II 

108TH CONGRESS 

2D SESSION S. 2461

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

with certain authority to regulate tobacco products. 

IN THE SENATE OF THE UNITED STATES 

MAY 20, 2004

Mr. DEWINE (for himself and Mr. KENNEDY) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL

To protect the public health by providing the Food and 

Drug Administration with certain authority to regulate 

tobacco products.

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

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

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

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

7 this Act is as follows:

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 

Sec. 3. Purpose. 

Sec. 4. Scope and effect. 
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Sec. 5. Severability. 

TITLE I—AUTHORITY OF THE FOOD AND DRUG 

ADMINISTRATION 

Sec. 101. Amendment of Federal food, drug, and cosmetic act. 

Sec. 102. Construction of current regulations. 

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

TITLE II—TOBACCO PRODUCT WARNINGS; CONSTITUENT AND 

SMOKE CONSTITUENT DISCLOSURE 

Sec. 201. Cigarette label and advertising warnings. 

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

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

Sec. 204. Smokeless tobacco labels and advertising warnings. 

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

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

TITLE III—PREVENTION OF ILLICIT TRADE IN TOBACCO 

PRODUCTS 

Sec. 301. Labeling, record keeping, records inspection. 

Sec. 302. Study and report.

1 SEC. 2. FINDINGS. 

2 The Congress finds the following: 

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

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

7 (2) A consensus exists within the scientific and 

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

10 and other serious adverse health effects. 

11 (3) Nicotine is an addictive drug. 

12 (4) Virtually all new users of tobacco products 

13 are under the minimum legal age to purchase such 

14 products. 
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1 (5) Tobacco advertising and marketing con2 tribute significantly to the use of nicotine-containing 

3 tobacco products by adolescents. 

4 (6) Because past efforts to restrict advertising 

5 and marketing of tobacco products have failed ade6 quately to curb tobacco use by adolescents, com7 prehensive restrictions on the sale, promotion, and 

8 distribution of such products are needed. 

9 (7) Federal and State governments have lacked 

10 the legal and regulatory authority and resources 

11 they need to address comprehensively the public 

12 health and societal problems caused by the use of to13 bacco products. 

14 (8) Federal and State public health officials, 

15 the public health community, and the public at large 

16 recognize that the tobacco industry should be subject 

17 to ongoing oversight. 

18 (9) Under article I, section 8 of the Constitu19 tion, the Congress is vested with the responsibility 

20 for regulating interstate commerce and commerce 

21 with Indian tribes. 

22 (10) The sale, distribution, marketing, adver23 tising, and use of tobacco products are activities in 

24 and substantially affecting interstate commerce be25 cause they are sold, marketed, advertised, and dis-
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1 tributed in interstate commerce on a nationwide 

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

3 economy. 

4 (11) The sale, distribution, marketing, adver5 tising, and use of such products substantially affect 

6 interstate commerce through the health care and 

7 other costs attributable to the use of tobacco prod8 ucts. 

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

10 enact legislation that provides the Food and Drug 

11 Administration with the authority to regulate to12 bacco products and the advertising and promotion of 

13 such products. The benefits to the American people 

14 from enacting such legislation would be significant 

15 in human and economic terms. 

16 (13) Tobacco use is the foremost preventable 

17 cause of premature death in America. It causes over 

18 400,000 deaths in the United States each year and 

19 approximately 8,600,000 Americans have chronic ill20 nesses related to smoking. 

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

22 50 percent would prevent well over 6,500,000 of to23 day’s children from becoming regular, daily smokers, 

24 saving over 2,000,000 of them from premature 

25 death due to tobacco induced disease. Such a reduc-
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1 tion in youth smoking would also result in approxi2 mately $75,000,000,000 in savings attributable to 

3 reduced health care costs. 

4 (15) Advertising, marketing, and promotion of 

5 tobacco products have been especially directed to at6 tract young persons to use tobacco products and 

7 these efforts have resulted in increased use of such 

8 products by youth. Past efforts to oversee these ac9 tivities have not been successful in adequately pre10 venting such increased use. 

11 (16) In 2001, the tobacco industry spent more 

12 than $11,000,000,000 to attract new users, retain 

13 current users, increase current consumption, and 

14 generate favorable long-term attitudes toward smok15 ing and tobacco use. 

16 (17) Tobacco product advertising often 

17 misleadingly portrays the use of tobacco as socially 

18 acceptable and healthful to minors. 

19 (18) Tobacco product advertising is regularly 

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

21 under the age of 18 are regularly exposed to tobacco 

22 product promotional efforts. 

23 (19) Through advertisements during and spon24 sorship of sporting events, tobacco has become 

25 strongly associated with sports and has become por-
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1 trayed as an integral part of sports and the healthy 

2 lifestyle associated with rigorous sporting activity. 

3 (20) Children are exposed to substantial and 

4 unavoidable tobacco advertising that leads to favor5 able beliefs about tobacco use, plays a role in leading 

6 young people to overestimate the prevalence of to7 bacco use, and increases the number of young people 

8 who begin to use tobacco. 

9 (21) The use of tobacco products in motion pic10 tures and other mass media glamorizes its use for 

11 young people and encourages them to use tobacco 

12 products. 

13 (22) Tobacco advertising expands the size of 

14 the tobacco market by increasing consumption of to15 bacco products including tobacco use by young peo16 ple. 

17 (23) Children are more influenced by tobacco 

18 advertising than adults, they smoke the most adver19 tised brands. 

20 (24) Tobacco company documents indicate that 

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

23 be more price-sensitive than adults, are influenced 

24 by advertising and promotion practices that result in 

25 drastically reduced cigarette prices.
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1 (25) Comprehensive advertising restrictions will 

2 have a positive effect on the smoking rates of young 

3 people. 

4 (26) Restrictions on advertising are necessary 

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

7 people and providing for education about tobacco 

8 use. 

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

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

14 (28) Text only requirements, although not as 

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

16 tobacco products while preserving the informational 

17 function of advertising. 

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

19 adopt legislation to address the public health crisis 

20 created by actions of the tobacco industry. 

21 (30) The final regulations promulgated by the 

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

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

25 of title 21, Code of Federal Regulations, are con-
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1 sistent with the First Amendment to the United 

2 States Constitution and with the standards set forth 

3 in the amendments made by this Act for the regula4 tion of tobacco products by the Food and Drug Ad5 ministration and the restriction on the sale and dis6 tribution, including access to and the advertising 

7 and promotion of, tobacco products contained in 

8 such regulations are substantially related to accom9 plishing the public health goals of this Act. 

10 (31) The regulations described in paragraph 

11 (30) will directly and materially advance the Federal 

12 Government’s substantial interest in reducing the 

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

15 life-threatening health consequences associated with 

16 tobacco use. An overwhelming majority of Americans 

17 who use tobacco products begin using such products 

18 while they are minors and become addicted to the 

19 nicotine in those products before reaching the age of 

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

22 using tobacco products. Less restrictive and less 

23 comprehensive approaches have not and will not be 

24 effective in reducing the problems addressed by such 

25 regulations. The reasonable restrictions on the ad-
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1 vertising and promotion of tobacco products con2 tained in such regulations will lead to a significant 

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

5 (32) The regulations described in paragraph 

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

8 than are necessary to reduce the number of children 

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

15 entice them into tobacco use, while affording tobacco 

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

19 (33) Tobacco dependence is a chronic disease, 

20 one that typically requires repeated interventions to 

21 achieve long-term or permanent abstinence. 

22 (34) Because the only known safe alternative to 

23 smoking is cessation, interventions should target all 

24 smokers to help them quit completely. 
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1 (35) Tobacco products have been used to facili2 tate and finance criminal activities both domestically 

3 and internationally. Illicit trade of tobacco products 

4 has been linked to organized crime and terrorist 

5 groups. 

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

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

10 any advertising and labeling for such products. It is 

11 also essential that manufacturers, prior to marketing 

12 such products, be required to demonstrate that such 

13 products will meet a series of rigorous criteria, and 

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

15 taking into account both users of tobacco products 

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

18 (37) Unless tobacco products that purport to 

19 reduce the risks to the public of tobacco use actually 

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

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

24 use tobacco products purporting to reduce risk. 

25 Those who use products sold or distributed as modi-
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1 fied risk products that do not in fact reduce risk, 

2 rather than quitting or reducing their use of tobacco 

3 products, have a substantially increased likelihood of 

4 suffering disability and premature death. The costs 

5 to society of the widespread use of products sold or 

6 distributed as modified risk products that do not in 

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

9 costs to our health care system. 

10 (38) As the National Cancer Institute has 

11 found, many smokers mistakenly believe that ‘‘low 

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

14 Institute has also found, mistaken beliefs about the 

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

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

17 smoking entirely and thereby lead to disease and 

18 death. 

19 (39) Recent studies have demonstrated that 

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

22 such products may actually increase the risk of to23 bacco use. 

24 (40) The dangers of products sold or distrib25 uted as modified risk tobacco products that do not 
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1 in fact reduce risk are so high that there is a com2 pelling governmental interest in insuring that state3 ments about modified risk tobacco products are com4 plete, accurate, and relate to the overall disease risk 

5 of the product. 

6 (41) As the Federal Trade Commission has 

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

9 harmful than a comparable product, even in the 

10 presence of disclosures and advisories intended to 

11 provide clarification. 

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

15 accompanied by disclaimers would be detrimental to 

16 the public health. 

17 (43) The only way to effectively protect the 

18 public health from the dangers of unsubstantiated 

19 modified risk tobacco products is to empower the 

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

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

24 support approval of these products is rigorous.
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1 SEC. 3. PURPOSE. 

2 The purposes of this Act are— 

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

4 Administration to regulate tobacco products under 

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

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

7 Federal regulatory authority with respect to the 

8 manufacture, marketing, and distribution of tobacco 

9 products; 

10 (2) to ensure that the Food and Drug Adminis11 tration has the authority to address issues of par12 ticular concern to public health officials, especially 

13 the use of tobacco by young people and dependence 

14 on tobacco; 

15 (3) to authorize the Food and Drug Adminis16 tration to set national standards controlling the 

17 manufacture of tobacco products and the identity, 

18 public disclosure, and amount of ingredients used in 

19 such products; 

20 (4) to provide new and flexible enforcement au21 thority to ensure that there is effective oversight of 

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

23 and promote less harmful tobacco products; 

24 (5) to vest the Food and Drug Administration 

25 with the authority to regulate the levels of tar, nico-
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1 tine, and other harmful components of tobacco prod2 ucts;

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

4 informed, to require tobacco product manufacturers 

5 to disclose research which has not previously been 

6 made available, as well as research generated in the 

7 future, relating to the health and dependency effects 

8 or safety of tobacco products; 

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

10 products to adults in conjunction with measures to 

11 ensure that they are not sold or accessible to under12 age purchasers; 

13 (8) to impose appropriate regulatory controls on 

14 the tobacco industry; 

15 (9) to promote cessation to reduce disease risk 

16 and the social costs associated with tobacco related 

17 diseases; and 

18 (10) to strengthen legislation against illicit 

19 trade in tobacco products. 

20 SEC. 4. SCOPE AND EFFECT. 

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

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

23 (1) establish a precedent with regard to any 

24 other industry, situation, circumstance, or legal ac25 tion; or 
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1 (2) affect any action pending in Federal, State, 

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

3 contract of any kind. 

4 (b) AGRICULTURAL ACTIVITIES.—The provisions of 

5 this Act (or an amendment made by this Act) which au6 thorize the Secretary to take certain actions with regard 

7 to tobacco and tobacco products shall not be construed to 

8 affect any authority of the Secretary of Agriculture under 

9 existing law regarding the growing, cultivation, or curing 

10 of raw tobacco. 

11 SEC. 5. SEVERABILITY. 

12 If any provision of this Act, the amendments made 

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

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

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

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

17 other person or circumstance shall not be affected and 

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

19 TITLE I—AUTHORITY OF THE 

20 FOOD AND DRUG ADMINIS21 TRATION 

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

23 COSMETIC ACT. 

24 (a) DEFINITION OF TOBACCO PRODUCTS.—Section 

25 201 of the Federal Food, Drug, and Cosmetic Act (21 
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1 U.S.C. 321) is amended by adding at the end the fol2 lowing: 

3 ‘‘(nn)(1) The term ‘tobacco product’ means any prod4 uct made or derived from tobacco that is intended for 

5 human consumption, including any component, part, or 

6 accessory of a tobacco product (except for raw materials 

7 other than tobacco used in manufacturing a component, 

8 part, or accessory of a tobacco product). 

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

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

11 (including water and chewing gum), a product rep12 resented for use as or for use in a conventional food, 

13 or a product that is intended for ingestion in cap14 sule, tablet, softgel, or liquid form; or 

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

16 as a drug by the Food and Drug Administration. 

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

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

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

20 subject to chapter V of this Act. 

21 ‘‘(4) A tobacco product may not be marketed in com22 bination with any other article or product regulated under 

23 this Act (including a drug, biologic, food, cosmetics, med24 ical device, or a dietary supplement).’’. 
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1 (b) FDA AUTHORITY OVER TOBACCO PRODUCTS.—

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

3 301 et seq.) is amended—

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

5 (2) by redesignating sections 901 through 907 

6 as sections 1001 through 1007; and 

7 (3) by inserting after section 803 the following: 

8 ‘‘CHAPTER IX—TOBACCO 

9 PRODUCTS 

10 ‘‘SEC. 900. DEFINITIONS. 

11 ‘‘In this chapter: 

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

13 any substance the intended use of which results or 

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

16 affecting the characteristic of any tobacco product 

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

19 packing, processing, preparing, treating, packaging, 

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

21 not include tobacco or a pesticide chemical residue 

22 in or on raw tobacco or a pesticide chemical. 

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

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

3 or any combination of such attributes. 

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

5 meaning given that term by section 3(1) of the Fed6 eral Cigarette Labeling and Advertising Act (15 

7 U.S.C. 1332(1)), but also includes tobacco, in any 

8 form, that is functional in the product, which, be9 cause of its appearance, the type of tobacco used in 

10 the filler, or its packaging and labeling, is likely to 

11 be offered to, or purchased by, consumers as a ciga12 rette or as roll-your-own tobacco. 

13 ‘‘(4) CIGARETTE TOBACCO.—The term ‘ciga14 rette tobacco’ means any product that consists of 

15 loose tobacco that is intended for use by consumers 

16 in a cigarette. Unless otherwise stated, the require17 ments for cigarettes shall also apply to cigarette to18 bacco. 

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

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

21 Federal Cigarette Labeling and Advertising Act (15 

22 U.S.C. 1332(2)). 

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

24 term ‘counterfeit tobacco product’ means a tobacco 

25 product (or the container or labeling of such a prod-
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1 uct) that, without authorization, bears the trade2 mark, trade name, or other identifying mark, im3 print or device, or any likeness thereof, of a tobacco 

4 product listed in a registration under section 

5 905(i)(1). 

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

7 regards a tobacco product means any person who 

8 furthers the distribution of a tobacco product, 

9 whether domestic or imported, at any point from the 

10 original place of manufacture to the person who sells 

11 or distributes the product to individuals for personal 

12 consumption. Common carriers are not considered 

13 distributors for purposes of this chapter. 

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

15 means any practice or conduct prohibited by law 

16 which relates to production, shipment, receipt, pos17 session, distribution, sale, or purchase of tobacco 

18 products including any practice or conduct intended 

19 to facilitate such activity. 

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

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

22 the Indian Self Determination and Education Assist23 ance Act (25 U.S.C. 450b(e)). 

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

25 has the meaning given that term by section 3(7) of 
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1 the Federal Cigarette Labeling and Advertising Act 

2 (15 U.S.C. 1332(7)). 

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

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

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

6 any salt or complex of nicotine. 

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

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

9 other container, any wrapping (including cello10 phane), in which a tobacco product is offered for 

11 sale, sold, or otherwise distributed to consumers. 

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

13 any person who sells tobacco products to individuals 

14 for personal consumption, or who operates a facility 

15 where self-service displays of tobacco products are 

16 permitted. 

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

18 ‘roll-your-own tobacco’ means any tobacco which, be19 cause of its appearance, type, packaging, or labeling, 

20 is suitable for use and likely to be offered to, or pur21 chased by, consumers as tobacco for making ciga22 rettes. 

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

24 constituent’ means any chemical or chemical com25 pound in mainstream or sidestream tobacco smoke 
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1 that either transfers from any component of the cig2 arette to the smoke or that is formed by the combus3 tion or heating of tobacco, additives, or other compo4 nent of the tobacco product. 

5 ‘‘(16) SMOKELESS TOBACCO.—The term 

6 ‘smokeless tobacco’ means any tobacco product that 

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

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

9 cavity. 

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

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

12 chapter, includes the District of Columbia, the Com13 monwealth of Puerto Rico, Guam, the Virgin Is14 lands, American Samoa, Wake Island, Midway Is15 lands, Kingman Reef, Johnston Atoll, the Northern 

16 Mariana Islands, and any other trust territory or 

17 possession of the United States. 

18 ‘‘(18) TOBACCO PRODUCT MANUFACTURER.—

19 Term ‘tobacco product manufacturer’ means any 

20 person, including any repacker or relabeler, who—

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

22 processes, or labels a tobacco product; or

23 ‘‘(B) imports a finished cigarette or 

24 smokeless tobacco product for sale or distribu25 tion in the United States. 
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1 ‘‘(19) UNITED STATES.—The term ‘United 

2 States’ means the 50 States of the United States of 

3 America and the District of Columbia, the Common4 wealth of Puerto Rico, Guam, the Virgin Islands, 

5 American Samoa, Wake Island, Midway Islands, 

6 Kingman Reef, Johnston Atoll, the Northern Mar7 iana Islands, and any other trust territory or posses8 sion of the United States. 

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

10 ‘‘(a) IN GENERAL.—Tobacco products shall be regu11 lated by the Secretary under this chapter and shall not 

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

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

14 diagnosis, cure, mitigation, treatment, or prevention 

15 of disease (within the meaning of section 

16 201(g)(1)(B) or section 201(h)(2)); or 

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

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

19 other than modified risk tobacco products approved 

20 in accordance with section 911. 

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

22 tobacco products subject to the regulations referred to in 

23 section 102 of the Family Smoking Prevention and To24 bacco Control Act, and to any other tobacco products that
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1 the Secretary by regulation deems to be subject to this 

2 chapter. 

