II 

110TH CONGRESS 

1ST SESSION S. 625 

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 

FEBRUARY 15, 2007 

Mr. KENNEDY (for himself, Mr. CORNYN, Mr. HARKIN, Mr. MCCAIN, Mr. 

DURBIN, Mr. LUGAR, Mr. DODD, Mr. SMITH, Mr. REED, Ms. SNOWE, 

Mr. LAUTENBERG, Ms. MURKOWSKI, Mr. BINGAMAN, Ms. COLLINS, Ms. 

MIKULSKI, Mr. STEVENS, Mrs. MURRAY, Mr. DOMENICI, Mrs. CLINTON, 

Mr. COCHRAN, Mrs. FEINSTEIN, Mr. LEAHY, Mr. OBAMA, Mr. SANDERS, 

Mr. BROWN, Mr. SCHUMER, Mr. AKAKA, Mr. KOHL, Ms. CANTWELL, Mr. 

CARPER, and Mr. NELSON of Florida) 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’’. 


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

2 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 

Sec. 3. Purpose. 

Sec. 4. Scope and effect. 

Sec. 5. Severability. 

TITLE I—AUTHORITY OF THE FOOD AND DRUG 

ADMINISTRATION 

Sec. 101. Amendment of Federal food, drug, and Cosmetic Act. 

Sec. 102. Final rule. 

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

TITLE II—TOBACCO PRODUCT WARNINGS; CONSTITUENT AND 

SMOKE CONSTITUENT DISCLOSURE 

Sec. 201. Cigarette label and advertising warnings. 

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

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

Sec. 204. Smokeless Tobacco labels and advertising warnings. 

Sec. 205. Authority to revise Smokeless Tobacco product warning label statements. 

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

TITLE III—PREVENTION OF ILLICIT TRADE IN TOBACCO 

PRODUCTS 

Sec. 301. Labeling, recordkeeping, records inspection. 

Sec. 302. Study and report. 

3 SEC. 2. FINDINGS. 

4 The Congress finds the following: 

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

6 children is a pediatric disease of considerable pro7 portions that results in new generations of tobacco8 dependent children and adults. 

9 (2) A consensus exists within the scientific and 

10 medical communities that tobacco products are in11 herently dangerous and cause cancer, heart disease, 

12 and other serious adverse health effects. 


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1 (3) Nicotine is an addictive drug. 

2 (4) Virtually all new users of tobacco products 

3 are under the minimum legal age to purchase such 

4 products. 

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

7 tobacco products by adolescents. 

8 (6) Because past efforts to restrict advertising 

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

12 distribution of such products are needed. 

13 (7) Federal and State governments have lacked 

14 the legal and regulatory authority and resources 

15 they need to address comprehensively the public 

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

18 (8) Federal and State public health officials, 

19 the public health community, and the public at large 

20 recognize that the tobacco industry should be subject 

21 to ongoing oversight. 

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

24 for regulating interstate commerce and commerce 

25 with Indian tribes. 


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

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

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

7 economy. 

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

10 interstate commerce through the health care and 

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

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

14 enact legislation that provides the Food and Drug 

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

17 such products. The benefits to the American people 

18 from enacting such legislation would be significant 

19 in human and economic terms. 

20 (13) Tobacco use is the foremost preventable 

21 cause of premature death in America. It causes over 

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

23 approximately 8,600,000 Americans have chronic ill24 nesses related to smoking. 


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

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

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

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

8 reduced health care costs. 

9 (15) Advertising, marketing, and promotion of 

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

12 these efforts have resulted in increased use of such 

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

16 (16) In 2003, the cigarette manufacturers 

17 spent more than $15,000,000,000 to attract new 

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

21 (17) Tobacco product advertising often 

22 misleadingly portrays the use of tobacco as socially 

23 acceptable and healthful to minors. 

24 (18) Tobacco product advertising is regularly 

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


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1 under the age of 18 are regularly exposed to tobacco 

2 product promotional efforts. 

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

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

7 lifestyle associated with rigorous sporting activity. 

8 (20) Children are exposed to substantial and 

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

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

13 who begin to use tobacco. 

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

16 young people and encourages them to use tobacco 

17 products. 

18 (22) Tobacco advertising expands the size of 

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

22 (23) Children are more influenced by tobacco 

23 marketing than adults: more than 80 percent of 

24 youth smoke three heavily marketed brands, while 


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

2 same brands. 

3 (24) Tobacco company documents indicate that 

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

6 be more price-sensitive than adults, are influenced 

7 by advertising and promotion practices that result in 

8 drastically reduced cigarette prices. 

9 (25) Comprehensive advertising restrictions will 

10 have a positive effect on the smoking rates of young 

11 people. 

12 (26) Restrictions on advertising are necessary 

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

15 people and providing for education about tobacco 

16 use. 

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

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

22 (28) Text only requirements, although not as 

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

24 tobacco products while preserving the informational 

25 function of advertising. 


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

2 adopt legislation to address the public health crisis 

3 created by actions of the tobacco industry. 

4 (30) The final regulations promulgated by the 

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

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

8 of title 21, Code of Federal Regulations, are con9 sistent with the First Amendment to the United 

10 States Constitution and with the standards set forth 

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

13 Administration and the restriction on the sale and 

14 distribution, including access to and the advertising 

15 and promotion of, tobacco products contained in 

16 such regulations are substantially related to accom17 plishing the public health goals of this Act. 

18 (31) The regulations described in paragraph 

19 (30) will directly and materially advance the Federal 

20 Government’s substantial interest in reducing the 

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

23 life-threatening health consequences associated with 

24 tobacco use. An overwhelming majority of Americans 

25 who use tobacco products begin using such products 


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1 while they are minors and become addicted to the 

2 nicotine in those products before reaching the age of 

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

5 using tobacco products. Less restrictive and less 

6 comprehensive approaches have not and will not be 

7 effective in reducing the problems addressed by such 

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

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

13 (32) The regulations described in paragraph 

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

16 than are necessary to reduce the number of children 

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

23 entice them into tobacco use, while affording tobacco 

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1 vey information about their products to adult con2 sumers. 

3 (33) Tobacco dependence is a chronic disease, 

4 one that typically requires repeated interventions to 

5 achieve long-term or permanent abstinence. 

6 (34) Because the only known safe alternative to 

7 smoking is cessation, interventions should target all 

8 smokers to help them quit completely. 

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

11 and internationally. Illicit trade of tobacco products 

12 has been linked to organized crime and terrorist 

13 groups. 

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

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

18 any advertising and labeling for such products. It is 

19 also essential that manufacturers, prior to marketing 

20 such products, be required to demonstrate that such 

21 products will meet a series of rigorous criteria, and 

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

23 taking into account both users of tobacco products 

24 and persons who do not currently use tobacco prod25 ucts. 


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1 (37) Unless tobacco products that purport to 

2 reduce the risks to the public of tobacco use actually 

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

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

7 use tobacco products purporting to reduce risk. 

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

10 rather than quitting or reducing their use of tobacco 

11 products, have a substantially increased likelihood of 

12 suffering disability and premature death. The costs 

13 to society of the widespread use of products sold or 

14 distributed as modified risk products that do not in 

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

17 costs to our health care system. 

18 (38) As the National Cancer Institute has 

19 found, many smokers mistakenly believe that ‘‘low 

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

22 Institute has also found, mistaken beliefs about the 

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

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


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1 smoking entirely and thereby lead to disease and 

2 death. 

3 (39) Recent studies have demonstrated that 

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

6 such products may actually increase the risk of to7 bacco use. 

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

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

14 of the product. 

15 (41) As the Federal Trade Commission has 

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

18 harmful than a comparable product, even in the 

19 presence of disclosures and advisories intended to 

20 provide clarification. 

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

24 accompanied by disclaimers would be detrimental to 

25 the public health. 


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1 (43) The only way to effectively protect the 

2 public health from the dangers of unsubstantiated 

3 modified risk tobacco products is to empower the 

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

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

8 support approval of these products is rigorous. 

9 SEC. 3. PURPOSE. 

10 The purposes of this Act are— 

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

12 Administration to regulate tobacco products under 

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

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

15 Federal regulatory authority with respect to the 

16 manufacture, marketing, and distribution of tobacco 

17 products; 

18 (2) to ensure that the Food and Drug Adminis19 tration has the authority to address issues of par20 ticular concern to public health officials, especially 

21 the use of tobacco by young people and dependence 

22 on tobacco; 

23 (3) to authorize the Food and Drug Adminis24 tration to set national standards controlling the 

25 manufacture of tobacco products and the identity, 


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1 public disclosure, and amount of ingredients used in 

2 such products; 

3 (4) to provide new and flexible enforcement au4 thority to ensure that there is effective oversight of 

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

6 and promote less harmful tobacco products; 

7 (5) to vest the Food and Drug Administration 

8 with the authority to regulate the levels of tar, nico9 tine, and other harmful components of tobacco prod10 ucts; 

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

12 informed, to require tobacco product manufacturers 

13 to disclose research which has not previously been 

14 made available, as well as research generated in the 

15 future, relating to the health and dependency effects 

16 or safety of tobacco products; 

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

18 products to adults in conjunction with measures to 

19 ensure that they are not sold or accessible to under20 age purchasers; 

21 (8) to impose appropriate regulatory controls on 

22 the tobacco industry; 

23 (9) to promote cessation to reduce disease risk 

24 and the social costs associated with tobacco related 

25 diseases; and 


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1 (10) to strengthen legislation against illicit 

2 trade in tobacco products. 

3 SEC. 4. SCOPE AND EFFECT. 

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

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

6 (1) establish a precedent with regard to any 

7 other industry, situation, circumstance, or legal ac8 tion; or 

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

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

11 contract of any kind. 

12 (b) AGRICULTURAL ACTIVITIES.—The provisions of 

13 this Act (or an amendment made by this Act) which au14 thorize the Secretary to take certain actions with regard 

15 to tobacco and tobacco products shall not be construed to 

16 affect any authority of the Secretary of Agriculture under 

17 existing law regarding the growing, cultivation, or curing 

18 of raw tobacco. 

19 SEC. 5. SEVERABILITY. 

20 If any provision of this Act, the amendments made 

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

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

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

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


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1 other person or circumstance shall not be affected and 

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

3 TITLE I—AUTHORITY OF THE 

4 FOOD AND DRUG ADMINIS5 TRATION 

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

7 COSMETIC ACT. 

8 (a) DEFINITION OF TOBACCO PRODUCTS.—Section 

9 201 of the Federal Food, Drug, and Cosmetic Act (21 

10 U.S.C. 321) is amended by adding at the end the fol11 lowing: 

12 ‘‘(rr)(1) The term ‘tobacco product’ means any prod13 uct made or derived from tobacco that is intended for 

14 human consumption, including any component, part, or 

15 accessory of a tobacco product (except for raw materials 

16 other than tobacco used in manufacturing a component, 

17 part, or accessory of a tobacco product). 

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

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

20 (including water and chewing gum), a product rep21 resented for use as or for use in a conventional food, 

22 or a product that is intended for ingestion in cap23 sule, tablet, softgel, or liquid form; or 

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

25 as a drug by the Food and Drug Administration. 


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

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

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

4 subject to chapter V of this Act. 

5 ‘‘(4) A tobacco product may not be marketed in com6 bination with any other article or product regulated under 

7 this Act (including a drug, biologic, food, cosmetics, med8 ical device, or a dietary supplement).’’. 

9 (b) FDA AUTHORITY OVER TOBACCO PRODUCTS.— 

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

11 301 et seq.) is amended— 

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

13 (2) by redesignating sections 901 through 909 

14 as sections 1001 through 1009; 

15 (3) in section 1009 (as so redesignated), by 

16 striking ‘‘section 908’’ and inserting ‘‘section 1008’’; 

17 and 

18 (4) by inserting after chapter VIII the fol19 lowing: 

20 ‘‘CHAPTER IX—TOBACCO PRODUCTS 

21 ‘‘SEC. 900. DEFINITIONS. 

22 ‘‘In this chapter: 

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

24 any substance the intended use of which results or 

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1 directly, in its becoming a component or otherwise 

2 affecting the characteristic of any tobacco product 

3 (including any substances intended for use as a fla4 voring, coloring or in producing, manufacturing, 

5 packing, processing, preparing, treating, packaging, 

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

7 not include tobacco or a pesticide chemical residue 

8 in or on raw tobacco or a pesticide chemical. 

9 ‘‘(2) BRAND.—The term ‘brand’ means a vari10 ety of tobacco product distinguished by the tobacco 

11 used, tar content, nicotine content, flavoring used, 

12 size, filtration, or packaging, logo, registered trade13 mark or brand name, identifiable pattern of colors, 

14 or any combination of such attributes. 

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

16 meaning given that term by section 3(1) of the Fed17 eral Cigarette Labeling and Advertising Act, but 

18 also includes tobacco, in any form, that is functional 

19 in the product, which, because of its appearance, the 

20 type of tobacco used in the filler, or its packaging 

21 and labeling, is likely to be offered to, or purchased 

22 by, consumers as a cigarette or as roll-your-own to23 bacco. 

24 ‘‘(4) CIGARETTE TOBACCO.—The term ‘ciga25 rette tobacco’ means any product that consists of 


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1 loose tobacco that is intended for use by consumers 

2 in a cigarette. Unless otherwise stated, the require3 ments for cigarettes shall also apply to cigarette to4 bacco. 

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

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

7 Federal Cigarette Labeling and Advertising Act. 

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

9 term ‘counterfeit tobacco product’ means a tobacco 

10 product (or the container or labeling of such a prod11 uct) that, without authorization, bears the trade12 mark, trade name, or other identifying mark, im13 print or device, or any likeness thereof, of a tobacco 

14 product listed in a registration under section 

15 905(i)(1). 

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

17 regards a tobacco product means any person who 

18 furthers the distribution of a tobacco product, 

19 whether domestic or imported, at any point from the 

20 original place of manufacture to the person who sells 

21 or distributes the product to individuals for personal 

22 consumption. Common carriers are not considered 

23 distributors for purposes of this chapter. 

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

25 means any practice or conduct prohibited by law 


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1 which relates to production, shipment, receipt, pos2 session, distribution, sale, or purchase of tobacco 

3 products including any practice or conduct intended 

4 to facilitate such activity. 

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

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

7 the Indian Self Determination and Education Assist8 ance Act. 

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

10 has the meaning given that term by section 3(7) of 

11 the Federal Cigarette Labeling and Advertising Act. 

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

13 the chemical substance named 3-(1–Methyl-2- 

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

15 any salt or complex of nicotine. 

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

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

18 other container, any wrapping (including cello19 phane), in which a tobacco product is offered for 

20 sale, sold, or otherwise distributed to consumers. 

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

22 any person who sells tobacco products to individuals 

23 for personal consumption, or who operates a facility 

24 where self-service displays of tobacco products are 

25 permitted. 


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

2 ‘roll-your-own tobacco’ means any tobacco which, be3 cause of its appearance, type, packaging, or labeling, 

4 is suitable for use and likely to be offered to, or pur5 chased by, consumers as tobacco for making ciga6 rettes. 

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

8 constituent’ means any chemical or chemical com9 pound in mainstream or sidestream tobacco smoke 

10 that either transfers from any component of the cig11 arette to the smoke or that is formed by the combus12 tion or heating of tobacco, additives, or other compo13 nent of the tobacco product. 

14 ‘‘(16) SMOKELESS TOBACCO.—The term 

15 ‘smokeless tobacco’ means any tobacco product that 

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

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

18 cavity. 

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

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

21 chapter, includes the District of Columbia, the Com22 monwealth of Puerto Rico, Guam, the Virgin Is23 lands, American Samoa, Wake Island, Midway Is24 lands, Kingman Reef, Johnston Atoll, the Northern 


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1 Mariana Islands, and any other trust territory or 

2 possession of the United States. 

3 ‘‘(18) TOBACCO PRODUCT MANUFACTURER.— 

4 The term ‘tobacco product manufacturer’ means any 

5 person, including any repacker or relabeler, who— 

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

7 processes, or labels a tobacco product; or 

8 ‘‘(B) imports a finished cigarette or 

9 smokeless tobacco product for sale or distribu10 tion in the United States. 

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

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

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

15 American Samoa, Wake Island, Midway Islands, 

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

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

20 ‘‘(a) IN GENERAL.—Tobacco products shall be regu21 lated by the Secretary under this chapter and shall not 

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

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

24 diagnosis, cure, mitigation, treatment, or prevention 


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1 of disease (within the meaning of section 

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

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

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

5 other than modified risk tobacco products approved 

6 in accordance with section 911. 

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

8 tobacco products subject to the regulations referred to in 

9 section 102 of the Family Smoking Prevention and To10 bacco Control Act, and to any other tobacco products that 

11 the Secretary by regulation deems to be subject to this 

12 chapter. 

13 ‘‘(c) SCOPE.— 

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

15 any policy issued or regulation promulgated there16 under, or in sections 101(a), 102, or 103 of title I, 

17 title II, or title III of the Family Smoking Preven18 tion and Tobacco Control Act, shall be construed to 

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

20 over (including the authority to determine whether 

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

22 products under this Act that are not tobacco prod23 ucts under chapter V or any other chapter. 

