II 

109TH CONGRESS 

1ST SESSION S. 666

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 

MARCH 17, 2005

Mr. DEWINE (for himself, Mr. KENNEDY, Mr. LUGAR, Mr. HARKIN, Ms. COLLINS, Mr. DURBIN, Mr. SMITH, Mr. DODD, Mr. CORNYN, Mr. LAUTENBERG, Mr. MCCAIN, Mr. REED, Ms. SNOWE, Ms. MURKOWSKI, Mr. 

CHAFEE, and Mr. SPECTER) introduced the following bill; which was read 

twice and referred to the Committee on Health, Education, Labor, and 

Pensions 

A BILL

To protect the public health by providing the Food and 

Drug Administration with certain authority to regulate 

tobacco products.

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

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

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

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

7 this Act is as follows:

Sec. 1. Short title; table of contents. 
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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. Interim 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.

1 SEC. 2. FINDINGS. 

2 The Congress finds the following: 

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

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

7 (2) A consensus exists within the scientific and 

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

10 and other serious adverse health effects. 

11 (3) Nicotine is an addictive drug. 
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1 (4) Virtually all new users of tobacco products 

2 are under the minimum legal age to purchase such 

3 products. 

4 (5) Tobacco advertising and marketing con5 tribute significantly to the use of nicotine-containing 

6 tobacco products by adolescents. 

7 (6) Because past efforts to restrict advertising 

8 and marketing of tobacco products have failed ade9 quately to curb tobacco use by adolescents, com10 prehensive restrictions on the sale, promotion, and 

11 distribution of such products are needed. 

12 (7) Federal and State governments have lacked 

13 the legal and regulatory authority and resources 

14 they need to address comprehensively the public 

15 health and societal problems caused by the use of to16 bacco products. 

17 (8) Federal and State public health officials, 

18 the public health community, and the public at large 

19 recognize that the tobacco industry should be subject 

20 to ongoing oversight. 

21 (9) Under article I, section 8 of the Constitu22 tion, the Congress is vested with the responsibility 

23 for regulating interstate commerce and commerce 

24 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 2002, the tobacco industry spent more 

17 than $12,466,000,000 to attract new users, retain 

18 current users, increase current consumption, and 

19 generate favorable long-term attitudes toward smok20 ing 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 advertising than adults, they smoke the most adver24 tised brands. 
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1 (24) Tobacco company documents indicate that 

2 young people are an important and often crucial seg3 ment of the tobacco market. Children, who tend to 

4 be more price-sensitive than adults, are influenced 

5 by advertising and promotion practices that result in 

6 drastically reduced cigarette prices. 

7 (25) Comprehensive advertising restrictions will 

8 have a positive effect on the smoking rates of young 

9 people. 

10 (26) Restrictions on advertising are necessary 

11 to prevent unrestricted tobacco advertising from un12 dermining legislation prohibiting access to young 

13 people and providing for education about tobacco 

14 use. 

15 (27) International experience shows that adver16 tising regulations that are stringent and comprehen17 sive have a greater impact on overall tobacco use 

18 and young people’s use than weaker or less com19 prehensive ones. 

20 (28) Text only requirements, although not as 

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

22 tobacco products while preserving the informational 

23 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 

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

3 (33) Tobacco dependence is a chronic disease, 

4 one that typically requires repeated interventions to 

5 achieve long-term or permanent abstinence. 

6 (34) Because the only known safe alternative to 

7 smoking is cessation, interventions should target all 

8 smokers to help them quit completely. 

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

11 and internationally. Illicit trade of tobacco products 

12 has been linked to organized crime and terrorist 

13 groups. 

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

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

18 any advertising and labeling for such products. It is 

19 also essential that manufacturers, prior to marketing 

20 such products, be required to demonstrate that such 

21 products will meet a series of rigorous criteria, and 

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

23 taking into account both users of tobacco products 

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

2 reduce the risks to the public of tobacco use actually 

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

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

7 use tobacco products purporting to reduce risk. 

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

10 rather than quitting or reducing their use of tobacco 

11 products, have a substantially increased likelihood of 

12 suffering disability and premature death. The costs 

13 to society of the widespread use of products sold or 

14 distributed as modified risk products that do not in 

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

17 costs to our health care system. 

18 (38) As the National Cancer Institute has 

19 found, many smokers mistakenly believe that ‘‘low 

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

22 Institute has also found, mistaken beliefs about the 

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

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

2 death. 

3 (39) Recent studies have demonstrated that 

4 there has been no reduction in risk on a population5 wide basis from ‘‘low tar’’ and ‘‘light’’ cigarettes 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 ‘‘(nn)(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 907 

14 as sections 1001 through 1007; and 

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

16 ‘‘CHAPTER IX—TOBACCO 

17 PRODUCTS 

18 ‘‘SEC. 900. DEFINITIONS. 

19 ‘‘In this chapter: 

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

21 any substance the intended use of which results or 

22 may reasonably be expected to result, directly or in23 directly, in its becoming a component or otherwise 

24 affecting the characteristic of any tobacco product 

25 (including any substances intended for use as a fla-
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1 voring, coloring or in producing, manufacturing, 

2 packing, processing, preparing, treating, packaging, 

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

4 not include tobacco or a pesticide chemical residue 

5 in or on raw tobacco or a pesticide chemical. 

6 ‘‘(2) BRAND.—The term ‘brand’ means a vari7 ety of tobacco product distinguished by the tobacco 

8 used, tar content, nicotine content, flavoring used, 

9 size, filtration, or packaging, logo, registered trade10 mark or brand name, identifiable pattern of colors, 

11 or any combination of such attributes. 

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

13 meaning given that term by section 3(1) of the Fed14 eral Cigarette Labeling and Advertising Act (15 

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

16 form, that is functional in the product, which, be17 cause of its appearance, the type of tobacco used in 

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

19 be offered to, or purchased by, consumers as a ciga20 rette or as roll-your-own tobacco. 

21 ‘‘(4) CIGARETTE TOBACCO.—The term ‘ciga22 rette tobacco’ means any product that consists of 

23 loose tobacco that is intended for use by consumers 

24 in a cigarette. Unless otherwise stated, the require-
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1 ments for cigarettes shall also apply to cigarette to2 bacco. 

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

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

5 Federal Cigarette Labeling and Advertising Act (15 

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

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

8 term ‘counterfeit tobacco product’ means a tobacco 

9 product (or the container or labeling of such a prod10 uct) that, without authorization, bears the trade11 mark, trade name, or other identifying mark, im12 print or device, or any likeness thereof, of a tobacco 

13 product listed in a registration under section 

14 905(i)(1). 

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

16 regards a tobacco product means any person who 

17 furthers the distribution of a tobacco product, 

18 whether domestic or imported, at any point from the 

19 original place of manufacture to the person who sells 

20 or distributes the product to individuals for personal 

21 consumption. Common carriers are not considered 

22 distributors for purposes of this chapter. 

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

24 means any practice or conduct prohibited by law 

25 which relates to production, shipment, receipt, pos-
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1 session, distribution, sale, or purchase of tobacco 

2 products including any practice or conduct intended 

3 to facilitate such activity. 

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

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

6 the Indian Self Determination and Education Assist7 ance Act (25 U.S.C. 450b(e)). 

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

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

10 the Federal Cigarette Labeling and Advertising Act 

11 (15 U.S.C. 1332(7)). 

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 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 the Family Smoking Prevention and To17 bacco Control Act, shall be construed to affect the 

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

19 products under this Act that are not tobacco prod20 ucts under chapter V or any other chapter. 

21 ‘‘(2) LIMITATION OF AUTHORITY.—

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

23 chapter shall not apply to tobacco leaf that is 

24 not in the possession of a manufacturer of to25 bacco products, or to the producers of tobacco 
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1 leaf, including tobacco growers, tobacco ware2 houses, and tobacco grower cooperatives, nor 

3 shall any employee of the Food and Drug Ad4 ministration have any authority to enter onto a 

5 farm owned by a producer of tobacco leaf with6 out the written consent of such producer. 

7 ‘‘(B) EXCEPTION.—Notwithstanding any 

8 other provision of this subparagraph, if a pro9 ducer of tobacco leaf is also a tobacco product 

10 manufacturer or controlled by a tobacco prod11 uct manufacturer, the producer shall be subject 

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

13 manufacturer. 

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

15 in this chapter shall be construed to grant the 

16 Secretary authority to promulgate regulations 

17 on any matter that involves the production of 

18 tobacco leaf or a producer thereof, other than 

19 activities by a manufacturer affecting produc20 tion. 

21 ‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS. 

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

23 if—

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

25 putrid, or decomposed substance, or is otherwise 
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1 contaminated by any added poisonous or added dele2 terious substance that may render the product inju3 rious to health; 

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

5 under insanitary conditions whereby it may have 

6 been contaminated with filth, or whereby it may 

7 have been rendered injurious to health; 

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

9 part, of any poisonous or deleterious substance 

10 which may render the contents injurious to health; 

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

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

13 product standard established under section 907 un14 less such tobacco product is in all respects in con15 formity with such standard; 

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

17 premarket approval and does not have an approved 

18 application in effect; or 

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

20 such an application; 

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

22 controls used for, its manufacture, packing or stor23 age are not in conformity with applicable require24 ments under section 906(e)(1) or an applicable con-
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1 dition prescribed by an order under section 

2 906(e)(2); or 

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

4 ‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS. 

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

6 deemed to be misbranded—

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

8 particular; 

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

10 containing—

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

12 tobacco product manufacturer, packer, or dis13 tributor; 

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

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

16 numerical count; 

17 ‘‘(C) an accurate statement of the percent18 age of the tobacco used in the product that is 

19 domestically grown tobacco and the percentage 

20 that is foreign grown tobacco; and 

21 ‘‘(D) the statement required under section 

22 921(a), 

23 except that under subparagraph (B) reasonable vari24 ations shall be permitted, and exemptions as to 
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1 small packages shall be established, by regulations 

2 prescribed by the Secretary; 

3 ‘‘(3) if any word, statement, or other informa4 tion required by or under authority of this chapter 

5 to appear on the label or labeling is not prominently 

6 placed thereon with such conspicuousness (as com7 pared with other words, statements or designs in the 

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

9 be read and understood by the ordinary individual 

10 under customary conditions of purchase and use; 

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

12 label bears, to the exclusion of any other nonpropri13 etary name, its established name prominently print14 ed in type as required by the Secretary by regula15 tion; 

16 ‘‘(5) if the Secretary has issued regulations re17 quiring that its labeling bear adequate directions for 

18 use, or adequate warnings against use by children, 

19 that are necessary for the protection of users unless 

20 its labeling conforms in all respects to such regula21 tions; 

22 ‘‘(6) if it was manufactured, prepared, propa23 gated, compounded, or processed in any State in an 

24 establishment not duly registered under section 

25 905(b), 905(c), 905(d), or 905(h), if it was not in-
28

•S 666 IS 

1 cluded in a list required by section 905(i), if a notice 

2 or other information respecting it was not provided 

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

4 it does not bear such symbols from the uniform sys5 tem for identification of tobacco products prescribed 

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

7 requires; 

8 ‘‘(7) if, in the case of any tobacco product dis9 tributed or offered for sale in any State—

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

11 in any particular; or 

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

13 regulations prescribed under section 906(d); 

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

15 distributed or offered for sale in any State, the man16 ufacturer, packer, or distributor thereof includes in 

17 all advertisements and other descriptive printed mat18 ter issued or caused to be issued by the manufac19 turer, packer, or distributor with respect to that to20 bacco product—

21 ‘‘(A) a true statement of the tobacco prod22 uct’s established name as described in para23 graph (4), printed prominently; and 

24 ‘‘(B) a brief statement of—
29

•S 666 IS 

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

2 and relevant warnings, precautions, side 

3 effects, and contraindications; and 

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

5 products made subject to a finding by the 

6 Secretary after notice and opportunity for 

7 comment that such action is appropriate to 

8 protect the public health, a full description 

9 of the components of such tobacco product 

10 or the formula showing quantitatively each 

11 ingredient of such tobacco product to the 

12 extent required in regulations which shall 

13 be issued by the Secretary after an oppor14 tunity for a hearing; 

15 ‘‘(9) if it is a tobacco product subject to a to16 bacco product standard established under section 

17 907, unless it bears such labeling as may be pre18 scribed in such tobacco product standard; or 

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

20 ‘‘(A) to comply with any requirement pre21 scribed under section 904 or 908; or 

22 ‘‘(B) to furnish any material or informa23 tion required under section 909. 

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

25 The Secretary may, by regulation, require prior approval 
30

•S 666 IS 

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

2 regulation issued under this subsection may require prior 

3 approval by the Secretary of the content of any advertise4 ment, except for modified risk tobacco products as pro5 vided in section 911. No advertisement of a tobacco prod6 uct published after the date of enactment of the Family 

7 Smoking Prevention and Tobacco Control Act shall, with 

8 respect to the language of label statements as prescribed 

9 under section 4 of the Cigarette Labeling and Advertising 

10 Act and section 3 of the Comprehensive Smokeless To11 bacco Health Education Act of 1986 or the regulations 

12 issued under such sections, be subject to the provisions 

13 of sections 12 through 15 of the Federal Trade Commis14 sion Act (15 U.S.C. 52 through 55). 

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

16 SECRETARY. 

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

18 the date of enactment of the Family Smoking Prevention 

19 and Tobacco Control Act, each tobacco product manufac20 turer or importer, or agents thereof, shall submit to the 

21 Secretary the following information: 

22 ‘‘(1) A listing of all ingredients, including to23 bacco, substances, compounds, and additives that 

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

25 the tobacco, paper, filter, or other part of each to-
31

•S 666 IS 

1 bacco product by brand and by quantity in each 

2 brand and subbrand. 

