IB 

Union Calendar No. 485 

110TH CONGRESS 

2D SESSION H. R. 1108 

[Report No. 110–762] 

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

with certain authority to regulate tobacco products. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 15, 2007 

Mr. WAXMAN (for himself, Mr. TOM DAVIS of Virginia, Mr. DINGELL, Mr. 

PALLONE, Mr. ABERCROMBIE, Mr. ACKERMAN, Mr. ALLEN, Ms. BALDWIN, Mr. BARTLETT of Maryland, Mr. BLUMENAUER, Ms. BORDALLO, 

Mrs. CAPPS, Mr. CAPUANO, Mr. CASTLE, Mrs. CHRISTENSEN, Mr. 

CUMMINGS, Mr. DAVIS of Illinois, Mrs. DAVIS of California, Ms. 

DEGETTE, Mr. DELAHUNT, Ms. DELAURO, Mr. ELLISON, Mr. EMANUEL, Mrs. EMERSON, Mr. ENGEL, Ms. ESHOO, Mr. FERGUSON, Mr. FILNER, Mr. FRANK of Massachusetts, Ms. GIFFORDS, Mr. GENE GREEN of 

Texas, Mr. GRIJALVA, Mr. GUTIERREZ, Mr. HIGGINS, Mr. HINCHEY, Ms. 

HIRONO, Mr. HOLT, Mr. HONDA, Mr. INSLEE, Mr. ISRAEL, Mr. JACKSON

of Illinois, Ms. JACKSON-LEE of Texas, Mr. KENNEDY, Mr. KILDEE, Mr. 

KING of New York, Mr. KIRK, Mr. LAHOOD, Mr. LANTOS, Mr. LARSEN

of Washington, Mr. LARSON of Connecticut, Ms. LEE, Mr. LEWIS of 

Georgia, Mr. LIPINSKI, Mr. LOBIONDO, Ms. ZOE LOFGREN of California, 

Mr. LYNCH, Mrs. MCCARTHY of New York, Ms. MCCOLLUM of Minnesota, Mr. MCDERMOTT, Mr. MCGOVERN, Mr. MCNULTY, Mrs. 

MALONEY of New York, Mr. MARKEY, Mr. MATHESON, Ms. MATSUI, Mr. 

MEEHAN, Mr. MICHAUD, Mrs. MILLER of Michigan, Mr. GEORGE MILLER of California, Mr. MOORE of Kansas, Mr. MORAN of Virginia, Mr. 

NADLER, Ms. NORTON, Mr. OBERSTAR, Mr. OLVER, Mr. PASCRELL, Mr. 

PAYNE, Mr. PLATTS, Ms. PRYCE of Ohio, Mr. RAMSTAD, Mr. REICHERT, 

Mr. ROTHMAN, Mr. RUSH, Ms. SCHAKOWSKY, Ms. SCHWARTZ, Mr. 

SHERMAN, Mr. SMITH of New Jersey, Ms. SOLIS, Mr. STARK, Mrs. 

TAUSCHER, Mr. TERRY, Mr. TIBERI, Mr. VAN HOLLEN, Mr. WALDEN of 

Oregon, Mr. WEINER, Mr. WELLER of Illinois, Mr. WEXLER, and Mr. 

WYNN) introduced the following bill; which was referred to the Committee 

on Energy and Commerce 


erowe on PROD1PC71 with BILLS
2 

•HR 1108 RH

JULY 17, 2008 

Additional sponsors: Ms. HARMAN, Mr. FRELINGHUYSEN, Mr. COHEN, Mr. 

BAIRD, Ms. WOOLSEY, Mr. MURPHY of Connecticut, Mr. DENT, Mr. 

BOSWELL, Mr. FATTAH, Mr. COURTNEY, Ms. WASSERMAN SCHULTZ, Mr. 

HARE, Mr. ROSKAM, Mr. TOWNS, Mr. UDALL of New Mexico, Mr. 

DOYLE, Mr. RAHALL, Mr. HALL of New York, Mr. ELLSWORTH, Mr. 

STUPAK, Mr. UPTON, Mr. MARSHALL, Mr. CROWLEY, Ms. HERSETH

SANDLIN, Ms. CARSON, Mr. LAMPSON, Ms. SHEA-PORTER, Mr. MITCHELL, Mr. DEFAZIO, Mr. JOHNSON of Georgia, Mr. COSTELLO, Mr. 

BRALEY of Iowa, Mrs. BONO MACK, Ms. SUTTON, Mr. FARR, Mr. GONZALEZ, Mr. ARCURI, Mr. KAGEN, Mr. BERRY, Mr. THOMPSON of Mississippi, Mr. COSTA, Mr. HOLDEN, Mr. HINOJOSA, Mr. SMITH of Washington, Mr. WALZ of Minnesota, Mr. LOEBSACK, Mr. NEAL of Massachusetts, Mr. AL GREEN of Texas, Mr. RODRIGUEZ, Mr. KIND, Mr. CARNEY, 

Mrs. CAPITO, Mr. UDALL of Colorado, Mr. PATRICK J. MURPHY of Pennsylvania, Mr. WELCH of Vermont, Ms. SLAUGHTER, Mr. SCHIFF, Mr. 

RUPPERSBERGER, Mrs. LOWEY, Mr. GERLACH, Ms. HOOLEY, Mr. 

WALSH of New York, Mr. SARBANES, Mr. POMEROY, Mr. PRICE of North 

Carolina, Mr. GILCHREST, Mr. SAXTON, Mr. WU, Mrs. BOYDA of Kansas, 

Mr. MEEKS of New York, Mr. HODES, Mr. SERRANO, Ms. BEAN, Mrs. 

GILLIBRAND, Mr. SNYDER, Mr. ALEXANDER, Mr. CARNAHAN, Mr. 

BRADY of Pennsylvania, Mr. KUCINICH, Ms. BERKLEY, Ms. CLARKE, Ms. 

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

Mrs. NAPOLITANO, Mr. BISHOP of New York, Ms. EDDIE BERNICE

JOHNSON of Texas, Ms. ROYBAL-ALLARD, Mr. LANGEVIN, Mr. HASTINGS

of Florida, Mr. ALTMIRE, Ms. CORRINE BROWN of Florida, Mr. BARROW, 

Mr. TIERNEY, Mr. CONYERS, Mr. KLEIN of Florida, Ms. LINDA T. 

SA ́NCHEZ of California, Mr. LATOURETTE, Mr. BISHOP of Georgia, Mr. 

EDWARDS, Mr. ANDREWS, Mr. LEVIN, Mr. DICKS, Mr. JEFFERSON, Mr. 

MEEK of Florida, Mr. SESTAK, Mr. PASTOR, Ms. VELA ́ZQUEZ, Mr. ROSS, 

Ms. WATSON, Ms. TSONGAS, Ms. CASTOR, Mrs. JONES of Ohio, Mr. 

SCOTT of Virginia, Mr. MCNERNEY, Ms. MOORE of Wisconsin, Mr. 

FALEOMAVAEGA, Mr. PICKERING, Mr. REYES, Mr. CLEAVER, Mr. 

BILBRAY, Mr. SHAYS, Mr. THOMPSON of California, Mr. YARMUTH, Mr. 

DREIER, Mr. MURTHA, Mr. CARSON, Mr. RENZI, Ms. SPEIER, Mr. 

YOUNG of Alaska, Mr. CANTOR, Mr. FOSTER, Ms. GINNY BROWN-WAITE

of Florida, Mr. KANJORSKI, Mr. BROWN of South Carolina, and Mr. 

MCCAUL of Texas 

JULY 17, 2008 

Deleted sponsor: Mr. PITTS (added March 1, 2007; deleted April 2, 2008) 

JULY 17, 2008 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 


erowe on PROD1PC71 with BILLS
3 

•HR 1108 RH

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on February 15, 2007] 

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 this 

7 Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 

Sec. 3. Purpose. 

Sec. 4. Scope and effect. 

Sec. 5. Severability. 

TITLE I—AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION 

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

Sec. 102. Final rule. 

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

Sec. 104. Study on raising the minimum age to purchase tobacco products. 

Sec. 105. Tobacco industry concentration. 

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. 


erowe on PROD1PC71 with BILLS
4 

•HR 1108 RH

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 propor5 tions that results in new generations of tobacco-de6 pendent children and adults. 

7 (2) A consensus exists within the scientific and 

8 medical communities that tobacco products are inher9 ently dangerous and cause cancer, heart disease, and 

10 other serious adverse health effects. 

11 (3) Nicotine is an addictive drug. 

12 (4) Virtually all new users of tobacco products 

13 are under the minimum legal age to purchase such 

14 products. 

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

17 tobacco products by adolescents. 

18 (6) Because past efforts to restrict advertising 

19 and marketing of tobacco products have failed ade20 quately to curb tobacco use by adolescents, comprehen21 sive restrictions on the sale, promotion, and distribu22 tion of such products are needed. 


erowe on PROD1PC71 with BILLS
5 

•HR 1108 RH

1 (7) Federal and State Governments have lacked 

2 the legal and regulatory authority and resources they 

3 need to address comprehensively the public health and 

4 societal problems caused by the use of tobacco prod5 ucts. 

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

7 public health community, and the public at large rec8 ognize that the tobacco industry should be subject to 

9 ongoing oversight. 

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

11 the Congress is vested with the responsibility for regu12 lating interstate commerce and commerce with Indian 

13 tribes. 

14 (10) The sale, distribution, marketing, adver15 tising, and use of tobacco products are activities in 

16 and substantially affecting interstate commerce be17 cause they are sold, marketed, advertised, and distrib18 uted in interstate commerce on a nationwide basis, 

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

20 (11) The sale, distribution, marketing, adver21 tising, and use of such products substantially affect 

22 interstate commerce through the health care and other 

23 costs attributable to the use of tobacco products. 

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

25 enact legislation that provides the Food and Drug AdVerDate Aug 31 2005 02:23 Jul 18, 2008 Jkt 069200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
6 

•HR 1108 RH

1 ministration with the authority to regulate tobacco 

2 products and the advertising and promotion of such 

3 products. The benefits to the American people from 

4 enacting such legislation would be significant in 

5 human and economic terms. 

6 (13) Tobacco use is the foremost preventable 

7 cause of premature death in America. It causes over 

8 400,000 deaths in the United States each year, and 

9 approximately 8,600,000 Americans have chronic ill10 nesses related to smoking. 

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

12 50 percent would prevent well over 10,000,000 of to13 day’s children from becoming regular, daily smokers, 

14 saving over 3,000,000 of them from premature death 

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

16 youth smoking would also result in approximately 

17 $75,000,000,000 in savings attributable to reduced 

18 health care costs. 

19 (15) Advertising, marketing, and promotion of 

20 tobacco products have been especially directed to at21 tract young persons to use tobacco products, and these 

22 efforts have resulted in increased use of such products 

23 by youth. Past efforts to oversee these activities have 

24 not been successful in adequately preventing such in25 creased use. 


erowe on PROD1PC71 with BILLS
7 

•HR 1108 RH

1 (16) In 2005, the cigarette manufacturers spent 

2 more than $13,000,000,000 to attract new users, re3 tain current users, increase current consumption, and 

4 generate favorable long-term attitudes toward smoking 

5 and tobacco use. 