24 ‘‘(2) LIMITATION OF AUTHORITY.— 


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

2 chapter shall not apply to tobacco leaf that is 

3 not in the possession of a manufacturer of to4 bacco products, or to the producers of tobacco 

5 leaf, including tobacco growers, tobacco ware6 houses, and tobacco grower cooperatives, nor 

7 shall any employee of the Food and Drug Ad8 ministration have any authority to enter onto a 

9 farm owned by a producer of tobacco leaf with10 out the written consent of such producer. 

11 ‘‘(B) EXCEPTION.—Notwithstanding sub12 paragraph (A), if a producer of tobacco leaf is 

13 also a tobacco product manufacturer or con14 trolled by a tobacco product manufacturer, the 

15 producer shall be subject to this chapter in the 

16 producer’s capacity as a manufacturer. 

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

18 in this chapter shall be construed to grant the 

19 Secretary authority to promulgate regulations 

20 on any matter that involves the production of 

21 tobacco leaf or a producer thereof, other than 

22 activities by a manufacturer affecting produc23 tion. 


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1 ‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS. 

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

3 if— 

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

5 putrid, or decomposed substance, or is otherwise 

6 contaminated by any added poisonous or added dele7 terious substance that may render the product inju8 rious to health; 

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

10 under insanitary conditions whereby it may have 

11 been contaminated with filth, or whereby it may 

12 have been rendered injurious to health; 

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

14 part, of any poisonous or deleterious substance 

15 which may render the contents injurious to health; 

16 ‘‘(4) it is, or purports to be or is represented 

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

18 product standard established under section 907 un19 less such tobacco product is in all respects in con20 formity with such standard; 

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

22 premarket approval and does not have an approved 

23 application in effect; or 

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

25 such an application; 


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

2 controls used for, its manufacture, packing, or stor3 age are not in conformity with applicable require4 ments under section 906(e)(1) or an applicable con5 dition prescribed by an order under section 

6 906(e)(2); or 

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

8 ‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS. 

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

10 deemed to be misbranded— 

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

12 particular; 

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

14 containing— 

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

16 tobacco product manufacturer, packer, or dis17 tributor; 

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

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

20 numerical count; 

21 ‘‘(C) an accurate statement of the percent22 age of the tobacco used in the product that is 

23 domestically grown tobacco and the percentage 

24 that is foreign grown tobacco; and 


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1 ‘‘(D) the statement required under section 

2 921(a), 

3 except that under subparagraph (B) reasonable vari4 ations shall be permitted, and exemptions as to 

5 small packages shall be established, by regulations 

6 prescribed by the Secretary; 

7 ‘‘(3) if any word, statement, or other informa8 tion required by or under authority of this chapter 

9 to appear on the label or labeling is not prominently 

10 placed thereon with such conspicuousness (as com11 pared with other words, statements or designs in the 

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

13 be read and understood by the ordinary individual 

14 under customary conditions of purchase and use; 

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

16 label bears, to the exclusion of any other nonpropri17 etary name, its established name prominently print18 ed in type as required by the Secretary by regula19 tion; 

20 ‘‘(5) if the Secretary has issued regulations re21 quiring that its labeling bear adequate directions for 

22 use, or adequate warnings against use by children, 

23 that are necessary for the protection of users unless 

24 its labeling conforms in all respects to such regula25 tions; 


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1 ‘‘(6) if it was manufactured, prepared, propa2 gated, compounded, or processed in any State in an 

3 establishment not duly registered under section 

4 905(b), 905(c), 905(d), or 905(h), if it was not in5 cluded in a list required by section 905(i), if a notice 

6 or other information respecting it was not provided 

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

8 it does not bear such symbols from the uniform sys9 tem for identification of tobacco products prescribed 

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

11 requires; 

12 ‘‘(7) if, in the case of any tobacco product dis13 tributed or offered for sale in any State— 

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

15 in any particular; or 

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

17 regulations prescribed under section 906(d); 

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

19 distributed or offered for sale in any State, the man20 ufacturer, packer, or distributor thereof includes in 

21 all advertisements and other descriptive printed mat22 ter issued or caused to be issued by the manufac23 turer, packer, or distributor with respect to that to24 bacco product— 


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1 ‘‘(A) a true statement of the tobacco prod2 uct’s established name as described in para3 graph (4), printed prominently; and 

4 ‘‘(B) a brief statement of— 

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

6 and relevant warnings, precautions, side 

7 effects, and contraindications; and 

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

9 products made subject to a finding by the 

10 Secretary after notice and opportunity for 

11 comment that such action is appropriate to 

12 protect the public health, a full description 

13 of the components of such tobacco product 

14 or the formula showing quantitatively each 

15 ingredient of such tobacco product to the 

16 extent required in regulations which shall 

17 be issued by the Secretary after an oppor18 tunity for a hearing; 

19 ‘‘(9) if it is a tobacco product subject to a to20 bacco product standard established under section 

21 907, unless it bears such labeling as may be pre22 scribed in such tobacco product standard; or 

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

24 ‘‘(A) to comply with any requirement pre25 scribed under section 904 or 908; or 


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1 ‘‘(B) to furnish any material or informa2 tion required under section 909. 

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

4 The Secretary may, by regulation, require prior approval 

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

6 regulation issued under this subsection may require prior 

7 approval by the Secretary of the content of any advertise8 ment, except for modified risk tobacco products as pro9 vided in section 911. No advertisement of a tobacco prod10 uct published after the date of enactment of the Family 

11 Smoking Prevention and Tobacco Control Act shall, with 

12 respect to the language of label statements as prescribed 

13 under section 4 of the Cigarette Labeling and Advertising 

14 Act and section 3 of the Comprehensive Smokeless To15 bacco Health Education Act of 1986 or the regulations 

16 issued under such sections, be subject to the provisions 

17 of sections 12 through 15 of the Federal Trade Commis18 sion Act. 

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

20 SECRETARY. 

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

22 the date of enactment of the Family Smoking Prevention 

23 and Tobacco Control Act, each tobacco product manufac24 turer or importer, or agents thereof, shall submit to the 

25 Secretary the following information: 


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1 ‘‘(1) A listing of all ingredients, including to2 bacco, substances, compounds, and additives that 

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

4 the tobacco, paper, filter, or other part of each to5 bacco product by brand and by quantity in each 

6 brand and subbrand. 

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

8 form of nicotine in each tobacco product measured 

9 in milligrams of nicotine in accordance with regula10 tions promulgated by the Secretary in accordance 

11 with section 4(a)(5) of the Federal Cigarette Label12 ing and Advertising Act. 

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

14 smoke constituents as applicable, identified by the 

15 Secretary as harmful or potentially harmful to 

16 health in each tobacco product, and as applicable in 

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

18 quantity in each brand and subbrand. Effective be19 ginning 2 years after the date of enactment of this 

20 chapter, the manufacturer, importer, or agent shall 

21 comply with regulations promulgated under section 

22 916 in reporting information under this paragraph, 

23 where applicable. 

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

25 enactment of the Family Smoking Prevention and 


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1 Tobacco Control Act that relate to health, toxi2 cological, behavioral, or physiologic effects of current 

3 or future tobacco products, their constituents (in4 cluding smoke constituents), ingredients, compo5 nents, and additives. 

6 ‘‘(b) DATA SUBMISSION.—At the request of the Sec7 retary, each tobacco product manufacturer or importer of 

8 tobacco products, or agents thereof, shall submit the fol9 lowing: 

10 ‘‘(1) Any or all documents (including under11 lying scientific information) relating to research ac12 tivities, and research findings, conducted, supported, 

13 or possessed by the manufacturer (or agents thereof) 

14 on the health, toxicological, behavioral, or physio15 logic effects of tobacco products and their constitu16 ents (including smoke constituents), ingredients, 

17 components, and additives. 

18 ‘‘(2) Any or all documents (including under19 lying scientific information) relating to research ac20 tivities, and research findings, conducted, supported, 

21 or possessed by the manufacturer (or agents thereof) 

22 that relate to the issue of whether a reduction in 

23 risk to health from tobacco products can occur upon 

24 the employment of technology available or known to 

25 the manufacturer. 


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1 ‘‘(3) Any or all documents (including under2 lying scientific or financial information) relating to 

3 marketing research involving the use of tobacco 

4 products or marketing practices and the effective5 ness of such practices used by tobacco manufactur6 ers and distributors. 

7 An importer of a tobacco product not manufactured in the 

8 United States shall supply the information required of a 

9 tobacco product manufacturer under this subsection. 

10 ‘‘(c) TIME FOR SUBMISSION.— 

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

12 the delivery for introduction into interstate com13 merce of a tobacco product not on the market on the 

14 date of enactment of the Family Smoking Preven15 tion and Tobacco Control Act, the manufacturer of 

16 such product shall provide the information required 

17 under subsection (a). 

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

19 time a tobacco product manufacturer adds to its to20 bacco products a new tobacco additive or increases 

21 the quantity of an existing tobacco additive, the 

22 manufacturer shall, except as provided in paragraph 

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

24 the Secretary in writing. 


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

2 any time a tobacco product manufacturer eliminates 

3 or decreases an existing additive, or adds or in4 creases an additive that has by regulation been des5 ignated by the Secretary as an additive that is not 

6 a human or animal carcinogen, or otherwise harmful 

7 to health under intended conditions of use, the man8 ufacturer shall within 60 days of such action so ad9 vise the Secretary in writing. 

10 ‘‘(d) DATA LIST.— 

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

12 after the date of enactment of the Family Smoking 

13 Prevention and Tobacco Control Act, and annually 

14 thereafter, the Secretary shall publish in a format 

15 that is understandable and not misleading to a lay 

16 person, and place on public display (in a manner de17 termined by the Secretary) the list established under 

18 subsection (e). 

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

20 shall conduct periodic consumer research to ensure 

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

22 misleading to lay persons. Not later than 5 years 

23 after the date of enactment of the Family Smoking 

24 Prevention and Tobacco Control Act, the Secretary 

25 shall submit to the appropriate committees of ConVerDate Aug 31 2005 19:44 Feb 24, 2007 Jkt 049200 PO 00000 Frm 00034 Fmt 6652 Sfmt 6201 E:\BILLS\S625.IS S625

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1 gress a report on the results of such research, to2 gether with recommendations on whether such publi3 cation should be continued or modified. 

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

5 after the date of enactment of the Family Smoking Pre6 vention and Tobacco Control Act, the Secretary shall es7 tablish a list of harmful and potentially harmful constitu8 ents, including smoke constituents, to health in each to9 bacco product by brand and by quantity in each brand 

10 and subbrand. The Secretary shall publish a public notice 

11 requesting the submission by interested persons of sci12 entific and other information concerning the harmful and 

13 potentially harmful constituents in tobacco products and 

14 tobacco smoke. 

15 ‘‘SEC. 905. ANNUAL REGISTRATION. 

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

17 ‘‘(1) MANUFACTURE, PREPARATION, 

18 COMPOUNDING, OR PROCESSING.—The term ‘manu19 facture, preparation, compounding, or processing’ 

20 shall include repackaging or otherwise changing the 

21 container, wrapper, or labeling of any tobacco prod22 uct package in furtherance of the distribution of the 

23 tobacco product from the original place of manufac24 ture to the person who makes final delivery or sale 

25 to the ultimate consumer or user. 


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

2 the case of a partnership the name of each partner 

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

4 corporate officer and director, and the State of in5 corporation. 

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

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

8 owns or operates any establishment in any State engaged 

9 in the manufacture, preparation, compounding, or proc10 essing of a tobacco product or tobacco products shall reg11 ister with the Secretary the name, places of business, and 

12 all such establishments of that person. 

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

16 product or tobacco products in any establishment owned 

17 or operated in any State by that person shall immediately 

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

19 business, and such establishment. 

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

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

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

24 in any State and in which that person begins the manufacVerDate Aug 31 2005 19:44 Feb 24, 2007 Jkt 049200 PO 00000 Frm 00036 Fmt 6652 Sfmt 6201 E:\BILLS\S625.IS S625

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1 ture, preparation, compounding, or processing of a tobacco 

2 product or tobacco products. 

3 ‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYS4 TEM.—The Secretary may by regulation prescribe a uni5 form system for the identification of tobacco products and 

6 may require that persons who are required to list such 

7 tobacco products under subsection (i) shall list such to8 bacco products in accordance with such system. 

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

11 to any person so requesting, any registration filed under 

12 this section. 

13 ‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB14 LISHMENTS.—Every establishment in any State registered 

15 with the Secretary under this section shall be subject to 

16 inspection under section 704, and every such establish17 ment engaged in the manufacture, compounding, or proc18 essing of a tobacco product or tobacco products shall be 

19 so inspected by 1 or more officers or employees duly des20 ignated by the Secretary at least once in the 2-year period 

21 beginning with the date of registration of such establish22 ment under this section and at least once in every succes23 sive 2-year period thereafter. 

24 ‘‘(h) FOREIGN ESTABLISHMENTS SHALL REG25 ISTER.—Any establishment within any foreign country enVerDate Aug 31 2005 19:44 Feb 24, 2007 Jkt 049200 PO 00000 Frm 00037 Fmt 6652 Sfmt 6201 E:\BILLS\S625.IS S625

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1 gaged in the manufacture, preparation, compounding, or 

2 processing of a tobacco product or tobacco products, shall 

3 register under this section under regulations promulgated 

4 by the Secretary. Such regulations shall require such es5 tablishment to provide the information required by sub6 section (i) of this section and shall include provisions for 

7 registration of any such establishment upon condition that 

8 adequate and effective means are available, by arrange9 ment with the government of such foreign country or oth10 erwise, to enable the Secretary to determine from time to 

11 time whether tobacco products manufactured, prepared, 

12 compounded, or processed in such establishment, if im13 ported or offered for import into the United States, shall 

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

15 section 801(a). 

16 ‘‘(i) REGISTRATION INFORMATION.— 

17 ‘‘(1) PRODUCT LIST.—Every person who reg18 isters with the Secretary under subsection (b), (c), 

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

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

21 all tobacco products which are being manufactured, 

22 prepared, compounded, or processed by that person 

23 for commercial distribution and which has not been 

24 included in any list of tobacco products filed by that 

25 person with the Secretary under this paragraph or 


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

2 list shall be prepared in such form and manner as 

3 the Secretary may prescribe and shall be accom4 panied by— 

5 ‘‘(A) in the case of a tobacco product con6 tained in the applicable list with respect to 

7 which a tobacco product standard has been es8 tablished under section 907 or which is subject 

9 to section 910, a reference to the authority for 

10 the marketing of such tobacco product and a 

11 copy of all labeling for such tobacco product; 

12 ‘‘(B) in the case of any other tobacco prod13 uct contained in an applicable list, a copy of all 

14 consumer information and other labeling for 

15 such tobacco product, a representative sampling 

16 of advertisements for such tobacco product, 

17 and, upon request made by the Secretary for 

18 good cause, a copy of all advertisements for a 

19 particular tobacco product; and 

20 ‘‘(C) if the registrant filing a list has de21 termined that a tobacco product contained in 

22 such list is not subject to a tobacco product 

23 standard established under section 907, a brief 

24 statement of the basis upon which the reg25 istrant made such determination if the SecVerDate Aug 31 2005 19:44 Feb 24, 2007 Jkt 049200 PO 00000 Frm 00039 Fmt 6652 Sfmt 6201 E:\BILLS\S625.IS S625

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1 retary requests such a statement with respect 

2 to that particular tobacco product. 

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

4 PRODUCT LIST.—Each person who registers with the 

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

7 and once during the month of December of each 

8 year the following: 

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

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

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

15 tobacco product by its established name and 

16 shall be accompanied by the other information 

17 required by paragraph (1). 

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

19 made a report under this paragraph that person 

20 has discontinued the manufacture, preparation, 

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

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

24 notice of such discontinuance, the date of such 


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1 discontinuance, and the identity of its estab2 lished name. 

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

9 of discontinuance was reported, notice of such 

10 resumption, the date of such resumption, the 

11 identity of such tobacco product by established 

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

14 reported such resumption to the Secretary 

15 under this subparagraph. 

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

18 or paragraph (1). 

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

21 INTERSTATE COMMERCE.— 

22 ‘‘(1) IN GENERAL.—Each person who is re23 quired to register under this section and who pro24 poses to begin the introduction or delivery for intro25 duction into interstate commerce for commercial disVerDate Aug 31 2005 19:44 Feb 24, 2007 Jkt 049200 PO 00000 Frm 00041 Fmt 6652 Sfmt 6201 E:\BILLS\S625.IS S625

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1 tribution of a tobacco product intended for human 

2 use that was not commercially marketed (other than 

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

4 1, 2003, shall, at least 90 days prior to making such 

5 introduction or delivery, report to the Secretary (in 

6 such form and manner as the Secretary shall pre7 scribe)— 

8 ‘‘(A) the basis for such person’s determina9 tion that the tobacco product is substantially 

10 equivalent, within the meaning of section 910, 

11 to a tobacco product commercially marketed 

12 (other than for test marketing) in the United 

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

14 with the requirements of this Act; and 

15 ‘‘(B) action taken by such person to com16 ply with the requirements under section 907 

17 that are applicable to the tobacco product. 