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

4 form of nicotine in each tobacco product measured 

5 in milligrams of nicotine in accordance with regula6 tions promulgated by the Secretary in accordance 

7 with section 4(a)(4) of the Federal Cigarette Label8 ing and Advertising Act. 

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

10 smoke constituents as applicable, identified by the 

11 Secretary as harmful or potentially harmful to 

12 health in each tobacco product, and as applicable in 

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

14 quantity in each brand and subbrand. Effective be15 ginning 2 years after the date of enactment of this 

16 chapter, the manufacturer, importer, or agent shall 

17 comply with regulations promulgated under section 

18 916 in reporting information under this paragraph, 

19 where applicable. 

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

21 enactment of the Family Smoking Prevention and 

22 Tobacco Control Act that relate to health, toxi23 cological, behavioral, or physiologic effects of current 

24 or future tobacco products, their constituents (in-
32

•S 666 IS 

1 cluding smoke constituents), ingredients, compo2 nents, and additives. 

3 ‘‘(b) DATA SUBMISSION.—At the request of the Sec4 retary, each tobacco product manufacturer or importer of 

5 tobacco products, or agents thereof, shall submit the fol6 lowing: 

7 ‘‘(1) Any or all documents (including under8 lying scientific information) relating to research ac9 tivities, and research findings, conducted, supported, 

10 or possessed by the manufacturer (or agents thereof) 

11 on the health, toxicological, behavioral, or physio12 logic effects of tobacco products and their constitu13 ents (including smoke constituents), ingredients, 

14 components, and additives. 

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

18 or possessed by the manufacturer (or agents thereof) 

19 that relate to the issue of whether a reduction in 

20 risk to health from tobacco products can occur upon 

21 the employment of technology available or known to 

22 the manufacturer. 

23 ‘‘(3) Any or all documents (including under24 lying scientific or financial information) relating to 

25 marketing research involving the use of tobacco 
33

•S 666 IS 

1 products or marketing practices and the effective2 ness of such practices used by tobacco manufactur3 ers and distributors. 

4 An importer of a tobacco product not manufactured in the 

5 United States shall supply the information required of a 

6 tobacco product manufacturer under this subsection. 

7 ‘‘(c) TIME FOR SUBMISSION.—

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

9 the delivery for introduction into interstate com10 merce of a tobacco product not on the market on the 

11 date of enactment of the Family Smoking Preven12 tion and Tobacco Control Act, the manufacturer of 

13 such product shall provide the information required 

14 under subsection (a). 

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

16 time a tobacco product manufacturer adds to its to17 bacco products a new tobacco additive or increases 

18 the quantity of an existing tobacco additive, the 

19 manufacturer shall, except as provided in paragraph 

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

21 the Secretary in writing. 

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

23 any time a tobacco product manufacturer eliminates 

24 or decreases an existing additive, or adds or in25 creases an additive that has by regulation been des-
34

•S 666 IS 

1 ignated by the Secretary as an additive that is not 

2 a human or animal carcinogen, or otherwise harmful 

3 to health under intended conditions of use, the man4 ufacturer shall within 60 days of such action so ad5 vise the Secretary in writing. 

6 ‘‘(d) DATA LIST.—

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

8 after the date of enactment of the Family Smoking 

9 Prevention and Tobacco Control Act, and annually 

10 thereafter, the Secretary shall publish in a format 

11 that is understandable and not misleading to a lay 

12 person, and place on public display (in a manner de13 termined by the Secretary) the list established under 

14 subsection (e). 

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

16 shall conduct periodic consumer research to ensure 

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

18 misleading to lay persons. Not later than 5 years 

19 after the date of enactment of the Family Smoking 

20 Prevention and Tobacco Control Act, the Secretary 

21 shall submit to the appropriate committees of Con22 gress a report on the results of such research, to23 gether with recommendations on whether such publi24 cation should be continued or modified. 
35

•S 666 IS 

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

2 after the date of enactment of the Family Smoking Pre3 vention and Tobacco Control Act, the Secretary shall es4 tablish a list of harmful and potentially harmful constitu5 ents, including smoke constituents, to health in each to6 bacco product by brand and by quantity in each brand 

7 and subbrand. The Secretary shall publish a public notice 

8 requesting the submission by interested persons of sci9 entific and other information concerning the harmful and 

10 potentially harmful constituents in tobacco products and 

11 tobacco smoke. 

12 ‘‘SEC. 905. ANNUAL REGISTRATION. 

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

14 ‘‘(1) MANUFACTURE, PREPARATION, 

15 COMPOUNDING, OR PROCESSING.—The term ‘manu16 facture, preparation, compounding, or processing’ 

17 shall include repackaging or otherwise changing the 

18 container, wrapper, or labeling of any tobacco prod19 uct package in furtherance of the distribution of the 

20 tobacco product from the original place of manufac21 ture to the person who makes final delivery or sale 

22 to the ultimate consumer or user. 

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

24 the case of a partnership the name of each partner 

25 and, in the case of a corporation, the name of each 
36

•S 666 IS 

1 corporate officer and director, and the State of in2 corporation. 

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

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

5 owns or operates any establishment in any State engaged 

6 in the manufacture, preparation, compounding, or proc7 essing of a tobacco product or tobacco products shall reg8 ister with the Secretary the name, places of business, and 

9 all such establishments of that person. 

10 ‘‘(c) REGISTRATION OF NEW OWNERS AND OPERA11 TORS.—Every person upon first engaging in the manufac12 ture, preparation, compounding, or processing of a tobacco 

13 product or tobacco products in any establishment owned 

14 or operated in any State by that person shall immediately 

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

16 business, and such establishment. 

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

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

19 (c) shall immediately register with the Secretary any addi20 tional establishment which that person owns or operates 

21 in any State and in which that person begins the manufac22 ture, preparation, compounding, or processing of a tobacco 

23 product or tobacco products. 

24 ‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYS25 TEM.—The Secretary may by regulation prescribe a uni-
37

•S 666 IS 

1 form system for the identification of tobacco products and 

2 may require that persons who are required to list such 

3 tobacco products under subsection (i) shall list such to4 bacco products in accordance with such system. 

5 ‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA6 TION.—The Secretary shall make available for inspection, 

7 to any person so requesting, any registration filed under 

8 this section. 

9 ‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB10 LISHMENTS.—Every establishment in any State registered 

11 with the Secretary under this section shall be subject to 

12 inspection under section 704, and every such establish13 ment engaged in the manufacture, compounding, or proc14 essing of a tobacco product or tobacco products shall be 

15 so inspected by 1 or more officers or employees duly des16 ignated by the Secretary at least once in the 2-year period 

17 beginning with the date of registration of such establish18 ment under this section and at least once in every succes19 sive 2-year period thereafter. 

20 ‘‘(h) FOREIGN ESTABLISHMENTS SHALL REG21 ISTER.—Any establishment within any foreign country en22 gaged in the manufacture, preparation, compounding, or 

23 processing of a tobacco product or tobacco products, shall 

24 register under this section under regulations promulgated 

25 by the Secretary. Such regulations shall require such es-
38

•S 666 IS 

1 tablishment to provide the information required by sub2 section (i) of this section and shall include provisions for 

3 registration of any such establishment upon condition that 

4 adequate and effective means are available, by arrange5 ment with the government of such foreign country or oth6 erwise, to enable the Secretary to determine from time to 

7 time whether tobacco products manufactured, prepared, 

8 compounded, or processed in such establishment, if im9 ported or offered for import into the United States, shall 

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

11 section 801(a). 

12 ‘‘(i) REGISTRATION INFORMATION.—

13 ‘‘(1) PRODUCT LIST.—Every person who reg14 isters with the Secretary under subsection (b), (c), 

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

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

17 all tobacco products which are being manufactured, 

18 prepared, compounded, or processed by that person 

19 for commercial distribution and which has not been 

20 included in any list of tobacco products filed by that 

21 person with the Secretary under this paragraph or 

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

23 list shall be prepared in such form and manner as 

24 the Secretary may prescribe and shall be accom25 panied by—
39

•S 666 IS 

1 ‘‘(A) in the case of a tobacco product con2 tained in the applicable list with respect to 

3 which a tobacco product standard has been es4 tablished under section 907 or which is subject 

5 to section 910, a reference to the authority for 

6 the marketing of such tobacco product and a 

7 copy of all labeling for such tobacco product; 

8 ‘‘(B) in the case of any other tobacco prod9 uct contained in an applicable list, a copy of all 

10 consumer information and other labeling for 

11 such tobacco product, a representative sampling 

12 of advertisements for such tobacco product, 

13 and, upon request made by the Secretary for 

14 good cause, a copy of all advertisements for a 

15 particular tobacco product; and 

16 ‘‘(C) if the registrant filing a list has de17 termined that a tobacco product contained in 

18 such list is not subject to a tobacco product 

19 standard established under section 907, a brief 

20 statement of the basis upon which the reg21 istrant made such determination if the Sec22 retary requests such a statement with respect 

23 to that particular tobacco product. 

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

25 PRODUCT LIST.—Each person who registers with the 
40

•S 666 IS 

1 Secretary under this section shall report to the Sec2 retary once during the month of June of each year 

3 and once during the month of December of each 

4 year the following: 

5 ‘‘(A) A list of each tobacco product intro6 duced by the registrant for commercial distribu7 tion which has not been included in any list 

8 previously filed by that person with the Sec9 retary under this subparagraph or paragraph 

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

11 tobacco product by its established name and 

12 shall be accompanied by the other information 

13 required by paragraph (1). 

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

15 made a report under this paragraph that person 

16 has discontinued the manufacture, preparation, 

17 compounding, or processing for commercial dis18 tribution of a tobacco product included in a list 

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

20 notice of such discontinuance, the date of such 

21 discontinuance, and the identity of its estab22 lished name. 

23 ‘‘(C) If since the date the registrant re24 ported under subparagraph (B) a notice of dis25 continuance that person has resumed the manu-
41

•S 666 IS 

1 facture, preparation, compounding, or proc2 essing for commercial distribution of the to3 bacco product with respect to which such notice 

4 of discontinuance was reported, notice of such 

5 resumption, the date of such resumption, the 

6 identity of such tobacco product by established 

7 name, and other information required by para8 graph (1), unless the registrant has previously 

9 reported such resumption to the Secretary 

10 under this subparagraph. 

11 ‘‘(D) Any material change in any informa12 tion previously submitted under this paragraph 

13 or paragraph (1). 

14 ‘‘(j) REPORT PRECEDING INTRODUCTION OF CER15 TAIN SUBSTANTIALLY-EQUIVALENT PRODUCTS INTO

16 INTERSTATE COMMERCE.—

17 ‘‘(1) IN GENERAL.—Each person who is re18 quired to register under this section and who pro19 poses to begin the introduction or delivery for intro20 duction into interstate commerce for commercial dis21 tribution of a tobacco product intended for human 

22 use that was not commercially marketed (other than 

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

24 1, 2003, shall, at least 90 days prior to making such 

25 introduction or delivery, report to the Secretary (in 
42

•S 666 IS 

1 such form and manner as the Secretary shall pre2 scribe)—

3 ‘‘(A) the basis for such person’s determina4 tion that the tobacco product is substantially 

5 equivalent, within the meaning of section 910, 

6 to a tobacco product commercially marketed 

7 (other than for test marketing) in the United 

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

9 with the requirements of this Act; and 

10 ‘‘(B) action taken by such person to com11 ply with the requirements under section 907 

12 that are applicable to the tobacco product. 

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

14 2003 PRODUCTS.—A report under this subsection for 

15 a tobacco product that was first introduced or deliv16 ered for introduction into interstate commerce for 

17 commercial distribution in the United States after 

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

19 months after the date of enactment of the Family 

20 Smoking Prevention and Tobacco Control Act shall 

21 be submitted to the Secretary not later than 15 

22 months after such date of enactment. 

23 ‘‘(3) EXEMPTIONS.—

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

25 regulation, exempt from the requirements of 
43

•S 666 IS 

1 this subsection tobacco products that are modi2 fied by adding or deleting a tobacco additive, or 

3 increasing or decreasing the quantity of an ex4 isting tobacco additive, if the Secretary deter5 mines that—

6 ‘‘(i) such modification would be a 

7 minor modification of a tobacco product 

8 authorized for sale under this Act; 

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

10 not necessary to ensure that permitting the 

11 tobacco product to be marketed would be 

12 appropriate for protection of the public 

13 health; and 

14 ‘‘(iii) an exemption is otherwise appro15 priate. 

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

17 months after the date of enactment of the Fam18 ily Smoking Prevention and Tobacco Control 

19 Act, the Secretary shall issue regulations to im20 plement this paragraph. 

21 ‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL 

22 OF TOBACCO PRODUCTS. 

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

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

25 tobacco product shall apply to such tobacco product until 
44

•S 666 IS 

1 the applicability of the requirement to the tobacco product 

2 has been changed by action taken under section 907, sec3 tion 910, section 911, or subsection (d) of this section, 

4 and any requirement established by or under section 902, 

5 903, 905, or 909 which is inconsistent with a requirement 

6 imposed on such tobacco product under section 907, sec7 tion 910, section 911, or subsection (d) of this section 

8 shall not apply to such tobacco product. 

