where self-service displays of to5 bacco products are permitted. 

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

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

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

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

10 or purchased by, consumers as tobacco for making 

11 cigarettes. 

12 ‘‘(16) SMALL TOBACCO PRODUCT MANUFAC13 TURER.—The term ‘small tobacco product manufac14 turer’ means a tobacco product manufacturer that 

15 employs fewer than 350 employees. For purposes of 

16 determining the number of employees of a manufac17 turer under the preceding sentence, the employees of 

18 a manufacturer are deemed to include the employees 

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

20 under common control with such manufacturer. 

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

22 constituent’ means any chemical or chemical com23 pound in mainstream or sidestream tobacco smoke 

24 that either transfers from any component of the ciga25 rette to the smoke or that is formed by the combustion 
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1 or heating of tobacco, additives, or other component of 

2 the tobacco product. 

3 ‘‘(18) SMOKELESS TOBACCO.—The term ‘smoke4 less tobacco’ means any tobacco product that consists 

5 of cut, ground, powdered, or leaf tobacco and that is 

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

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

8 and ‘Territory’ shall have the meanings given to such 

9 terms in section 201. 

10 ‘‘(20) TOBACCO PRODUCT MANUFACTURER.—The 

11 term ‘tobacco product manufacturer’ means any per12 son, including any repacker or relabeler, who— 

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

14 processes, or labels a tobacco product; or 

15 ‘‘(B) imports a finished tobacco product for 

16 sale or distribution in the United States. 

17 ‘‘(21) TOBACCO WAREHOUSE.— 

18 ‘‘(A) Subject to subparagraphs (B) and (C), 

19 the term ‘tobacco warehouse’ includes any per20 son— 

21 ‘‘(i) who— 

22 ‘‘(I) removes foreign material 

23 from tobacco leaf through nothing other 

24 than a mechanical process; 
27 

† HR 1256 EAS 

1 ‘‘(II) humidifies tobacco leaf with 

2 nothing other than potable water in the 

3 form of steam or mist; or 

4 ‘‘(III) de-stems, dries, and packs 

5 tobacco leaf for storage and shipment; 

6 ‘‘(ii) who performs no other actions 

7 with respect to tobacco leaf; and 

8 ‘‘(iii) who provides to any manufac9 turer to whom the person sells tobacco all 

10 information related to the person’s actions 

11 described in clause (i) that is necessary for 

12 compliance with this Act. 

13 ‘‘(B) The term ‘tobacco warehouse’ excludes 

14 any person who— 

15 ‘‘(i) reconstitutes tobacco leaf; 

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

17 retailer of a tobacco product; or 

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

19 or substance to the tobacco leaf other than 

20 potable water in the form of steam or mist. 

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

22 warehouse’ in subparagraph (A) shall not apply 

23 to the extent to which the Secretary determines, 

24 through rulemaking, that regulation under this 

25 chapter of the actions described in such subpara-
28 

† HR 1256 EAS 

1 graph is appropriate for the protection of the 

2 public health. 

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

4 States’ means the 50 States of the United States of 

5 America and the District of Columbia, the Common6 wealth of Puerto Rico, Guam, the Virgin Islands, 

7 American Samoa, Wake Island, Midway Islands, 

8 Kingman Reef, Johnston Atoll, the Northern Mariana 

9 Islands, and any other trust territory or possession of 

10 the United States. 

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

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

13 modified risk tobacco products for which an order has been 

14 issued in accordance with section 911, shall be regulated 

15 by the Secretary under this chapter and shall not be subject 

16 to the provisions of chapter V. 

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

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

19 smokeless tobacco and to any other tobacco products that 

20 the Secretary by regulation deems to be subject to this chap21 ter. 

22 ‘‘(c) SCOPE.— 

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

24 any policy issued or regulation promulgated there25 under, or in sections 101(a), 102, or 103 of title I, 
29 

† HR 1256 EAS 

1 title II, or title III of the Family Smoking Prevention 

2 and Tobacco Control Act, shall be construed to affect, 

3 expand, or limit the Secretary’s authority over (in4 cluding the authority to determine whether products 

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

6 under this Act that are not tobacco products under 

7 chapter V or any other chapter. 

8 ‘‘(2) LIMITATION OF AUTHORITY.— 

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

10 chapter shall not apply to tobacco leaf that is not 

11 in the possession of a manufacturer of tobacco 

12 products, or to the producers of tobacco leaf, in13 cluding tobacco growers, tobacco warehouses, and 

14 tobacco grower cooperatives, nor shall any em15 ployee of the Food and Drug Administration 

16 have any authority to enter onto a farm owned 

17 by a producer of tobacco leaf without the written 

18 consent of such producer. 

19 ‘‘(B) EXCEPTION.—Notwithstanding sub20 paragraph (A), if a producer of tobacco leaf is 

21 also a tobacco product manufacturer or con22 trolled by a tobacco product manufacturer, the 

23 producer shall be subject to this chapter in the 

24 producer’s capacity as a manufacturer. The ex25 ception in this subparagraph shall not apply to 
30 

† HR 1256 EAS 

1 a producer of tobacco leaf who grows tobacco 

2 under a contract with a tobacco product manu3 facturer and who is not otherwise engaged in the 

4 manufacturing process. 

5 ‘‘(C) RULE OF CONSTRUCTION.—Nothing in 

6 this chapter shall be construed to grant the Sec7 retary authority to promulgate regulations on 

8 any matter that involves the production of to9 bacco leaf or a producer thereof, other than ac10 tivities by a manufacturer affecting production. 

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

12 under this chapter shall be in accordance with chapter 5 

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

14 construed to affect the rulemaking provisions of section 

15 102(a) of the Family Smoking Prevention and Tobacco 

16 Control Act. 

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

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

19 Smoking Prevention and Tobacco Control Act, the Sec20 retary shall establish within the Food and Drug Adminis21 tration the Center for Tobacco Products, which shall report 

22 to the Commissioner of Food and Drugs in the same man23 ner as the other agency centers within the Food and Drug 

24 Administration. The Center shall be responsible for the im-
31 

† HR 1256 EAS 

1 plementation of this chapter and related matters assigned 

2 by the Commissioner. 

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

4 MANUFACTURERS.—The Secretary shall establish within 

5 the Food and Drug Administration an identifiable office 

6 to provide technical and other nonfinancial assistance to 

7 small tobacco product manufacturers to assist them in com8 plying with the requirements of this Act. 

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

10 to promulgating rules under this chapter, the Secretary 

11 shall endeavor to consult with other Federal agencies as ap12 propriate. 

13 ‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS. 

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

15 if— 

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

17 putrid, or decomposed substance, or is otherwise con18 taminated by any added poisonous or added delete19 rious substance that may render the product injurious 

20 to health; 

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

22 insanitary conditions whereby it may have been con23 taminated with filth, or whereby it may have been 

24 rendered injurious to health; 
32 

† HR 1256 EAS 

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

2 part, of any poisonous or deleterious substance which 

3 may render the contents injurious to health; 

4 ‘‘(4) the manufacturer or importer of the tobacco 

5 product fails to pay a user fee assessed to such manu6 facturer or importer pursuant to section 919 by the 

7 date specified in section 919 or by the 30th day after 

8 final agency action on a resolution of any dispute as 

9 to the amount of such fee; 

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

11 a tobacco product which is subject to a tobacco prod12 uct standard established under section 907 unless such 

13 tobacco product is in all respects in conformity with 

14 such standard; 

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

16 premarket review and does not have an order in effect 

17 under section 910(c)(1)(A)(i); or 

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

19 910(c)(1)(A); 

20 ‘‘(7) the methods used in, or the facilities or con21 trols used for, its manufacture, packing, or storage 

22 are not in conformity with applicable requirements 

23 under section 906(e)(1) or an applicable condition 

24 prescribed by an order under section 906(e)(2); or 

25 ‘‘(8) it is in violation of section 911. 
33 

† HR 1256 EAS 

1 ‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS. 

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

3 to be misbranded— 

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

5 particular; 

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

7 containing— 

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

9 tobacco product manufacturer, packer, or dis10 tributor; 

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

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

13 numerical count; 

14 ‘‘(C) an accurate statement of the percent15 age of the tobacco used in the product that is do16 mestically grown tobacco and the percentage that 

17 is foreign grown tobacco; and 

18 ‘‘(D) the statement required under section 

19 920(a), 

20 except that under subparagraph (B) reasonable vari21 ations shall be permitted, and exemptions as to small 

22 packages shall be established, by regulations pre23 scribed by the Secretary; 

24 ‘‘(3) if any word, statement, or other informa25 tion required by or under authority of this chapter to 

26 appear on the label or labeling is not prominently 
34 

† HR 1256 EAS 

1 placed thereon with such conspicuousness (as com2 pared with other words, statements, or designs in the 

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

4 be read and understood by the ordinary individual 

5 under customary conditions of purchase and use; 

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

7 label bears, to the exclusion of any other nonpropri8 etary name, its established name prominently printed 

9 in type as required by the Secretary by regulation; 

10 ‘‘(5) if the Secretary has issued regulations re11 quiring that its labeling bear adequate directions for 

12 use, or adequate warnings against use by children, 

13 that are necessary for the protection of users unless its 

14 labeling conforms in all respects to such regulations; 

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

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

18 905(d), or 905(h), if it was not included in a list re19 quired by section 905(i), if a notice or other informa20 tion respecting it was not provided as required by 

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

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

24 905(e) as the Secretary by regulation requires; 
35 

† HR 1256 EAS 

1 ‘‘(7) if, in the case of any tobacco product dis2 tributed or offered for sale in any State— 

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

4 in any particular; or 

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

6 regulations prescribed under section 906(d); 

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

8 distributed or offered for sale in any State, the manu9 facturer, packer, or distributor thereof includes in all 

10 advertisements and other descriptive printed matter 

11 issued or caused to be issued by the manufacturer, 

12 packer, or distributor with respect to that tobacco 

13 product— 

14 ‘‘(A) a true statement of the tobacco prod15 uct’s established name as described in paragraph 

16 (4), printed prominently; and 

17 ‘‘(B) a brief statement of— 

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

19 relevant warnings, precautions, side effects, 

20 and contraindications; and 

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

22 products made subject to a finding by the 

23 Secretary after notice and opportunity for 

24 comment that such action is appropriate to 

25 protect the public health, a full description 
36 

† HR 1256 EAS 

1 of the components of such tobacco product or 

2 the formula showing quantitatively each in3 gredient of such tobacco product to the ex4 tent required in regulations which shall be 

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

7 ‘‘(9) if it is a tobacco product subject to a to8 bacco product standard established under section 907, 

9 unless it bears such labeling as may be prescribed in 

10 such tobacco product standard; or 

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

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

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

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

17 Secretary may, by regulation, require prior approval of 

18 statements made on the label of a tobacco product to ensure 

19 that such statements do not violate the misbranding provi20 sions of subsection (a) and that such statements comply 

21 with other provisions of the Family Smoking Prevention 

22 and Tobacco Control Act (including the amendments made 

23 by such Act). No regulation issued under this subsection 

24 may require prior approval by the Secretary of the content 

25 of any advertisement, except for modified risk tobacco prod-
37 

† HR 1256 EAS 

1 ucts as provided in section 911. No advertisement of a to2 bacco product published after the date of enactment of the 

3 Family Smoking Prevention and Tobacco Control Act shall, 

4 with respect to the language of label statements as pre5 scribed under section 4 of the Federal Cigarette Labeling 

6 and Advertising Act and section 3 of the Comprehensive 

7 Smokeless Tobacco Health Education Act of 1986 or the reg8 ulations issued under such sections, be subject to the provi9 sions of sections 12 through 15 of the Federal Trade Com10 mission Act. 

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

12 SECRETARY. 

13 ‘‘(a) REQUIREMENT.—Each tobacco product manufac14 turer or importer, or agents thereof, shall submit to the Sec15 retary the following information: 

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

17 enactment of the Family Smoking Prevention and To18 bacco Control Act, a listing of all ingredients, includ19 ing tobacco, substances, compounds, and additives 

20 that are, as of such date, added by the manufacturer 

21 to the tobacco, paper, filter, or other part of each to22 bacco product by brand and by quantity in each 

23 brand and subbrand. 

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

25 form of nicotine in each tobacco product measured in 
38 

† HR 1256 EAS 

1 milligrams of nicotine in accordance with regulations 

2 promulgated by the Secretary in accordance with sec3 tion 4(e) of the Federal Cigarette Labeling and Adver4 tising Act. 

5 ‘‘(3) Beginning 3 years after the date of enact6 ment of the Family Smoking Prevention and Tobacco 

7 Control Act, a listing of all constituents, including 

8 smoke constituents as applicable, identified by the 

9 Secretary as harmful or potentially harmful to health 

10 in each tobacco product, and as applicable in the 

11 smoke of each tobacco product, by brand and by 

12 quantity in each brand and subbrand. Effective be13 ginning 3 years after such date of enactment, the 

14 manufacturer, importer, or agent shall comply with 

15 regulations promulgated under section 915 in report16 ing information under this paragraph, where applica17 ble. 

18 ‘‘(4) Beginning 6 months after the date of enact19 ment of the Family Smoking Prevention and Tobacco 

20 Control Act, all documents developed after such date 

21 of enactment that relate to health, toxicological, be22 havioral, or physiologic effects of current or future to23 bacco products, their constituents (including smoke 

24 constituents), ingredients, components, and additives. 
39 

† HR 1256 EAS 

1 ‘‘(b) DATA SUBMISSION.—At the request of the Sec2 retary, each tobacco product manufacturer or importer of 

3 tobacco products, or agents thereof, shall submit the fol4 lowing: 

5 ‘‘(1) Any or all documents (including underlying 

6 scientific information) relating to research activities, 

7 and research findings, conducted, supported, or pos8 sessed by the manufacturer (or agents thereof) on the 

9 health, toxicological, behavioral, or physiologic effects 

10 of tobacco products and their constituents (including 

11 smoke constituents), ingredients, components, and ad12 ditives. 

13 ‘‘(2) Any or all documents (including underlying 

14 scientific information) relating to research activities, 

15 and research findings, conducted, supported, or pos16 sessed by the manufacturer (or agents thereof) that re17 late to the issue of whether a reduction in risk to 

18 health from tobacco products can occur upon the em19 ployment of technology available or known to the 

20 manufacturer. 

21 ‘‘(3) Any or all documents (including underlying 

22 scientific or financial information) relating to mar23 keting research involving the use of tobacco products 

24 or marketing practices and the effectiveness of such 
40 

† HR 1256 EAS 

1 practices used by tobacco manufacturers and distribu2 tors. 

3 An importer of a tobacco product not manufactured in the 

4 United States shall supply the information required of a 

5 tobacco product manufacturer under this subsection. 

6 ‘‘(c) TIME FOR SUBMISSION.— 

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

8 delivery for introduction into interstate commerce of 

9 a tobacco product not on the market on the date of 

10 enactment of the Family Smoking Prevention and To11 bacco Control Act, the manufacturer of such product 

12 shall provide the information required under sub13 section (a). 

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

15 a tobacco product manufacturer adds to its tobacco 

16 products a new tobacco additive or increases the 

17 quantity of an existing tobacco additive, the manufac18 turer shall, except as provided in paragraph (3), at 

19 least 90 days prior to such action so advise the Sec20 retary in writing. 

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

22 any time a tobacco product manufacturer eliminates 

23 or decreases an existing additive, or adds or increases 

24 an additive that has by regulation been designated by 

25 the Secretary as an additive that is not a human or 
41 

† HR 1256 EAS 

1 animal carcinogen, or otherwise harmful to health 

2 under intended conditions of use, the manufacturer 

3 shall within 60 days of such action so advise the Sec4 retary in writing. 

5 ‘‘(d) DATA LIST.— 

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

7 the date of enactment of the Family Smoking Preven8 tion and Tobacco Control Act, and annually there9 after, the Secretary shall publish in a format that is 

10 understandable and not misleading to a lay person, 

11 and place on public display (in a manner determined 

12 by the Secretary) the list established under subsection 

13 (e). 

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

15 shall conduct periodic consumer research to ensure 

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

17 misleading to lay persons. Not later than 5 years 

18 after the date of enactment of the Family Smoking 

19 Prevention and Tobacco Control Act, the Secretary 

20 shall submit to the appropriate committees of Con21 gress a report on the results of such research, together 

22 with recommendations on whether such publication 

23 should be continued or modified. 

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

25 after the date of enactment of the Family Smoking Preven-
42 

† HR 1256 EAS 

1 tion and Tobacco Control Act, the Secretary shall establish, 

2 and periodically revise as appropriate, a list of harmful 

3 and potentially harmful constituents, including smoke con4 stituents, to health in each tobacco product by brand and 

5 by quantity in each brand and subbrand. The Secretary 

6 shall publish a public notice requesting the submission by 

7 interested persons of scientific and other information con8 cerning the harmful and potentially harmful constituents 

9 in tobacco products and tobacco smoke. 

10 ‘‘SEC. 905. ANNUAL REGISTRATION. 

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

12 ‘‘(1) MANUFACTURE, PREPARATION, 

13 COMPOUNDING, OR PROCESSING.—The term ‘manufac14 ture, preparation, compounding, or processing’ shall 

15 include repackaging or otherwise changing the con16 tainer, wrapper, or labeling of any tobacco product 

17 package in furtherance of the distribution of the to18 bacco product from the original place of manufacture 

19 to the person who makes final delivery or sale to the 

20 ultimate consumer or user. 

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

22 the case of a partnership the name of each partner 

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

24 corporate officer and director, and the State of incor25 poration. 
43 

† HR 1256 EAS 

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

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

3 owns or operates any establishment in any State engaged 

4 in the manufacture, preparation, compounding, or proc5 essing of a tobacco product or tobacco products shall register 

6 with the Secretary the name, places of business, and all such 

7 establishments of that person. If enactment of the Family 

8 Smoking Prevention and Tobacco Control Act occurs in the 

9 second half of the calendar year, the Secretary shall des10 ignate a date no later than 6 months into the subsequent 

11 calendar year by which registration pursuant to this sub12 section shall occur. 

13 ‘‘(c) REGISTRATION BY NEW OWNERS AND OPERA14 TORS.—Every person upon first engaging in the manufac15 ture, preparation, compounding, or processing of a tobacco 

16 product or tobacco products in any establishment owned or 

17 operated in any State by that person shall immediately reg18 ister with the Secretary that person’s name, place of busi19 ness, and such establishment. 

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

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

22 (c) shall immediately register with the Secretary any addi23 tional establishment which that person owns or operates in 

24 any State and in which that person begins the manufacture, 
44 

† HR 1256 EAS 

1 preparation, compounding, or processing of a tobacco prod2 uct or tobacco products. 

3 ‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYSTEM.— 

4 The Secretary may by regulation prescribe a uniform sys5 tem for the identification of tobacco products and may re6 quire that persons who are required to list such tobacco 

7 products under subsection (i) shall list such tobacco prod8 ucts in accordance with such system. 

9 ‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA10 TION.—The Secretary shall make available for inspection, 

11 to any person so requesting, any registration filed under 

12 this section. 

13 ‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB14 LISHMENTS.—Every establishment registered with the Sec15 retary under this section shall be subject to inspection under 

16 section 704 or subsection (h), and every such establishment 

17 engaged in the manufacture, compounding, or processing 

18 of a tobacco product or tobacco products shall be so in19 spected by 1 or more officers or employees duly designated 

20 by the Secretary at least once in the 2-year period begin21 ning with the date of registration of such establishment 

22 under this section and at least once in every successive 2- 

23 year period thereafter. 

24 ‘‘(h) REGISTRATION BY FOREIGN ESTABLISHMENTS.— 

25 Any establishment within any foreign country engaged in 
45 

† HR 1256 EAS 

1 the manufacture, preparation, compounding, or processing 

2 of a tobacco product or tobacco products, shall register 

3 under this section under regulations promulgated by the 

4 Secretary. Such regulations shall require such establishment 

5 to provide the information required by subsection (i) and 

6 shall include provisions for registration of any such estab7 lishment upon condition that adequate and effective means 

8 are available, by arrangement with the government of such 

9 foreign country or otherwise, to enable the Secretary to de10 termine from time to time whether tobacco products manu11 factured, prepared, compounded, or processed in such estab12 lishment, if imported or offered for import into the United 

13 States, shall be refused admission on any of the grounds 

14 set forth in section 801(a). 

15 ‘‘(i) REGISTRATION INFORMATION.— 

16 ‘‘(1) PRODUCT LIST.—Every person who reg17 isters with the Secretary under subsection (b), (c), (d), 

18 or (h) shall, at the time of registration under any 

19 such subsection, file with the Secretary a list of all to20 bacco products which are being manufactured, pre21 pared, compounded, or processed by that person for 

22 commercial distribution and which have not been in23 cluded in any list of tobacco products filed by that 

24 person with the Secretary under this paragraph or 

25 paragraph (2) before such time of registration. Such 
46 

† HR 1256 EAS 

1 list shall be prepared in such form and manner as the 

2 Secretary may prescribe and shall be accompanied 

3 by— 

4 ‘‘(A) in the case of a tobacco product con5 tained in the applicable list with respect to 

6 which a tobacco product standard has been estab7 lished under section 907 or which is subject to 

8 section 910, a reference to the authority for the 

9 marketing of such tobacco product and a copy of 

10 all labeling for such tobacco product; 

11 ‘‘(B) in the case of any other tobacco prod12 uct contained in an applicable list, a copy of all 

13 consumer information and other labeling for 

14 such tobacco product, a representative sampling 

15 of advertisements for such tobacco product, and, 

16 upon request made by the Secretary for good 

17 cause, a copy of all advertisements for a par18 ticular tobacco product; and 

19 ‘‘(C) if the registrant filing a list has deter20 mined that a tobacco product contained in such 

21 list is not subject to a tobacco product standard 

22 established under section 907, a brief statement 

23 of the basis upon which the registrant made such 

24 determination if the Secretary requests such a 
47 

† HR 1256 EAS 

1 statement with respect to that particular tobacco 

2 product. 

3 ‘‘(2) CONSULTATION WITH RESPECT TO

4 FORMS.—The Secretary shall consult with the Sec5 retary of the Treasury in developing the forms to be 

6 used for registration under this section to minimize 

7 the burden on those persons required to register with 

8 both the Secretary and the Tax and Trade Bureau of 

9 the Department of the Treasury. 

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

11 PRODUCT LIST.—Each person who registers with the 

12 Secretary under this section shall report to the Sec13 retary once during the month of June of each year 

14 and once during the month of December of each year 

15 the following: 

16 ‘‘(A) A list of each tobacco product intro17 duced by the registrant for commercial distribu18 tion which has not been included in any list pre19 viously filed by that person with the Secretary 

20 under this subparagraph or paragraph (1). A 

21 list under this subparagraph shall list a tobacco 

22 product by its established name and shall be ac23 companied by the other information required by 

24 paragraph (1). 
48 

† HR 1256 EAS 

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

2 made a report under this paragraph that person 

3 has discontinued the manufacture, preparation, 

4 compounding, or processing for commercial dis5 tribution of a tobacco product included in a list 

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

7 notice of such discontinuance, the date of such 

8 discontinuance, and the identity of its estab9 lished name. 

10 ‘‘(C) If since the date the registrant reported 

11 under subparagraph (B) a notice of discontinu12 ance that person has resumed the manufacture, 

13 preparation, compounding, or processing for 

14 commercial distribution of the tobacco product 

15 with respect to which such notice of discontinu16 ance was reported, notice of such resumption, the 

17 date of such resumption, the identity of such to18 bacco product by established name, and other in19 formation required by paragraph (1), unless the 

20 registrant has previously reported such resump21 tion to the Secretary under this subparagraph. 

22 ‘‘(D) Any material change in any informa23 tion previously submitted under this paragraph 

24 or paragraph (1). 
49 

† HR 1256 EAS 

1 ‘‘(j) REPORT PRECEDING INTRODUCTION OF CERTAIN

2 SUBSTANTIALLY EQUIVALENT PRODUCTS INTO INTER3 STATE COMMERCE.— 

4 ‘‘(1) IN GENERAL.—Each person who is required 

5 to register under this section and who proposes to 

6 begin the introduction or delivery for introduction 

7 into interstate commerce for commercial distribution 

8 of a tobacco product intended for human use that was 

9 not commercially marketed (other than for test mar10 keting) in the United States as of February 15, 2007, 

11 shall, at least 90 days prior to making such introduc12 tion or delivery, report to the Secretary (in such form 

13 and manner as the Secretary shall prescribe)— 

14 ‘‘(A) the basis for such person’s determina15 tion that— 

16 ‘‘(i) the tobacco product is substan17 tially equivalent, within the meaning of sec18 tion 910, to a tobacco product commercially 

19 marketed (other than for test marketing) in 

20 the United States as of February 15, 2007, 

21 or to a tobacco product that the Secretary 

22 has previously determined, pursuant to sub23 section (a)(3) of section 910, is substantially 

24 equivalent and that is in compliance with 

25 the requirements of this Act; or 
50 

† HR 1256 EAS 

1 ‘‘(ii) the tobacco product is modified 

2 within the meaning of paragraph (3), the 

3 modifications are to a product that is com4 mercially marketed and in compliance with 

5 the requirements of this Act, and all of the 

6 modifications are covered by exemptions 

7 granted by the Secretary pursuant to para8 graph (3); and 

9 ‘‘(B) action taken by such person to comply 

10 with the requirements under section 907 that are 

11 applicable to the tobacco product. 

12 ‘‘(2) APPLICATION TO CERTAIN POST-FEBRUARY

13 15, 2007, PRODUCTS.—A report under this subsection 

14 for a tobacco product that was first introduced or de15 livered for introduction into interstate commerce for 

16 commercial distribution in the United States after 

17 February 15, 2007, and prior to the date that is 21 

18 months after the date of enactment of the Family 

19 Smoking Prevention and Tobacco Control Act shall be 

20 submitted to the Secretary not later than 21 months 

21 after such date of enactment. 