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

19 2003 PRODUCTS.—A report under this subsection for 

20 a tobacco product that was first introduced or deliv21 ered for introduction into interstate commerce for 

22 commercial distribution in the United States after 

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

24 months after the date of enactment of the Family 

25 Smoking Prevention and Tobacco Control Act shall 


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1 be submitted to the Secretary not later than 15 

2 months after such date of enactment. 

3 ‘‘(3) EXEMPTIONS.— 

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

5 regulation, exempt from the requirements of 

6 this subsection tobacco products that are modi7 fied by adding or deleting a tobacco additive, or 

8 increasing or decreasing the quantity of an ex9 isting tobacco additive, if the Secretary deter10 mines that— 

11 ‘‘(i) such modification would be a 

12 minor modification of a tobacco product 

13 authorized for sale under this Act; 

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

15 not necessary to ensure that permitting the 

16 tobacco product to be marketed would be 

17 appropriate for protection of the public 

18 health; and 

19 ‘‘(iii) an exemption is otherwise appro20 priate. 

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

22 months after the date of enactment of the Fam23 ily Smoking Prevention and Tobacco Control 

24 Act, the Secretary shall issue regulations to im25 plement this paragraph. 


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1 ‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL 

2 OF TOBACCO PRODUCTS. 

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

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

5 tobacco product shall apply to such tobacco product until 

6 the applicability of the requirement to the tobacco product 

7 has been changed by action taken under section 907, sec8 tion 910, section 911, or subsection (d) of this section, 

9 and any requirement established by or under section 902, 

10 903, 905, or 909 which is inconsistent with a requirement 

11 imposed on such tobacco product under section 907, sec12 tion 910, section 911, or subsection (d) of this section 

13 shall not apply to such tobacco product. 

14 ‘‘(b) INFORMATION ON PUBLIC ACCESS AND COM15 MENT.—Each notice of proposed rulemaking or other noti16 fication under section 907, 908, 909, 910, or 911 or under 

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

18 Federal Register with respect to any other action taken 

19 under any such section and which states the reasons for 

20 such action, and each publication of findings required to 

21 be made in connection with rulemaking under any such 

22 section shall set forth— 

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

24 may examine data and other information on which 

25 the notice or findings is based; and 


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

2 may present their comments on the notice or find3 ings (including the need therefore) orally or in writ4 ing, which period shall be at least 60 days but may 

5 not exceed 90 days unless the time is extended by 

6 the Secretary by a notice published in the Federal 

7 Register stating good cause therefore. 

8 ‘‘(c) LIMITED CONFIDENTIALITY OF INFORMA9 TION.—Any information reported to or otherwise obtained 

10 by the Secretary or the Secretary’s representative under 

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

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

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

14 5, United States Code, by reason of subsection (b)(4) of 

15 that section shall be considered confidential and shall not 

16 be disclosed, except that the information may be disclosed 

17 to other officers or employees concerned with carrying out 

18 this chapter, or when relevant in any proceeding under 

19 this chapter. 

20 ‘‘(d) RESTRICTIONS.— 

21 ‘‘(1) IN GENERAL.—The Secretary may by reg22 ulation require restrictions on the sale and distribu23 tion of a tobacco product, including restrictions on 

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

25 the tobacco product, if the Secretary determines that 


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1 such regulation would be appropriate for the protec2 tion of the public health. The Secretary may by reg3 ulation impose restrictions on the advertising and 

4 promotion of a tobacco product consistent with and 

5 to full extent permitted by the first amendment to 

6 the Constitution. The finding as to whether such 

7 regulation would be appropriate for the protection of 

8 the public health shall be determined with respect to 

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

10 including users and non-users of the tobacco prod11 uct, and taking into account— 

12 ‘‘(A) the increased or decreased likelihood 

13 that existing users of tobacco products will stop 

14 using such products; and 

15 ‘‘(B) the increased or decreased likelihood 

16 that those who do not use tobacco products will 

17 start using such products. 

18 No such regulation may require that the sale or dis19 tribution of a tobacco product be limited to the writ20 ten or oral authorization of a practitioner licensed 

21 by law to prescribe medical products. 

22 ‘‘(2) LABEL STATEMENTS.—The label of a to23 bacco product shall bear such appropriate state24 ments of the restrictions required by a regulation 


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

2 regulation prescribe. 

3 ‘‘(3) LIMITATIONS.— 

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

5 paragraph (1) may— 

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

7 product in face-to-face transactions by a 

8 specific category of retail outlets; or 

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

10 of tobacco products to any person older 

11 than 18 years of age. 

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

13 regulations issued by the Secretary, matchbooks 

14 of conventional size containing not more than 

15 20 paper matches, and which are customarily 

16 given away for free with the purchase of to17 bacco products shall be considered as adult 

18 written publications which shall be permitted to 

19 contain advertising. Notwithstanding the pre20 ceding sentence, if the Secretary finds that such 

21 treatment of matchbooks is not appropriate for 

22 the protection of the public health, the Sec23 retary may determine by regulation that match24 books shall not be considered adult written pub25 lications. 


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1 ‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE2 MENTS.— 

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

4 CONFORM.— 

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

6 accordance with subparagraph (B), prescribe 

7 regulations (which may differ based on the type 

8 of tobacco product involved) requiring that the 

9 methods used in, and the facilities and controls 

10 used for, the manufacture, pre-production de11 sign validation (including a process to assess 

12 the performance of a tobacco product), packing 

13 and storage of a tobacco product, conform to 

14 current good manufacturing practice, as pre15 scribed in such regulations, to assure that the 

16 public health is protected and that the tobacco 

17 product is in compliance with this chapter. 

18 Good manufacturing practices may include the 

19 testing of raw tobacco for pesticide chemical 

20 residues regardless of whether a tolerance for 

21 such chemical residues has been established. 

22 ‘‘(B) REQUIREMENTS.—The Secretary 

23 shall— 

24 ‘‘(i) before promulgating any regula25 tion under subparagraph (A), afford the 


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1 Tobacco Products Scientific Advisory Com2 mittee an opportunity to submit rec3 ommendations with respect to the regula4 tion proposed to be promulgated; 

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

8 ‘‘(iii) provide the Tobacco Products 

9 Scientific Advisory Committee a reasonable 

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

13 ‘‘(iv) in establishing the effective date 

14 of a regulation promulgated under this 

15 subsection, take into account the dif16 ferences in the manner in which the dif17 ferent types of tobacco products have his18 torically been produced, the financial re19 sources of the different tobacco product 

20 manufacturers, and the state of their exist21 ing manufacturing facilities, and shall pro22 vide for a reasonable period of time for 

23 such manufacturers to conform to good 

24 manufacturing practices. 

25 ‘‘(2) EXEMPTIONS; VARIANCES.— 


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

2 any requirement prescribed under paragraph 

3 (1) may petition the Secretary for a permanent 

4 or temporary exemption or variance from such 

5 requirement. Such a petition shall be submitted 

6 to the Secretary in such form and manner as 

7 the Secretary shall prescribe and shall— 

8 ‘‘(i) in the case of a petition for an ex9 emption from a requirement, set forth the 

10 basis for the petitioner’s determination 

11 that compliance with the requirement is 

12 not required to assure that the tobacco 

13 product will be in compliance with this 

14 chapter; 

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

16 variance from a requirement, set forth the 

17 methods proposed to be used in, and the 

18 facilities and controls proposed to be used 

19 for, the manufacture, packing, and storage 

20 of the tobacco product in lieu of the meth21 ods, facilities, and controls prescribed by 

22 the requirement; and 

23 ‘‘(iii) contain such other information 

24 as the Secretary shall prescribe. 


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1 ‘‘(B) REFERRAL TO THE TOBACCO PROD2 UCTS SCIENTIFIC ADVISORY COMMITTEE.—The 

3 Secretary may refer to the Tobacco Products 

4 Scientific Advisory Committee any petition sub5 mitted under subparagraph (A). The Tobacco 

6 Products Scientific Advisory Committee shall 

7 report its recommendations to the Secretary 

8 with respect to a petition referred to it within 

9 60 days after the date of the petition’s referral. 

10 Within 60 days after— 

11 ‘‘(i) the date the petition was sub12 mitted to the Secretary under subpara13 graph (A); or 

14 ‘‘(ii) the day after the petition was re15 ferred to the Tobacco Products Scientific 

16 Advisory Committee, 

17 whichever occurs later, the Secretary shall by 

18 order either deny the petition or approve it. 

19 ‘‘(C) APPROVAL.—The Secretary may ap20 prove— 

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

22 tobacco product from a requirement if the 

23 Secretary determines that compliance with 

24 such requirement is not required to assure 


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1 that the tobacco product will be in compli2 ance with this chapter; and 

3 ‘‘(ii) a petition for a variance for a to4 bacco product from a requirement if the 

5 Secretary determines that the methods to 

6 be used in, and the facilities and controls 

7 to be used for, the manufacture, packing, 

8 and storage of the tobacco product in lieu 

9 of the methods, controls, and facilities pre10 scribed by the requirement are sufficient to 

11 assure that the tobacco product will be in 

12 compliance with this chapter. 

13 ‘‘(D) CONDITIONS.—An order of the Sec14 retary approving a petition for a variance shall 

15 prescribe such conditions respecting the meth16 ods used in, and the facilities and controls used 

17 for, the manufacture, packing, and storage of 

18 the tobacco product to be granted the variance 

19 under the petition as may be necessary to as20 sure that the tobacco product will be in compli21 ance with this chapter. 

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

23 order under subparagraph (B) respecting a pe24 tition, the petitioner shall have an opportunity 

25 for an informal hearing on such order. 


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1 ‘‘(3) COMPLIANCE.—Compliance with require2 ments under this subsection shall not be required be3 fore the period ending 3 years after the date of en4 actment of the Family Smoking Prevention and To5 bacco Control Act. 

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

7 may enter into contracts for research, testing, and dem8 onstrations respecting tobacco products and may obtain 

9 tobacco products for research, testing, and demonstration 

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

11 31, United States Code, and section 5 of title 41, United 

12 States Code. 

13 ‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 

14 ‘‘(a) IN GENERAL.— 

15 ‘‘(1) SPECIAL RULE FOR CIGARETTES.—A ciga16 rette or any of its component parts (including the 

17 tobacco, filter, or paper) shall not contain, as a con18 stituent (including a smoke constituent) or additive, 

19 an artificial or natural flavor (other than tobacco or 

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

21 grape, orange, clove, cinnamon, pineapple, vanilla, 

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

23 that is a characterizing flavor of the tobacco product 

24 or tobacco smoke. Nothing in this subparagraph 

25 shall be construed to limit the Secretary’s authority 


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1 to take action under this section or other sections of 

2 this Act applicable to menthol or any artificial or 

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

4 paragraph. 

5 ‘‘(2) REVISION OF TOBACCO PRODUCT STAND6 ARDS.—The Secretary may revise the tobacco prod7 uct standards in paragraph (1) in accordance with 

8 subsection (b). 

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

10 Secretary may adopt tobacco product standards in 

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

12 finds that a tobacco product standard is appropriate 

13 for the protection of the public health. This finding 

14 shall be determined with respect to the risks and 

15 benefits to the population as a whole, including 

16 users and non-users of the tobacco product, and tak17 ing into account— 

18 ‘‘(A) the increased or decreased likelihood 

19 that existing users of tobacco products will stop 

20 using such products; and 

21 ‘‘(B) the increased or decreased likelihood 

22 that those who do not use tobacco products will 

23 start using such products. 


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1 ‘‘(4) CONTENT OF TOBACCO PRODUCT STAND2 ARDS.—A tobacco product standard established 

3 under this section for a tobacco product— 

4 ‘‘(A) shall include provisions that are ap5 propriate for the protection of the public health, 

6 including provisions, where appropriate— 

7 ‘‘(i) for the reduction of nicotine 

8 yields of the product; 

9 ‘‘(ii) for the reduction or elimination 

10 of other constituents, including smoke con11 stituents, or harmful components of the 

12 product; or 

13 ‘‘(iii) relating to any other require14 ment under subparagraph (B); 

15 ‘‘(B) shall, where appropriate for the pro16 tection of the public health, include— 

17 ‘‘(i) provisions respecting the con18 struction, components, ingredients, addi19 tives, constituents, including smoke con20 stituents, and properties of the tobacco 

21 product; 

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

23 sample basis or, if necessary, on an indi24 vidual basis) of the tobacco product; 


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1 ‘‘(iii) provisions for the measurement 

2 of the tobacco product characteristics of 

3 the tobacco product; 

4 ‘‘(iv) provisions requiring that the re5 sults of each or of certain of the tests of 

6 the tobacco product required to be made 

7 under clause (ii) show that the tobacco 

8 product is in conformity with the portions 

9 of the standard for which the test or tests 

10 were required; and 

11 ‘‘(v) a provision requiring that the 

12 sale and distribution of the tobacco prod13 uct be restricted but only to the extent 

14 that the sale and distribution of a tobacco 

15 product may be restricted under a regula16 tion under section 906(d); and 

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

18 use and prescribe the form and content of label19 ing for the proper use of the tobacco product. 

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

21 PRODUCT STANDARDS.—The Secretary shall provide 

22 for periodic evaluation of tobacco product standards 

23 established under this section to determine whether 

24 such standards should be changed to reflect new 

25 medical, scientific, or other technological data. The 


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1 Secretary may provide for testing under paragraph 

2 (4)(B) by any person. 

3 ‘‘(6) INVOLVEMENT OF OTHER AGENCIES; IN4 FORMED PERSONS.—In carrying out duties under 

5 this section, the Secretary shall endeavor to— 

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

7 technical support available in other Federal 

8 agencies; 

9 ‘‘(B) consult with other Federal agencies 

10 concerned with standard-setting and other na11 tionally or internationally recognized standard12 setting entities; and 

13 ‘‘(C) invite appropriate participation, 

14 through joint or other conferences, workshops, 

15 or other means, by informed persons represent16 ative of scientific, professional, industry, agri17 cultural, or consumer organizations who in the 

18 Secretary’s judgment can make a significant 

19 contribution. 

20 ‘‘(b) ESTABLISHMENT OF STANDARDS.— 

21 ‘‘(1) NOTICE.— 

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

23 publish in the Federal Register a notice of pro24 posed rulemaking for the establishment, amendVerDate Aug 31 2005 19:44 Feb 24, 2007 Jkt 049200 PO 00000 Frm 00057 Fmt 6652 Sfmt 6201 E:\BILLS\S625.IS S625

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1 ment, or revocation of any tobacco product 

2 standard. 

3 ‘‘(B) REQUIREMENTS OF NOTICE.—A no4 tice of proposed rulemaking for the establish5 ment or amendment of a tobacco product stand6 ard for a tobacco product shall— 

7 ‘‘(i) set forth a finding with sup8 porting justification that the tobacco prod9 uct standard is appropriate for the protec10 tion of the public health; 

11 ‘‘(ii) set forth proposed findings with 

12 respect to the risk of illness or injury that 

13 the tobacco product standard is intended 

14 to reduce or eliminate; and 

15 ‘‘(iii) invite interested persons to sub16 mit an existing tobacco product standard 

17 for the tobacco product, including a draft 

18 or proposed tobacco product standard, for 

19 consideration by the Secretary. 

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

21 by the Secretary that an additive, constituent 

22 (including smoke constituent), or other compo23 nent of the product that is the subject of the 

24 proposed tobacco product standard is harmful, 

25 it shall be the burden of any party challenging 


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1 the proposed standard to prove that the pro2 posed standard will not reduce or eliminate the 

3 risk of illness or injury. 

4 ‘‘(D) FINDING.—A notice of proposed rule5 making for the revocation of a tobacco product 

6 standard shall set forth a finding with sup7 porting justification that the tobacco product 

8 standard is no longer appropriate for the pro9 tection of the public health. 

10 ‘‘(E) CONSIDERATION BY SECRETARY.— 

11 The Secretary shall consider all information 

12 submitted in connection with a proposed stand13 ard, including information concerning the coun14 tervailing effects of the tobacco product stand15 ard on the health of adolescent tobacco users, 

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

17 as the creation of a significant demand for con18 traband or other tobacco products that do not 

19 meet the requirements of this chapter and the 

20 significance of such demand, and shall issue the 

21 standard if the Secretary determines that the 

22 standard would be appropriate for the protec23 tion of the public health. 


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1 ‘‘(F) COMMENT.—The Secretary shall pro2 vide for a comment period of not less than 60 

3 days. 