9 ‘‘(b) INFORMATION ON PUBLIC ACCESS AND COM10 MENT.—Each notice of proposed rulemaking under section 

11 907, 908, 909, 910, or 911 or under this section, any 

12 other notice which is published in the Federal Register 

13 with respect to any other action taken under any such sec14 tion and which states the reasons for such action, and 

15 each publication of findings required to be made in con16 nection with rulemaking under any such section shall set 

17 forth—

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

19 may examine data and other information on which 

20 the notice or findings is based; and 

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

22 may present their comments on the notice or find23 ings (including the need therefore) orally or in writ24 ing, which period shall be at least 60 days but may 

25 not exceed 90 days unless the time is extended by 
45

•S 666 IS 

1 the Secretary by a notice published in the Federal 

2 Register stating good cause therefore. 

3 ‘‘(c) LIMITED CONFIDENTIALITY OF INFORMA4 TION.—Any information reported to or otherwise obtained 

5 by the Secretary or the Secretary’s representative under 

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

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

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

9 5, United States Code, by reason of subsection (b)(4) of 

10 that section shall be considered confidential and shall not 

11 be disclosed, except that the information may be disclosed 

12 to other officers or employees concerned with carrying out 

13 this chapter, or when relevant in any proceeding under 

14 this chapter. 

15 ‘‘(d) RESTRICTIONS.—

16 ‘‘(1) IN GENERAL.—The Secretary may by reg17 ulation require restrictions on the sale and distribu18 tion of a tobacco product, including restrictions on 

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

20 the tobacco product, if the Secretary determines that 

21 such regulation would be appropriate for the protec22 tion of the public health. The Secretary may by reg23 ulation impose restrictions on the advertising and 

24 promotion of a tobacco product consistent with and 

25 to full extent permitted by the first amendment to 
46

•S 666 IS 

1 the Constitution. The finding as to whether such 

2 regulation would be appropriate for the protection of 

3 the public health shall be determined with respect to 

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

5 including users and non-users of the tobacco prod6 uct, and taking into account—

7 ‘‘(A) the increased or decreased likelihood 

8 that existing users of tobacco products will stop 

9 using such products; and 

10 ‘‘(B) the increased or decreased likelihood 

11 that those who do not use tobacco products will 

12 start using such products. 

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

16 by law to prescribe medical products. 

17 ‘‘(2) LABEL STATEMENTS.—The label of a to18 bacco product shall bear such appropriate state19 ments of the restrictions required by a regulation 

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

21 regulation prescribe. 

22 ‘‘(3) LIMITATIONS.—

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

24 paragraph (1) may—
47

•S 666 IS 

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

2 product in face-to-face transactions by a 

3 specific category of retail outlets; or 

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

5 of tobacco products to any person older 

6 than 18 years of age. 

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

8 regulations issued by the Secretary, matchbooks 

9 of conventional size containing not more than 

10 20 paper matches, and which are customarily 

11 given away for free with the purchase of to12 bacco products shall be considered as adult 

13 written publications which shall be permitted to 

14 contain advertising. Notwithstanding the pre15 ceding sentence, if the Secretary finds that such 

16 treatment of matchbooks is not appropriate for 

17 the protection of the public health, the Sec18 retary may determine by regulation that match19 books shall not be considered adult written pub20 lications. 

21 ‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE22 MENTS.—

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

24 CONFORM.—
48

•S 666 IS 

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

2 accordance with subparagraph (B), prescribe 

3 regulations (which may differ based on the type 

4 of tobacco product involved) requiring that the 

5 methods used in, and the facilities and controls 

6 used for, the manufacture, pre-production de7 sign validation (including a process to assess 

8 the performance of a tobacco product), packing 

9 and storage of a tobacco product, conform to 

10 current good manufacturing practice, as pre11 scribed in such regulations, to assure that the 

12 public health is protected and that the tobacco 

13 product is in compliance with this chapter. 

14 Good manufacturing practices may include the 

15 testing of raw tobacco for pesticide chemical 

16 residues regardless of whether a tolerance for 

17 such chemical residues has been established. 

18 ‘‘(B) REQUIREMENTS.—The Secretary 

19 shall—

20 ‘‘(i) before promulgating any regula21 tion under subparagraph (A), afford the 

22 Tobacco Products Scientific Advisory Com23 mittee an opportunity to submit rec24 ommendations with respect to the regula25 tion proposed to be promulgated; 
49

•S 666 IS 

1 ‘‘(ii) before promulgating any regula2 tion under subparagraph (A), afford oppor3 tunity for an oral hearing; 

4 ‘‘(iii) provide the advisory committee a 

5 reasonable time to make its recommenda6 tion with respect to proposed regulations 

7 under subparagraph (A); and 

8 ‘‘(iv) in establishing the effective date 

9 of a regulation promulgated under this 

10 subsection, take into account the dif11 ferences in the manner in which the dif12 ferent types of tobacco products have his13 torically been produced, the financial re14 sources of the different tobacco product 

15 manufacturers, and the state of their exist16 ing manufacturing facilities, and shall pro17 vide for a reasonable period of time for 

18 such manufacturers to conform to good 

19 manufacturing practices. 

20 ‘‘(2) EXEMPTIONS; VARIANCES.—

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

22 any requirement prescribed under paragraph 

23 (1) may petition the Secretary for a permanent 

24 or temporary exemption or variance from such 

25 requirement. Such a petition shall be submitted 
50

•S 666 IS 

1 to the Secretary in such form and manner as 

2 the Secretary shall prescribe and shall—

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

5 basis for the petitioner’s determination 

6 that compliance with the requirement is 

7 not required to assure that the tobacco 

8 product will be in compliance with this 

9 chapter; 

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

11 variance from a requirement, set forth the 

12 methods proposed to be used in, and the 

13 facilities and controls proposed to be used 

14 for, the manufacture, packing, and storage 

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

17 the requirement; and 

18 ‘‘(iii) contain such other information 

19 as the Secretary shall prescribe. 

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

22 Secretary may refer to the Tobacco Products 

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

25 Products Scientific Advisory Committee shall 
51

•S 666 IS 

1 report its recommendations to the Secretary 

2 with respect to a petition referred to it within 

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

4 Within 60 days after—

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

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

10 Advisory Committee, 

11 whichever occurs later, the Secretary shall by 

12 order either deny the petition or approve it. 

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

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

16 tobacco product from a requirement if the 

17 Secretary determines that compliance with 

18 such requirement is not required to assure 

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

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

23 Secretary determines that the methods to 

24 be used in, and the facilities and controls 

25 to be used for, the manufacture, packing, 
52

•S 666 IS 

1 and storage of the tobacco product in lieu 

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

4 assure that the tobacco product will be in 

5 compliance with this chapter. 

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

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

10 for, the manufacture, packing, and storage of 

11 the tobacco product to be granted the variance 

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

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

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

18 for an informal hearing on such order. 

19 ‘‘(3) COMPLIANCE.—Compliance with require20 ments under this subsection shall not be required be21 fore the period ending 3 years after the date of en22 actment of the Family Smoking Prevention and To23 bacco Control Act. 

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

25 may enter into contracts for research, testing, and dem-
53

•S 666 IS 

1 onstrations respecting tobacco products and may obtain 

2 tobacco products for research, testing, and demonstration 

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

4 31, United States Code, and section 5 of title 41, United 

5 States Code. 

6 ‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 

7 ‘‘(a) IN GENERAL.—

8 ‘‘(1) SPECIAL RULE FOR CIGARETTES.—A ciga9 rette or any of its component parts (including the 

10 tobacco, filter, or paper) shall not contain, as a con11 stituent (including a smoke constituent) or additive, 

12 an artificial or natural flavor (other than tobacco or 

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

14 grape, orange, clove, cinnamon, pineapple, vanilla, 

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

16 that is a characterizing flavor of the tobacco product 

17 or tobacco smoke. Nothing in this subparagraph 

18 shall be construed to limit the Secretary’s authority 

19 to take action under this section or other sections of 

20 this Act applicable to menthol or any artificial or 

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

22 paragraph. 

23 ‘‘(2) REVISION OF TOBACCO PRODUCT STAND24 ARDS.—The Secretary may revise the tobacco prod-
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1 uct standards in paragraph (1) in accordance with 

2 subsection (b). 

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

4 Secretary may adopt tobacco product standards in 

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

6 finds that a tobacco product standard is appropriate 

7 for the protection of the public health. This finding 

8 shall be determined with respect to the risks and 

9 benefits to the population as a whole, including 

10 users and non-users of the tobacco product, and tak11 ing 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 ‘‘(4) CONTENT OF TOBACCO PRODUCT STAND19 ARDS.—A tobacco product standard established 

20 under this section for a tobacco product—

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

23 including provisions, where appropriate— 

24 ‘‘(i) for the reduction of nicotine 

25 yields of the product; 
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•S 666 IS 

1 ‘‘(ii) for the reduction or elimination 

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

4 product; or 

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

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

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

13 product; 

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

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

17 ‘‘(iii) provisions for the measurement 

18 of the tobacco product characteristics of 

19 the tobacco product; 

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

22 the tobacco product required to be made 

23 under clause (ii) show that the tobacco 

24 product is in conformity with the portions 
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1 of the standard for which the test or tests 

2 were required; and 

3 ‘‘(v) a provision requiring that the 

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

6 that the sale and distribution of a tobacco 

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

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

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

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

13 PRODUCT STANDARDS.—The Secretary shall provide 

14 for periodic evaluation of tobacco product standards 

15 established under this section to determine whether 

16 such standards should be changed to reflect new 

17 medical, scientific, or other technological data. The 

18 Secretary may provide for testing under paragraph 

19 (4)(B) by any person. 

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

22 this section, the Secretary shall endeavor to—

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

24 technical support available in other Federal 

25 agencies; 
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•S 666 IS 

1 ‘‘(B) consult with other Federal agencies 

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

5 ‘‘(C) invite appropriate participation, 

6 through joint or other conferences, workshops, 

7 or other means, by informed persons represent8 ative of scientific, professional, industry, agri9 cultural, or consumer organizations who in the 

10 Secretary’s judgment can make a significant 

11 contribution. 

12 ‘‘(b) ESTABLISHMENT OF STANDARDS.—

13 ‘‘(1) NOTICE.—

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

15 publish in the Federal Register a notice of pro16 posed rulemaking for the establishment, amend17 ment, or revocation of any tobacco product 

18 standard. 

19 ‘‘(B) REQUIREMENTS OF NOTICE.—A no20 tice of proposed rulemaking for the establish21 ment or amendment of a tobacco product stand22 ard for a tobacco product shall—

23 ‘‘(i) set forth a finding with sup24 porting justification that the tobacco prod-
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1 uct standard is appropriate for the protec2 tion of the public health; 

3 ‘‘(ii) set forth proposed findings with 

4 respect to the risk of illness or injury that 

5 the tobacco product standard is intended 

6 to reduce or eliminate; and 

7 ‘‘(iii) invite interested persons to sub8 mit an existing tobacco product standard 

9 for the tobacco product, including a draft 

10 or proposed tobacco product standard, for 

11 consideration by the Secretary. 

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

13 by the Secretary that an additive, constituent 

14 (including smoke constituent), or other compo15 nent of the product that is the subject of the 

16 proposed tobacco product standard is harmful, 

17 it shall be the burden of any party challenging 

18 the proposed standard to prove that the pro19 posed standard will not reduce or eliminate the 

20 risk of illness or injury. 

21 ‘‘(D) FINDING.—A notice of proposed rule22 making for the revocation of a tobacco product 

23 standard shall set forth a finding with sup24 porting justification that the tobacco product 
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1 standard is no longer appropriate for the pro2 tection of the public health. 

3 ‘‘(E) CONSIDERATION BY SECRETARY.—

4 The Secretary shall consider all information 

5 submitted in connection with a proposed stand6 ard, including information concerning the coun7 tervailing effects of the tobacco product stand8 ard on the health of adolescent tobacco users, 

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

10 as the creation of a significant demand for con11 traband or other tobacco products that do not 

12 meet the requirements of this chapter and the 

13 significance of such demand, and shall issue the 

14 standard if the Secretary determines that the 

15 standard would be appropriate for the protec16 tion of the public health. 

17 ‘‘(F) COMMENT.—The Secretary shall pro18 vide for a comment period of not less than 60 

19 days. 

20 ‘‘(2) PROMULGATION.—

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

22 the period for comment on a notice of proposed 

23 rulemaking published under paragraph (1) re24 specting a tobacco product standard and after 

25 consideration of such comments and any report 
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1 from the Tobacco Products Scientific Advisory 

2 Committee, the Secretary shall—

3 ‘‘(i) promulgate a regulation estab4 lishing a tobacco product standard and 

5 publish in the Federal Register findings on 

6 the matters referred to in paragraph (1); 

7 or 

8 ‘‘(ii) publish a notice terminating the 

9 proceeding for the development of the 

10 standard together with the reasons for 

11 such termination. 

12 ‘‘(B) EFFECTIVE DATE.—A regulation es13 tablishing a tobacco product standard shall set 

14 forth the date or dates upon which the standard 

15 shall take effect, but no such regulation may 

16 take effect before 1 year after the date of its 

17 publication unless the Secretary determines 

18 that an earlier effective date is necessary for 

19 the protection of the public health. Such date or 

20 dates shall be established so as to minimize, 

21 consistent with the public health, economic loss 

22 to, and disruption or dislocation of, domestic 

23 and international trade. 