22 ‘‘(3) EXEMPTIONS.— 

23 ‘‘(A) IN GENERAL.—The Secretary may ex24 empt from the requirements of this subsection re25 lating to the demonstration that a tobacco prod-
51 

† HR 1256 EAS 

1 uct is substantially equivalent within the mean2 ing of section 910, tobacco products that are 

3 modified by adding or deleting a tobacco addi4 tive, or increasing or decreasing the quantity of 

5 an existing tobacco additive, if the Secretary de6 termines that— 

7 ‘‘(i) such modification would be a 

8 minor modification of a tobacco product 

9 that can be sold under this Act; 

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

11 not necessary to ensure that permitting the 

12 tobacco product to be marketed would be ap13 propriate for protection of the public health; 

14 and 

15 ‘‘(iii) an exemption is otherwise appro16 priate. 

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

18 months after the date of enactment of the Family 

19 Smoking Prevention and Tobacco Control Act, 

20 the Secretary shall issue regulations to imple21 ment this paragraph. 

22 ‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL 

23 OF TOBACCO PRODUCTS. 

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

25 under section 902, 903, 905, or 909 applicable to a tobacco 
52 

† HR 1256 EAS 

1 product shall apply to such tobacco product until the appli2 cability of the requirement to the tobacco product has been 

3 changed by action taken under section 907, section 910, sec4 tion 911, or subsection (d) of this section, and any require5 ment established by or under section 902, 903, 905, or 909 

6 which is inconsistent with a requirement imposed on such 

7 tobacco product under section 907, section 910, section 911, 

8 or subsection (d) of this section shall not apply to such to9 bacco product. 

10 ‘‘(b) INFORMATION ON PUBLIC ACCESS AND COM11 MENT.—Each notice of proposed rulemaking or other notifi12 cation under section 907, 908, 909, 910, or 911 or under 

13 this section, any other notice which is published in the Fed14 eral Register with respect to any other action taken under 

15 any such section and which states the reasons for such ac16 tion, and each publication of findings required to be made 

17 in connection with rulemaking under any such section shall 

18 set forth— 

19 ‘‘(1) the manner in which interested persons may 

20 examine data and other information on which the no21 tice or findings is based; and 

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

23 may present their comments on the notice or findings 

24 (including the need therefore) orally or in writing, 

25 which period shall be at least 60 days but may not 
53 

† HR 1256 EAS 

1 exceed 90 days unless the time is extended by the Sec2 retary by a notice published in the Federal Register 

3 stating good cause therefore. 

4 ‘‘(c) LIMITED CONFIDENTIALITY OF INFORMATION.— 

5 Any information reported to or otherwise obtained by the 

6 Secretary or the Secretary’s representative under section 

7 903, 904, 907, 908, 909, 910, 911, or 704, or under sub8 section (e) or (f) of this section, which is exempt from disclo9 sure under subsection (a) of section 552 of title 5, United 

10 States Code, by reason of subsection (b)(4) of that section 

11 shall be considered confidential and shall not be disclosed, 

12 except that the information may be disclosed to other offi13 cers or employees concerned with carrying out this chapter, 

14 or when relevant in any proceeding under this chapter. 

15 ‘‘(d) RESTRICTIONS.— 

16 ‘‘(1) IN GENERAL.—The Secretary may by regu17 lation require restrictions on the sale and distribution 

18 of a tobacco product, including restrictions on the ac19 cess to, and the advertising and promotion of, the to20 bacco product, if the Secretary determines that such 

21 regulation would be appropriate for the protection of 

22 the public health. The Secretary may by regulation 

23 impose restrictions on the advertising and promotion 

24 of a tobacco product consistent with and to full extent 

25 permitted by the first amendment to the Constitution. 
54 

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1 The finding as to whether such regulation would be 

2 appropriate for the protection of the public health 

3 shall be determined with respect to the risks and bene4 fits to the population as a whole, including users and 

5 nonusers of the tobacco product, and taking into ac6 count— 

7 ‘‘(A) the increased or decreased likelihood 

8 that existing users of tobacco products will stop 

9 using such products; and 

10 ‘‘(B) the increased or decreased likelihood 

11 that those who do not use tobacco products will 

12 start using such products. 

13 No such regulation may require that the sale or dis14 tribution of a tobacco product be limited to the writ15 ten or oral authorization of a practitioner licensed by 

16 law to prescribe medical products. 

17 ‘‘(2) LABEL STATEMENTS.—The label of a to18 bacco product shall bear such appropriate statements 

19 of the restrictions required by a regulation under sub20 section (a) as the Secretary may in such regulation 

21 prescribe. 

22 ‘‘(3) LIMITATIONS.— 

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

24 paragraph (1) may— 
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† HR 1256 EAS 

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

2 product in face-to-face transactions by a 

3 specific category of retail outlets; or 

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

5 of tobacco products to any person older than 

6 18 years of age. 

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

8 regulations issued by the Secretary, matchbooks 

9 of conventional size containing not more than 20 

10 paper matches, and which are customarily given 

11 away for free with the purchase of tobacco prod12 ucts, shall be considered as adult-written publi13 cations which shall be permitted to contain ad14 vertising. Notwithstanding the preceding sen15 tence, if the Secretary finds that such treatment 

16 of matchbooks is not appropriate for the protec17 tion of the public health, the Secretary may de18 termine by regulation that matchbooks shall not 

19 be considered adult-written publications. 

20 ‘‘(4) REMOTE SALES.— 

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

22 ‘‘(i) within 18 months after the date of 

23 enactment of the Family Smoking Preven24 tion and Tobacco Control Act, promulgate 

25 regulations regarding the sale and distribu-
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† HR 1256 EAS 

1 tion of tobacco products that occur through 

2 means other than a direct, face-to-face ex3 change between a retailer and a consumer 

4 in order to prevent the sale and distribution 

5 of tobacco products to individuals who have 

6 not attained the minimum age established 

7 by applicable law for the purchase of such 

8 products, including requirements for age 

9 verification; and 

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

11 enactment, issue regulations to address the 

12 promotion and marketing of tobacco prod13 ucts that are sold or distributed through 

14 means other than a direct, face-to-face ex15 change between a retailer and a consumer 

16 in order to protect individuals who have not 

17 attained the minimum age established by 

18 applicable law for the purchase of such 

19 products. 

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

21 Nothing in this paragraph limits the authority 

22 of the Secretary to take additional actions under 

23 the other paragraphs of this subsection. 

24 ‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE25 MENTS.— 
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† HR 1256 EAS 

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

2 CONFORM.— 

3 ‘‘(A) IN GENERAL.—In applying manufac4 turing restrictions to tobacco, the Secretary shall, 

5 in accordance with subparagraph (B), prescribe 

6 regulations (which may differ based on the type 

7 of tobacco product involved) requiring that the 

8 methods used in, and the facilities and controls 

9 used for, the manufacture, preproduction design 

10 validation (including a process to assess the per11 formance of a tobacco product), packing, and 

12 storage of a tobacco product conform to current 

13 good manufacturing practice, or hazard analysis 

14 and critical control point methodology, as pre15 scribed in such regulations to assure that the 

16 public health is protected and that the tobacco 

17 product is in compliance with this chapter. Such 

18 regulations may provide for the testing of raw 

19 tobacco for pesticide chemical residues regardless 

20 of whether a tolerance for such chemical residues 

21 has been established. 

22 ‘‘(B) REQUIREMENTS.—The Secretary 

23 shall— 

24 ‘‘(i) before promulgating any regula25 tion under subparagraph (A), afford the To-
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† HR 1256 EAS 

1 bacco Products Scientific Advisory Com2 mittee an opportunity to submit rec3 ommendations with respect to the regulation 

4 proposed to be promulgated; 

5 ‘‘(ii) before promulgating any regula6 tion under subparagraph (A), afford oppor7 tunity for an oral hearing; 

8 ‘‘(iii) provide the Tobacco Products 

9 Scientific Advisory Committee a reasonable 

10 time to make its recommendation with re11 spect to proposed regulations under sub12 paragraph (A); 

13 ‘‘(iv) in establishing the effective date 

14 of a regulation promulgated under this sub15 section, take into account the differences in 

16 the manner in which the different types of 

17 tobacco products have historically been pro18 duced, the financial resources of the dif19 ferent tobacco product manufacturers, and 

20 the state of their existing manufacturing fa21 cilities, and shall provide for a reasonable 

22 period of time for such manufacturers to 

23 conform to good manufacturing practices; 

24 and 
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1 ‘‘(v) not require any small tobacco 

2 product manufacturer to comply with a reg3 ulation under subparagraph (A) for at least 

4 4 years following the effective date estab5 lished by the Secretary for such regulation. 

6 ‘‘(2) EXEMPTIONS; VARIANCES.— 

7 ‘‘(A) PETITION.—Any person subject to any 

8 requirement prescribed under paragraph (1) 

9 may petition the Secretary for a permanent or 

10 temporary exemption or variance from such re11 quirement. Such a petition shall be submitted to 

12 the Secretary in such form and manner as the 

13 Secretary shall prescribe and shall— 

14 ‘‘(i) in the case of a petition for an ex15 emption from a requirement, set forth the 

16 basis for the petitioner’s determination that 

17 compliance with the requirement is not re18 quired to assure that the tobacco product 

19 will be in compliance with this chapter; 

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

21 variance from a requirement, set forth the 

22 methods proposed to be used in, and the fa23 cilities and controls proposed to be used for, 

24 the manufacture, packing, and storage of 

25 the tobacco product in lieu of the methods, 
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1 facilities, and controls prescribed by the re2 quirement; and 

3 ‘‘(iii) contain such other information 

4 as the Secretary shall prescribe. 

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

7 Secretary may refer to the Tobacco Products Sci8 entific Advisory Committee any petition sub9 mitted under subparagraph (A). The Tobacco 

10 Products Scientific Advisory Committee shall re11 port its recommendations to the Secretary with 

12 respect to a petition referred to it within 60 days 

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

14 days after— 

15 ‘‘(i) the date the petition was sub16 mitted to the Secretary under subparagraph 

17 (A); or 

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

20 Advisory Committee, 

21 whichever occurs later, the Secretary shall by 

22 order either deny the petition or approve it. 

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

2 tobacco product from a requirement if the 

3 Secretary determines that compliance with 

4 such requirement is not required to assure 

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

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

9 Secretary determines that the methods to be 

10 used in, and the facilities and controls to be 

11 used for, the manufacture, packing, and 

12 storage of the tobacco product in lieu of the 

13 methods, facilities, and controls prescribed 

14 by the requirement are sufficient to assure 

15 that the tobacco product will be in compli16 ance with this chapter. 

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

19 prescribe such conditions respecting the methods 

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

21 the manufacture, packing, and storage of the to22 bacco product to be granted the variance under 

23 the petition as may be necessary to assure that 

24 the tobacco product will be in compliance with 

25 this chapter. 
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† HR 1256 EAS 

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

2 order under subparagraph (B) respecting a peti3 tion, the petitioner shall have an opportunity for 

4 an informal hearing on such order. 

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

8 enactment of the Family Smoking Prevention and To9 bacco Control Act. 

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

11 may enter into contracts for research, testing, and dem12 onstrations respecting tobacco products and may obtain to13 bacco products for research, testing, and demonstration pur14 poses. 

15 ‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 

16 ‘‘(a) IN GENERAL.— 

17 ‘‘(1) SPECIAL RULES.— 

18 ‘‘(A) SPECIAL RULE FOR CIGARETTES.—Be19 ginning 3 months after the date of enactment of 

20 the Family Smoking Prevention and Tobacco 

21 Control Act, a cigarette or any of its component 

22 parts (including the tobacco, filter, or paper) 

23 shall not contain, as a constituent (including a 

24 smoke constituent) or additive, an artificial or 

25 natural flavor (other than tobacco or menthol) or 
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† HR 1256 EAS 

1 an herb or spice, including strawberry, grape, 

2 orange, clove, cinnamon, pineapple, vanilla, co3 conut, licorice, cocoa, chocolate, cherry, or coffee, 

4 that is a characterizing flavor of the tobacco 

5 product or tobacco smoke. Nothing in this sub6 paragraph shall be construed to limit the Sec7 retary’s authority to take action under this sec8 tion or other sections of this Act applicable to 

9 menthol or any artificial or natural flavor, herb, 

10 or spice not specified in this subparagraph. 

11 ‘‘(B) ADDITIONAL SPECIAL RULE.—Begin12 ning 2 years after the date of enactment of the 

13 Family Smoking Prevention and Tobacco Con14 trol Act, a tobacco product manufacturer shall 

15 not use tobacco, including foreign grown tobacco, 

16 that contains a pesticide chemical residue that is 

17 at a level greater than is specified by any toler18 ance applicable under Federal law to domesti19 cally grown tobacco. 

20 ‘‘(2) REVISION OF TOBACCO PRODUCT STAND21 ARDS.—The Secretary may revise the tobacco product 

22 standards in paragraph (1) in accordance with sub23 section (c). 

24 ‘‘(3) TOBACCO PRODUCT STANDARDS.— 
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† HR 1256 EAS 

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

2 adopt tobacco product standards in addition to 

3 those in paragraph (1) if the Secretary finds 

4 that a tobacco product standard is appropriate 

5 for the protection of the public health. 

6 ‘‘(B) DETERMINATIONS.— 

7 ‘‘(i) CONSIDERATIONS.—In making a 

8 finding described in subparagraph (A), the 

9 Secretary shall consider scientific evidence 

10 concerning— 

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

12 population as a whole, including users 

13 and nonusers of tobacco products, of 

14 the proposed standard; 

15 ‘‘(II) the increased or decreased 

16 likelihood that existing users of tobacco 

17 products will stop using such products; 

18 and 

19 ‘‘(III) the increased or decreased 

20 likelihood that those who do not use to21 bacco products will start using such 

22 products. 

23 ‘‘(ii) ADDITIONAL CONSIDERATIONS.— 

24 In the event that the Secretary makes a de25 termination, set forth in a proposed tobacco 
65 

† HR 1256 EAS 

1 product standard in a proposed rule, that it 

2 is appropriate for the protection of public 

3 health to require the reduction or elimi4 nation of an additive, constituent (includ5 ing a smoke constituent), or other compo6 nent of a tobacco product because the Sec7 retary has found that the additive, con8 stituent, or other component is or may be 

9 harmful, any party objecting to the pro10 posed standard on the ground that the pro11 posed standard will not reduce or eliminate 

12 the risk of illness or injury may provide for 

13 the Secretary’s consideration scientific evi14 dence that demonstrates that the proposed 

15 standard will not reduce or eliminate the 

16 risk of illness or injury. 

17 ‘‘(4) CONTENT OF TOBACCO PRODUCT STAND18 ARDS.—A tobacco product standard established under 

19 this section for a tobacco product— 

20 ‘‘(A) shall include provisions that are ap21 propriate for the protection of the public health, 

22 including provisions, where appropriate— 

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

24 ‘‘(ii) for the reduction or elimination 

25 of other constituents, including smoke con-
66 

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1 stituents, or harmful components of the 

2 product; or 

3 ‘‘(iii) relating to any other require4 ment under subparagraph (B); 

5 ‘‘(B) shall, where appropriate for the protec6 tion of the public health, include— 

7 ‘‘(i) provisions respecting the construc8 tion, components, ingredients, additives, 

9 constituents, including smoke constituents, 

10 and properties of the tobacco product; 

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

12 sample basis or, if necessary, on an indi13 vidual basis) of the tobacco product; 

14 ‘‘(iii) provisions for the measurement 

15 of the tobacco product characteristics of the 

16 tobacco product; 

17 ‘‘(iv) provisions requiring that the re18 sults of each or of certain of the tests of the 

19 tobacco product required to be made under 

20 clause (ii) show that the tobacco product is 

21 in conformity with the portions of the 

22 standard for which the test or tests were re23 quired; and 

24 ‘‘(v) a provision requiring that the sale 

25 and distribution of the tobacco product be 
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† HR 1256 EAS 

1 restricted but only to the extent that the sale 

2 and distribution of a tobacco product may 

3 be restricted under a regulation under sec4 tion 906(d); 

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

6 use and prescribe the form and content of label7 ing for the proper use of the tobacco product; and 

8 ‘‘(D) shall require tobacco products con9 taining foreign-grown tobacco to meet the same 

10 standards applicable to tobacco products con11 taining domestically grown tobacco. 

12 ‘‘(5) PERIODIC REEVALUATION OF TOBACCO

13 PRODUCT STANDARDS.—The Secretary shall provide 

14 for periodic evaluation of tobacco product standards 

15 established under this section to determine whether 

16 such standards should be changed to reflect new med17 ical, scientific, or other technological data. The Sec18 retary may provide for testing under paragraph 

19 (4)(B) by any person. 

20 ‘‘(6) INVOLVEMENT OF OTHER AGENCIES; IN21 FORMED PERSONS.—In carrying out duties under this 

22 section, the Secretary shall endeavor to— 

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

24 technical support available in other Federal 

25 agencies; 
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† HR 1256 EAS 

1 ‘‘(B) consult with other Federal agencies 

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

5 ‘‘(C) invite appropriate participation, 

6 through joint or other conferences, workshops, or 

7 other means, by informed persons representative 

8 of scientific, professional, industry, agricultural, 

9 or consumer organizations who in the Secretary’s 

10 judgment can make a significant contribution. 

11 ‘‘(b) CONSIDERATIONS BY SECRETARY.— 

12 ‘‘(1) TECHNICAL ACHIEVABILITY.—The Secretary 

13 shall consider information submitted in connection 

14 with a proposed standard regarding the technical 

15 achievability of compliance with such standard. 

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

17 shall consider all other information submitted in con18 nection with a proposed standard, including informa19 tion concerning the countervailing effects of the to20 bacco product standard on the health of adolescent to21 bacco users, adult tobacco users, or nontobacco users, 

22 such as the creation of a significant demand for con23 traband or other tobacco products that do not meet 

24 the requirements of this chapter and the significance 

25 of such demand. 
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† HR 1256 EAS 

1 ‘‘(c) PROPOSED STANDARDS.— 

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

3 in the Federal Register a notice of proposed rule4 making for the establishment, amendment, or revoca5 tion of any tobacco product standard. 

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

7 proposed rulemaking for the establishment or amend8 ment of a tobacco product standard for a tobacco 

9 product shall— 

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

11 justification that the tobacco product standard is 

12 appropriate for the protection of the public 

13 health; 

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

15 draft or proposed tobacco product standard for 

16 consideration by the Secretary; 

17 ‘‘(C) invite interested persons to submit 

18 comments on structuring the standard so that it 

19 does not advantage foreign-grown tobacco over 

20 domestically grown tobacco; and 

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

22 provide any information or analysis which the 

23 Secretary of Agriculture believes is relevant to 

24 the proposed tobacco product standard. 
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† HR 1256 EAS 

1 ‘‘(3) FINDING.—A notice of proposed rulemaking 

2 for the revocation of a tobacco product standard shall 

3 set forth a finding with supporting justification that 

4 the tobacco product standard is no longer appropriate 

5 for the protection of the public health. 

6 ‘‘(4) COMMENT.—The Secretary shall provide for 

7 a comment period of not less than 60 days. 

8 ‘‘(d) PROMULGATION.— 

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

10 period for comment on a notice of proposed rule11 making published under subsection (c) respecting a 

12 tobacco product standard and after consideration of 

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

14 and any report from the Tobacco Products Scientific 

15 Advisory Committee, the Secretary shall— 

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

17 standard would be appropriate for the protection 

18 of the public health, promulgate a regulation es19 tablishing a tobacco product standard and pub20 lish in the Federal Register findings on the mat21 ters referred to in subsection (c); or 

22 ‘‘(B) publish a notice terminating the pro23 ceeding for the development of the standard to24 gether with the reasons for such termination. 
71 

† HR 1256 EAS 

1 ‘‘(2) EFFECTIVE DATE.—A regulation estab2 lishing a tobacco product standard shall set forth the 

3 date or dates upon which the standard shall take ef4 fect, but no such regulation may take effect before 1 

5 year after the date of its publication unless the Sec6 retary determines that an earlier effective date is nec7 essary for the protection of the public health. Such 

8 date or dates shall be established so as to minimize, 

9 consistent with the public health, economic loss to, 

10 and disruption or dislocation of, domestic and inter11 national trade. In establishing such effective date or 

12 dates, the Secretary shall consider information sub13 mitted in connection with a proposed product stand14 ard by interested parties, including manufacturers 

15 and tobacco growers, regarding the technical 

16 achievability of compliance with the standard, and 

17 including information concerning the existence of pat18 ents that make it impossible to comply in the time19 frame envisioned in the proposed standard. If the Sec20 retary determines, based on the Secretary’s evaluation 

21 of submitted comments, that a product standard can 

22 be met only by manufacturers requiring substantial 

23 changes to the methods of farming the domestically 

24 grown tobacco used by the manufacturer, the effective 

25 date of that product standard shall be not less than 
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† HR 1256 EAS 

1 2 years after the date of publication of the final regu2 lation establishing the standard. 

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

4 FOOD AND DRUG ADMINISTRATION.—Because of the 

5 importance of a decision of the Secretary to issue a 

6 regulation— 

7 ‘‘(A) banning all cigarettes, all smokeless to8 bacco products, all little cigars, all cigars other 

9 than little cigars, all pipe tobacco, or all roll10 your-own tobacco products; or 

11 ‘‘(B) requiring the reduction of nicotine 

12 yields of a tobacco product to zero, 

13 the Secretary is prohibited from taking such actions 

14 under this Act. 

15 ‘‘(4) AMENDMENT; REVOCATION.— 

16 ‘‘(A) AUTHORITY.—The Secretary, upon the 

17 Secretary’s own initiative or upon petition of an 

18 interested person, may by a regulation, promul19 gated in accordance with the requirements of 

20 subsection (c) and paragraph (2), amend or re21 voke a tobacco product standard. 

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

23 may declare a proposed amendment of a tobacco 

24 product standard to be effective on and after its 

25 publication in the Federal Register and until the 
73 

† HR 1256 EAS 

1 effective date of any final action taken on such 

2 amendment if the Secretary determines that 

3 making it so effective is in the public interest. 

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

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

6 refer a proposed regulation for the establishment, 

7 amendment, or revocation of a tobacco product 

8 standard to the Tobacco Products Scientific Ad9 visory Committee for a report and recommenda10 tion with respect to any matter involved in the 

11 proposed regulation which requires the exercise of 

12 scientific judgment. 

13 ‘‘(B) INITIATION OF REFERRAL.—The Sec14 retary may make a referral under this para15 graph— 

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

17 or 

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

19 person that— 

20 ‘‘(I) demonstrates good cause for 

21 the referral; and 

22 ‘‘(II) is made before the expira23 tion of the period for submission of 

24 comments on the proposed regulation. 
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† HR 1256 EAS 

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

2 regulation is referred under this paragraph to 

3 the Tobacco Products Scientific Advisory Com4 mittee, the Secretary shall provide the Advisory 

5 Committee with the data and information on 

6 which such proposed regulation is based. 

7 ‘‘(D) REPORT AND RECOMMENDATION.—The 

8 Tobacco Products Scientific Advisory Committee 

9 shall, within 60 days after the referral of a pro10 posed regulation under this paragraph and after 

11 independent study of the data and information 

12 furnished to it by the Secretary and other data 

13 and information before it, submit to the Sec14 retary a report and recommendation respecting 

15 such regulation, together with all underlying 

16 data and information and a statement of the 

17 reason or basis for the recommendation. 

18 ‘‘(E) PUBLIC AVAILABILITY.—The Secretary 

19 shall make a copy of each report and rec20 ommendation under subparagraph (D) publicly 

21 available. 

22 ‘‘(e) MENTHOL CIGARETTES.— 

23 ‘‘(1) REFERRAL; CONSIDERATIONS.—Imme24 diately upon the establishment of the Tobacco Prod25 ucts Scientific Advisory Committee under section 
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† HR 1256 EAS 

1 917(a), the Secretary shall refer to the Committee for 

2 report and recommendation, under section 917(c)(4), 

3 the issue of the impact of the use of menthol in ciga4 rettes on the public health, including such use among 

5 children, African-Americans, Hispanics, and other 

6 racial and ethnic minorities. In its review, the To7 bacco Products Scientific Advisory Committee shall 

8 address the considerations listed in subsections 

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

10 ‘‘(2) REPORT AND RECOMMENDATION.—Not later 

11 than 1 year after its establishment, the Tobacco Prod12 uct Scientific Advisory Committee shall submit to the 

13 Secretary the report and recommendations required 

14 pursuant to paragraph (1). 

15 ‘‘(3) RULE OF CONSTRUCTION.—Nothing in this 

16 subsection shall be construed to limit the Secretary’s 

17 authority to take action under this section or other 

18 sections of this Act applicable to menthol. 

19 ‘‘(f) DISSOLVABLE TOBACCO PRODUCTS.— 

20 ‘‘(1) REFERRAL; CONSIDERATIONS.—The Sec21 retary shall refer to the Tobacco Products Scientific 

22 Advisory Committee for report and recommendation, 

23 under section 917(c)(4), the issue of the nature and 

24 impact of the use of dissolvable tobacco products on 

25 the public health, including such use among children. 
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† HR 1256 EAS 

1 In its review, the Tobacco Products Scientific Advi2 sory Committee shall address the considerations listed 

3 in subsection (a)(3)(B)(i). 

4 ‘‘(2) REPORT AND RECOMMENDATION.—Not later 

5 than 2 years after its establishment, the Tobacco 

6 Product Scientific Advisory Committee shall submit 

7 to the Secretary the report and recommendations re8 quired pursuant to paragraph (1). 