4 ‘‘(2) PROMULGATION.— 

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

6 the period for comment on a notice of proposed 

7 rulemaking published under paragraph (1) re8 specting a tobacco product standard and after 

9 consideration of such comments and any report 

10 from the Tobacco Products Scientific Advisory 

11 Committee, the Secretary shall— 

12 ‘‘(i) promulgate a regulation estab13 lishing a tobacco product standard and 

14 publish in the Federal Register findings on 

15 the matters referred to in paragraph (1); 

16 or 

17 ‘‘(ii) publish a notice terminating the 

18 proceeding for the development of the 

19 standard together with the reasons for 

20 such termination. 

21 ‘‘(B) EFFECTIVE DATE.—A regulation es22 tablishing a tobacco product standard shall set 

23 forth the date or dates upon which the standard 

24 shall take effect, but no such regulation may 

25 take effect before 1 year after the date of its 


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1 publication unless the Secretary determines 

2 that an earlier effective date is necessary for 

3 the protection of the public health. Such date or 

4 dates shall be established so as to minimize, 

5 consistent with the public health, economic loss 

6 to, and disruption or dislocation of, domestic 

7 and international trade. 

8 ‘‘(3) POWER RESERVED TO CONGRESS.—Be9 cause of the importance of a decision of the Sec10 retary to issue a regulation establishing a tobacco 

11 product standard— 

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

13 tobacco products, all little cigars, all cigars 

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

15 roll your own tobacco products; or 

16 ‘‘(B) requiring the reduction of nicotine 

17 yields of a tobacco product to zero, 

18 Congress expressly reserves to itself such power. 

19 ‘‘(4) AMENDMENT; REVOCATION.— 

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

21 the Secretary’s own initiative or upon petition 

22 of an interested person may by a regulation, 

23 promulgated in accordance with the require24 ments of paragraphs (1) and (2)(B), amend or 

25 revoke a tobacco product standard. 


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

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

4 after its publication in the Federal Register and 

5 until the effective date of any final action taken 

6 on such amendment if the Secretary determines 

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

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

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

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

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

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

17 the exercise of scientific judgment. 

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

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

22 or 

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

24 person that— 


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1 ‘‘(I) demonstrates good cause for 

2 the referral; and 

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

5 comments on the proposed regulation. 

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

7 regulation is referred under this paragraph to 

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

10 Committee with the data and information on 

11 which such proposed regulation is based. 

12 ‘‘(D) REPORT AND RECOMMENDATION.— 

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

15 a proposed regulation under this paragraph and 

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

18 other data and information before it, submit to 

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

22 of the reason or basis for the recommendation. 

23 ‘‘(E) PUBLIC AVAILABILITY.—The Sec24 retary shall make a copy of each report and recVerDate Aug 31 2005 19:44 Feb 24, 2007 Jkt 049200 PO 00000 Frm 00063 Fmt 6652 Sfmt 6201 E:\BILLS\S625.IS S625

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1 ommendation under subparagraph (D) publicly 

2 available. 

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

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

5 that— 

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

7 delivered for introduction into interstate commerce 

8 for commercial distribution presents an unreasonable 

9 risk of substantial harm to the public health; and 

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

12 harm and no more practicable means is available 

13 under the provisions of this chapter (other than this 

14 section) to eliminate such risk, 

15 the Secretary may issue such order as may be necessary 

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

18 under the circumstances involved, to all persons who 

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

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

23 Secretary shall consult with the persons who are to give 

24 notice under the order. 


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

2 Compliance with an order issued under this section shall 

3 not relieve any person from liability under Federal or 

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

5 action brought for the enforcement of any such liability, 

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

7 provided under such order shall be taken into account. 

8 ‘‘(c) RECALL AUTHORITY.— 

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

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

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

15 order requiring the appropriate person (including 

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

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

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

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

23 on whether the order should be amended to require 

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

25 an opportunity for such a hearing, the Secretary deVerDate Aug 31 2005 19:44 Feb 24, 2007 Jkt 049200 PO 00000 Frm 00065 Fmt 6652 Sfmt 6201 E:\BILLS\S625.IS S625

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1 termines that inadequate grounds exist to support 

2 the actions required by the order, the Secretary shall 

3 vacate the order. 

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

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

7 opportunity for an informal hearing under 

8 paragraph (1), the Secretary determines that 

9 the order should be amended to include a recall 

10 of the tobacco product with respect to which the 

11 order was issued, the Secretary shall, except as 

12 provided in subparagraph (B), amend the order 

13 to require a recall. The Secretary shall specify 

14 a timetable in which the tobacco product recall 

15 will occur and shall require periodic reports to 

16 the Secretary describing the progress of the re17 call. 

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

19 subparagraph (A)— 

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

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

24 the use of such tobacco product. 


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

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

5 persons cannot be identified, the Secretary shall 

6 notify such persons under section 705(b). 

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

8 provided by this subsection shall be in addition to 

9 remedies provided by subsection (a) of this section. 

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

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

13 product manufacturer or importer of a tobacco product 

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

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

18 otherwise protect public health. Regulations prescribed 

19 under the preceding sentence— 

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

24 suggests that one of its marketed tobacco products 

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1 pected adverse experience associated with the use of 

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

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

6 adverse tobacco product experiences as determined 

7 by the Secretary to be necessary to be reported; 

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

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

13 this chapter; 

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

15 requests for reports or information, shall require 

16 that each request made under such regulations for 

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

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

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

22 information to the Secretary, shall state the reason 

23 or purpose for the submission of such report or in24 formation and identify to the fullest extent prac25 ticable such report or information; and 


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

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

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

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

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

10 the medical profession and the interests of patients. The 

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

12 reports, and information concerning any individual who 

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

14 ceases to be a patient. 

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

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

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

20 any corrective action taken or removal from the 

21 market of a tobacco product undertaken by such 

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

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

25 the tobacco product; or 


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

2 caused by the tobacco product which may 

3 present a risk to health. 

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

6 removal from the market of a tobacco product which 

7 is not required to be reported under this subsection 

8 shall keep a record of such correction or removal. 

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

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

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

16 ‘‘(a) IN GENERAL.— 

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

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

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

21 products in test markets) that was not commer22 cially marketed in the United States as of June 

23 1, 2003; or 

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

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1 stituent, including a smoke constituent, or in 

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

3 other additive or ingredient) of a tobacco prod4 uct where the modified product was commer5 cially marketed in the United States after June 

6 1, 2003. 

7 ‘‘(2) PREMARKET APPROVAL REQUIRED.— 

8 ‘‘(A) NEW PRODUCTS.—Approval under 

9 this section of an application for premarket ap10 proval for any new tobacco product is required 

11 unless— 

12 ‘‘(i) the manufacturer has submitted a 

13 report under section 905(j); and 

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

15 that the tobacco product— 

16 ‘‘(I) is substantially equivalent to 

17 a tobacco product commercially mar18 keted (other than for test marketing) 

19 in the United States as of June 1, 

20 2003; and 

21 ‘‘(II)(aa) is in compliance with 

22 the requirements of this Act; or 

23 ‘‘(bb) is exempt from the require24 ments of section 905(j) pursuant to a 


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1 regulation issued under section 

2 905(j)(3). 

3 ‘‘(B) APPLICATION TO CERTAIN POST

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

5 shall not apply to a tobacco product— 

6 ‘‘(i) that was first introduced or deliv7 ered for introduction into interstate com8 merce for commercial distribution in the 

9 United States after June 1, 2003, and 

10 prior to the date that is 15 months after 

11 the date of enactment of the Family Smok12 ing Prevention and Tobacco Control Act; 

13 and 

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

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

16 period, 

17 except that subparagraph (A) shall apply to the 

18 tobacco product if the Secretary issues an order 

19 that the tobacco product is not substantially 

20 equivalent. 

21 ‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.— 

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

23 section 905(j), the terms ‘substantially equiva24 lent’ or ‘substantial equivalence’ mean, with re25 spect to the tobacco product being compared to 


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1 the predicate tobacco product, that the Sec2 retary by order has found that the tobacco 

3 product— 

4 ‘‘(i) has the same characteristics as 

5 the predicate tobacco product; or 

6 ‘‘(ii) has different characteristics and 

7 the information submitted contains infor8 mation, including clinical data if deemed 

9 necessary by the Secretary, that dem10 onstrates that it is not appropriate to reg11 ulate the product under this section be12 cause the product does not raise different 

13 questions of public health. 

14 ‘‘(B) CHARACTERISTICS.—In subpara15 graph (A), the term ‘characteristics’ means the 

16 materials, ingredients, design, composition, 

17 heating source, or other features of a tobacco 

18 product. 

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

20 not be found to be substantially equivalent to a 

21 predicate tobacco product that has been re22 moved from the market at the initiative of the 

23 Secretary or that has been determined by a ju24 dicial order to be misbranded or adulterated. 

25 ‘‘(4) HEALTH INFORMATION.— 


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

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

5 adequate summary of any health information 

6 related to the tobacco product or state that 

7 such information will be made available upon 

8 request by any person. 

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

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

14 by the Secretary within 30 days of the issuance 

15 of a determination that such tobacco product is 

16 substantially equivalent to another tobacco 

17 product. 

18 ‘‘(b) APPLICATION.— 

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

20 approval shall contain— 

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

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

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1 er such tobacco product presents less risk than 

2 other tobacco products; 

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

4 ingredients, additives, and properties, and of 

5 the principle or principles of operation, of such 

6 tobacco product; 

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

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

9 manufacture, processing, and, when relevant, 

10 packing and installation of, such tobacco prod11 uct; 

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

14 which would be applicable to any aspect of such 

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

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

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

21 and of components thereof as the Secretary 

22 may reasonably require; 

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

24 be used for such tobacco product; and 


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1 ‘‘(G) such other information relevant to 

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

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

6 application meeting the requirements set forth in 

7 paragraph (1), the Secretary— 

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

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

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

14 submission (within such period as the Secretary may 

15 establish) of a report and recommendation respect16 ing approval of the application, together with all un17 derlying data and the reasons or basis for the rec18 ommendation. 

19 ‘‘(c) ACTION ON APPLICATION.— 

20 ‘‘(1) DEADLINE.— 

21 ‘‘(A) IN GENERAL.—As promptly as pos22 sible, but in no event later than 180 days after 

23 the receipt of an application under subsection 

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


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1 and recommendation submitted under para2 graph (2) of such subsection, shall— 

3 ‘‘(i) issue an order approving the ap4 plication if the Secretary finds that none of 

5 the grounds for denying approval specified 

6 in paragraph (2) of this subsection applies; 

7 or 

8 ‘‘(ii) deny approval of the application 

9 if the Secretary finds (and sets forth the 

10 basis for such finding as part of or accom11 panying such denial) that 1 or more 

12 grounds for denial specified in paragraph 

13 (2) of this subsection apply. 

14 ‘‘(B) RESTRICTIONS ON SALE AND DIS15 TRIBUTION.—An order approving an application 

16 for a tobacco product may require as a condi17 tion to such approval that the sale and distribu18 tion of the tobacco product be restricted but 

19 only to the extent that the sale and distribution 

20 of a tobacco product may be restricted under a 

21 regulation under section 906(d). 

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

23 shall deny approval of an application for a tobacco 

24 product if, upon the basis of the information sub25 mitted to the Secretary as part of the application 


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1 and any other information before the Secretary with 

2 respect to such tobacco product, the Secretary finds 

3 that— 

4 ‘‘(A) there is a lack of a showing that per5 mitting such tobacco product to be marketed 

6 would be appropriate for the protection of the 

7 public health; 

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

9 or controls used for, the manufacture, proc10 essing, or packing of such tobacco product do 

11 not conform to the requirements of section 

12 906(e); 

13 ‘‘(C) based on a fair evaluation of all mate14 rial facts, the proposed labeling is false or mis15 leading in any particular; or 

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

17 conform in all respects to a tobacco product 

18 standard in effect under section 907, compli19 ance with which is a condition to approval of 

20 the application, and there is a lack of adequate 

21 information to justify the deviation from such 

22 standard. 

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

24 application shall, insofar as the Secretary determines 

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1 forming the applicant of the measures required to 

2 place such application in approvable form (which 

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

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

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

8 tobacco product is appropriate for the protection of 

9 the public health shall be determined with respect to 

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

11 including users and nonusers of the tobacco product, 

12 and taking into account— 

13 ‘‘(A) the increased or decreased likelihood 

14 that existing users of tobacco products will stop 

15 using such products; and 

16 ‘‘(B) the increased or decreased likelihood 

17 that those who do not use tobacco products will 

18 start using such products. 

19 ‘‘(5) BASIS FOR ACTION.— 

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

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

22 product to be marketed would be appropriate 

23 for the protection of the public health shall, 

24 when appropriate, be determined on the basis of 

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1 clude 1 or more clinical investigations by ex2 perts qualified by training and experience to 

3 evaluate the tobacco product. 

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

5 determines that there exists valid scientific evi6 dence (other than evidence derived from inves7 tigations described in subparagraph (A)) which 

8 is sufficient to evaluate the tobacco product the 

9 Secretary may authorize that the determination 

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

11 the basis of such evidence. 

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

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

14 obtaining, where appropriate, advice on scientific 

15 matters from the Tobacco Products Scientific Advi16 sory Committee, and after due notice and oppor17 tunity for informal hearing to the holder of an ap18 proved application for a tobacco product, issue an 

19 order withdrawing approval of the application if the 

20 Secretary finds— 

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

22 tobacco product no longer is appropriate for the 

23 protection of the public health; 


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

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

4 ‘‘(C) that the applicant— 

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

6 for maintaining records, or has repeatedly 

7 or deliberately failed to maintain records 

8 or to make reports, required by an applica9 ble regulation under section 909; 

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

11 or copying or verification of, such records 

12 as required by section 704; or 

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

15 ‘‘(D) on the basis of new information be16 fore the Secretary with respect to such tobacco 

17 product, evaluated together with the evidence 

18 before the Secretary when the application was 

19 approved, that the methods used in, or the fa20 cilities and controls used for, the manufacture, 

21 processing, packing, or installation of such to22 bacco product do not conform with the require23 ments of section 906(e) and were not brought 

24 into conformity with such requirements within a 


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1 reasonable time after receipt of written notice 

2 from the Secretary of nonconformity; 

3 ‘‘(E) on the basis of new information be4 fore the Secretary, evaluated together with the 

5 evidence before the Secretary when the applica6 tion was approved, that the labeling of such to7 bacco product, based on a fair evaluation of all 

8 material facts, is false or misleading in any par9 ticular and was not corrected within a reason10 able time after receipt of written notice from 

11 the Secretary of such fact; or 

12 ‘‘(F) on the basis of new information be13 fore the Secretary, evaluated together with the 

14 evidence before the Secretary when the applica15 tion was approved, that such tobacco product is 

16 not shown to conform in all respects to a to17 bacco product standard which is in effect under 

18 section 907, compliance with which was a con19 dition to approval of the application, and that 

20 there is a lack of adequate information to jus21 tify the deviation from such standard. 

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

23 subject to an order issued under paragraph (1) with24 drawing approval of the application may, by petition 

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


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1 which such holder receives notice of such with2 drawal, obtain review thereof in accordance with sec3 tion 912. 

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

6 Secretary determines there is reasonable probability 

7 that the continuation of distribution of a tobacco 

8 product under an approved application would cause 

9 serious, adverse health consequences or death, that 

10 is greater than ordinarily caused by tobacco prod11 ucts on the market, the Secretary shall by order 

12 temporarily suspend the approval of the application 

13 approved under this section. If the Secretary issues 

14 such an order, the Secretary shall proceed expedi15 tiously under paragraph (1) to withdraw such appli16 cation. 

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

18 Secretary under this section shall be served— 

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

20 department designated by the Secretary; or 

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

22 certified mail addressed to the applicant at the ap23 plicant’s last known address in the records of the 

24 Secretary. 

25 ‘‘(f) RECORDS.— 


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

2 of any tobacco product for which an approval of an 

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

4 applicant shall establish and maintain such records, 

5 and make such reports to the Secretary, as the Sec6 retary may by regulation, or by order with respect 

7 to such application, prescribe on the basis of a find8 ing that such records and reports are necessary in 

9 order to enable the Secretary to determine, or facili10 tate a determination of, whether there is or may be 

11 grounds for withdrawing or temporarily suspending 

12 such approval. 

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

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

16 request of an officer or employee designated by the 

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

19 such records. 

20 ‘‘(g) INVESTIGATIONAL TOBACCO PRODUCT EXEMP21 TION FOR INVESTIGATIONAL USE.—The Secretary may 

22 exempt tobacco products intended for investigational use 

23 from the provisions of this chapter under such conditions 

24 as the Secretary may by regulation prescribe. 


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

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

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

6 to such product. 

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

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

9 term ‘modified risk tobacco product’ means any to10 bacco product that is sold or distributed for use to 

11 reduce harm or the risk of tobacco-related disease 

12 associated with commercially marketed tobacco prod13 ucts. 