3 ‘‘(c) SCOPE.—

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

5 any policy issued or regulation promulgated there6 under, or the Family Smoking Prevention and To7 bacco Control Act, shall be construed to affect the 

8 Secretary’s authority over, or the regulation of, 

9 products under this Act that are not tobacco prod10 ucts under chapter V or any other chapter. 

11 ‘‘(2) LIMITATION OF AUTHORITY.—

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

13 chapter shall not apply to tobacco leaf that is 

14 not in the possession of a manufacturer of to15 bacco products, or to the producers of tobacco 

16 leaf, including tobacco growers, tobacco ware17 houses, and tobacco grower cooperatives, nor 

18 shall any employee of the Food and Drug Ad19 ministration have any authority to enter onto a 

20 farm owned by a producer of tobacco leaf with21 out the written consent of such producer. 

22 ‘‘(B) EXCEPTION.—Notwithstanding any 

23 other provision of this subparagraph, if a pro24 ducer of tobacco leaf is also a tobacco product 

25 manufacturer or controlled by a tobacco prod-
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1 uct manufacturer, the producer shall be subject 

2 to this chapter in the producer’s capacity as a 

3 manufacturer. 

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

5 in this chapter shall be construed to grant the 

6 Secretary authority to promulgate regulations 

7 on any matter that involves the production of 

8 tobacco leaf or a producer thereof, other than 

9 activities by a manufacturer affecting produc10 tion. 

11 ‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS. 

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

13 if—

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

15 putrid, or decomposed substance, or is otherwise 

16 contaminated by any added poisonous or added dele17 terious substance that may render the product inju18 rious to health; 

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

20 under insanitary conditions whereby it may have 

21 been contaminated with filth, or whereby it may 

22 have been rendered injurious to health; 

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

24 part, of any poisonous or deleterious substance 

25 which may render the contents injurious to health; 
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1 ‘‘(4) it is, or purports to be or is represented 

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

3 product standard established under section 907 un4 less such tobacco product is in all respects in con5 formity with such standard; 

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

7 premarket approval and does not have an approved 

8 application in effect; 

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

10 such an application; or 

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

12 controls used for, its manufacture, packing or stor13 age are not in conformity with applicable require14 ments under section 906(e)(1) or an applicable con15 dition prescribed by an order under section 

16 906(e)(2); or 

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

18 ‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS. 

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

20 deemed to be misbranded—

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

22 particular; 

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

24 containing—
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1 ‘‘(A) the name and place of business of the 

2 tobacco product manufacturer, packer, or dis3 tributor; 

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

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

6 numerical count; 

7 ‘‘(C) an accurate statement of the percent8 age of the tobacco used in the product that is 

9 domestically grown tobacco and the percentage 

10 that is foreign grown tobacco; and 

11 ‘‘(D) the statement required under section 

12 921(a), 

13 except that under subparagraph (B) reasonable vari14 ations shall be permitted, and exemptions as to 

15 small packages shall be established, by regulations 

16 prescribed by the Secretary; 

17 ‘‘(3) if any word, statement, or other informa18 tion required by or under authority of this chapter 

19 to appear on the label or labeling is not prominently 

20 placed thereon with such conspicuousness (as com21 pared with other words, statements or designs in the 

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

23 be read and understood by the ordinary individual 

24 under customary conditions of purchase and use; 
27

•S 2461 IS 

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

2 label bears, to the exclusion of any other nonpropri3 etary name, its established name prominently print4 ed in type as required by the Secretary by regula5 tion; 

6 ‘‘(5) if the Secretary has issued regulations re7 quiring that its labeling bear adequate directions for 

8 use, or adequate warnings against use by children, 

9 that are necessary for the protection of users unless 

10 its labeling conforms in all respects to such regula11 tions; 

12 ‘‘(6) if it was manufactured, prepared, propa13 gated, compounded, or processed in any State in an 

14 establishment not duly registered under section 

15 905(b), 905(c), 905(d), or 905(h), if it was not in16 cluded in a list required by section 905(i), if a notice 

17 or other information respecting it was not provided 

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

19 it does not bear such symbols from the uniform sys20 tem for identification of tobacco products prescribed 

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

22 requires; 

23 ‘‘(7) if, in the case of any tobacco product dis24 tributed or offered for sale in any State—
28

•S 2461 IS 

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

2 in any particular; or 

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

4 regulations prescribed under section 906(d); 

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

6 distributed or offered for sale in any State, the man7 ufacturer, packer, or distributor thereof includes in 

8 all advertisements and other descriptive printed mat9 ter issued or caused to be issued by the manufac10 turer, packer, or distributor with respect to that to11 bacco product—

12 ‘‘(A) a true statement of the tobacco prod13 uct’s established name as described in para14 graph (4), printed prominently; and 

15 ‘‘(B) a brief statement of—

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

17 and relevant warnings, precautions, side 

18 effects, and contraindications; and 

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

20 products made subject to a finding by the 

21 Secretary after notice and opportunity for 

22 comment that such action is appropriate to 

23 protect the public health, a full description 

24 of the components of such tobacco product 

25 or the formula showing quantitatively each 
29

•S 2461 IS 

1 ingredient of such tobacco product to the 

2 extent required in regulations which shall 

3 be issued by the Secretary after an oppor4 tunity for a hearing; 

5 ‘‘(9) if it is a tobacco product subject to a to6 bacco product standard established under section 

7 907, unless it bears such labeling as may be pre8 scribed in such tobacco product standard; or 

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

10 ‘‘(A) to comply with any requirement pre11 scribed under section 904 or 908; or 

12 ‘‘(B) to furnish any material or informa13 tion required under section 909. 

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

15 The Secretary may, by regulation, require prior approval 

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

17 regulation issued under this subsection may require prior 

18 approval by the Secretary of the content of any advertise19 ment, except for modified risk tobacco products as pro20 vided in section 911. No advertisement of a tobacco prod21 uct published after the date of enactment of the Family 

22 Smoking Prevention and Tobacco Control Act shall, with 

23 respect to the language of label statements as prescribed 

24 under section 4 of the Cigarette Labeling and Advertising 

25 Act and section 3 of the Comprehensive Smokeless To-
30

•S 2461 IS 

1 bacco Health Education Act of 1986 or the regulations 

2 issued under such sections, be subject to the provisions 

3 of sections 12 through 15 of the Federal Trade Commis4 sion Act (15 U.S.C. 52 through 55). 

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

6 SECRETARY. 

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

8 the date of enactment of the Family Smoking Prevention 

9 and Tobacco Control Act, each tobacco product manufac10 turer or importer, or agents thereof, shall submit to the 

11 Secretary the following information: 

12 ‘‘(1) A listing of all ingredients, including to13 bacco, substances, compounds, and additives that 

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

15 the tobacco, paper, filter, or other part of each to16 bacco product by brand and by quantity in each 

17 brand and subbrand. 

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

19 form of nicotine in each tobacco product measured 

20 in milligrams of nicotine in accordance with regula21 tions promulgated by the Secretary in accordance 

22 with section 4(a)(4) of the Federal Cigarette Label23 ing and Advertising Act. 

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

25 smoke constituents as applicable, identified by the 
31

•S 2461 IS 

1 Secretary as harmful or potentially harmful to 

2 health in each tobacco product, and as applicable in 

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

4 quantity in each brand and subbrand. Effective be5 ginning 2 years after the date of enactment of this 

6 chapter, the manufacturer, importer, or agent shall 

7 comply with regulations promulgated under section 

8 915 in reporting information under this paragraph, 

9 where applicable. 

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

11 enactment of the Family Smoking Prevention and 

12 Tobacco Control Act that relate to health, toxi13 cological, behavioral, or physiologic effects of current 

14 or future tobacco products, their constituents (in15 cluding smoke constituents), ingredients, compo16 nents, and additives.

17 ‘‘(b) DATA SUBMISSION.—At the request of the Sec18 retary, each tobacco product manufacturer or importer of 

19 tobacco products, or agents thereof, shall submit the fol20 lowing: 

21 ‘‘(1) Any or all documents (including under22 lying scientific information) relating to research ac23 tivities, and research findings, conducted, supported, 

24 or possessed by the manufacturer (or agents thereof) 

25 on the health, toxicological, behavioral, or physio-
32

•S 2461 IS 

1 logic effects of tobacco products and their constitu2 ents (including smoke constituents), ingredients, 

3 components, and additives. 

4 ‘‘(2) Any or all documents (including under5 lying scientific information) relating to research ac6 tivities, and research findings, conducted, supported, 

7 or possessed by the manufacturer (or agents thereof) 

8 that relate to the issue of whether a reduction in 

9 risk to health from tobacco products can occur upon 

10 the employment of technology available or known to 

11 the manufacturer. 

12 ‘‘(3) Any or all documents (including under13 lying scientific or financial information) relating to 

14 marketing research involving the use of tobacco 

15 products or marketing practices and the effective16 ness of such practices used by tobacco manufactur17 ers and distributors. 

18 An importer of a tobacco product not manufactured in the 

19 United States shall supply the information required of a 

20 tobacco product manufacturer under this subsection. 

21 ‘‘(c) TIME FOR SUBMISSION.—

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

23 the delivery for introduction into interstate com24 merce of a tobacco product not on the market on the 

25 date of enactment of the Family Smoking Preven-
33

•S 2461 IS 

1 tion and Tobacco Control Act, the manufacturer of 

2 such product shall provide the information required 

3 under subsection (a). 

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

5 time a tobacco product manufacturer adds to its to6 bacco products a new tobacco additive or increases 

7 the quantity of an existing tobacco additive, the 

8 manufacturer shall, except as provided in paragraph 

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

10 the Secretary in writing. 

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

12 any time a tobacco product manufacturer eliminates 

13 or decreases an existing additive, or adds or in14 creases an additive that has by regulation been des15 ignated by the Secretary as an additive that is not 

16 a human or animal carcinogen, or otherwise harmful 

17 to health under intended conditions of use, the man18 ufacturer shall within 60 days of such action so ad19 vise the Secretary in writing. 

20 ‘‘(d) DATA LIST.—

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

22 after the date of enactment of the Family Smoking 

23 Prevention and Tobacco Control Act, and annually 

24 thereafter, the Secretary shall publish in a format 

25 that is understandable and not misleading to a lay
34

•S 2461 IS 

1 person, and place on public display (in a manner de2 termined by the Secretary) the list established under 

3 subsection (e). 

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

5 shall conduct periodic consumer research to ensure 

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

7 misleading to lay persons. Not later than 5 years 

8 after the date of enactment of the Family Smoking 

9 Prevention and Tobacco Control Act, the Secretary 

10 shall submit to the appropriate committees of Con11 gress a report on the results of such research, to12 gether with recommendations on whether such publi13 cation should be continued or modified. 

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

15 after the date of enactment of the Family Smoking Pre16 vention and Tobacco Control Act, the Secretary shall es17 tablish a list of harmful and potentially harmful constitu18 ents, including smoke constituents, to health in each to19 bacco product by brand and by quantity in each brand 

20 and subbrand. The Secretary shall publish a public notice 

21 requesting the submission by interested persons of sci22 entific and other information concerning the harmful and 

23 potentially harmful constituents in tobacco products and 

24 tobacco smoke. 
35

•S 2461 IS 

1 ‘‘SEC. 905. ANNUAL REGISTRATION. 

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

3 ‘‘(1) MANUFACTURE, PREPARATION, 

4 COMPOUNDING, OR PROCESSING.—The term ‘manu5 facture, preparation, compounding, or processing’ 

6 shall include repackaging or otherwise changing the 

7 container, wrapper, or labeling of any tobacco prod8 uct package in furtherance of the distribution of the 

9 tobacco product from the original place of manufac10 ture to the person who makes final delivery or sale 

11 to the ultimate consumer or user. 

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

13 the case of a partnership the name of each partner 

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

15 corporate officer and director, and the State of in16 corporation. 

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

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

19 owns or operates any establishment in any State engaged 

20 in the manufacture, preparation, compounding, or proc21 essing of a tobacco product or tobacco products shall reg22 ister with the Secretary the name, places of business, and 

23 all such establishments of that person. 

24 ‘‘(c) REGISTRATION OF NEW OWNERS AND OPERA25 TORS.—Every person upon first engaging in the manufac26 ture, preparation, compounding, or processing of a tobacco 
36

•S 2461 IS 

1 product or tobacco products in any establishment owned 

2 or operated in any State by that person shall immediately 

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

4 business, and such establishment. 

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

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

7 (c) shall immediately register with the Secretary any addi8 tional establishment which that person owns or operates 

9 in any State and in which that person begins the manufac10 ture, preparation, compounding, or processing of a tobacco 

11 product or tobacco products. 

12 ‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYS13 TEM.—The Secretary may by regulation prescribe a uni14 form system for the identification of tobacco products and 

15 may require that persons who are required to list such 

16 tobacco products under subsection (i) shall list such to17 bacco products in accordance with such system. 

18 ‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA19 TION.—The Secretary shall make available for inspection, 

20 to any person so requesting, any registration filed under 

21 this section. 

22 ‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB23 LISHMENTS.—Every establishment in any State registered 

24 with the Secretary under this section shall be subject to 

25 inspection under section 704, and every such establish-
37

•S 2461 IS 

1 ment engaged in the manufacture, compounding, or proc2 essing of a tobacco product or tobacco products shall be 

3 so inspected by 1 or more officers or employees duly des4 ignated by the Secretary at least once in the 2-year period 

5 beginning with the date of registration of such establish6 ment under this section and at least once in every succes7 sive 2-year period thereafter. 

8 ‘‘(h) FOREIGN ESTABLISHMENTS SHALL REG9 ISTER.—Any establishment within any foreign country en10 gaged in the manufacture, preparation, compounding, or 

11 processing of a tobacco product or tobacco products, shall 

12 register under this section under regulations promulgated 

13 by the Secretary. Such regulations shall require such es14 tablishment to provide the information required by sub15 section (i) of this section and shall include provisions for 

16 registration of any such establishment upon condition that 

17 adequate and effective means are available, by arrange18 ment with the government of such foreign country or oth19 erwise, to enable the Secretary to determine from time to 

20 time whether tobacco products manufactured, prepared, 

21 compounded, or processed in such establishment, if im22 ported or offered for import into the United States, shall 

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

24 section 801(a). 

25 ‘‘(i) REGISTRATION INFORMATION.—
38

•S 2461 IS 

1 ‘‘(1) PRODUCT LIST.—Every person who reg2 isters with the Secretary under subsection (b), (c), 

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

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

5 all tobacco products which are being manufactured, 

6 prepared, compounded, or processed by that person 

7 for commercial distribution and which has not been 

8 included in any list of tobacco products filed by that 

9 person with the Secretary under this paragraph or 

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

11 list shall be prepared in such form and manner as 

12 the Secretary may prescribe and shall be accom13 panied by—

14 ‘‘(A) in the case of a tobacco product con15 tained in the applicable list with respect to 

16 which a tobacco product standard has been es17 tablished under section 907 or which is subject 

18 to section 910, a reference to the authority for 

19 the marketing of such tobacco product and a 

20 copy of all labeling for such tobacco product; 

21 ‘‘(B) in the case of any other tobacco prod22 uct contained in an applicable list, a copy of all 

23 consumer information and other labeling for 

24 such tobacco product, a representative sampling 

25 of advertisements for such tobacco product,
39

•S 2461 IS 

1 and, upon request made by the Secretary for 

2 good cause, a copy of all advertisements for a 

3 particular tobacco product; and 

4 ‘‘(C) if the registrant filing a list has de5 termined that a tobacco product contained in 

6 such list is not subject to a tobacco product 

7 standard established under section 907, a brief 

8 statement of the basis upon which the reg9 istrant made such determination if the Sec10 retary requests such a statement with respect 

11 to that particular tobacco product. 

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

13 PRODUCT LIST.—Each person who registers with the 

14 Secretary under this section shall report to the Sec15 retary once during the month of June of each year 

16 and once during the month of December of each 

17 year the following: 

18 ‘‘(A) A list of each tobacco product intro19 duced by the registrant for commercial distribu20 tion which has not been included in any list 

21 previously filed by that person with the Sec22 retary under this subparagraph or paragraph 

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

24 tobacco product by its established name and 
40

•S 2461 IS 

1 shall be accompanied by the other information 

2 required by paragraph (1). 

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

4 made a report under this paragraph that person 

5 has discontinued the manufacture, preparation, 

6 compounding, or processing for commercial dis7 tribution of a tobacco product included in a list 

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

9 notice of such discontinuance, the date of such 

10 discontinuance, and the identity of its estab11 lished name. 

12 ‘‘(C) If since the date the registrant re13 ported under subparagraph (B) a notice of dis14 continuance that person has resumed the manu15 facture, preparation, compounding, or proc16 essing for commercial distribution of the to17 bacco product with respect to which such notice 

18 of discontinuance was reported, notice of such 

19 resumption, the date of such resumption, the 

20 identity of such tobacco product by established 

21 name, and other information required by para22 graph (1), unless the registrant has previously 

23 reported such resumption to the Secretary 

24 under this subparagraph. 
41

•S 2461 IS 

1 ‘‘(D) Any material change in any informa2 tion previously submitted under this paragraph 

3 or paragraph (1). 

4 ‘‘(j) REPORT PRECEDING INTRODUCTION OF CER5 TAIN SUBSTANTIALLY-EQUIVALENT PRODUCTS INTO

6 INTERSTATE COMMERCE.—

7 ‘‘(1) IN GENERAL.—Each person who is re8 quired to register under this section and who pro9 poses to begin the introduction or delivery for intro10 duction into interstate commerce for commercial dis11 tribution of a tobacco product intended for human 

12 use that was not commercially marketed (other than 

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

14 1, 2003, shall, at least 90 days prior to making such 

15 introduction or delivery, report to the Secretary (in 

16 such form and manner as the Secretary shall pre17 scribe)—

18 ‘‘(A) the basis for such person’s determina19 tion that the tobacco product is substantially 

20 equivalent, within the meaning of section 910, 

21 to a tobacco product commercially marketed 

22 (other than for test marketing) in the United 

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

24 with the requirements of this Act; and 
42

•S 2461 IS 

1 ‘‘(B) action taken by such person to com2 ply with the requirements under section 907 

3 that are applicable to the tobacco product. 