6 (17) Tobacco product advertising often 

7 misleadingly portrays the use of tobacco as socially 

8 acceptable and healthful to minors. 

9 (18) Tobacco product advertising is regularly 

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

11 under the age of 18 are regularly exposed to tobacco 

12 product promotional efforts. 

13 (19) Through advertisements during and spon14 sorship of sporting events, tobacco has become strongly 

15 associated with sports and has become portrayed as 

16 an integral part of sports and the healthy lifestyle as17 sociated with rigorous sporting activity. 

18 (20) Children are exposed to substantial and un19 avoidable tobacco advertising that leads to favorable 

20 beliefs about tobacco use, plays a role in leading 

21 young people to overestimate the prevalence of tobacco 

22 use, and increases the number of young people who 

23 begin to use tobacco. 

24 (21) The use of tobacco products in motion pic25 tures and other mass media glamorizes its use for 


erowe on PROD1PC71 with BILLS
8 

•HR 1108 RH

1 young people and encourages them to use tobacco 

2 products. 

3 (22) Tobacco advertising expands the size of the 

4 tobacco market by increasing consumption of tobacco 

5 products including tobacco use by young people. 

6 (23) Children are more influenced by tobacco 

7 marketing than adults: more than 80 percent of youth 

8 smoke three heavily marketed brands, while only 54 

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

10 brands. 

11 (24) Tobacco company documents indicate that 

12 young people are an important and often crucial seg13 ment of the tobacco market. Children, who tend to be 

14 more price sensitive than adults, are influenced by 

15 advertising and promotion practices that result in 

16 drastically reduced cigarette prices. 

17 (25) Comprehensive advertising restrictions will 

18 have a positive effect on the smoking rates of young 

19 people. 

20 (26) Restrictions on advertising are necessary to 

21 prevent unrestricted tobacco advertising from under22 mining legislation prohibiting access to young people 

23 and providing for education about tobacco use. 

24 (27) International experience shows that adver25 tising regulations that are stringent and comprehenVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
9 

•HR 1108 RH

1 sive have a greater impact on overall tobacco use and 

2 young people’s use than weaker or less comprehensive 

3 ones. 

4 (28) Text only requirements, although not as 

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

6 tobacco products while preserving the informational 

7 function of advertising. 

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

9 adopt legislation to address the public health crisis 

10 created by actions of the tobacco industry. 

11 (30) The final regulations promulgated by the 

12 Secretary of Health and Human Services in the Au13 gust 28, 1996, issue of the Federal Register (61 Fed. 

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

15 21, Code of Federal Regulations, are consistent with 

16 the first amendment to the United States Constitution 

17 and with the standards set forth in the amendments 

18 made by this subtitle for the regulation of tobacco 

19 products by the Food and Drug Administration, and 

20 the restriction on the sale and distribution of, includ21 ing access to and the advertising and promotion of, 

22 tobacco products contained in such regulations are 

23 substantially related to accomplishing the public 

24 health goals of this Act. 


erowe on PROD1PC71 with BILLS
10 

•HR 1108 RH

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

2 will directly and materially advance the Federal Gov3 ernment’s substantial interest in reducing the number 

4 of children and adolescents who use cigarettes and 

5 smokeless tobacco and in preventing the life-threat6 ening health consequences associated with tobacco use. 

7 An overwhelming majority of Americans who use to8 bacco products begin using such products while they 

9 are minors and become addicted to the nicotine in 

10 those products before reaching the age of 18. Tobacco 

11 advertising and promotion play a crucial role in the 

12 decision of these minors to begin using tobacco prod13 ucts. Less restrictive and less comprehensive ap14 proaches have not and will not be effective in reduc15 ing the problems addressed by such regulations. The 

16 reasonable restrictions on the advertising and pro17 motion of tobacco products contained in such regula18 tions will lead to a significant decrease in the number 

19 of minors using and becoming addicted to those prod20 ucts. 

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

22 impose no more extensive restrictions on communica23 tion by tobacco manufacturers and sellers than are 

24 necessary to reduce the number of children and ado25 lescents who use cigarettes and smokeless tobacco and 


erowe on PROD1PC71 with BILLS
11 

•HR 1108 RH

1 to prevent the life-threatening health consequences as2 sociated with tobacco use. Such regulations are nar3 rowly tailored to restrict those advertising and pro4 motional practices which are most likely to be seen or 

5 heard by youth and most likely to entice them into 

6 tobacco use, while affording tobacco manufacturers 

7 and sellers ample opportunity to convey information 

8 about their products to adult consumers. 

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

10 that typically requires repeated interventions to 

11 achieve long-term or permanent abstinence. 

12 (34) Because the only known safe alternative to 

13 smoking is cessation, interventions should target all 

14 smokers to help them quit completely. 

15 (35) Tobacco products have been used to facili16 tate and finance criminal activities both domestically 

17 and internationally. Illicit trade of tobacco products 

18 has been linked to organized crime and terrorist 

19 groups. 

20 (36) It is essential that the Food and Drug Ad21 ministration review products sold or distributed for 

22 use to reduce risks or exposures associated with to23 bacco products and that it be empowered to review 

24 any advertising and labeling for such products. It is 

25 also essential that manufacturers, prior to marketing 


erowe on PROD1PC71 with BILLS
12 

•HR 1108 RH

1 such products, be required to demonstrate that such 

2 products will meet a series of rigorous criteria, and 

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

4 taking into account both users of tobacco products 

5 and persons who do not currently use tobacco prod6 ucts. 

7 (37) Unless tobacco products that purport to re8 duce the risks to the public of tobacco use actually re9 duce such risks, those products can cause substantial 

10 harm to the public health to the extent that the indi11 viduals, who would otherwise not consume tobacco 

12 products or would consume such products less, use to13 bacco products purporting to reduce risk. Those who 

14 use products sold or distributed as modified risk prod15 ucts that do not in fact reduce risk, rather than quit16 ting or reducing their use of tobacco products, have 

17 a substantially increased likelihood of suffering dis18 ability and premature death. The costs to society of 

19 the widespread use of products sold or distributed as 

20 modified risk products that do not in fact reduce risk 

21 or that increase risk include thousands of unnecessary 

22 deaths and injuries and huge costs to our health care 

23 system. 

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

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


erowe on PROD1PC71 with BILLS
13 

•HR 1108 RH

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

2 other cigarettes. As the National Cancer Institute has 

3 also found, mistaken beliefs about the health con4 sequences of smoking ‘‘low tar’’ and ‘‘light’’ cigarettes 

5 can reduce the motivation to quit smoking entirely 

6 and thereby lead to disease and death. 

7 (39) Recent studies have demonstrated that there 

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

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

10 products may actually increase the risk of tobacco 

11 use. 

12 (40) The dangers of products sold or distributed 

13 as modified risk tobacco products that do not in fact 

14 reduce risk are so high that there is a compelling gov15 ernmental interest in ensuring that statements about 

16 modified risk tobacco products are complete, accurate, 

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

18 (41) As the Federal Trade Commission has 

19 found, consumers have misinterpreted advertisements 

20 in which one product is claimed to be less harmful 

21 than a comparable product, even in the presence of 

22 disclosures and advisories intended to provide clari23 fication. 

24 (42) Permitting manufacturers to make unsub25 stantiated statements concerning modified risk toVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
14 

•HR 1108 RH

1 bacco products, whether express or implied, even if ac2 companied by disclaimers would be detrimental to the 

3 public health. 

4 (43) The only way to effectively protect the pub5 lic health from the dangers of unsubstantiated modi6 fied risk tobacco products is to empower the Food and 

7 Drug Administration to require that products that to8 bacco manufacturers sold or distributed for risk re9 duction be reviewed in advance of marketing, and to 

10 require that the evidence relied on to support claims 

11 be fully verified. 

12 (44) The Food and Drug Administration is a 

13 regulatory agency with the scientific expertise to iden14 tify harmful substances in products to which con15 sumers are exposed, to design standards to limit expo16 sure to those substances, to evaluate scientific studies 

17 supporting claims about the safety of products, and to 

18 evaluate the impact of labels, labeling, and adver19 tising on consumer behavior in order to reduce the 

20 risk of harm and promote understanding of the im21 pact of the product on health. In connection with its 

22 mandate to promote health and reduce the risk of 

23 harm, the Food and Drug Administration routinely 

24 makes decisions about whether and how products may 

25 be marketed in the United States. 


erowe on PROD1PC71 with BILLS
15 

•HR 1108 RH

1 (45) The Federal Trade Commission was created 

2 to protect consumers from unfair or deceptive acts or 

3 practices, and to regulate unfair methods of competi4 tion. Its focus is on those marketplace practices that 

5 deceive or mislead consumers, and those that give 

6 some competitors an unfair advantage. Its mission is 

7 to regulate activities in the marketplace. Neither the 

8 Federal Trade Commission nor any other Federal 

9 agency except the Food and Drug Administration 

10 possesses the scientific expertise needed to implement 

11 effectively all provisions of the Family Smoking Pre12 vention and Tobacco Control Act. 

13 (46) If manufacturers state or imply in commu14 nications directed to consumers through the media or 

15 through a label, labeling, or advertising, that a to16 bacco product is approved or inspected by the Food 

17 and Drug Administration or complies with Food and 

18 Drug Administration standards, consumers are likely 

19 to be confused and misled. Depending upon the par20 ticular language used and its context, such a state21 ment could result in consumers being misled into be22 lieving that the product is endorsed by the Food and 

23 Drug Administration for use or in consumers being 

24 misled about the harmfulness of the product because 


erowe on PROD1PC71 with BILLS
16 

•HR 1108 RH

1 of such regulation, inspection, approval, or compli2 ance. 

3 (47) If manufacturers are permitted to state or 

4 imply in communications directed to consumers that 

5 a tobacco product is approved or inspected by the 

6 Food and Drug Administration or complies with 

7 Food and Drug Administration standards, consumers 

8 are likely to be confused and misled. Such a statement 

9 could result in consumers being misled into believing 

10 that the product is endorsed by the Food and Drug 

11 Administration for use or in consumers being misled 

12 about the harmfulness of the product because of such 

13 regulation, inspection, or compliance. 

14 (48) In August 2006 a United States district 

15 court judge found that the major United States ciga16 rette companies continue to target and market to 

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

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

19 (49) In August 2006 a United States district 

20 court judge found that the major United States ciga21 rette companies dramatically increased their adver22 tising and promotional spending in ways that en23 courage youth to start smoking subsequent to the sign24 ing of the Master Settlement Agreement in 1998. USA 


erowe on PROD1PC71 with BILLS
17 

•HR 1108 RH

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

2 99–2496 (GK), August 17, 2006). 

3 (50) In August 2006 a United States district 

4 court judge found that the major United States ciga5 rette companies have designed their cigarettes to pre6 cisely control nicotine delivery levels and provide 

7 doses of nicotine sufficient to create and sustain ad8 diction while also concealing much of their nicotine9 related research. USA v Philip Morris, USA, Inc., et 

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

11 2006). 