14 ‘‘(2) SOLD OR DISTRIBUTED.— 

15 ‘‘(A) IN GENERAL.—With respect to a to16 bacco product, the term ‘sold or distributed for 

17 use to reduce harm or the risk of tobacco-re18 lated disease associated with commercially mar19 keted tobacco products’ means a tobacco prod20 uct— 

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

22 of which represents explicitly or implicitly 

23 that— 

24 ‘‘(I) the tobacco product presents 

25 a lower risk of tobacco-related disease 

26 or is less harmful than one or more 


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1 other commercially marketed tobacco 

2 products; 

3 ‘‘(II) the tobacco product or its 

4 smoke contains a reduced level of a 

5 substance or presents a reduced expo6 sure to a substance; or 

7 ‘‘(III) the tobacco product or its 

8 smoke does not contain or is free of a 

9 substance; 

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

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

12 or ‘low’ or similar descriptors; or 

13 ‘‘(iii) the tobacco product manufac14 turer of which has taken any action di15 rected to consumers through the media or 

16 otherwise, other than by means of the to17 bacco product’s label, labeling, or adver18 tising, after the date of enactment of the 

19 Family Smoking Prevention and Tobacco 

20 Control Act, respecting the product that 

21 would be reasonably expected to result in 

22 consumers believing that the tobacco prod23 uct or its smoke may present a lower risk 

24 of disease or is less harmful than one or 

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1 ucts, or presents a reduced exposure to, or 

2 does not contain or is free of, a substance 

3 or substances. 

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

5 shall be considered to be ‘sold or distributed for 

6 use to reduce harm or the risk of tobacco-re7 lated disease associated with commercially mar8 keted tobacco products’, except as described in 

9 subparagraph (A). 

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

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

12 dependence, including smoking cessation, is not a modified 

13 risk tobacco product under this section and is subject to 

14 the requirements of chapter V. 

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

17 Such application shall include— 

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

19 any proposed advertising and labeling; 

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

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

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

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

25 conducted, supported, or possessed by the tobacco 


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1 product manufacturer relating to the effect of the 

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

5 reduce risk or exposure and relating to human 

6 health; 

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

8 actually use the tobacco product; and 

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

10 may require. 

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

12 make the application described in subsection (d) publicly 

13 available (except matters in the application which are 

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

16 on the information contained in the application and on the 

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

19 ‘‘(f) ADVISORY COMMITTEE.— 

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

21 the Tobacco Products Scientific Advisory Committee 

22 any application submitted under this subsection. 

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

24 days after the date an application is referred to the 

25 Tobacco Products Scientific Advisory Committee 


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1 under paragraph (1), the Advisory Committee shall 

2 report its recommendations on the application to the 

3 Secretary. 

4 ‘‘(g) APPROVAL.— 

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

6 provided in paragraph (2), the Secretary shall ap7 prove an application for a modified risk tobacco 

8 product filed under this section only if the Secretary 

9 determines that the applicant has demonstrated that 

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

11 will— 

12 ‘‘(A) significantly reduce harm and the 

13 risk of tobacco-related disease to individual to14 bacco users; and 

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

16 as a whole taking into account both users of to17 bacco products and persons who do not cur18 rently use tobacco products. 

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

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

21 approve an application for a tobacco product 

22 that has not been approved as a modified risk 

23 tobacco product pursuant to paragraph (1) if 

24 the Secretary makes the findings required 


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1 under this paragraph and determines that the 

2 applicant has demonstrated that— 

3 ‘‘(i) the approval of the application 

4 would be appropriate to promote the public 

5 health; 

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

7 and advertising for such product that 

8 would cause the tobacco product to be a 

9 modified risk tobacco product under sub10 section (b)(2) is limited to an explicit or 

11 implicit representation that such tobacco 

12 product or its smoke contains or is free of 

13 a substance or contains a reduced level of 

14 a substance, or presents a reduced expo15 sure to a substance in tobacco smoke; 

16 ‘‘(iii) scientific evidence is not avail17 able and, using the best available scientific 

18 methods, cannot be made available without 

19 conducting long-term epidemiological stud20 ies for an application to meet the stand21 ards set forth in paragraph (1); and 

22 ‘‘(iv) the scientific evidence that is 

23 available without conducting long-term epi24 demiological studies demonstrates that a 

25 measurable and substantial reduction in 


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1 morbidity or mortality among individual 

2 tobacco users is anticipated in subsequent 

3 studies. 

4 ‘‘(B) ADDITIONAL FINDINGS REQUIRED.— 

5 In order to approve an application under sub6 paragraph (A) the Secretary must also find 

7 that the applicant has demonstrated that— 

8 ‘‘(i) the magnitude of the overall re9 ductions in exposure to the substance or 

10 substances which are the subject of the ap11 plication is substantial, such substance or 

12 substances are harmful, and the product as 

13 actually used exposes consumers to the 

14 specified reduced level of the substance or 

15 substances; 

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

17 consumers will not expose them to higher 

18 levels of other harmful substances com19 pared to the similar types of tobacco prod20 ucts then on the market unless such in21 creases are minimal and the anticipated 

22 overall impact of use of the product re23 mains a substantial and measurable reduc24 tion in overall morbidity and mortality 

25 among individual tobacco users; 


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

5 that the product— 

6 ‘‘(I) is or has been demonstrated 

7 to be less harmful; or 

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

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

12 ‘‘(iv) approval of the application is ex13 pected to benefit the health of the popu14 lation as a whole taking into account both 

15 users of tobacco products and persons who 

16 do not currently use tobacco products. 

17 ‘‘(C) CONDITIONS OF APPROVAL.— 

18 ‘‘(i) IN GENERAL.—Applications ap19 proved under this paragraph shall be lim20 ited to a term of not more than 5 years, 

21 but may be renewed upon a finding by the 

22 Secretary that the requirements of this 

23 paragraph continue to be satisfied based 

24 on the filing of a new application. 


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1 ‘‘(ii) AGREEMENTS BY APPLICANT.— 

2 Applications approved under this para3 graph shall be conditioned on the appli4 cant’s agreement to conduct post-market 

5 surveillance and studies and to submit to 

6 the Secretary the results of such surveil7 lance and studies to determine the impact 

8 of the application approval on consumer 

9 perception, behavior, and health and to en10 able the Secretary to review the accuracy 

11 of the determinations upon which the ap12 proval was based in accordance with a pro13 tocol approved by the Secretary. 

14 ‘‘(iii) ANNUAL SUBMISSION.—The re15 sults of such post-market surveillance and 

16 studies described in clause (ii) shall be 

17 submitted annually. 

18 ‘‘(3) BASIS.—The determinations under para19 graphs (1) and (2) shall be based on— 

20 ‘‘(A) the scientific evidence submitted by 

21 the applicant; and 

22 ‘‘(B) scientific evidence and other informa23 tion that is available to the Secretary. 

24 ‘‘(4) BENEFIT TO HEALTH OF INDIVIDUALS

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


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

2 Secretary shall take into account— 

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

4 of the tobacco product that is the subject of the 

5 application; 

6 ‘‘(B) the increased or decreased likelihood 

7 that existing users of tobacco products who 

8 would otherwise stop using such products will 

9 switch to the tobacco product that is the subject 

10 of the application; 

11 ‘‘(C) the increased or decreased likelihood 

12 that persons who do not use tobacco products 

13 will start using the tobacco product that is the 

14 subject of the application; 

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

16 from the use of the tobacco product that is the 

17 subject of the application as compared to the 

18 use of products for smoking cessation approved 

19 under chapter V to treat nicotine dependence; 

20 and 

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

22 submitted by interested persons. 

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

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1 tion under this section that any advertising or label2 ing concerning modified risk products enable the 

3 public to comprehend the information concerning 

4 modified risk and to understand the relative signifi5 cance of such information in the context of total 

6 health and in relation to all of the diseases and 

7 health-related conditions associated with the use of 

8 tobacco products. 

9 ‘‘(2) COMPARATIVE CLAIMS.— 

10 ‘‘(A) IN GENERAL.—The Secretary may re11 quire for the approval of an application under 

12 this subsection that a claim comparing a to13 bacco product to 1 or more other commercially 

14 marketed tobacco products shall compare the 

15 tobacco product to a commercially marketed to16 bacco product that is representative of that type 

17 of tobacco product on the market (for example 

18 the average value of the top 3 brands of an es19 tablished regular tobacco product). 

20 ‘‘(B) QUANTITATIVE COMPARISONS.—The 

21 Secretary may also require, for purposes of sub22 paragraph (A), that the percent (or fraction) of 

23 change and identity of the reference tobacco 

24 product and a quantitative comparison of the 

25 amount of the substance claimed to be reduced 


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1 shall be stated in immediate proximity to the 

2 most prominent claim. 

3 ‘‘(3) LABEL DISCLOSURE.— 

4 ‘‘(A) IN GENERAL.—The Secretary may re5 quire the disclosure on the label of other sub6 stances in the tobacco product, or substances 

7 that may be produced by the consumption of 

8 that tobacco product, that may affect a disease 

9 or health-related condition or may increase the 

10 risk of other diseases or health-related condi11 tions associated with the use of tobacco prod12 ucts. 

13 ‘‘(B) CONDITIONS OF USE.—If the condi14 tions of use of the tobacco product may affect 

15 the risk of the product to human health, the 

16 Secretary may require the labeling of conditions 

17 of use. 

18 ‘‘(4) TIME.—The Secretary shall limit an ap19 proval under subsection (g)(1) for a specified period 

20 of time. 

21 ‘‘(5) ADVERTISING.—The Secretary may re22 quire that an applicant, whose application has been 

23 approved under this subsection, comply with require24 ments relating to advertising and promotion of the 

25 tobacco product. 


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

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

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

4 post market surveillance and studies for a tobacco 

5 product for which an application has been approved 

6 to determine the impact of the application approval 

7 on consumer perception, behavior, and health, to en8 able the Secretary to review the accuracy of the de9 terminations upon which the approval was based, 

10 and to provide information that the Secretary deter11 mines is otherwise necessary regarding the use or 

12 health risks involving the tobacco product. The re13 sults of post-market surveillance and studies shall be 

14 submitted to the Secretary on an annual basis. 

15 ‘‘(2) SURVEILLANCE PROTOCOL.—Each appli16 cant required to conduct a surveillance of a tobacco 

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

18 after receiving notice that the applicant is required 

19 to conduct such surveillance, submit, for the ap20 proval of the Secretary, a protocol for the required 

21 surveillance. The Secretary, within 60 days of the 

22 receipt of such protocol, shall determine if the prin23 cipal investigator proposed to be used in the surveil24 lance has sufficient qualifications and experience to 

25 conduct such surveillance and if such protocol will 


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1 result in collection of the data or other information 

2 designated by the Secretary as necessary to protect 

3 the public health. 

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

5 after an opportunity for an informal hearing, shall with6 draw the approval of an application under this section if 

7 the Secretary determines that— 

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

9 can no longer make the demonstrations required 

10 under subsection (g), or the Secretary can no longer 

11 make the determinations required under subsection 

12 (g); 

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

14 information or included any untrue statement of ma15 terial fact; 

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

17 the product reduces risk or exposure is no longer 

18 valid, including if— 

19 ‘‘(A) a tobacco product standard is estab20 lished pursuant to section 907; 

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

22 risks presented by other commercially marketed 

23 tobacco products that were compared to the 

24 product that is the subject of the application; or 


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1 ‘‘(C) any postmarket surveillance or stud2 ies reveal that the approval of the application is 

3 no longer consistent with the protection of the 

4 public health; 

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

6 the postmarket surveillance and studies required 

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

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

9 imposed under subsection (h). 

10 ‘‘(k) CHAPTER IV OR V.—A product approved in ac11 cordance with this section shall not be subject to chapter 

12 IV or V. 

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

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

15 years after the date of enactment of the Family 

16 Smoking Prevention and Tobacco Control Act, the 

17 Secretary shall issue regulations or guidance (or any 

18 combination thereof) on the scientific evidence re19 quired for assessment and ongoing review of modi20 fied risk tobacco products. Such regulations or guid21 ance shall— 

22 ‘‘(A) establish minimum standards for sci23 entific studies needed prior to approval to show 

24 that a substantial reduction in morbidity or 


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1 mortality among individual tobacco users is 

2 likely; 

3 ‘‘(B) include validated biomarkers, inter4 mediate clinical endpoints, and other feasible 

5 outcome measures, as appropriate; 

6 ‘‘(C) establish minimum standards for post 

7 market studies, that shall include regular and 

8 long-term assessments of health outcomes and 

9 mortality, intermediate clinical endpoints, con10 sumer perception of harm reduction, and the 

11 impact on quitting behavior and new use of to12 bacco products, as appropriate; 

13 ‘‘(D) establish minimum standards for re14 quired postmarket surveillance, including ongo15 ing assessments of consumer perception; and 

16 ‘‘(E) require that data from the required 

17 studies and surveillance be made available to 

18 the Secretary prior to the decision on renewal 

19 of a modified risk tobacco product. 

20 ‘‘(2) CONSULTATION.—The regulations or guid21 ance issued under paragraph (1) shall be developed 

22 in consultation with the Institute of Medicine, and 

23 with the input of other appropriate scientific and 

24 medical experts, on the design and conduct of such 

25 studies and surveillance. 


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1 ‘‘(3) REVISION.—The regulations or guidance 

2 under paragraph (1) shall be revised on a regular 

3 basis as new scientific information becomes avail4 able. 

5 ‘‘(4) NEW TOBACCO PRODUCTS.—Not later 

6 than 2 years after the date of enactment of the 

7 Family Smoking Prevention and Tobacco Control 

8 Act, the Secretary shall issue a regulation or guid9 ance that permits the filing of a single application 

10 for any tobacco product that is a new tobacco prod11 uct under section 910 and for which the applicant 

12 seeks approval as a modified risk tobacco product 

13 under this section. 

14 ‘‘(m) DISTRIBUTORS.—No distributor may take any 

15 action, after the date of enactment of the Family Smoking 

16 Prevention and Tobacco Control Act, with respect to a to17 bacco product that would reasonably be expected to result 

18 in consumers believing that the tobacco product or its 

19 smoke may present a lower risk of disease or is less harm20 ful than one or more commercially marketed tobacco prod21 ucts, or presents a reduced exposure to, or does not con22 tain or is free of, a substance or substances. 

23 ‘‘SEC. 912. JUDICIAL REVIEW. 

24 ‘‘(a) RIGHT TO REVIEW.— 


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1 ‘‘(1) IN GENERAL.—Not later than 30 days 

2 after— 

3 ‘‘(A) the promulgation of a regulation 

4 under section 907 establishing, amending, or 

5 revoking a tobacco product standard; or 

6 ‘‘(B) a denial of an application for ap7 proval under section 910(c), 

8 any person adversely affected by such regulation or 

9 denial may file a petition for judicial review of such 

10 regulation or denial with the United States Court of 

11 Appeals for the District of Columbia or for the cir12 cuit in which such person resides or has their prin13 cipal place of business. 

14 ‘‘(2) REQUIREMENTS.— 

15 ‘‘(A) COPY OF PETITION.—A copy of the 

16 petition filed under paragraph (1) shall be 

17 transmitted by the clerk of the court involved to 

18 the Secretary. 

19 ‘‘(B) RECORD OF PROCEEDINGS.—On re20 ceipt of a petition under subparagraph (A), the 

21 Secretary shall file in the court in which such 

22 petition was filed— 

23 ‘‘(i) the record of the proceedings on 

24 which the regulation or order was based; 

25 and 


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1 ‘‘(ii) a statement of the reasons for 

2 the issuance of such a regulation or order. 

3 ‘‘(C) DEFINITION OF RECORD.—In this 

4 section, the term ‘record’ means— 

5 ‘‘(i) all notices and other matter pub6 lished in the Federal Register with respect 

7 to the regulation or order reviewed; 

8 ‘‘(ii) all information submitted to the 

9 Secretary with respect to such regulation 

10 or order; 

11 ‘‘(iii) proceedings of any panel or ad12 visory committee with respect to such reg13 ulation or order; 

14 ‘‘(iv) any hearing held with respect to 

15 such regulation or order; and 

16 ‘‘(v) any other information identified 

17 by the Secretary, in the administrative pro18 ceeding held with respect to such regula19 tion or order, as being relevant to such 

20 regulation or order. 

21 ‘‘(b) STANDARD OF REVIEW.—Upon the filing of the 

22 petition under subsection (a) for judicial review of a regu23 lation or order, the court shall have jurisdiction to review 

24 the regulation or order in accordance with chapter 7 of 

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1 lief, including interim relief, as provided for in such chap2 ter. A regulation or denial described in subsection (a) shall 

3 be reviewed in accordance with section 706(2)(A) of title 

4 5, United States Code. 

5 ‘‘(c) FINALITY OF JUDGMENT.—The judgment of the 

6 court affirming or setting aside, in whole or in part, any 

7 regulation or order shall be final, subject to review by the 

8 Supreme Court of the United States upon certiorari or 

9 certification, as provided in section 1254 of title 28, 

10 United States Code. 

11 ‘‘(d) OTHER REMEDIES.—The remedies provided for 

12 in this section shall be in addition to, and not in lieu of, 

13 any other remedies provided by law. 