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

5 2003 PRODUCTS.—A report under this subsection for 

6 a tobacco product that was first introduced or deliv7 ered for introduction into interstate commerce for 

8 commercial distribution in the United States after 

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

10 months after the date of enactment of the Family 

11 Smoking Prevention and Tobacco Control Act shall 

12 be submitted to the Secretary not later than 15 

13 months after such date of enactment. 

14 ‘‘(3) EXEMPTIONS.—

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

16 regulation, exempt from the requirements of 

17 this subsection tobacco products that are modi18 fied by adding or deleting a tobacco additive, or 

19 increasing or decreasing the quantity of an ex20 isting tobacco additive, if the Secretary deter21 mines that—

22 ‘‘(i) such modification would be a 

23 minor modification of a tobacco product 

24 authorized for sale under this Act; 
43

•S 2461 IS 

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

2 not necessary to ensure that permitting the 

3 tobacco product to be marketed would be 

4 appropriate for protection of the public 

5 health; and 

6 ‘‘(iii) an exemption is otherwise appro7 priate. 

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

9 months after the date of enactment of the Fam10 ily Smoking Prevention and Tobacco Control 

11 Act, the Secretary shall issue regulations to im12 plement this paragraph. 

13 ‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL 

14 OF TOBACCO PRODUCTS. 

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

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

17 tobacco product shall apply to such tobacco product until 

18 the applicability of the requirement to the tobacco product 

19 has been changed by action taken under section 907, sec20 tion 910, section 911, or subsection (d) of this section, 

21 and any requirement established by or under section 902, 

22 903, 905, or 909 which is inconsistent with a requirement 

23 imposed on such tobacco product under section 907, sec24 tion 910, section 911, or subsection (d) of this section 

25 shall not apply to such tobacco product.
44

•S 2461 IS 

1 ‘‘(b) INFORMATION ON PUBLIC ACCESS AND COM2 MENT.—Each notice of proposed rulemaking under section 

3 907, 908, 909, 910, or 911 or under this section, any 

4 other notice which is published in the Federal Register 

5 with respect to any other action taken under any such sec6 tion and which states the reasons for such action, and 

7 each publication of findings required to be made in con8 nection with rulemaking under any such section shall set 

9 forth—

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

11 may examine data and other information on which 

12 the notice or findings is based; and 

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

14 may present their comments on the notice or find15 ings (including the need therefore) orally or in writ16 ing, which period shall be at least 60 days but may 

17 not exceed 90 days unless the time is extended by 

18 the Secretary by a notice published in the Federal 

19 Register stating good cause therefore. 

20 ‘‘(c) LIMITED CONFIDENTIALITY OF INFORMA21 TION.—Any information reported to or otherwise obtained 

22 by the Secretary or the Secretary’s representative under 

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

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

25 from disclosure under subsection (a) of section 552 of title 
45

•S 2461 IS 

1 5, United States Code, by reason of subsection (b)(4) of 

2 that section shall be considered confidential and shall not 

3 be disclosed, except that the information may be disclosed 

4 to other officers or employees concerned with carrying out 

5 this chapter, or when relevant in any proceeding under 

6 this chapter. 

7 ‘‘(d) RESTRICTIONS.—

8 ‘‘(1) IN GENERAL.—The Secretary may by reg9 ulation require restrictions on the sale and distribu10 tion of a tobacco product, including restrictions on 

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

12 the tobacco product, if the Secretary determines that 

13 such regulation would be appropriate for the protec14 tion of the public health. The Secretary may by reg15 ulation impose restrictions on the advertising and 

16 promotion of a tobacco product consistent with and 

17 to full extent permitted by the first amendment to 

18 the Constitution. The finding as to whether such 

19 regulation would be appropriate for the protection of 

20 the public health shall be determined with respect to 

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

22 including users and non-users of the tobacco prod23 uct, and taking into account—
46

•S 2461 IS 

1 ‘‘(A) the increased or decreased likelihood 

2 that existing users of tobacco products will stop 

3 using such products; and 

4 ‘‘(B) the increased or decreased likelihood 

5 that those who do not use tobacco products will 

6 start using such products. 

7 No such regulation may require that the sale or dis8 tribution of a tobacco product be limited to the writ9 ten or oral authorization of a practitioner licensed 

10 by law to prescribe medical products. 

11 ‘‘(2) LABEL STATEMENTS.—The label of a to12 bacco product shall bear such appropriate state13 ments of the restrictions required by a regulation 

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

15 regulation prescribe. 

16 ‘‘(3) LIMITATIONS.—

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

18 paragraph (1) may—

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

20 product in face-to-face transactions by a 

21 specific category of retail outlets; or 

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

23 of tobacco products to any person older 

24 than 18 years of age. 
47

•S 2461 IS 

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

2 regulations issued by the Secretary, matchbooks 

3 of conventional size containing not more than 

4 20 paper matches, and which are customarily 

5 given away for free with the purchase of to6 bacco products shall be considered as adult 

7 written publications which shall be permitted to 

8 contain advertising. Notwithstanding the pre9 ceding sentence, if the Secretary finds that such 

10 treatment of matchbooks is not appropriate for 

11 the protection of the public health, the Sec12 retary may determine by regulation that match13 books shall not be considered adult written pub14 lications. 

15 ‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE16 MENTS.—

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

18 CONFORM.—

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

20 accordance with subparagraph (B), prescribe 

21 regulations (which may differ based on the type 

22 of tobacco product involved) requiring that the 

23 methods used in, and the facilities and controls 

24 used for, the manufacture, pre-production de25 sign validation (including a process to assess 
48

•S 2461 IS 

1 the performance of a tobacco product), packing 

2 and storage of a tobacco product, conform to 

3 current good manufacturing practice, as pre4 scribed in such regulations, to assure that the 

5 public health is protected and that the tobacco 

6 product is in compliance with this chapter. 

7 Good manufacturing practices may include the 

8 testing of raw tobacco for pesticide chemical 

9 residues regardless of whether a tolerance for 

10 such chemical residues has been established. 

11 ‘‘(B) REQUIREMENTS.—The Secretary 

12 shall—

13 ‘‘(i) before promulgating any regula14 tion under subparagraph (A), afford the 

15 Tobacco Products Scientific Advisory Com16 mittee an opportunity to submit rec17 ommendations with respect to the regula18 tion proposed to be promulgated; 

19 ‘‘(ii) before promulgating any regula20 tion under subparagraph (A), afford oppor21 tunity for an oral hearing;

22 ‘‘(iii) provide the advisory committee a 

23 reasonable time to make its recommenda24 tion with respect to proposed regulations 

25 under subparagraph (A); and
49

•S 2461 IS 

1 ‘‘(iv) in establishing the effective date 

2 of a regulation promulgated under this 

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

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

11 such manufacturers to conform to good 

12 manufacturing practices. 

13 ‘‘(2) EXEMPTIONS; VARIANCES.—

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

15 any requirement prescribed under paragraph 

16 (1) may petition the Secretary for a permanent 

17 or temporary exemption or variance from such 

18 requirement. Such a petition shall be submitted 

19 to the Secretary in such form and manner as 

20 the Secretary shall prescribe and shall—

21 ‘‘(i) in the case of a petition for an ex22 emption from a requirement, set forth the 

23 basis for the petitioner’s determination 

24 that compliance with the requirement is 

25 not required to assure that the tobacco 
50

•S 2461 IS 

1 product will be in compliance with this 

2 chapter; 

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

4 variance from a requirement, set forth the 

5 methods proposed to be used in, and the 

6 facilities and controls proposed to be used 

7 for, the manufacture, packing, and storage 

8 of the tobacco product in lieu of the meth9 ods, facilities, and controls prescribed by 

10 the requirement; and 

11 ‘‘(iii) contain such other information 

12 as the Secretary shall prescribe. 

13 ‘‘(B) REFERRAL TO THE TOBACCO PROD14 UCTS SCIENTIFIC ADVISORY COMMITTEE.—The 

15 Secretary may refer to the Tobacco Products 

16 Scientific Advisory Committee any petition sub17 mitted under subparagraph (A). The Tobacco 

18 Products Scientific Advisory Committee shall 

19 report its recommendations to the Secretary 

20 with respect to a petition referred to it within 

21 60 days after the date of the petition’s referral. 

22 Within 60 days after—

23 ‘‘(i) the date the petition was sub24 mitted to the Secretary under subpara25 graph (A); or 
51

•S 2461 IS 

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

3 Advisory Committee, 

4 whichever occurs later, the Secretary shall by 

5 order either deny the petition or approve it. 

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

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

9 tobacco product from a requirement if the 

10 Secretary determines that compliance with 

11 such requirement is not required to assure 

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

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

16 Secretary determines that the methods to 

17 be used in, and the facilities and controls 

18 to be used for, the manufacture, packing, 

19 and storage of the tobacco product in lieu 

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

22 assure that the tobacco product will be in 

23 compliance with this chapter. 

24 ‘‘(D) CONDITIONS.—An order of the Sec25 retary approving a petition for a variance shall 
52

•S 2461 IS 

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

3 for, the manufacture, packing, and storage of 

4 the tobacco product to be granted the variance 

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

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

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

11 for an informal hearing on such order. 

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

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

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

20 tobacco products for research, testing, and demonstration 

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

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

23 States Code. 

24 ‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 

25 ‘‘(a) IN GENERAL.—
53

•S 2461 IS 

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

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

5 an artificial or natural flavor (other than tobacco or 

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

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

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

9 that is a characterizing flavor of the tobacco product 

10 or tobacco smoke. Nothing in this subparagraph 

11 shall be construed to limit the Secretary’s authority 

12 to take action under this section or other sections of 

13 this Act applicable to menthol or any artificial or 

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

15 paragraph. 

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

19 subsection (b). 

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

21 Secretary may adopt tobacco product standards in 

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

23 finds that a tobacco product standard is appropriate 

24 for the protection of the public health. This finding 

25 shall be determined with respect to the risks and 
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•S 2461 IS 

1 benefits to the population as a whole, including 

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

4 ‘‘(A) the increased or decreased likelihood 

5 that existing users of tobacco products will stop 

6 using such products; and 

7 ‘‘(B) the increased or decreased likelihood 

8 that those who do not use tobacco products will 

9 start using such products. 

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

12 under this section for a tobacco product—

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

15 including provisions, where appropriate— 

16 ‘‘(i) for the reduction of nicotine 

17 yields of the product; 

18 ‘‘(ii) for the reduction or elimination 

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

21 product; or 

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

24 ‘‘(B) shall, where appropriate for the pro25 tection of the public health, include—
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•S 2461 IS 

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

5 product; 

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

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

9 ‘‘(iii) provisions for the measurement 

10 of the tobacco product characteristics of 

11 the tobacco product; 

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

14 the tobacco product required to be made 

15 under clause (ii) show that the tobacco 

16 product is in conformity with the portions 

17 of the standard for which the test or tests 

18 were required; and 

19 ‘‘(v) a provision requiring that the 

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

22 that the sale and distribution of a tobacco 

23 product may be restricted under a regula24 tion under section 906(d); and
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•S 2461 IS 

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

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

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

5 PRODUCT STANDARDS.—The Secretary shall provide 

6 for periodic evaluation of tobacco product standards 

7 established under this section to determine whether 

8 such standards should be changed to reflect new 

9 medical, scientific, or other technological data. The 

10 Secretary may provide for testing under paragraph 

11 (4)(B) by any person. 

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

14 this section, the Secretary shall endeavor to—

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

16 technical support available in other Federal 

17 agencies; 

18 ‘‘(B) consult with other Federal agencies 

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

22 ‘‘(C) invite appropriate participation, 

23 through joint or other conferences, workshops, 

24 or other means, by informed persons represent25 ative of scientific, professional, industry, agri-
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•S 2461 IS 

1 cultural, or consumer organizations who in the 

2 Secretary’s judgment can make a significant 

3 contribution. 

4 ‘‘(b) ESTABLISHMENT OF STANDARDS.—

5 ‘‘(1) NOTICE.—

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

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

10 standard. 

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

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

19 ‘‘(ii) set forth proposed findings with 

20 respect to the risk of illness or injury that 

21 the tobacco product standard is intended 

22 to reduce or eliminate; and 

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

25 for the tobacco product, including a draft 
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•S 2461 IS 

1 or proposed tobacco product standard, for 

2 consideration by the Secretary. 

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

4 by the Secretary that an additive, constituent 

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

7 proposed tobacco product standard is harmful, 

8 it shall be the burden of any party challenging 

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

11 risk of illness or injury. 

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

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

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

18 ‘‘(E) CONSIDERATION BY SECRETARY.—

19 The Secretary shall consider all information 

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

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

25 as the creation of a significant demand for con-
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•S 2461 IS 

1 traband or other tobacco products that do not 

2 meet the requirements of this chapter and the 

3 significance of such demand, and shall issue the 

4 standard if the Secretary determines that the 

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

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

9 days. 

10 ‘‘(2) PROMULGATION.—

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

12 the period for comment on a notice of proposed 

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

15 consideration of such comments and any report 

16 from the Tobacco Products Scientific Advisory 

17 Committee, the Secretary shall—

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

20 publish in the Federal Register findings on 

21 the matters referred to in paragraph (1); 

22 or 

23 ‘‘(ii) publish a notice terminating the 

24 proceeding for the development of the 
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1 standard together with the reasons for 

2 such termination. 

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

5 forth the date or dates upon which the standard 

6 shall take effect, but no such regulation may 

7 take effect before 1 year after the date of its 

8 publication unless the Secretary determines 

9 that an earlier effective date is necessary for 

10 the protection of the public health. Such date or 

11 dates shall be established so as to minimize, 

12 consistent with the public health, economic loss 

13 to, and disruption or dislocation of, domestic 

14 and international trade. 

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

18 product standard—

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

20 tobacco products, all little cigars, all cigars 

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

22 roll your own tobacco products; or 

23 ‘‘(B) requiring the reduction of nicotine 

24 yields of a tobacco product to zero, 

25 Congress expressly reserves to itself such power.
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•S 2461 IS 

1 ‘‘(4) AMENDMENT; REVOCATION.—

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

3 the Secretary’s own initiative or upon petition 

4 of an interested person may by a regulation, 

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

7 revoke a tobacco product standard. 

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

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

11 after its publication in the Federal Register and 

12 until the effective date of any final action taken 

13 on such amendment if the Secretary determines 

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

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

17 The Secretary may—

18 ‘‘(A) on the Secretary’s own initiative, 

19 refer a proposed regulation for the establish20 ment, amendment, or revocation of a tobacco 

21 product standard; or 

22 ‘‘(B) upon the request of an interested per23 son which demonstrates good cause for referral 

24 and which is made before the expiration of the 
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1 period for submission of comments on such pro2 posed regulation, 

3 refer such proposed regulation to the Tobacco Products 

4 Scientific Advisory Committee, for a report and rec5 ommendation with respect to any matter involved in the 

6 proposed regulation which requires the exercise of sci7 entific judgment. If a proposed regulation is referred 

8 under this paragraph to the Tobacco Products Scientific 

9 Advisory Committee, the Secretary shall provide the advi10 sory committee with the data and information on which 

11 such proposed regulation is based. The Tobacco Products 

12 Scientific Advisory Committee shall, within 60 days after 

13 the referral of a proposed regulation and after inde14 pendent study of the data and information furnished to 

15 it by the Secretary and other data and information before 

16 it, submit to the Secretary a report and recommendation 

17 respecting such regulation, together with all underlying 

18 data and information and a statement of the reason or 

19 basis for the recommendation. A copy of such report and 

20 recommendation shall be made public by the Secretary. 

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

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

23 that—

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

25 delivered for introduction into interstate commerce 
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•S 2461 IS 

1 for commercial distribution presents an unreasonable 

2 risk of substantial harm to the public health; and 

3 ‘‘(2) notification under this subsection is nec4 essary to eliminate the unreasonable risk of such 

5 harm and no more practicable means is available 

6 under the provisions of this chapter (other than this 

7 section) to eliminate such risk, 

8 the Secretary may issue such order as may be necessary 

9 to assure that adequate notification is provided in an ap10 propriate form, by the persons and means best suited 

11 under the circumstances involved, to all persons who 

12 should properly receive such notification in order to elimi13 nate such risk. The Secretary may order notification by 

14 any appropriate means, including public service announce15 ments. Before issuing an order under this subsection, the 

16 Secretary shall consult with the persons who are to give 

17 notice under the order. 

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

19 Compliance with an order issued under this section shall 

20 not relieve any person from liability under Federal or 

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

22 action brought for the enforcement of any such liability, 

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

24 provided under such order shall be taken into account. 

25 ‘‘(c) RECALL AUTHORITY.—
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•S 2461 IS 

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

2 there is a reasonable probability that a tobacco prod3 uct contains a manufacturing or other defect not or4 dinarily contained in tobacco products on the market 

5 that would cause serious, adverse health con6 sequences or death, the Secretary shall issue an 

7 order requiring the appropriate person (including 

8 the manufacturers, importers, distributors, or retail9 ers of the tobacco product) to immediately cease dis10 tribution of such tobacco product. The order shall 

11 provide the person subject to the order with an op12 portunity for an informal hearing, to be held not 

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

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

15 on whether the order should be amended to require 

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

17 an opportunity for such a hearing, the Secretary de18 termines that inadequate grounds exist to support 

19 the actions required by the order, the Secretary shall 

20 vacate the order. 

21 ‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE22 CALL.—

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

24 opportunity for an informal hearing under 

25 paragraph (1), the Secretary determines that 
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•S 2461 IS 

1 the order should be amended to include a recall 

2 of the tobacco product with respect to which the 

3 order was issued, the Secretary shall, except as 

4 provided in subparagraph (B), amend the order 

5 to require a recall. The Secretary shall specify 

6 a timetable in which the tobacco product recall 

7 will occur and shall require periodic reports to 

8 the Secretary describing the progress of the re9 call. 

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

11 subparagraph (A)—

12 ‘‘(i) shall not include recall of a to13 bacco product from individuals; and 

14 ‘‘(ii) shall provide for notice to per15 sons subject to the risks associated with 

16 the use of such tobacco product. 

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

18 the Secretary may use the assistance of retail19 ers and other persons who distributed such to20 bacco product. If a significant number of such 

21 persons cannot be identified, the Secretary shall 

22 notify such persons under section 705(b). 