9 ‘‘(3) RULE OF CONSTRUCTION.—Nothing in this 

10 subsection shall be construed to limit the Secretary’s 

11 authority to take action under this section or other 

12 sections of this Act at any time applicable to any dis13 solvable tobacco product. 

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

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

16 that— 

17 ‘‘(1) a tobacco product which is introduced or de18 livered for introduction into interstate commerce for 

19 commercial distribution presents an unreasonable risk 

20 of substantial harm to the public health; and 

21 ‘‘(2) notification under this subsection is nec22 essary to eliminate the unreasonable risk of such 

23 harm and no more practicable means is available 

24 under the provisions of this chapter (other than this 

25 section) to eliminate such risk, 
77 

† HR 1256 EAS 

1 the Secretary may issue such order as may be necessary 

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

4 the circumstances involved, to all persons who should prop5 erly receive such notification in order to eliminate such 

6 risk. The Secretary may order notification by any appro7 priate means, including public service announcements. Be8 fore issuing an order under this subsection, the Secretary 

9 shall consult with the persons who are to give notice under 

10 the order. 

11 ‘‘(b) NO EXEMPTION FROM OTHER LIABILITY.—Com12 pliance with an order issued under this section shall not 

13 relieve any person from liability under Federal or State 

14 law. In awarding damages for economic loss in an action 

15 brought for the enforcement of any such liability, the value 

16 to the plaintiff in such action of any remedy provided under 

17 such order shall be taken into account. 

18 ‘‘(c) RECALL AUTHORITY.— 

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

20 there is a reasonable probability that a tobacco prod21 uct contains a manufacturing or other defect not ordi22 narily contained in tobacco products on the market 

23 that would cause serious, adverse health consequences 

24 or death, the Secretary shall issue an order requiring 

25 the appropriate person (including the manufacturers, 
78 

† HR 1256 EAS 

1 importers, distributors, or retailers of the tobacco 

2 product) to immediately cease distribution of such to3 bacco product. The order shall provide the person sub4 ject to the order with an opportunity for an informal 

5 hearing, to be held not later than 10 days after the 

6 date of the issuance of the order, on the actions re7 quired by the order and on whether the order should 

8 be amended to require a recall of such tobacco prod9 uct. If, after providing an opportunity for such a 

10 hearing, the Secretary determines that inadequate 

11 grounds exist to support the actions required by the 

12 order, the Secretary shall vacate the order. 

13 ‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE14 CALL.— 

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

16 opportunity for an informal hearing under 

17 paragraph (1), the Secretary determines that the 

18 order should be amended to include a recall of 

19 the tobacco product with respect to which the 

20 order was issued, the Secretary shall, except as 

21 provided in subparagraph (B), amend the order 

22 to require a recall. The Secretary shall specify a 

23 timetable in which the tobacco product recall will 

24 occur and shall require periodic reports to the 

25 Secretary describing the progress of the recall. 
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† HR 1256 EAS 

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

2 subparagraph (A)— 

3 ‘‘(i) shall not include recall of a to4 bacco product from individuals; and 

5 ‘‘(ii) shall provide for notice to persons 

6 subject to the risks associated with the use 

7 of such tobacco product. 

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

9 the Secretary may use the assistance of retailers 

10 and other persons who distributed such tobacco 

11 product. If a significant number of such persons 

12 cannot be identified, the Secretary shall notify 

13 such persons under section 705(b). 

14 ‘‘(3) REMEDY NOT EXCLUSIVE.—The remedy pro15 vided by this subsection shall be in addition to rem16 edies provided by subsection (a). 

17 ‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PROD18 UCTS. 

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

20 product manufacturer or importer of a tobacco product 

21 shall establish and maintain such records, make such re22 ports, and provide such information, as the Secretary may 

23 by regulation reasonably require to assure that such tobacco 

24 product is not adulterated or misbranded and to otherwise 
80 

† HR 1256 EAS 

1 protect public health. Regulations prescribed under the pre2 ceding sentence— 

3 ‘‘(1) may require a tobacco product manufac4 turer or importer to report to the Secretary whenever 

5 the manufacturer or importer receives or otherwise be6 comes aware of information that reasonably suggests 

7 that one of its marketed tobacco products may have 

8 caused or contributed to a serious unexpected adverse 

9 experience associated with the use of the product or 

10 any significant increase in the frequency of a serious, 

11 expected adverse product experience; 

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

13 adverse tobacco product experiences as determined by 

14 the Secretary to be necessary to be reported; 

15 ‘‘(3) shall not impose requirements unduly bur16 densome to a tobacco product manufacturer or im17 porter, taking into account the cost of complying with 

18 such requirements and the need for the protection of 

19 the public health and the implementation of this 

20 chapter; 

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

22 requests for reports or information, shall require that 

23 each request made under such regulations for submis24 sion of a report or information to the Secretary state 

25 the reason or purpose for such request and identify to 
81 

† HR 1256 EAS 

1 the fullest extent practicable such report or informa2 tion; 

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

4 information to the Secretary, shall state the reason or 

5 purpose for the submission of such report or informa6 tion and identify to the fullest extent practicable such 

7 report or information; and 

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

9 patient or user be disclosed in records, reports, or in10 formation required under this subsection unless re11 quired for the medical welfare of an individual, to de12 termine risks to public health of a tobacco product, or 

13 to verify a record, report, or information submitted 

14 under this chapter. 

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

17 the medical profession and the interests of patients. The 

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

19 reports, and information concerning any individual who 

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

21 to be a patient. 

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

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

25 tobacco product manufacturer or importer of a to-
82 

† HR 1256 EAS 

1 bacco product to report promptly to the Secretary any 

2 corrective action taken or removal from the market of 

3 a tobacco product undertaken by such manufacturer 

4 or importer if the removal or correction was under5 taken— 

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

7 tobacco product; or 

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

9 caused by the tobacco product which may present 

10 a risk to health. 

11 A tobacco product manufacturer or importer of a to12 bacco product who undertakes a corrective action or 

13 removal from the market of a tobacco product which 

14 is not required to be reported under this subsection 

15 shall keep a record of such correction or removal. 

16 ‘‘(2) EXCEPTION.—No report of the corrective ac17 tion or removal of a tobacco product may be required 

18 under paragraph (1) if a report of the corrective ac19 tion or removal is required and has been submitted 

20 under subsection (a). 

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

23 ‘‘(a) IN GENERAL.— 
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† HR 1256 EAS 

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

2 purposes of this section the term ‘new tobacco product’ 

3 means— 

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

5 products in test markets) that was not commer6 cially marketed in the United States as of Feb7 ruary 15, 2007; or 

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

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

11 content, delivery or form of nicotine, or any 

12 other additive or ingredient) of a tobacco product 

13 where the modified product was commercially 

14 marketed in the United States after February 15, 

15 2007. 

16 ‘‘(2) PREMARKET REVIEW REQUIRED.— 

17 ‘‘(A) NEW PRODUCTS.—An order under sub18 section (c)(1)(A)(i) for a new tobacco product is 

19 required unless— 

20 ‘‘(i) the manufacturer has submitted a 

21 report under section 905(j); and the Sec22 retary has issued an order that the tobacco 

23 product— 

24 ‘‘(I) is substantially equivalent to 

25 a tobacco product commercially mar-
84 

† HR 1256 EAS 

1 keted (other than for test marketing) in 

2 the United States as of February 15, 

3 2007; and 

4 ‘‘(II) is in compliance with the re5 quirements of this Act; or 

6 ‘‘(ii) the tobacco product is exempt 

7 from the requirements of section 905(j) pur8 suant to a regulation issued under section 

9 905(j)(3). 

10 ‘‘(B) APPLICATION TO CERTAIN POST-FEB11 RUARY 15, 2007, PRODUCTS.—Subparagraph (A) 

12 shall not apply to a tobacco product— 

13 ‘‘(i) that was first introduced or deliv14 ered for introduction into interstate com15 merce for commercial distribution in the 

16 United States after February 15, 2007, and 

17 prior to the date that is 21 months after the 

18 date of enactment of the Family Smoking 

19 Prevention and Tobacco Control Act; and 

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

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

22 period, 

23 except that subparagraph (A) shall apply to the 

24 tobacco product if the Secretary issues an order 
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† HR 1256 EAS 

1 that the tobacco product is not substantially 

2 equivalent. 

3 ‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.— 

4 ‘‘(A) IN GENERAL.—In this section and sec5 tion 905(j), the term ‘substantially equivalent’ or 

6 ‘substantial equivalence’ means, with respect to 

7 the tobacco product being compared to the predi8 cate tobacco product, that the Secretary by order 

9 has found that the tobacco product— 

10 ‘‘(i) has the same characteristics as the 

11 predicate tobacco product; or 

12 ‘‘(ii) has different characteristics and 

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

15 necessary by the Secretary, that dem16 onstrates that it is not appropriate to regu17 late the product under this section because 

18 the product does not raise different ques19 tions of public health. 

20 ‘‘(B) CHARACTERISTICS.—In subparagraph 

21 (A), the term ‘characteristics’ means the mate22 rials, ingredients, design, composition, heating 

23 source, or other features of a tobacco product. 

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

25 not be found to be substantially equivalent to a 
86 

† HR 1256 EAS 

1 predicate tobacco product that has been removed 

2 from the market at the initiative of the Secretary 

3 or that has been determined by a judicial order 

4 to be misbranded or adulterated. 

5 ‘‘(4) HEALTH INFORMATION.— 

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

7 under section 905(j) respecting a tobacco prod8 uct, the person required to file a premarket noti9 fication under such section shall provide an ade10 quate summary of any health information re11 lated to the tobacco product or state that such in12 formation will be made available upon request 

13 by any person. 

14 ‘‘(B) REQUIRED INFORMATION.—Any sum15 mary under subparagraph (A) respecting a to16 bacco product shall contain detailed information 

17 regarding data concerning adverse health effects 

18 and shall be made available to the public by the 

19 Secretary within 30 days of the issuance of a de20 termination that such tobacco product is sub21 stantially equivalent to another tobacco product. 

22 ‘‘(b) APPLICATION.— 

23 ‘‘(1) CONTENTS.—An application under this sec24 tion shall contain— 
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† HR 1256 EAS 

1 ‘‘(A) full reports of all information, pub2 lished or known to, or which should reasonably 

3 be known to, the applicant, concerning investiga4 tions which have been made to show the health 

5 risks of such tobacco product and whether such 

6 tobacco product presents less risk than other to7 bacco products; 

8 ‘‘(B) a full statement of the components, in9 gredients, additives, and properties, and of the 

10 principle or principles of operation, of such to11 bacco product; 

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

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

14 manufacture, processing, and, when relevant, 

15 packing and installation of, such tobacco prod16 uct; 

17 ‘‘(D) an identifying reference to any tobacco 

18 product standard under section 907 which would 

19 be applicable to any aspect of such tobacco prod20 uct, and either adequate information to show 

21 that such aspect of such tobacco product fully 

22 meets such tobacco product standard or adequate 

23 information to justify any deviation from such 

24 standard; 
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† HR 1256 EAS 

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

2 and of components thereof as the Secretary may 

3 reasonably require; 

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

5 be used for such tobacco product; and 

6 ‘‘(G) such other information relevant to the 

7 subject matter of the application as the Secretary 

8 may require. 

9 ‘‘(2) REFERRAL TO TOBACCO PRODUCTS SCI10 ENTIFIC ADVISORY COMMITTEE.—Upon receipt of an 

11 application meeting the requirements set forth in 

12 paragraph (1), the Secretary— 

13 ‘‘(A) may, on the Secretary’s own initiative; 

14 or 

15 ‘‘(B) may, upon the request of an applicant, 

16 refer such application to the Tobacco Products Sci17 entific Advisory Committee for reference and for sub18 mission (within such period as the Secretary may es19 tablish) of a report and recommendation respecting 

20 the application, together with all underlying data 

21 and the reasons or basis for the recommendation. 

22 ‘‘(c) ACTION ON APPLICATION.— 

23 ‘‘(1) DEADLINE.— 

24 ‘‘(A) IN GENERAL.—As promptly as pos25 sible, but in no event later than 180 days after 
89 

† HR 1256 EAS 

1 the receipt of an application under subsection 

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

3 and recommendation submitted under subsection 

4 (b)(2), shall— 

5 ‘‘(i) issue an order that the new prod6 uct may be introduced or delivered for in7 troduction into interstate commerce if the 

8 Secretary finds that none of the grounds 

9 specified in paragraph (2) of this subsection 

10 applies; or 

11 ‘‘(ii) issue an order that the new prod12 uct may not be introduced or delivered for 

13 introduction into interstate commerce if the 

14 Secretary finds (and sets forth the basis for 

15 such finding as part of or accompanying 

16 such denial) that 1 or more grounds for de17 nial specified in paragraph (2) of this sub18 section apply. 

19 ‘‘(B) RESTRICTIONS ON SALE AND DIS20 TRIBUTION.—An order under subparagraph 

21 (A)(i) may require that the sale and distribution 

22 of the tobacco product be restricted but only to 

23 the extent that the sale and distribution of a to24 bacco product may be restricted under a regula25 tion under section 906(d). 
90 

† HR 1256 EAS 

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

2 shall deny an application submitted under subsection 

3 (b) if, upon the basis of the information submitted to 

4 the Secretary as part of the application and any 

5 other information before the Secretary with respect to 

6 such tobacco product, the Secretary finds that— 

7 ‘‘(A) there is a lack of a showing that per8 mitting such tobacco product to be marketed 

9 would be appropriate for the protection of the 

10 public health; 

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

12 controls used for, the manufacture, processing, or 

13 packing of such tobacco product do not conform 

14 to the requirements of section 906(e); 

15 ‘‘(C) based on a fair evaluation of all mate16 rial facts, the proposed labeling is false or mis17 leading in any particular; or 

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

19 conform in all respects to a tobacco product 

20 standard in effect under section 907, and there 

21 is a lack of adequate information to justify the 

22 deviation from such standard. 

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

24 application shall, insofar as the Secretary determines 

25 to be practicable, be accompanied by a statement in-
91 

† HR 1256 EAS 

1 forming the applicant of the measures required to re2 move such application from deniable form (which 

3 measures may include further research by the appli4 cant in accordance with 1 or more protocols pre5 scribed by the Secretary). 

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

7 section, the finding as to whether the marketing of a 

8 tobacco product for which an application has been 

9 submitted is appropriate for the protection of the pub10 lic health shall be determined with respect to the risks 

11 and benefits to the population as a whole, including 

12 users and nonusers of the tobacco product, and taking 

13 into account— 

14 ‘‘(A) the increased or decreased likelihood 

15 that existing users of tobacco products will stop 

16 using such products; and 

17 ‘‘(B) the increased or decreased likelihood 

18 that those who do not use tobacco products will 

19 start using such products. 

20 ‘‘(5) BASIS FOR ACTION.— 

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

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

23 product to be marketed would be appropriate for 

24 the protection of the public health shall, when 

25 appropriate, be determined on the basis of well- 
92 

† HR 1256 EAS 

1 controlled investigations, which may include 1 or 

2 more clinical investigations by experts qualified 

3 by training and experience to evaluate the to4 bacco product. 

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

6 determines that there exists valid scientific evi7 dence (other than evidence derived from inves8 tigations described in subparagraph (A)) which 

9 is sufficient to evaluate the tobacco product, the 

10 Secretary may authorize that the determination 

11 for purposes of paragraph (2)(A) be made on the 

12 basis of such evidence. 

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

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

15 obtaining, where appropriate, advice on scientific 

16 matters from the Tobacco Products Scientific Advi17 sory Committee, and after due notice and opportunity 

18 for informal hearing for a tobacco product for which 

19 an order was issued under subsection (c)(1)(A)(i), 

20 issue an order withdrawing the order if the Secretary 

21 finds— 

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

23 tobacco product no longer is appropriate for the 

24 protection of the public health; 
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† HR 1256 EAS 

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

2 accompanied by an untrue statement of a mate3 rial fact; 

4 ‘‘(C) that the applicant— 

5 ‘‘(i) has failed to establish a system for 

6 maintaining records, or has repeatedly or 

7 deliberately failed to maintain records or to 

8 make reports, required by an applicable reg9 ulation under section 909; 

10 ‘‘(ii) has refused to permit access to, or 

11 copying or verification of, such records as 

12 required by section 704; or 

13 ‘‘(iii) has not complied with the re14 quirements of section 905; 

15 ‘‘(D) on the basis of new information before 

16 the Secretary with respect to such tobacco prod17 uct, evaluated together with the evidence before 

18 the Secretary when the application was reviewed, 

19 that the methods used in, or the facilities and 

20 controls used for, the manufacture, processing, 

21 packing, or installation of such tobacco product 

22 do not conform with the requirements of section 

23 906(e) and were not brought into conformity 

24 with such requirements within a reasonable time 
94 

† HR 1256 EAS 

1 after receipt of written notice from the Secretary 

2 of nonconformity; 

3 ‘‘(E) on the basis of new information before 

4 the Secretary, evaluated together with the evi5 dence before the Secretary when the application 

6 was reviewed, that the labeling of such tobacco 

7 product, based on a fair evaluation of all mate8 rial facts, is false or misleading in any par9 ticular and was not corrected within a reason10 able time after receipt of written notice from the 

11 Secretary of such fact; or 

12 ‘‘(F) on the basis of new information before 

13 the Secretary, evaluated together with the evi14 dence before the Secretary when such order was 

15 issued, that such tobacco product is not shown to 

16 conform in all respects to a tobacco product 

17 standard which is in effect under section 907, 

18 compliance with which was a condition to the 

19 issuance of an order relating to the application, 

20 and that there is a lack of adequate information 

21 to justify the deviation from such standard. 

22 ‘‘(2) APPEAL.—The holder of an application sub23 ject to an order issued under paragraph (1) with24 drawing an order issued pursuant to subsection 

25 (c)(1)(A)(i) may, by petition filed on or before the 
95 

† HR 1256 EAS 

1 30th day after the date upon which such holder re2 ceives notice of such withdrawal, obtain review thereof 

3 in accordance with section 912. 

4 ‘‘(3) TEMPORARY SUSPENSION.—If, after pro5 viding an opportunity for an informal hearing, the 

6 Secretary determines there is reasonable probability 

7 that the continuation of distribution of a tobacco 

8 product under an order would cause serious, adverse 

9 health consequences or death, that is greater than or10 dinarily caused by tobacco products on the market, 

11 the Secretary shall by order temporarily suspend the 

12 authority of the manufacturer to market the product. 

13 If the Secretary issues such an order, the Secretary 

14 shall proceed expeditiously under paragraph (1) to 

15 withdraw such application. 

16 ‘‘(e) SERVICE OF ORDER.—An order issued by the Sec17 retary under this section shall be served— 

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

19 department designated by the Secretary; or 

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

21 certified mail addressed to the applicant at the appli22 cant’s last known address in the records of the Sec23 retary. 

24 ‘‘(f) RECORDS.— 
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† HR 1256 EAS 

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

2 any tobacco product for which an order issued pursu3 ant to subsection (c)(1)(A)(i) for an application filed 

4 under subsection (b) is in effect, the applicant shall 

5 establish and maintain such records, and make such 

6 reports to the Secretary, as the Secretary may by reg7 ulation, or by order with respect to such application, 

8 prescribe on the basis of a finding that such records 

9 and reports are necessary in order to enable the Sec10 retary to determine, or facilitate a determination of, 

11 whether there is or may be grounds for withdrawing 

12 or temporarily suspending such order. 

13 ‘‘(2) ACCESS TO RECORDS.—Each person re14 quired under this section to maintain records, and 

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

16 request of an officer or employee designated by the 

17 Secretary, permit such officer or employee at all rea18 sonable times to have access to and copy and verify 

19 such records. 

20 ‘‘(g) INVESTIGATIONAL TOBACCO PRODUCT EXEMP21 TION FOR INVESTIGATIONAL USE.—The Secretary may ex22 empt tobacco products intended for investigational use from 

23 the provisions of this chapter under such conditions as the 

24 Secretary may by regulation prescribe. 
97 

† HR 1256 EAS 

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

2 ‘‘(a) IN GENERAL.—No person may introduce or de3 liver for introduction into interstate commerce any modi4 fied risk tobacco product unless an order issued pursuant 

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

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

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

8 term ‘modified risk tobacco product’ means any to9 bacco product that is sold or distributed for use to re10 duce harm or the risk of tobacco-related disease asso11 ciated with commercially marketed tobacco products. 

12 ‘‘(2) SOLD OR DISTRIBUTED.— 

13 ‘‘(A) IN GENERAL.—With respect to a to14 bacco product, the term ‘sold or distributed for 

15 use to reduce harm or the risk of tobacco-related 

16 disease associated with commercially marketed 

17 tobacco products’ means a tobacco product— 

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

19 of which represents explicitly or implicitly 

20 that— 

21 ‘‘(I) the tobacco product presents 

22 a lower risk of tobacco-related disease 

23 or is less harmful than one or more 

24 other commercially marketed tobacco 

25 products; 
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† HR 1256 EAS 

1 ‘‘(II) the tobacco product or its 

2 smoke contains a reduced level of a 

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

5 ‘‘(III) the tobacco product or its 

6 smoke does not contain or is free of a 

7 substance; 

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

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

10 or ‘low’ or similar descriptors; or 

11 ‘‘(iii) the tobacco product manufac12 turer of which has taken any action directed 

13 to consumers through the media or other14 wise, other than by means of the tobacco 

15 product’s label, labeling, or advertising, 

16 after the date of enactment of the Family 

17 Smoking Prevention and Tobacco Control 

18 Act, respecting the product that would be 

19 reasonably expected to result in consumers 

20 believing that the tobacco product or its 

21 smoke may present a lower risk of disease 

22 or is less harmful than one or more com23 mercially marketed tobacco products, or 

24 presents a reduced exposure to, or does not 
99 

† HR 1256 EAS 

1 contain or is free of, a substance or sub2 stances. 

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

4 shall be considered to be ‘sold or distributed for 

5 use to reduce harm or the risk of tobacco-related 

6 disease associated with commercially marketed 

7 tobacco products’, except as described in sub8 paragraph (A). 

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

10 smokeless tobacco product shall be considered to 

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

12 the risk of tobacco-related disease associated with 

13 commercially marketed tobacco products’ solely 

14 because its label, labeling, or advertising uses the 

15 following phrases to describe such product and 

16 its use: ‘smokeless tobacco’, ‘smokeless tobacco 

17 product’, ‘not consumed by smoking’, ‘does not 

18 produce smoke’, ‘smokefree’, ‘smoke-free’, ‘without 

19 smoke’, ‘no smoke’, or ‘not smoke’. 

20 ‘‘(3) EFFECTIVE DATE.—The provisions of para21 graph (2)(A)(ii) shall take effect 12 months after the 

22 date of enactment of the Family Smoking Prevention 

23 and Tobacco Control Act for those products whose 

24 label, labeling, or advertising contains the terms de25 scribed in such paragraph on such date of enactment. 
100 

† HR 1256 EAS 

1 The effective date shall be with respect to the date of 

2 manufacture, provided that, in any case, beginning 

3 30 days after such effective date, a manufacturer shall 

4 not introduce into the domestic commerce of the 

5 United States any product, irrespective of the date of 

6 manufacture, that is not in conformance with para7 graph (2)(A)(ii). 

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

9 that is intended to be used for the treatment of tobacco de10 pendence, including smoking cessation, is not a modified 

11 risk tobacco product under this section if it has been ap12 proved as a drug or device by the Food and Drug Adminis13 tration and is subject to the requirements of chapter V. 

14 ‘‘(d) FILING.—Any person may file with the Secretary 

15 an application for a modified risk tobacco product. Such 

16 application shall include— 

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

18 any proposed advertising and labeling; 

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

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

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

22 ‘‘(5) all documents (including underlying sci23 entific information) relating to research findings con24 ducted, supported, or possessed by the tobacco product 

25 manufacturer relating to the effect of the product on 
101 

† HR 1256 EAS 

1 tobacco-related diseases and health-related conditions, 

2 including information both favorable and unfavorable 

3 to the ability of the product to reduce risk or exposure 

4 and relating to human health; 

5 ‘‘(6) data and information on how consumers ac6 tually use the tobacco product; and 

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

8 may require. 

9 ‘‘(e) PUBLIC AVAILABILITY.—The Secretary shall make 

10 the application described in subsection (d) publicly avail11 able (except matters in the application which are trade se12 crets or otherwise confidential, commercial information) 

13 and shall request comments by interested persons on the in14 formation contained in the application and on the label, 

15 labeling, and advertising accompanying such application. 

16 ‘‘(f) ADVISORY COMMITTEE.— 

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

18 the Tobacco Products Scientific Advisory Committee 

19 any application submitted under this section. 

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

21 days after the date an application is referred to the 

22 Tobacco Products Scientific Advisory Committee 

23 under paragraph (1), the Advisory Committee shall 

24 report its recommendations on the application to the 

25 Secretary. 
102 

† HR 1256 EAS 

1 ‘‘(g) MARKETING.— 

2 ‘‘(1) MODIFIED RISK PRODUCTS.—Except as pro3 vided in paragraph (2), the Secretary shall, with re4 spect to an application submitted under this section, 

5 issue an order that a modified risk product may be 

6 commercially marketed only if the Secretary deter7 mines that the applicant has demonstrated that such 

8 product, as it is actually used by consumers, will— 

9 ‘‘(A) significantly reduce harm and the risk 

10 of tobacco-related disease to individual tobacco 

11 users; and 

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

13 a whole taking into account both users of tobacco 

14 products and persons who do not currently use 

15 tobacco products. 