14 ‘‘(e) REGULATIONS AND ORDERS MUST RECITE

15 BASIS IN RECORD.—To facilitate judicial review, a regula16 tion or order issued under section 906, 907, 908, 909, 

17 910, or 916 shall contain a statement of the reasons for 

18 the issuance of such regulation or order in the record of 

19 the proceedings held in connection with its issuance. 

20 ‘‘SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS. 

21 ‘‘The Secretary shall issue regulations to require that 

22 retail establishments for which the predominant business 

23 is the sale of tobacco products comply with any advertising 

24 restrictions applicable to retail establishments accessible 

25 to individuals under the age of 18. 


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1 ‘‘SEC. 914. JURISDICTION OF AND COORDINATION WITH 

2 THE FEDERAL TRADE COMMISSION. 

3 ‘‘(a) JURISDICTION.— 

4 ‘‘(1) IN GENERAL.—Except where expressly 

5 provided in this chapter, nothing in this chapter 

6 shall be construed as limiting or diminishing the au7 thority of the Federal Trade Commission to enforce 

8 the laws under its jurisdiction with respect to the 

9 advertising, sale, or distribution of tobacco products. 

10 ‘‘(2) ENFORCEMENT.—Any advertising that vio11 lates this chapter or a provision of the regulations 

12 referred to in section 102 of the Family Smoking 

13 Prevention and Tobacco Control Act, is an unfair or 

14 deceptive act or practice under section 5(a) of the 

15 Federal Trade Commission Act and shall be consid16 ered a violation of a rule promulgated under section 

17 18 of that Act. 

18 ‘‘(b) COORDINATION.—With respect to the require19 ments of section 4 of the Federal Cigarette Labeling and 

20 Advertising Act and section 3 of the Comprehensive 

21 Smokeless Tobacco Health Education Act of 1986— 

22 ‘‘(1) the Chairman of the Federal Trade Com23 mission shall coordinate with the Secretary con24 cerning the enforcement of such Act as such enforce25 ment relates to unfair or deceptive acts or practices 


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1 in the advertising of cigarettes or smokeless tobacco; 

2 and 

3 ‘‘(2) the Secretary shall consult with the Chair4 man of such Commission in revising the label state5 ments and requirements under such sections. 

6 ‘‘SEC. 915. CONGRESSIONAL REVIEW PROVISIONS. 

7 ‘‘In accordance with section 801 of title 5, United 

8 States Code, Congress shall review, and may disapprove, 

9 any rule under this chapter that is subject to section 801. 

10 This section and section 801 do not apply to the final rule 

11 referred to in paragraphs (1) and (2) of section 102(a) 

12 of the Family Smoking Prevention and Tobacco Control 

13 Act. 

14 ‘‘SEC. 916. REGULATION REQUIREMENT. 

15 ‘‘(a) TESTING, REPORTING, AND DISCLOSURE.—Not 

16 later than 24 months after the date of enactment of the 

17 Family Smoking Prevention and Tobacco Control Act, the 

18 Secretary, acting through the Commissioner of Food and 

19 Drugs, shall promulgate regulations under this Act that 

20 meet the requirements of subsection (b). 

21 ‘‘(b) CONTENTS OF RULES.—The regulations pro22 mulgated under subsection (a) shall require testing and 

23 reporting of tobacco product constituents, ingredients, and 

24 additives, including smoke constituents, by brand and sub25 brand that the Secretary determines should be tested to 


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1 protect the public health. The regulations may require 

2 that tobacco product manufacturers, packagers, or import3 ers make disclosures relating to the results of the testing 

4 of tar and nicotine through labels or advertising or other 

5 appropriate means, and make disclosures regarding the re6 sults of the testing of other constituents, including smoke 

7 constituents, ingredients, or additives, that the Secretary 

8 determines should be disclosed to the public to protect the 

9 public health and will not mislead consumers about the 

10 risk of tobacco related disease. 

11 ‘‘(c) AUTHORITY.—The Food and Drug Administra12 tion shall have the authority under this chapter to conduct 

13 or to require the testing, reporting, or disclosure of to14 bacco product constituents, including smoke constituents. 

15 ‘‘SEC. 917. PRESERVATION OF STATE AND LOCAL AUTHOR16 ITY. 

17 ‘‘(a) IN GENERAL.— 

18 ‘‘(1) PRESERVATION.—Except as provided in 

19 paragraph (2)(A), nothing in this chapter, or rules 

20 promulgated under this chapter, shall be construed 

21 to limit the authority of a Federal agency (including 

22 the Armed Forces), a State or political subdivision 

23 of a State, or the government of an Indian tribe to 

24 enact, adopt, promulgate, and enforce any law, rule, 

25 regulation, or other measure with respect to tobacco 


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1 products that is in addition to, or more stringent 

2 than, requirements established under this chapter, 

3 including a law, rule, regulation, or other measure 

4 relating to or prohibiting the sale, distribution, pos5 session, exposure to, access to, advertising and pro6 motion of, or use of tobacco products by individuals 

7 of any age, information reporting to the State, or 

8 measures relating to fire safety standards for to9 bacco products. No provision of this chapter shall 

10 limit or otherwise affect any State, Tribal, or local 

11 taxation of tobacco products. 

12 ‘‘(2) PREEMPTION OF CERTAIN STATE AND

13 LOCAL REQUIREMENTS.— 

14 ‘‘(A) IN GENERAL.—No State or political 

15 subdivision of a State may establish or continue 

16 in effect with respect to a tobacco product any 

17 requirement which is different from, or in addi18 tion to, any requirement under the provisions of 

19 this chapter relating to tobacco product stand20 ards, premarket approval, adulteration, mis21 branding, labeling, registration, good manufac22 turing standards, or modified risk tobacco prod23 ucts. 

24 ‘‘(B) EXCEPTION.—Subparagraph (A) 

25 does not apply to requirements relating to the 


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1 sale, distribution, possession, information re2 porting to the State, exposure to, access to, the 

3 advertising and promotion of, or use of, tobacco 

4 products by individuals of any age, or relating 

5 to fire safety standards for tobacco products. 

6 Information disclosed to a State under subpara7 graph (A) that is exempt from disclosure under 

8 section 552(b)(4) of title 5, United States Code, 

9 shall be treated as a trade secret and confiden10 tial information by the State. 

11 ‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT

12 LIABILITY.—No provision of this chapter relating to a to13 bacco product shall be construed to modify or otherwise 

14 affect any action or the liability of any person under the 

15 product liability law of any State. 

16 ‘‘SEC. 918. TOBACCO PRODUCTS SCIENTIFIC ADVISORY 

17 COMMITTEE. 

18 ‘‘(a) ESTABLISHMENT.—Not later than 1 year after 

19 the date of enactment of the Family Smoking Prevention 

20 and Tobacco Control Act, the Secretary shall establish an 

21 11-member advisory committee, to be known as the ‘To22 bacco Products Scientific Advisory Committee’ (in this 

23 section referred to as the ‘Advisory Committee’). 

24 ‘‘(b) MEMBERSHIP.— 

25 ‘‘(1) IN GENERAL.— 


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1 ‘‘(A) MEMBERS.—The Secretary shall ap2 point as members of the Tobacco Products Sci3 entific Advisory Committee individuals who are 

4 technically qualified by training and experience 

5 in the medicine, medical ethics, science, or tech6 nology involving the manufacture, evaluation, or 

7 use of tobacco products, who are of appro8 priately diversified professional backgrounds. 

9 The committee shall be composed of— 

10 ‘‘(i) 7 individuals who are physicians, 

11 dentists, scientists, or health care profes12 sionals practicing in the area of oncology, 

13 pulmonology, cardiology, toxicology, phar14 macology, addiction, or any other relevant 

15 specialty; 

16 ‘‘(ii) 1 individual who is an officer or 

17 employee of a State or local government or 

18 of the Federal Government; 

19 ‘‘(iii) 1 individual as a representative 

20 of the general public; 

21 ‘‘(iv) 1 individual as a representative 

22 of the interests in the tobacco manufac23 turing industry; and 

24 ‘‘(v) 1 individual as a representative 

25 of the interests of the tobacco growers. 


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1 ‘‘(B) NONVOTING MEMBERS.—The mem2 bers of the committee appointed under clauses 

3 (iv) and (v) of subparagraph (A) shall serve as 

4 consultants to those described in clauses (i) 

5 through (iii) of subparagraph (A) and shall be 

6 nonvoting representatives. 

7 ‘‘(2) LIMITATION.—The Secretary may not ap8 point to the Advisory Committee any individual who 

9 is in the regular full-time employ of the Food and 

10 Drug Administration or any agency responsible for 

11 the enforcement of this Act. The Secretary may ap12 point Federal officials as ex officio members. 

13 ‘‘(3) CHAIRPERSON.—The Secretary shall des14 ignate 1 of the members of the Advisory Committee 

15 to serve as chairperson. 

16 ‘‘(c) DUTIES.—The Tobacco Products Scientific Ad17 visory Committee shall provide advice, information, and 

18 recommendations to the Secretary— 

19 ‘‘(1) as provided in this chapter; 

20 ‘‘(2) on the effects of the alteration of the nico21 tine yields from tobacco products; 

22 ‘‘(3) on whether there is a threshold level below 

23 which nicotine yields do not produce dependence on 

24 the tobacco product involved; and 


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1 ‘‘(4) on its review of other safety, dependence, 

2 or health issues relating to tobacco products as re3 quested by the Secretary. 

4 ‘‘(d) COMPENSATION; SUPPORT; FACA.— 

5 ‘‘(1) COMPENSATION AND TRAVEL.—Members 

6 of the Advisory Committee who are not officers or 

7 employees of the United States, while attending con8 ferences or meetings of the committee or otherwise 

9 engaged in its business, shall be entitled to receive 

10 compensation at rates to be fixed by the Secretary, 

11 which may not exceed the daily equivalent of the 

12 rate in effect under the Senior Executive Schedule 

13 under section 5382 of title 5, United States Code, 

14 for each day (including travel time) they are so en15 gaged; and while so serving away from their homes 

16 or regular places of business each member may be 

17 allowed travel expenses, including per diem in lieu of 

18 subsistence, as authorized by section 5703 of title 5, 

19 United States Code, for persons in the Government 

20 service employed intermittently. 

21 ‘‘(2) ADMINISTRATIVE SUPPORT.—The Sec22 retary shall furnish the Advisory Committee clerical 

23 and other assistance. 


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1 ‘‘(3) NONAPPLICATION OF FACA.—Section 14 of 

2 the Federal Advisory Committee Act does not apply 

3 to the Advisory Committee. 

4 ‘‘(e) PROCEEDINGS OF ADVISORY PANELS AND COM5 MITTEES.—The Advisory Committee shall make and 

6 maintain a transcript of any proceeding of the panel or 

7 committee. Each such panel and committee shall delete 

8 from any transcript made under this subsection informa9 tion which is exempt from disclosure under section 552(b) 

10 of title 5, United States Code. 

11 ‘‘SEC. 919. DRUG PRODUCTS USED TO TREAT TOBACCO DE12 PENDENCE. 

13 ‘‘The Secretary shall— 

14 ‘‘(1) at the request of the applicant, consider 

15 designating nicotine replacement products as fast 

16 track research and approval products within the 

17 meaning of section 506; 

18 ‘‘(2) consider approving the extended use of nic19 otine replacement products (such as nicotine patch20 es, nicotine gum, and nicotine lozenges) for the 

21 treatment of tobacco dependence; and 

22 ‘‘(3) review and consider the evidence for addi23 tional indications for nicotine replacement products, 

24 such as for craving relief or relapse prevention. 


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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 2008, 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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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 paragraph 

9 (2) shall be allocated by the Secretary on a pro rata 

10 basis among the classes of tobacco products that are 

11 subject to a user fee under this section. Such pro 

12 rata allocation for each class of tobacco products 

13 that is subject to a user fee under this section shall 

14 be the quotient of— 

15 ‘‘(A) the percentage assigned to such class 

16 under paragraph (2); divided by 

17 ‘‘(B) the sum of the percentages assigned 

18 to all classes of tobacco products subject to this 

19 section. 

20 ‘‘(4) ANNUAL LIMIT ON ASSESSMENT.—The 

21 total assessment under this section— 

22 ‘‘(A) for fiscal year 2008 shall be 

23 $85,000,000; 

24 ‘‘(B) for fiscal year 2009 shall be 

25 $175,000,000; 


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1 ‘‘(C) for fiscal year 2010 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 preceding the fis13 cal 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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1 ‘‘(f) MEASUREMENT OF GROSS DOMESTIC VOL2 UME.— 

3 ‘‘(1) IN GENERAL.—Each tobacco product man4 ufacturer and importer shall submit to the Secretary 

5 a certified copy of each of the returns or forms de6 scribed by this paragraph that are required to be 

7 filed with a Government agency on the same date 

8 that those returns or forms are required to be filed 

9 with such agency. The returns and forms described 

10 by this paragraph are those returns and forms re11 lated to the removal, as defined by section 5702(j) 

12 of the Internal Revenue Code of 1986, of tobacco 

13 products into domestic commerce or the payment of 

14 the taxes imposed under chapter 52 of such Code. 

15 ‘‘(2) PENALTIES.—Any person that knowingly 

16 fails to provide information required under this sub17 section or that provides false information under this 

18 subsection shall be subject to the penalties described 

19 in section 1001 of title 18, United States Code. In 

20 addition, such person may be subject to a civil pen21 alty in an amount not to exceed 2 percent of the 

22 value of the kind of tobacco products manufactured 

23 or imported by such person during the applicable 

24 quarter, as determined by the Secretary. 


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1 ‘‘(g) EFFECTIVE DATE.—The user fees prescribed by 

2 this section shall be assessed in fiscal year 2008, based 

3 on domestic sales of tobacco products during fiscal year 

4 2007 and shall be assessed in each fiscal year thereafter.’’. 

5 SEC. 102. FINAL RULE. 

6 (a) CIGARETTES AND SMOKELESS TOBACCO.— 

7 (1) IN GENERAL.—Not later than 30 days after 

8 the date of enactment of this Act, the Secretary of 

9 Health and Human Services shall publish in the 

10 Federal Register a final rule regarding cigarettes 

11 and smokeless tobacco, which is hereby deemed to be 

12 in compliance with the Administrative Procedures 

13 Act and other applicable law. 

14 (2) CONTENTS OF RULE.—Except as provided 

15 in this subsection, the final rule published under 

16 paragraph (1), shall be identical in its provisions to 

17 part 897 of the regulations promulgated by the Sec18 retary of Health and Human Services in the August 

19 28, 1996, issue of the Federal Register (61 Fed. 

20 Reg., 44615–44618). Such rule shall— 

21 (A) provide for the designation of jurisdic22 tional authority that is in accordance with this 

23 subsection; 

24 (B) strike Subpart C—Labels and section 

25 897.32(c); and 


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1 (C) become effective not later than 1 year 

2 after the date of enactment of this Act. 

3 (3) AMENDMENTS TO RULE.—Prior to making 

4 amendments to the rule published under paragraph 

5 (1), the Secretary shall promulgate a proposed rule 

6 in accordance with the Administrative Procedures 

7 Act. 

8 (4) RULE OF CONSTRUCTION.—Except as pro9 vided in paragraph (3), nothing in this section shall 

10 be construed to limit the authority of the Secretary 

11 to amend, in accordance with the Administrative 

12 Procedures Act, the regulation promulgated pursu13 ant to this section. 

14 (b) LIMITATION ON ADVISORY OPINIONS.—As of the 

15 date of enactment of this Act, the following documents 

16 issued by the Food and Drug Administration shall not 

17 constitute advisory opinions under section 10.85(d)(1) of 

18 title 21, Code of Federal Regulations, except as they apply 

19 to tobacco products, and shall not be cited by the Sec20 retary of Health and Human Services or the Food and 

21 Drug Administration as binding precedent: 

22 (1) The preamble to the proposed rule in the 

23 document entitled ‘‘Regulations Restricting the Sale 

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1 cents’’ (60 Fed. Reg. 41314–41372 (August 11, 

2 1995)). 

3 (2) The document entitled ‘‘Nicotine in Ciga4 rettes and Smokeless Tobacco Products is a Drug 

5 and These Products Are Nicotine Delivery Devices 

6 Under the Federal Food, Drug, and Cosmetic Act’’ 

7 (60 Fed. Reg. 41453–41787 (August 11, 1995)). 

8 (3) The preamble to the final rule in the docu9 ment entitled ‘‘Regulations Restricting the Sale and 

10 Distribution of Cigarettes and Smokeless Tobacco to 

11 Protect Children and Adolescents’’ (61 Fed. Reg. 

12 44396–44615 (August 28, 1996)). 

13 (4) The document entitled ‘‘Nicotine in Ciga14 rettes and Smokeless Tobacco is a Drug and These 

15 Products are Nicotine Delivery Devices Under the 

16 Federal Food, Drug, and Cosmetic Act; Jurisdic17 tional Determination’’ (61 Fed. Reg. 44619–45318 

18 (August 28, 1996)). 