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

24 provided by this subsection shall be in addition to 

25 remedies provided by subsection (a) of this section. 
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1 ‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PROD2 UCTS. 

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

4 product manufacturer or importer of a tobacco product 

5 shall establish and maintain such records, make such re6 ports, and provide such information, as the Secretary may 

7 by regulation reasonably require to assure that such to8 bacco product is not adulterated or misbranded and to 

9 otherwise protect public health. Regulations prescribed 

10 under the preceding sentence—

11 ‘‘(1) may require a tobacco product manufac12 turer or importer to report to the Secretary when13 ever the manufacturer or importer receives or other14 wise becomes aware of information that reasonably 

15 suggests that one of its marketed tobacco products 

16 may have caused or contributed to a serious unex17 pected adverse experience associated with the use of 

18 the product or any significant increase in the fre19 quency of a serious, expected adverse product experi20 ence; 

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

22 adverse tobacco product experiences as determined 

23 by the Secretary to be necessary to be reported; 

24 ‘‘(3) shall not impose requirements unduly bur25 densome to a tobacco product manufacturer or im26 porter, taking into account the cost of complying
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1 with such requirements and the need for the protec2 tion of the public health and the implementation of 

3 this chapter; 

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

5 requests for reports or information, shall require 

6 that each request made under such regulations for 

7 submission of a report or information to the Sec8 retary state the reason or purpose for such request 

9 and identify to the fullest extent practicable such re10 port or information; 

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

12 information to the Secretary, shall state the reason 

13 or purpose for the submission of such report or in14 formation and identify to the fullest extent prac15 ticable such report or information; and 

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

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

18 information required under this subsection unless re19 quired for the medical welfare of an individual, to 

20 determine risks to public health of a tobacco prod21 uct, or to verify a record, report, or information sub22 mitted under this chapter. 

23 In prescribing regulations under this subsection, the Sec24 retary shall have due regard for the professional ethics of 

25 the medical profession and the interests of patients. The 
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•S 2461 IS 

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

2 reports, and information concerning any individual who 

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

4 ceases to be a patient. 

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

6 ‘‘(1) IN GENERAL.—Except as provided in para7 graph (2), the Secretary shall by regulation require 

8 a tobacco product manufacturer or importer of a to9 bacco product to report promptly to the Secretary 

10 any corrective action taken or removal from the 

11 market of a tobacco product undertaken by such 

12 manufacturer or importer if the removal or correc13 tion was undertaken—

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

15 the tobacco product; or 

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

17 caused by the tobacco product which may 

18 present a risk to health. 

19 A tobacco product manufacturer or importer of a to20 bacco product who undertakes a corrective action or 

21 removal from the market of a tobacco product which 

22 is not required to be reported under this subsection 

23 shall keep a record of such correction or removal. 

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

25 action or removal of a tobacco product may be re-
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1 quired under paragraph (1) if a report of the correc2 tive action or removal is required and has been sub3 mitted under subsection (a).

4 ‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TO5 BACCO PRODUCTS. 

6 ‘‘(a) IN GENERAL.—

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

8 purposes of this section the term ‘new tobacco prod9 uct’ means—

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

11 products in test markets) that was not commer12 cially marketed in the United States as of June 

13 1, 2003; or 

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

15 in design, any component, any part, or any con16 stituent, including a smoke constituent, or in 

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

18 other additive or ingredient) of a tobacco prod19 uct where the modified product was commer20 cially marketed in the United States after June 

21 1, 2003. 

22 ‘‘(2) PREMARKET APPROVAL REQUIRED.—

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

24 this section of an application for premarket ap-
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•S 2461 IS 

1 proval for any new tobacco product is required 

2 unless—

3 ‘‘(i) the manufacturer has submitted a 

4 report under section 905(j); and 

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

6 that the tobacco product—

7 ‘‘(I) is substantially equivalent to 

8 a tobacco product commercially mar9 keted (other than for test marketing) 

10 in the United States as of June 1, 

11 2003; and 

12 ‘‘(II)(aa) is in compliance with 

13 the requirements of this Act; or 

14 ‘‘(bb) is exempt from the require15 ments of section 905(j) pursuant to a 

16 regulation issued under section 

17 905(j)(3). 

18 ‘‘(B) APPLICATION TO CERTAIN POST

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

20 shall not apply to a tobacco product—

21 ‘‘(i) that was first introduced or deliv22 ered for introduction into interstate com23 merce for commercial distribution in the 

24 United States after June 1, 2003, and 

25 prior to the date that is 15 months after 
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•S 2461 IS 

1 the date of enactment of the Family Smok2 ing Prevention and Tobacco Control Act; 

3 and 

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

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

6 period, until the Secretary issues an order 

7 that the tobacco product is not substan8 tially equivalent. 

9 ‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.—

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

11 section 905(j), the terms ‘substantially equiva12 lent’ or ‘substantial equivalence’ mean, with re13 spect to the tobacco product being compared to 

14 the predicate tobacco product, that the Sec15 retary by order has found that the tobacco 

16 product—

17 ‘‘(i) has the same characteristics as 

18 the predicate tobacco product; or 

19 ‘‘(ii) has different characteristics and 

20 the information submitted contains infor21 mation, including clinical data if deemed 

22 necessary by the Secretary, that dem23 onstrates that it is not appropriate to reg24 ulate the product under this section be-
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•S 2461 IS 

1 cause the product does not raise different 

2 questions of public health. 

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

5 materials, ingredients, design, composition, 

6 heating source, or other features of a tobacco 

7 product. 

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

9 not be found to be substantially equivalent to a 

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

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

14 ‘‘(4) HEALTH INFORMATION.—

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

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

19 adequate summary of any health information 

20 related to the tobacco product or state that 

21 such information will be made available upon 

22 request by any person. 

23 ‘‘(B) REQUIRED INFORMATION.—Any sum24 mary under subparagraph (A) respecting a to25 bacco product shall contain detailed information
73

•S 2461 IS 

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

3 by the Secretary within 30 days of the issuance 

4 of a determination that such tobacco product is 

5 substantially equivalent to another tobacco 

6 product. 

7 ‘‘(b) APPLICATION.—

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

9 approval shall contain—

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

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

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

16 other tobacco products; 

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

18 ingredients, additives, and properties, and of 

19 the principle or principles of operation, of such 

20 tobacco product; 

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

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

23 manufacture, processing, and, when relevant, 

24 packing and installation of, such tobacco prod25 uct; 
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•S 2461 IS 

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

3 which would be applicable to any aspect of such 

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

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

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

10 and of components thereof as the Secretary 

11 may reasonably require; 

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

13 be used for such tobacco product; and 

14 ‘‘(G) such other information relevant to 

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

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

19 application meeting the requirements set forth in 

20 paragraph (1), the Secretary—

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

23 ‘‘(B) may, upon the request of an appli24 cant, 
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•S 2461 IS 

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

3 submission (within such period as the Secretary may 

4 establish) of a report and recommendation respect5 ing approval of the application, together with all un6 derlying data and the reasons or basis for the rec7 ommendation. 

8 ‘‘(c) ACTION ON APPLICATION.—

9 ‘‘(1) DEADLINE.—

10 ‘‘(A) IN GENERAL.—As promptly as pos11 sible, but in no event later than 180 days after 

12 the receipt of an application under subsection 

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

14 and recommendation submitted under para15 graph (2) of such subsection, shall—

16 ‘‘(i) issue an order approving the ap17 plication if the Secretary finds that none of 

18 the grounds for denying approval specified 

19 in paragraph (2) of this subsection applies; 

20 or 

21 ‘‘(ii) deny approval of the application 

22 if the Secretary finds (and sets forth the 

23 basis for such finding as part of or accom24 panying such denial) that 1 or more 
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•S 2461 IS 

1 grounds for denial specified in paragraph 

2 (2) of this subsection apply. 

3 ‘‘(B) RESTRICTIONS ON SALE AND DIS4 TRIBUTION.—An order approving an application 

5 for a tobacco product may require as a condi6 tion to such approval that the sale and distribu7 tion of the tobacco product be restricted but 

8 only to the extent that the sale and distribution 

9 of a tobacco product may be restricted under a 

10 regulation under section 906(d). 

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

12 shall deny approval of an application for a tobacco 

13 product if, upon the basis of the information sub14 mitted to the Secretary as part of the application 

15 and any other information before the Secretary with 

16 respect to such tobacco product, the Secretary finds 

17 that—

18 ‘‘(A) there is a lack of a showing that per19 mitting such tobacco product to be marketed 

20 would be appropriate for the protection of the 

21 public health; 

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

23 or controls used for, the manufacture, proc24 essing, or packing of such tobacco product do 
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•S 2461 IS 

1 not conform to the requirements of section 

2 906(e); 

3 ‘‘(C) based on a fair evaluation of all mate4 rial facts, the proposed labeling is false or mis5 leading in any particular; or 

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

7 conform in all respects to a tobacco product 

8 standard in effect under section 907, compli9 ance with which is a condition to approval of 

10 the application, and there is a lack of adequate 

11 information to justify the deviation from such 

12 standard. 

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

14 application shall, insofar as the Secretary determines 

15 to be practicable, be accompanied by a statement in16 forming the applicant of the measures required to 

17 place such application in approvable form (which 

18 measures may include further research by the appli19 cant in accordance with 1 or more protocols pre20 scribed by the Secretary). 

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

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

23 tobacco product is appropriate for the protection of 

24 the public health shall be determined with respect to 

25 the risks and benefits to the population as a whole, 
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•S 2461 IS 

1 including users and nonusers of the tobacco product, 

2 and taking into account—

3 ‘‘(A) the increased or decreased likelihood 

4 that existing users of tobacco products will stop 

5 using such products; and 

6 ‘‘(B) the increased or decreased likelihood 

7 that those who do not use tobacco products will 

8 start using such products. 

9 ‘‘(5) BASIS FOR ACTION.—

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

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

12 product to be marketed would be appropriate 

13 for the protection of the public health shall, 

14 when appropriate, be determined on the basis of 

15 well-controlled investigations, which may in16 clude 1 or more clinical investigations by ex17 perts qualified by training and experience to 

18 evaluate the tobacco product. 

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

20 determines that there exists valid scientific evi21 dence (other than evidence derived from inves22 tigations described in subparagraph (A)) which 

23 is sufficient to evaluate the tobacco product the 

24 Secretary may authorize that the determination
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•S 2461 IS 

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

2 the basis of such evidence. 

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

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

5 obtaining, where appropriate, advice on scientific 

6 matters from an advisory committee, and after due 

7 notice and opportunity for informal hearing to the 

8 holder of an approved application for a tobacco 

9 product, issue an order withdrawing approval of the 

10 application if the Secretary finds—

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

12 tobacco product no longer is appropriate for the 

13 protection of the public health; 

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

15 accompanied by an untrue statement of a mate16 rial fact; 

17 ‘‘(C) that the applicant—

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

19 for maintaining records, or has repeatedly 

20 or deliberately failed to maintain records 

21 or to make reports, required by an applica22 ble regulation under section 909; 

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

24 or copying or verification of, such records 

25 as required by section 704; or 
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•S 2461 IS 

1 ‘‘(iii) has not complied with the re2 quirements of section 905; 

3 ‘‘(D) on the basis of new information be4 fore the Secretary with respect to such tobacco 

5 product, evaluated together with the evidence 

6 before the Secretary when the application was 

7 approved, that the methods used in, or the fa8 cilities and controls used for, the manufacture, 

9 processing, packing, or installation of such to10 bacco product do not conform with the require11 ments of section 906(e) and were not brought 

12 into conformity with such requirements within a 

13 reasonable time after receipt of written notice 

14 from the Secretary of nonconformity; 

15 ‘‘(E) on the basis of new information be16 fore the Secretary, evaluated together with the 

17 evidence before the Secretary when the applica18 tion was approved, that the labeling of such to19 bacco product, based on a fair evaluation of all 

20 material facts, is false or misleading in any par21 ticular and was not corrected within a reason22 able time after receipt of written notice from 

23 the Secretary of such fact; or 

24 ‘‘(F) on the basis of new information be25 fore the Secretary, evaluated together with the 
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1 evidence before the Secretary when the applica2 tion was approved, that such tobacco product is 

3 not shown to conform in all respects to a to4 bacco product standard which is in effect under 

5 section 907, compliance with which was a con6 dition to approval of the application, and that 

7 there is a lack of adequate information to jus8 tify the deviation from such standard. 

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

10 subject to an order issued under paragraph (1) with11 drawing approval of the application may, by petition 

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

13 which such holder receives notice of such with14 drawal, obtain review thereof in accordance with 

15 subsection (e). 

16 ‘‘(3) TEMPORARY SUSPENSION.—If, after pro17 viding an opportunity for an informal hearing, the 

18 Secretary determines there is reasonable probability 

19 that the continuation of distribution of a tobacco 

20 product under an approved application would cause 

21 serious, adverse health consequences or death, that 

22 is greater than ordinarily caused by tobacco prod23 ucts on the market, the Secretary shall by order 

24 temporarily suspend the approval of the application 

25 approved under this section. If the Secretary issues 
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•S 2461 IS 

1 such an order, the Secretary shall proceed expedi2 tiously under paragraph (1) to withdraw such appli3 cation. 

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

5 Secretary under this section shall be served— 

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

7 department designated by the Secretary; or 

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

9 certified mail addressed to the applicant at the ap10 plicant’s last known address in the records of the 

11 Secretary. 

12 ‘‘(f) RECORDS.—

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

14 of any tobacco product for which an approval of an 

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

16 applicant shall establish and maintain such records, 

17 and make such reports to the Secretary, as the Sec18 retary may by regulation, or by order with respect 

19 to such application, prescribe on the basis of a find20 ing that such records and reports are necessary in 

21 order to enable the Secretary to determine, or facili22 tate a determination of, whether there is or may be 

23 grounds for withdrawing or temporarily suspending 

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

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

4 request of an officer or employee designated by the 

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

7 such records. 

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

10 exempt tobacco products intended for investigational use 

11 from the provisions of this chapter under such conditions 

12 as the Secretary may by regulation prescribe. 

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

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

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

18 to such product. 

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

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

21 term ‘modified risk tobacco product’ means any to22 bacco product that is sold or distributed for use to 

23 reduce harm or the risk of tobacco-related disease 

24 associated with commercially marketed tobacco prod25 ucts.
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•S 2461 IS 

1 ‘‘(2) SOLD OR DISTRIBUTED.—

2 ‘‘(A) IN GENERAL.—With respect to a to3 bacco product, the term ‘sold or distributed for 

4 use to reduce harm or the risk of tobacco-re5 lated disease associated with commercially mar6 keted tobacco products’ means a tobacco prod7 uct—

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

9 of which represents explicitly or implicitly 

10 that—

11 ‘‘(I) the tobacco product presents 

12 a lower risk of tobacco-related disease 

13 or is less harmful than one or more 

14 other commercially marketed tobacco 

15 products; 

16 ‘‘(II) the tobacco product or its 

17 smoke contains a reduced level of a 

18 substance or presents a reduced expo19 sure to a substance; or 

20 ‘‘(III) the tobacco product or its 

21 smoke does not contain or is free of a 

22 substance; 

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

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

25 or ‘low’ or similar descriptors; or 
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•S 2461 IS 

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

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

7 Family Smoking Prevention and Tobacco 

8 Control Act, respecting the product that 

9 would be reasonably expected to result in 

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

12 of disease or is less harmful than one or 

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

15 does not contain or is free of, a substance 

16 or substances. 

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

18 shall be considered to be ‘sold or distributed for 

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

22 subparagraph (A). 

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

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

25 dependence, including smoking cessation, is not a modified 
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•S 2461 IS 

1 risk tobacco product under this section and is subject to 

2 the requirements of chapter V. 

3 ‘‘(d) FILING.—Any person may file with the Sec4 retary an application for a modified risk tobacco product. 

5 Such application shall include—

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

7 any proposed advertising and labeling; 

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

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

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

11 ‘‘(5) all documents (including underlying sci12 entific information) relating to research findings 

13 conducted, supported, or possessed by the tobacco 

14 product manufacturer relating to the effect of the 

15 product on tobacco related diseases and health-re16 lated conditions, including information both favor17 able and unfavorable to the ability of the product to 

18 reduce risk or exposure and relating to human 

19 health; 

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

21 actually use the tobacco product; and 

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

23 may require. 

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

25 make the application described in subsection (d) publicly 
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•S 2461 IS 

1 available (except matters in the application which are 

2 trade secrets or otherwise confidential, commercial infor3 mation) and shall request comments by interested persons 

4 on the information contained in the application and on the 

5 label, labeling, and advertising accompanying such appli6 cation. 

7 ‘‘(f) ADVISORY COMMITTEE.—

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

9 an advisory committee any application submitted 

10 under this subsection. 

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

12 days after the date an application is referred to an 

13 advisory committee under paragraph (1), the advi14 sory committee shall report its recommendations on 

15 the application to the Secretary. 

16 ‘‘(g) APPROVAL.—

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

18 provided in paragraph (2), the Secretary shall ap19 prove an application for a modified risk tobacco 

20 product filed under this section only if the Secretary 

21 determines that the applicant has demonstrated that 

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

23 will—
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1 ‘‘(A) significantly reduce harm and the 

2 risk of tobacco-related disease to individual to3 bacco users; and 

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

5 as a whole taking into account both users of to6 bacco products and persons who do not cur7 rently use tobacco products. 

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

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

10 approve an application for a tobacco product 

11 that has not been approved as a modified risk 

12 tobacco product pursuant to paragraph (1) if 

13 the Secretary makes the findings required 

14 under this paragraph and determines that the 

15 applicant has demonstrated that—

16 ‘‘(i) the approval of the application 

17 would be appropriate to promote the public 

18 health; 

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

20 and advertising for such product that 

21 would cause the tobacco product to be a 

22 modified risk tobacco product under sub23 section (b)(2) is limited to an explicit or 

24 implicit representation that such tobacco 

25 product or its smoke contains or is free of 
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•S 2461 IS 

1 a substance or contains a reduced level of 

2 a substance, or presents a reduced expo3 sure to a substance in tobacco smoke. 