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

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

18 issue an order that a tobacco product may be in19 troduced or delivered for introduction into inter20 state commerce, pursuant to an application 

21 under this section, with respect to a tobacco 

22 product that may not be commercially marketed 

23 under paragraph (1) if the Secretary makes the 

24 findings required under this paragraph and de-
103 

† HR 1256 EAS 

1 termines that the applicant has demonstrated 

2 that— 

3 ‘‘(i) such order would be appropriate 

4 to promote the public health; 

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

6 and advertising for such product that would 

7 cause the tobacco product to be a modified 

8 risk tobacco product under subsection (b) is 

9 limited to an explicit or implicit represen10 tation that such tobacco product or its 

11 smoke does not contain or is free of a sub12 stance or contains a reduced level of a sub13 stance, or presents a reduced exposure to a 

14 substance in tobacco smoke; 

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

17 methods, cannot be made available without 

18 conducting long-term epidemiological stud19 ies for an application to meet the standards 

20 set forth in paragraph (1); and 

21 ‘‘(iv) the scientific evidence that is 

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

24 measurable and substantial reduction in 

25 morbidity or mortality among individual 
104 

† HR 1256 EAS 

1 tobacco users is reasonably likely in subse2 quent studies. 

3 ‘‘(B) ADDITIONAL FINDINGS REQUIRED.— 

4 To issue an order under subparagraph (A) the 

5 Secretary must also find that the applicant has 

6 demonstrated that— 

7 ‘‘(i) the magnitude of the overall reduc8 tions in exposure to the substance or sub9 stances which are the subject of the applica10 tion is substantial, such substance or sub11 stances are harmful, and the product as ac12 tually used exposes consumers to the speci13 fied reduced level of the substance or sub14 stances; 

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

16 consumers will not expose them to higher 

17 levels of other harmful substances compared 

18 to the similar types of tobacco products then 

19 on the market unless such increases are 

20 minimal and the reasonably likely overall 

21 impact of use of the product remains a sub22 stantial and measurable reduction in over23 all morbidity and mortality among indi24 vidual tobacco users; 
105 

† HR 1256 EAS 

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

5 the product— 

6 ‘‘(I) is or has been demonstrated 

7 to be less harmful; or 

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

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

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

13 to the application is expected to benefit the 

14 health of the population as a whole taking 

15 into account both users of tobacco products 

16 and persons who do not currently use to17 bacco products. 

18 ‘‘(C) CONDITIONS OF MARKETING.— 

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

21 be limited to a term of not more than 5 

22 years, but may be renewed upon a finding 

23 by the Secretary that the requirements of 

24 this paragraph continue to be satisfied 

25 based on the filing of a new application. 
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† HR 1256 EAS 

1 ‘‘(ii) AGREEMENTS BY APPLICANT.— 

2 An order under this paragraph shall be con3 ditioned on the applicant’s agreement to 

4 conduct postmarket surveillance and studies 

5 and to submit to the Secretary the results of 

6 such surveillance and studies to determine 

7 the impact of the order on consumer percep8 tion, behavior, and health and to enable the 

9 Secretary to review the accuracy of the de10 terminations upon which the order was 

11 based in accordance with a protocol ap12 proved by the Secretary. 

13 ‘‘(iii) ANNUAL SUBMISSION.—The re14 sults of such postmarket surveillance and 

15 studies described in clause (ii) shall be sub16 mitted annually. 

17 ‘‘(3) BASIS.—The determinations under para18 graphs (1) and (2) shall be based on— 

19 ‘‘(A) the scientific evidence submitted by the 

20 applicant; and 

21 ‘‘(B) scientific evidence and other informa22 tion that is made available to the Secretary. 

23 ‘‘(4) BENEFIT TO HEALTH OF INDIVIDUALS AND

24 OF POPULATION AS A WHOLE.—In making the deter-
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1 minations under paragraphs (1) and (2), the Sec2 retary shall take into account— 

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

4 of the tobacco product that is the subject of the 

5 application; 

6 ‘‘(B) the increased or decreased likelihood 

7 that existing users of tobacco products who would 

8 otherwise stop using such products will switch to 

9 the tobacco product that is the subject of the ap10 plication; 

11 ‘‘(C) the increased or decreased likelihood 

12 that persons who do not use tobacco products 

13 will start using the tobacco product that is the 

14 subject of the application; 

15 ‘‘(D) the risks and benefits to persons from 

16 the use of the tobacco product that is the subject 

17 of the application as compared to the use of 

18 products for smoking cessation approved under 

19 chapter V to treat nicotine dependence; and 

20 ‘‘(E) comments, data, and information sub21 mitted by interested persons. 

22 ‘‘(h) ADDITIONAL CONDITIONS FOR MARKETING.— 

23 ‘‘(1) MODIFIED RISK PRODUCTS.—The Secretary 

24 shall require for the marketing of a product under 

25 this section that any advertising or labeling con-
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1 cerning modified risk products enable the public to 

2 comprehend the information concerning modified risk 

3 and to understand the relative significance of such in4 formation in the context of total health and in rela5 tion to all of the diseases and health-related condi6 tions associated with the use of tobacco products. 

7 ‘‘(2) COMPARATIVE CLAIMS.— 

8 ‘‘(A) IN GENERAL.—The Secretary may re9 quire for the marketing of a product under this 

10 subsection that a claim comparing a tobacco 

11 product to 1 or more other commercially mar12 keted tobacco products shall compare the tobacco 

13 product to a commercially marketed tobacco 

14 product that is representative of that type of to15 bacco product on the market (for example the av16 erage value of the top 3 brands of an established 

17 regular tobacco product). 

18 ‘‘(B) QUANTITATIVE COMPARISONS.—The 

19 Secretary may also require, for purposes of sub20 paragraph (A), that the percent (or fraction) of 

21 change and identity of the reference tobacco 

22 product and a quantitative comparison of the 

23 amount of the substance claimed to be reduced 

24 shall be stated in immediate proximity to the 

25 most prominent claim. 
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1 ‘‘(3) LABEL DISCLOSURE.— 

2 ‘‘(A) IN GENERAL.—The Secretary may re3 quire the disclosure on the label of other sub4 stances in the tobacco product, or substances that 

5 may be produced by the consumption of that to6 bacco product, that may affect a disease or 

7 health-related condition or may increase the risk 

8 of other diseases or health-related conditions as9 sociated with the use of tobacco products. 

10 ‘‘(B) CONDITIONS OF USE.—If the condi11 tions of use of the tobacco product may affect the 

12 risk of the product to human health, the Sec13 retary may require the labeling of conditions of 

14 use. 

15 ‘‘(4) TIME.—An order issued under subsection 

16 (g)(1) shall be effective for a specified period of time. 

17 ‘‘(5) ADVERTISING.—The Secretary may require, 

18 with respect to a product for which an applicant ob19 tained an order under subsection (g)(1), that the 

20 product comply with requirements relating to adver21 tising and promotion of the tobacco product. 

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

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

24 with respect to a product for which an applicant ob25 tained an order under subsection (g)(1), that the ap-
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1 plicant conduct postmarket surveillance and studies 

2 for such a tobacco product to determine the impact of 

3 the order issuance on consumer perception, behavior, 

4 and health, to enable the Secretary to review the accu5 racy of the determinations upon which the order was 

6 based, and to provide information that the Secretary 

7 determines is otherwise necessary regarding the use or 

8 health risks involving the tobacco product. The results 

9 of postmarket surveillance and studies shall be sub10 mitted to the Secretary on an annual basis. 

11 ‘‘(2) SURVEILLANCE PROTOCOL.—Each appli12 cant required to conduct a surveillance of a tobacco 

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

14 after receiving notice that the applicant is required to 

15 conduct such surveillance, submit, for the approval of 

16 the Secretary, a protocol for the required surveillance. 

17 The Secretary, within 60 days of the receipt of such 

18 protocol, shall determine if the principal investigator 

19 proposed to be used in the surveillance has sufficient 

20 qualifications and experience to conduct such surveil21 lance and if such protocol will result in collection of 

22 the data or other information designated by the Sec23 retary as necessary to protect the public health. 

24 ‘‘(j) WITHDRAWAL OF AUTHORIZATION.—The Sec25 retary, after an opportunity for an informal hearing, shall 
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1 withdraw an order under subsection (g) if the Secretary de2 termines that— 

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

4 can no longer make the demonstrations required 

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

6 make the determinations required under subsection 

7 (g); 

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

9 information or included any untrue statement of ma10 terial fact; 

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

12 the product reduces risk or exposure is no longer 

13 valid, including if— 

14 ‘‘(A) a tobacco product standard is estab15 lished pursuant to section 907; 

16 ‘‘(B) an action is taken that affects the risks 

17 presented by other commercially marketed to18 bacco products that were compared to the prod19 uct that is the subject of the application; or 

20 ‘‘(C) any postmarket surveillance or studies 

21 reveal that the order is no longer consistent with 

22 the protection of the public health; 

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

24 the postmarket surveillance and studies required 

25 under subsection (g)(2)(C)(ii) or subsection (i); or 
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1 ‘‘(5) the applicant failed to meet a condition im2 posed under subsection (h). 

3 ‘‘(k) CHAPTER IV OR V.—A product for which the Sec4 retary has issued an order pursuant to subsection (g) shall 

5 not be subject to chapter IV or V. 

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

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

8 years after the date of enactment of the Family Smok9 ing Prevention and Tobacco Control Act, the Sec10 retary shall issue regulations or guidance (or any 

11 combination thereof) on the scientific evidence re12 quired for assessment and ongoing review of modified 

13 risk tobacco products. Such regulations or guidance 

14 shall— 

15 ‘‘(A) to the extent that adequate scientific 

16 evidence exists, establish minimum standards for 

17 scientific studies needed prior to issuing an 

18 order under subsection (g) to show that a sub19 stantial reduction in morbidity or mortality 

20 among individual tobacco users occurs for prod21 ucts described in subsection (g)(1) or is reason22 ably likely for products described in subsection 

23 (g)(2); 
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1 ‘‘(B) include validated biomarkers, inter2 mediate clinical endpoints, and other feasible 

3 outcome measures, as appropriate; 

4 ‘‘(C) establish minimum standards for 

5 postmarket studies, that shall include regular 

6 and long-term assessments of health outcomes 

7 and mortality, intermediate clinical endpoints, 

8 consumer perception of harm reduction, and the 

9 impact on quitting behavior and new use of to10 bacco products, as appropriate; 

11 ‘‘(D) establish minimum standards for re12 quired postmarket surveillance, including ongo13 ing assessments of consumer perception; 

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

15 studies and surveillance be made available to the 

16 Secretary prior to the decision on renewal of a 

17 modified risk tobacco product; and 

18 ‘‘(F) establish a reasonable timetable for the 

19 Secretary to review an application under this 

20 section. 

21 ‘‘(2) CONSULTATION.—The regulations or guid22 ance issued under paragraph (1) shall be developed in 

23 consultation with the Institute of Medicine, and with 

24 the input of other appropriate scientific and medical 
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1 experts, on the design and conduct of such studies and 

2 surveillance. 

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

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

5 basis as new scientific information becomes available. 

6 ‘‘(4) NEW TOBACCO PRODUCTS.—Not later than 

7 2 years after the date of enactment of the Family 

8 Smoking Prevention and Tobacco Control Act, the 

9 Secretary shall issue a regulation or guidance that 

10 permits the filing of a single application for any to11 bacco product that is a new tobacco product under 

12 section 910 and which the applicant seeks to commer13 cially market under this section. 

14 ‘‘(m) DISTRIBUTORS.—Except as provided in this sec15 tion, no distributor may take any action, after the date of 

16 enactment of the Family Smoking Prevention and Tobacco 

17 Control Act, with respect to a tobacco product that would 

18 reasonably be expected to result in consumers believing that 

19 the tobacco product or its smoke may present a lower risk 

20 of disease or is less harmful than one or more commercially 

21 marketed tobacco products, or presents a reduced exposure 

22 to, or does not contain or is free of, a substance or sub23 stances. 

24 ‘‘SEC. 912. JUDICIAL REVIEW. 

25 ‘‘(a) RIGHT TO REVIEW.— 
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1 ‘‘(1) IN GENERAL.—Not later than 30 days 

2 after— 

3 ‘‘(A) the promulgation of a regulation 

4 under section 907 establishing, amending, or re5 voking a tobacco product standard; or 

6 ‘‘(B) a denial of an application under sec7 tion 910(c), 

8 any person adversely affected by such regulation or 

9 denial may file a petition for judicial review of such 

10 regulation or denial with the United States Court of 

11 Appeals for the District of Columbia or for the circuit 

12 in which such person resides or has their principal 

13 place of business. 

14 ‘‘(2) REQUIREMENTS.— 

15 ‘‘(A) COPY OF PETITION.—A copy of the pe16 tition filed under paragraph (1) shall be trans17 mitted by the clerk of the court involved to the 

18 Secretary. 

19 ‘‘(B) RECORD OF PROCEEDINGS.—On re20 ceipt of a petition under subparagraph (A), the 

21 Secretary shall file in the court in which such 

22 petition was filed— 

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

24 which the regulation or order was based; 

25 and 
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1 ‘‘(ii) a statement of the reasons for the 

2 issuance of such a regulation or order. 

3 ‘‘(C) DEFINITION OF RECORD.—In this sec4 tion, the term ‘record’ means— 

5 ‘‘(i) all notices and other matter pub6 lished in the Federal Register with respect 

7 to the regulation or order reviewed; 

8 ‘‘(ii) all information submitted to the 

9 Secretary with respect to such regulation or 

10 order; 

11 ‘‘(iii) proceedings of any panel or ad12 visory committee with respect to such regu13 lation or order; 

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

15 such regulation or order; and 

16 ‘‘(v) any other information identified 

17 by the Secretary, in the administrative pro18 ceeding held with respect to such regulation 

19 or order, as being relevant to such regula20 tion or order. 

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

22 petition under subsection (a) for judicial review of a regula23 tion or order, the court shall have jurisdiction to review 

24 the regulation or order in accordance with chapter 7 of title 

25 5, United States Code, and to grant appropriate relief, in-
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1 cluding interim relief, as provided for in such chapter. A 

2 regulation or denial described in subsection (a) shall be re3 viewed in accordance with section 706(2)(A) of title 5, 

4 United States Code. 

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

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

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

8 Supreme Court of the United States upon certiorari or cer9 tification, as provided in section 1254 of title 28, United 

10 States Code. 

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

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

13 any other remedies provided by law. 

14 ‘‘(e) REGULATIONS AND ORDERS MUST RECITE BASIS

15 IN RECORD.—To facilitate judicial review, a regulation or 

16 order issued under section 906, 907, 908, 909, 910, or 916 

17 shall contain a statement of the reasons for the issuance 

18 of such regulation or order in the record of the proceedings 

19 held in connection with its issuance. 

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

21 ‘‘The Secretary shall issue regulations to require that 

22 retail establishments for which the predominant business is 

23 the sale of tobacco products comply with any advertising 

24 restrictions applicable to retail establishments accessible to 

25 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 pro5 vided in this chapter, nothing in this chapter shall be 

6 construed as limiting or diminishing the authority of 

7 the Federal Trade Commission to enforce the laws 

8 under its jurisdiction with respect to the advertising, 

9 sale, or distribution of tobacco products. 

10 ‘‘(2) ENFORCEMENT.—Any advertising that vio11 lates this chapter or a provision of the regulations re12 ferred to in section 102 of the Family Smoking Pre13 vention and Tobacco Control Act, is an unfair or de14 ceptive act or practice under section 5(a) of the Fed15 eral Trade Commission Act and shall be considered a 

16 violation of a rule promulgated under section 18 of 

17 that Act. 

18 ‘‘(b) COORDINATION.—With respect to the requirements 

19 of section 4 of the Federal Cigarette Labeling and Adver20 tising Act and section 3 of the Comprehensive Smokeless 

21 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 promul13 gated under subsection (a)— 

14 ‘‘(1) shall require testing and reporting of to15 bacco product constituents, ingredients, and additives, 

16 including smoke constituents, by brand and subbrand 

17 that the Secretary determines should be tested to pro18 tect the public health, provided that, for purposes of 

19 the testing requirements of this paragraph, tobacco 

20 products manufactured and sold by a single tobacco 

21 product manufacturer that are identical in all re22 spects except the labels, packaging design, logo, trade 

23 dress, trademark, brand name, or any combination 

24 thereof, shall be considered as a single brand; and 
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1 ‘‘(2) may require that tobacco product manufac2 turers, packagers, or importers make disclosures relat3 ing to the results of the testing of tar and nicotine 

4 through labels or advertising or other appropriate 

5 means, and make disclosures regarding the results of 

6 the testing of other constituents, including smoke con7 stituents, ingredients, or additives, that the Secretary 

8 determines should be disclosed to the public to protect 

9 the public health and will not mislead consumers 

10 about the risk of tobacco-related disease. 

11 ‘‘(c) AUTHORITY.—The Secretary shall have the au12 thority under this chapter to conduct or to require the test13 ing, reporting, or disclosure of tobacco product constituents, 

14 including smoke constituents. 

15 ‘‘(d) SMALL TOBACCO PRODUCT MANUFACTURERS.— 

16 ‘‘(1) FIRST COMPLIANCE DATE.—The initial reg17 ulations promulgated under subsection (a) shall not 

18 impose requirements on small tobacco product manu19 facturers before the later of— 

20 ‘‘(A) the end of the 2-year period following 

21 the final promulgation of such regulations; and 

22 ‘‘(B) the initial date set by the Secretary for 

23 compliance with such regulations by manufac24 turers that are not small tobacco product manu25 facturers. 
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1 ‘‘(2) TESTING AND REPORTING INITIAL COMPLI2 ANCE PERIOD.— 

3 ‘‘(A) 4-YEAR PERIOD.—The initial regula4 tions promulgated under subsection (a) shall give 

5 each small tobacco product manufacturer a 4- 

6 year period over which to conduct testing and re7 porting for all of its tobacco products. Subject to 

8 paragraph (1), the end of the first year of such 

9 4-year period shall coincide with the initial date 

10 of compliance under this section set by the Sec11 retary with respect to manufacturers that are 

12 not small tobacco product manufacturers or the 

13 end of the 2-year period following the final pro14 mulgation of such regulations, as described in 

15 paragraph (1)(A). A small tobacco product man16 ufacturer shall be required— 

17 ‘‘(i) to conduct such testing and report18 ing for 25 percent of its tobacco products 

19 during each year of such 4-year period; and 

20 ‘‘(ii) to conduct such testing and re21 porting for its largest-selling tobacco prod22 ucts (as determined by the Secretary) before 

23 its other tobacco products, or in such other 

24 order of priority as determined by the Sec25 retary. 
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1 ‘‘(B) CASE-BY-CASE DELAY.—Notwith2 standing subparagraph (A), the Secretary may, 

3 on a case-by-case basis, delay the date by which 

4 an individual small tobacco product manufac5 turer must conduct testing and reporting for its 

6 tobacco products under this section based upon a 

7 showing of undue hardship to such manufac8 turer. Notwithstanding the preceding sentence, 

9 the Secretary shall not extend the deadline for a 

10 small tobacco product manufacturer to conduct 

11 testing and reporting for all of its tobacco prod12 ucts beyond a total of 5 years after the initial 

13 date of compliance under this section set by the 

14 Secretary with respect to manufacturers that are 

15 not small tobacco product manufacturers. 

16 ‘‘(3) SUBSEQUENT AND ADDITIONAL TESTING

17 AND REPORTING.—The regulations promulgated under 

18 subsection (a) shall provide that, with respect to any 

19 subsequent or additional testing and reporting of to20 bacco products required under this section, such test21 ing and reporting by a small tobacco product manu22 facturer shall be conducted in accordance with the 

23 timeframes described in paragraph (2)(A), except 

24 that, in the case of a new product, or if there has been 

25 a modification described in section 910(a)(1)(B) of 
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1 any product of a small tobacco product manufacturer 

2 since the last testing and reporting required under 

3 this section, the Secretary shall require that any sub4 sequent or additional testing and reporting be con5 ducted in accordance with the same timeframe appli6 cable to manufacturers that are not small tobacco 

7 product manufacturers. 

8 ‘‘(4) JOINT LABORATORY TESTING SERVICES.— 

9 The Secretary shall allow any 2 or more small to10 bacco product manufacturers to join together to pur11 chase laboratory testing services required by this sec12 tion on a group basis in order to ensure that such 

13 manufacturers receive access to, and fair pricing of, 

14 such testing services. 

15 ‘‘(e) EXTENSIONS FOR LIMITED LABORATORY CAPAC16 ITY.— 

17 ‘‘(1) IN GENERAL.—The regulations promulgated 

18 under subsection (a) shall provide that a small to19 bacco product manufacturer shall not be considered to 

20 be in violation of this section before the deadline ap21 plicable under paragraphs (3) and (4), if— 

22 ‘‘(A) the tobacco products of such manufac23 turer are in compliance with all other require24 ments of this chapter; and 
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1 ‘‘(B) the conditions described in paragraph 

2 (2) are met. 

3 ‘‘(2) CONDITIONS.—Notwithstanding the require4 ments of this section, the Secretary may delay the 

5 date by which a small tobacco product manufacturer 

6 must be in compliance with the testing and reporting 

7 required by this section until such time as the testing 

8 is reported if, not later than 90 days before the dead9 line for reporting in accordance with this section, a 

10 small tobacco product manufacturer provides evidence 

11 to the Secretary demonstrating that— 

12 ‘‘(A) the manufacturer has submitted the re13 quired products for testing to a laboratory and 

14 has done so sufficiently in advance of the dead15 line to create a reasonable expectation of comple16 tion by the deadline; 

17 ‘‘(B) the products currently are awaiting 

18 testing by the laboratory; and 

19 ‘‘(C) neither that laboratory nor any other 

20 laboratory is able to complete testing by the 

21 deadline at customary, nonexpedited testing fees. 

22 ‘‘(3) EXTENSION.—The Secretary, taking into 

23 account the laboratory testing capacity that is avail24 able to tobacco product manufacturers, shall review 

25 and verify the evidence submitted by a small tobacco 
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1 product manufacturer in accordance with paragraph 

2 (2). If the Secretary finds that the conditions de3 scribed in such paragraph are met, the Secretary 

4 shall notify the small tobacco product manufacturer 

5 that the manufacturer shall not be considered to be in 

6 violation of the testing and reporting requirements of 

7 this section until the testing is reported or until 1 

8 year after the reporting deadline has passed, which9 ever occurs sooner. If, however, the Secretary has not 

10 made a finding before the reporting deadline, the 

11 manufacturer shall not be considered to be in viola12 tion of such requirements until the Secretary finds 

13 that the conditions described in paragraph (2) have 

14 not been met, or until 1 year after the reporting dead15 line, whichever occurs sooner. 

16 ‘‘(4) ADDITIONAL EXTENSION.—In addition to 

17 the time that may be provided under paragraph (3), 

18 the Secretary may provide further extensions of time, 

19 in increments of no more than 1 year, for required 

20 testing and reporting to occur if the Secretary deter21 mines, based on evidence properly and timely sub22 mitted by a small tobacco product manufacturer in 

23 accordance with paragraph (2), that a lack of avail24 able laboratory capacity prevents the manufacturer 
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1 from completing the required testing during the pe2 riod described in paragraph (3). 

3 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in subsection 

4 (d) or (e) shall be construed to authorize the extension of 

5 any deadline, or to otherwise affect any timeframe, under 

6 any provision of this Act or the Family Smoking Preven7 tion and Tobacco Control Act other than this section. 

8 ‘‘SEC. 916. PRESERVATION OF STATE AND LOCAL AUTHOR9 ITY. 

10 ‘‘(a) IN GENERAL.— 

11 ‘‘(1) PRESERVATION.—Except as provided in 

12 paragraph (2)(A), nothing in this chapter, or rules 

13 promulgated under this chapter, shall be construed to 

14 limit the authority of a Federal agency (including the 

15 Armed Forces), a State or political subdivision of a 

16 State, or the government of an Indian tribe to enact, 

17 adopt, promulgate, and enforce any law, rule, regula18 tion, or other measure with respect to tobacco prod19 ucts that is in addition to, or more stringent than, 

20 requirements established under this chapter, including 

21 a law, rule, regulation, or other measure relating to 

22 or prohibiting the sale, distribution, possession, expo23 sure to, access to, advertising and promotion of, or 

24 use of tobacco products by individuals of any age, in25 formation reporting to the State, or measures relating 
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1 to fire safety standards for tobacco products. No pro2 vision of this chapter shall limit or otherwise affect 

3 any State, tribal, or local taxation of tobacco prod4 ucts. 

5 ‘‘(2) PREEMPTION OF CERTAIN STATE AND LOCAL

6 REQUIREMENTS.— 

7 ‘‘(A) IN GENERAL.—No State or political 

8 subdivision of a State may establish or continue 

9 in effect with respect to a tobacco product any 

10 requirement which is different from, or in addi11 tion to, any requirement under the provisions of 

12 this chapter relating to tobacco product stand13 ards, premarket review, adulteration, mis14 branding, labeling, registration, good manufac15 turing standards, or modified risk tobacco prod16 ucts. 

17 ‘‘(B) EXCEPTION.—Subparagraph (A) does 

18 not apply to requirements relating to the sale, 

19 distribution, possession, information reporting to 

20 the State, exposure to, access to, the advertising 

21 and promotion of, or use of, tobacco products by 

22 individuals of any age, or relating to fire safety 

23 standards for tobacco products. Information dis24 closed to a State under subparagraph (A) that is 

25 exempt from disclosure under section 552(b)(4) 
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1 of title 5, United States Code, shall be treated as 

2 a trade secret and confidential information by 

3 the State. 

4 ‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT

5 LIABILITY.—No provision of this chapter relating to a to6 bacco product shall be construed to modify or otherwise af7 fect any action or the liability of any person under the 

8 product liability law of any State. 