24 ‘‘(3) POWER RESERVED TO CONGRESS.—Be25 cause of the importance of a decision of the Sec-
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•S 666 IS 

1 retary to issue a regulation establishing a tobacco 

2 product standard—

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

4 tobacco products, all little cigars, all cigars 

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

6 roll your own tobacco products; or 

7 ‘‘(B) requiring the reduction of nicotine 

8 yields of a tobacco product to zero, 

9 Congress expressly reserves to itself such power. 

10 ‘‘(4) AMENDMENT; REVOCATION.—

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

12 the Secretary’s own initiative or upon petition 

13 of an interested person may by a regulation, 

14 promulgated in accordance with the require15 ments of paragraphs (1) and (2)(B), amend or 

16 revoke a tobacco product standard. 

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

18 may declare a proposed amendment of a to19 bacco product standard to be effective on and 

20 after its publication in the Federal Register and 

21 until the effective date of any final action taken 

22 on such amendment if the Secretary determines 

23 that making it so effective is in the public inter24 est. 
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1 ‘‘(5) REFERENCE TO ADVISORY COMMITTEE.—

2 The Secretary may—

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

4 refer a proposed regulation for the establish5 ment, amendment, or revocation of a tobacco 

6 product standard; or 

7 ‘‘(B) upon the request of an interested per8 son which demonstrates good cause for referral 

9 and which is made before the expiration of the 

10 period for submission of comments on such pro11 posed regulation, 

12 refer such proposed regulation to the Tobacco Products 

13 Scientific Advisory Committee, for a report and rec14 ommendation with respect to any matter involved in the 

15 proposed regulation which requires the exercise of sci16 entific judgment. If a proposed regulation is referred 

17 under this paragraph to the Tobacco Products Scientific 

18 Advisory Committee, the Secretary shall provide the advi19 sory committee with the data and information on which 

20 such proposed regulation is based. The Tobacco Products 

21 Scientific Advisory Committee shall, within 60 days after 

22 the referral of a proposed regulation and after inde23 pendent study of the data and information furnished to 

24 it by the Secretary and other data and information before 

25 it, submit to the Secretary a report and recommendation 
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•S 666 IS 

1 respecting such regulation, together with all underlying 

2 data and information and a statement of the reason or 

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

4 recommendation shall be made public by the Secretary. 

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

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

7 that—

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

9 delivered for introduction into interstate commerce 

10 for commercial distribution presents an unreasonable 

11 risk of substantial harm to the public health; and 

12 ‘‘(2) notification under this subsection is nec13 essary to eliminate the unreasonable risk of such 

14 harm and no more practicable means is available 

15 under the provisions of this chapter (other than this 

16 section) to eliminate such risk, 

17 the Secretary may issue such order as may be necessary 

18 to assure that adequate notification is provided in an ap19 propriate form, by the persons and means best suited 

20 under the circumstances involved, to all persons who 

21 should properly receive such notification in order to elimi22 nate such risk. The Secretary may order notification by 

23 any appropriate means, including public service announce24 ments. Before issuing an order under this subsection, the 
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1 Secretary shall consult with the persons who are to give 

2 notice under the order. 

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

4 Compliance with an order issued under this section shall 

5 not relieve any person from liability under Federal or 

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

7 action brought for the enforcement of any such liability, 

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

9 provided under such order shall be taken into account. 

10 ‘‘(c) RECALL AUTHORITY.—

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

12 there is a reasonable probability that a tobacco prod13 uct contains a manufacturing or other defect not or14 dinarily contained in tobacco products on the market 

15 that would cause serious, adverse health con16 sequences or death, the Secretary shall issue an 

17 order requiring the appropriate person (including 

18 the manufacturers, importers, distributors, or retail19 ers of the tobacco product) to immediately cease dis20 tribution of such tobacco product. The order shall 

21 provide the person subject to the order with an op22 portunity for an informal hearing, to be held not 

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

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

25 on whether the order should be amended to require 
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1 a recall of such tobacco product. If, after providing 

2 an opportunity for such a hearing, the Secretary de3 termines that inadequate grounds exist to support 

4 the actions required by the order, the Secretary shall 

5 vacate the order. 

6 ‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE7 CALL.—

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

9 opportunity for an informal hearing under 

10 paragraph (1), the Secretary determines that 

11 the order should be amended to include a recall 

12 of the tobacco product with respect to which the 

13 order was issued, the Secretary shall, except as 

14 provided in subparagraph (B), amend the order 

15 to require a recall. The Secretary shall specify 

16 a timetable in which the tobacco product recall 

17 will occur and shall require periodic reports to 

18 the Secretary describing the progress of the re19 call. 

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

21 subparagraph (A)—

22 ‘‘(i) shall not include recall of a to23 bacco product from individuals; and 
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1 ‘‘(ii) shall provide for notice to per2 sons subject to the risks associated with 

3 the use of such tobacco product. 

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

5 the Secretary may use the assistance of retail6 ers and other persons who distributed such to7 bacco product. If a significant number of such 

8 persons cannot be identified, the Secretary shall 

9 notify such persons under section 705(b). 

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

11 provided by this subsection shall be in addition to 

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

13 ‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PROD14 UCTS. 

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

16 product manufacturer or importer of a tobacco product 

17 shall establish and maintain such records, make such re18 ports, and provide such information, as the Secretary may 

19 by regulation reasonably require to assure that such to20 bacco product is not adulterated or misbranded and to 

21 otherwise protect public health. Regulations prescribed 

22 under the preceding sentence—

23 ‘‘(1) may require a tobacco product manufac24 turer or importer to report to the Secretary when25 ever the manufacturer or importer receives or other-
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1 wise becomes aware of information that reasonably 

2 suggests that one of its marketed tobacco products 

3 may have caused or contributed to a serious unex4 pected adverse experience associated with the use of 

5 the product or any significant increase in the fre6 quency of a serious, expected adverse product experi7 ence; 

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

9 adverse tobacco product experiences as determined 

10 by the Secretary to be necessary to be reported; 

11 ‘‘(3) shall not impose requirements unduly bur12 densome to a tobacco product manufacturer or im13 porter, taking into account the cost of complying 

14 with such requirements and the need for the protec15 tion of the public health and the implementation of 

16 this chapter; 

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

18 requests for reports or information, shall require 

19 that each request made under such regulations for 

20 submission of a report or information to the Sec21 retary state the reason or purpose for such request 

22 and identify to the fullest extent practicable such re23 port or information; 

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

25 information to the Secretary, shall state the reason 
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1 or purpose for the submission of such report or in2 formation and identify to the fullest extent prac3 ticable such report or information; and 

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

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

6 information required under this subsection unless re7 quired for the medical welfare of an individual, to 

8 determine risks to public health of a tobacco prod9 uct, or to verify a record, report, or information sub10 mitted under this chapter. 

11 In prescribing regulations under this subsection, the Sec12 retary shall have due regard for the professional ethics of 

13 the medical profession and the interests of patients. The 

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

15 reports, and information concerning any individual who 

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

17 ceases to be a patient. 

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

19 ‘‘(1) IN GENERAL.—Except as provided in para20 graph (2), the Secretary shall by regulation require 

21 a tobacco product manufacturer or importer of a to22 bacco product to report promptly to the Secretary 

23 any corrective action taken or removal from the 

24 market of a tobacco product undertaken by such 
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1 manufacturer or importer if the removal or correc2 tion was undertaken—

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

4 the tobacco product; or 

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

6 caused by the tobacco product which may 

7 present a risk to health. 

8 A tobacco product manufacturer or importer of a to9 bacco product who undertakes a corrective action or 

10 removal from the market of a tobacco product which 

11 is not required to be reported under this subsection 

12 shall keep a record of such correction or removal. 

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

14 action or removal of a tobacco product may be re15 quired under paragraph (1) if a report of the correc16 tive action or removal is required and has been sub17 mitted under subsection (a). 

18 ‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TO19 BACCO PRODUCTS. 

20 ‘‘(a) IN GENERAL.—

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

22 purposes of this section the term ‘new tobacco prod23 uct’ means—

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

25 products in test markets) that was not commer-
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1 cially marketed in the United States as of June 

2 1, 2003; or 

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

4 in design, any component, any part, or any con5 stituent, including a smoke constituent, or in 

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

7 other additive or ingredient) of a tobacco prod8 uct where the modified product was commer9 cially marketed in the United States after June 

10 1, 2003. 

11 ‘‘(2) PREMARKET APPROVAL REQUIRED.—

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

13 this section of an application for premarket ap14 proval for any new tobacco product is required 

15 unless—

16 ‘‘(i) the manufacturer has submitted a 

17 report under section 905(j); and 

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

19 that the tobacco product—

20 ‘‘(I) is substantially equivalent to 

21 a tobacco product commercially mar22 keted (other than for test marketing) 

23 in the United States as of June 1, 

24 2003; and 
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1 ‘‘(II)(aa) is in compliance with 

2 the requirements of this Act; or 

3 ‘‘(bb) is exempt from the require4 ments of section 905(j) pursuant to a 

5 regulation issued under section 

6 905(j)(3). 

7 ‘‘(B) APPLICATION TO CERTAIN POST

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

9 shall not apply to a tobacco product—

10 ‘‘(i) that was first introduced or deliv11 ered for introduction into interstate com12 merce for commercial distribution in the 

13 United States after June 1, 2003, and 

14 prior to the date that is 15 months after 

15 the date of enactment of the Family Smok16 ing Prevention and Tobacco Control Act; 

17 and 

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

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

20 period, until the Secretary issues an order 

21 that the tobacco product is not substan22 tially equivalent. 

23 ‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.—

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

25 section 905(j), the terms ‘substantially equiva-
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1 lent’ or ‘substantial equivalence’ mean, with re2 spect to the tobacco product being compared to 

3 the predicate tobacco product, that the Sec4 retary by order has found that the tobacco 

5 product—

6 ‘‘(i) has the same characteristics as 

7 the predicate tobacco product; or 

8 ‘‘(ii) has different characteristics and 

9 the information submitted contains infor10 mation, including clinical data if deemed 

11 necessary by the Secretary, that dem12 onstrates that it is not appropriate to reg13 ulate the product under this section be14 cause the product does not raise different 

15 questions of public health. 

16 ‘‘(B) CHARACTERISTICS.—In subpara17 graph (A), the term ‘characteristics’ means the 

18 materials, ingredients, design, composition, 

19 heating source, or other features of a tobacco 

20 product. 

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

22 not be found to be substantially equivalent to a 

23 predicate tobacco product that has been re24 moved from the market at the initiative of the 
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1 Secretary or that has been determined by a ju2 dicial order to be misbranded or adulterated. 

3 ‘‘(4) HEALTH INFORMATION.—

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

5 under section 905(j) respecting a tobacco prod6 uct, the person required to file a premarket no7 tification under such section shall provide an 

8 adequate summary of any health information 

9 related to the tobacco product or state that 

10 such information will be made available upon 

11 request by any person. 

12 ‘‘(B) REQUIRED INFORMATION.—Any sum13 mary under subparagraph (A) respecting a to14 bacco product shall contain detailed information 

15 regarding data concerning adverse health ef16 fects and shall be made available to the public 

17 by the Secretary within 30 days of the issuance 

18 of a determination that such tobacco product is 

19 substantially equivalent to another tobacco 

20 product. 

21 ‘‘(b) APPLICATION.—

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

23 approval shall contain—

24 ‘‘(A) full reports of all information, pub25 lished or known to, or which should reasonably 
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•S 666 IS 

1 be known to, the applicant, concerning inves2 tigations which have been made to show the 

3 health risks of such tobacco product and wheth4 er such tobacco product presents less risk than 

5 other tobacco products; 

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

7 ingredients, additives, and properties, and of 

8 the principle or principles of operation, of such 

9 tobacco product; 

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

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

12 manufacture, processing, and, when relevant, 

13 packing and installation of, such tobacco prod14 uct; 

15 ‘‘(D) an identifying reference to any to16 bacco product standard under section 907 

17 which would be applicable to any aspect of such 

18 tobacco product, and either adequate informa19 tion to show that such aspect of such tobacco 

20 product fully meets such tobacco product stand21 ard or adequate information to justify any devi22 ation from such standard; 

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

24 and of components thereof as the Secretary 

25 may reasonably require; 
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1 ‘‘(F) specimens of the labeling proposed to 

2 be used for such tobacco product; and 

3 ‘‘(G) such other information relevant to 

4 the subject matter of the application as the Sec5 retary may require. 

6 ‘‘(2) REFERENCE TO TOBACCO PRODUCTS SCI7 ENTIFIC ADVISORY COMMITTEE.—Upon receipt of an 

8 application meeting the requirements set forth in 

9 paragraph (1), the Secretary—

10 ‘‘(A) may, on the Secretary’s own initia11 tive; or 

12 ‘‘(B) may, upon the request of an appli13 cant, 

14 refer such application to the Tobacco Products Sci15 entific Advisory Committee for reference and for 

16 submission (within such period as the Secretary may 

17 establish) of a report and recommendation respect18 ing approval of the application, together with all un19 derlying data and the reasons or basis for the rec20 ommendation. 

21 ‘‘(c) ACTION ON APPLICATION.—

22 ‘‘(1) DEADLINE.—

23 ‘‘(A) IN GENERAL.—As promptly as pos24 sible, but in no event later than 180 days after 

25 the receipt of an application under subsection 
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1 (b), the Secretary, after considering the report 

2 and recommendation submitted under para3 graph (2) of such subsection, shall—

4 ‘‘(i) issue an order approving the ap5 plication if the Secretary finds that none of 

6 the grounds for denying approval specified 

7 in paragraph (2) of this subsection applies; 

8 or 

9 ‘‘(ii) deny approval of the application 

10 if the Secretary finds (and sets forth the 

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

13 grounds for denial specified in paragraph 

14 (2) of this subsection apply. 