4 ‘‘(iii) scientific evidence is not avail5 able and, using the best available scientific 

6 methods, cannot be made available without 

7 conducting long-term epidemiological stud8 ies for an application to meet the stand9 ards set forth in paragraph (1); and 

10 ‘‘(iv) the scientific evidence that is 

11 available without conducting long-term epi12 demiological studies demonstrates that a 

13 measurable and substantial reduction in 

14 morbidity or mortality among individual 

15 tobacco users is anticipated in subsequent 

16 studies. 

17 ‘‘(B) ADDITIONAL FINDINGS REQUIRED.—

18 In order to approve an application under sub19 paragraph (A) the Secretary must also find 

20 that the applicant has demonstrated that—

21 ‘‘(i) the magnitude of the overall re22 ductions in exposure to the substance or 

23 substances which are the subject of the ap24 plication is substantial, such substance or 

25 substances are harmful, and the product as
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•S 2461 IS 

1 actually used exposes consumers to the 

2 specified reduced level of the substance or 

3 substances; 

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

5 consumers will not expose them to higher 

6 levels of other harmful substances com7 pared to the similar types of tobacco prod8 ucts then on the market unless such in9 creases are minimal and the anticipated 

10 overall impact of use of the product re11 mains a substantial and measurable reduc12 tion in overall morbidity and mortality 

13 among individual tobacco users; 

14 ‘‘(iii) testing of actual consumer per15 ception shows that, as the applicant pro16 poses to label and market the product, con17 sumers will not be misled into believing 

18 that the product—

19 ‘‘(I) is or has been demonstrated 

20 to be less harmful; or 

21 ‘‘(II) presents or has been dem22 onstrated to present less of a risk of 

23 disease than 1 or more other commer24 cially marketed tobacco products; and 
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1 ‘‘(iv) approval of the application is ex2 pected to benefit the health of the popu3 lation as a whole taking into account both 

4 users of tobacco products and persons who 

5 do not currently use tobacco products. 

6 ‘‘(C) CONDITIONS OF APPROVAL.—

7 ‘‘(i) IN GENERAL.—Applications ap8 proved under this paragraph shall be lim9 ited to a term of not more than 5 years, 

10 but may be renewed upon a finding by the 

11 Secretary that the requirements of this 

12 paragraph continue to be satisfied based 

13 on the filing of a new application. 

14 ‘‘(ii) AGREEMENTS BY APPLICANT.—

15 Applications approved under this para16 graph shall be conditioned on the appli17 cant’s agreement to conduct post-market 

18 surveillance and studies and to submit to 

19 the Secretary the results of such surveil20 lance and studies to determine the impact 

21 of the application approval on consumer 

22 perception, behavior, and health and to en23 able the Secretary to review the accuracy 

24 of the determinations upon which the ap-
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•S 2461 IS 

1 proval was based in accordance with a pro2 tocol approved by the Secretary. 

3 ‘‘(iii) ANNUAL SUBMISSION.—The re4 sults of such post-market surveillance and 

5 studies described in clause (ii) shall be 

6 submitted annually. 

7 ‘‘(3) BASIS.—The determinations under para8 graphs (1) and (2) shall be based on—

9 ‘‘(A) the scientific evidence submitted by 

10 the applicant; and 

11 ‘‘(B) scientific evidence and other informa12 tion that is available to the Secretary. 

13 ‘‘(4) BENEFIT TO HEALTH OF INDIVIDUALS

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

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

16 Secretary shall take into account—

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

18 of the tobacco product that is the subject of the 

19 application; 

20 ‘‘(B) the increased or decreased likelihood 

21 that existing users of tobacco products who 

22 would otherwise stop using such products will 

23 switch to the tobacco product that is the subject 

24 of the application; 
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•S 2461 IS 

1 ‘‘(C) the increased or decreased likelihood 

2 that persons who do not use tobacco products 

3 will start using the tobacco product that is the 

4 subject of the application; 

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

6 from the use of the tobacco product that is the 

7 subject of the application as compared to the 

8 use of products for smoking cessation approved 

9 under chapter V to treat nicotine dependence; 

10 and 

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

12 submitted by interested persons. 

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

14 ‘‘(1) MODIFIED RISK PRODUCTS.—The Sec15 retary shall require for the approval of an applica16 tion under this section that any advertising or label17 ing concerning modified risk products enable the 

18 public to comprehend the information concerning 

19 modified risk and to understand the relative signifi20 cance of such information in the context of total 

21 health and in relation to all of the diseases and 

22 health-related conditions associated with the use of 

23 tobacco products. 

24 ‘‘(2) COMPARATIVE CLAIMS.—
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1 ‘‘(A) IN GENERAL.—The Secretary may re2 quire for the approval of an application under 

3 this subsection that a claim comparing a to4 bacco product to 1 or more other commercially 

5 marketed tobacco products shall compare the 

6 tobacco product to a commercially marketed to7 bacco product that is representative of that type 

8 of tobacco product on the market (for example 

9 the average value of the top 3 brands of an es10 tablished regular tobacco product). 

11 ‘‘(B) QUANTITATIVE COMPARISONS.—The 

12 Secretary may also require, for purposes of sub13 paragraph (A), that the percent (or fraction) of 

14 change and identity of the reference tobacco 

15 product and a quantitative comparison of the 

16 amount of the substance claimed to be reduced 

17 shall be stated in immediate proximity to the 

18 most prominent claim. 

19 ‘‘(3) LABEL DISCLOSURE.—

20 ‘‘(A) IN GENERAL.—The Secretary may re21 quire the disclosure on the label of other sub22 stances in the tobacco product, or substances 

23 that may be produced by the consumption of 

24 that tobacco product, that may affect a disease 

25 or health-related condition or may increase the 
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•S 2461 IS 

1 risk of other diseases or health-related condi2 tions associated with the use of tobacco prod3 ucts. 

4 ‘‘(B) CONDITIONS OF USE.—If the condi5 tions of use of the tobacco product may affect 

6 the risk of the product to human health, the 

7 Secretary may require the labeling of conditions 

8 of use. 

9 ‘‘(4) TIME.—The Secretary shall limit an ap10 proval under subsection (g)(1) for a specified period 

11 of time. 

12 ‘‘(5) ADVERTISING.—The Secretary may re13 quire that an applicant, whose application has been 

14 approved under this subsection, comply with require15 ments relating to advertising and promotion of the 

16 tobacco product. 

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

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

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

20 post market surveillance and studies for a tobacco 

21 product for which an application has been approved 

22 to determine the impact of the application approval 

23 on consumer perception, behavior, and health, to en24 able the Secretary to review the accuracy of the de25 terminations upon which the approval was based,
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•S 2461 IS 

1 and to provide information that the Secretary deter2 mines is otherwise necessary regarding the use or 

3 health risks involving the tobacco product. The re4 sults of post-market surveillance and studies shall be 

5 submitted to the Secretary on an annual basis. 

6 ‘‘(2) SURVEILLANCE PROTOCOL.—Each appli7 cant required to conduct a surveillance of a tobacco 

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

9 after receiving notice that the applicant is required 

10 to conduct such surveillance, submit, for the ap11 proval of the Secretary, a protocol for the required 

12 surveillance. The Secretary, within 60 days of the 

13 receipt of such protocol, shall determine if the prin14 cipal investigator proposed to be used in the surveil15 lance has sufficient qualifications and experience to 

16 conduct such surveillance and if such protocol will 

17 result in collection of the data or other information 

18 designated by the Secretary as necessary to protect 

19 the public health. 

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

21 after an opportunity for an informal hearing, shall with22 draw the approval of an application under this section if 

23 the Secretary determines that—

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

25 can no longer make the demonstrations required 
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1 under subsection (g), or the Secretary can no longer 

2 make the determinations required under subsection 

3 (g); 

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

5 information or included any untrue statement of ma6 terial fact; 

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

8 the product reduces risk or exposure is no longer 

9 valid, including if—

10 ‘‘(A) a tobacco product standard is estab11 lished pursuant to section 907; 

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

13 risks presented by other commercially marketed 

14 tobacco products that were compared to the 

15 product that is the subject of the application; or 

16 ‘‘(C) any postmarket surveillance or stud17 ies reveal that the approval of the application is 

18 no longer consistent with the protection of the 

19 public health; 

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

21 the postmarket surveillance and studies required 

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

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

24 imposed under subsection (h). 
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1 ‘‘(k) CHAPTER IV OR V.—A product approved in ac2 cordance with this section shall not be subject to chapter 

3 IV or V. 

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

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

6 years after the date of enactment of the Family 

7 Smoking Prevention and Tobacco Control Act, the 

8 Secretary shall issue regulations or guidance (or any 

9 combination thereof) on the scientific evidence re10 quired for assessment and ongoing review of modi11 fied risk tobacco products. Such regulations or guid12 ance shall—

13 ‘‘(A) establish minimum standards for sci14 entific studies needed prior to approval to show 

15 that a substantial reduction in morbidity or 

16 mortality among individual tobacco users is 

17 likely; 

18 ‘‘(B) include validated biomarkers, inter19 mediate clinical endpoints, and other feasible 

20 outcome measures, as appropriate; 

21 ‘‘(C) establish minimum standards for post 

22 market studies, that shall include regular and 

23 long-term assessments of health outcomes and 

24 mortality, intermediate clinical endpoints, con25 sumer perception of harm reduction, and the 
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1 impact on quitting behavior and new use of to2 bacco products, as appropriate; 

3 ‘‘(D) establish minimum standards for re4 quired postmarket surveillance, including ongo5 ing assessments of consumer perception; and 

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

7 studies and surveillance be made available to 

8 the Secretary prior to the decision on renewal 

9 of a modified risk tobacco product. 

10 ‘‘(2) CONSULTATION.—The regulations or guid11 ance issued under paragraph (1) shall be developed 

12 in consultation with the Institute of Medicine, and 

13 with the input of other appropriate scientific and 

14 medical experts, on the design and conduct of such 

15 studies and surveillance. 

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

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

18 basis as new scientific information becomes avail19 able. 

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

21 than 2 years after the date of enactment of the 

22 Family Smoking Prevention and Tobacco Control 

23 Act, the Secretary shall issue a regulation or guid24 ance that permits the filing of a single application 

25 for any tobacco product that is a new tobacco prod-
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1 uct under section 910 and for which the applicant 

2 seeks approval as a modified risk tobacco product 

3 under this section. 

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

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

6 Prevention and Tobacco Control Act, with respect to a to7 bacco product that would reasonably be expected to result 

8 in consumers believing that the tobacco product or its 

9 smoke may present a lower risk of disease or is less harm10 ful than one or more commercially marketed tobacco prod11 ucts, or presents a reduced exposure to, or does not con12 tain or is free of, a substance or substances. 

13 ‘‘SEC. 912. JUDICIAL REVIEW. 

14 ‘‘(a) RIGHT TO REVIEW.—

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

16 after—

17 ‘‘(A) the promulgation of a regulation 

18 under section 907 establishing, amending, or 

19 revoking a tobacco product standard; or 

20 ‘‘(B) a denial of an application for ap21 proval under section 910(c), 

22 any person adversely affected by such regulation or 

23 denial may file a petition for judicial review of such 

24 regulation or denial with the United States Court of 

25 Appeals for the District of Columbia or for the cir-
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1 cuit in which such person resides or has their prin2 cipal place of business. 

3 ‘‘(2) REQUIREMENTS.—

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

5 petition filed under paragraph (1) shall be 

6 transmitted by the clerk of the court involved to 

7 the Secretary. 

8 ‘‘(B) RECORD OF PROCEEDINGS.—On re9 ceipt of a petition under subparagraph (A), the 

10 Secretary shall file in the court in which such 

11 petition was filed—

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

13 which the regulation or order was based; 

14 and 

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

16 the issuance of such a regulation or order. 

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

18 section, the term ‘record’ means—

19 ‘‘(i) all notices and other matter pub20 lished in the Federal Register with respect 

21 to the regulation or order reviewed; 

22 ‘‘(ii) all information submitted to the 

23 Secretary with respect to such regulation 

24 or order;
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1 ‘‘(iii) proceedings of any panel or ad2 visory committee with respect to such reg3 ulation or order; 

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

5 such regulation or order; and 

6 ‘‘(v) any other information identified 

7 by the Secretary, in the administrative pro8 ceeding held with respect to such regula9 tion or order, as being relevant to such 

10 regulation or order. 

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

12 petition under subsection (a) for judicial review of a regu13 lation or order, the court shall have jurisdiction to review 

14 the regulation or order in accordance with chapter 7 of 

15 title 5, United States Code, and to grant appropriate re16 lief, including interim relief, as provided for in such chap17 ter. A regulation or denial described in subsection (a) shall 

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

19 5, United States Code. 

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

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

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

23 Supreme Court of the United States upon certiorari or 

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

25 United States Code. 
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1 ‘‘(d) OTHER REMEDIES.—The remedies provided for 

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

3 any other remedies provided by law. 

4 ‘‘(e) REGULATIONS AND ORDERS MUST RECITE

5 BASIS IN RECORD.—To facilitate judicial review, a regula6 tion or order issued under section 906, 907, 908, 909, 

7 910, or 916 shall contain a statement of the reasons for 

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

9 the proceedings held in connection with its issuance. 

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

11 ‘‘The Secretary shall issue regulations to require that 

12 retail establishments for which the predominant business 

13 is the sale of tobacco products comply with any advertising 

14 restrictions applicable to retail establishments accessible 

15 to individuals under the age of 18.

16 ‘‘SEC. 914. JURISDICTION OF AND COORDINATION WITH 

17 THE FEDERAL TRADE COMMISSION. 

18 ‘‘(a) JURISDICTION.—

19 ‘‘(1) IN GENERAL.—Except where expressly 

20 provided in this chapter, nothing in this chapter 

21 shall be construed as limiting or diminishing the au22 thority of the Federal Trade Commission to enforce 

23 the laws under its jurisdiction with respect to the 

24 advertising, sale, or distribution of tobacco products. 
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1 ‘‘(2) ENFORCEMENT.—Any advertising that vio2 lates this chapter or a provision of the regulations 

3 referred to in section 102 of the Family Smoking 

4 Prevention and Tobacco Control Act, is an unfair or 

5 deceptive act or practice under section 5(a) of the 

6 Federal Trade Commission Act (15 U.S.C. 45(a)) 

7 and shall be considered a violation of a rule promul8 gated under section 18 of that Act (15 U.S.C. 57a). 

9 ‘‘(b) COORDINATION.—With respect to the require10 ments of section 4 of the Federal Cigarette Labeling and 

11 Advertising Act (15 U.S.C. 1333) and section 3 of the 

12 Comprehensive Smokeless Tobacco Health Education Act 

13 of 1986 (15 U.S.C. 4402)—

14 ‘‘(1) the Chairman of the Federal Trade Com15 mission shall coordinate with the Secretary con16 cerning the enforcement of such Act as such enforce17 ment relates to unfair or deceptive acts or practices 

18 in the advertising of cigarettes or smokeless tobacco; 

19 and 

20 ‘‘(2) the Secretary shall consult with the Chair21 man of such Commission in revising the label state22 ments and requirements under such sections. 

23 ‘‘SEC. 915. CONGRESSIONAL REVIEW PROVISIONS. 

24 ‘‘In accordance with section 801 of title 5, United 

25 States Code, Congress shall review, and may disapprove, 
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1 any rule under this chapter that is subject to section 801. 

2 This section and section 801 do not apply to the regula3 tions referred to in section 102 of the Family Smoking 

4 Prevention and Tobacco Control Act. 

5 ‘‘SEC. 916. REGULATION REQUIREMENT. 

6 ‘‘(a) TESTING, REPORTING, AND DISCLOSURE.—Not 

7 later than 24 months after the date of enactment of the 

8 Family Smoking Prevention and Tobacco Control Act, the 

9 Secretary, acting through the Commissioner of the Food 

10 and Drug Administration, shall promulgate regulations 

11 under this Act that meet the requirements of subsection 

12 (b). 

13 ‘‘(b) CONTENTS OF RULES.—The regulations pro14 mulgated under subsection (a) shall require testing and 

15 reporting of tobacco product constituents, ingredients, and 

16 additives, including smoke constituents, by brand and sub17 brand that the Secretary determines should be tested to 

18 protect the public health. The regulations may require 

19 that tobacco product manufacturers, packagers, or import20 ers make disclosures relating to the results of the testing 

21 of tar and nicotine through labels or advertising or other 

22 appropriate means, and make disclosures regarding the re23 sults of the testing of other constituents, including smoke 

24 constituents, ingredients, or additives, that the Secretary 

25 determines should be disclosed to the public to protect the 
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1 public health and will not mislead consumers about the 

2 risk of tobacco related disease. 

3 ‘‘(c) AUTHORITY.—The Food and Drug Administra4 tion shall have the authority under this chapter to conduct 

5 or to require the testing, reporting, or disclosure of to6 bacco product constituents, including smoke constituents. 

7 ‘‘SEC. 917. PRESERVATION OF STATE AND LOCAL AUTHOR8 ITY. 

9 ‘‘(a) IN GENERAL.—

10 ‘‘(1) PRESERVATION.—Nothing in this chapter, 

11 or rules promulgated under this chapter, shall be 

12 construed to limit the authority of a Federal agency 

13 (including the Armed Forces), a State or political 

14 subdivision of a State, or the government of an In15 dian tribe to enact, adopt, promulgate, and enforce 

16 any law, rule, regulation, or other measure with re17 spect to tobacco products that is in addition to, or 

18 more stringent than, requirements established under 

19 this chapter, including a law, rule, regulation, or 

20 other measure relating to or prohibiting the sale, 

21 distribution, possession, exposure to, access to, ad22 vertising and promotion of, or use of tobacco prod23 ucts by individuals of any age, information reporting 

24 to the State, or measures relating to fire safety 

25 standards for tobacco products. No provision of this
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1 chapter shall limit or otherwise affect any State, 

2 Tribal, or local taxation of tobacco products. 

3 ‘‘(2) PREEMPTION OF CERTAIN STATE AND

4 LOCAL REQUIREMENTS.—

5 ‘‘(A) IN GENERAL.—Except as provided in 

6 paragraph (1) and subparagraph (B), no State 

7 or political subdivision of a State may establish 

8 or continue in effect with respect to a tobacco 

9 product any requirement which is different 

10 from, or in addition to, any requirement under 

11 the provisions of this chapter relating to to12 bacco product standards, premarket approval, 

13 adulteration, misbranding, labeling, registra14 tion, good manufacturing standards, or reduced 

15 risk products. 