9 ‘‘SEC. 917. TOBACCO PRODUCTS SCIENTIFIC ADVISORY 

10 COMMITTEE. 

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

12 the date of enactment of the Family Smoking Prevention 

13 and Tobacco Control Act, the Secretary shall establish a 12- 

14 member advisory committee, to be known as the Tobacco 

15 Products Scientific Advisory Committee (in this section re16 ferred to as the ‘Advisory Committee’). 

17 ‘‘(b) MEMBERSHIP.— 

18 ‘‘(1) IN GENERAL.— 

19 ‘‘(A) MEMBERS.—The Secretary shall ap20 point as members of the Tobacco Products Sci21 entific Advisory Committee individuals who are 

22 technically qualified by training and experience 

23 in medicine, medical ethics, science, or tech24 nology involving the manufacture, evaluation, or 

25 use of tobacco products, who are of appropriately 
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1 diversified professional backgrounds. The com2 mittee shall be composed of— 

3 ‘‘(i) 7 individuals who are physicians, 

4 dentists, scientists, or health care profes5 sionals practicing in the area of oncology, 

6 pulmonology, cardiology, toxicology, phar7 macology, addiction, or any other relevant 

8 specialty; 

9 ‘‘(ii) 1 individual who is an officer or 

10 employee of a State or local government or 

11 of the Federal Government; 

12 ‘‘(iii) 1 individual as a representative 

13 of the general public; 

14 ‘‘(iv) 1 individual as a representative 

15 of the interests of the tobacco manufacturing 

16 industry; 

17 ‘‘(v) 1 individual as a representative of 

18 the interests of the small business tobacco 

19 manufacturing industry, which position 

20 may be filled on a rotating, sequential basis 

21 by representatives of different small business 

22 tobacco manufacturers based on areas of ex23 pertise relevant to the topics being consid24 ered by the Advisory Committee; and 
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1 ‘‘(vi) 1 individual as a representative 

2 of the interests of the tobacco growers. 

3 ‘‘(B) NONVOTING MEMBERS.—The members 

4 of the committee appointed under clauses (iv), 

5 (v), and (vi) of subparagraph (A) shall serve as 

6 consultants to those described in clauses (i) 

7 through (iii) of subparagraph (A) and shall be 

8 nonvoting representatives. 

9 ‘‘(C) CONFLICTS OF INTEREST.—No mem10 bers of the committee, other than members ap11 pointed pursuant to clauses (iv), (v), and (vi) of 

12 subparagraph (A) shall, during the member’s 

13 tenure on the committee or for the 18-month pe14 riod prior to becoming such a member, receive 

15 any salary, grants, or other payments or support 

16 from any business that manufactures, distrib17 utes, markets, or sells cigarettes or other tobacco 

18 products. 

19 ‘‘(2) LIMITATION.—The Secretary may not ap20 point to the Advisory Committee any individual who 

21 is in the regular full-time employ of the Food and 

22 Drug Administration or any agency responsible for 

23 the enforcement of this Act. The Secretary may ap24 point Federal officials as ex officio members. 
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1 ‘‘(3) CHAIRPERSON.—The Secretary shall des2 ignate 1 of the members appointed under clauses (i), 

3 (ii), and (iii) of paragraph (1)(A) to serve as chair4 person. 

5 ‘‘(c) DUTIES.—The Tobacco Products Scientific Advi6 sory Committee shall provide advice, information, and rec7 ommendations to the Secretary— 

8 ‘‘(1) as provided in this chapter; 

9 ‘‘(2) on the effects of the alteration of the nicotine 

10 yields from tobacco products; 

11 ‘‘(3) on whether there is a threshold level below 

12 which nicotine yields do not produce dependence on 

13 the tobacco product involved; and 

14 ‘‘(4) on its review of other safety, dependence, or 

15 health issues relating to tobacco products as requested 

16 by the Secretary. 

17 ‘‘(d) COMPENSATION; SUPPORT; FACA.— 

18 ‘‘(1) COMPENSATION AND TRAVEL.—Members of 

19 the Advisory Committee who are not officers or em20 ployees of the United States, while attending con21 ferences or meetings of the committee or otherwise en22 gaged in its business, shall be entitled to receive com23 pensation at rates to be fixed by the Secretary, which 

24 may not exceed the daily equivalent of the rate in ef25 fect under the Senior Executive Schedule under sec-
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1 tion 5382 of title 5, United States Code, for each day 

2 (including travel time) they are so engaged; and while 

3 so serving away from their homes or regular places of 

4 business each member may be allowed travel expenses, 

5 including per diem in lieu of subsistence, as author6 ized by section 5703 of title 5, United States Code, for 

7 persons in the Government service employed intermit8 tently. 

9 ‘‘(2) ADMINISTRATIVE SUPPORT.—The Secretary 

10 shall furnish the Advisory Committee clerical and 

11 other assistance. 

12 ‘‘(3) NONAPPLICATION OF FACA.—Section 14 of 

13 the Federal Advisory Committee Act does not apply 

14 to the Advisory Committee. 

15 ‘‘(e) PROCEEDINGS OF ADVISORY PANELS AND COM16 MITTEES.—The Advisory Committee shall make and main17 tain a transcript of any proceeding of the panel or com18 mittee. Each such panel and committee shall delete from 

19 any transcript made under this subsection information 

20 which is exempt from disclosure under section 552(b) of title 

21 5, United States Code. 

22 ‘‘SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DE23 PENDENCE. 

24 ‘‘(a) IN GENERAL.—The Secretary shall— 
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1 ‘‘(1) at the request of the applicant, consider des2 ignating products for smoking cessation, including 

3 nicotine replacement products as fast track research 

4 and approval products within the meaning of section 

5 506; 

6 ‘‘(2) consider approving the extended use of nico7 tine replacement products (such as nicotine patches, 

8 nicotine gum, and nicotine lozenges) for the treatment 

9 of tobacco dependence; and 

10 ‘‘(3) review and consider the evidence for addi11 tional indications for nicotine replacement products, 

12 such as for craving relief or relapse prevention. 

13 ‘‘(b) REPORT ON INNOVATIVE PRODUCTS.— 

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

15 the date of enactment of the Family Smoking Preven16 tion and Tobacco Control Act, the Secretary, after 

17 consultation with recognized scientific, medical, and 

18 public health experts (including both Federal agencies 

19 and nongovernmental entities, the Institute of Medi20 cine of the National Academy of Sciences, and the So21 ciety for Research on Nicotine and Tobacco), shall 

22 submit to the Congress a report that examines how 

23 best to regulate, promote, and encourage the develop24 ment of innovative products and treatments (includ25 ing nicotine-based and non-nicotine-based products 
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1 and treatments) to better achieve, in a manner that 

2 best protects and promotes the public health— 

3 ‘‘(A) total abstinence from tobacco use; 

4 ‘‘(B) reductions in consumption of tobacco; 

5 and 

6 ‘‘(C) reductions in the harm associated with 

7 continued tobacco use. 

8 ‘‘(2) RECOMMENDATIONS.—The report under 

9 paragraph (1) shall include the recommendations of 

10 the Secretary on how the Food and Drug Administra11 tion should coordinate and facilitate the exchange of 

12 information on such innovative products and treat13 ments among relevant offices and centers within the 

14 Administration and within the National Institutes of 

15 Health, the Centers for Disease Control and Preven16 tion, and other relevant agencies. 

17 ‘‘SEC. 919. USER FEES. 

18 ‘‘(a) ESTABLISHMENT OF QUARTERLY FEE.—Begin19 ning on the date of enactment of the Family Smoking Pre20 vention and Tobacco Control Act, the Secretary shall in ac21 cordance with this section assess user fees on, and collect 

22 such fees from, each manufacturer and importer of tobacco 

23 products subject to this chapter. The fees shall be assessed 

24 and collected with respect to each quarter of each fiscal year, 

25 and the total amount assessed and collected for a fiscal year 
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1 shall be the amount specified in subsection (b)(1) for such 

2 year, subject to subsection (c). 

3 ‘‘(b) ASSESSMENT OF USER FEE.— 

4 ‘‘(1) AMOUNT OF ASSESSMENT.—The total 

5 amount of user fees authorized to be assessed and col6 lected under subsection (a) for a fiscal year is the fol7 lowing, as applicable to the fiscal year involved: 

8 ‘‘(A) For fiscal year 2009, $85,000,000 

9 (subject to subsection (e)). 

10 ‘‘(B) For fiscal year 2010, $235,000,000. 

11 ‘‘(C) For fiscal year 2011, $450,000,000. 

12 ‘‘(D) For fiscal year 2012, $477,000,000. 

13 ‘‘(E) For fiscal year 2013, $505,000,000. 

14 ‘‘(F) For fiscal year 2014, $534,000,000. 

15 ‘‘(G) For fiscal year 2015, $566,000,000. 

16 ‘‘(H) For fiscal year 2016, $599,000,000. 

17 ‘‘(I) For fiscal year 2017, $635,000,000. 

18 ‘‘(J) For fiscal year 2018, $672,000,000. 

19 ‘‘(K) For fiscal year 2019 and each subse20 quent fiscal year, $712,000,000. 

21 ‘‘(2) ALLOCATIONS OF ASSESSMENT BY CLASS OF

22 TOBACCO PRODUCTS.— 

23 ‘‘(A) IN GENERAL.—The total user fees as24 sessed and collected under subsection (a) each fis25 cal year with respect to each class of tobacco 
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1 products shall be an amount that is equal to the 

2 applicable percentage of each class for the fiscal 

3 year multiplied by the amount specified in para4 graph (1) for the fiscal year. 

5 ‘‘(B) APPLICABLE PERCENTAGE.— 

6 ‘‘(i) IN GENERAL.—For purposes of 

7 subparagraph (A), the applicable percentage 

8 for a fiscal year for each of the following 

9 classes of tobacco products shall be deter10 mined in accordance with clause (ii): 

11 ‘‘(I) Cigarettes. 

12 ‘‘(II) Cigars, including small ci13 gars and cigars other than small ci14 gars. 

15 ‘‘(III) Snuff. 

16 ‘‘(IV) Chewing tobacco. 

17 ‘‘(V) Pipe tobacco. 

18 ‘‘(VI) Roll-your-own tobacco. 

19 ‘‘(ii) ALLOCATIONS.—The applicable 

20 percentage of each class of tobacco product 

21 described in clause (i) for a fiscal year shall 

22 be the percentage determined under section 

23 625(c) of Public Law 108–357 for each such 

24 class of product for such fiscal year. 
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1 ‘‘(iii) REQUIREMENT OF REGULA2 TIONS.—Notwithstanding clause (ii), no 

3 user fees shall be assessed on a class of to4 bacco products unless such class of tobacco 

5 products is listed in section 901(b) or is 

6 deemed by the Secretary in a regulation 

7 under section 901(b) to be subject to this 

8 chapter. 

9 ‘‘(iv) REALLOCATIONS.—In the case of 

10 a class of tobacco products that is not listed 

11 in section 901(b) or deemed by the Sec12 retary in a regulation under section 901(b) 

13 to be subject to this chapter, the amount of 

14 user fees that would otherwise be assessed to 

15 such class of tobacco products shall be re16 allocated to the classes of tobacco products 

17 that are subject to this chapter in the same 

18 manner and based on the same relative per19 centages otherwise determined under clause 

20 (ii). 

21 ‘‘(3) DETERMINATION OF USER FEE BY COM22 PANY.— 

23 ‘‘(A) IN GENERAL.—The total user fee to be 

24 paid by each manufacturer or importer of a par-
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1 ticular class of tobacco products shall be deter2 mined for each quarter by multiplying— 

3 ‘‘(i) such manufacturer’s or importer’s 

4 percentage share as determined under para5 graph (4); by 

6 ‘‘(ii) the portion of the user fee amount 

7 for the current quarter to be assessed on all 

8 manufacturers and importers of such class 

9 of tobacco products as determined under 

10 paragraph (2). 

11 ‘‘(B) NO FEE IN EXCESS OF PERCENTAGE

12 SHARE.—No manufacturer or importer of to13 bacco products shall be required to pay a user fee 

14 in excess of the percentage share of such manu15 facturer or importer. 

16 ‘‘(4) ALLOCATION OF ASSESSMENT WITHIN EACH

17 CLASS OF TOBACCO PRODUCT.—The percentage share 

18 of each manufacturer or importer of a particular 

19 class of tobacco products of the total user fee to be 

20 paid by all manufacturers or importers of that class 

21 of tobacco products shall be the percentage determined 

22 for purposes of allocations under subsections (e) 

23 through (h) of section 625 of Public Law 108–357. 

24 ‘‘(5) ALLOCATION FOR CIGARS.—Notwith25 standing paragraph (4), if a user fee assessment is 
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1 imposed on cigars, the percentage share of each manu2 facturer or importer of cigars shall be based on the ex3 cise taxes paid by such manufacturer or importer 

4 during the prior fiscal year. 

5 ‘‘(6) TIMING OF ASSESSMENT.—The Secretary 

6 shall notify each manufacturer and importer of to7 bacco products subject to this section of the amount of 

8 the quarterly assessment imposed on such manufac9 turer or importer under this subsection for each quar10 ter of each fiscal year. Such notifications shall occur 

11 not later than 30 days prior to the end of the quarter 

12 for which such assessment is made, and payments of 

13 all assessments shall be made by the last day of the 

14 quarter involved. 

15 ‘‘(7) MEMORANDUM OF UNDERSTANDING.— 

16 ‘‘(A) IN GENERAL.—The Secretary shall re17 quest the appropriate Federal agency to enter 

18 into a memorandum of understanding that pro19 vides for the regular and timely transfer from 

20 the head of such agency to the Secretary of the 

21 information described in paragraphs (2)(B)(ii) 

22 and (4) and all necessary information regarding 

23 all tobacco product manufacturers and importers 

24 required to pay user fees. The Secretary shall 

25 maintain all disclosure restrictions established 
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1 by the head of such agency regarding the infor2 mation provided under the memorandum of un3 derstanding. 

4 ‘‘(B) ASSURANCES.—Beginning not later 

5 than fiscal year 2015, and for each subsequent 

6 fiscal year, the Secretary shall ensure that the 

7 Food and Drug Administration is able to deter8 mine the applicable percentages described in 

9 paragraph (2) and the percentage shares de10 scribed in paragraph (4). The Secretary may 

11 carry out this subparagraph by entering into a 

12 contract with the head of the Federal agency re13 ferred to in subparagraph (A) to continue to pro14 vide the necessary information. 

15 ‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 

16 ‘‘(1) IN GENERAL.—Fees authorized under sub17 section (a) shall be collected and available for obliga18 tion only to the extent and in the amount provided 

19 in advance in appropriations Acts, subject to para20 graph (2)(D). Such fees are authorized to remain 

21 available until expended. Such sums as may be nec22 essary may be transferred from the Food and Drug 

23 Administration salaries and expenses appropriation 

24 account without fiscal year limitation to such appro-
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1 priation account for salaries and expenses with such 

2 fiscal year limitation. 

3 ‘‘(2) AVAILABILITY.— 

4 ‘‘(A) IN GENERAL.—Fees appropriated 

5 under paragraph (3) are available only for the 

6 purpose of paying the costs of the activities of the 

7 Food and Drug Administration related to the 

8 regulation of tobacco products under this chapter 

9 and the Family Smoking Prevention and To10 bacco Control Act (referred to in this subsection 

11 as ‘tobacco regulation activities’), except that 

12 such fees may be used for the reimbursement 

13 specified in subparagraph (C). 

14 ‘‘(B) PROHIBITION AGAINST USE OF OTHER

15 FUNDS.— 

16 ‘‘(i) IN GENERAL.—Except as provided 

17 in clause (ii), fees collected under subsection 

18 (a) are the only funds authorized to be 

19 made available for tobacco regulation ac20 tivities. 

21 ‘‘(ii) STARTUP COSTS.—Clause (i) does 

22 not apply until October 1, 2009. Until such 

23 date, any amounts available to the Food 

24 and Drug Administration (excluding user 

25 fees) shall be available and allocated as 
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1 needed to pay the costs of tobacco regulation 

2 activities. 

3 ‘‘(C) REIMBURSEMENT OF START-UP

4 AMOUNTS.— 

5 ‘‘(i) IN GENERAL.—Any amounts allo6 cated for the start-up period pursuant to 

7 subparagraph (B)(ii) shall be reimbursed 

8 through any appropriated fees collected 

9 under subsection (a), in such manner as the 

10 Secretary determines appropriate to ensure 

11 that such allocation results in no net change 

12 in the total amount of funds otherwise 

13 available, for the period from October 1, 

14 2008, through September 30, 2010, for Food 

15 and Drug Administration programs and 

16 activities (other than tobacco regulation ac17 tivities) for such period. 

18 ‘‘(ii) TREATMENT OF REIMBURSED

19 AMOUNTS.—Amounts reimbursed under 

20 clause (i) shall be available for the pro21 grams and activities for which funds allo22 cated for the start-up period were available, 

23 prior to such allocation, until September 

24 30, 2010, notwithstanding any otherwise 
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1 applicable limits on amounts for such pro2 grams or activities for a fiscal year. 

3 ‘‘(D) FEE COLLECTED DURING START-UP

4 PERIOD.—Notwithstanding the first sentence of 

5 paragraph (1), fees under subsection (a) may be 

6 collected through September 30, 2009 under sub7 paragraph (B)(ii) and shall be available for obli8 gation and remain available until expended. 

9 Such offsetting collections shall be credited to the 

10 salaries and expenses account of the Food and 

11 Drug Administration. 

12 ‘‘(E) OBLIGATION OF START-UP COSTS IN

13 ANTICIPATION OF AVAILABLE FEE COLLEC14 TIONS.—Notwithstanding any other provision of 

15 law, following the enactment of an appropriation 

16 for fees under this section for fiscal year 2010, 

17 or any portion thereof, obligations for costs of to18 bacco regulation activities during the start-up 

19 period may be incurred in anticipation of the re20 ceipt of offsetting fee collections through proce21 dures specified in section 1534 of title 31, United 

22 States Code. 

23 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For 

24 fiscal year 2009 and each subsequent fiscal year, there 

25 is authorized to be appropriated for fees under this 
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1 section an amount equal to the amount specified in 

2 subsection (b)(1) for the fiscal year. 

3 ‘‘(d) COLLECTION OF UNPAID FEES.—In any case 

4 where the Secretary does not receive payment of a fee as5 sessed under subsection (a) within 30 days after it is due, 

6 such fee shall be treated as a claim of the United States 

7 Government subject to subchapter II of chapter 37 of title 

8 31, United States Code. 

9 ‘‘(e) APPLICABILITY TO FISCAL YEAR 2009.—If the 

10 date of enactment of the Family Smoking Prevention and 

11 Tobacco Control Act occurs during fiscal year 2009, the fol12 lowing applies, subject to subsection (c): 

13 ‘‘(1) The Secretary shall determine the fees that 

14 would apply for a single quarter of such fiscal year 

15 according to the application of subsection (b) to the 

16 amount specified in paragraph (1)(A) of such sub17 section (referred to in this subsection as the ‘quarterly 

18 fee amounts’). 

19 ‘‘(2) For the quarter in which such date of enact20 ment occurs, the amount of fees assessed shall be a pro 

21 rata amount, determined according to the number of 

22 days remaining in the quarter (including such date 

23 of enactment) and according to the daily equivalent 

24 of the quarterly fee amounts. Fees assessed under the 
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1 preceding sentence shall not be collected until the next 

2 quarter. 

3 ‘‘(3) For the quarter following the quarter to 

4 which paragraph (2) applies, the full quarterly fee 

5 amounts shall be assessed and collected, in addition to 

6 collection of the pro rata fees assessed under para7 graph (2).’’. 

8 (c) CONFORMING AMENDMENT.—Section 9(1) of the 

9 Comprehensive Smokeless Tobacco Health Education Act of 

10 1986 (15 U.S.C. 4408(i)) is amended to read as follows: 

11 ‘‘(1) The term ‘smokeless tobacco’ has the mean12 ing given such term by section 900(18) of the Federal 

13 Food, Drug, and Cosmetic Act.’’. 

14 SEC. 102. FINAL RULE. 

15 (a) CIGARETTES AND SMOKELESS TOBACCO.— 

16 (1) IN GENERAL.—On the first day of publica17 tion of the Federal Register that is 180 days or more 

18 after the date of enactment of this Act, the Secretary 

19 of Health and Human Services shall publish in the 

20 Federal Register a final rule regarding cigarettes and 

21 smokeless tobacco, which— 

22 (A) is deemed to be issued under chapter 9 

23 of the Federal Food, Drug, and Cosmetic Act, as 

24 added by section 101 of this division; and 
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1 (B) shall be deemed to be in compliance 

2 with all applicable provisions of chapter 5 of 

3 title 5, United States Code, and all other provi4 sions of law relating to rulemaking procedures. 

5 (2) CONTENTS OF RULE.—Except as provided in 

6 this subsection, the final rule published under para7 graph (1), shall be identical in its provisions to part 

8 897 of the regulations promulgated by the Secretary 

9 of Health and Human Services in the August 28, 

10 1996, issue of the Federal Register (61 Fed. Reg. 

11 44615–44618). Such rule shall— 

12 (A) provide for the designation of jurisdic13 tional authority that is in accordance with this 

14 subsection in accordance with this division and 

15 the amendments made by this division; 

16 (B) strike Subpart C—Labels and section 

17 897.32(c); 

18 (C) strike paragraphs (a), (b), and (i) of 

19 section 897.3 and insert definitions of the terms 

20 ‘‘cigarette’’, ‘‘cigarette tobacco’’, and ‘‘smokeless 

21 tobacco’’ as defined in section 900 of the Federal 

22 Food, Drug, and Cosmetic Act; 

23 (D) insert ‘‘or roll-your-own paper’’ in sec24 tion 897.34(a) after ‘‘other than cigarettes or 

25 smokeless tobacco’’; 
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1 (E) include such modifications to section 

2 897.30(b), if any, that the Secretary determines 

3 are appropriate in light of governing First 

4 Amendment case law, including the decision of 

5 the Supreme Court of the United States in 

6 Lorillard Tobacco Co. v. Reilly (533 U.S. 525 

7 (2001)); 

8 (F) become effective on the date that is 1 

9 year after the date of enactment of this Act; and 

10 (G) amend paragraph (d) of section 897.16 

11 to read as follows: 

12 ‘‘(d)(1) Except as provided in subparagraph (2), no 

13 manufacturer, distributor, or retailer may distribute or 

14 cause to be distributed any free samples of cigarettes, smoke15 less tobacco, or other tobacco products (as such term is de16 fined in section 201 of the Federal Food, Drug, and Cos17 metic Act). 

18 ‘‘(2)(A) Subparagraph (1) does not prohibit a manu19 facturer, distributor, or retailer from distributing or caus20 ing to be distributed free samples of smokeless tobacco in 

21 a qualified adult-only facility. 

22 ‘‘(B) This subparagraph does not affect the authority 

23 of a State or local government to prohibit or otherwise re24 strict the distribution of free samples of smokeless tobacco. 
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1 ‘‘(C) For purposes of this paragraph, the term ‘quali2 fied adult-only facility’ means a facility or restricted area 

3 that— 

4 ‘‘(i) requires each person present to provide to a 

5 law enforcement officer (whether on or off duty) or to 

6 a security guard licensed by a governmental entity 

7 government-issued identification showing a photo8 graph and at least the minimum age established by 

9 applicable law for the purchase of smokeless tobacco; 

10 ‘‘(ii) does not sell, serve, or distribute alcohol; 

11 ‘‘(iii) is not located adjacent to or immediately 

12 across from (in any direction) a space that is used 

13 primarily for youth-oriented marketing, promotional, 

14 or other activities; 

15 ‘‘(iv) is a temporary structure constructed, des16 ignated, and operated as a distinct enclosed area for 

17 the purpose of distributing free samples of smokeless 

18 tobacco in accordance with this subparagraph; 

19 ‘‘(v) is enclosed by a barrier that— 

20 ‘‘(I) is constructed of, or covered with, an 

21 opaque material (except for entrances and exits); 

22 ‘‘(II) extends from no more than 12 inches 

23 above the ground or floor (which area at the bot24 tom of the barrier must be covered with material 

25 that restricts visibility but may allow airflow) to 
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1 at least 8 feet above the ground or floor (or to 

2 the ceiling); and 

3 ‘‘(III) prevents persons outside the qualified 

4 adult-only facility from seeing into the qualified 

5 adult-only facility, unless they make unreason6 able efforts to do so; and 

7 ‘‘(vi) does not display on its exterior— 

8 ‘‘(I) any tobacco product advertising; 

9 ‘‘(II) a brand name other than in conjunc10 tion with words for an area or enclosure to iden11 tify an adult-only facility; or 

12 ‘‘(III) any combination of words that would 

13 imply to a reasonable observer that the manufac14 turer, distributor, or retailer has a sponsorship 

15 that would violate section 897.34(c). 

16 ‘‘(D) Distribution of samples of smokeless tobacco 

17 under this subparagraph permitted to be taken out of the 

18 qualified adult-only facility shall be limited to 1 package 

19 per adult consumer containing no more than 0.53 ounces 

20 (15 grams) of smokeless tobacco. If such package of smoke21 less tobacco contains individual portions of smokeless to22 bacco, the individual portions of smokeless tobacco shall not 

23 exceed 8 individual portions and the collective weight of 

24 such individual portions shall not exceed 0.53 ounces (15 

25 grams). Any manufacturer, distributor, or retailer who dis-
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1 tributes or causes to be distributed free samples also shall 

2 take reasonable steps to ensure that the above amounts are 

3 limited to one such package per adult consumer per day. 

4 ‘‘(3) Notwithstanding subparagraph (2), no manufac5 turer, distributor, or retailer may distribute or cause to be 

6 distributed any free samples of smokeless tobacco— 

7 ‘‘(A) to a sports team or entertainment group; or 

8 ‘‘(B) at any football, basketball, baseball, soccer, 

9 or hockey event or any other sporting or entertain10 ment event determined by the Secretary to be covered 

11 by this subparagraph. 