15 ‘‘(B) RESTRICTIONS ON SALE AND DIS16 TRIBUTION.—An order approving an application 

17 for a tobacco product may require as a condi18 tion to such approval that the sale and distribu19 tion of the tobacco product be restricted but 

20 only to the extent that the sale and distribution 

21 of a tobacco product may be restricted under a 

22 regulation under section 906(d). 

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

24 shall deny approval of an application for a tobacco 

25 product if, upon the basis of the information sub-
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1 mitted to the Secretary as part of the application 

2 and any other information before the Secretary with 

3 respect to such tobacco product, the Secretary finds 

4 that—

5 ‘‘(A) there is a lack of a showing that per6 mitting such tobacco product to be marketed 

7 would be appropriate for the protection of the 

8 public health; 

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

10 or controls used for, the manufacture, proc11 essing, or packing of such tobacco product do 

12 not conform to the requirements of section 

13 906(e); 

14 ‘‘(C) based on a fair evaluation of all mate15 rial facts, the proposed labeling is false or mis16 leading in any particular; or 

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

18 conform in all respects to a tobacco product 

19 standard in effect under section 907, compli20 ance with which is a condition to approval of 

21 the application, and there is a lack of adequate 

22 information to justify the deviation from such 

23 standard. 

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

25 application shall, insofar as the Secretary determines 
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1 to be practicable, be accompanied by a statement in2 forming the applicant of the measures required to 

3 place such application in approvable form (which 

4 measures may include further research by the appli5 cant in accordance with 1 or more protocols pre6 scribed by the Secretary). 

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

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

9 tobacco product is appropriate for the protection of 

10 the public health shall be determined with respect to 

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

12 including users and nonusers of the tobacco product, 

13 and taking into account—

14 ‘‘(A) the increased or decreased likelihood 

15 that existing users of tobacco products will stop 

16 using such products; and 

17 ‘‘(B) the increased or decreased likelihood 

18 that those who do not use tobacco products will 

19 start using such products. 

20 ‘‘(5) BASIS FOR ACTION.—

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

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

23 product to be marketed would be appropriate 

24 for the protection of the public health shall, 

25 when appropriate, be determined on the basis of 
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1 well-controlled investigations, which may in2 clude 1 or more clinical investigations by ex3 perts qualified by training and experience to 

4 evaluate the tobacco product. 

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

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

9 is sufficient to evaluate the tobacco product the 

10 Secretary may authorize that the determination 

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

12 the basis of such evidence. 

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

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

15 obtaining, where appropriate, advice on scientific 

16 matters from an advisory committee, and after due 

17 notice and opportunity for informal hearing to the 

18 holder of an approved application for a tobacco 

19 product, issue an order withdrawing approval of the 

20 application if the 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 

3 subsection (e). 

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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•S 666 IS 

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 

25 more commercially marketed tobacco prod-
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•S 666 IS 

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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•S 666 IS 

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 an advisory committee any application submitted 

22 under this subsection. 

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

24 days after the date an application is referred to an 

25 advisory committee under paragraph (1), the advi-
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•S 666 IS 

1 sory committee shall report its recommendations on 

2 the application to the Secretary. 

3 ‘‘(g) APPROVAL.—

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

5 provided in paragraph (2), the Secretary shall ap6 prove an application for a modified risk tobacco 

7 product filed under this section only if the Secretary 

8 determines that the applicant has demonstrated that 

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

10 will—

11 ‘‘(A) significantly reduce harm and the 

12 risk of tobacco-related disease to individual to13 bacco users; and 

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

15 as a whole taking into account both users of to16 bacco products and persons who do not cur17 rently use tobacco products. 

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

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

20 approve an application for a tobacco product 

21 that has not been approved as a modified risk 

22 tobacco product pursuant to paragraph (1) if 

23 the Secretary makes the findings required 

24 under this paragraph and determines that the 

25 applicant has demonstrated that—
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1 ‘‘(i) the approval of the application 

2 would be appropriate to promote the public 

3 health; 

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

5 and advertising for such product that 

6 would cause the tobacco product to be a 

7 modified risk tobacco product under sub8 section (b)(2) is limited to an explicit or 

9 implicit representation that such tobacco 

10 product or its smoke contains or is free of 

11 a substance or contains a reduced level of 

12 a substance, or presents a reduced expo13 sure to a substance in tobacco smoke; 

14 ‘‘(iii) scientific evidence is not avail15 able and, using the best available scientific 

16 methods, cannot be made available without 

17 conducting long-term epidemiological stud18 ies for an application to meet the stand19 ards set forth in paragraph (1); and 

20 ‘‘(iv) the scientific evidence that is 

21 available without conducting long-term epi22 demiological studies demonstrates that a 

23 measurable and substantial reduction in 

24 morbidity or mortality among individual 
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•S 666 IS 

1 tobacco users is anticipated in subsequent 

2 studies. 

3 ‘‘(B) ADDITIONAL FINDINGS REQUIRED.—

4 In order to approve an application under sub5 paragraph (A) the Secretary must also find 

6 that the applicant has demonstrated that—

7 ‘‘(i) the magnitude of the overall re8 ductions in exposure to the substance or 

9 substances which are the subject of the ap10 plication is substantial, such substance or 

11 substances are harmful, and the product as 

12 actually used exposes consumers to the 

13 specified reduced level of the substance or 

14 substances; 

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

16 consumers will not expose them to higher 

17 levels of other harmful substances com18 pared to the similar types of tobacco prod19 ucts then on the market unless such in20 creases are minimal and the anticipated 

21 overall impact of use of the product re22 mains a substantial and measurable reduc23 tion in overall morbidity and mortality 

24 among individual tobacco users; 
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•S 666 IS 

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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•S 666 IS 

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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•S 666 IS 

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.—

24 ‘‘(1) MODIFIED RISK PRODUCTS.—The Sec25 retary shall require for the approval of an applica-
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•S 666 IS 

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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•S 666 IS 

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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•S 666 IS 

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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•S 666 IS 

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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•S 666 IS 

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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•S 666 IS 

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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•S 666 IS 

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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•S 666 IS 

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 

25 title 5, United States Code, and to grant appropriate re-
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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 (15 U.S.C. 45(a)) 

16 and shall be considered a violation of a rule promul17 gated under section 18 of that Act (15 U.S.C. 57a). 

18 ‘‘(b) COORDINATION.—With respect to the require19 ments of section 4 of the Federal Cigarette Labeling and 

20 Advertising Act (15 U.S.C. 1333) and section 3 of the 

21 Comprehensive Smokeless Tobacco Health Education Act 

22 of 1986 (15 U.S.C. 4402)—

23 ‘‘(1) the Chairman of the Federal Trade Com24 mission shall coordinate with the Secretary con25 cerning the enforcement of such Act as such enforce26 ment relates to unfair or deceptive acts or practices 
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•S 666 IS 

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 regula11 tions referred to in section 102 of the Family Smoking 

12 Prevention and Tobacco Control Act. 

13 ‘‘SEC. 916. REGULATION REQUIREMENT. 

14 ‘‘(a) TESTING, REPORTING, AND DISCLOSURE.—Not 

15 later than 24 months after the date of enactment of the 

16 Family Smoking Prevention and Tobacco Control Act, the 

17 Secretary, acting through the Commissioner of the Food 

18 and Drug Administration, shall promulgate regulations 

19 under this Act that meet the requirements of subsection 

20 (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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•S 666 IS 

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.—Nothing in this chapter, 

19 or rules promulgated under this chapter, shall be 

20 construed to limit the authority of a Federal agency 

21 (including the Armed Forces), a State or political 

22 subdivision of a State, or the government of an In23 dian tribe to enact, adopt, promulgate, and enforce 

24 any law, rule, regulation, or other measure with re25 spect to tobacco products that is in addition to, or 
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1 more stringent than, requirements established under 

2 this chapter, including a law, rule, regulation, or 

3 other measure relating to or prohibiting the sale, 

4 distribution, possession, exposure to, access to, ad5 vertising and promotion of, or use of tobacco prod6 ucts by individuals of any age, information reporting 

7 to the State, or measures relating to fire safety 

8 standards for tobacco products. No provision of this 

9 chapter shall limit or otherwise affect any State, 

10 Tribal, or local taxation of tobacco products. 

11 ‘‘(2) PREEMPTION OF CERTAIN STATE AND

12 LOCAL REQUIREMENTS.—

13 ‘‘(A) IN GENERAL.—Except as provided in 

14 paragraph (1) and subparagraph (B), no State 

15 or political subdivision of a State may establish 

16 or continue in effect with respect to a tobacco 

17 product any requirement which is different 

18 from, or in addition to, any requirement under 

19 the provisions of this chapter relating to to20 bacco product standards, premarket approval, 

21 adulteration, misbranding, labeling, registra22 tion, good manufacturing standards, or modi23 fied risk tobacco products. 

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 554(b)(4) of title 5, United States Code, 

9 shall be treated as trade secret and confidential 

10 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 a 

21 11-member advisory committee, to be known as the ‘To22 bacco Products Scientific Advisory Committee’. 

23 ‘‘(b) MEMBERSHIP.—

24 ‘‘(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 for level 4 of the Senior Executive 

13 Schedule under section 5382 of title 5, United 

14 States Code, for each day (including travel time) 

15 they are so engaged; and while so serving away from 

16 their homes or regular places of business each mem17 ber may be allowed travel expenses, including per 

18 diem in lieu of subsistence, as authorized by section 

19 5703 of title 5, United States Code, for persons in 

20 the Government 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 (5 U.S.C. 

3 App.) does not apply 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 2005, 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 subsection 

9 (d)(2) shall be allocated by the Secretary on a pro 

10 rata basis among the classes of tobacco products 

11 that are subject to a user fee under this section. 

12 Such pro rata allocation for each class of tobacco 

13 products that are subject to a user fee under this 

14 section shall be the quotient of—

15 ‘‘(A) the sum of the percentages assigned 

16 to all classes of tobacco products subject to this 

17 section; divided by 

18 ‘‘(B) the percentage assigned to such class 

19 under paragraph (2). 

20 ‘‘(4) ANNUAL LIMIT ON ASSESSMENT.—The 

21 total assessment under this section—

22 ‘‘(A) for fiscal year 2005 shall be 

23 $85,000,000; 

24 ‘‘(B) for fiscal year 2006 shall be 

25 $175,000,000; 
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1 ‘‘(C) for fiscal year 2007 shall be 

2 $300,000,000; and 

3 ‘‘(D) for each subsequent fiscal year, shall 

4 not exceed the limit on the assessment imposed 

5 during the previous fiscal year, as adjusted by 

6 the Secretary (after notice, published in the 

7 Federal Register) to reflect the greater of—

8 ‘‘(i) the total percentage change that 

9 occurred in the Consumer Price Index for 

10 all urban consumers (all items; United 

11 States city average) for the 12-month pe12 riod ending on June 30 of the preceding 

13 fiscal year for which fees are being estab14 lished; or 

15 ‘‘(ii) the total percentage change for 

16 the previous fiscal year in basic pay under 

17 the General Schedule in accordance with 

18 section 5332 of title 5, United States 

19 Code, as adjusted by any locality-based 

20 comparability payment pursuant to section 

21 5304 of such title for Federal employees 

22 stationed in the District of Columbia. 

23 ‘‘(5) TIMING OF USER FEE ASSESSMENT.—The 

24 Secretary shall notify each manufacturer and im25 porter of tobacco products subject to this section of 
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1 the amount of the quarterly assessment imposed on 

2 such manufacturer or importer under subsection (f) 

3 during each quarter of each fiscal year. Such notifi4 cations shall occur not earlier than 3 months prior 

5 to the end of the quarter for which such assessment 

6 is made, and payments of all assessments shall be 

7 made not later than 60 days after each such notifi8 cation. 

9 ‘‘(d) DETERMINATION OF USER FEE BY COMPANY

10 MARKET SHARE.—

11 ‘‘(1) IN GENERAL.—The user fee to be paid by 

12 each manufacturer or importer of a given class of to13 bacco products shall be determined in each quarter 

14 by multiplying—

15 ‘‘(A) such manufacturer’s or importer’s 

16 market share of such class of tobacco products; 

17 by 

18 ‘‘(B) the portion of the user fee amount 

19 for the current quarter to be assessed on manu20 facturers and importers of such class of tobacco 

21 products as determined under subsection (e). 

22 ‘‘(2) NO FEE IN EXCESS OF MARKET SHARE.—

23 No manufacturer or importer of tobacco products 

24 shall be required to pay a user fee in excess of the 

25 market share of such manufacturer or importer. 
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1 ‘‘(e) DETERMINATION OF VOLUME OF DOMESTIC

2 SALES.—

3 ‘‘(1) IN GENERAL.—The calculation of gross 

4 domestic volume of a class of tobacco product by a 

5 manufacturer or importer, and by all manufacturers 

6 and importers as a group, shall be made by the Sec7 retary using information provided by manufacturers 

8 and importers pursuant to subsection (f), as well as 

9 any other relevant information provided to or ob10 tained by the Secretary. 