12 SEC. 3. PURPOSE. 

13 The purposes of this Act are— 

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

15 Administration to regulate tobacco products under the 

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

17 et seq.), by recognizing it as the primary Federal reg18 ulatory authority with respect to the manufacture, 

19 marketing, and distribution of tobacco products as 

20 provided for in this Act; 

21 (2) to ensure that the Food and Drug Adminis22 tration has the authority to address issues of par23 ticular concern to public health officials, especially 

24 the use of tobacco by young people and dependence on 

25 tobacco; 


erowe on PROD1PC71 with BILLS
18 

•HR 1108 RH

1 (3) to authorize the Food and Drug Administra2 tion to set national standards controlling the manu3 facture of tobacco products and the identity, public 

4 disclosure, and amount of ingredients used in such 

5 products; 

6 (4) to provide new and flexible enforcement au7 thority to ensure that there is effective oversight of the 

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

9 promote less harmful tobacco products; 

10 (5) to vest the Food and Drug Administration 

11 with the authority to regulate the levels of tar, nico12 tine, and other harmful components of tobacco prod13 ucts; 

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

15 informed, to require tobacco product manufacturers to 

16 disclose research which has not previously been made 

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

18 relating to the health and dependency effects or safety 

19 of tobacco products; 

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

21 products to adults in conjunction with measures to 

22 ensure that they are not sold or accessible to underage 

23 purchasers; 

24 (8) to impose appropriate regulatory controls on 

25 the tobacco industry; 


erowe on PROD1PC71 with BILLS
19 

•HR 1108 RH

1 (9) to promote cessation to reduce disease risk 

2 and the social costs associated with tobacco-related 

3 diseases; and 

4 (10) to strengthen legislation against illicit trade 

5 in tobacco products. 

6 SEC. 4. SCOPE AND EFFECT. 

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

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

9 (1) establish a precedent with regard to any 

10 other industry, situation, circumstance, or legal ac11 tion; or 

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

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

14 contract of any kind. 

15 (b) AGRICULTURAL ACTIVITIES.—The provisions of 

16 this Act (or an amendment made by this Act) which author17 ize the Secretary to take certain actions with regard to to18 bacco and tobacco products shall not be construed to affect 

19 any authority of the Secretary of Agriculture under existing 

20 law regarding the growing, cultivation, or curing of raw 

21 tobacco. 

22 (c) REVENUE ACTIVITIES.—The provisions of this Act 

23 (or an amendment made by this Act) which authorize the 

24 Secretary to take certain actions with regard to tobacco 

25 products shall not be construed to affect any authority of 


erowe on PROD1PC71 with BILLS
20 

•HR 1108 RH

1 the Secretary of the Treasury under chapter 52 of the Inter2 nal Revenue Code of 1986. 

3 SEC. 5. SEVERABILITY. 

4 If any provision of this Act, the amendments made by 

5 this Act, or the application of any provision of this Act 

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

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

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

9 other person or circumstance shall not be affected and shall 

10 continue to be enforced to the fullest extent possible. 

11 TITLE I—AUTHORITY OF THE 

12 FOOD AND DRUG ADMINIS13 TRATION 

14 SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COS15 METIC ACT. 

16 (a) DEFINITION OF TOBACCO PRODUCTS.—Section 

17 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

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

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

20 made or derived from tobacco that is intended for human 

21 consumption, including any component, part, or accessory 

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

23 tobacco used in manufacturing a component, part, or acces24 sory of a tobacco product). 


erowe on PROD1PC71 with BILLS
21 

•HR 1108 RH

1 ‘‘(2) The term ‘tobacco product’ does not mean an arti2 cle that is a drug under subsection (g)(1), a device under 

3 subsection (h), or a combination product described in sec4 tion 503(g). 

5 ‘‘(3) The products described in paragraph (2) shall be 

6 subject to chapter V of this Act. 

7 ‘‘(4) A tobacco product may not be marketed in com8 bination with any other article or product regulated under 

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

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

11 (b) FDA AUTHORITY OVER TOBACCO PRODUCTS.— 

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

13 et seq.) is amended— 

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

15 (2) by redesignating sections 901 through 910 as 

16 sections 1001 through 1010; and 

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

18 ‘‘CHAPTER IX—TOBACCO PRODUCTS 

19 ‘‘SEC. 900. DEFINITIONS. 

20 ‘‘In this chapter: 

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

22 substance the intended use of which results or may 

23 reasonably be expected to result, directly or indirectly, 

24 in its becoming a component or otherwise affecting 

25 the characteristic of any tobacco product (including 


erowe on PROD1PC71 with BILLS
22 

•HR 1108 RH

1 any substances intended for use as a flavoring or 

2 coloring or in producing, manufacturing, packing, 

3 processing, preparing, treating, packaging, trans4 porting, or holding), except that such term does not 

5 include tobacco or a pesticide chemical residue in or 

6 on raw tobacco or a pesticide chemical. 

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

8 of tobacco product distinguished by the tobacco used, 

9 tar content, nicotine content, flavoring used, size, fil10 tration, packaging, logo, registered trademark, brand 

11 name, identifiable pattern of colors, or any combina12 tion of such attributes. 

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

14 ‘‘(A) means a product that— 

15 ‘‘(i) is a tobacco product; and 

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

17 ‘cigarette’ in section 3(1) of the Federal Cig18 arette Labeling and Advertising Act; and 

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

20 functional in the product, which, because of its 

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

22 or its packaging and labeling, is likely to be of23 fered to, or purchased by, consumers as a ciga24 rette or as roll-your-own tobacco. 


erowe on PROD1PC71 with BILLS
23 

•HR 1108 RH

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

2 tobacco’ means any product that consists of loose to3 bacco that is intended for use by consumers in a ciga4 rette. Unless otherwise stated, the requirements appli5 cable to cigarettes under this chapter shall also apply 

6 to cigarette tobacco. 

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

8 meaning given that term by section 3(2) of the Fed9 eral Cigarette Labeling and Advertising Act. 

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

11 term ‘counterfeit tobacco product’ means a tobacco 

12 product (or the container or labeling of such a prod13 uct) that, without authorization, bears the trademark, 

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

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

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

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

18 regards a tobacco product means any person who fur19 thers the distribution of a tobacco product, whether 

20 domestic or imported, at any point from the original 

21 place of manufacture to the person who sells or dis22 tributes the product to individuals for personal con23 sumption. Common carriers are not considered dis24 tributors for purposes of this chapter. 


erowe on PROD1PC71 with BILLS
24 

•HR 1108 RH

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

2 means any practice or conduct prohibited by law 

3 which relates to production, shipment, receipt, posses4 sion, distribution, sale, or purchase of tobacco prod5 ucts including any practice or conduct intended to fa6 cilitate such activity. 

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

8 the meaning given such term in section 4(e) of the In9 dian Self-Determination and Education Assistance 

10 Act. 

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

12 means a product that— 

13 ‘‘(A) is a tobacco product; and 

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

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

16 Labeling and Advertising Act. 

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

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

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

20 complex of nicotine. 

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

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

23 other container, any wrapping (including cellophane), 

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

25 otherwise distributed to consumers. 


erowe on PROD1PC71 with BILLS
25 

•HR 1108 RH

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

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

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

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

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

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

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

10 or purchased by, consumers as tobacco for making 

11 cigarettes. 

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

15 employs fewer than 350 employees. For purposes of 

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

18 a manufacturer are deemed to include the employees 

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

20 under common control with such manufacturer. 

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

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

24 that either transfers from any component of the ciga25 rette to the smoke or that is formed by the combustion 


erowe on PROD1PC71 with BILLS
26 

•HR 1108 RH

1 or heating of tobacco, additives, or other component of 

2 the tobacco product. 

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

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

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

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

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

9 terms in section 201. 

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

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

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

14 processes, or labels a tobacco product; or 

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

16 sale or distribution in the United States. 

17 ‘‘(20) TOBACCO WAREHOUSE.— 

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

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

21 ‘‘(i) who— 

22 ‘‘(I) removes foreign material 

23 from tobacco leaf through nothing other 

24 than a mechanical process; 


erowe on PROD1PC71 with BILLS
27 

•HR 1108 RH

1 ‘‘(II) humidifies tobacco leaf with 

2 nothing other than potable water in the 

3 form of steam or mist; or 

4 ‘‘(III) de-stems, dries, and packs 

5 tobacco leaf for storage and shipment; 

6 ‘‘(ii) who performs no other actions 

7 with respect to tobacco leaf; and 

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

10 information related to the person’s actions 

11 described in clause (i) that is necessary for 

12 compliance with this Act. 

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

14 any person who— 

15 ‘‘(i) reconstitutes tobacco leaf; 

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

17 retailer of a tobacco product; or 

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

19 or substance to the tobacco leaf other than 

20 potable water in the form of steam or mist. 

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

22 warehouse’ in subparagraph (A) shall not apply 

23 to the extent to which the Secretary determines, 

24 through rulemaking, that regulation under this 

25 chapter of the actions described in such subparaVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00027 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
28 

•HR 1108 RH

1 graph is appropriate for the protection of the 

2 public health. 

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

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

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

7 American Samoa, Wake Island, Midway Islands, 

8 Kingman Reef, Johnston Atoll, the Northern Mariana 

9 Islands, and any other trust territory or possession of 

10 the United States. 

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

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

13 modified risk tobacco products for which an order has been 

14 issued in accordance with section 911, shall be regulated 

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

16 to the provisions of chapter V. 

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

18 cigarettes, cigarette tobacco, and smokeless tobacco and to 

19 any other tobacco products that the Secretary by regulation 

20 deems to be subject to this chapter. 

21 ‘‘(c) SCOPE.— 

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

23 any policy issued or regulation promulgated there24 under, or in sections 101(a), 102, or 103 of title I, 

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


erowe on PROD1PC71 with BILLS
29 

•HR 1108 RH

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

2 expand, or limit the Secretary’s authority over (in3 cluding the authority to determine whether products 

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

5 under this Act that are not tobacco products under 

6 chapter V or any other chapter. 

7 ‘‘(2) LIMITATION OF AUTHORITY.— 

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

9 chapter shall not apply to tobacco leaf that is not 

10 in the possession of a manufacturer of tobacco 

11 products, or to the producers of tobacco leaf, in12 cluding tobacco growers, tobacco warehouses, and 

13 tobacco grower cooperatives, nor shall any em14 ployee of the Food and Drug Administration 

15 have any authority to enter onto a farm owned 

16 by a producer of tobacco leaf without the written 

17 consent of such producer. 

18 ‘‘(B) EXCEPTION.—Notwithstanding sub19 paragraph (A), if a producer of tobacco leaf is 

20 also a tobacco product manufacturer or con21 trolled by a tobacco product manufacturer, the 

22 producer shall be subject to this chapter in the 

23 producer’s capacity as a manufacturer. The ex24 ception in this subparagraph shall not apply to 

25 a producer of tobacco leaf who grows tobacco 


erowe on PROD1PC71 with BILLS
30 

•HR 1108 RH

1 under a contract with a tobacco product manu2 facturer and who is not otherwise engaged in the 

3 manufacturing process. 