19 SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GEN20 ERAL PROVISIONS. 

21 (a) AMENDMENT OF FEDERAL FOOD, DRUG, AND

22 COSMETIC ACT.—Except as otherwise expressly provided, 

23 whenever in this section an amendment is expressed in 

24 terms of an amendment to, or repeal of, a section or other 

25 provision, the reference is to a section or other provision 


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

2 301 et seq.). 

3 (b) SECTION 301.—Section 301 (21 U.S.C. 331) is 

4 amended— 

5 (1) in subsection (a), by inserting ‘‘tobacco 

6 product,’’ after ‘‘device,’’; 

7 (2) in subsection (b), by inserting ‘‘tobacco 

8 product,’’ after ‘‘device,’’; 

9 (3) in subsection (c), by inserting ‘‘tobacco 

10 product,’’ after ‘‘device,’’; 

11 (4) in subsection (e) (as amended by sections 

12 2(c) and 3(b) of the Dietary Supplement and Non13 prescription Drug Consumer Protection Act (Public 

14 Law 109–462; 120 Stat. 3472)), by inserting ‘‘, or 

15 909’’ before ‘‘or the refusal to permit access to’’; 

16 (5) in subsection (g), by inserting ‘‘tobacco 

17 product,’’ after ‘‘device,’’; 

18 (6) in subsection (h), by inserting ‘‘tobacco 

19 product,’’ after ‘‘device,’’; 

20 (7) in subsection (j), by striking ‘‘708, or 721’’ 

21 and inserting ‘‘708, 721, 904, 905, 906, 907, 908, 

22 909, or section 921(b)’’; 

23 (8) in subsection (k), by inserting ‘‘tobacco 

24 product,’’ after ‘‘device,’’; 


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1 (9) by striking subsection (p) and inserting the 

2 following: 

3 ‘‘(p) The failure to register in accordance with section 

4 510 or 905, the failure to provide any information re5 quired by section 510(j), 510(k), 905(i), or 905(j), or the 

6 failure to provide a notice required by section 510(j)(2) 

7 or 905(i)(2).’’; 

8 (10) by striking subsection (q)(1) and inserting 

9 the following: 

10 ‘‘(q)(1) The failure or refusal— 

11 ‘‘(A) to comply with any requirement prescribed 

12 under section 518, 520(g), 903(b), or 908; 

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 the term ‘‘device’’ each time that 

22 such term appears; and 

23 (13) by adding at the end (as amended by sec24 tion 4(a) of the Dietary Supplement and NonVerDate Aug 31 2005 19:44 Feb 24, 2007 Jkt 049200 PO 00000 Frm 00125 Fmt 6652 Sfmt 6201 E:\BILLS\S625.IS S625

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1 prescription Drug Consumer Protection Act (Public 

2 Law 109–462; 120 Stat. 3475)) the following: 

3 ‘‘(jj) The sale of tobacco products in violation 

4 of a no-tobacco-sale order issued under section 

5 303(f). 

6 ‘‘(kk) The introduction or delivery for introduc7 tion into interstate commerce of a tobacco product 

8 in violation of section 911. 

9 ‘‘(ll)(1) Forging, counterfeiting, simulating, or 

10 falsely representing, or without proper authority 

11 using any mark, stamp (including tax stamp), tag, 

12 label, or other identification device upon any tobacco 

13 product or container or labeling thereof so as to 

14 render such tobacco product a counterfeit tobacco 

15 product. 

16 ‘‘(2) Making, selling, disposing of, or keeping in 

17 possession, control, or custody, or concealing any 

18 punch, die, plate, stone, or other item that is de19 signed to print, imprint, or reproduce the trade20 mark, trade name, or other identifying mark, im21 print, or device of another or any likeness of any of 

22 the foregoing upon any tobacco product or container 

23 or labeling thereof so as to render such tobacco 

24 product a counterfeit tobacco product. 


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1 ‘‘(3) The doing of any act that causes a tobacco 

2 product to be a counterfeit tobacco product, or the 

3 sale or dispensing, or the holding for sale or dis4 pensing, of a counterfeit tobacco product. 

5 ‘‘(mm) The charitable distribution of tobacco 

6 products. 

7 ‘‘(nn) The failure of a manufacturer or dis8 tributor to notify the Attorney General of their 

9 knowledge of tobacco products used in illicit trade.’’. 

10 (c) SECTION 303.—Section 303 (21 U.S.C. 333(f)) 

11 is amended by redesignating the subsection that follows 

12 subsection (e) as subsection (f) and in subsection (f) (as 

13 so redesignated)— 

14 (1) in paragraph (1)(A), by inserting ‘‘or to15 bacco products’’ after ‘‘devices’’; 

16 (2) in paragraph (2)(C), by striking ‘‘paragraph 

17 (3)(A)’’ and inserting ‘‘paragraph (4)(A)’’; 

18 (3) by redesignating paragraphs (3), (4), and 

19 (5) as paragraphs (4), (5), and (6), and inserting 

20 after paragraph (2) the following: 

21 ‘‘(3) If the Secretary finds that a person has 

22 committed repeated violations of restrictions promul23 gated under section 906(d) at a particular retail out24 let then the Secretary may impose a no-tobacco-sale 

25 order on that person prohibiting the sale of tobacco 


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1 products in that outlet. A no-tobacco-sale order may 

2 be imposed with a civil penalty under paragraph 

3 (1).’’; 

4 (4) in paragraph (4) as so redesignated— 

5 (A) in subparagraph (A)— 

6 (i) by striking ‘‘assessed’’ the first 

7 time it appears and inserting ‘‘assessed, or 

8 a no-tobacco-sale order may be imposed,’’; 

9 and 

10 (ii) by striking ‘‘penalty’’ and insert11 ing ‘‘penalty, or upon whom a no-tobacco12 order is to be imposed,’’; 

13 (B) in subparagraph (B)— 

14 (i) by inserting after ‘‘penalty,’’ the 

15 following: ‘‘or the period to be covered by 

16 a no-tobacco-sale order,’’; and 

17 (ii) by adding at the end the fol18 lowing: ‘‘A no-tobacco-sale order perma19 nently prohibiting an individual retail out20 let from selling tobacco products shall in21 clude provisions that allow the outlet, after 

22 a specified period of time, to request that 

23 the Secretary compromise, modify, or ter24 minate the order.’’; and 

25 (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 the term ‘‘penalty’’ 

9 the first 2 places such term 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 the term ‘‘paragraph (4)’’ each place such 

15 term appears and 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: ‘‘device, and (E) Any adulterated or 

22 misbranded 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 the term ‘‘device’’ each place 

3 such term appears; and 

4 (4) in subsection (g)(2)(A), by inserting ‘‘or to5 bacco product’’ after the term ‘‘device’’ each place 

6 such term appears. 

7 (e) SECTION 702.—Section 702(a) (21 U.S.C. 

8 372(a)) is amended by adding at the end of paragraph 

9 (1) the following: ‘‘For a tobacco product, to the extent 

10 feasible, the Secretary shall contract with the States in 

11 accordance with this paragraph to carry out inspections 

12 of retailers within that State in connection with the en13 forcement of this Act.’’. 

14 (f) SECTION 703.—Section 703 (21 U.S.C. 373) is 

15 amended— 

16 (1) by inserting ‘‘tobacco product,’’ after the 

17 term ‘‘device,’’ each place such term appears; and 

18 (2) by inserting ‘‘tobacco products,’’ after the 

19 term ‘‘devices,’’ each place such term 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 the term ‘‘devices,’’ each 

24 place such term appears; 


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1 (2) in subsection (a)(1)(B), by inserting ‘‘or to2 bacco product’’ after the term ‘‘restricted devices’’ 

3 each place such term 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 ‘‘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 the term ‘‘devices,’’ the first time such term ap16 pears; 

17 (B) by inserting ‘‘or section 905(j)’’ after 

18 ‘‘section 510’’; and 

19 (C) by striking the term ‘‘drugs or de20 vices’’ each time such term appears and insert21 ing ‘‘drugs, devices, or tobacco products’’; 

22 (2) in subsection (e)(1), by inserting ‘‘tobacco 

23 product,’’ after ‘‘device,’’; and 

24 (3) by adding at the end the following: 


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1 ‘‘(p)(1) Not later than 2 years after the date of enact2 ment of the Family Smoking Prevention and Tobacco 

3 Control Act, and annually thereafter, the Secretary shall 

4 submit to the Committee on Health, Education, Labor, 

5 and Pensions of the Senate and the Committee on Energy 

6 and Commerce of the House of Representatives, a report 

7 regarding— 

8 ‘‘(A) the nature, extent, and destination of 

9 United States tobacco product exports that do not 

10 conform to tobacco product standards established 

11 pursuant to this Act; 

12 ‘‘(B) the public health implications of such ex13 ports, including any evidence of a negative public 

14 health impact; and 

15 ‘‘(C) recommendations or assessments of policy 

16 alternatives available to Congress and the Executive 

17 Branch to reduce any negative public health impact 

18 caused by such exports. 

19 ‘‘(2) The Secretary is authorized to establish appro20 priate information disclosure requirements to carry out 

21 this subsection.’’. 

22 (k) SECTION 1003.—Section 1003(d)(2)(C) (as re23 designated by section 101(b)) is amended— 

24 (1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 


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1 (2) inserting ‘‘, and tobacco products’’ after 

2 ‘‘devices’’. 

3 (l) GUIDANCE AND EFFECTIVE DATES.— 

4 (1) IN GENERAL.—The Secretary of Health and 

5 Human Services shall issue guidance— 

6 (A) defining the term ‘‘repeated violation’’, 

7 as used in section 303(f) of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 333(f)) as 

9 amended by subsection (c), by identifying the 

10 number of violations of particular requirements 

11 over a specified period of time at a particular 

12 retail outlet that constitute a repeated violation; 

13 (B) providing for timely and effective no14 tice to the retailer of each alleged violation at 

15 a particular retail outlet; 

16 (C) providing for an expedited procedure 

17 for the administrative appeal of an alleged vio18 lation; 

19 (D) providing that a person may not be 

20 charged with a violation at a particular retail 

21 outlet unless the Secretary has provided notice 

22 to the retailer of all previous violations at that 

23 outlet; 

24 (E) establishing a period of time during 

25 which, if there are no violations by a particular 


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1 retail outlet, that outlet will not be considered 

2 to have been the site of repeated violations 

3 when the next violation occurs; and 

4 (F) providing that good faith reliance on 

5 the presentation of a false government issued 

6 photographic identification that contains a date 

7 of birth does not constitute a violation of any 

8 minimum age requirement for the sale of to9 bacco products if the retailer has taken effective 

10 steps to prevent such violations, including— 

11 (i) adopting and enforcing a written 

12 policy against sales to minors; 

13 (ii) informing its employees of all ap14 plicable laws; 

15 (iii) establishing disciplinary sanctions 

16 for employee noncompliance; and 

17 (iv) requiring its employees to verify 

18 age by way of photographic identification 

19 or electronic scanning device. 

20 (2) GENERAL EFFECTIVE DATE.—The amend21 ments made by subsection (c), other than the 

22 amendment made by paragraph (2) of such sub23 section, shall take effect upon the issuance of guid24 ance described in paragraph (1). 


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1 (3) SPECIAL EFFECTIVE DATE.—The amend2 ments made by paragraph (2) of subsection (c) shall 

3 take effect on the date of enactment of this Act. 

4 TITLE II—TOBACCO PRODUCT 

5 WARNINGS; CONSTITUENT 

6 AND SMOKE CONSTITUENT 

7 DISCLOSURE 

8 SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS. 

9 Section 4 of the Federal Cigarette Labeling and Ad10 vertising Act (15 U.S.C. 1333) is amended to read as fol11 lows: 

12 ‘‘SEC. 4. LABELING. 

13 ‘‘(a) LABEL REQUIREMENTS.— 

14 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

15 person to manufacture, package, sell, offer to sell, 

16 distribute, or import for sale or distribution within 

17 the United States any cigarettes the package of 

18 which fails to bear, in accordance with the require19 ments of this section, one of the following labels: 

20 ‘‘ ‘WARNING: Cigarettes are addictive’. 

21 ‘‘ ‘WARNING: Tobacco smoke can harm your 

22 children’. 

23 ‘‘ ‘WARNING: Cigarettes cause fatal lung dis24 ease’. 

25 ‘‘ ‘WARNING: Cigarettes cause cancer’. 


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1 ‘‘ ‘WARNING: Cigarettes cause strokes and 

2 heart disease’. 

3 ‘‘ ‘WARNING: Smoking during pregnancy can 

4 harm your baby’. 

5 ‘‘ ‘WARNING: Smoking can kill you’. 

6 ‘‘ ‘WARNING: Tobacco smoke causes fatal lung 

7 disease in non-smokers’. 

8 ‘‘ ‘WARNING: Quitting smoking now greatly 

9 reduces serious risks to your health’. 

10 ‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.— 

11 ‘‘(A) IN GENERAL.—Each label statement 

12 required by paragraph (1) shall be located in 

13 the upper portion of the front and rear panels 

14 of the package, directly on the package under15 neath the cellophane or other clear wrapping. 

16 Except as provided in subparagraph (B), each 

17 label statement shall comprise at least the top 

18 30 percent of the front and rear panels of the 

19 package. The word ‘WARNING’ shall appear in 

20 capital letters and all text shall be in con21 spicuous and legible 17-point type, unless the 

22 text of the label statement would occupy more 

23 than 70 percent of such area, in which case the 

24 text may be in a smaller conspicuous and leg25 ible type size, provided that at least 60 percent 


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1 of such area is occupied by required text. The 

2 text shall be black on a white background, or 

3 white on a black background, in a manner that 

4 contrasts, by typography, layout, or color, with 

5 all other printed material on the package, in an 

6 alternating fashion under the plan submitted 

7 under subsection (b)(4). 

8 ‘‘(B) HINGED LID BOXES.—For any ciga9 rette brand package manufactured or distrib10 uted before January 1, 2000, which employs a 

11 hinged lid style (if such packaging was used for 

12 that brand in commerce prior to June 21, 

13 1997), the label statement required by para14 graph (1) shall be located on the hinged lid 

15 area of the package, even if such area is less 

16 than 25 percent of the area of the front panel. 

17 Except as provided in this paragraph, the provi18 sions of this subsection shall apply to such 

19 packages. 

20 ‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU21 TION.—The provisions of this subsection do not 

22 apply to a tobacco product manufacturer or dis23 tributor of cigarettes which does not manufacture, 

24 package, or import cigarettes for sale or distribution 

25 within the United States. 


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1 ‘‘(4) APPLICABILITY TO RETAILERS.—A retailer 

2 of cigarettes shall not be in violation of this sub3 section for packaging that is supplied to the retailer 

4 by a tobacco product manufacturer, importer, or dis5 tributor and is not altered by the retailer in a way 

6 that is material to the requirements of this sub7 section except that this paragraph shall not relieve 

8 a retailer of liability if the retailer sells or distributes 

9 tobacco products that are not labeled in accordance 

10 with this subsection. 

11 ‘‘(b) ADVERTISING REQUIREMENTS.— 

12 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

13 tobacco product manufacturer, importer, distributor, 

14 or retailer of cigarettes to advertise or cause to be 

15 advertised within the United States any cigarette 

16 unless its advertising bears, in accordance with the 

17 requirements of this section, one of the labels speci18 fied in subsection (a) of this section. 

19 ‘‘(2) TYPOGRAPHY, ETC.—Each label statement 

20 required by subsection (a) of this section in cigarette 

21 advertising shall comply with the standards set forth 

22 in this paragraph. For press and poster advertise23 ments, each such statement and (where applicable) 

24 any required statement relating to tar, nicotine, or 

25 other constituent (including a smoke constituent) 


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1 yield shall comprise at least 20 percent of the area 

2 of the advertisement and shall appear in a con3 spicuous and prominent format and location at the 

4 top of each advertisement within the trim area. The 

5 Secretary may revise the required type sizes in such 

6 area in such manner as the Secretary determines ap7 propriate. The word ‘WARNING’ shall appear in 

8 capital letters, and each label statement shall appear 

9 in conspicuous and legible type. The text of the label 

10 statement shall be black if the background is white 

11 and white if the background is black, under the plan 

12 submitted under paragraph (4) of this subsection. 

13 The label statements shall be enclosed by a rectan14 gular border that is the same color as the letters of 

15 the statements and that is the width of the first 

16 downstroke of the capital ‘W’ of the word ‘WARN17 ING’ in the label statements. The text of such label 

18 statements shall be in a typeface pro rata to the fol19 lowing requirements: 45-point type for a whole-page 

20 broadsheet newspaper advertisement; 39-point type 

21 for a half-page broadsheet newspaper advertisement; 

22 39-point type for a whole-page tabloid newspaper ad23 vertisement; 27-point type for a half-page tabloid 

24 newspaper advertisement; 31.5-point type for a dou25 ble page spread magazine or whole-page magazine 


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1 advertisement; 22.5-point type for a 28 centimeter 

2 by 3 column advertisement; and 15-point type for a 

3 20 centimeter by 2 column advertisement. The label 

4 statements shall be in English, except that in the 

5 case of— 

6 ‘‘(A) an advertisement that appears in a 

7 newspaper, magazine, periodical, or other publi8 cation that is not in English, the statements 

9 shall appear in the predominant language of the 

10 publication; and 

11 ‘‘(B) in the case of any other advertise12 ment that is not in English, the statements 

13 shall appear in the same language as that prin14 cipally used in the advertisement. 