11 ‘‘(2) MEASUREMENT.—For purposes of the cal12 culations under this subsection and the information 

13 provided under subsection (f) by the Secretary, gross 

14 domestic volume shall be measured by—

15 ‘‘(A) in the case of cigarettes, the number 

16 of cigarettes sold; 

17 ‘‘(B) in the case of little cigars, the num18 ber of little cigars sold; 

19 ‘‘(C) in the case of large cigars, the num20 ber of cigars weighing more than 3 pounds per 

21 thousand sold; and 

22 ‘‘(D) in the case of other classes of tobacco 

23 products, in terms of number of pounds, or 

24 fraction thereof, of these products sold. 
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1 ‘‘(f) MEASUREMENT OF GROSS DOMESTIC VOL2 UME.—

3 ‘‘(1) IN GENERAL.—Each manufacturer and 

4 importer of tobacco products shall submit to the 

5 Secretary a certified copy of each of the returns or 

6 forms described by this paragraph that are required 

7 to be filed with a Government agency on the same 

8 date that those returns or forms are filed, or re9 quired to be filed, with such agency. The returns 

10 and forms described by this paragraph are those re11 turns and forms related to the release of tobacco 

12 products into domestic commerce, as defined by sec13 tion 5702(k) of the Internal Revenue Code of 1986, 

14 and the repayment of the taxes imposed under chap15 ter 52 of such Code (ATF Form 500.24 and United 

16 States Customs Form 7501 under currently applica17 ble regulations). 

18 ‘‘(2) PENALTIES.—Any person that knowingly 

19 fails to provide information required under this sub20 section or that provides false information under this 

21 subsection shall be subject to the penalties described 

22 in section 1003 of title 18, United States Code. In 

23 addition, such person may be subject to a civil pen24 alty in an amount not to exceed 2 percent of the 

25 value of the kind of tobacco products manufactured 
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1 or imported by such person during the applicable 

2 quarter, as determined by the Secretary. 

3 ‘‘(h) EFFECTIVE DATE.—The user fees prescribed by 

4 this section shall be assessed in fiscal year 2005, based 

5 on domestic sales of tobacco products during fiscal year 

6 2004 and shall be assessed in each fiscal year thereafter.’’. 

7 SEC. 102. INTERIM FINAL RULE. 

8 (a) CIGARETTES AND SMOKELESS TOBACCO.—

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

10 the date of enactment of this Act, the Secretary of 

11 Health and Human Services shall publish in the 

12 Federal Register an interim final rule regarding 

13 cigarettes and smokeless tobacco, which is hereby 

14 deemed to be in compliance with the Administrative 

15 Procedures Act and other applicable law. 

16 (2) CONTENTS OF RULE.—Except as provided 

17 in this subsection, the interim final rule published 

18 under paragraph (1), shall be identical in its provi19 sions to part 897 of the regulations promulgated by 

20 the Secretary of Health and Human Services in the 

21 August 28, 1996, issue of the Federal Register (61 

22 Fed. Reg., 44615–44618). Such rule shall—

23 (A) provide for the designation of jurisdic24 tional authority that is in accordance with this 

25 subsection; 
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1 (B) strike Subpart C—Labeling and sec2 tion 897.32(c); and 

3 (C) become effective not later than 1 year 

4 after the date of enactment of this Act. 

5 (3) AMENDMENTS TO RULE.—Prior to making 

6 amendments to the rule published under paragraph 

7 (1), the Secretary shall promulgate a proposed rule 

8 in accordance with the Administrative Procedures 

9 Act. 

10 (4) RULE OF CONSTRUCTION.—Except as pro11 vided in paragraph (3), nothing in this section shall 

12 be construed to limit the authority of the Secretary 

13 to amend, in accordance with the Administrative 

14 Procedures Act, the regulation promulgated pursu15 ant to this section. 

16 (b) LIMITATION ON ADVISORY OPINIONS.—As of the 

17 date of enactment of this Act, the following documents 

18 issued by the Food and Drug Administration shall not 

19 constitute advisory opinions under section 10.85(d)(1) of 

20 title 21, Code of Federal Regulations, except as they apply 

21 to tobacco products, and shall not be cited by the Sec22 retary of Health and Human Services or the Food and 

23 Drug Administration as binding precedent: 

24 (1) The preamble to the proposed rule in the 

25 document entitled ‘‘Regulations Restricting the Sale 
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1 and Distribution of Cigarettes and Smokeless To2 bacco Products to Protect Children and Adoles3 cents’’ (60 Fed. Reg. 41314–41372 (August 11, 

4 1995)). 

5 (2) The document entitled ‘‘Nicotine in Ciga6 rettes and Smokeless Tobacco Products is a Drug 

7 and These Products Are Nicotine Delivery Devices 

8 Under the Federal Food, Drug, and Cosmetic Act’’ 

9 (60 Fed. Reg. 41453–41787 (August 11, 1995)). 

10 (3) The preamble to the final rule in the docu11 ment entitled ‘‘Regulations Restricting the Sale and 

12 Distribution of Cigarettes and Smokeless Tobacco to 

13 Protect Children and Adolescents’’ (61 Fed. Reg. 

14 44396–44615 (August 28, 1996)). 

15 (4) The document entitled ‘‘Nicotine in Ciga16 rettes and Smokeless Tobacco is a Drug and These 

17 Products are Nicotine Delivery Devices Under the 

18 Federal Food, Drug, and Cosmetic Act; Jurisdic19 tional Determination’’ (61 Fed. Reg. 44619–45318 

20 (August 28, 1996)). 

21 SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GEN22 ERAL PROVISIONS. 

23 (a) AMENDMENT OF FEDERAL FOOD, DRUG, AND

24 COSMETIC ACT.—Except as otherwise expressly provided, 

25 whenever in this section an amendment is expressed in 
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1 terms of an amendment to, or repeal of, a section or other 

2 provision, the reference is to a section or other provision 

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

4 301 et seq.). 

5 (b) SECTION 301.—Section 301 (21 U.S.C. 331) is 

6 amended—

7 (1) in subsection (a), by inserting ‘‘tobacco 

8 product,’’ after ‘‘device,’’; 

9 (2) in subsection (b), by inserting ‘‘tobacco 

10 product,’’ after ‘‘device,’’; 

11 (3) in subsection (c), by inserting ‘‘tobacco 

12 product,’’ after ‘‘device,’’; 

13 (4) in subsection (e), by striking ‘‘515(f), or 

14 519’’ and inserting ‘‘515(f), 519, or 909’’; 

15 (5) in subsection (g), by inserting ‘‘tobacco 

16 product,’’ after ‘‘device,’’; 

17 (6) in subsection (h), by inserting ‘‘tobacco 

18 product,’’ after ‘‘device,’’; 

19 (7) in subsection (j), by striking ‘‘708, or 721’’ 

20 and inserting ‘‘708, 721, 904, 905, 906, 907, 908, 

21 909, or section 921(b)’’; 

22 (8) in subsection (k), by inserting ‘‘tobacco 

23 product,’’ after ‘‘device,’’; 

24 (9) by striking subsection (p) and inserting the 

25 following: 
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1 ‘‘(p) The failure to register in accordance with section 

2 510 or 905, the failure to provide any information re3 quired by section 510(j), 510(k), 905(i), or 905(j), or the 

4 failure to provide a notice required by section 510(j)(2) 

5 or 905(i)(2).’’; 

6 (10) by striking subsection (q)(1) and inserting 

7 the following: 

8 ‘‘(q)(1) The failure or refusal—

9 ‘‘(A) to comply with any requirement prescribed 

10 under section 518, 520(g), 903(b)(8), or 908, or 

11 condition prescribed under section 

12 903(b)(6)(B)(ii)(II); 

13 ‘‘(B) to furnish any notification or other mate14 rial or information required by or under section 519, 

15 520(g), 904, 909, or section 921; or 

16 ‘‘(C) to comply with a requirement under sec17 tion 522 or 913.’’; 

18 (11) in subsection (q)(2), by striking ‘‘device,’’ 

19 and inserting ‘‘device or tobacco product,’’; 

20 (12) in subsection (r), by inserting ‘‘or tobacco 

21 product’’ after ‘‘device’’ each time that it appears; 

22 and 

23 (13) by adding at the end the following: 
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1 ‘‘(aa) The sale of tobacco products in violation 

2 of a no-tobacco-sale order issued under section 

3 303(f). 

4 ‘‘(bb) The introduction or delivery for introduc5 tion into interstate commerce of a tobacco product 

6 in violation of section 911. 

7 ‘‘(cc)(1) Forging, counterfeiting, simulating, or 

8 falsely representing, or without proper authority 

9 using any mark, stamp (including tax stamp), tag, 

10 label, or other identification device upon any tobacco 

11 product or container or labeling thereof so as to 

12 render such tobacco product a counterfeit tobacco 

13 product. 

14 ‘‘(2) Making, selling, disposing of, or keeping in 

15 possession, control, or custody, or concealing any 

16 punch, die, plate, stone, or other item that is de17 signed to print, imprint, or reproduce the trade18 mark, trade name, or other identifying mark, im19 print, or device of another or any likeness of any of 

20 the foregoing upon any tobacco product or container 

21 or labeling thereof so as to render such tobacco 

22 product a counterfeit tobacco product. 

23 ‘‘(3) The doing of any act that causes a tobacco 

24 product to be a counterfeit tobacco product, or the 
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1 sale or dispensing, or the holding for sale or dis2 pensing, of a counterfeit tobacco product. 

3 ‘‘(dd) The charitable distribution of tobacco 

4 products. 

5 ‘‘(ee) The failure of a manufacturer or dis6 tributor to notify the Attorney General of their 

7 knowledge of tobacco products used in illicit trade.’’. 

8 (c) SECTION 303.—Section 303 (21 U.S.C. 333(f)) 

9 is amended in subsection (f)—

10 (1) by striking the subsection heading and in11 serting the following: 

12 ‘‘(f) CIVIL PENALTIES; NO-TOBACCO-SALE OR13 DERS.—’’; 

14 (2) in paragraph (1)(A), by inserting ‘‘or to15 bacco products’’ after ‘‘devices’’; 

16 (3) in paragraph (2)(C), by striking ‘‘paragraph 

17 (3)(A)’’ and inserting ‘‘paragraph (4)(A)’’; 

18 (4) 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 (5) 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 (6) in paragraph (5) as so redesignated—

5 (A) by striking ‘‘(3)(A)’’ as redesignated, 

6 and inserting ‘‘(4)(A)’’; 

7 (B) by inserting ‘‘or the imposition of a 

8 no-tobacco-sale order’’ after ‘‘penalty’’ the first 

9 2 places it appears; and 

10 (C) by striking ‘‘issued.’’ and inserting 

11 ‘‘issued, or on which the no-tobacco-sale order 

12 was imposed, as the case may be.’’; and 

13 (7) in paragraph (6), as so redesignated, by 

14 striking ‘‘paragraph (4)’’ each place it appears and 

15 inserting ‘‘paragraph (5)’’. 

16 (d) SECTION 304.—Section 304 (21 U.S.C. 334) is 

17 amended—

18 (1) in subsection (a)(2)—

19 (A) by striking ‘‘and’’ before ‘‘(D)’’; and 

20 (B) by striking ‘‘device.’’ and inserting the 

21 following: ‘‘, (E) Any adulterated or misbranded 

22 tobacco product.’’; 

23 (2) in subsection (d)(1), by inserting ‘‘tobacco 

24 product,’’ after ‘‘device,’’; 
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1 (3) in subsection (g)(1), by inserting ‘‘or to2 bacco product’’ after ‘‘device’’ each place it appears; 

3 and 

4 (4) in subsection (g)(2)(A), by inserting ‘‘or to5 bacco product’’ after ‘‘device’’ each place it appears. 

6 (e) SECTION 702.—Section 702(a) (21 U.S.C. 

7 372(a)) is amended—

8 (1) by inserting ‘‘(1)’’ after ‘‘(a)’’; and 

9 (2) by adding at the end thereof the following: 

10 ‘‘(2) For a tobacco product, to the extent feasible, 

11 the Secretary shall contract with the States in accordance 

12 with paragraph (1) to carry out inspections of retailers 

13 within that State in connection with the enforcement of 

14 this Act.’’. 

15 (f) SECTION 703.—Section 703 (21 U.S.C. 373) is 

16 amended—

17 (1) by inserting ‘‘tobacco product,’’ after ‘‘de18 vice,’’ each place it appears; and 

19 (2) by inserting ‘‘tobacco products,’’ after ‘‘de20 vices,’’ each place it appears. 

21 (g) SECTION 704.—Section 704 (21 U.S.C. 374) is 

22 amended—

23 (1) in subsection (a)(1)(A), by inserting ‘‘to24 bacco products,’’ after ‘‘devices,’’ each place it ap25 pears; 
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1 (2) in subsection (a)(1)(B), by inserting ‘‘or to2 bacco product’’ after ‘‘restricted devices’’ each place 

3 it appears; and 

4 (3) in subsection (b), by inserting ‘‘tobacco 

5 product,’’ after ‘‘device,’’. 

6 (h) SECTION 705.—Section 705(b) (21 U.S.C. 

7 375(b)) is amended by inserting ‘‘tobacco products,’’ after 

8 ‘‘devices,’’. 

9 (i) SECTION 709.—Section 709 (21 U.S.C. 379) is 

10 amended by inserting ‘‘or tobacco product’’ after ‘‘device’’. 

11 (j) SECTION 801.—Section 801 (21 U.S.C. 381) is 

12 amended—

13 (1) in subsection (a)—

14 (A) by inserting ‘‘tobacco products,’’ after 

15 ‘‘devices,’’ the first time it appears; 

16 (B) by inserting ‘‘or section 905(j)’’ after 

17 ‘‘section 510’’; and 

18 (C) by striking ‘‘drugs or devices’’ each 

19 time it appears and inserting ‘‘drugs, devices, 

20 or tobacco products’’; 

21 (2) in subsection (e)(1), by inserting ‘‘tobacco 

22 product,’’ after ‘‘device,’’; and 

23 (3) by adding at the end the following: 

24 ‘‘(p)(1) Not later than 2 years after the date of enact25 ment of the Family Smoking Prevention and Tobacco 
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1 Control Act, and annually thereafter, the Secretary shall 

2 submit to the Committee on Health, Education, Labor, 

3 and Pensions of the Senate and the Committee on Energy 

4 and Commerce of the House of Representatives, a report 

5 regarding—

6 ‘‘(A) the nature, extent, and destination of 

7 United States tobacco product exports that do not 

8 conform to tobacco product standards established 

9 pursuant to this Act; 

10 ‘‘(B) the public health implications of such ex11 ports, including any evidence of a negative public 

12 health impact; and 

13 ‘‘(C) recommendations or assessments of policy 

14 alternatives available to Congress and the Executive 

15 Branch to reduce any negative public health impact 

16 caused by such exports. 