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

5 this chapter shall be construed to grant the Sec6 retary authority to promulgate regulations on 

7 any matter that involves the production of to8 bacco leaf or a producer thereof, other than ac9 tivities by a manufacturer affecting production. 

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

11 under this chapter shall be in accordance with chapter 5 

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

13 construed to affect the rulemaking provisions of section 

14 102(a) of the Family Smoking Prevention and Tobacco 

15 Control Act. 

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

17 than 90 days after the date of enactment of this chapter, 

18 the Secretary shall establish within the Food and Drug Ad19 ministration the Center for Tobacco Products, which shall 

20 report to the Commissioner of Food and Drugs in the same 

21 manner as the other agency centers within the Food and 

22 Drug Administration. The Center shall be responsible for 

23 the implementation of this chapter and related matters as24 signed by the Commissioner. 


erowe on PROD1PC71 with BILLS
31 

•HR 1108 RH

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

2 MANUFACTURERS.—The Secretary shall establish within 

3 the Food and Drug Administration an identifiable office 

4 to provide technical and other nonfinancial assistance to 

5 small tobacco product manufacturers to assist them in com6 plying with the requirements of this Act. 

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

8 to promulgating rules under this chapter, the Secretary 

9 shall endeavor to consult with other Federal agencies as ap10 propriate. 

11 ‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS. 

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

13 if— 

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

15 putrid, or decomposed substance, or is otherwise con16 taminated by any added poisonous or added delete17 rious substance that may render the product injurious 

18 to health; 

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

20 insanitary conditions whereby it may have been con21 taminated with filth, or whereby it may have been 

22 rendered injurious to health; 

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

24 part, of any poisonous or deleterious substance which 

25 may render the contents injurious to health; 


erowe on PROD1PC71 with BILLS
32 

•HR 1108 RH

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

2 product fails to pay a user fee assessed to such manu3 facturer or importer pursuant to section 919 by the 

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

5 final agency action on a resolution of any dispute as 

6 to the amount of such fee; 

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

8 a tobacco product which is subject to a tobacco prod9 uct standard established under section 907 unless such 

10 tobacco product is in all respects in conformity with 

11 such standard; 

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

13 premarket review and does not have an order in effect 

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

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

16 910(c)(1)(A); 

17 ‘‘(7) the methods used in, or the facilities or con18 trols used for, its manufacture, packing, or storage 

19 are not in conformity with applicable requirements 

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

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

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

23 ‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS. 

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

25 to be misbranded— 


erowe on PROD1PC71 with BILLS
33 

•HR 1108 RH

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

2 particular; 

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

4 containing— 

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

6 tobacco product manufacturer, packer, or dis7 tributor; 

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

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

10 numerical count; 

11 ‘‘(C) an accurate statement of the percent12 age of the tobacco used in the product that is do13 mestically grown tobacco and the percentage that 

14 is foreign grown tobacco; and 

15 ‘‘(D) the statement required under section 

16 920(a), 

17 except that under subparagraph (B) reasonable vari18 ations shall be permitted, and exemptions as to small 

19 packages shall be established, by regulations pre20 scribed by the Secretary; 

21 ‘‘(3) if any word, statement, or other informa22 tion required by or under authority of this chapter to 

23 appear on the label or labeling is not prominently 

24 placed thereon with such conspicuousness (as com25 pared with other words, statements, or designs in the 


erowe on PROD1PC71 with BILLS
34 

•HR 1108 RH

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

2 be read and understood by the ordinary individual 

3 under customary conditions of purchase and use; 

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

5 label bears, to the exclusion of any other nonpropri6 etary name, its established name prominently printed 

7 in type as required by the Secretary by regulation; 

8 ‘‘(5) if the Secretary has issued regulations re9 quiring that its labeling bear adequate directions for 

10 use, or adequate warnings against use by children, 

11 that are necessary for the protection of users unless its 

12 labeling conforms in all respects to such regulations; 

13 ‘‘(6) if it was manufactured, prepared, propa14 gated, compounded, or processed in an establishment 

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

16 905(d), or 905(h), if it was not included in a list re17 quired by section 905(i), if a notice or other informa18 tion respecting it was not provided as required by 

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

20 such symbols from the uniform system for identifica21 tion of tobacco products prescribed under section 

22 905(e) as the Secretary by regulation requires; 

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


erowe on PROD1PC71 with BILLS
35 

•HR 1108 RH

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

2 in any particular; or 

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

4 regulations prescribed under section 906(d); 

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

6 distributed or offered for sale in any State, the manu7 facturer, packer, or distributor thereof includes in all 

8 advertisements and other descriptive printed matter 

9 issued or caused to be issued by the manufacturer, 

10 packer, or distributor with respect to that tobacco 

11 product— 

12 ‘‘(A) a true statement of the tobacco prod13 uct’s established name as described in paragraph 

14 (4), printed prominently; and 

15 ‘‘(B) a brief statement of— 

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

17 relevant warnings, precautions, side effects, 

18 and contraindications; and 

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

20 products made subject to a finding by the 

21 Secretary after notice and opportunity for 

22 comment that such action is appropriate to 

23 protect the public health, a full description 

24 of the components of such tobacco product or 

25 the formula showing quantitatively each inVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00035 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
36 

•HR 1108 RH

1 gredient of such tobacco product to the ex2 tent required in regulations which shall be 

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

5 ‘‘(9) if it is a tobacco product subject to a to6 bacco product standard established under section 907, 

7 unless it bears such labeling as may be prescribed in 

8 such tobacco product standard; or 

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

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

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

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

15 Secretary may, by regulation, require prior approval of 

16 statements made on the label of a tobacco product. No regu17 lation issued under this subsection may require prior ap18 proval by the Secretary of the content of any advertisement, 

19 except for modified risk tobacco products as provided in sec20 tion 911. No advertisement of a tobacco product published 

21 after the date of enactment of the Family Smoking Preven22 tion and Tobacco Control Act shall, with respect to the lan23 guage of label statements as prescribed under section 4 of 

24 the Federal Cigarette Labeling and Advertising Act and sec25 tion 3 of the Comprehensive Smokeless Tobacco Health EduVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00036 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
37 

•HR 1108 RH

1 cation Act of 1986 or the regulations issued under such sec2 tions, be subject to the provisions of sections 12 through 15 

3 of the Federal Trade Commission Act. 

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

5 SECRETARY. 

6 ‘‘(a) REQUIREMENT.—Each tobacco product manufac7 turer or importer, or agents thereof, shall submit to the Sec8 retary the following information: 

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

10 enactment of the Family Smoking Prevention and To11 bacco Control Act, a listing of all ingredients, includ12 ing tobacco, substances, compounds, and additives 

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

14 to the tobacco, paper, filter, or other part of each to15 bacco product by brand and by quantity in each 

16 brand and subbrand. 

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

18 form of nicotine in each tobacco product measured in 

19 milligrams of nicotine in accordance with regulations 

20 promulgated by the Secretary in accordance with sec21 tion 4(e) of the Federal Cigarette Labeling and Adver22 tising Act. 

23 ‘‘(3) Beginning 3 years after the date of enact24 ment of this Act, a listing of all constituents, includ25 ing smoke constituents as applicable, identified by the 


erowe on PROD1PC71 with BILLS
38 

•HR 1108 RH

1 Secretary as harmful or potentially harmful to health 

2 in each tobacco product, and as applicable in the 

3 smoke of each tobacco product, by brand and by 

4 quantity in each brand and subbrand. Effective be5 ginning 3 years after the date of enactment of this 

6 chapter, the manufacturer, importer, or agent shall 

7 comply with regulations promulgated under section 

8 915 in reporting information under this paragraph, 

9 where applicable. 

10 ‘‘(4) Beginning 6 months after the date of enact11 ment of the Family Smoking Prevention and Tobacco 

12 Control Act, all documents developed after the date of 

13 enactment of the Family Smoking Prevention and To14 bacco Control Act that relate to health, toxicological, 

15 behavioral, or physiologic effects of current or future 

16 tobacco products, their constituents (including smoke 

17 constituents), ingredients, components, and additives. 

18 ‘‘(b) DATA SUBMISSION.—At the request of the Sec19 retary, each tobacco product manufacturer or importer of 

20 tobacco products, or agents thereof, shall submit the fol21 lowing: 

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

23 scientific information) relating to research activities, 

24 and research findings, conducted, supported, or pos25 sessed by the manufacturer (or agents thereof) on the 


erowe on PROD1PC71 with BILLS
39 

•HR 1108 RH

1 health, toxicological, behavioral, or physiologic effects 

2 of tobacco products and their constituents (including 

3 smoke constituents), ingredients, components, and ad4 ditives. 

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

6 scientific information) relating to research activities, 

7 and research findings, conducted, supported, or pos8 sessed by the manufacturer (or agents thereof) that re9 late to the issue of whether a reduction in risk to 

10 health from tobacco products can occur upon the em11 ployment of technology available or known to the 

12 manufacturer. 

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

14 scientific or financial information) relating to mar15 keting research involving the use of tobacco products 

16 or marketing practices and the effectiveness of such 

17 practices used by tobacco manufacturers and distribu18 tors. 

19 An importer of a tobacco product not manufactured in the 

20 United States shall supply the information required of a 

21 tobacco product manufacturer under this subsection. 

22 ‘‘(c) TIME FOR SUBMISSION.— 

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

24 delivery for introduction into interstate commerce of 

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


erowe on PROD1PC71 with BILLS
40 

•HR 1108 RH

1 enactment of the Family Smoking Prevention and To2 bacco Control Act, the manufacturer of such product 

3 shall provide the information required under sub4 section (a). 

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

6 a tobacco product manufacturer adds to its tobacco 

7 products a new tobacco additive or increases the 

8 quantity of an existing tobacco additive, the manufac9 turer shall, except as provided in paragraph (3), at 

10 least 90 days prior to such action so advise the Sec11 retary in writing. 

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

13 any time a tobacco product manufacturer eliminates 

14 or decreases an existing additive, or adds or increases 

15 an additive that has by regulation been designated by 

16 the Secretary as an additive that is not a human or 

17 animal carcinogen, or otherwise harmful to health 

18 under intended conditions of use, the manufacturer 

19 shall within 60 days of such action so advise the Sec20 retary in writing. 

21 ‘‘(d) DATA LIST.— 

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

23 the date of enactment of the Family Smoking Preven24 tion and Tobacco Control Act, and annually there25 after, the Secretary shall publish in a format that is 


erowe on PROD1PC71 with BILLS
41 

•HR 1108 RH

1 understandable and not misleading to a lay person, 

2 and place on public display (in a manner determined 

3 by the Secretary) the list established under subsection 

4 (e). 

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

6 shall conduct periodic consumer research to ensure 

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

8 misleading to lay persons. Not later than 5 years 

9 after the date of enactment of the Family Smoking 

10 Prevention and Tobacco Control Act, the Secretary 

11 shall submit to the appropriate committees of Con12 gress a report on the results of such research, together 

13 with recommendations on whether such publication 

14 should be continued or modified. 