12 ‘‘(4) The Secretary shall implement a program to en13 sure compliance with this paragraph and submit a report 

14 to the Congress on such compliance not later than 18 

15 months after the date of enactment of the Family Smoking 

16 Prevention and Tobacco Control Act. 

17 ‘‘(5) Nothing in this paragraph shall be construed to 

18 authorize any person to distribute or cause to be distributed 

19 any sample of a tobacco product to any individual who has 

20 not attained the minimum age established by applicable 

21 law for the purchase of such product.’’. 

22 (3) AMENDMENTS TO RULE.—Prior to making 

23 amendments to the rule published under paragraph 

24 (1), the Secretary shall promulgate a proposed rule in 
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1 accordance with chapter 5 of title 5, United States 

2 Code. 

3 (4) RULE OF CONSTRUCTION.—Except as pro4 vided in paragraph (3), nothing in this section shall 

5 be construed to limit the authority of the Secretary to 

6 amend, in accordance with chapter 5 of title 5, 

7 United States Code, the regulation promulgated pur8 suant to this section, including the provisions of such 

9 regulation relating to distribution of free samples. 

10 (5) ENFORCEMENT OF RETAIL SALE PROVI11 SIONS.—The Secretary of Health and Human Serv12 ices shall ensure that the provisions of this division, 

13 the amendments made by this division, and the im14 plementing regulations (including such provisions, 

15 amendments, and regulations relating to the retail 

16 sale of tobacco products) are enforced with respect to 

17 the United States and Indian tribes. 

18 (6) QUALIFIED ADULT-ONLY FACILITY.—A quali19 fied adult-only facility (as such term is defined in 

20 section 897.16(d) of the final rule published under 

21 paragraph (1)) that is also a retailer and that com22 mits a violation as a retailer shall not be subject to 

23 the limitations in section 103(q) and shall be subject 

24 to penalties applicable to a qualified adult-only facil25 ity. 
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1 (7) CONGRESSIONAL REVIEW PROVISIONS.—Sec2 tion 801 of title 5, United States Code, shall not 

3 apply to the final rule published under paragraph 

4 (1). 

5 (b) LIMITATION ON ADVISORY OPINIONS.—As of the 

6 date of enactment of this Act, the following documents 

7 issued by the Food and Drug Administration shall not con8 stitute advisory opinions under section 10.85(d)(1) of title 

9 21, Code of Federal Regulations, except as they apply to 

10 tobacco products, and shall not be cited by the Secretary 

11 of Health and Human Services or the Food and Drug Ad12 ministration as binding precedent: 

13 (1) The preamble to the proposed rule in the doc14 ument titled ‘‘Regulations Restricting the Sale and 

15 Distribution of Cigarettes and Smokeless Tobacco 

16 Products to Protect Children and Adolescents’’ (60 

17 Fed. Reg. 41314–41372 (August 11, 1995)). 

18 (2) The document titled ‘‘Nicotine in Cigarettes 

19 and Smokeless Tobacco Products is a Drug and These 

20 Products Are Nicotine Delivery Devices Under the 

21 Federal Food, Drug, and Cosmetic Act’’ (60 Fed. Reg. 

22 41453–41787 (August 11, 1995)). 

23 (3) The preamble to the final rule in the docu24 ment titled ‘‘Regulations Restricting the Sale and 

25 Distribution of Cigarettes and Smokeless Tobacco to 
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1 Protect Children and Adolescents’’ (61 Fed. Reg. 

2 44396–44615 (August 28, 1996)). 

3 (4) The document titled ‘‘Nicotine in Cigarettes 

4 and Smokeless Tobacco is a Drug and These Products 

5 are Nicotine Delivery Devices Under the Federal 

6 Food, Drug, and Cosmetic Act; Jurisdictional Deter7 mination’’ (61 Fed. Reg. 44619–45318 (August 28, 

8 1996)). 

9 SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GEN10 ERAL PROVISIONS. 

11 (a) AMENDMENT OF FEDERAL FOOD, DRUG, AND COS12 METIC ACT.—Except as otherwise expressly provided, when13 ever in this section an amendment is expressed in terms 

14 of an amendment to, or repeal of, a section or other provi15 sion, the reference is to a section or other provision of the 

16 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

17 seq.). 

18 (b) SECTION 301.—Section 301 (21 U.S.C. 331) is 

19 amended— 

20 (1) in subsection (a), by inserting ‘‘tobacco prod21 uct,’’ after ‘‘device,’’; 

22 (2) in subsection (b), by inserting ‘‘tobacco prod23 uct,’’ after ‘‘device,’’; 

24 (3) in subsection (c), by inserting ‘‘tobacco prod25 uct,’’ after ‘‘device,’’; 
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1 (4) in subsection (e)— 

2 (A) by striking the period after ‘‘572(i)’’; 

3 and 

4 (B) by striking ‘‘or 761 or the refusal to 

5 permit access to’’ and inserting ‘‘761, 909, or 

6 920 or the refusal to permit access to’’; 

7 (5) in subsection (g), by inserting ‘‘tobacco prod8 uct,’’ after ‘‘device,’’; 

9 (6) in subsection (h), by inserting ‘‘tobacco prod10 uct,’’ after ‘‘device,’’; 

11 (7) in subsection (j)— 

12 (A) by striking the period after ‘‘573’’; and 

13 (B) by striking ‘‘708, or 721’’ and inserting 

14 ‘‘708, 721, 904, 905, 906, 907, 908, 909, or 

15 920(b)’’; 

16 (8) in subsection (k), by inserting ‘‘tobacco prod17 uct,’’ after ‘‘device,’’; 

18 (9) by striking subsection (p) and inserting the 

19 following: 

20 ‘‘(p) The failure to register in accordance with section 

21 510 or 905, the failure to provide any information required 

22 by section 510(j), 510(k), 905(i), or 905(j), or the failure 

23 to provide a notice required by section 510(j)(2) or 

24 905(i)(3).’’; 
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1 (10) by striking subsection (q)(1) and inserting 

2 the following: 

3 ‘‘(q)(1) The failure or refusal— 

4 ‘‘(A) to comply with any requirement prescribed 

5 under section 518, 520(g), 903(b), 907, 908, or 915; 

6 ‘‘(B) to furnish any notification or other mate7 rial or information required by or under section 519, 

8 520(g), 904, 909, or 920; or 

9 ‘‘(C) to comply with a requirement under section 

10 522 or 913.’’; 

11 (11) in subsection (q)(2), by striking ‘‘device,’’ 

12 and inserting ‘‘device or tobacco product,’’; 

13 (12) in subsection (r), by inserting ‘‘or tobacco 

14 product’’ after the term ‘‘device’’ each time that such 

15 term appears; and 

16 (13) by adding at the end the following: 

17 ‘‘(oo) The sale of tobacco products in violation of a 

18 no-tobacco-sale order issued under section 303(f). 

19 ‘‘(pp) The introduction or delivery for introduction 

20 into interstate commerce of a tobacco product in violation 

21 of section 911. 

22 ‘‘(qq)(1) Forging, counterfeiting, simulating, or falsely 

23 representing, or without proper authority using any mark, 

24 stamp (including tax stamp), tag, label, or other identifica25 tion device upon any tobacco product or container or label-
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1 ing thereof so as to render such tobacco product a counterfeit 

2 tobacco product. 

3 ‘‘(2) Making, selling, disposing of, or keeping in posses4 sion, control, or custody, or concealing any punch, die, 

5 plate, stone, or other item that is designed to print, imprint, 

6 or reproduce the trademark, trade name, or other identi7 fying mark, imprint, or device of another or any likeness 

8 of any of the foregoing upon any tobacco product or con9 tainer or labeling thereof so as to render such tobacco prod10 uct a counterfeit tobacco product. 

11 ‘‘(3) The doing of any act that causes a tobacco prod12 uct to be a counterfeit tobacco product, or the sale or dis13 pensing, or the holding for sale or dispensing, of a counter14 feit tobacco product. 

15 ‘‘(rr) The charitable distribution of tobacco products. 

16 ‘‘(ss) The failure of a manufacturer or distributor to 

17 notify the Attorney General and the Secretary of the Treas18 ury of their knowledge of tobacco products used in illicit 

19 trade. 

20 ‘‘(tt) Making any express or implied statement or rep21 resentation directed to consumers with respect to a tobacco 

22 product, in a label or labeling or through the media or ad23 vertising, that either conveys, or misleads or would mislead 

24 consumers into believing, that— 
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1 ‘‘(1) the product is approved by the Food and 

2 Drug Administration; 

3 ‘‘(2) the Food and Drug Administration deems 

4 the product to be safe for use by consumers; 

5 ‘‘(3) the product is endorsed by the Food and 

6 Drug Administration for use by consumers; or 

7 ‘‘(4) the product is safe or less harmful by virtue 

8 of— 

9 ‘‘(A) its regulation or inspection by the 

10 Food and Drug Administration; or 

11 ‘‘(B) its compliance with regulatory re12 quirements set by the Food and Drug Adminis13 tration; 

14 including any such statement or representation ren15 dering the product misbranded under section 903.’’. 

16 (c) SECTION 303.—Section 303(f) (21 U.S.C. 333(f)) 

17 is amended— 

18 (1) in paragraph (5)— 

19 (A) by striking ‘‘paragraph (1), (2), (3), or 

20 (4)’’ each place such appears and inserting 

21 ‘‘paragraph (1), (2), (3), (4), or (9)’’; 

22 (B) in subparagraph (A)— 

23 (i) by striking ‘‘assessed’’ the first time 

24 it appears and inserting ‘‘assessed, or a no25 tobacco-sale order may be imposed,’’; and 
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1 (ii) by striking ‘‘penalty’’ the second 

2 time it appears and inserting ‘‘penalty, or 

3 upon whom a no-tobacco-sale order is to be 

4 imposed,’’; 

5 (C) in subparagraph (B)— 

6 (i) by inserting after ‘‘penalty,’’ the 

7 following: ‘‘or the period to be covered by a 

8 no-tobacco-sale order,’’; and 

9 (ii) by adding at the end the following: 

10 ‘‘A no-tobacco-sale order permanently pro11 hibiting an individual retail outlet from 

12 selling tobacco products shall include provi13 sions that allow the outlet, after a specified 

14 period of time, to request that the Secretary 

15 compromise, modify, or terminate the 

16 order.’’; and 

17 (D) by adding at the end the following: 

18 ‘‘(D) The Secretary may compromise, modify, or ter19 minate, with or without conditions, any no-tobacco-sale 

20 order.’’; 

21 (2) in paragraph (6)— 

22 (A) by inserting ‘‘or the imposition of a no23 tobacco-sale order’’ after the term ‘‘penalty’’ each 

24 place such term appears; and 
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1 (B) by striking ‘‘issued.’’ and inserting 

2 ‘‘issued, or on which the no-tobacco-sale order 

3 was imposed, as the case may be.’’; and 

4 (3) by adding at the end the following: 

5 ‘‘(8) If the Secretary finds that a person has committed 

6 repeated violations of restrictions promulgated under sec7 tion 906(d) at a particular retail outlet then the Secretary 

8 may impose a no-tobacco-sale order on that person prohib9 iting the sale of tobacco products in that outlet. A no-to10 bacco-sale order may be imposed with a civil penalty under 

11 paragraph (1). Prior to the entry of a no-sale order under 

12 this paragraph, a person shall be entitled to a hearing pur13 suant to the procedures established through regulations of 

14 the Food and Drug Administration for assessing civil 

15 money penalties, including at a retailer’s request a hearing 

16 by telephone, or at the nearest regional or field office of the 

17 Food and Drug Administration, or at a Federal, State, or 

18 county facility within 100 miles from the location of the 

19 retail outlet, if such a facility is available. 

20 ‘‘(9) CIVIL MONETARY PENALTIES FOR VIOLATION OF

21 TOBACCO PRODUCT REQUIREMENTS.— 

22 ‘‘(A) IN GENERAL.—Subject to subparagraph 

23 (B), any person who violates a requirement of this 

24 Act which relates to tobacco products shall be liable 

25 to the United States for a civil penalty in an amount 
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1 not to exceed $15,000 for each such violation, and not 

2 to exceed $1,000,000 for all such violations adju3 dicated in a single proceeding. 

4 ‘‘(B) ENHANCED PENALTIES.— 

5 ‘‘(i) Any person who intentionally violates 

6 a requirement of section 902(5), 902(6), 904, 

7 908(c), or 911(a), shall be subject to a civil mon8 etary penalty of— 

9 ‘‘(I) not to exceed $250,000 per viola10 tion, and not to exceed $1,000,000 for all 

11 such violations adjudicated in a single pro12 ceeding; or 

13 ‘‘(II) in the case of a violation that 

14 continues after the Secretary provides writ15 ten notice to such person, $250,000 for the 

16 first 30-day period (or any portion thereof) 

17 that the person continues to be in violation, 

18 and such amount shall double for every 30- 

19 day period thereafter that the violation con20 tinues, not to exceed $1,000,000 for any 30- 

21 day period, and not to exceed $10,000,000 

22 for all such violations adjudicated in a sin23 gle proceeding. 
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1 ‘‘(ii) Any person who violates a requirement 

2 of section 911(g)(2)(C)(ii) or 911(i)(1), shall be 

3 subject to a civil monetary penalty of— 

4 ‘‘(I) not to exceed $250,000 per viola5 tion, and not to exceed $1,000,000 for all 

6 such violations adjudicated in a single pro7 ceeding; or 

8 ‘‘(II) in the case of a violation that 

9 continues after the Secretary provides writ10 ten notice to such person, $250,000 for the 

11 first 30-day period (or any portion thereof) 

12 that the person continues to be in violation, 

13 and such amount shall double for every 30- 

14 day period thereafter that the violation con15 tinues, not to exceed $1,000,000 for any 30- 

16 day period, and not to exceed $10,000,000 

17 for all such violations adjudicated in a sin18 gle proceeding. 

19 ‘‘(iii) In determining the amount of a civil 

20 penalty under clause (i)(II) or (ii)(II), the Sec21 retary shall take into consideration whether the 

22 person is making efforts toward correcting the 

23 violation of the requirements of the section for 

24 which such person is subject to such civil pen25 alty.’’. 
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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 tobacco 

11 product’’ after the term ‘‘device’’ each place such term 

12 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 insert17 ing ‘‘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 this 

5 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 on 

9 Indian country without the express written consent of the 

10 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)— 

20 (A) by striking ‘‘devices, or cosmetics’’ each 

21 place it appears and inserting ‘‘devices, tobacco 

22 products, or cosmetics’’; 

23 (B) by striking ‘‘or restricted devices’’ each 

24 place it appears and inserting ‘‘restricted de25 vices, or tobacco products’’; and 
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1 (C) by striking ‘‘and devices and subject to’’ 

2 and all that follows through ‘‘other drugs or de3 vices’’ and inserting ‘‘devices, and tobacco prod4 ucts and subject to reporting and inspection 

5 under regulations lawfully issued pursuant to 

6 section 505 (i) or (k), section 519, section 520(g), 

7 or chapter IX and data relating to other drugs, 

8 devices, or tobacco products’’; 

9 (2) in subsection (b), by inserting ‘‘tobacco prod10 uct,’’ after ‘‘device,’’; and 

11 (3) in subsection (g)(13), by striking ‘‘section 

12 903(g)’’ and inserting ‘‘section 1003(g)’’. 

13 (j) SECTION 705.—Section 705(b) (21 U.S.C. 375(b)) 

14 is amended by inserting ‘‘tobacco products,’’ after ‘‘de15 vices,’’. 

16 (k) SECTION 709.—Section 709 (21 U.S.C. 379a) is 

17 amended by inserting ‘‘tobacco product,’’ after ‘‘device,’’. 

18 (l) SECTION 801.—Section 801 (21 U.S.C. 381) is 

19 amended— 

20 (1) in subsection (a)— 

21 (A) by inserting ‘‘tobacco products,’’ after 

22 the term ‘‘devices,’’; 

23 (B) by inserting ‘‘or section 905(h)’’ after 

24 ‘‘section 510’’; and 
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1 (C) by striking the term ‘‘drugs or devices’’ 

2 each time such term appears and inserting 

3 ‘‘drugs, devices, or tobacco products’’; 

4 (2) in subsection (e)(1)— 

5 (A) by inserting ‘‘tobacco product’’ after 

6 ‘‘drug, device,’’; and 

7 (B) by inserting ‘‘, and a tobacco product 

8 intended for export shall not be deemed to be in 

9 violation of section 906(e), 907, 911, or 920(a),’’ 

10 before ‘‘if it—’’; and 

11 (3) by adding at the end the following: 

12 ‘‘(p)(1) Not later than 36 months after the date of en13 actment of the Family Smoking Prevention and Tobacco 

14 Control Act, and annually thereafter, the Secretary shall 

15 submit to the Committee on Health, Education, Labor, and 

16 Pensions of the Senate and the Committee on Energy and 

17 Commerce of the House of Representatives, a report regard18 ing— 

19 ‘‘(A) the nature, extent, and destination of 

20 United States tobacco product exports that do not 

21 conform to tobacco product standards established pur22 suant to this Act; 

23 ‘‘(B) the public health implications of such ex24 ports, including any evidence of a negative public 

25 health impact; and 
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1 ‘‘(C) recommendations or assessments of policy 

2 alternatives available to Congress and the executive 

3 branch to reduce any negative public health impact 

4 caused by such exports. 

5 ‘‘(2) The Secretary is authorized to establish appro6 priate information disclosure requirements to carry out this 

7 subsection.’’. 

8 (m) SECTION 1003.—Section 1003(d)(2)(C) (as redes9 ignated by section 101(b)) is amended— 

10 (1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 

11 (2) inserting ‘‘, and tobacco products’’ after ‘‘de12 vices’’. 

13 (n) SECTION 1009.—Section 1009(b) (as redesignated 

14 by section 101(b)) is amended by striking ‘‘section 908’’ and 

15 inserting ‘‘section 1008’’. 

16 (o) SECTION 409 OF THE FEDERAL MEAT INSPECTION

17 ACT.—Section 409(a) of the Federal Meat Inspection Act 

18 (21 U.S.C. 679(a)) is amended by striking ‘‘section 902(b)’’ 

19 and inserting ‘‘section 1002(b)’’. 

20 (p) RULE OF CONSTRUCTION.—Nothing in this section 

21 is intended or shall be construed to expand, contract, or 

22 otherwise modify or amend the existing limitations on State 

23 government authority over tribal restricted fee or trust 

24 lands. 

25 (q) GUIDANCE AND EFFECTIVE DATES.— 
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1 (1) IN GENERAL.—The Secretary of Health and 

2 Human Services shall issue guidance— 

3 (A) defining the term ‘‘repeated violation’’, 

4 as used in section 303(f)(8) of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 333(f)(8)) as 

6 amended by subsection (c), as including at least 

7 5 violations of particular requirements over a 

8 36-month period at a particular retail outlet 

9 that constitute a repeated violation and pro10 viding for civil penalties in accordance with 

11 paragraph (2); 

12 (B) providing for timely and effective notice 

13 by certified or registered mail or personal deliv14 ery to the retailer of each alleged violation at a 

15 particular retail outlet prior to conducting a fol16 lowup compliance check, such notice to be sent to 

17 the location specified on the retailer’s registra18 tion or to the retailer’s registered agent if the re19 tailer has provider such agent information to the 

20 Food and Drug Administration prior to the vio21 lation; 

22 (C) providing for a hearing pursuant to the 

23 procedures established through regulations of the 

24 Food and Drug Administration for assessing 

25 civil money penalties, including at a retailer’s 
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1 request a hearing by telephone or at the nearest 

2 regional or field office of the Food and Drug Ad3 ministration, and providing for an expedited 

4 procedure for the administrative appeal of an al5 leged violation; 

6 (D) providing that a person may not be 

7 charged with a violation at a particular retail 

8 outlet unless the Secretary has provided notice to 

9 the retailer of all previous violations at that out10 let; 

11 (E) establishing that civil money penalties 

12 for multiple violations shall increase from one 

13 violation to the next violation pursuant to para14 graph (2) within the time periods provided for 

15 in such paragraph; 

16 (F) providing that good faith reliance on 

17 the presentation of a false government-issued 

18 photographic identification that contains a date 

19 of birth does not constitute a violation of any 

20 minimum age requirement for the sale of tobacco 

21 products if the retailer has taken effective steps 

22 to prevent such violations, including— 

23 (i) adopting and enforcing a written 

24 policy against sales to minors; 
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1 (ii) informing its employees of all ap2 plicable laws; 

3 (iii) establishing disciplinary sanctions 

4 for employee noncompliance; and 

5 (iv) requiring its employees to verify 

6 age by way of photographic identification 

7 or electronic scanning device; and 

8 (G) providing for the Secretary, in deter9 mining whether to impose a no-tobacco-sale order 

10 and in determining whether to compromise, 

11 modify, or terminate such an order, to consider 

12 whether the retailer has taken effective steps to 

13 prevent violations of the minimum age require14 ments for the sale of tobacco products, including 

15 the steps listed in subparagraph (F). 

16 (2) PENALTIES FOR VIOLATIONS.— 

17 (A) IN GENERAL.—The amount of the civil 

18 penalty to be applied for violations of restric19 tions promulgated under section 906(d), as de20 scribed in paragraph (1), shall be as follows: 

21 (i) With respect to a retailer with an 

22 approved training program, the amount of 

23 the civil penalty shall not exceed— 
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1 (I) in the case of the first viola2 tion, $0.00 together with the issuance 

3 of a warning letter to the retailer; 

4 (II) in the case of a second viola5 tion within a 12-month period, $250; 

6 (III) in the case of a third viola7 tion within a 24-month period, $500; 

8 (IV) in the case of a fourth viola9 tion within a 24-month period, $2,000; 

10 (V) in the case of a fifth violation 

11 within a 36-month period, $5,000; and 

12 (VI) in the case of a sixth or sub13 sequent violation within a 48-month 

14 period, $10,000 as determined by the 

15 Secretary on a case-by-case basis. 

16 (ii) With respect to a retailer that does 

17 not have an approved training program, the 

18 amount of the civil penalty shall not ex19 ceed— 

20 (I) in the case of the first viola21 tion, $250; 

22 (II) in the case of a second viola23 tion within a 12-month period, $500; 

24 (III) in the case of a third viola25 tion within a 24-month period, $1,000; 
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1 (IV) in the case of a fourth viola2 tion within a 24-month period, $2,000; 

3 (V) in the case of a fifth violation 

4 within a 36-month period, $5,000; and 

5 (VI) in the case of a sixth or sub6 sequent violation within a 48-month 

7 period, $10,000 as determined by the 

8 Secretary on a case-by-case basis. 

9 (B) TRAINING PROGRAM.—For purposes of 

10 subparagraph (A), the term ‘‘approved training 

11 program’’ means a training program that com12 plies with standards developed by the Food and 

13 Drug Administration for such programs. 

14 (C) CONSIDERATION OF STATE PEN15 ALTIES.—The Secretary shall coordinate with the 

16 States in enforcing the provisions of this Act 

17 and, for purposes of mitigating a civil penalty 

18 to be applied for a violation by a retailer of any 

19 restriction promulgated under section 906(d), 

20 shall consider the amount of any penalties paid 

21 by the retailer to a State for the same violation. 

22 (3) GENERAL EFFECTIVE DATE.—The amend23 ments made by paragraphs (2), (3), and (4) of sub24 section (c) shall take effect upon the issuance of guid25 ance described in paragraph (1) of this subsection. 
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1 (4) SPECIAL EFFECTIVE DATE.—The amendment 

2 made by subsection (c)(1) shall take effect on the date 

3 of enactment of this Act. 

4 (5) PACKAGE LABEL REQUIREMENTS.—The pack5 age label requirements of paragraphs (3) and (4) of 

6 section 903(a) of the Federal Food, Drug, and Cos7 metic Act (as amended by this division) shall take ef8 fect on the date that is 12 months after the date of 

9 enactment of this Act. The package label requirements 

10 of paragraph (2) of such section 903(a) for cigarettes 

11 shall take effect on the date that is 15 months after 

12 the issuance of the regulations required by section 

13 4(d) of the Federal Cigarette Labeling and Adver14 tising Act (15 U.S.C. 1333), as amended by section 

15 201 of this division. The package label requirements 

16 of paragraph (2) of such section 903(a) for tobacco 

17 products other than cigarettes shall take effect on the 

18 date that is 12 months after the date of enactment of 

19 this Act. The effective date shall be with respect to the 

20 date of manufacture, provided that, in any case, be21 ginning 30 days after such effective date, a manufac22 turer shall not introduce into the domestic commerce 

23 of the United States any product, irrespective of the 

24 date of manufacture, that is not in conformance with 
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1 section 903(a) (2), (3), and (4) and section 920(a) of 

2 the Federal Food, Drug, and Cosmetic Act. 

3 (6) ADVERTISING REQUIREMENTS.—The adver4 tising requirements of section 903(a)(8) of the Federal 

5 Food, Drug, and Cosmetic Act (as amended by this 

6 division) shall take effect on the date that is 12 

7 months after the date of enactment of this Act. 

8 SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PUR9 CHASE TOBACCO PRODUCTS. 

10 The Secretary of Health and Human Services shall— 

11 (1) convene an expert panel to conduct a study 

12 on the public health implications of raising the min13 imum age to purchase tobacco products; and 

14 (2) not later than 5 years after the date of enact15 ment of this Act, submit a report to the Congress on 

16 the results of such study. 

17 SEC. 105. ENFORCEMENT ACTION PLAN FOR ADVERTISING 

18 AND PROMOTION RESTRICTIONS. 

19 (a) ACTION PLAN.— 

20 (1) DEVELOPMENT.—Not later than 6 months 

21 after the date of enactment of this Act, the Secretary 

22 of Health and Human Services (in this section re23 ferred to as the ‘‘Secretary’’) shall develop and pub24 lish an action plan to enforce restrictions adopted 

25 pursuant to section 906 of the Federal Food, Drug, 
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1 and Cosmetic Act, as added by section 101(b) of this 

2 division, or pursuant to section 102(a) of this divi3 sion, on promotion and advertising of menthol and 

4 other cigarettes to youth. 