15 ‘‘(3) MATCHBOOKS.—Notwithstanding para16 graph (2), for matchbooks (defined as containing not 

17 more than 20 matches) customarily given away with 

18 the purchase of tobacco products, each label state19 ment required by subsection (a) may be printed on 

20 the inside cover of the matchbook. 

21 ‘‘(4) ADJUSTMENT BY SECRETARY.—The Sec22 retary may, through a rulemaking under section 553 

23 of title 5, United States Code, adjust the format and 

24 type sizes for the label statements required by this 

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1 quired tar, nicotine yield, or other constituent (in2 cluding smoke constituent) disclosures, or to estab3 lish the text, format, and type sizes for any other 

4 disclosures required under the Federal Food, Drug, 

5 and Cosmetic Act. The text of any such label state6 ments or disclosures shall be required to appear only 

7 within the 20 percent area of cigarette advertise8 ments provided by paragraph (2) of this subsection. 

9 The Secretary shall promulgate regulations which 

10 provide for adjustments in the format and type sizes 

11 of any text required to appear in such area to ensure 

12 that the total text required to appear by law will fit 

13 within such area. 

14 ‘‘(c) MARKETING REQUIREMENTS.— 

15 ‘‘(1) RANDOM DISPLAY.—The label statements 

16 specified in subsection (a)(1) shall be randomly dis17 played in each 12-month period, in as equal a num18 ber of times as is possible on each brand of the 

19 product and be randomly distributed in all areas of 

20 the United States in which the product is marketed 

21 in accordance with a plan submitted by the tobacco 

22 product manufacturer, importer, distributor, or re23 tailer and approved by the Secretary. 

24 ‘‘(2) ROTATION.—The label statements speci25 fied in subsection (a)(1) shall be rotated quarterly in 


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1 alternating sequence in advertisements for each 

2 brand of cigarettes in accordance with a plan sub3 mitted by the tobacco product manufacturer, im4 porter, distributor, or retailer to, and approved by, 

5 the Secretary. 

6 ‘‘(3) REVIEW.—The Secretary shall review each 

7 plan submitted under paragraph (2) and approve it 

8 if the plan— 

9 ‘‘(A) will provide for the equal distribution 

10 and display on packaging and the rotation re11 quired in advertising under this subsection; and 

12 ‘‘(B) assures that all of the labels required 

13 under this section will be displayed by the to14 bacco product manufacturer, importer, dis15 tributor, or retailer at the same time. 

16 ‘‘(4) APPLICABILITY TO RETAILERS.—This sub17 section and subsection (b) apply to a retailer only if 

18 that retailer is responsible for or directs the label 

19 statements required under this section except that 

20 this paragraph shall not relieve a retailer of liability 

21 if the retailer displays, in a location open to the pub22 lic, an advertisement that is not labeled in accord23 ance with the requirements of this subsection and 

24 subsection (b).’’. 


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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 ‘‘(d) CHANGE IN REQUIRED STATEMENTS.—The 

8 Secretary may, by a rulemaking conducted under section 

9 553 of title 5, United States Code, adjust the format, type 

10 size, and text of any of the label requirements, require 

11 color graphics to accompany the text, increase the re12 quired label area from 30 percent up to 50 percent of the 

13 front and rear panels of the package, or establish the for14 mat, type size, and text of any other disclosures required 

15 under the Federal Food, Drug, and Cosmetic Act, if the 

16 Secretary finds that such a change would promote greater 

17 public understanding of the risks associated with the use 

18 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 

19 cancer’. 

20 ‘‘ ‘WARNING: This product can cause gum dis21 ease and tooth loss’. 

22 ‘‘ ‘WARNING: This product is not a safe alter23 native to cigarettes’. 

24 ‘‘ ‘WARNING: Smokeless tobacco is addictive’. 


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1 ‘‘(2) Each label statement required by para2 graph (1) shall be— 

3 ‘‘(A) located on the 2 principal display 

4 panels of the package, and each label statement 

5 shall comprise at least 30 percent of each such 

6 display panel; and 

7 ‘‘(B) in 17-point conspicuous and legible 

8 type and in black text on a white background, 

9 or white text on a black background, in a man10 ner that contrasts by typography, layout, or 

11 color, with all other printed material on the 

12 package, in an alternating fashion under the 

13 plan submitted under subsection (b)(3), except 

14 that if the text of a label statement would oc15 cupy more than 70 percent of the area specified 

16 by subparagraph (A), such text may appear in 

17 a smaller type size, so long as at least 60 per18 cent of such warning area is occupied by the 

19 label statement. 

20 ‘‘(3) The label statements required by para21 graph (1) shall be introduced by each tobacco prod22 uct manufacturer, packager, importer, distributor, or 

23 retailer of smokeless tobacco products concurrently 

24 into the distribution chain of such products. 


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1 ‘‘(4) The provisions of this subsection do not 

2 apply to a tobacco product manufacturer or dis3 tributor of any smokeless tobacco product that does 

4 not manufacture, package, or import smokeless to5 bacco products for sale or distribution within the 

6 United States. 

7 ‘‘(5) A retailer of smokeless tobacco products 

8 shall not be in violation of this subsection for pack9 aging that is supplied to the retailer by a tobacco 

10 products manufacturer, importer, or distributor and 

11 that is not altered by the retailer unless the retailer 

12 offers for sale, sells, or distributes a smokeless to13 bacco product that is not labeled in accordance with 

14 this subsection. 

15 ‘‘(b) REQUIRED LABELS.— 

16 ‘‘(1) It shall be unlawful for any tobacco prod17 uct manufacturer, packager, importer, distributor, or 

18 retailer of smokeless tobacco products to advertise or 

19 cause to be advertised within the United States any 

20 smokeless tobacco product unless its advertising 

21 bears, in accordance with the requirements of this 

22 section, one of the labels specified in subsection (a). 

23 ‘‘(2) Each label statement required by sub24 section (a) in smokeless tobacco advertising shall 

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1 graph. For press and poster advertisements, each 

2 such statement and (where applicable) any required 

3 statement relating to tar, nicotine, or other con4 stituent yield shall— 

5 ‘‘(A) comprise at least 20 percent of the 

6 area of the advertisement, and the warning area 

7 shall be delineated by a dividing line of con8 trasting color from the advertisement; and 

9 ‘‘(B) the word ‘WARNING’ shall appear in 

10 capital letters and each label statement shall 

11 appear in conspicuous and legible type. The text 

12 of the label statement shall be black on a white 

13 background, or white on a black background, in 

14 an alternating fashion under the plan submitted 

15 under paragraph (3). 

16 ‘‘(3)(A) The label statements specified in sub17 section (a)(1) shall be randomly displayed in each 

18 12-month period, in as equal a number of times as 

19 is possible on each brand of the product and be ran20 domly distributed in all areas of the United States 

21 in which the product is marketed in accordance with 

22 a plan submitted by the tobacco product manufac23 turer, importer, distributor, or retailer and approved 

24 by the Secretary. 


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1 ‘‘(B) The label statements specified in sub2 section (a)(1) shall be rotated quarterly in alter3 nating sequence in advertisements for each brand of 

4 smokeless tobacco product in accordance with a plan 

5 submitted by the tobacco product manufacturer, im6 porter, distributor, or retailer to, and approved by, 

7 the Secretary. 

8 ‘‘(C) The Secretary shall review each plan sub9 mitted under subparagraph (B) and approve it if the 

10 plan— 

11 ‘‘(i) will provide for the equal distribution 

12 and display on packaging and the rotation re13 quired in advertising under this subsection; and 

14 ‘‘(ii) assures that all of the labels required 

15 under this section will be displayed by the to16 bacco product manufacturer, importer, dis17 tributor, or retailer at the same time. 

18 ‘‘(D) This paragraph applies to a retailer only 

19 if that retailer is responsible for or directs the label 

20 statements under this section, unless the retailer dis21 plays in a location open to the public, an advertise22 ment that is not labeled in accordance with the re23 quirements of this subsection. 

24 ‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is 

25 unlawful to advertise smokeless tobacco on any medium 


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1 of electronic communications subject to the jurisdiction of 

2 the Federal Communications Commission.’’. 

3 SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO 

4 PRODUCT WARNING LABEL STATEMENTS. 

5 Section 3 of the Comprehensive Smokeless Tobacco 

6 Health Education Act of 1986 (15 U.S.C. 4402), as 

7 amended by section 204, is further amended by adding 

8 at the end the following: 

9 ‘‘(d) AUTHORITY TO REVISE WARNING LABEL

10 STATEMENTS.—The Secretary may, by a rulemaking con11 ducted under section 553 of title 5, United States Code, 

12 adjust the format, type size, and text of any of the label 

13 requirements, require color graphics to accompany the 

14 text, increase the required label area from 30 percent up 

15 to 50 percent of the front and rear panels of the package, 

16 or establish the format, type size, and text of any other 

17 disclosures required under the Federal Food, Drug, and 

18 Cosmetic Act, if the Secretary finds that such a change 

19 would promote greater public understanding of the risks 

20 associated with the use of smokeless tobacco products.’’. 

21 SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CON22 STITUENT DISCLOSURE TO THE PUBLIC. 

23 Section 4 of the Federal Cigarette Labeling and Ad24 vertising Act (15 U.S.C. 1333), as amended by sections 


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1 201 and 202, is further amended by adding at the end 

2 the following: 

3 ‘‘(e) TAR, NICOTINE, AND OTHER SMOKE CON4 STITUENT DISCLOSURE.— 

5 ‘‘(1) IN GENERAL.—The Secretary shall, by a 

6 rulemaking conducted under section 553 of title 5, 

7 United States Code, determine (in the Secretary’s 

8 sole discretion) whether cigarette and other tobacco 

9 product manufacturers shall be required to include 

10 in the area of each cigarette advertisement specified 

11 by subsection (b) of this section, or on the package 

12 label, or both, the tar and nicotine yields of the ad13 vertised or packaged brand. Any such disclosure 

14 shall be in accordance with the methodology estab15 lished under such regulations, shall conform to the 

16 type size requirements of subsection (b) of this sec17 tion, and shall appear within the area specified in 

18 subsection (b) of this section. 

19 ‘‘(2) RESOLUTION OF DIFFERENCES.—Any dif20 ferences between the requirements established by the 

21 Secretary under paragraph (1) and tar and nicotine 

22 yield reporting requirements established by the Fed23 eral Trade Commission shall be resolved by a memo24 randum of understanding between the Secretary and 

25 the Federal Trade Commission. 


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1 ‘‘(3) CIGARETTE AND OTHER TOBACCO PROD2 UCT CONSTITUENTS.—In addition to the disclosures 

3 required by paragraph (1), the Secretary may, under 

4 a rulemaking conducted under section 553 of title 5, 

5 United States Code, prescribe disclosure require6 ments regarding the level of any cigarette or other 

7 tobacco product constituent including any smoke 

8 constituent. Any such disclosure may be required if 

9 the Secretary determines that disclosure would be of 

10 benefit to the public health, or otherwise would in11 crease consumer awareness of the health con12 sequences of the use of tobacco products, except that 

13 no such prescribed disclosure shall be required on 

14 the face of any cigarette package or advertisement. 

15 Nothing in this section shall prohibit the Secretary 

16 from requiring such prescribed disclosure through a 

17 cigarette or other tobacco product package or adver18 tisement insert, or by any other means under the 

19 Federal Food, Drug, and Cosmetic Act. 

20 ‘‘(4) RETAILERS.—This subsection applies to a 

21 retailer only if that retailer is responsible for or di22 rects the label statements required under this sec23 tion, except that this subsection shall not relieve a 

24 retailer of liability if the retailer sells or distributes 


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1 tobacco products that are not labeled in accordance 

2 with the requirements of subsection (a).’’. 

3 TITLE III—PREVENTION OF IL4 LICIT TRADE IN TOBACCO 

5 PRODUCTS 

6 SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPEC7 TION. 

8 Chapter IX of the Federal Food, Drug, and Cosmetic 

9 Act, as added by section 101, is further amended by add10 ing at the end the following: 

11 ‘‘SEC. 921. LABELING, RECORDKEEPING, RECORDS INSPEC12 TION. 

13 ‘‘(a) ORIGIN LABELING.—The label, packaging, and 

14 shipping containers of tobacco products for introduction 

15 or delivery for introduction into interstate commerce in the 

16 United States shall bear the statement ‘sale only allowed 

17 in the United States.’ 

18 ‘‘(b) REGULATIONS CONCERNING RECORDKEEPING

19 FOR TRACKING AND TRACING.— 

20 ‘‘(1) IN GENERAL.—Not later than 9 months 

21 after the date of enactment of the Family Smoking 

22 Prevention and Tobacco Control Act, the Secretary 

23 shall promulgate regulations regarding the establish24 ment and maintenance of records by any person who 

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1 ceives, packages, holds, exports, or imports tobacco 

2 products. 

3 ‘‘(2) INSPECTION.—In promulgating the regula4 tions described in paragraph (1), the Secretary shall 

5 consider which records are needed for inspection to 

6 monitor the movement of tobacco products from the 

7 point of manufacture through distribution to retail 

8 outlets to assist in investigating potential illicit 

9 trade, smuggling or counterfeiting of tobacco prod10 ucts. 

11 ‘‘(3) CODES.—The Secretary may require codes 

12 on the labels of tobacco products or other designs or 

13 devices for the purpose of tracking or tracing the to14 bacco product through the distribution system. 

15 ‘‘(4) SIZE OF BUSINESS.—The Secretary shall 

16 take into account the size of a business in promul17 gating regulations under this section. 

18 ‘‘(5) RECORDKEEPING BY RETAILERS.—The 

19 Secretary shall not require any retailer to maintain 

20 records relating to individual purchasers of tobacco 

21 products for personal consumption. 

22 ‘‘(c) RECORDS INSPECTION.—If the Secretary has a 

23 reasonable belief that a tobacco product is part of an illicit 

24 trade or smuggling or is a counterfeit product, each person 

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1 ceives, holds, packages, exports, or imports tobacco prod2 ucts shall, at the request of an officer or employee duly 

3 designated by the Secretary, permit such officer or em4 ployee, at reasonable times and within reasonable limits 

5 and in a reasonable manner, upon the presentation of ap6 propriate credentials and a written notice to such person, 

7 to have access to and copy all records (including financial 

8 records) relating to such article that are needed to assist 

9 the Secretary in investigating potential illicit trade, smug10 gling or counterfeiting of tobacco products. 

11 ‘‘(d) KNOWLEDGE OF ILLEGAL TRANSACTION.— 

12 ‘‘(1) NOTIFICATION.—If the manufacturer or 

13 distributor of a tobacco product has knowledge 

14 which reasonably supports the conclusion that a to15 bacco product manufactured or distributed by such 

16 manufacturer or distributor that has left the control 

17 of such person may be or has been— 

18 ‘‘(A) imported, exported, distributed or of19 fered for sale in interstate commerce by a per20 son without paying duties or taxes required by 

21 law; or 

22 ‘‘(B) imported, exported, distributed or di23 verted for possible illicit marketing, 

24 the manufacturer or distributor shall promptly notify the 

25 Attorney General of such knowledge. 


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1 ‘‘(2) KNOWLEDGE DEFINED.—For purposes of 

2 this subsection, the term ‘knowledge’ as applied to 

3 a manufacturer or distributor means— 

4 ‘‘(A) the actual knowledge that the manu5 facturer or distributor had; or 

6 ‘‘(B) the knowledge which a reasonable 

7 person would have had under like circumstances 

8 or which would have been obtained upon the ex9 ercise of due care.’’. 

10 SEC. 302. STUDY AND REPORT. 

11 (a) STUDY.—The Comptroller General of the United 

12 States shall conduct a study of cross-border trade in to13 bacco products to— 

14 (1) collect data on cross-border trade in tobacco 

15 products, including illicit trade and trade of counter16 feit tobacco products and make recommendations on 

17 the monitoring of such trade; 

18 (2) collect data on cross-border advertising (any 

19 advertising intended to be broadcast, transmitted, or 

20 distributed from the United States to another coun21 try) of tobacco products and make recommendations 

22 on how to prevent or eliminate, and what tech23 nologies could help facilitate the elimination of, 

24 cross-border advertising. 


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1 (b) REPORT.—Not later than 18 months after the 

2 date of enactment of this Act, the Comptroller General 

3 of the United States shall submit to the Committee on 

4 Health, Education, Labor, and Pensions of the Senate and 

5 the Committee on Energy and Commerce of the House 

6 of Representatives a report on the study described in sub7 section (a). 

Æ 


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