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

16 after the date of enactment of the Family Smoking Preven17 tion and Tobacco Control Act, the Secretary shall establish, 

18 and periodically revise as appropriate, a list of harmful 

19 and potentially harmful constituents, including smoke con20 stituents, to health in each tobacco product by brand and 

21 by quantity in each brand and subbrand. The Secretary 

22 shall publish a public notice requesting the submission by 

23 interested persons of scientific and other information con24 cerning the harmful and potentially harmful constituents 

25 in tobacco products and tobacco smoke. 


erowe on PROD1PC71 with BILLS
42 

•HR 1108 RH

1 ‘‘SEC. 905. ANNUAL REGISTRATION. 

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

3 ‘‘(1) MANUFACTURE, PREPARATION, 

4 COMPOUNDING, OR PROCESSING.—The term 

5 ‘manufacture, preparation, compounding, or proc6 essing’ shall include repackaging or otherwise chang7 ing the container, wrapper, or labeling of any tobacco 

8 product package in furtherance of the distribution of 

9 the tobacco product from the original place of manu10 facture to the person who makes final delivery or sale 

11 to the ultimate consumer or user. 

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

13 the case of a partnership the name of each partner 

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

15 corporate officer and director, and the State of incor16 poration. 

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

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

19 owns or operates any establishment in any State engaged 

20 in the manufacture, preparation, compounding, or proc21 essing of a tobacco product or tobacco products shall register 

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

23 establishments of that person. If the enactment of this Act 

24 occurs in the second half of the calendar year, the Secretary 

25 shall designate a date no later than 6 months into the subseVerDate Aug 31 2005 02:23 Jul 18, 2008 Jkt 069200 PO 00000 Frm 00042 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
43 

•HR 1108 RH

1 quent calendar year by which registration pursuant to this 

2 subsection shall occur. 

3 ‘‘(c) REGISTRATION BY NEW OWNERS AND OPERA4 TORS.—Every person upon first engaging in the manufac5 ture, preparation, compounding, or processing of a tobacco 

6 product or tobacco products in any establishment owned or 

7 operated in any State by that person shall immediately reg8 ister with the Secretary that person’s name, place of busi9 ness, and such establishment. 

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

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

12 (c) shall immediately register with the Secretary any addi13 tional establishment which that person owns or operates in 

14 any State and in which that person begins the manufacture, 

15 preparation, compounding, or processing of a tobacco prod16 uct or tobacco products. 

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

18 The Secretary may by regulation prescribe a uniform sys19 tem for the identification of tobacco products and may re20 quire that persons who are required to list such tobacco 

21 products under subsection (i) shall list such tobacco prod22 ucts in accordance with such system. 

23 ‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA24 TION.—The Secretary shall make available for inspection, 


erowe on PROD1PC71 with BILLS
44 

•HR 1108 RH

1 to any person so requesting, any registration filed under 

2 this section. 

3 ‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB4 LISHMENTS.—Every establishment registered with the Sec5 retary under this section shall be subject to inspection under 

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

7 engaged in the manufacture, compounding, or processing 

8 of a tobacco product or tobacco products shall be so in9 spected by 1 or more officers or employees duly designated 

10 by the Secretary at least once in the 2-year period begin11 ning with the date of registration of such establishment 

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

13 year period thereafter. 

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

15 Any establishment within any foreign country engaged in 

16 the manufacture, preparation, compounding, or processing 

17 of a tobacco product or tobacco products, shall register 

18 under this section under regulations promulgated by the 

19 Secretary. Such regulations shall require such establishment 

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

21 shall include provisions for registration of any such estab22 lishment upon condition that adequate and effective means 

23 are available, by arrangement with the government of such 

24 foreign country or otherwise, to enable the Secretary to de25 termine from time to time whether tobacco products manuVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00044 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
45 

•HR 1108 RH

1 factured, prepared, compounded, or processed in such estab2 lishment, if imported or offered for import into the United 

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

4 set forth in section 801(a). 

5 ‘‘(i) REGISTRATION INFORMATION.— 

6 ‘‘(1) PRODUCT LIST.—Every person who reg7 isters with the Secretary under subsection (b), (c), (d), 

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

9 such subsection, file with the Secretary a list of all to10 bacco products which are being manufactured, pre11 pared, compounded, or processed by that person for 

12 commercial distribution and which have not been in13 cluded in any list of tobacco products filed by that 

14 person with the Secretary under this paragraph or 

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

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

17 Secretary may prescribe and shall be accompanied 

18 by— 

19 ‘‘(A) in the case of a tobacco product con20 tained in the applicable list with respect to 

21 which a tobacco product standard has been estab22 lished under section 907 or which is subject to 

23 section 910, a reference to the authority for the 

24 marketing of such tobacco product and a copy of 

25 all labeling for such tobacco product; 


erowe on PROD1PC71 with BILLS
46 

•HR 1108 RH

1 ‘‘(B) in the case of any other tobacco prod2 uct contained in an applicable list, a copy of all 

3 consumer information and other labeling for 

4 such tobacco product, a representative sampling 

5 of advertisements for such tobacco product, and, 

6 upon request made by the Secretary for good 

7 cause, a copy of all advertisements for a par8 ticular tobacco product; and 

9 ‘‘(C) if the registrant filing a list has deter10 mined that a tobacco product contained in such 

11 list is not subject to a tobacco product standard 

12 established under section 907, a brief statement 

13 of the basis upon which the registrant made such 

14 determination if the Secretary requests such a 

15 statement with respect to that particular tobacco 

16 product. 

17 ‘‘(2) CONSULTATION WITH RESPECT TO

18 FORMS.—The Secretary shall consult with the Sec19 retary of the Treasury in developing the forms to be 

20 used for registration under this section to minimize 

21 the burden on those persons required to register with 

22 both the Secretary and the Tax and Trade Bureau of 

23 the Department of the Treasury. 

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

25 PRODUCT LIST.—Each person who registers with the 


erowe on PROD1PC71 with BILLS
47 

•HR 1108 RH

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 year 

4 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 pre8 viously filed by that person with the Secretary 

9 under this subparagraph or paragraph (1). A 

10 list under this subparagraph shall list a tobacco 

11 product by its established name and shall be ac12 companied by the other information required by 

13 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 reported 

24 under subparagraph (B) a notice of discontinu25 ance that person has resumed the manufacture, 


erowe on PROD1PC71 with BILLS
48 

•HR 1108 RH

1 preparation, compounding, or processing for 

2 commercial distribution of the tobacco product 

3 with respect to which such notice of discontinu4 ance was reported, notice of such resumption, the 

5 date of such resumption, the identity of such to6 bacco product by established name, and other in7 formation required by paragraph (1), unless the 

8 registrant has previously reported such resump9 tion to the Secretary under this subparagraph. 

10 ‘‘(D) Any material change in any informa11 tion previously submitted under this paragraph 

12 or paragraph (1). 

13 ‘‘(j) REPORT PRECEDING INTRODUCTION OF CERTAIN

14 SUBSTANTIALLY EQUIVALENT PRODUCTS INTO INTER15 STATE COMMERCE.— 

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

17 to register under this section and who proposes to 

18 begin the introduction or delivery for introduction 

19 into interstate commerce for commercial distribution 

20 of a tobacco product intended for human use that was 

21 not commercially marketed (other than for test mar22 keting) in the United States as of February 15, 2007, 

23 shall, at least 90 days prior to making such introduc24 tion or delivery, report to the Secretary (in such form 

25 and manner as the Secretary shall prescribe)— 


erowe on PROD1PC71 with BILLS
49 

•HR 1108 RH

1 ‘‘(A) the basis for such person’s determina2 tion that— 

3 ‘‘(i) the tobacco product is substan4 tially equivalent, within the meaning of sec5 tion 910, to a tobacco product commercially 

6 marketed (other than for test marketing) in 

7 the United States as of February 15, 2007, 

8 or to a tobacco product that the Secretary 

9 has previously determined, pursuant to sub10 section (a)(3) of section 910, is substantially 

11 equivalent and that is in compliance with 

12 the requirements of this Act; or 

13 ‘‘(ii) the tobacco product is modified 

14 within the meaning of paragraph (3), the 

15 modifications are to a product that is com16 mercially marketed and in compliance with 

17 the requirements of this Act, and all of the 

18 modifications are covered by exemptions 

19 granted by the Secretary pursuant to para20 graph (3); and 

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

22 with the requirements under section 907 that are 

23 applicable to the tobacco product. 

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

25 15, 2007, PRODUCTS.—A report under this subsection 


erowe on PROD1PC71 with BILLS
50 

•HR 1108 RH

1 for a tobacco product that was first introduced or de2 livered for introduction into interstate commerce for 

3 commercial distribution in the United States after 

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

5 months after the date of enactment of the Family 

6 Smoking Prevention and Tobacco Control Act shall be 

7 submitted to the Secretary not later than 21 months 

8 after such date of enactment. 

9 ‘‘(3) EXEMPTIONS.— 

10 ‘‘(A) IN GENERAL.—The Secretary may ex11 empt from the requirements of this subsection re12 lating to the demonstration that a tobacco prod13 uct is substantially equivalent within the mean14 ing of section 910, tobacco products that are 

15 modified by adding or deleting a tobacco addi16 tive, or increasing or decreasing the quantity of 

17 an existing tobacco additive, if the Secretary de18 termines that— 

19 ‘‘(i) such modification would be a 

20 minor modification of a tobacco product 

21 that can be sold under this Act; 

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

23 not necessary to ensure that permitting the 

24 tobacco product to be marketed would be apVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00050 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
51 

•HR 1108 RH

1 propriate for protection of the public health; 

2 and 

3 ‘‘(iii) an exemption is otherwise appro4 priate. 

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

6 months after the date of enactment of the Family 

7 Smoking Prevention and Tobacco Control Act, 

8 the Secretary shall issue regulations to imple9 ment this paragraph. 

10 ‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL 

11 OF TOBACCO PRODUCTS. 

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

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

14 product shall apply to such tobacco product until the appli15 cability of the requirement to the tobacco product has been 

16 changed by action taken under section 907, section 910, sec17 tion 911, or subsection (d) of this section, and any require18 ment established by or under section 902, 903, 905, or 909 

19 which is inconsistent with a requirement imposed on such 

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

21 or subsection (d) of this section shall not apply to such to22 bacco product. 

23 ‘‘(b) INFORMATION ON PUBLIC ACCESS AND COM24 MENT.—Each notice of proposed rulemaking or other notifi25 cation under section 907, 908, 909, 910, or 911 or under 


erowe on PROD1PC71 with BILLS
52 

•HR 1108 RH

1 this section, any other notice which is published in the Fed2 eral Register with respect to any other action taken under 

3 any such section and which states the reasons for such ac4 tion, and each publication of findings required to be made 

5 in connection with rulemaking under any such section shall 

6 set forth— 

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

8 examine data and other information on which the no9 tice or findings is based; and 

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

11 may present their comments on the notice or findings 

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

13 which period shall be at least 60 days but may not 

14 exceed 90 days unless the time is extended by the Sec15 retary by a notice published in the Federal Register 

16 stating good cause therefore. 