5 (2) CONSULTATION.—The action plan required 

6 by paragraph (1) shall be developed in consultation 

7 with public health organizations and other stake8 holders with demonstrated expertise and experience in 

9 serving minority communities. 

10 (3) PRIORITY.—The action plan required by 

11 paragraph (1) shall include provisions designed to en12 sure enforcement of the restrictions described in para13 graph (1) in minority communities. 

14 (b) STATE AND LOCAL ACTIVITIES.— 

15 (1) INFORMATION ON AUTHORITY.—Not later 

16 than 3 months after the date of enactment of this Act, 

17 the Secretary shall inform State, local, and tribal 

18 governments of the authority provided to such entities 

19 under section 5(c) of the Federal Cigarette Labeling 

20 and Advertising Act, as added by section 203 of this 

21 division, or preserved by such entities under section 

22 916 of the Federal Food, Drug, and Cosmetic Act, as 

23 added by section 101(b) of this division. 

24 (2) COMMUNITY ASSISTANCE.—At the request of 

25 communities seeking assistance to prevent underage 
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1 tobacco use, the Secretary shall provide such assist2 ance, including assistance with strategies to address 

3 the prevention of underage tobacco use in commu4 nities with a disproportionate use of menthol ciga5 rettes by minors. 

6 SEC. 106. STUDIES OF PROGRESS AND EFFECTIVENESS. 

7 (a) FDA REPORT.—Not later than 3 years after the 

8 date of enactment of this Act, and not less than every 2 

9 years thereafter, the Secretary of Health and Human Serv10 ices shall submit to the Committee on Health, Education, 

11 Labor, and Pensions of the Senate and the Committee on 

12 Energy and Commerce of the House of Representatives, a 

13 report concerning— 

14 (1) the progress of the Food and Drug Adminis15 tration in implementing this division, including 

16 major accomplishments, objective measurements of 

17 progress, and the identification of any areas that 

18 have not been fully implemented; 

19 (2) impediments identified by the Food and 

20 Drug Administration to progress in implementing 

21 this division and to meeting statutory timeframes; 

22 (3) data on the number of new product applica23 tions received under section 910 of the Federal Food, 

24 Drug, and Cosmetic Act and modified risk product 

25 applications received under section 911 of such Act, 
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1 and the number of applications acted on under each 

2 category; and 

3 (4) data on the number of full time equivalents 

4 engaged in implementing this division. 

5 (b) GAO REPORT.—Not later than 5 years after the 

6 date of enactment of this Act, the Comptroller General of 

7 the United States shall conduct a study of, and submit to 

8 the Committees described in subsection (a) a report con9 cerning— 

10 (1) the adequacy of the authority and resources 

11 provided to the Secretary of Health and Human 

12 Services for this division to carry out its goals and 

13 purposes; and 

14 (2) any recommendations for strengthening that 

15 authority to more effectively protect the public health 

16 with respect to the manufacture, marketing, and dis17 tribution of tobacco products. 

18 (c) PUBLIC AVAILABILITY.—The Secretary of Health 

19 and Human Services and the Comptroller General of the 

20 United States, respectively, shall make the reports required 

21 under subsection (a) and (b) available to the public, includ22 ing by posting such reports on the respective Internet 

23 websites of the Food and Drug Administration and the Gov24 ernment Accountability Office. 
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1 TITLE II—TOBACCO PRODUCT 

2 WARNINGS; CONSTITUENT 

3 AND SMOKE CONSTITUENT 

4 DISCLOSURE 

5 SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS. 

6 (a) AMENDMENT.—Section 4 of the Federal Cigarette 

7 Labeling and Advertising Act (15 U.S.C. 1333) is amended 

8 to read as follows: 

9 ‘‘SEC. 4. LABELING. 

10 ‘‘(a) LABEL REQUIREMENTS.— 

11 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

12 person to manufacture, package, sell, offer to sell, dis13 tribute, or import for sale or distribution within the 

14 United States any cigarettes the package of which 

15 fails to bear, in accordance with the requirements of 

16 this section, one of the following labels: 

17 ‘‘WARNING: Cigarettes are addictive. 

18 ‘‘WARNING: Tobacco smoke can harm your 

19 children. 

20 ‘‘WARNING: Cigarettes cause fatal lung 

21 disease. 

22 ‘‘WARNING: Cigarettes cause cancer. 

23 ‘‘WARNING: Cigarettes cause strokes and 

24 heart disease. 
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1 ‘‘WARNING: Smoking during pregnancy 

2 can harm your baby. 

3 ‘‘WARNING: Smoking can kill you. 

4 ‘‘WARNING: Tobacco smoke causes fatal 

5 lung disease in nonsmokers. 

6 ‘‘WARNING: Quitting smoking now greatly 

7 reduces serious risks to your health. 

8 ‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—Each 

9 label statement required by paragraph (1) shall be lo10 cated in the upper portion of the front and rear pan11 els of the package, directly on the package underneath 

12 the cellophane or other clear wrapping. Each label 

13 statement shall comprise the top 50 percent of the 

14 front and rear panels of the package. The word 

15 ‘WARNING’ shall appear in capital letters and all 

16 text shall be in conspicuous and legible 17-point type, 

17 unless the text of the label statement would occupy 

18 more than 70 percent of such area, in which case the 

19 text may be in a smaller conspicuous and legible type 

20 size, provided that at least 60 percent of such area is 

21 occupied by required text. The text shall be black on 

22 a white background, or white on a black background, 

23 in a manner that contrasts, by typography, layout, or 

24 color, with all other printed material on the package, 
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1 in an alternating fashion under the plan submitted 

2 under subsection (c). 

3 ‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU4 TION.—The provisions of this subsection do not apply 

5 to a tobacco product manufacturer or distributor of 

6 cigarettes which does not manufacture, package, or 

7 import cigarettes for sale or distribution within the 

8 United States. 

9 ‘‘(4) APPLICABILITY TO RETAILERS.—A retailer 

10 of cigarettes shall not be in violation of this subsection 

11 for packaging that— 

12 ‘‘(A) contains a warning label; 

13 ‘‘(B) is supplied to the retailer by a license14 or permit-holding tobacco product manufacturer, 

15 importer, or distributor; and 

16 ‘‘(C) is not altered by the retailer in a way 

17 that is material to the requirements of this sub18 section. 

19 ‘‘(b) ADVERTISING REQUIREMENTS.— 

20 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

21 tobacco product manufacturer, importer, distributor, 

22 or retailer of cigarettes to advertise or cause to be ad23 vertised within the United States any cigarette unless 

24 its advertising bears, in accordance with the require-
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1 ments of this section, one of the labels specified in 

2 subsection (a). 

3 ‘‘(2) TYPOGRAPHY, ETC.—Each label statement 

4 required by subsection (a) in cigarette advertising 

5 shall comply with the standards set forth in this 

6 paragraph. For press and poster advertisements, each 

7 such statement and (where applicable) any required 

8 statement relating to tar, nicotine, or other con9 stituent (including a smoke constituent) yield shall 

10 comprise at least 20 percent of the area of the adver11 tisement and shall appear in a conspicuous and 

12 prominent format and location at the top of each ad13 vertisement within the trim area. The Secretary may 

14 revise the required type sizes in such area in such 

15 manner as the Secretary determines appropriate. The 

16 word ‘WARNING’ shall appear in capital letters, and 

17 each label statement shall appear in conspicuous and 

18 legible type. The text of the label statement shall be 

19 black if the background is white and white if the 

20 background is black, under the plan submitted under 

21 subsection (c). The label statements shall be enclosed 

22 by a rectangular border that is the same color as the 

23 letters of the statements and that is the width of the 

24 first downstroke of the capital ‘W’ of the word 

25 ‘WARNING’ in the label statements. The text of such 
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1 label statements shall be in a typeface pro rata to the 

2 following requirements: 45-point type for a whole3 page broadsheet newspaper advertisement; 39-point 

4 type for a half-page broadsheet newspaper advertise5 ment; 39-point type for a whole-page tabloid news6 paper advertisement; 27-point type for a half-page 

7 tabloid newspaper advertisement; 31.5-point type for 

8 a double page spread magazine or whole-page maga9 zine advertisement; 22.5-point type for a 28 centi10 meter by 3 column advertisement; and 15-point type 

11 for a 20 centimeter by 2 column advertisement. The 

12 label statements shall be in English, except that— 

13 ‘‘(A) in the case of an advertisement that 

14 appears in a newspaper, magazine, periodical, 

15 or other publication that is not in English, the 

16 statements shall appear in the predominant lan17 guage of the publication; and 

18 ‘‘(B) in the case of any other advertisement 

19 that is not in English, the statements shall ap20 pear in the same language as that principally 

21 used in the advertisement. 

22 ‘‘(3) MATCHBOOKS.—Notwithstanding para23 graph (2), for matchbooks (defined as containing not 

24 more than 20 matches) customarily given away with 

25 the purchase of tobacco products, each label statement 
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1 required by subsection (a) may be printed on the in2 side cover of the matchbook. 

3 ‘‘(4) ADJUSTMENT BY SECRETARY.—The Sec4 retary may, through a rulemaking under section 553 

5 of title 5, United States Code, adjust the format and 

6 type sizes for the label statements required by this sec7 tion; the text, format, and type sizes of any required 

8 tar, nicotine yield, or other constituent (including 

9 smoke constituent) disclosures; or the text, format, 

10 and type sizes for any other disclosures required 

11 under the Federal Food, Drug, and Cosmetic Act. The 

12 text of any such label statements or disclosures shall 

13 be required to appear only within the 20 percent area 

14 of cigarette advertisements provided by paragraph 

15 (2). The Secretary shall promulgate regulations which 

16 provide for adjustments in the format and type sizes 

17 of any text required to appear in such area to ensure 

18 that the total text required to appear by law will fit 

19 within such area. 

20 ‘‘(c) MARKETING REQUIREMENTS.— 

21 ‘‘(1) RANDOM DISPLAY.—The label statements 

22 specified in subsection (a)(1) shall be randomly dis23 played in each 12-month period, in as equal a num24 ber of times as is possible on each brand of the prod25 uct and be randomly distributed in all areas of the 
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1 United States in which the product is marketed in ac2 cordance with a plan submitted by the tobacco prod3 uct manufacturer, importer, distributor, or retailer 

4 and approved by the Secretary. 

5 ‘‘(2) ROTATION.—The label statements specified 

6 in subsection (a)(1) shall be rotated quarterly in al7 ternating sequence in advertisements for each brand 

8 of cigarettes in accordance with a plan submitted by 

9 the tobacco product manufacturer, importer, dis10 tributor, or retailer to, and approved by, the Sec11 retary. 

12 ‘‘(3) REVIEW.—The Secretary shall review each 

13 plan submitted under paragraph (2) and approve it 

14 if the plan— 

15 ‘‘(A) will provide for the equal distribution 

16 and display on packaging and the rotation re17 quired in advertising under this subsection; and 

18 ‘‘(B) assures that all of the labels required 

19 under this section will be displayed by the to20 bacco product manufacturer, importer, dis21 tributor, or retailer at the same time. 

22 ‘‘(4) APPLICABILITY TO RETAILERS.—This sub23 section and subsection (b) apply to a retailer only if 

24 that retailer is responsible for or directs the label 

25 statements required under this section except that this 
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1 paragraph shall not relieve a retailer of liability if 

2 the retailer displays, in a location open to the public, 

3 an advertisement that does not contain a warning 

4 label or has been altered by the retailer in a way that 

5 is material to the requirements of this subsection and 

6 subsection (b). 

7 ‘‘(d) GRAPHIC LABEL STATEMENTS.—Not later than 

8 24 months after the date of enactment of the Family Smok9 ing Prevention and Tobacco Control Act, the Secretary shall 

10 issue regulations that require color graphics depicting the 

11 negative health consequences of smoking to accompany the 

12 label statements specified in subsection (a)(1). The Sec13 retary may adjust the type size, text and format of the label 

14 statements specified in subsections (a)(2) and (b)(2) as the 

15 Secretary determines appropriate so that both the graphics 

16 and the accompanying label statements are clear, con17 spicuous, legible and appear within the specified area.’’. 

18 (b) EFFECTIVE DATE.—The amendment made by sub19 section (a) shall take effect 15 months after the issuance 

20 of the regulations required by subsection (a). Such effective 

21 date shall be with respect to the date of manufacture, pro22 vided that, in any case, beginning 30 days after such effec23 tive date, a manufacturer shall not introduce into the do24 mestic commerce of the United States any product, irrespec25 tive of the date of manufacture, that is not in conformance 
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1 with section 4 of the Federal Cigarette Labeling and Adver2 tising Act (15 U.S.C. 1333), as amended by subsection (a). 

3 SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING 

4 LABEL STATEMENTS. 

5 (a) PREEMPTION.—Section 5(a) of the Federal Ciga6 rette Labeling and Advertising Act (15 U.S.C. 1334(a)) is 

7 amended by striking ‘‘No’’ and inserting ‘‘Except to the ex8 tent the Secretary requires additional or different state9 ments on any cigarette package by a regulation, by an 

10 order, by a standard, by an authorization to market a prod11 uct, or by a condition of marketing a product, pursuant 

12 to the Family Smoking Prevention and Tobacco Control Act 

13 (and the amendments made by that Act), or as required 

14 under section 903(a)(2) or section 920(a) of the Federal 

15 Food, Drug, and Cosmetic Act, no’’. 

16 (b) CHANGE IN REQUIRED STATEMENTS.—Section 4 

17 of the Federal Cigarette Labeling and Advertising Act (15 

18 U.S.C. 1333), as amended by section 201, is further amend19 ed by adding at the end the following: 

20 ‘‘(d) CHANGE IN REQUIRED STATEMENTS.—The Sec21 retary through a rulemaking conducted under section 553 

22 of title 5, United States Code, may adjust the format, type 

23 size, color graphics, and text of any of the label require24 ments, or establish the format, type size, and text of any 

25 other disclosures required under the Federal Food, Drug, 
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1 and Cosmetic Act, if the Secretary finds that such a change 

2 would promote greater public understanding of the risks as3 sociated with the use of tobacco products.’’. 

4 SEC. 203. STATE REGULATION OF CIGARETTE ADVERTISING 

5 AND PROMOTION. 

6 Section 5 of the Federal Cigarette Labeling and Adver7 tising Act (15 U.S.C. 1334) is amended by adding at the 

8 end the following: 

9 ‘‘(c) EXCEPTION.—Notwithstanding subsection (b), a 

10 State or locality may enact statutes and promulgate regula11 tions, based on smoking and health, that take effect after 

12 the effective date of the Family Smoking Prevention and 

13 Tobacco Control Act, imposing specific bans or restrictions 

14 on the time, place, and manner, but not content, of the ad15 vertising or promotion of any cigarettes.’’. 

16 SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING 

17 WARNINGS. 

18 (a) AMENDMENT.—Section 3 of the Comprehensive 

19 Smokeless Tobacco Health Education Act of 1986 (15 

20 U.S.C. 4402) is amended to read as follows: 

21 ‘‘SEC. 3. SMOKELESS TOBACCO WARNING. 

22 ‘‘(a) GENERAL RULE.— 

23 ‘‘(1) It shall be unlawful for any person to man24 ufacture, package, sell, offer to sell, distribute, or im25 port for sale or distribution within the United States 
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1 any smokeless tobacco product unless the product 

2 package bears, in accordance with the requirements of 

3 this Act, one of the following labels: 

4 ‘‘WARNING: This product can cause mouth 

5 cancer. 

6 ‘‘WARNING: This product can cause gum 

7 disease and tooth loss. 

8 ‘‘WARNING: This product is not a safe al9 ternative to cigarettes. 

10 ‘‘WARNING: Smokeless tobacco is addictive. 

11 ‘‘(2) Each label statement required by paragraph 

12 (1) shall be— 

13 ‘‘(A) located on the 2 principal display 

14 panels of the package, and each label statement 

15 shall comprise at least 30 percent of each such 

16 display panel; and 

17 ‘‘(B) in 17-point conspicuous and legible 

18 type and in black text on a white background, or 

19 white text on a black background, in a manner 

20 that contrasts by typography, layout, or color, 

21 with all other printed material on the package, 

22 in an alternating fashion under the plan sub23 mitted under subsection (b)(3), except that if the 

24 text of a label statement would occupy more than 

25 70 percent of the area specified by subparagraph 
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1 (A), such text may appear in a smaller type size, 

2 so long as at least 60 percent of such warning 

3 area is occupied by the label statement. 

4 ‘‘(3) The label statements required by paragraph 

5 (1) shall be introduced by each tobacco product manu6 facturer, packager, importer, distributor, or retailer of 

7 smokeless tobacco products concurrently into the dis8 tribution chain of such products. 

9 ‘‘(4) The provisions of this subsection do not 

10 apply to a tobacco product manufacturer or dis11 tributor of any smokeless tobacco product that does 

12 not manufacture, package, or import smokeless to13 bacco products for sale or distribution within the 

14 United States. 

15 ‘‘(5) A retailer of smokeless tobacco products 

16 shall not be in violation of this subsection for pack17 aging that— 

18 ‘‘(A) contains a warning label; 

19 ‘‘(B) is supplied to the retailer by a license20 or permit-holding tobacco product manufacturer, 

21 importer, or distributor; and 

22 ‘‘(C) is not altered by the retailer in a way 

23 that is material to the requirements of this sub24 section. 

25 ‘‘(b) REQUIRED LABELS.— 
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1 ‘‘(1) It shall be unlawful for any tobacco product 

2 manufacturer, packager, importer, distributor, or re3 tailer of smokeless tobacco products to advertise or 

4 cause to be advertised within the United States any 

5 smokeless tobacco product unless its advertising bears, 

6 in accordance with the requirements of this section, 

7 one of the labels specified in subsection (a). 

8 ‘‘(2)(A) Each label statement required by sub9 section (a) in smokeless tobacco advertising shall com10 ply with the standards set forth in this paragraph. 

11 ‘‘(B) For press and poster advertisements, each 

12 such statement and (where applicable) any required 

13 statement relating to tar, nicotine, or other con14 stituent yield shall comprise at least 20 percent of the 

15 area of the advertisement. 

16 ‘‘(C) The word ‘WARNING’ shall appear in cap17 ital letters, and each label statement shall appear in 

18 conspicuous and legible type. 

19 ‘‘(D) The text of the label statement shall be 

20 black on a white background, or white on a black 

21 background, in an alternating fashion under the plan 

22 submitted under paragraph (3). 

23 ‘‘(E) The label statements shall be enclosed by a 

24 rectangular border that is the same color as the letters 

25 of the statements and that is the width of the first 
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1 downstroke of the capital ‘W’ of the word ‘WARNING’ 

2 in the label statements. 

3 ‘‘(F) The text of such label statements shall be in 

4 a typeface pro rata to the following requirements: 45- 

5 point type for a whole-page broadsheet newspaper ad6 vertisement; 39-point type for a half-page broadsheet 

7 newspaper advertisement; 39-point type for a whole8 page tabloid newspaper advertisement; 27-point type 

9 for a half-page tabloid newspaper advertisement; 

10 31.5-point type for a double page spread magazine or 

11 whole-page magazine advertisement; 22.5-point type 

12 for a 28 centimeter by 3 column advertisement; and 

13 15-point type for a 20 centimeter by 2 column adver14 tisement. 

15 ‘‘(G) The label statements shall be in English, ex16 cept that— 

17 ‘‘(i) in the case of an advertisement that ap18 pears in a newspaper, magazine, periodical, or 

19 other publication that is not in English, the 

20 statements shall appear in the predominant lan21 guage of the publication; and 

22 ‘‘(ii) in the case of any other advertisement 

23 that is not in English, the statements shall ap24 pear in the same language as that principally 

25 used in the advertisement. 
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1 ‘‘(3)(A) The label statements specified in sub2 section (a)(1) shall be randomly displayed in each 12- 

3 month period, in as equal a number of times as is 

4 possible on each brand of the product and be ran5 domly distributed in all areas of the United States in 

6 which the product is marketed in accordance with a 

7 plan submitted by the tobacco product manufacturer, 

8 importer, distributor, or retailer and approved by the 

9 Secretary. 

10 ‘‘(B) The label statements specified in subsection 

11 (a)(1) shall be rotated quarterly in alternating se12 quence in advertisements for each brand of smokeless 

13 tobacco product in accordance with a plan submitted 

14 by the tobacco product manufacturer, importer, dis15 tributor, or retailer to, and approved by, the Sec16 retary. 

17 ‘‘(C) The Secretary shall review each plan sub18 mitted under subparagraphs (A) and (B) and ap19 prove it if the plan— 

20 ‘‘(i) will provide for the equal distribution 

21 and display on packaging and the rotation re22 quired in advertising under this subsection; and 

23 ‘‘(ii) assures that all of the labels required 

24 under this section will be displayed by the to-
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1 bacco product manufacturer, importer, dis2 tributor, or retailer at the same time. 

3 ‘‘(D) This paragraph applies to a retailer only 

4 if that retailer is responsible for or directs the label 

5 statements under this section, unless the retailer dis6 plays, in a location open to the public, an advertise7 ment that does not contain a warning label or has 

8 been altered by the retailer in a way that is material 

9 to the requirements of this subsection. 

10 ‘‘(4) The Secretary may, through a rulemaking 

11 under section 553 of title 5, United States Code, ad12 just the format and type sizes for the label statements 

13 required by this section; the text, format, and type 

14 sizes of any required tar, nicotine yield, or other con15 stituent disclosures; or the text, format, and type sizes 

16 for any other disclosures required under the Federal 

17 Food, Drug, and Cosmetic Act. The text of any such 

18 label statements or disclosures shall be required to ap19 pear only within the 20 percent area of advertise20 ments provided by paragraph (2). The Secretary shall 

21 promulgate regulations which provide for adjustments 

22 in the format and type sizes of any text required to 

23 appear in such area to ensure that the total text re24 quired to appear by law will fit within such area. 
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1 ‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is un2 lawful to advertise smokeless tobacco on any medium of elec3 tronic communications subject to the jurisdiction of the 

4 Federal Communications Commission.’’. 

5 (b) EFFECTIVE DATE.—The amendment made by sub6 section (a) shall take effect 12 months after the date of en7 actment of this Act. Such effective date shall be with respect 

8 to the date of manufacture, provided that, in any case, be9 ginning 30 days after such effective date, a manufacturer 

10 shall not introduce into the domestic commerce of the 

11 United States any product, irrespective of the date of manu12 facture, that is not in conformance with section 3 of the 

13 Comprehensive Smokeless Tobacco Health Education Act of 

14 1986 (15 U.S.C. 4402), as amended by subsection (a). 

15 SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO 

16 PRODUCT WARNING LABEL STATEMENTS. 

17 (a) IN GENERAL.—Section 3 of the Comprehensive 

18 Smokeless Tobacco Health Education Act of 1986 (15 

19 U.S.C. 4402), as amended by section 204, is further amend20 ed by adding at the end the following: 

21 ‘‘(d) AUTHORITY TO REVISE WARNING LABEL STATE22 MENTS.—The Secretary may, by a rulemaking conducted 

23 under section 553 of title 5, United States Code, adjust the 

24 format, type size, and text of any of the label requirements, 

25 require color graphics to accompany the text, increase the 
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1 required label area from 30 percent up to 50 percent of the 

2 front and rear panels of the package, or establish the format, 

3 type size, and text of any other disclosures required under 

4 the Federal Food, Drug, and Cosmetic Act, if the Secretary 

5 finds that such a change would promote greater public un6 derstanding of the risks associated with the use of smokeless 

7 tobacco products.’’. 

8 (b) PREEMPTION.—Section 7(a) of the Comprehensive 

9 Smokeless Tobacco Health Education Act of 1986 (15 

10 U.S.C. 4406(a)) is amended by striking ‘‘No’’ and inserting 

11 ‘‘Except as provided in the Family Smoking Prevention 

12 and Tobacco Control Act (and the amendments made by 

13 that Act), no’’. 

14 SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CON15 STITUENT DISCLOSURE TO THE PUBLIC. 

16 Section 4 of the Federal Cigarette Labeling and Adver17 tising Act (15 U.S.C. 1333), as amended by sections 201 

18 and 202, is further amended by adding at the end the fol19 lowing: 

20 ‘‘(e) TAR, NICOTINE, AND OTHER SMOKE CON21 STITUENT DISCLOSURE.— 

22 ‘‘(1) IN GENERAL.—The Secretary shall, by a 

23 rulemaking conducted under section 553 of title 5, 

24 United States Code, determine (in the Secretary’s sole 

25 discretion) whether cigarette and other tobacco prod-
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1 uct manufacturers shall be required to include in the 

2 area of each cigarette advertisement specified by sub3 section (b) of this section, or on the package label, or 

4 both, the tar and nicotine yields of the advertised or 

5 packaged brand. Any such disclosure shall be in ac6 cordance with the methodology established under such 

7 regulations, shall conform to the type size require8 ments of subsection (b) of this section, and shall ap9 pear within the area specified in subsection (b) of this 

10 section. 

11 ‘‘(2) RESOLUTION OF DIFFERENCES.—Any dif12 ferences between the requirements established by the 

13 Secretary under paragraph (1) and tar and nicotine 

14 yield reporting requirements established by the Fed15 eral Trade Commission shall be resolved by a memo16 randum of understanding between the Secretary and 

17 the Federal Trade Commission. 

18 ‘‘(3) CIGARETTE AND OTHER TOBACCO PRODUCT

19 CONSTITUENTS.—In addition to the disclosures re20 quired by paragraph (1), the Secretary may, under a 

21 rulemaking conducted under section 553 of title 5, 

22 United States Code, prescribe disclosure requirements 

23 regarding the level of any cigarette or other tobacco 

24 product constituent including any smoke constituent. 