17 ‘‘(2) The Secretary is authorized to establish appro18 priate information disclosure requirements to carry out 

19 this subsection.’’. 

20 (k) SECTION 1003.—Section 1003(d)(2)(C) (as re21 designated by section 101(a)) is amended—

22 (1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 

23 (2) inserting a comma and ‘‘and tobacco prod24 ucts’’ after ‘‘devices’’. 

25 (l) GUIDANCE AND EFFECTIVE DATES.—
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1 (1) IN GENERAL.—The Secretary of Health and 

2 Human Services shall issue guidance—

3 (A) defining the term ‘‘repeated violation’’, 

4 as used in section 303(f) of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 333(f)) as 

6 amended by subsection (c), by identifying the 

7 number of violations of particular requirements 

8 over a specified period of time at a particular 

9 retail outlet that constitute a repeated violation; 

10 (B) providing for timely and effective no11 tice to the retailer of each alleged violation at 

12 a particular retail outlet; 

13 (C) providing for an expedited procedure 

14 for the administrative appeal of an alleged vio15 lation; 

16 (D) providing that a person may not be 

17 charged with a violation at a particular retail 

18 outlet unless the Secretary has provided notice 

19 to the retailer of all previous violations at that 

20 outlet; 

21 (E) establishing a period of time during 

22 which, if there are no violations by a particular 

23 retail outlet, that outlet will not be considered 

24 to have been the site of repeated violations 

25 when the next violation occurs; and 
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1 (F) providing that good faith reliance on 

2 the presentation of a false government issued 

3 photographic identification that contains a date 

4 of birth does not constitute a violation of any 

5 minimum age requirement for the sale of to6 bacco products if the retailer has taken effective 

7 steps to prevent such violations, including—

8 (i) adopting and enforcing a written 

9 policy against sales to minors; 

10 (ii) informing its employees of all ap11 plicable laws; 

12 (iii) establishing disciplinary sanctions 

13 for employee noncompliance; and 

14 (iv) requiring its employees to verify 

15 age by way of photographic identification 

16 or electronic scanning device. 

17 (2) GENERAL EFFECTIVE DATE.—The amend18 ments made by subsection (c), other than the 

19 amendment made by paragraph (2) of such sub20 section, shall take effect upon the issuance of guid21 ance described in paragraph (1). 

22 (3) SPECIAL EFFECTIVE DATE.—The amend23 ments made by paragraph (2) of subsection (c) shall 

24 take effect on the date of enactment of this Act. 
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1 TITLE II—TOBACCO PRODUCT 

2 WARNINGS; CONSTITUENT 

3 AND SMOKE CONSTITUENT 

4 DISCLOSURE 

5 SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS. 

6 Section 4 of the Federal Cigarette Labeling and Ad7 vertising Act (15 U.S.C. 1333) is amended to read as fol8 lows: 

9 ‘‘SEC. 4. LABELING. 

10 ‘‘(a) LABEL REQUIREMENTS.—

11 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

12 person to manufacture, package, sell, offer to sell, 

13 distribute, or import for sale or distribution within 

14 the United States any cigarettes the package of 

15 which fails to bear, in accordance with the require16 ments of this section, one of the following labels: 

17 ‘WARNING: Cigarettes are addictive’. 

18 ‘WARNING: Tobacco smoke can harm your chil19 dren’. 

20 ‘WARNING: Cigarettes cause fatal lung disease’. 

21 ‘WARNING: Cigarettes cause cancer’. 

22 ‘WARNING: Cigarettes cause strokes and heart dis23 ease’. 

24 ‘WARNING: Smoking during pregnancy can harm 

25 your baby’. 
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1 ‘WARNING: Smoking can kill you’. 

2 ‘WARNING: Tobacco smoke causes fatal lung dis3 ease in non-smokers’. 

4 ‘WARNING: Quitting smoking now greatly reduces 

5 serious risks to your health’. 

6 ‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—

7 ‘‘(A) IN GENERAL.—Each label statement 

8 required by paragraph (1) shall be located in 

9 the upper portion of the front and rear panels 

10 of the package, directly on the package under11 neath the cellophane or other clear wrapping. 

12 Except as provided in subparagraph (B), each 

13 label statement shall comprise at least the top 

14 30 percent of the front and rear panels of the 

15 package. The word ‘WARNING’ shall appear in 

16 capital letters and all text shall be in con17 spicuous and legible 17-point type, unless the 

18 text of the label statement would occupy more 

19 than 70 percent of such area, in which case the 

20 text may be in a smaller conspicuous and leg21 ible type size, provided that at least 60 percent 

22 of such area is occupied by required text. The 

23 text shall be black on a white background, or 

24 white on a black background, in a manner that 

25 contrasts, by typography, layout, or color, with 
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1 all other printed material on the package, in an 

2 alternating fashion under the plan submitted 

3 under subsection (b)(4). 

4 ‘‘(B) HINGED LID BOXES.—For any ciga5 rette brand package manufactured or distrib6 uted before January 1, 2000, which employs a 

7 hinged lid style (if such packaging was used for 

8 that brand in commerce prior to June 21, 

9 1997), the label statement required by para10 graph (1) shall be located on the hinged lid 

11 area of the package, even if such area is less 

12 than 25 percent of the area of the front panel. 

13 Except as provided in this paragraph, the provi14 sions of this subsection shall apply to such 

15 packages. 

16 ‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU17 TION.—The provisions of this subsection do not 

18 apply to a tobacco product manufacturer or dis19 tributor of cigarettes which does not manufacture, 

20 package, or import cigarettes for sale or distribution 

21 within the United States. 

22 ‘‘(4) APPLICABILITY TO RETAILERS.—A retailer 

23 of cigarettes shall not be in violation of this sub24 section for packaging that is supplied to the retailer 

25 by a tobacco product manufacturer, importer, or dis-
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1 tributor and is not altered by the retailer in a way 

2 that is material to the requirements of this sub3 section except that this paragraph shall not relieve 

4 a retailer of liability if the retailer sells or distributes 

5 tobacco products that are not labeled in accordance 

6 with this subsection. 

7 ‘‘(b) ADVERTISING REQUIREMENTS.—

8 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

9 tobacco product manufacturer, importer, distributor, 

10 or retailer of cigarettes to advertise or cause to be 

11 advertised within the United States any cigarette 

12 unless its advertising bears, in accordance with the 

13 requirements of this section, one of the labels speci14 fied in subsection (a) of this section. 

15 ‘‘(2) TYPOGRAPHY, ETC.—Each label statement 

16 required by subsection (a) of this section in cigarette 

17 advertising shall comply with the standards set forth 

18 in this paragraph. For press and poster advertise19 ments, each such statement and (where applicable) 

20 any required statement relating to tar, nicotine, or 

21 other constituent (including a smoke constituent) 

22 yield shall comprise at least 20 percent of the area 

23 of the advertisement and shall appear in a con24 spicuous and prominent format and location at the 

25 top of each advertisement within the trim area. The 
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1 Secretary may revise the required type sizes in such 

2 area in such manner as the Secretary determines ap3 propriate. The word ‘WARNING’ shall appear in 

4 capital letters, and each label statement shall appear 

5 in conspicuous and legible type. The text of the label 

6 statement shall be black if the background is white 

7 and white if the background is black, under the plan 

8 submitted under paragraph (4) of this subsection. 

9 The label statements shall be enclosed by a rectan10 gular border that is the same color as the letters of 

11 the statements and that is the width of the first 

12 downstroke of the capital ‘W’ of the word ‘WARN13 ING’ in the label statements. The text of such label 

14 statements shall be in a typeface pro rata to the fol15 lowing requirements: 45-point type for a whole-page 

16 broadsheet newspaper advertisement; 39-point type 

17 for a half-page broadsheet newspaper advertisement; 

18 39-point type for a whole-page tabloid newspaper ad19 vertisement; 27-point type for a half-page tabloid 

20 newspaper advertisement; 31.5-point type for a dou21 ble page spread magazine or whole-page magazine 

22 advertisement; 22.5-point type for a 28 centimeter 

23 by 3 column advertisement; and 15-point type for a 

24 20 centimeter by 2 column advertisement. The label 
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1 statements shall be in English, except that in the 

2 case of—

3 ‘‘(A) an advertisement that appears in a 

4 newspaper, magazine, periodical, or other publi5 cation that is not in English, the statements 

6 shall appear in the predominant language of the 

7 publication; and 

8 ‘‘(B) in the case of any other advertise9 ment that is not in English, the statements 

10 shall appear in the same language as that prin11 cipally used in the advertisement. 

12 ‘‘(3) MATCHBOOKS.—Notwithstanding para13 graph (2), for matchbooks (defined as containing not 

14 more than 20 matches) customarily given away with 

15 the purchase of tobacco products, each label state16 ment required by subsection (a) may be printed on 

17 the inside cover of the matchbook. 

18 ‘‘(4) ADJUSTMENT BY SECRETARY.—The Sec19 retary may, through a rulemaking under section 553 

20 of title 5, United States Code, adjust the format and 

21 type sizes for the label statements required by this 

22 section or the text, format, and type sizes of any re23 quired tar, nicotine yield, or other constituent (in24 cluding smoke constituent) disclosures, or to estab25 lish the text, format, and type sizes for any other 
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1 disclosures required under the Federal Food, Drug, 

2 and Cosmetic Act (21 U.S.C. 301 et. seq.). The text 

3 of any such label statements or disclosures shall be 

4 required to appear only within the 20 percent area 

5 of cigarette advertisements provided by paragraph 

6 (2) of this subsection. The Secretary shall promul7 gate regulations which provide for adjustments in 

8 the format and type sizes of any text required to ap9 pear in such area to ensure that the total text re10 quired to appear by law will fit within such area. 

11 ‘‘(c) MARKETING REQUIREMENTS.—

12 ‘‘(1) RANDOM DISPLAY.—The label statements 

13 specified in subsection (a)(1) shall be randomly dis14 played in each 12-month period, in as equal a num15 ber of times as is possible on each brand of the 

16 product and be randomly distributed in all areas of 

17 the United States in which the product is marketed 

18 in accordance with a plan submitted by the tobacco 

19 product manufacturer, importer, distributor, or re20 tailer and approved by the Secretary. 

21 ‘‘(2) ROTATION.—The label statements speci22 fied in subsection (a)(1) shall be rotated quarterly in 

23 alternating sequence in advertisements for each 

24 brand of cigarettes in accordance with a plan sub25 mitted by the tobacco product manufacturer, im-
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1 porter, distributor, or retailer to, and approved by, 

2 the Secretary. 

3 ‘‘(3) REVIEW.—The Secretary shall review each 

4 plan submitted under paragraph (2) and approve it 

5 if the plan—

6 ‘‘(A) will provide for the equal distribution 

7 and display on packaging and the rotation re8 quired in advertising under this subsection; and 

9 ‘‘(B) assures that all of the labels required 

10 under this section will be displayed by the to11 bacco product manufacturer, importer, dis12 tributor, or retailer at the same time. 

13 ‘‘(4) APPLICABILITY TO RETAILERS.—This sub14 section and subsection (b) apply to a retailer only if 

15 that retailer is responsible for or directs the label 

16 statements required under this section except that 

17 this paragraph shall not relieve a retailer of liability 

18 if the retailer displays, in a location open to the pub19 lic, an advertisement that is not labeled in accord20 ance with the requirements of this subsection and 

21 subsection (b).’’. 

22 SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING 

23 LABEL STATEMENTS. 

24 Section 4 of the Federal Cigarette Labeling and Ad25 vertising Act (15 U.S.C. 1333), as amended by section 
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1 201, is further amended by adding at the end the fol2 lowing: 

3 ‘‘(d) CHANGE IN REQUIRED STATEMENTS.—The 

4 Secretary may, by a rulemaking conducted under section 

5 553 of title 5, United States Code, adjust the format, type 

6 size, and text of any of the label requirements, require 

7 color graphics to accompany the text, increase the re8 quired label area from 30 percent up to 50 percent of the 

9 front and rear panels of the package, or establish the for10 mat, type size, and text of any other disclosures required 

11 under the Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 301 et seq.), if the Secretary finds that such a 

13 change would promote greater public understanding of the 

14 risks associated with the use of tobacco products.’’. 

15 SEC. 203. STATE REGULATION OF CIGARETTE ADVER16 TISING AND PROMOTION. 

17 Section 5 of the Federal Cigarette Labeling and Ad18 vertising Act (15 U.S.C. 1334) is amended by adding at 

19 the end the following: 

20 ‘‘(c) EXCEPTION.—Notwithstanding subsection (b), a 

21 State or locality may enact statutes and promulgate regu22 lations, based on smoking and health, that take effect 

23 after the effective date of the Family Smoking Prevention 

24 and Tobacco Control Act, imposing specific bans or re-
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1 strictions on the time, place, and manner, but not content, 

2 of the advertising or promotion of any cigarettes.’’. 