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

18 Any information reported to or otherwise obtained by the 

19 Secretary or the Secretary’s representative under section 

20 903, 904, 907, 908, 909, 910, 911, or 704, or under sub21 section (e) or (f) of this section, which is exempt from disclo22 sure under subsection (a) of section 552 of title 5, United 

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

24 shall be considered confidential and shall not be disclosed, 

25 except that the information may be disclosed to other offiVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00052 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
53 

•HR 1108 RH

1 cers or employees concerned with carrying out this chapter, 

2 or when relevant in any proceeding under this chapter. 

3 ‘‘(d) RESTRICTIONS.— 

4 ‘‘(1) IN GENERAL.—The Secretary may by regu5 lation require restrictions on the sale and distribution 

6 of a tobacco product, including restrictions on the ac7 cess to, and the advertising and promotion of, the to8 bacco product, if the Secretary determines that such 

9 regulation would be appropriate for the protection of 

10 the public health. The Secretary may by regulation 

11 impose restrictions on the advertising and promotion 

12 of a tobacco product consistent with and to full extent 

13 permitted by the first amendment to the Constitution. 

14 The finding as to whether such regulation would be 

15 appropriate for the protection of the public health 

16 shall be determined with respect to the risks and bene17 fits to the population as a whole, including users and 

18 nonusers of the tobacco product, and taking into ac19 count— 

20 ‘‘(A) the increased or decreased likelihood 

21 that existing users of tobacco products will stop 

22 using such products; and 

23 ‘‘(B) the increased or decreased likelihood 

24 that those who do not use tobacco products will 

25 start using such products. 


erowe on PROD1PC71 with BILLS
54 

•HR 1108 RH

1 No such regulation may require that the sale or dis2 tribution of a tobacco product be limited to the writ3 ten or oral authorization of a practitioner licensed by 

4 law to prescribe medical products. 

5 ‘‘(2) LABEL STATEMENTS.—The label of a to6 bacco product shall bear such appropriate statements 

7 of the restrictions required by a regulation under sub8 section (a) as the Secretary may in such regulation 

9 prescribe. 

10 ‘‘(3) LIMITATIONS.— 

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

12 paragraph (1) may— 

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

14 product in face-to-face transactions by a 

15 specific category of retail outlets; or 

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

17 of tobacco products to any person older than 

18 18 years of age. 

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

20 regulations issued by the Secretary, matchbooks 

21 of conventional size containing not more than 20 

22 paper matches, and which are customarily given 

23 away for free with the purchase of tobacco prod24 ucts, shall be considered as adult-written publi25 cations which shall be permitted to contain adVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00054 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
55 

•HR 1108 RH

1 vertising. Notwithstanding the preceding sen2 tence, if the Secretary finds that such treatment 

3 of matchbooks is not appropriate for the protec4 tion of the public health, the Secretary may de5 termine by regulation that matchbooks shall not 

6 be considered adult-written publications. 

7 ‘‘(4) REMOTE SALES.— 

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

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

10 enactment of this chapter, promulgate regu11 lations regarding the sale and distribution 

12 of tobacco products that occur through 

13 means other than a direct, face-to-face ex14 change between a retailer and a consumer 

15 in order to prevent the sale and distribution 

16 of tobacco products to individuals who have 

17 not attained the minimum age established 

18 by applicable law for the purchase of such 

19 products, including requirements for age 

20 verification; and 

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

22 enactment, issue regulations to address the 

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

25 means other than a direct, face-to-face exVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00055 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
56 

•HR 1108 RH

1 change between a retailer and a consumer 

2 in order to protect individuals who have not 

3 attained the minimum age established by 

4 applicable law for the purchase of such 

5 products. 

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

7 Nothing in this paragraph limits the authority 

8 of the Secretary to take additional actions under 

9 the other paragraphs of this subsection. 

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

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

13 CONFORM.— 

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

16 in accordance with subparagraph (B), prescribe 

17 regulations (which may differ based on the type 

18 of tobacco product involved) requiring that the 

19 methods used in, and the facilities and controls 

20 used for, the manufacture, preproduction design 

21 validation (including a process to assess the per22 formance of a tobacco product), packing, and 

23 storage of a tobacco product conform to current 

24 good manufacturing practice, or hazard analysis 

25 and critical control point methodology, as preVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00056 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
57 

•HR 1108 RH

1 scribed in such regulations to assure that the 

2 public health is protected and that the tobacco 

3 product is in compliance with this chapter. Such 

4 regulations may provide for the testing of raw 

5 tobacco for pesticide chemical residues regardless 

6 of whether a tolerance for such chemical residues 

7 has been established. 

8 ‘‘(B) REQUIREMENTS.—The Secretary 

9 shall— 

10 ‘‘(i) before promulgating any regula11 tion under subparagraph (A), afford the To12 bacco Products Scientific Advisory Com13 mittee an opportunity to submit rec14 ommendations with respect to the regulation 

15 proposed to be promulgated; 

16 ‘‘(ii) before promulgating any regula17 tion under subparagraph (A), afford oppor18 tunity for an oral hearing; 

19 ‘‘(iii) provide the Tobacco Products 

20 Scientific Advisory Committee a reasonable 

21 time to make its recommendation with re22 spect to proposed regulations under sub23 paragraph (A); 

24 ‘‘(iv) in establishing the effective date 

25 of a regulation promulgated under this subVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00057 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
58 

•HR 1108 RH

1 section, take into account the differences in 

2 the manner in which the different types of 

3 tobacco products have historically been pro4 duced, the financial resources of the dif5 ferent tobacco product manufacturers, and 

6 the state of their existing manufacturing fa7 cilities, and shall provide for a reasonable 

8 period of time for such manufacturers to 

9 conform to good manufacturing practices; 

10 and 

11 ‘‘(v) not require any small tobacco 

12 product manufacturer to comply with a reg13 ulation under subparagraph (A) for at least 

14 4 years following the effective date estab15 lished by the Secretary for such regulation. 

16 ‘‘(2) EXEMPTIONS; VARIANCES.— 

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

18 requirement prescribed under paragraph (1) 

19 may petition the Secretary for a permanent or 

20 temporary exemption or variance from such re21 quirement. Such a petition shall be submitted to 

22 the Secretary in such form and manner as the 

23 Secretary shall prescribe and shall— 

24 ‘‘(i) in the case of a petition for an ex25 emption from a requirement, set forth the 


erowe on PROD1PC71 with BILLS
59 

•HR 1108 RH

1 basis for the petitioner’s determination that 

2 compliance with the requirement is not re3 quired to assure that the tobacco product 

4 will be in compliance with this chapter; 

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

6 variance from a requirement, set forth the 

7 methods proposed to be used in, and the fa8 cilities and controls proposed to be used for, 

9 the manufacture, packing, and storage of 

10 the tobacco product in lieu of the methods, 

11 facilities, and controls prescribed by the re12 quirement; and 

13 ‘‘(iii) contain such other information 

14 as the Secretary shall prescribe. 

15 ‘‘(B) REFERRAL TO THE TOBACCO PROD16 UCTS SCIENTIFIC ADVISORY COMMITTEE.—The 

17 Secretary may refer to the Tobacco Products Sci18 entific Advisory Committee any petition sub19 mitted under subparagraph (A). The Tobacco 

20 Products Scientific Advisory Committee shall re21 port its recommendations to the Secretary with 

22 respect to a petition referred to it within 60 days 

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

24 days after— 


erowe on PROD1PC71 with BILLS
60 

•HR 1108 RH

1 ‘‘(i) the date the petition was sub2 mitted to the Secretary under subparagraph 

3 (A); or 

4 ‘‘(ii) the day after the petition was re5 ferred to the Tobacco Products Scientific 

6 Advisory Committee, 

7 whichever occurs later, the Secretary shall by 

8 order either deny the petition or approve it. 

9 ‘‘(C) APPROVAL.—The Secretary may ap10 prove— 

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

12 tobacco product from a requirement if the 

13 Secretary determines that compliance with 

14 such requirement is not required to assure 

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

17 ‘‘(ii) a petition for a variance for a to18 bacco product from a requirement if the 

19 Secretary determines that the methods to be 

20 used in, and the facilities and controls to be 

21 used for, the manufacture, packing, and 

22 storage of the tobacco product in lieu of the 

23 methods, facilities, and controls prescribed 

24 by the requirement are sufficient to assure 


erowe on PROD1PC71 with BILLS
61 

•HR 1108 RH

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

3 ‘‘(D) CONDITIONS.—An order of the Sec4 retary approving a petition for a variance shall 

5 prescribe such conditions respecting the methods 

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

7 the manufacture, packing, and storage of the to8 bacco product to be granted the variance under 

9 the petition as may be necessary to assure that 

10 the tobacco product will be in compliance with 

11 this chapter. 

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

13 order under subparagraph (B) respecting a peti14 tion, the petitioner shall have an opportunity for 

15 an informal hearing on such order. 

16 ‘‘(3) COMPLIANCE.—Compliance with require17 ments under this subsection shall not be required be18 fore the end of the 3-year period following the date of 

19 enactment of the Family Smoking Prevention and To20 bacco Control Act. 

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

22 may enter into contracts for research, testing, and dem23 onstrations respecting tobacco products and may obtain to24 bacco products for research, testing, and demonstration pur25 poses. 


erowe on PROD1PC71 with BILLS
62 

•HR 1108 RH

1 ‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 

2 ‘‘(a) IN GENERAL.— 

3 ‘‘(1) SPECIAL RULES.— 

4 ‘‘(A) SPECIAL RULE FOR CIGARETTES.—Be5 ginning 3 months after the date of enactment of 

6 the Family Smoking Prevention and Tobacco 

7 Control Act, a cigarette or any of its component 

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

9 shall not contain, as a constituent (including a 

10 smoke constituent) or additive, an artificial or 

11 natural flavor (other than tobacco or menthol) or 

12 an herb or spice, including strawberry, grape, 

13 orange, clove, cinnamon, pineapple, vanilla, co14 conut, licorice, cocoa, chocolate, cherry, or coffee, 

15 that is a characterizing flavor of the tobacco 

16 product or tobacco smoke. Nothing in this sub17 paragraph shall be construed to limit the Sec18 retary’s authority to take action under this sec19 tion or other sections of this Act applicable to 

20 menthol or any artificial or natural flavor, herb, 

21 or spice not specified in this subparagraph. For 

22 purposes of this section, a cigarette or any of its 

23 component parts has a characterizing flavor if 

24 the cigarette, its tobacco smoke, or the component 

25 part imparts a distinguishable taste or aroma 

26 other than tobacco or menthol either prior to 


erowe on PROD1PC71 with BILLS
63 

•HR 1108 RH

1 consumption or during consumption, or is adver2 tised or marketed as having or producing a fla3 vor, taste, or aroma other than tobacco or men4 thol. 

5 ‘‘(B) ADDITIONAL SPECIAL RULE.—No to6 bacco product manufactured in or imported into 

7 the United States shall contain foreign-grown to8 bacco that— 

9 ‘‘(i) contains a level of any pesticide 

10 chemical residue in excess of any maximum 

11 permissible residue level that is applicable 

12 to domestically grown tobacco; or 

13 ‘‘(ii) was grown or processed using any 

14 pesticide chemical not approved under Fed15 eral law for use in domestic tobacco farm16 ing or processing. 