25 Any such disclosure may be required if the Secretary 
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1 determines that disclosure would be of benefit to the 

2 public health, or otherwise would increase consumer 

3 awareness of the health consequences of the use of to4 bacco products, except that no such prescribed disclo5 sure shall be required on the face of any cigarette 

6 package or advertisement. Nothing in this section 

7 shall prohibit the Secretary from requiring such pre8 scribed disclosure through a cigarette or other tobacco 

9 product package or advertisement insert, or by any 

10 other means under the Federal Food, Drug, and Cos11 metic Act. 

12 ‘‘(4) RETAILERS.—This subsection applies to a 

13 retailer only if that retailer is responsible for or di14 rects the label statements required under this sec15 tion.’’. 

16 TITLE III—PREVENTION OF IL17 LICIT TRADE IN TOBACCO 

18 PRODUCTS 

19 SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPEC20 TION. 

21 Chapter IX of the Federal Food, Drug, and Cosmetic 

22 Act, as added by section 101, is further amended by adding 

23 at the end the following: 
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1 ‘‘SEC. 920. LABELING, RECORDKEEPING, RECORDS INSPEC2 TION. 

3 ‘‘(a) ORIGIN LABELING.— 

4 ‘‘(1) REQUIREMENT.—Beginning 1 year after the 

5 date of enactment of the Family Smoking Prevention 

6 and Tobacco Control Act, the label, packaging, and 

7 shipping containers of tobacco products other than 

8 cigarettes for introduction or delivery for introduction 

9 into interstate commerce in the United States shall 

10 bear the statement ‘sale only allowed in the United 

11 States’. Beginning 15 months after the issuance of the 

12 regulations required by section 4(d) of the Federal 

13 Cigarette Labeling and Advertising Act (15 U.S.C. 

14 1333), as amended by section 201 of Family Smoking 

15 Prevention and Tobacco Control Act, the label, pack16 aging, and shipping containers of cigarettes for intro17 duction or delivery for introduction into interstate 

18 commerce in the United States shall bear the state19 ment ‘Sale only allowed in the United States’. 

20 ‘‘(2) EFFECTIVE DATE.—The effective date speci21 fied in paragraph (1) shall be with respect to the date 

22 of manufacture, provided that, in any case, beginning 

23 30 days after such effective date, a manufacturer shall 

24 not introduce into the domestic commerce of the 

25 United States any product, irrespective of the date of 
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1 manufacture, that is not in conformance with such 

2 paragraph. 

3 ‘‘(b) REGULATIONS CONCERNING RECORDKEEPING

4 FOR TRACKING AND TRACING.— 

5 ‘‘(1) IN GENERAL.—The Secretary shall promul6 gate regulations regarding the establishment and 

7 maintenance of records by any person who manufac8 tures, processes, transports, distributes, receives, pack9 ages, holds, exports, or imports tobacco products. 

10 ‘‘(2) INSPECTION.—In promulgating the regula11 tions described in paragraph (1), the Secretary shall 

12 consider which records are needed for inspection to 

13 monitor the movement of tobacco products from the 

14 point of manufacture through distribution to retail 

15 outlets to assist in investigating potential illicit 

16 trade, smuggling, or counterfeiting of tobacco prod17 ucts. 

18 ‘‘(3) CODES.—The Secretary may require codes 

19 on the labels of tobacco products or other designs or 

20 devices for the purpose of tracking or tracing the to21 bacco product through the distribution system. 

22 ‘‘(4) SIZE OF BUSINESS.—The Secretary shall 

23 take into account the size of a business in promul24 gating regulations under this section. 
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1 ‘‘(5) RECORDKEEPING BY RETAILERS.—The Sec2 retary shall not require any retailer to maintain 

3 records relating to individual purchasers of tobacco 

4 products for personal consumption. 

5 ‘‘(c) RECORDS INSPECTION.—If the Secretary has a 

6 reasonable belief that a tobacco product is part of an illicit 

7 trade or smuggling or is a counterfeit product, each person 

8 who manufactures, processes, transports, distributes, re9 ceives, holds, packages, exports, or imports tobacco products 

10 shall, at the request of an officer or employee duly des11 ignated by the Secretary, permit such officer or employee, 

12 at reasonable times and within reasonable limits and in 

13 a reasonable manner, upon the presentation of appropriate 

14 credentials and a written notice to such person, to have ac15 cess to and copy all records (including financial records) 

16 relating to such article that are needed to assist the Sec17 retary in investigating potential illicit trade, smuggling, or 

18 counterfeiting of tobacco products. The Secretary shall not 

19 authorize an officer or employee of the government of any 

20 of the several States to exercise authority under the pre21 ceding sentence on Indian country without the express writ22 ten consent of the Indian tribe involved. 

23 ‘‘(d) KNOWLEDGE OF ILLEGAL TRANSACTION.— 

24 ‘‘(1) NOTIFICATION.—If the manufacturer or dis25 tributor of a tobacco product has knowledge which 
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1 reasonably supports the conclusion that a tobacco 

2 product manufactured or distributed by such manu3 facturer or distributor that has left the control of such 

4 person may be or has been— 

5 ‘‘(A) imported, exported, distributed, or of6 fered for sale in interstate commerce by a person 

7 without paying duties or taxes required by law; 

8 or 

9 ‘‘(B) imported, exported, distributed, or di10 verted for possible illicit marketing, 

11 the manufacturer or distributor shall promptly notify 

12 the Attorney General and the Secretary of the Treas13 ury of such knowledge. 

14 ‘‘(2) KNOWLEDGE DEFINED.—For purposes of 

15 this subsection, the term ‘knowledge’ as applied to a 

16 manufacturer or distributor means— 

17 ‘‘(A) the actual knowledge that the manu18 facturer or distributor had; or 

19 ‘‘(B) the knowledge which a reasonable per20 son would have had under like circumstances or 

21 which would have been obtained upon the exer22 cise of due care. 

23 ‘‘(e) CONSULTATION.—In carrying out this section, the 

24 Secretary shall consult with the Attorney General of the 
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1 United States and the Secretary of the Treasury, as appro2 priate.’’. 

3 SEC. 302. STUDY AND REPORT. 

4 (a) STUDY.—The Comptroller General of the United 

5 States shall conduct a study of cross-border trade in tobacco 

6 products to— 

7 (1) collect data on cross-border trade in tobacco 

8 products, including illicit trade and trade of counter9 feit tobacco products and make recommendations on 

10 the monitoring of such trade; 

11 (2) collect data on cross-border advertising (any 

12 advertising intended to be broadcast, transmitted, or 

13 distributed from the United States to another coun14 try) of tobacco products and make recommendations 

15 on how to prevent or eliminate, and what technologies 

16 could help facilitate the elimination of, cross-border 

17 advertising; and 

18 (3) collect data on the health effects (particularly 

19 with respect to individuals under 18 years of age) re20 sulting from cross-border trade in tobacco products, 

21 including the health effects resulting from— 

22 (A) the illicit trade of tobacco products and 

23 the trade of counterfeit tobacco products; and 

24 (B) the differing tax rates applicable to to25 bacco products. 
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1 (b) REPORT.—Not later than 18 months after the date 

2 of enactment of this Act, the Comptroller General of the 

3 United States shall submit to the Committee on Health, 

4 Education, Labor, and Pensions of the Senate and the Com5 mittee on Energy and Commerce of the House of Represent6 atives a report on the study described in subsection (a). 

7 (c) DEFINITION.—In this section: 

8 (1) The term ‘‘cross-border trade’’ means trade 

9 across a border of the United States, a State or Terri10 tory, or Indian country. 

11 (2) The term ‘‘Indian country’’ has the meaning 

12 given to such term in section 1151 of title 18, United 

13 States Code. 

14 (3) The terms ‘‘State’’ and ‘‘Territory’’ have the 

15 meanings given to those terms in section 201 of the 

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

17 321). 

18 DIVISION B—FEDERAL 

19 RETIREMENT REFORM ACT 

20 SEC. 100. SHORT TITLE; TABLE OF CONTENTS. 

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

22 ‘‘Federal Retirement Reform Act of 2009’’. 

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

24 this division is as follows: 

DIVISION B—FEDERAL RETIREMENT REFORM ACT 

Sec. 100. Short title; table of contents. 
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TITLE I—PROVISIONS RELATING TO FEDERAL EMPLOYEES 

RETIREMENT 

Sec. 101. Short title. 

Sec. 102. Automatic enrollments and immediate employing agency contributions. 

Sec. 103. Qualified Roth contribution program. 

Sec. 104. Authority to establish mutual fund window. 

Sec. 105. Reporting requirements. 

Sec. 106. Acknowledgment of risk. 

Sec. 107. Subpoena authority. 

Sec. 108. Amounts in Thrift Savings Funds subject to legal proceedings. 

Sec. 109. Accounts for surviving spouses. 

Sec. 110. Treatment of members of the uniformed services under the Thrift Savings Plan. 

TITLE II—SPECIAL SURVIVOR INDEMNITY ALLOWANCE FOR 

SURVIVING SPOUSES OF ARMED FORCES MEMBERS 

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

for widows and widowers of deceased members of the Armed 

Forces affected by required Survivor Benefit Plan annuity offset 

for dependency and indemnity compensation. 

1 TITLE I—PROVISIONS RELATING 

2 TO FEDERAL EMPLOYEES RE3 TIREMENT 

4 SEC. 101. SHORT TITLE. 

5 This title may be cited as the ‘‘Thrift Savings Plan 

6 Enhancement Act of 2009’’. 

7 SEC. 102. AUTOMATIC ENROLLMENTS AND IMMEDIATE EM8 PLOYING AGENCY CONTRIBUTIONS. 

9 (a) IN GENERAL.—Section 8432(b) of title 5, United 

10 States Code, is amended by striking paragraphs (2) through 

11 (4) and inserting the following: 

12 ‘‘(2)(A) The Executive Director shall by regulation 

13 provide for an eligible individual to be automatically en14 rolled to make contributions under subsection (a) at the de15 fault percentage of basic pay. 
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1 ‘‘(B) For purposes of this paragraph, the default per2 centage shall be equal to 3 percent or such other percentage, 

3 not less than 2 percent nor more than 5 percent, as the 

4 Board may prescribe. 

5 ‘‘(C) The regulations shall include provisions under 

6 which any individual who would otherwise be automati7 cally enrolled in accordance with subparagraph (A) may— 

8 ‘‘(i) modify the percentage or amount to be con9 tributed pursuant to automatic enrollment, effective 

10 not later than the first full pay period following re11 ceipt of the election by the appropriate processing en12 tity; or 

13 ‘‘(ii) decline automatic enrollment altogether. 

14 ‘‘(D)(i) Except as provided in clause (ii), for purposes 

15 of this paragraph, the term ‘eligible individual’ means any 

16 individual who, after any regulations under subparagraph 

17 (A) first take effect, is appointed, transferred, or re18 appointed to a position in which that individual becomes 

19 eligible to contribute to the Thrift Savings Fund. 

20 ‘‘(ii) Members of the uniformed services shall not be 

21 eligible individuals for purposes of this paragraph. 

22 ‘‘(E) Sections 8351(a)(1), 8440a(a)(1), 8440b(a)(1), 

23 8440c(a)(1), 8440d(a)(1), and 8440e(a)(1) shall be applied 

24 in a manner consistent with the purposes of this para25 graph.’’. 
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1 (b) TECHNICAL AMENDMENT.—Section 8432(b)(1) of 

2 title 5, United States Code, is amended by striking the par3 enthetical matter in subparagraph (B). 

4 SEC. 103. QUALIFIED ROTH CONTRIBUTION PROGRAM. 

5 (a) IN GENERAL.—Subchapter III of chapter 84 of 

6 title 5, United States Code, is amended by inserting after 

7 section 8432c the following: 

8 ‘‘§ 8432d. Qualified Roth contribution program 

9 ‘‘(a) DEFINITIONS.—For purposes of this section— 

10 ‘‘(1) the term ‘qualified Roth contribution pro11 gram’ means a program described in paragraph (1) 

12 of section 402A(b) of the Internal Revenue Code of 

13 1986 which meets the requirements of paragraph (2) 

14 of such section; and 

15 ‘‘(2) the terms ‘designated Roth contribution’ 

16 and ‘elective deferral’ have the meanings given such 

17 terms in section 402A of the Internal Revenue Code 

18 of 1986. 

19 ‘‘(b) AUTHORITY TO ESTABLISH.—The Executive Di20 rector shall by regulation provide for the inclusion in the 

21 Thrift Savings Plan of a qualified Roth contribution pro22 gram, under such terms and conditions as the Board may 

23 prescribe. 

24 ‘‘(c) REQUIRED PROVISIONS.—The regulations under 

25 subsection (b) shall include— 
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1 ‘‘(1) provisions under which an election to make 

2 designated Roth contributions may be made— 

3 ‘‘(A) by any individual who is eligible to 

4 make contributions under section 8351, 8432(a), 

5 8440a, 8440b, 8440c, 8440d, or 8440e; and 

6 ‘‘(B) by any individual, not described in 

7 subparagraph (A), who is otherwise eligible to 

8 make elective deferrals under the Thrift Savings 

9 Plan; 

10 ‘‘(2) any provisions which may, as a result of 

11 enactment of this section, be necessary in order to 

12 clarify the meaning of any reference to an ‘account’ 

13 made in section 8432(f), 8433, 8434(d), 8435, 8437, 

14 or any other provision of law; and 

15 ‘‘(3) any other provisions which may be nec16 essary to carry out this section.’’. 

17 (b) CLERICAL AMENDMENT.—The analysis for chapter 

18 84 of title 5, United States Code, is amended by inserting 

19 after the item relating to section 8432c the following: 

‘‘8432d. Qualified Roth contribution program.’’. 

20 SEC. 104. AUTHORITY TO ESTABLISH MUTUAL FUND WIN21 DOW. 

22 (a) IN GENERAL.—Section 8438(b)(1) of title 5, 

23 United States Code, is amended— 

24 (1) in subparagraph (D), by striking ‘‘and’’ at 

25 the end; 
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1 (2) in subparagraph (E), by striking the period 

2 and inserting ‘‘; and’’; and 

3 (3) by adding after subparagraph (E) the fol4 lowing: 

5 ‘‘(F) a service that enables participants to 

6 invest in mutual funds, if the Board authorizes 

7 the mutual fund window under paragraph (5).’’. 

8 (b) REQUIREMENTS.—Section 8438(b) of title 5, 

9 United States Code, is amended by adding at the end the 

10 following: 

11 ‘‘(5)(A) The Board may authorize the addition of a 

12 mutual fund window under the Thrift Savings Plan if the 

13 Board determines that such addition would be in the best 

14 interests of participants. 

15 ‘‘(B) The Board shall ensure that any expenses charged 

16 for use of the mutual fund window are borne solely by the 

17 participants who use such window. 

18 ‘‘(C) The Board may establish such other terms and 

19 conditions for the mutual fund window as the Board con20 siders appropriate to protect the interests of participants, 

21 including requirements relating to risk disclosure. 

22 ‘‘(D) The Board shall consult with the Employee Thrift 

23 Advisory Council (established under section 8473) before 

24 authorizing the addition of a mutual fund window or estab-
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1 lishing a service that enables participants to invest in mu2 tual funds.’’. 

3 (c) TECHNICAL AND CONFORMING AMENDMENT.—Sec4 tion 8438(d)(1) of title 5, United States Code, is amended 

5 by inserting ‘‘and options’’ after ‘‘investment funds’’. 

6 SEC. 105. REPORTING REQUIREMENTS. 

7 (a) ANNUAL REPORT.—The Board shall, not later than 

8 June 30 of each year, submit to Congress an annual report 

9 on the operations of the Thrift Savings Plan. Such report 

10 shall include, for the prior calendar year, information on 

11 the number of participants as of the last day of such prior 

12 calendar year, the median balance in participants’ ac13 counts as of such last day, demographic information on 

14 participants, the percentage allocation of amounts among 

15 investment funds or options, the status of the development 

16 and implementation of the mutual fund window, the diver17 sity demographics of any company, investment adviser, or 

18 other entity retained to invest and manage the assets of the 

19 Thrift Savings Fund, and such other information as the 

20 Board considers appropriate. A copy of each annual report 

21 under this subsection shall be made available to the public 

22 through an Internet website. 

23 (b) REPORTING OF FEES AND OTHER INFORMATION.— 

24 (1) IN GENERAL.—The Board shall include in 

25 the periodic statements provided to participants 
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1 under section 8439(c) of title 5, United States Code, 

2 the amount of the investment management fees, ad3 ministrative expenses, and any other fees or expenses 

4 paid with respect to each investment fund and option 

5 under the Thrift Savings Plan. Any such statement 

6 shall also provide a statement notifying participants 

7 as to how they may access the annual report described 

8 in subsection (a), as well as any other information 

9 concerning the Thrift Savings Plan that might be use10 ful. 

11 (2) USE OF ESTIMATES.—For purposes of pro12 viding the information required under this subsection, 

13 the Board may provide a reasonable and representa14 tive estimate of any fees or expenses described in 

15 paragraph (1) and shall indicate any such estimate 

16 as being such an estimate. Any such estimate shall be 

17 based on the previous year’s experience. 

18 (c) DEFINITIONS.—For purposes of this section— 

19 (1) the term ‘‘Board’’ has the meaning given 

20 such term by 8401(5) of title 5, United States Code; 

21 (2) the term ‘‘participant’’ has the meaning 

22 given such term by section 8471(3) of title 5, United 

23 States Code; and 
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1 (3) the term ‘‘account’’ means an account estab2 lished under section 8439 of title 5, United States 

3 Code. 

4 SEC. 106. ACKNOWLEDGMENT OF RISK. 

5 (a) IN GENERAL.—Section 8439(d) of title 5, United 

6 States Code, is amended— 

7 (1) by striking the matter after ‘‘who elects to in8 vest in’’ and before ‘‘shall sign an acknowledgment’’ 

9 and inserting ‘‘any investment fund or option under 

10 this chapter, other than the Government Securities 

11 Investment Fund,’’; and 

12 (2) by striking ‘‘either such Fund’’ and inserting 

13 ‘‘any such fund or option’’. 

14 (b) COORDINATION WITH PROVISIONS RELATING TO

15 FIDUCIARY RESPONSIBILITIES, LIABILITIES, AND PEN16 ALTIES.—Section 8477(e)(1)(C) of title 5, United States 

17 Code, is amended— 

18 (1) by redesignating subparagraph (C) as sub19 paragraph (C)(i); and 

20 (2) by adding at the end the following: 

21 ‘‘(ii) A fiduciary shall not be liable under subpara22 graph (A), and no civil action may be brought against a 

23 fiduciary— 
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1 ‘‘(I) for providing for the automatic enrollment 

2 of a participant in accordance with section 

3 8432(b)(2)(A); 

4 ‘‘(II) for enrolling a participant in a default in5 vestment fund in accordance with section 8438(c)(2); 

6 or 

7 ‘‘(III) for allowing a participant to invest 

8 through the mutual fund window or for establishing 

9 restrictions applicable to participants’ ability to in10 vest through the mutual fund window.’’. 

11 SEC. 107. SUBPOENA AUTHORITY. 

12 (a) IN GENERAL.—Chapter 84 of title 5, United States 

13 Code, is amended by inserting after section 8479 the fol14 lowing: 

15 ‘‘§ 8480. Subpoena authority 

16 ‘‘(a) In order to carry out the responsibilities specified 

17 in this subchapter and subchapter III of this chapter, the 

18 Executive Director may issue subpoenas commanding each 

19 person to whom the subpoena is directed to produce des20 ignated books, documents, records, electronically stored in21 formation, or tangible materials in the possession or control 

22 of that individual. 

23 ‘‘(b) Notwithstanding any Federal, State, or local law, 

24 any person, including officers, agents, and employees, re25 ceiving a subpoena under this section, who complies in good 
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1 faith with the subpoena and thus produces the materials 

2 sought, shall not be liable in any court of any State or the 

3 United States to any individual, domestic or foreign cor4 poration or upon a partnership or other unincorporated as5 sociation for such production. 

6 ‘‘(c) When a person fails to obey a subpoena issued 

7 under this section, the district court of the United States 

8 for the district in which the investigation is conducted or 

9 in which the person failing to obey is found, shall on proper 

10 application issue an order directing that person to comply 

11 with the subpoena. The court may punish as contempt any 

12 disobedience of its order. 

13 ‘‘(d) The Executive Director shall prescribe regulations 

14 to carry out subsection (a).’’. 

15 (b) TECHNICAL AND CONFORMING AMENDMENT.—The 

16 table of sections for chapter 84 of title 5, United States 

17 Code, is amended by inserting after the item relating to 

18 section 8479 the following: 

‘‘8480. Subpoena authority.’’. 

19 SEC. 108. AMOUNTS IN THRIFT SAVINGS FUNDS SUBJECT 

20 TO LEGAL PROCEEDINGS. 

21 Section 8437(e)(3) of title 5, United States Code, is 

22 amended in the first sentence by striking ‘‘or relating to 

23 the enforcement of a judgment for the physically, sexually, 

24 or emotionally abusing a child as provided under section 

25 8467(a)’’ and inserting ‘‘the enforcement of an order for res-
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1 titution under section 3663A of title 18, forfeiture under 

2 section 8432(g)(5) of this title, or an obligation of the Exec3 utive Director to make a payment to another person under 

4 section 8467 of this title’’. 

5 SEC. 109. ACCOUNTS FOR SURVIVING SPOUSES. 

6 Section 8433(e) of title 5, United States Code, is 

7 amended— 

8 (1) by inserting ‘‘(1)’’ after ‘‘(e)’’; and 

9 (2) by adding at the end the following: 

10 ‘‘(2) Notwithstanding section 8424(d), if an employee, 

11 Member, former employee, or former Member dies and has 

12 designated as sole or partial beneficiary his or her spouse 

13 at the time of death, or, if an employee, Member, former 

14 employee, or former Member, dies with no designated bene15 ficiary and is survived by a spouse, the spouse may main16 tain the portion of the employee’s or Member’s account to 

17 which the spouse is entitled in accordance with the following 

18 terms: 

19 ‘‘(A) Subject to the limitations of subparagraph 

20 (B), the spouse shall have the same withdrawal op21 tions under subsection (b) as the employee or Member 

22 were the employee or Member living. 

23 ‘‘(B) The spouse may not make withdrawals 

24 under subsection (g) or (h). 
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1 ‘‘(C) The spouse may not make contributions or 

2 transfers to the account. 

3 ‘‘(D) The account shall be disbursed upon the 

4 death of the surviving spouse. A beneficiary or sur5 viving spouse of a deceased spouse who has inherited 

6 an account is ineligible to maintain the inherited 

7 spousal account. 

8 ‘‘(3) The Executive Director shall prescribe regulations 

9 to carry out this subsection.’’. 

10 SEC. 110. TREATMENT OF MEMBERS OF THE UNIFORMED 

11 SERVICES UNDER THE THRIFT SAVINGS 

12 PLAN. 

13 (a) SENSE OF CONGRESS.—It is the sense of Congress 

14 that— 

15 (1) members of the uniformed services should 

16 have a retirement system that is at least as generous 

17 as the one which is available to Federal civilian em18 ployees; and 

19 (2) Federal civilian employees receive matching 

20 contributions from their employing agencies for their 

21 contributions to the Thrift Savings Fund, but the 

22 costs of requiring such a matching contribution from 

23 the Department of Defense could be significant. 
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1 (b) REPORTING REQUIREMENT.—Not later than 180 

2 days after the date of the enactment of this Act, the Sec3 retary of Defense shall report to Congress on— 

4 (1) the cost to the Department of Defense of pro5 viding a matching payment with respect to contribu6 tions made to the Thrift Savings Fund by members 

7 of the Armed Forces; 

8 (2) the effect that requiring such a matching 

9 payment would have on recruitment and retention; 

10 and 

11 (3) any other information that the Secretary of 

12 Defense considers appropriate. 
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1 TITLE II—SPECIAL SURVIVOR IN2 DEMNITY ALLOWANCE FOR 

3 SURVIVING SPOUSES OF 

4 ARMED FORCES MEMBERS 

5 SEC. 201. INCREASE IN MONTHLY AMOUNT OF SPECIAL 

6 SURVIVOR INDEMNITY ALLOWANCE FOR WID7 OWS AND WIDOWERS OF DECEASED MEMBERS 

8 OF THE ARMED FORCES AFFECTED BY RE9 QUIRED SURVIVOR BENEFIT PLAN ANNUITY 

10 OFFSET FOR DEPENDENCY AND INDEMNITY 

11 COMPENSATION. 

12 (a) PAYMENT AMOUNT PER FISCAL YEAR.—Para13 graph (2) of section 1450(m) of title 10, United States Code, 

14 is amended— 

15 (1) in subparagraph (E), by striking ‘‘and’’ after 

16 the semicolon; and 

17 (2) by striking subparagraph (F) and inserting 

18 the following new subparagraphs: 

19 ‘‘(F) for months during fiscal year 2014, 

20 $150; 

21 ‘‘(G) for months during fiscal year 2015, 

22 $200; 

23 ‘‘(H) for months during fiscal year 2016, 

24 $275; and 
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1 ‘‘(I) for months during fiscal year 2017, 

2 $310.’’. 

3 (b) DURATION.—Paragraph (6) of such section is 

4 amended— 

5 (1) by striking ‘‘February 28, 2016’’ and insert6 ing ‘‘September 30, 2017’’; and 

7 (2) by striking ‘‘March 1, 2016’’ both places it 

8 appears and inserting ‘‘October 1, 2017’’. 

Attest: 

Secretary. 
111TH CONGRESS 

1ST SESSION H.R. 1256 

AMENDMENT