16 ‘‘(B) EXCEPTION.—Subparagraph (A) 

17 does not apply to requirements relating to the 

18 sale, distribution, possession, information re19 porting to the State, exposure to, access to, the 

20 advertising and promotion of, or use of, tobacco 

21 products by individuals of any age, or relating 

22 to fire safety standards for tobacco products. 

23 Information disclosed to a State under subpara24 graph (A) that is exempt from disclosure under 

25 section 554(b)(4) of title 5, United States Code, 
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1 shall be treated as trade secret and confidential 

2 information by the State. 

3 ‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT

4 LIABILITY.—No provision of this chapter relating to a to5 bacco product shall be construed to modify or otherwise 

6 affect any action or the liability of any person under the 

7 product liability law of any State. 

8 ‘‘SEC. 918. TOBACCO PRODUCTS SCIENTIFIC ADVISORY 

9 COMMITTEE. 

10 ‘‘(a) ESTABLISHMENT.—Not later than 1 year after 

11 the date of enactment of the Family Smoking Prevention 

12 and Tobacco Control Act, the Secretary shall establish a 

13 11-member advisory committee, to be known as the ‘To14 bacco Products Scientific Advisory Committee’. 

15 ‘‘(b) MEMBERSHIP.—

16 ‘‘(1) IN GENERAL.—

17 ‘‘(A) MEMBERS.—The Secretary shall ap18 point as members of the Tobacco Products Sci19 entific Advisory Committee individuals who are 

20 technically qualified by training and experience 

21 in the medicine, medical ethics, science, or tech22 nology involving the manufacture, evaluation, or 

23 use of tobacco products, who are of appro24 priately diversified professional backgrounds. 

25 The committee shall be composed of—
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1 ‘‘(i) 7 individuals who are physicians, 

2 dentists, scientists, or health care profes3 sionals practicing in the area of oncology, 

4 pulmonology, cardiology, toxicology, phar5 macology, addiction, or any other relevant 

6 specialty; 

7 ‘‘(ii) 1 individual who is an officer or 

8 employee of a State or local government or 

9 of the Federal Government; 

10 ‘‘(iii) 1 individual as a representative 

11 of the general public; 

12 ‘‘(iv) 1 individual as a representative 

13 of the interests in the tobacco manufac14 turing industry; and 

15 ‘‘(v) 1 individual as a representative 

16 of the interests of the tobacco growers. 

17 ‘‘(B) NONVOTING MEMBERS.—The mem18 bers of the committee appointed under clauses 

19 (iv) and (v) of subparagraph (A) shall serve as 

20 consultants to those described in clauses (i) 

21 through (iii) of subparagraph (A) and shall be 

22 nonvoting representatives. 

23 ‘‘(2) LIMITATION.—The Secretary may not ap24 point to the Advisory Committee any individual who 

25 is in the regular full-time employ of the Food and 
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1 Drug Administration or any agency responsible for 

2 the enforcement of this Act. The Secretary may ap3 point Federal officials as ex officio members. 

4 ‘‘(3) CHAIRPERSON.—The Secretary shall des5 ignate 1 of the members of the Advisory Committee 

6 to serve as chairperson. 

7 ‘‘(c) DUTIES.—The Tobacco Products Scientific Ad8 visory Committee shall provide advice, information, and 

9 recommendations to the Secretary—

10 ‘‘(1) as provided in this chapter; 

11 ‘‘(2) on the effects of the alteration of the nico12 tine yields from tobacco products; 

13 ‘‘(3) on whether there is a threshold level below 

14 which nicotine yields do not produce dependence on 

15 the tobacco product involved; and 

16 ‘‘(4) on its review of other safety, dependence, 

17 or health issues relating to tobacco products as re18 quested by the Secretary. 

19 ‘‘(d) COMPENSATION; SUPPORT; FACA.—

20 ‘‘(1) COMPENSATION AND TRAVEL.—Members 

21 of the Advisory Committee who are not officers or 

22 employees of the United States, while attending con23 ferences or meetings of the committee or otherwise 

24 engaged in its business, shall be entitled to receive 

25 compensation at rates to be fixed by the Secretary, 
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1 which may not exceed the daily equivalent of the 

2 rate in effect for level 4 of the Senior Executive 

3 Schedule under section 5382 of title 5, United 

4 States Code, for each day (including travel time) 

5 they are so engaged; and while so serving away from 

6 their homes or regular places of business each mem7 ber may be allowed travel expenses, including per 

8 diem in lieu of subsistence, as authorized by section 

9 5703 of title 5, United States Code, for persons in 

10 the Government service employed intermittently. 

11 ‘‘(2) ADMINISTRATIVE SUPPORT.—The Sec12 retary shall furnish the Advisory Committee clerical 

13 and other assistance. 

14 ‘‘(3) NONAPPLICATION OF FACA.—Section 14 of 

15 the Federal Advisory Committee Act (5 U.S.C.

16 App.) does not apply to the Advisory Committee. 

17 ‘‘(e) PROCEEDINGS OF ADVISORY PANELS AND COM18 MITTEES.—The Advisory Committee shall make and 

19 maintain a transcript of any proceeding of the panel or 

20 committee. Each such panel and committee shall delete 

21 from any transcript made under this subsection informa22 tion which is exempt from disclosure under section 552(b) 

23 of title 5, United States Code. 
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1 ‘‘SEC. 919. DRUG PRODUCTS USED TO TREAT TOBACCO DE2 PENDENCE. 

3 The Secretary shall consider—

4 ‘‘(1) at the request of the applicant, designating 

5 nicotine replacement products as fast track research 

6 and approval products within the meaning of section 

7 506; 

8 ‘‘(2) direct the Commissioner to consider ap9 proving the extended use of nicotine replacement 

10 products (such as nicotine patches, nicotine gum, 

11 and nicotine lozenges) for the treatment of tobacco 

12 dependence; 

13 ‘‘(3) review and consider the evidence for addi14 tional indications for nicotine replacement products, 

15 such as for craving relief or relapse prevention; and 

16 ‘‘(4) consider—

17 ‘‘(A) relieving companies of premarket bur18 dens under section 505 if the requirement is re19 dundant considering other nicotine replacement 

20 therapies already on the market; and 

21 ‘‘(B) time and extent applications for nico22 tine replacement therapies that have been ap23 proved by a regulatory body in a foreign coun24 try and have marketing experience in such 

25 country.
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1 ‘‘SEC. 920. USER FEE. 

2 ‘‘(a) ESTABLISHMENT OF QUARTERLY USER FEE.—

3 The Secretary shall assess a quarterly user fee with re4 spect to every quarter of each fiscal year commencing fis5 cal year 2004, calculated in accordance with this section, 

6 upon each manufacturer and importer of tobacco products 

7 subject to this chapter. 

8 ‘‘(b) FUNDING OF FDA REGULATION OF TOBACCO

9 PRODUCTS.—The Secretary shall make user fees collected 

10 pursuant to this section available to pay, in each fiscal 

11 year, for the costs of the activities of the Food and Drug 

12 Administration related to the regulation of tobacco prod13 ucts under this chapter. 

14 ‘‘(c) ASSESSMENT OF USER FEE.—

15 ‘‘(1) AMOUNT OF ASSESSMENT.—Except as 

16 provided in paragraph (4), the total user fees as17 sessed each year pursuant to this section shall be 

18 sufficient, and shall not exceed what is necessary, to 

19 pay for the costs of the activities described in sub20 section (b) for each fiscal year. 

21 ‘‘(2) ALLOCATION OF ASSESSMENT BY CLASS

22 OF TOBACCO PRODUCTS.—

23 ‘‘(A) IN GENERAL.—Subject to paragraph 

24 (3), the total user fees assessed each fiscal year 

25 with respect to each class of importers and 

26 manufacturers shall be equal to an amount that 
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1 is the applicable percentage of the total costs of 

2 activities of the Food and Drug Administration 

3 described in subsection (b). 

4 ‘‘(B) APPLICABLE PERCENTAGE.—For 

5 purposes of subparagraph (A) the applicable 

6 percentage for a fiscal year shall be the fol7 lowing: 

8 ‘‘(i) 92.07 percent shall be assessed 

9 on manufacturers and importers of ciga10 rettes; 

11 ‘‘(ii) 0.05 percent shall be assessed on 

12 manufacturers and importers of little ci13 gars; 

14 ‘‘(iii) 7.15 percent shall be assessed 

15 on manufacturers and importers of cigars 

16 other than little cigars; 

17 ‘‘(iv) 0.43 percent shall be assessed on 

18 manufacturers and importers of snuff; 

19 ‘‘(v) 0.10 percent shall be assessed on 

20 manufacturers and importers of chewing 

21 tobacco; 

22 ‘‘(vi) 0.06 percent shall be assessed on 

23 manufacturers and importers of pipe to24 bacco; and 
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•S 2461 IS 

1 ‘‘(vii) 0.14 percent shall be assessed 

2 on manufacturers and importers of roll3 your-own tobacco. 

4 ‘‘(3) DISTRIBUTION OF FEE SHARES OF MANU5 FACTURERS AND IMPORTERS EXEMPT FROM USER

6 FEE.—Where a class of tobacco products is not sub7 ject to a user fee under this section, the portion of 

8 the user fee assigned to such class under subsection 

9 (d)(2) shall be allocated by the Secretary on a pro 

10 rata basis among the classes of tobacco products 

11 that are subject to a user fee under this section. 

12 Such pro rata allocation for each class of tobacco 

13 products that are subject to a user fee under this 

14 section shall be the quotient of—

15 ‘‘(A) the sum of the percentages assigned 

16 to all classes of tobacco products subject to this 

17 section; divided by 

18 ‘‘(B) the percentage assigned to such class 

19 under paragraph (2). 

20 ‘‘(4) ANNUAL LIMIT ON ASSESSMENT.—The 

21 total assessment under this section—

22 ‘‘(A) for fiscal year 2004 shall be 

23 $85,000,000; 

24 ‘‘(B) for fiscal year 2005 shall be 

25 $175,000,000; 
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•S 2461 IS 

1 ‘‘(C) for fiscal year 2006 shall be 

2 $300,000,000; and 

3 ‘‘(D) for each subsequent fiscal year, shall 

4 not exceed the limit on the assessment imposed 

5 during the previous fiscal year, as adjusted by 

6 the Secretary (after notice, published in the 

7 Federal Register) to reflect the greater of—

8 ‘‘(i) the total percentage change that 

9 occurred in the Consumer Price Index for 

10 all urban consumers (all items; United 

11 States city average) for the 12-month pe12 riod ending on June 30 of the preceding 

13 fiscal year for which fees are being estab14 lished; or 

15 ‘‘(ii) the total percentage change for 

16 the previous fiscal year in basic pay under 

17 the General Schedule in accordance with 

18 section 5332 of title 5, United States 

19 Code, as adjusted by any locality-based 

20 comparability payment pursuant to section 

21 5304 of such title for Federal employees 

22 stationed in the District of Columbia. 

23 ‘‘(5) TIMING OF USER FEE ASSESSMENT.—The 

24 Secretary shall notify each manufacturer and im25 porter of tobacco products subject to this section of 
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1 the amount of the quarterly assessment imposed on 

2 such manufacturer or importer under subsection (f) 

3 during each quarter of each fiscal year. Such notifi4 cations shall occur not earlier than 3 months prior 

5 to the end of the quarter for which such assessment 

6 is made, and payments of all assessments shall be 

7 made not later than 60 days after each such notifi8 cation. 

9 ‘‘(d) DETERMINATION OF USER FEE BY COMPANY

10 MARKET SHARE.—

11 ‘‘(1) IN GENERAL.—The user fee to be paid by 

12 each manufacturer or importer of a given class of to13 bacco products shall be determined in each quarter 

14 by multiplying—

15 ‘‘(A) such manufacturer’s or importer’s 

16 market share of such class of tobacco products; 

17 by 

18 ‘‘(B) the portion of the user fee amount 

19 for the current quarter to be assessed on manu20 facturers and importers of such class of tobacco 

21 products as determined under subsection (e). 

22 ‘‘(2) NO FEE IN EXCESS OF MARKET SHARE.—

23 No manufacturer or importer of tobacco products 

24 shall be required to pay a user fee in excess of the 

25 market share of such manufacturer or importer. 
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1 ‘‘(e) DETERMINATION OF VOLUME OF DOMESTIC

2 SALES.—

3 ‘‘(1) IN GENERAL.—The calculation of gross 

4 domestic volume of a class of tobacco product by a 

5 manufacturer or importer, and by all manufacturers 

6 and importers as a group, shall be made by the Sec7 retary using information provided by manufacturers 

8 and importers pursuant to subsection (f), as well as 

9 any other relevant information provided to or ob10 tained by the Secretary. 

11 ‘‘(2) MEASUREMENT.—For purposes of the cal12 culations under this subsection and the information 

13 provided under subsection (f) by the Secretary, gross 

14 domestic volume shall be measured by—

15 ‘‘(A) in the case of cigarettes, the number 

16 of cigarettes sold; 

17 ‘‘(B) in the case of little cigars, the num18 ber of little cigars sold; 

19 ‘‘(C) in the case of large cigars, the num20 ber of cigars weighing more than 3 pounds per 

21 thousand sold; and 

22 ‘‘(D) in the case of other classes of tobacco 

23 products, in terms of number of pounds, or 

24 fraction thereof, of these products sold.
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•S 2461 IS 

1 ‘‘(f) MEASUREMENT OF GROSS DOMESTIC VOL2 UME.—

3 ‘‘(1) IN GENERAL.—Each manufacturer and 

4 importer of tobacco products shall submit to the 

5 Secretary a certified copy of each of the returns or 

6 forms described by this paragraph that are required 

7 to be filed with a Government agency on the same 

8 date that those returns or forms are filed, or re9 quired to be filed, with such agency. The returns 

10 and forms described by this paragraph are those re11 turns and forms related to the release of tobacco 

12 products into domestic commerce, as defined by sec13 tion 5702(k) of the Internal Revenue Code of 1986, 

14 and the repayment of the taxes imposed under chap15 ter 52 of such Code (ATF Form 500.24 and United 

16 States Customs Form 7501 under currently applica17 ble regulations). 

18 ‘‘(2) PENALTIES.—Any person that knowingly 

19 fails to provide information required under this sub20 section or that provides false information under this 

21 subsection shall be subject to the penalties described 

22 in section 1003 of title 18, United States Code. In 

23 addition, such person may be subject to a civil pen24 alty in an amount not to exceed 2 percent of the 

25 value of the kind of tobacco products manufactured 
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•S 2461 IS 

1 or imported by such person during the applicable 

2 quarter, as determined by the Secretary. 

3 ‘‘(h) EFFECTIVE DATE.—The user fees prescribed by 

4 this section shall be assessed in fiscal year 2004, based 

5 on domestic sales of tobacco products during fiscal year 

6 2003 and shall be assessed in each fiscal year thereafter.’’. 

7 SEC. 102. INTERIM FINAL RULE. 

8 (a) CIGARETTES AND SMOKELESS TOBACCO.—

9 (1) IN GENERAL.—Not later than 30 days after 

10 the date of enactment of this Act, the Secretary of 

11 Health and Human Services shall publish in the 

12 Federal Register an interim final rule regarding 

13 cigarettes and smokeless tobacco, which is hereby 

14 deemed to be in compliance with the Administrative 

15 Procedures Act and other applicable law. 

16 (2) CONTENTS OF RULE.—Except as provided 

17 in this subsection, the interim final rule published 

18 under paragraph (1), shall be identical in its provi19 sions to part 897 of the regulations promulgated by 

20 the Secretary of Health and Human Services in the 

21 August 28, 1996, issue of the Federal Register (61 

22 Fed. Reg., 44615–44618). Such rule shall—

23 (A) provide for the designation of jurisdic24 tional authority that is in accordance with this 

25 subsection; 
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•S 2461 IS 

1 (B) strike Subpart C—Labeling and sec2 tion 897.32(c); and 

3 (C) become effective not later than 1 year 

4 after the date of enactment of this Act. 

5 (3) AMENDMENTS TO RULE.—Prior to making 

6 amendments to the rule published under paragraph 

7 (1), the Secretary shall promulgate a proposed rule 

8 in accordance with the Administrative Procedures 

9 Act. 

10 (4) RULE OF CONSTRUCTION.—Except as pro11 vided in paragraph (3), nothing in this section shall 

12 be construed to limit the authority of the Secretary 

13 to amend, in accordance with the Administrative 

14 Procedures Act, the regulation promulgated pursu15 ant to this section.

16 (b) LIMITATION ON ADVISORY OPINIONS.—As of the 

17 date of enactment of this Act, the following documents 

18 issued by the Food and Drug Administration shall not 

19 constitute advisory opinions under section 10.85(d)(1) of 

20 title 21, Code of Federal Regulations, except as they apply 

21 to tobacco products, and shall not be cited by the Sec22 retary of Health and Human Services or the Food and 

23 Drug Administration as binding precedent: 

24 (1) The preamble to the proposed rule in the 

25 document entitled ‘‘Regulations Restricting the Sale 
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1 and Distribution of Cigarettes and Smokeless To2 bacco Products to Protect Children and Adoles3 cents’’ (60 Fed. Reg. 41314–41372 (August 11, 

4 1995)). 

5 (2) The document entitled ‘‘Nicotine in Ciga6 rettes and Smokeless Tobacco Products is a Drug 

7 and These Products Are Nicotine Delivery Devices 

8 Under the Federal Food, Drug, and Cosmetic Act’’ 

9 (60 Fed. Reg. 41453–41787 (August 11, 1995)).

10 (3) The preamble to the final rule in the docu11 ment entitled ‘‘Regulations Restricting the Sale and 

12 Distribution of Cigarettes and Smokeless Tobacco to 

13 Protect Children and Adolescents’’ (61 Fed. Reg. 

14 44396–44615 (August 28, 1996)). 

15 (4) The document entitled ‘‘Nicotine in Ciga16 rettes and Smokeless Tobacco is a Drug and These 

17 Products are Nicotine Delivery Devices Under the 

18 Federal Food, Drug, and Cosmetic Act; Jurisdic19 tional Determination’’ (61 Fed. Reg. 44619–45318 

20 (August 28, 1996)). 