3 SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING 

4 WARNINGS. 

5 Section 3 of the Comprehensive Smokeless Tobacco 

6 Health Education Act of 1986 (15 U.S.C. 4402) is amend7 ed to read as follows: 

8 ‘‘SEC. 3. SMOKELESS TOBACCO WARNING. 

9 ‘‘(a) GENERAL RULE.— 

10 ‘‘(1) It shall be unlawful for any person to man11 ufacture, package, sell, offer to sell, distribute, or 

12 import for sale or distribution within the United 

13 States any smokeless tobacco product unless the 

14 product package bears, in accordance with the re15 quirements of this Act, one of the following labels: 

16 ‘WARNING: This product can cause mouth cancer’. 

17 ‘WARNING: This product can cause gum disease 

18 and tooth loss’. 

19 ‘WARNING: This product is not a safe alternative 

20 to cigarettes’. 

21 ‘WARNING: Smokeless tobacco is addictive’. 

22 ‘‘(2) Each label statement required by para23 graph (1) shall be—

24 ‘‘(A) located on the 2 principal display 

25 panels of the package, and each label statement 
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1 shall comprise at least 30 percent of each such 

2 display panel; and 

3 ‘‘(B) in 17-point conspicuous and legible 

4 type and in black text on a white background, 

5 or white text on a black background, in a man6 ner that contrasts by typography, layout, or 

7 color, with all other printed material on the 

8 package, in an alternating fashion under the 

9 plan submitted under subsection (b)(3), except 

10 that if the text of a label statement would oc11 cupy more than 70 percent of the area specified 

12 by subparagraph (A), such text may appear in 

13 a smaller type size, so long as at least 60 per14 cent of such warning area is occupied by the 

15 label statement. 

16 ‘‘(3) The label statements required by para17 graph (1) shall be introduced by each tobacco prod18 uct manufacturer, packager, importer, distributor, or 

19 retailer of smokeless tobacco products concurrently 

20 into the distribution chain of such products. 

21 ‘‘(4) The provisions of this subsection do not 

22 apply to a tobacco product manufacturer or dis23 tributor of any smokeless tobacco product that does 

24 not manufacture, package, or import smokeless to-
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1 bacco products for sale or distribution within the 

2 United States. 

3 ‘‘(5) A retailer of smokeless tobacco products 

4 shall not be in violation of this subsection for pack5 aging that is supplied to the retailer by a tobacco 

6 products manufacturer, importer, or distributor and 

7 that is not altered by the retailer unless the retailer 

8 offers for sale, sells, or distributes a smokeless to9 bacco product that is not labeled in accordance with 

10 this subsection. 

11 ‘‘(b) REQUIRED LABELS.—

12 ‘‘(1) It shall be unlawful for any tobacco prod13 uct manufacturer, packager, importer, distributor, or 

14 retailer of smokeless tobacco products to advertise or 

15 cause to be advertised within the United States any 

16 smokeless tobacco product unless its advertising 

17 bears, in accordance with the requirements of this 

18 section, one of the labels specified in subsection (a). 

19 ‘‘(2) Each label statement required by sub20 section (a) in smokeless tobacco advertising shall 

21 comply with the standards set forth in this para22 graph. For press and poster advertisements, each 

23 such statement and (where applicable) any required 

24 statement relating to tar, nicotine, or other con25 stituent yield shall—
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1 ‘‘(A) comprise at least 20 percent of the 

2 area of the advertisement, and the warning area 

3 shall be delineated by a dividing line of con4 trasting color from the advertisement; and 

5 ‘‘(B) the word ‘WARNING’ shall appear in 

6 capital letters and each label statement shall 

7 appear in conspicuous and legible type. The text 

8 of the label statement shall be black on a white 

9 background, or white on a black background, in 

10 an alternating fashion under the plan submitted 

11 under paragraph (3). 

12 ‘‘(3)(A) The label statements specified in sub13 section (a)(1) shall be randomly displayed in each 

14 12-month period, in as equal a number of times as 

15 is possible on each brand of the product and be ran16 domly distributed in all areas of the United States 

17 in which the product is marketed in accordance with 

18 a plan submitted by the tobacco product manufac19 turer, importer, distributor, or retailer and approved 

20 by the Secretary. 

21 ‘‘(B) The label statements specified in sub22 section (a)(1) shall be rotated quarterly in alter23 nating sequence in advertisements for each brand of 

24 smokeless tobacco product in accordance with a plan 

25 submitted by the tobacco product manufacturer, im-
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1 porter, distributor, or retailer to, and approved by, 

2 the Secretary. 

3 ‘‘(C) The Secretary shall review each plan sub4 mitted under subparagraph (B) and approve it if the 

5 plan—

6 ‘‘(i) will provide for the equal distribution 

7 and display on packaging and the rotation re8 quired in advertising under this subsection; and 

9 ‘‘(ii) assures that all of the labels required 

10 under this section will be displayed by the to11 bacco product manufacturer, importer, dis12 tributor, or retailer at the same time. 

13 ‘‘(D) This paragraph applies to a retailer only 

14 if that retailer is responsible for or directs the label 

15 statements under this section, unless the retailer dis16 plays in a location open to the public, an advertise17 ment that is not labeled in accordance with the re18 quirements of this subsection. 

19 ‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is 

20 unlawful to advertise smokeless tobacco on any medium 

21 of electronic communications subject to the jurisdiction of 

22 the Federal Communications Commission.’’. 
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1 SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO 

2 PRODUCT WARNING LABEL STATEMENTS. 

3 Section 3 of the Comprehensive Smokeless Tobacco 

4 Health Education Act of 1986 (15 U.S.C. 4402), as 

5 amended by section 203, is further amended by adding 

6 at the end the following: 

7 ‘‘(d) AUTHORITY TO REVISE WARNING LABEL

8 STATEMENTS.—The Secretary may, by a rulemaking con9 ducted under section 553 of title 5, United States Code, 

10 adjust the format, type size, and text of any of the label 

11 requirements, require color graphics to accompany the 

12 text, increase the required label area from 30 percent up 

13 to 50 percent of the front and rear panels of the package, 

14 or establish the format, type size, and text of any other 

15 disclosures required under the Federal Food, Drug, and 

16 Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary 

17 finds that such a change would promote greater public un18 derstanding of the risks associated with the use of smoke19 less tobacco products.’’. 

20 SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CON21 STITUENT DISCLOSURE TO THE PUBLIC. 

22 Section 4(a) of the Federal Cigarette Labeling and 

23 Advertising Act (15 U.S.C. 1333 (a)), as amended by sec24 tion 201, is further amended by adding at the end the 

25 following: 
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1 ‘‘(4)(A) The Secretary shall, by a rulemaking 

2 conducted under section 553 of title 5, United 

3 States Code, determine (in the Secretary’s sole dis4 cretion) whether cigarette and other tobacco product 

5 manufacturers shall be required to include in the 

6 area of each cigarette advertisement specified by 

7 subsection (b) of this section, or on the package 

8 label, or both, the tar and nicotine yields of the ad9 vertised or packaged brand. Any such disclosure 

10 shall be in accordance with the methodology estab11 lished under such regulations, shall conform to the 

12 type size requirements of subsection (b) of this sec13 tion, and shall appear within the area specified in 

14 subsection (b) of this section. 

15 ‘‘(B) Any differences between the requirements 

16 established by the Secretary under subparagraph (A) 

17 and tar and nicotine yield reporting requirements es18 tablished by the Federal Trade Commission shall be 

19 resolved by a memorandum of understanding be20 tween the Secretary and the Federal Trade Commis21 sion. 

22 ‘‘(C) In addition to the disclosures required by 

23 subparagraph (A) of this paragraph, the Secretary 

24 may, under a rulemaking conducted under section 

25 553 of title 5, United States Code, prescribe disclo-
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1 sure requirements regarding the level of any ciga2 rette or other tobacco product constituent including 

3 any smoke constituent. Any such disclosure may be 

4 required if the Secretary determines that disclosure 

5 would be of benefit to the public health, or otherwise 

6 would increase consumer awareness of the health 

7 consequences of the use of tobacco products, except 

8 that no such prescribed disclosure shall be required 

9 on the face of any cigarette package or advertise10 ment. Nothing in this section shall prohibit the Sec11 retary from requiring such prescribed disclosure 

12 through a cigarette or other tobacco product pack13 age or advertisement insert, or by any other means 

14 under the Federal Food, Drug, and Cosmetic Act 

15 (21 U.S.C. 301 et seq.). 

16 ‘‘(D) This paragraph applies to a retailer only 

17 if that retailer is responsible for or directs the label 

18 statements required under this section, except that 

19 this paragraph shall not relieve a retailer of liability 

20 if the retailer sells or distributes tobacco products 

21 that are not labeled in accordance with the require22 ments of this subsection.’’. 
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1 TITLE III—PREVENTION OF IL2 LICIT TRADE IN TOBACCO 

3 PRODUCTS 

4 SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPEC5 TION. 

6 Chapter IX of the Federal Food, Drug, and Cosmetic 

7 Act, as added by section 101, is further amended by add8 ing at the end the following: 

9 ‘‘SEC. 921. LABELING, RECORDKEEPING, RECORDS INSPEC10 TION. 

11 ‘‘(a) ORIGIN LABELING.—The label, packaging, and 

12 shipping containers of tobacco products for introduction 

13 or delivery for introduction into interstate commerce in the 

14 United States shall bear the statement ‘sale only allowed 

15 in the United States.’

16 ‘‘(b) REGULATIONS CONCERNING RECORDKEEPING

17 FOR TRACKING AND TRACING.—

18 ‘‘(1) IN GENERAL.—Not later than 9 months 

19 after the date of enactment of the Family Smoking 

20 Prevention and Tobacco Control Act, the Secretary 

21 shall promulgate regulations regarding the establish22 ment and maintenance of records by any person who 

23 manufactures, processes, transports, distributes, re24 ceives, packages, holds, exports, or imports tobacco 

25 products. 
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1 ‘‘(2) INSPECTION.—In promulgating the regula2 tions described in paragraph (1), the Secretary shall 

3 consider which records are needed for inspection to 

4 monitor the movement of tobacco products from the 

5 point of manufacture through distribution to retail 

6 outlets to assist in investigating potential illicit 

7 trade, smuggling or counterfeiting of tobacco prod8 ucts. 

9 ‘‘(3) CODES.—The Secretary may require codes 

10 on the labels of tobacco products or other designs or 

11 devices for the purpose of tracking or tracing the to12 bacco product through the distribution system. 

13 ‘‘(4) SIZE OF BUSINESS.—The Secretary shall 

14 take into account the size of a business in promul15 gating regulations under this section. 

16 ‘‘(5) RECORDKEEPING BY RETAILERS.—The 

17 Secretary shall not require any retailer to maintain 

18 records relating to individual purchasers of tobacco 

19 products for personal consumption. 

20 ‘‘(c) RECORDS INSPECTION.—If the Secretary has a 

21 reasonable belief that a tobacco product is part of an illicit 

22 trade or smuggling or is a counterfeit product, each person 

23 who manufactures, processes, transports, distributes, re24 ceives, holds, packages, exports, or imports tobacco prod25 ucts shall, at the request of an officer or employee duly 
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1 designated by the Secretary, permit such officer or em2 ployee, at reasonable times and within reasonable limits 

3 and in a reasonable manner, upon the presentation of ap4 propriate credentials and a written notice to such person, 

5 to have access to and copy all records (including financial 

6 records) relating to such article that are needed to assist 

7 the Secretary in investigating potential illicit trade, smug8 gling or counterfeiting of tobacco products. 

9 ‘‘(d) KNOWLEDGE OF ILLEGAL TRANSACTION.—If 

10 the manufacturer or distributor of a tobacco product has 

11 knowledge which reasonably supports the conclusion that 

12 a tobacco product manufactured or distributed by such 

13 manufacturer or distributor that has left the control of 

14 such person may be or has been—

15 ‘‘(A) imported, exported, distributed or of16 fered for sale in interstate commerce by a per17 son without paying duties or taxes required by 

18 law; or 

19 ‘‘(B) imported, exported, distributed or di20 verted for possible illicit marketing, 

21 the manufacturer or distributor shall promptly notify the 

22 Attorney General of such knowledge. 

23 ‘‘(2) KNOWLEDGE DEFINED.—For purposes of 

24 this subsection, the term ‘knowledge’ as applied to 

25 a manufacturer or distributor means—
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1 ‘‘(A) the actual knowledge that the manu2 facturer or distributor had; or 

3 ‘‘(B) the knowledge which a reasonable 

4 person would have had under like circumstances 

5 or which would have been obtained upon the ex6 ercise of due care.’’. 

7 SEC. 302. STUDY AND REPORT. 

8 (a) STUDY.—The Comptroller General of the United 

9 States shall conduct a study of cross-border trade in to10 bacco products to—

11 (1) collect data on cross-border trade in tobacco 

12 products, including illicit trade and trade of counter13 feit tobacco products and make recommendations on 

14 the monitoring of such trade; 

15 (2) collect data on cross-border advertising (any 

16 advertising intended to be broadcast, transmitted, or 

17 distributed from the United States to another coun18 try) of tobacco products and make recommendations 

19 on how to prevent or eliminate, and what tech20 nologies could help facilitate the elimination of, 

21 cross-border advertising. 

22 (b) REPORT.—Not later than 18 months after the 

23 date of enactment of this Act, the Comptroller General 

24 of the United States shall submit to the Committee on 

25 Health, Education, Labor, and Pensions of the Senate and 
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1 the Committee on Energy and Commerce of the House 

2 of Representatives a report on the study described in sub3 section (a).

Æ