17 ‘‘(2) REVISION OF TOBACCO PRODUCT STAND18 ARDS.—The Secretary may revise the tobacco product 

19 standards in paragraph (1) in accordance with sub20 section (c). 

21 ‘‘(3) TOBACCO PRODUCT STANDARDS.— 

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

23 adopt tobacco product standards in addition to 

24 those in paragraph (1) if the Secretary finds 


erowe on PROD1PC71 with BILLS
64 

•HR 1108 RH

1 that a tobacco product standard is appropriate 

2 for the protection of the public health. 

3 ‘‘(B) DETERMINATIONS.— 

4 ‘‘(i) CONSIDERATIONS.—In making a 

5 finding described in subparagraph (A), the 

6 Secretary shall consider scientific evidence 

7 concerning— 

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

9 population as a whole, including users 

10 and nonusers of tobacco products, of 

11 the proposed standard; 

12 ‘‘(II) the increased or decreased 

13 likelihood that existing users of tobacco 

14 products will stop using such products; 

15 and 

16 ‘‘(III) the increased or decreased 

17 likelihood that those who do not use to18 bacco products will start using such 

19 products. 

20 ‘‘(ii) ADDITIONAL CONSIDERATIONS.— 

21 In the event that the Secretary makes a de22 termination, set forth in a proposed tobacco 

23 product standard in a proposed rule, that it 

24 is appropriate for the protection of public 

25 health to require the reduction or elimiVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00064 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
65 

•HR 1108 RH

1 nation of an additive, constituent (includ2 ing a smoke constituent), or other compo3 nent of a tobacco product because the Sec4 retary has found that the additive, con5 stituent, or other component is or may be 

6 harmful, any party objecting to the pro7 posed standard on the ground that the pro8 posed standard will not reduce or eliminate 

9 the risk of illness or injury may provide for 

10 the Secretary’s consideration scientific evi11 dence that demonstrates that the proposed 

12 standard will not reduce or eliminate the 

13 risk of illness or injury. 

14 ‘‘(4) CONTENT OF TOBACCO PRODUCT STAND15 ARDS.—A tobacco product standard established under 

16 this section for a tobacco product— 

17 ‘‘(A) shall include provisions that are ap18 propriate for the protection of the public health, 

19 including provisions, where appropriate— 

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

21 ‘‘(ii) for the reduction or elimination 

22 of other constituents, including smoke con23 stituents, or harmful components of the 

24 product; or 


erowe on PROD1PC71 with BILLS
66 

•HR 1108 RH

1 ‘‘(iii) relating to any other require2 ment under subparagraph (B); 

3 ‘‘(B) shall, where appropriate for the protec4 tion of the public health, include— 

5 ‘‘(i) provisions respecting the construc6 tion, components, ingredients, additives, 

7 constituents, including smoke constituents, 

8 and properties of the tobacco product; 

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

10 sample basis or, if necessary, on an indi11 vidual basis) of the tobacco product; 

12 ‘‘(iii) provisions for the measurement 

13 of the tobacco product characteristics of the 

14 tobacco product; 

15 ‘‘(iv) provisions requiring that the re16 sults of each or of certain of the tests of the 

17 tobacco product required to be made under 

18 clause (ii) show that the tobacco product is 

19 in conformity with the portions of the 

20 standard for which the test or tests were re21 quired; and 

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

23 and distribution of the tobacco product be 

24 restricted but only to the extent that the sale 

25 and distribution of a tobacco product may 


erowe on PROD1PC71 with BILLS
67 

•HR 1108 RH

1 be restricted under a regulation under sec2 tion 906(d); 

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

4 use and prescribe the form and content of label5 ing for the proper use of the tobacco product; and 

6 ‘‘(D) shall require tobacco products con7 taining foreign-grown tobacco to meet the same 

8 standards applicable to tobacco products con9 taining domestically grown tobacco. 

10 ‘‘(5) PERIODIC REEVALUATION OF TOBACCO

11 PRODUCT STANDARDS.—The Secretary shall provide 

12 for periodic evaluation of tobacco product standards 

13 established under this section to determine whether 

14 such standards should be changed to reflect new med15 ical, scientific, or other technological data. The Sec16 retary may provide for testing under paragraph 

17 (4)(B) by any person. 

18 ‘‘(6) INVOLVEMENT OF OTHER AGENCIES; IN19 FORMED PERSONS.—In carrying out duties under this 

20 section, the Secretary shall endeavor to— 

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

22 technical support available in other Federal 

23 agencies; 

24 ‘‘(B) consult with other Federal agencies 

25 concerned with standard setting and other naVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00067 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
68 

•HR 1108 RH

1 tionally or internationally recognized standard2 setting entities; and 

3 ‘‘(C) invite appropriate participation, 

4 through joint or other conferences, workshops, or 

5 other means, by informed persons representative 

6 of scientific, professional, industry, agricultural, 

7 or consumer organizations who in the Secretary’s 

8 judgment can make a significant contribution. 

9 ‘‘(b) CONSIDERATIONS BY SECRETARY.— 

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

11 shall consider information submitted in connection 

12 with a proposed standard regarding the technical 

13 achievability of compliance with such standard. 

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

15 shall consider all other information submitted in con16 nection with a proposed standard, including informa17 tion concerning the countervailing effects of the to18 bacco product standard on the health of adolescent to19 bacco users, adult tobacco users, or nontobacco users, 

20 such as the creation of a significant demand for con21 traband or other tobacco products that do not meet 

22 the requirements of this chapter and the significance 

23 of such demand. 

24 ‘‘(c) PROPOSED STANDARDS.— 


erowe on PROD1PC71 with BILLS
69 

•HR 1108 RH

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

2 in the Federal Register a notice of proposed rule3 making for the establishment, amendment, or revoca4 tion of any tobacco product standard. 

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

6 proposed rulemaking for the establishment or amend7 ment of a tobacco product standard for a tobacco 

8 product shall— 

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

10 justification that the tobacco product standard is 

11 appropriate for the protection of the public 

12 health; 

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

14 draft or proposed tobacco product standard for 

15 consideration by the Secretary; 

16 ‘‘(C) invite interested persons to submit 

17 comments on structuring the standard so that it 

18 does not advantage foreign-grown tobacco over 

19 domestically grown tobacco; and 

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

21 provide any information or analysis which the 

22 Secretary of Agriculture believes is relevant to 

23 the proposed tobacco product standard. 

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

25 for the revocation of a tobacco product standard shall 


erowe on PROD1PC71 with BILLS
70 

•HR 1108 RH

1 set forth a finding with supporting justification that 

2 the tobacco product standard is no longer appropriate 

3 for the protection of the public health. 

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

5 a comment period of not less than 60 days. 

6 ‘‘(d) PROMULGATION.— 

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

8 period for comment on a notice of proposed rule9 making published under subsection (c) respecting a 

10 tobacco product standard and after consideration of 

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

12 and any report from the Tobacco Products Scientific 

13 Advisory Committee, if the Secretary determines that 

14 the standard would be appropriate for the protection 

15 of the public health, the Secretary shall— 

16 ‘‘(A) promulgate a regulation establishing a 

17 tobacco product standard and publish in the 

18 Federal Register findings on the matters referred 

19 to in subsection (c); or 

20 ‘‘(B) publish a notice terminating the pro21 ceeding for the development of the standard to22 gether with the reasons for such termination. 

23 ‘‘(2) EFFECTIVE DATE.—A regulation estab24 lishing a tobacco product standard shall set forth the 

25 date or dates upon which the standard shall take efVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00070 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
71 

•HR 1108 RH

1 fect, but no such regulation may take effect before 1 

2 year after the date of its publication unless the Sec3 retary determines that an earlier effective date is nec4 essary for the protection of the public health. Such 

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

6 consistent with the public health, economic loss to, 

7 and disruption or dislocation of, domestic and inter8 national trade. In establishing such effective date or 

9 dates, the Secretary shall consider information sub10 mitted in connection with a proposed product stand11 ard by interested parties, including manufacturers 

12 and tobacco growers, regarding the technical 

13 achievability of compliance with the standard, and 

14 including information concerning the existence of pat15 ents that make it impossible to comply in the time16 frame envisioned in the proposed standard. If the Sec17 retary determines, based on the Secretary’s evaluation 

18 of submitted comments, that a product standard can 

19 be met only by manufacturers requiring substantial 

20 changes to the methods of farming the domestically 

21 grown tobacco used by the manufacturer, the effective 

22 date of that product standard shall be not less than 

23 2 years after the date of publication of the final regu24 lation establishing the standard. 


erowe on PROD1PC71 with BILLS
72 

•HR 1108 RH

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

2 FOOD AND DRUG ADMINISTRATION.—Because of the 

3 importance of a decision of the Secretary to issue a 

4 regulation— 

5 ‘‘(A) banning all cigarettes, all smokeless to6 bacco products, all little cigars, all cigars other 

7 than little cigars, all pipe tobacco, or all roll8 your-own tobacco products; or 

9 ‘‘(B) requiring the reduction of nicotine 

10 yields of a tobacco product to zero, 

11 the Secretary is prohibited from taking such actions 

12 under this Act. 

13 ‘‘(4) AMENDMENT; REVOCATION.— 

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

15 Secretary’s own initiative or upon petition of an 

16 interested person, may by a regulation, promul17 gated in accordance with the requirements of 

18 subsection (c) and paragraph (2), amend or re19 voke a tobacco product standard. 

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

21 may declare a proposed amendment of a tobacco 

22 product standard to be effective on and after its 

23 publication in the Federal Register and until the 

24 effective date of any final action taken on such 


erowe on PROD1PC71 with BILLS
73 

•HR 1108 RH

1 amendment if the Secretary determines that 

2 making it so effective is in the public interest. 

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

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

5 refer a proposed regulation for the establishment, 

6 amendment, or revocation of a tobacco product 

7 standard to the Tobacco Products Scientific Ad8 visory Committee for a report and recommenda9 tion with respect to any matter involved in the 

10 proposed regulation which requires the exercise of 

11 scientific judgment. 

12 ‘‘(B) INITIATION OF REFERRAL.—The Sec13 retary may make a referral under this para14 graph— 

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

16 or 

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

18 person that— 

19 ‘‘(I) demonstrates good cause for 

20 the referral; and 

21 ‘‘(II) is made before the expira22 tion of the period for submission of 

23 comments on the proposed regulation. 

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

25 regulation is referred under this paragraph to 


erowe on PROD1PC71 with BILLS
74 

•HR 1108 RH

1 the Tobacco Products Scientific Advisory Com2 mittee, the Secretary shall provide the Advisory 

3 Committee with the data and information on 

4 which such proposed regulation is based. 

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

6 Tobacco Products Scientific Advisory Committee 

7 shall, within 60 days after the referral of a pro8 posed regulation under this paragraph and after 

9 independent study of the data and information 

10 furnished to it by the Secretary and other data 

11 and information before it, submit to the Sec12 retary a report and recommendation respecting 

13 such regulation, together with all underlying 

14 data and information and a statement of the 

15 reason or basis for the recommendation. 

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

17 shall make a copy of each report and rec18 ommendation under subparagraph (D) publicly 

19 available. 