21 SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GEN22 ERAL PROVISIONS. 

23 (a) AMENDMENT OF FEDERAL FOOD, DRUG, AND

24 COSMETIC ACT.—Except as otherwise expressly provided, 

25 whenever in this section an amendment is expressed in 
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1 terms of an amendment to, or repeal of, a section or other 

2 provision, the reference is to a section or other provision 

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

4 301 et seq.). 

5 (b) SECTION 301.—Section 301 (21 U.S.C. 331) is 

6 amended—

7 (1) in subsection (a), by inserting ‘‘tobacco 

8 product,’’ after ‘‘device,’’; 

9 (2) in subsection (b), by inserting ‘‘tobacco 

10 product,’’ after ‘‘device,’’; 

11 (3) in subsection (c), by inserting ‘‘tobacco 

12 product,’’ after ‘‘device,’’; 

13 (4) in subsection (e), by striking ‘‘515(f), or 

14 519’’ and inserting ‘‘515(f), 519, or 909’’; 

15 (5) in subsection (g), by inserting ‘‘tobacco 

16 product,’’ after ‘‘device,’’; 

17 (6) in subsection (h), by inserting ‘‘tobacco 

18 product,’’ after ‘‘device,’’; 

19 (7) in subsection (j), by striking ‘‘708, or 721’’ 

20 and inserting ‘‘708, 721, 904, 905, 906, 907, 908, 

21 909, or section 921(b)’’; 

22 (8) in subsection (k), by inserting ‘‘tobacco 

23 product,’’ after ‘‘device,’’; 

24 (9) by striking subsection (p) and inserting the 

25 following:
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1 ‘‘(p) The failure to register in accordance with section 

2 510 or 905, the failure to provide any information re3 quired by section 510(j), 510(k), 905(i), or 905(j), or the 

4 failure to provide a notice required by section 510(j)(2) 

5 or 905(i)(2).’’; 

6 (10) by striking subsection (q)(1) and inserting 

7 the following: 

8 ‘‘(q)(1) The failure or refusal—

9 ‘‘(A) to comply with any requirement prescribed 

10 under section 518, 520(g), 903(b)(8), or 908, or 

11 condition prescribed under section 

12 903(b)(6)(B)(ii)(II); 

13 ‘‘(B) to furnish any notification or other mate14 rial or information required by or under section 519, 

15 520(g), 904, 909, or section 921; or 

16 ‘‘(C) to comply with a requirement under sec17 tion 522 or 913.’’; 

18 (11) in subsection (q)(2), by striking ‘‘device,’’ 

19 and inserting ‘‘device or tobacco product,’’;

20 (12) in subsection (r), by inserting ‘‘or tobacco 

21 product’’ after ‘‘device’’ each time that it appears; 

22 and 

23 (13) by adding at the end the following: 
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1 ‘‘(aa) The sale of tobacco products in violation 

2 of a no-tobacco-sale order issued under section 

3 303(f). 

4 ‘‘(bb) The introduction or delivery for introduc5 tion into interstate commerce of a tobacco product 

6 in violation of section 911. 

7 ‘‘(cc)(1) Forging, counterfeiting, simulating, or 

8 falsely representing, or without proper authority 

9 using any mark, stamp (including tax stamp), tag, 

10 label, or other identification device upon any tobacco 

11 product or container or labeling thereof so as to 

12 render such tobacco product a counterfeit tobacco 

13 product. 

14 ‘‘(2) Making, selling, disposing of, or keeping in 

15 possession, control, or custody, or concealing any 

16 punch, die, plate, stone, or other item that is de17 signed to print, imprint, or reproduce the trade18 mark, trade name, or other identifying mark, im19 print, or device of another or any likeness of any of 

20 the foregoing upon any tobacco product or container 

21 or labeling thereof so as to render such tobacco 

22 product a counterfeit tobacco product. 

23 ‘‘(3) The doing of any act that causes a tobacco 

24 product to be a counterfeit tobacco product, or the 
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1 sale or dispensing, or the holding for sale or dis2 pensing, of a counterfeit tobacco product. 

3 ‘‘(dd) The charitable distribution of tobacco 

4 products.

5 ‘‘(ee) The failure of a manufacturer or dis6 tributor to notify the Attorney General of their 

7 knowledge of tobacco products used in illicit trade.’’. 

8 (c) SECTION 303.—Section 303 (21 U.S.C. 333(f)) 

9 is amended in subsection (f)—

10 (1) by striking the subsection heading and in11 serting the following: 

12 ‘‘(f) CIVIL PENALTIES; NO-TOBACCO-SALE OR13 DERS.—’’; 

14 (2) in paragraph (1)(A), by inserting ‘‘or to15 bacco products’’ after ‘‘devices’’; 

16 (3) by redesignating paragraphs (3), (4), and 

17 (5) as paragraphs (4), (5), and (6), and inserting 

18 after paragraph (2) the following: 

19 ‘‘(3) If the Secretary finds that a person has 

20 committed repeated violations of restrictions promul21 gated under section 906(d) at a particular retail out22 let then the Secretary may impose a no-tobacco-sale 

23 order on that person prohibiting the sale of tobacco 

24 products in that outlet. A no-tobacco-sale order may 
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1 be imposed with a civil penalty under paragraph 

2 (1).’’; 

3 (4) in paragraph (4) as so redesignated—

4 (A) in subparagraph (A)—

5 (i) by striking ‘‘assessed’’ the first 

6 time it appears and inserting ‘‘assessed, or 

7 a no-tobacco-sale order may be imposed,’’; 

8 and 

9 (ii) by striking ‘‘penalty’’ and insert10 ing ‘‘penalty, or upon whom a no-tobacco11 order is to be imposed,’’; 

12 (B) in subparagraph (B)—

13 (i) by inserting after ‘‘penalty,’’ the 

14 following: ‘‘or the period to be covered by 

15 a no-tobacco-sale order,’’; and 

16 (ii) by adding at the end the fol17 lowing: ‘‘A no-tobacco-sale order perma18 nently prohibiting an individual retail out19 let from selling tobacco products shall in20 clude provisions that allow the outlet, after 

21 a specified period of time, to request that 

22 the Secretary compromise, modify, or ter23 minate the order.’’; and 

24 (C) by adding at the end, the following: 
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1 ‘‘(D) The Secretary may compromise, mod2 ify, or terminate, with or without conditions, 

3 any no-tobacco-sale order.’’; 

4 (5) in paragraph (5) as so redesignated—

5 (A) by striking ‘‘(3)(A)’’ as redesignated, 

6 and inserting ‘‘(4)(A)’’; 

7 (B) by inserting ‘‘or the imposition of a 

8 no-tobacco-sale order’’ after ‘‘penalty’’ the first 

9 2 places it appears; and 

10 (C) by striking ‘‘issued.’’ and inserting 

11 ‘‘issued, or on which the no-tobacco-sale order 

12 was imposed, as the case may be.’’; and 

13 (6) in paragraph (6), as so redesignated, by 

14 striking ‘‘paragraph (4)’’ each place it appears and 

15 inserting ‘‘paragraph (5)’’. 

16 (d) SECTION 304.—Section 304 (21 U.S.C. 334) is 

17 amended—

18 (1) in subsection (a)(2)—

19 (A) by striking ‘‘and’’ before ‘‘(D)’’; and 

20 (B) by striking ‘‘device.’’ and inserting the 

21 following: ‘‘, (E) Any adulterated or misbranded 

22 tobacco product.’’; 

23 (2) in subsection (d)(1), by inserting ‘‘tobacco 

24 product,’’ after ‘‘device,’’; 
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1 (3) in subsection (g)(1), by inserting ‘‘or to2 bacco product’’ after ‘‘device’’ each place it appears; 

3 and 

4 (4) in subsection (g)(2)(A), by inserting ‘‘or to5 bacco product’’ after ‘‘device’’ each place it appears. 

6 (e) SECTION 702.—Section 702(a) (21 U.S.C. 

7 372(a)) is amended—

8 (1) by inserting ‘‘(1)’’ after ‘‘(a)’’; and 

9 (2) by adding at the end thereof the following: 

10 ‘‘(2) For a tobacco product, to the extent feasible, 

11 the Secretary shall contract with the States in accordance 

12 with paragraph (1) to carry out inspections of retailers 

13 in connection with the enforcement of this Act.’’. 

14 (f) SECTION 703.—Section 703 (21 U.S.C. 373) is 

15 amended—

16 (1) by inserting ‘‘tobacco product,’’ after ‘‘de17 vice,’’ each place it appears; and 

18 (2) by inserting ‘‘tobacco products,’’ after ‘‘de19 vices,’’ each place it appears. 

20 (g) SECTION 704.—Section 704 (21 U.S.C. 374) is 

21 amended—

22 (1) in subsection (a)(1)(A), by inserting ‘‘to23 bacco products,’’ after ‘‘devices,’’ each place it ap24 pears;
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1 (2) in subsection (a)(1)(B), by inserting ‘‘or to2 bacco product’’ after ‘‘restricted devices’’ each place 

3 it appears; and 

4 (3) in subsection (b), by inserting ‘‘tobacco 

5 product,’’ after ‘‘device,’’. 

6 (h) SECTION 705.—Section 705(b) (21 U.S.C. 

7 375(b)) is amended by inserting ‘‘tobacco products,’’ after 

8 ‘‘devices,’’. 

9 (i) SECTION 709.—Section 709 (21 U.S.C. 379) is 

10 amended by inserting ‘‘or tobacco product’’ after ‘‘device’’. 

11 (j) SECTION 801.—Section 801 (21 U.S.C. 381) is 

12 amended—

13 (1) in subsection (a)—

14 (A) by inserting ‘‘tobacco products,’’ after 

15 ‘‘devices,’’ the first time it appears; 

16 (B) by inserting ‘‘or section 905(j)’’ after 

17 ‘‘section 510’’; and 

18 (C) by striking ‘‘drugs or devices’’ each 

19 time it appears and inserting ‘‘drugs, devices, 

20 or tobacco products’’; 

21 (2) in subsection (e)(1), by inserting ‘‘tobacco 

22 product,’’ after ‘‘device,’’; and 

23 (3) by adding at the end the following: 

24 ‘‘(p)(1) Not later than 2 years after the date of enact25 ment of the Family Smoking Prevention and Tobacco 
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1 Control Act, and annually thereafter, the Secretary shall 

2 submit to the Committee on Health, Education, Labor, 

3 and Pensions of the Senate and the Committee on Energy 

4 and Commerce of the House of Representatives, a report 

5 regarding—

6 ‘‘(A) the nature, extent, and destination of 

7 United States tobacco product exports that do not 

8 conform to tobacco product standards established 

9 pursuant to this Act; 

10 ‘‘(B) the public health implications of such ex11 ports, including any evidence of a negative public 

12 health impact; and 

13 ‘‘(C) recommendations or assessments of policy 

14 alternatives available to Congress and the Executive 

15 Branch to reduce any negative public health impact 

16 caused by such exports. 

17 ‘‘(2) The Secretary is authorized to establish appro18 priate information disclosure requirements to carry out 

19 this subsection.’’. 

20 (k) SECTION 1003.—Section 1003(d)(2)(C) (as re21 designated by section 101(a)) is amended—

22 (1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 

23 (2) inserting a comma and ‘‘and tobacco prod24 ucts’’ after ‘‘devices’’. 
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1 (l) EFFECTIVE DATE FOR NO-TOBACCO-SALE

2 ORDER AMENDMENTS.—The amendments made by sub3 section (c), other than the amendment made by paragraph 

4 (2) of such subsection, shall take effect upon the issuance 

5 of guidance by the Secretary of Health and Human Serv6 ices—

7 (1) defining the term ‘‘repeated violation’’, as 

8 used in section 303(f) of the Federal Food, Drug, 

9 and Cosmetic Act (21 U.S.C. 333(f)) as amended by 

10 subsection (c), by identifying the number of viola11 tions of particular requirements over a specified pe12 riod of time at a particular retail outlet that con13 stitute a repeated violation; 

14 (2) providing for timely and effective notice to 

15 the retailer of each alleged violation at a particular 

16 retail outlet and an expedited procedure for the ad17 ministrative appeal of an alleged violation; 

18 (3) providing that a person may not be charged 

19 with a violation at a particular retail outlet unless 

20 the Secretary has provided notice to the retailer of 

21 all previous violations at that outlet; 

22 (4) establishing a period of time during which, 

23 if there are no violations by a particular retail out24 let, that outlet will not be considered to have been 
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1 the site of repeated violations when the next viola2 tion occurs; and 

3 (5) providing that good faith reliance on the 

4 presentation of a false government issued photo5 graphic identification that contains the bearer’s date 

6 of birth does not constitute a violation of any min7 imum age requirement for the sale of tobacco prod8 ucts if the retailer has taken effective steps to pre9 vent such violations, including—

10 (A) adopting and enforcing a written policy 

11 against sales to minors; 

12 (B) informing its employees of all applica13 ble laws; 

14 (C) establishing disciplinary sanctions for 

15 employee noncompliance; and 

16 (D) requiring its employees to verify age 

17 by way of photographic identification or elec18 tronic scanning device.
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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 Section 4 of the Federal Cigarette Labeling and Ad7 vertising Act (15 U.S.C. 1333) is amended to read as fol8 lows: 

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, 

13 distribute, or import for sale or distribution within 

14 the United States any cigarettes the package of 

15 which fails to bear, in accordance with the require16 ments of this section, one of the following labels: 

17 ‘WARNING: Cigarettes are addictive’. 

18 ‘WARNING: Tobacco smoke can harm your chil19 dren’. 

20 ‘WARNING: Cigarettes cause fatal lung disease’. 

21 ‘WARNING: Cigarettes cause cancer’. 

22 ‘WARNING: Cigarettes cause strokes and heart dis23 ease’. 

24 ‘WARNING: Smoking during pregnancy can harm 

25 your baby’.
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1 ‘WARNING: Smoking can kill you’. 

2 ‘WARNING: Tobacco smoke causes fatal lung dis3 ease in non-smokers’. 

4 ‘WARNING: Quitting smoking now greatly reduces 

5 serious risks to your health’. 

6 ‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—

7 ‘‘(A) IN GENERAL.—Each label statement 

8 required by paragraph (1) shall be located in 

9 the upper portion of the front and rear panels 

10 of the package, directly on the package under11 neath the cellophane or other clear wrapping. 

12 Except as provided in subparagraph (B), each 

13 label statement shall comprise at least the top 

14 30 percent of the front and rear panels of the 

15 package. The word ‘WARNING’ shall appear in 

16 capital letters and all text shall be in con17 spicuous and legible 17-point type, unless the 

18 text of the label statement would occupy more 

19 than 70 percent of such area, in which case the 

20 text may be in a smaller conspicuous and leg21 ible type size, provided that at least 60 percent 

22 of such area is occupied by required text. The 

23 text shall be black on a white background, or 

24 white on a black background, in a manner that 

25 contrasts, by typography, layout, or color, with 
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1 all other printed material on the package, in an 

2 alternating fashion under the plan submitted 

3 under subsection (b)(4). 

4 ‘‘(B) FLIP-TOP BOXES.—For any cigarette 

5 brand package manufactured or distributed be6 fore January 1, 2000, which employs a flip-top 

7 style (if such packaging was used for that 

8 brand in commerce prior to June 21, 1997), the 

9 label statement required by paragraph (1) shall 

10 be located on the flip-top area of the package, 

11 even if such area is less than 25 percent of the 

12 area of the front panel. Except as provided in 

13 this paragraph, the provisions of this subsection 

14 shall apply to such packages. 

15 ‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU16 TION.—The provisions of this subsection do not 

17 apply to a tobacco product manufacturer or dis18 tributor of cigarettes which does not manufacture, 

19 package, or import cigarettes for sale or distribution 

20 within the United States. 

21 ‘‘(4) APPLICABILITY TO RETAILERS.—A retailer 

22 of cigarettes shall not be in violation of this sub23 section for packaging that is supplied to the retailer 

24 by a tobacco product manufacturer, importer, or dis25 tributor and is not altered by the retailer in a way 
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1 that is material to the requirements of this sub2 section except that this paragraph shall not relieve 

3 a retailer of liability if the retailer sells or distributes 

4 tobacco products that are not labeled in accordance 

5 with this subsection. 

6 ‘‘(b) ADVERTISING REQUIREMENTS.—

7 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

8 tobacco product manufacturer, importer, distributor, 

9 or retailer of cigarettes to advertise or cause to be 

10 advertised within the United States any cigarette 

11 unless its advertising bears, in accordance with the 

12 requirements of this section, one of the labels speci13 fied in subsection (a) of this section. 

14 ‘‘(2) TYPOGRAPHY, ETC.—Each label statement 

15 required by subsection (a) of this section in cigarette 

16 advertising shall comply with the standards set forth 

17 in this paragraph. For press and poster advertise18 ments, each such statement and (where applicable) 

19 any required statement relating to tar, nicotine, or 

20 other constituent (including a smoke constituent) 

21 yield shall comprise at least 20 percent of the area 

22 of the advertisement and shall appear in a con23 spicuous and prominent format and location at the 

24 top of each advertisement within the trim area. The 

25 Secretary may revise the required type sizes in such 
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1 area in such manner as the Secretary determines ap2 propriate. The word ‘WARNING’ shall appear in 

3 capital letters, and each label statement shall appear 

4 in conspicuous and legible type. The text of the label 

5 statement shall be black if the background is white 

6 and white if the background is black, under the plan 

7 submitted under paragraph (4) of this subsection. 

8 The label statements shall be enclosed by a rectan9 gular border that is the same color as the letters of 

10 the statements and that is the width of the first 

11 downstroke of the capital ‘W’ of the word ‘WARN12 ING’ in the label statements. The text of such label 

13 statements shall be in a typeface pro rata to the fol14 lowing requirements: 45-point type for a whole-page 

15 broadsheet newspaper advertisement; 39-point type 

16 for a half-page broadsheet newspaper advertisement; 

17 39-point type for a whole-page tabloid newspaper ad18 vertisement; 27-point type for a half-page tabloid 

19 newspaper advertisement; 31.5-point type for a dou20 ble page spread magazine or whole-page magazine 

21 advertisement; 22.5-point type for a 28 centimeter 

22 by 3 column advertisement; and 15-point type for a 

23 20 centimeter by 2 column advertisement. The label 

24 statements shall be in English, except that in the 

25 case of—
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1 ‘‘(A) an advertisement that appears in a 

2 newspaper, magazine, periodical, or other publi3 cation that is not in English, the statements 

4 shall appear in the predominant language of the 

5 publication; and 

6 ‘‘(B) in the case of any other advertise7 ment that is not in English, the statements 

8 shall appear in the same language as that prin9 cipally used in the advertisement. 

10 ‘‘(3) MATCHBOOKS.—Notwithstanding para11 graph (2), for matchbooks (defined as containing not 

12 more than 20 matches) customarily given away with 

13 the purchase of tobacco products, each label state14 ment required by subsection (a) may be printed on 

15 the inside cover of the matchbook. 

16 ‘‘(4) ADJUSTMENT BY SECRETARY.—The Sec17 retary may, through a rulemaking under section 553 

18 of title 5, United States Code, adjust the format and 

19 type sizes for the label statements required by this 

20 section or the text, format, and type sizes of any re21 quired tar, nicotine yield, or other constituent (in22 cluding smoke constituent) disclosures, or to estab23 lish the text, format, and type sizes for any other 

24 disclosures required under the Federal Food, Drug, 

25 and Cosmetic Act (21 U.S.C. 301 et. seq.). The text 
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1 of any such label statements or disclosures shall be 

2 required to appear only within the 20 percent area 

3 of cigarette advertisements provided by paragraph 

4 (2) of this subsection. The Secretary shall promul5 gate regulations which provide for adjustments in 

6 the format and type sizes of any text required to ap7 pear in such area to ensure that the total text re8 quired to appear by law will fit within such area. 

9 ‘‘(5) MARKETING REQUIREMENTS.—

10 ‘‘(A) The label statements specified in sub11 section (a)(1) shall be randomly displayed in 

12 each 12-month period, in as equal a number of 

13 times as is possible on each brand of the prod14 uct and be randomly distributed in all areas of 

15 the United States in which the product is mar16 keted in accordance with a plan submitted by 

17 the tobacco product manufacturer, importer, 

18 distributor, or retailer and approved by the Sec19 retary. 

20 ‘‘(B) The label statements specified in sub21 section (a)(1) shall be rotated quarterly in al22 ternating sequence in advertisements for each 

23 brand of cigarettes in accordance with a plan 

24 submitted by the tobacco product manufacturer,
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1 importer, distributor, or retailer to, and ap2 proved by, the Secretary. 

3 ‘‘(C) The Secretary shall review each plan 

4 submitted under subparagraph (B) and approve 

5 it if the plan—

6 ‘‘(i) will provide for the equal distribu7 tion and display on packaging and the ro8 tation required in advertising under this 

9 subsection; and 

10 ‘‘(ii) assures that all of the labels re11 quired under this section will be displayed 

12 by the tobacco product manufacturer, im13 porter, distributor, or retailer at the same 

14 time. 

15 ‘‘(6) APPLICABILITY TO RETAILERS.—This sub16 section applies to a retailer only if that retailer is re17 sponsible for or directs the label statements required 

18 under this section except that this paragraph shall 

19 not relieve a retailer of liability if the retailer dis20 plays, in a location open to the public, an advertise21 ment that is not labeled in accordance with the re22 quirements of this subsection.’’. 
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1 SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING 

2 LABEL STATEMENTS. 

3 Section 4 of the Federal Cigarette Labeling and Ad4 vertising Act (15 U.S.C. 1333), as amended by section 

5 201, is further amended by adding at the end the fol6 lowing: 

7 ‘‘(c) CHANGE IN REQUIRED STATEMENTS.—The Sec8 retary may, by a rulemaking conducted under section 553 

9 of title 5, United States Code, adjust the format, type size, 

10 and text of any of the label requirements, require color 

11 graphics to accompany the text, increase the required label 

12 area from 30 percent up to 50 percent of the front and 

13 rear panels of the package, or establish the format, type 

14 size, and text of any other disclosures required under the 

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

16 et seq.), if the Secretary finds that such a change would 

17 promote greater public understanding of the risks associ18 ated with the use of tobacco products.’’. 

19 SEC. 203. STATE REGULATION OF CIGARETTE ADVER20 TISING AND PROMOTION. 

21 Section 5 of the Federal Cigarette Labeling and Ad22 vertising Act (15 U.S.C. 1334) is amended by adding at 

23 the end the following: 

24 ‘‘(c) EXCEPTION.—Notwithstanding subsection (b), a 

25 State or locality may enact statutes and promulgate regu26 lations, based on smoking and health, that take effect 
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1 after the effective date of the Family Smoking Prevention 

2 and Tobacco Control Act, imposing specific bans or re3 strictions on the time, place, and manner, but not content, 

4 of the advertising or promotion of any cigarettes.’’. 

5 SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING 

6 WARNINGS. 

7 Section 3 of the Comprehensive Smokeless Tobacco 

8 Health Education Act of 1986 (15 U.S.C. 4402) is amend9 ed to read as follows: 

10 ‘‘SEC. 3. SMOKELESS TOBACCO WARNING. 

11 ‘‘(a) GENERAL RULE.— 

12 ‘‘(1) It shall be unlawful for any person to man13 ufacture, package, sell, offer to sell, distribute, or 

14 import for sale or distribution within the United 

15 States any smokeless tobacco product unless the 

16 product package bears, in accordance with the re17 quirements of this Act, one of the following labels: 

18 ‘WARNING: This product can cause mouth cancer’. 

19 ‘WARNING: This product can cause gum disease 

20 and tooth loss’. 

21 ‘WARNING: This product is not a safe alternative 

22 to cigarettes’. 

23 ‘WARNING: Smokeless tobacco is addictive’. 

24 ‘‘(2) Each label statement required by para25 graph (1) shall be—
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1 ‘‘(A) located on the 2 principal display 

2 panels of the package, and each label statement 

3 shall comprise at least 30 percent of each such 

4 display panel; and 

5 ‘‘(B) in 17-point conspicuous and legible 

6 type and in black text on a white background, 

7 or white text on a black background, in a man8 ner that contrasts by typography, layout, or 

9 color, with all other printed material on the 

10 package, in an alternating fashion under the 

11 plan submitted under subsection (b)(3), except 

12 that if the text of a label statement would oc13 cupy more than 70 percent of the area specified 

14 by subparagraph (A), such text may appear in 

15 a smaller type size, so long as at least 60 per16 cent of such warning area is occupied by the 

17 label statement. 

18 ‘‘(3) The label statements required by para19 graph (1) shall be introduced by each tobacco prod20 uct manufacturer, packager, importer, distributor, or 

21 retailer of smokeless tobacco products concurrently 

22 into the distribution chain of such products. 

23 ‘‘(4) The provisions of this subsection do not 

24 apply to a tobacco product manufacturer or dis25 tributor of any smokeless tobacco product that does 
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1 not manufacture, package, or import smokeless to2 bacco products for sale or distribution within the 

3 United States. 

4 ‘‘(5) A retailer of smokeless tobacco products 

5 shall not be in violation of this subsection for pack6 aging that is supplied to the retailer by a tobacco 

7 products manufacturer, importer, or distributor and 

8 that is not altered by the retailer unless the retailer 

9 offers for sale, sells, or distributes a smokeless to10 bacco product that is not labeled in accordance with 

11 this subsection. 

12 ‘‘(b) REQUIRED LABELS.—

13 ‘‘(1) It shall be unlawful for any tobacco prod14 uct manufacturer, packager, importer, distributor, or 

15 retailer of smokeless tobacco products to advertise or 

16 cause to be advertised within the United States any 

17 smokeless tobacco product unless its advertising 

18 bears, in accordance with the requirements of this 

19 section, one of the labels specified in subsection (a). 

20 ‘‘(2) Each label statement required by sub21 section (a) in smokeless tobacco advertising shall 

22 comply with the standards set forth in this para23 graph. For press and poster advertisements, each 

24 such statement and (where applicable) any required
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1 statement relating to tar, nicotine, or other con2 stituent yield shall—

3 ‘‘(A) comprise at least 20 percent of the 

4 area of the advertisement, and the warning area 

5 shall be delineated by a dividing line of con6 trasting color from the advertisement; and 

7 ‘‘(B) the word ‘WARNING’ shall appear in 

8 capital letters and each label statement shall 

9 appear in conspicuous and legible type. The text 

10 of the label statement shall be black on a white 

11 background, or white on a black background, in 

12 an alternating fashion under the plan submitted 

13 under paragraph (3). 

14 ‘‘(3)(A) The label statements specified in sub15 section (a)(1) shall be randomly displayed in each 

16 12-month period, in as equal a number of times as 

17 is possible on each brand of the product and be ran18 domly distributed in all areas of the United States 

19 in which the product is marketed in accordance with 

20 a plan submitted by the tobacco product manufac21 turer, importer, distributor, or retailer and approved 

22 by the Secretary. 

23 ‘‘(B) The label statements specified in sub24 section (a)(1) shall be rotated quarterly in alter25 nating sequence in advertisements for each brand of 
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1 smokeless tobacco product in accordance with a plan 

2 submitted by the tobacco product manufacturer, im3 porter, distributor, or retailer to, and approved by, 

4 the Secretary. 

5 ‘‘(C) The Secretary shall review each plan sub6 mitted under subparagraph (B) and approve it if the 

7 plan—

8 ‘‘(i) will provide for the equal distribution 

9 and display on packaging and the rotation re10 quired in advertising under this subsection; and 

11 ‘‘(ii) assures that all of the labels required 

12 under this section will be displayed by the to13 bacco product manufacturer, importer, dis14 tributor, or retailer at the same time. 

15 ‘‘(D) This paragraph applies to a retailer only 

16 if that retailer is responsible for or directs the label 

17 statements under this section, unless the retailer dis18 plays in a location open to the public, an advertise19 ment that is not labeled in accordance with the re20 quirements of this subsection. 

21 ‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is 

22 unlawful to advertise smokeless tobacco on any medium 

23 of electronic communications subject to the jurisdiction of 

24 the Federal Communications Commission.’’. 
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1 SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO 

2 PRODUCT WARNING LABEL STATEMENTS. 

3 Section 3 of the Comprehensive Smokeless Tobacco 

4 Health Education Act of 1986 (15 U.S.C. 4402), as 

5 amended by section 203, is further amended by adding 

6 at the end the following: 

7 ‘‘(d) AUTHORITY TO REVISE WARNING LABEL

8 STATEMENTS.—The Secretary may, by a rulemaking con9 ducted under section 553 of title 5, United States Code, 

10 adjust the format, type size, and text of any of the label 

11 requirements, require color graphics to accompany the 

12 text, increase the required label area from 30 percent up 

13 to 50 percent of the front and rear panels of the package, 

14 or establish the format, type size, and text of any other 

15 disclosures required under the Federal Food, Drug, and 

16 Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary 

17 finds that such a change would promote greater public un18 derstanding of the risks associated with the use of smoke19 less tobacco products.’’. 

20 SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CON21 STITUENT DISCLOSURE TO THE PUBLIC. 

22 Section 4(a) of the Federal Cigarette Labeling and 

23 Advertising Act (15 U.S.C. 1333 (a)), as amended by sec24 tion 201, is further amended by adding at the end the 

25 following: 
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1 ‘‘(4)(A) The Secretary shall, by a rulemaking 

2 conducted under section 553 of title 5, United 

3 States Code, determine (in the Secretary’s sole dis4 cretion) whether cigarette and other tobacco product 

5 manufacturers shall be required to include in the 

6 area of each cigarette advertisement specified by 

7 subsection (b) of this section, or on the package 

8 label, or both, the tar and nicotine yields of the ad9 vertised or packaged brand. Any such disclosure 

10 shall be in accordance with the methodology estab11 lished under such regulations, shall conform to the 

12 type size requirements of subsection (b) of this sec13 tion, and shall appear within the area specified in 

14 subsection (b) of this section. 

15 ‘‘(B) Any differences between the requirements 

16 established by the Secretary under subparagraph (A) 

17 and tar and nicotine yield reporting requirements es18 tablished by the Federal Trade Commission shall be 

19 resolved by a memorandum of understanding be20 tween the Secretary and the Federal Trade Commis21 sion. 

22 ‘‘(C) In addition to the disclosures required by 

23 subparagraph (A) of this paragraph, the Secretary 

24 may, under a rulemaking conducted under section 

25 553 of title 5, United States Code, prescribe disclo-
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1 sure requirements regarding the level of any ciga2 rette or other tobacco product constituent including 

3 any smoke constituent. Any such disclosure may be 

4 required if the Secretary determines that disclosure 

5 would be of benefit to the public health, or otherwise 

6 would increase consumer awareness of the health 

7 consequences of the use of tobacco products, except 

8 that no such prescribed disclosure shall be required 

9 on the face of any cigarette package or advertise10 ment. Nothing in this section shall prohibit the Sec11 retary from requiring such prescribed disclosure 

12 through a cigarette or other tobacco product pack13 age or advertisement insert, or by any other means 

14 under the Federal Food, Drug, and Cosmetic Act 

15 (21 U.S.C. 301 et seq.). 

16 ‘‘(D) This paragraph applies to a retailer only 

17 if that retailer is responsible for or directs the label 

18 statements required under this section, except that 

19 this paragraph shall not relieve a retailer of liability 

20 if the retailer sells or distributes tobacco products 

21 that are not labeled in accordance with the require22 ments of this subsection.’’.
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1 TITLE III—PREVENTION OF IL2 LICIT TRADE IN TOBACCO 

3 PRODUCTS 

4 SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPEC5 TION. 

6 Chapter IX of the Federal Food, Drug, and Cosmetic 

7 Act, as added by section 101, is further amended by add8 ing at the end the following: 

9 ‘‘SEC. 921. LABELING, RECORDKEEPING, RECORDS INSPEC10 TION. 

11 ‘‘(a) ORIGIN LABELING.—The label, packaging, and 

12 shipping containers of tobacco products for introduction 

13 or delivery for introduction into interstate commerce shall 

14 bear the statement ‘sale only allowed in the United 

15 States.’

16 ‘‘(b) REGULATIONS CONCERNING RECORDKEEPING

17 FOR TRACKING AND TRACING.—

18 ‘‘(1) IN GENERAL.—Not later than 9 months 

19 after the date of enactment of the Family Smoking 

20 Prevention and Tobacco Control Act, the Secretary 

21 shall promulgate regulations regarding the establish22 ment and maintenance of records by any person who 

23 manufactures, processes, transports, distributes, re24 ceives, packages, holds, exports, or imports tobacco 

25 products. 
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1 ‘‘(2) INSPECTION.—In promulgating the regula2 tions described in paragraph (1), the Secretary shall 

3 consider which records are needed for inspection to 

4 monitor the movement of tobacco products from the 

5 point of manufacture through distribution to retail 

6 outlets to assist in investigating potential illicit 

7 trade, smuggling or counterfeiting of tobacco prod8 ucts. 

9 ‘‘(3) CODES.—The Secretary may require codes 

10 on the labels of tobacco products or other designs or 

11 devices for the purpose of tracking or tracing the to12 bacco product through the distribution system. 

13 ‘‘(4) SIZE OF BUSINESS.—The Secretary shall 

14 take into account the size of a business in promul15 gating regulations under this section. 

16 ‘‘(5) RECORDKEEPING BY RETAILERS.—The 

17 Secretary shall not require any retailer to maintain 

18 records relating to individual purchasers of tobacco 

19 products for personal consumption. 

20 ‘‘(c) RECORDS INSPECTION.—If the Secretary has a 

21 reasonable belief that a tobacco product is part of an illicit 

22 trade or smuggling or is a counterfeit product, each person 

23 who manufactures, processes, transports, distributes, re24 ceives, holds, packages, exports, or imports tobacco prod25 ucts shall, at the request of an officer or employee duly 
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1 designated by the Secretary, permit such officer or em2 ployee, at reasonable times and within reasonable limits 

3 and in a reasonable manner, upon the presentation of ap4 propriate credentials and a written notice to such person, 

5 to have access to and copy all records (including financial 

6 records) relating to such article that are needed to assist 

7 the Secretary in investigating potential illicit trade, smug8 gling or counterfeiting of tobacco products. 

9 ‘‘(d) KNOWLEDGE OF ILLEGAL TRANSACTION.—If 

10 the manufacturer or distributor of a tobacco product has 

11 knowledge which reasonably supports the conclusion that 

12 a tobacco product manufactured or distributed by such 

13 manufacturer or distributor that has left the control of 

14 such person may be or has been—

15 ‘‘(A) imported, exported, distributed or of16 fered for sale in interstate commerce by a per17 son without paying duties or taxes required by 

18 law; or 

19 ‘‘(B) imported, exported, distributed or di20 verted for possible illicit marketing, 

21 the manufacturer or distributor shall promptly notify the 

22 Attorney General of such knowledge. 

23 ‘‘(2) KNOWLEDGE DEFINED.—For purposes of 

24 this subsection, the term ‘knowledge’ as applied to 

25 a manufacturer or distributor means—
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•S 2461 IS 

1 ‘‘(A) the actual knowledge that the manu2 facturer or distributor had; or 

3 ‘‘(B) the knowledge which a reasonable 

4 person would have had under like circumstances 

5 or which would have been obtained upon the ex6 ercise of due care. 

7 SEC. 302. STUDY AND REPORT. 

8 (a) STUDY.—The Comptroller General of the United 

9 States shall conduct a study of cross-border trade in to10 bacco products to—

11 (1) collect data on cross-border trade in tobacco 

12 products, including illicit trade and trade of counter13 feit tobacco products and make recommendations on 

14 the monitoring of such trade; 

15 (2) collect data on cross-border advertising (any 

16 advertising intended to be broadcast, transmitted, or 

17 distributed from the United States to another coun18 try) of tobacco products and make recommendations 

19 on how to prevent or eliminate, and what tech20 nologies could help facilitate the elimination of, 

21 cross-border advertising. 

22 (b) REPORT.—Not later than 18 months after the 

23 date of enactment of this Act, the Comptroller General 

24 of the United States shall submit to the Committee on 

25 Health, Education, Labor, and Pensions of the Senate and 
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1 the Committee on Energy and Commerce of the House 

2 of Representatives a report on the study described in sub3 section (a).

Æ