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

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

22 that— 

23 ‘‘(1) a tobacco product which is introduced or de24 livered for introduction into interstate commerce for 


erowe on PROD1PC71 with BILLS
75 

•HR 1108 RH

1 commercial distribution presents an unreasonable risk 

2 of substantial harm to the public health; and 

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

5 harm and no more practicable means is available 

6 under the provisions of this chapter (other than this 

7 section) to eliminate such risk, 

8 the Secretary may issue such order as may be necessary 

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

11 the circumstances involved, to all persons who should prop12 erly receive such notification in order to eliminate such 

13 risk. The Secretary may order notification by any appro14 priate means, including public service announcements. Be15 fore issuing an order under this subsection, the Secretary 

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

17 the order. 

18 ‘‘(b) NO EXEMPTION FROM OTHER LIABILITY.—Com19 pliance with an order issued under this section shall not 

20 relieve any person from liability under Federal or State 

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

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

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

24 such order shall be taken into account. 

25 ‘‘(c) RECALL AUTHORITY.— 


erowe on PROD1PC71 with BILLS
76 

•HR 1108 RH

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

2 there is a reasonable probability that a tobacco prod3 uct contains a manufacturing or other defect not ordi4 narily contained in tobacco products on the market 

5 that would cause serious, adverse health consequences 

6 or death, the Secretary shall issue an order requiring 

7 the appropriate person (including the manufacturers, 

8 importers, distributors, or retailers of the tobacco 

9 product) to immediately cease distribution of such to10 bacco product. The order shall provide the person sub11 ject to the order with an opportunity for an informal 

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

13 date of the issuance of the order, on the actions re14 quired by the order and on whether the order should 

15 be amended to require a recall of such tobacco prod16 uct. If, after providing an opportunity for such a 

17 hearing, the Secretary determines that inadequate 

18 grounds exist to support the actions required by the 

19 order, the Secretary shall vacate the order. 

20 ‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE21 CALL.— 

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

23 opportunity for an informal hearing under 

24 paragraph (1), the Secretary determines that the 

25 order should be amended to include a recall of 


erowe on PROD1PC71 with BILLS
77 

•HR 1108 RH

1 the tobacco product with respect to which the 

2 order was issued, the Secretary shall, except as 

3 provided in subparagraph (B), amend the order 

4 to require a recall. The Secretary shall specify a 

5 timetable in which the tobacco product recall will 

6 occur and shall require periodic reports to the 

7 Secretary describing the progress of the recall. 

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

9 subparagraph (A)— 

10 ‘‘(i) shall not include recall of a to11 bacco product from individuals; and 

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

13 subject to the risks associated with the use 

14 of such tobacco product. 

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

16 the Secretary may use the assistance of retailers 

17 and other persons who distributed such tobacco 

18 product. If a significant number of such persons 

19 cannot be identified, the Secretary shall notify 

20 such persons under section 705(b). 

21 ‘‘(3) REMEDY NOT EXCLUSIVE.—The remedy pro22 vided by this subsection shall be in addition to rem23 edies provided by subsection (a). 


erowe on PROD1PC71 with BILLS
78 

•HR 1108 RH

1 ‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PROD2 UCTS. 

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

4 product manufacturer or importer of a tobacco product 

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

7 by regulation reasonably require to assure that such tobacco 

8 product is not adulterated or misbranded and to otherwise 

9 protect public health. Regulations prescribed under the pre10 ceding sentence— 

11 ‘‘(1) may require a tobacco product manufac12 turer or importer to report to the Secretary whenever 

13 the manufacturer or importer receives or otherwise be14 comes aware of information that reasonably suggests 

15 that one of its marketed tobacco products may have 

16 caused or contributed to a serious unexpected adverse 

17 experience associated with the use of the product or 

18 any significant increase in the frequency of a serious, 

19 expected adverse product experience; 

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

21 adverse tobacco product experiences as determined by 

22 the Secretary to be necessary to be reported; 

23 ‘‘(3) shall not impose requirements unduly bur24 densome to a tobacco product manufacturer or im25 porter, taking into account the cost of complying with 

26 such requirements and the need for the protection of 


erowe on PROD1PC71 with BILLS
79 

•HR 1108 RH

1 the public health and the implementation of this 

2 chapter; 

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

4 requests for reports or information, shall require that 

5 each request made under such regulations for submis6 sion of a report or information to the Secretary state 

7 the reason or purpose for such request and identify to 

8 the fullest extent practicable such report or informa9 tion; 

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

11 information to the Secretary, shall state the reason or 

12 purpose for the submission of such report or informa13 tion and identify to the fullest extent practicable such 

14 report or information; and 

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

16 patient or user be disclosed in records, reports, or in17 formation required under this subsection unless re18 quired for the medical welfare of an individual, to de19 termine risks to public health of a tobacco product, or 

20 to verify a record, report, or information submitted 

21 under this chapter. 

22 In prescribing regulations under this subsection, the Sec23 retary shall have due regard for the professional ethics of 

24 the medical profession and the interests of patients. The 

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


erowe on PROD1PC71 with BILLS
80 

•HR 1108 RH

1 reports, and information concerning any individual who 

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

3 to be a patient. 

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

5 ‘‘(1) IN GENERAL.—Except as provided in para6 graph (2), the Secretary shall by regulation require a 

7 tobacco product manufacturer or importer of a to8 bacco product to report promptly to the Secretary any 

9 corrective action taken or removal from the market of 

10 a tobacco product undertaken by such manufacturer 

11 or importer if the removal or correction was under12 taken— 

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

14 tobacco product; or 

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

16 caused by the tobacco product which may present 

17 a risk to health. 

18 A tobacco product manufacturer or importer of a to19 bacco product who undertakes a corrective action or 

20 removal from the market of a tobacco product which 

21 is not required to be reported under this subsection 

22 shall keep a record of such correction or removal. 

23 ‘‘(2) EXCEPTION.—No report of the corrective ac24 tion or removal of a tobacco product may be required 

25 under paragraph (1) if a report of the corrective acVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00080 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
81 

•HR 1108 RH

1 tion or removal is required and has been submitted 

2 under subsection (a). 

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

5 ‘‘(a) IN GENERAL.— 

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

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

8 means— 

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

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

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

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

16 content, delivery or form of nicotine, or any 

17 other additive or ingredient) of a tobacco product 

18 where the modified product was commercially 

19 marketed in the United States after February 15, 

20 2007. 

21 ‘‘(2) PREMARKET REVIEW REQUIRED.— 

22 ‘‘(A) NEW PRODUCTS.—An order under sub23 section (c)(1)(A)(i) for a new tobacco product is 

24 required unless— 


erowe on PROD1PC71 with BILLS
82 

•HR 1108 RH

1 ‘‘(i) the manufacturer has submitted a 

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

4 product— 

5 ‘‘(I) is substantially equivalent to 

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

8 the United States as of February 15, 

9 2007; and 

10 ‘‘(II) is in compliance with the re11 quirements of this Act; or 

12 ‘‘(ii) the tobacco product is exempt 

13 from the requirements of section 905(j) pur14 suant to a regulation issued under section 

15 905(j)(3). 

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

18 shall not apply to a tobacco product— 

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

22 United States after February 15, 2007, and 

23 prior to the date that is 21 months after the 

24 date of enactment of the Family Smoking 

25 Prevention and Tobacco Control Act; and 


erowe on PROD1PC71 with BILLS
83 

•HR 1108 RH

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

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

3 period, 

4 except that subparagraph (A) shall apply to the 

5 tobacco product if the Secretary issues an order 

6 that the tobacco product is not substantially 

7 equivalent. 

8 ‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.— 

9 ‘‘(A) IN GENERAL.—In this section and sec10 tion 905(j), the term ‘substantially equivalent’ or 

11 ‘substantial equivalence’ means, with respect to 

12 the tobacco product being compared to the predi13 cate tobacco product, that the Secretary by order 

14 has found that the tobacco product— 

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

16 predicate tobacco product; or 

17 ‘‘(ii) has different characteristics and 

18 the information submitted contains infor19 mation, including clinical data if deemed 

20 necessary by the Secretary, that dem21 onstrates that it is not appropriate to regu22 late the product under this section because 

23 the product does not raise different ques24 tions of public health. 


erowe on PROD1PC71 with BILLS
84 

•HR 1108 RH

1 ‘‘(B) CHARACTERISTICS.—In subparagraph 

2 (A), the term ‘characteristics’ means the mate3 rials, ingredients, design, composition, heating 

4 source, or other features of a tobacco product. 

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

6 not be found to be substantially equivalent to a 

7 predicate tobacco product that has been removed 

8 from the market at the initiative of the Secretary 

9 or that has been determined by a judicial order 

10 to be misbranded or adulterated. 

11 ‘‘(4) HEALTH INFORMATION.— 

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

13 under section 905(j) respecting a tobacco prod14 uct, the person required to file a premarket noti15 fication under such section shall provide an ade16 quate summary of any health information re17 lated to the tobacco product or state that such in18 formation will be made available upon request 

19 by any person. 

20 ‘‘(B) REQUIRED INFORMATION.—Any sum21 mary under subparagraph (A) respecting a to22 bacco product shall contain detailed information 

23 regarding data concerning adverse health effects 

24 and shall be made available to the public by the 

25 Secretary within 30 days of the issuance of a deVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00084 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
85 

•HR 1108 RH

1 termination that such tobacco product is sub2 stantially equivalent to another tobacco product. 

3 ‘‘(b) APPLICATION.— 

4 ‘‘(1) CONTENTS.—An application under this sec5 tion shall contain— 

6 ‘‘(A) full reports of all information, pub7 lished or known to, or which should reasonably 

8 be known to, the applicant, concerning investiga9 tions which have been made to show the health 

10 risks of such tobacco product and whether such 

11 tobacco product presents less risk than other to12 bacco products; 

13 ‘‘(B) a full statement of the components, in14 gredients, additives, and properties, and of the 

15 principle or principles of operation, of such to16 bacco product; 

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

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

19 manufacture, processing, and, when relevant, 

20 packing and installation of, such tobacco prod21 uct; 

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

23 product standard under section 907 which would 

24 be applicable to any aspect of such tobacco prod25 uct, and either adequate information to show 


erowe on PROD1PC71 with BILLS
86 

•HR 1108 RH

1 that such aspect of such tobacco product fully 

2 meets such tobacco product standard or adequate 

3 information to justify any deviation from such 

4 standard; 

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

6 and of components thereof as the Secretary may 

7 reasonably require; 

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

9 be used for such tobacco product; and 

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

11 subject matter of the application as the Secretary 

12 may require. 

13 ‘‘(2) REFERRAL TO TOBACCO PRODUCTS SCI14 ENTIFIC ADVISORY COMMITTEE.—Upon receipt of an 

15 application meeting the requirements set forth in 

16 paragraph (1), the Secretary— 

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

18 or 

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

20 refer such application to the Tobacco Products Sci21 entific Advisory Committee for reference and for sub22 mission (within such period as the Secretary may es23 tablish) of a report and recommendation respecting 

24 the application, together with all underlying data 

25 and the reasons or basis for the recommendation. 


erowe on PROD1PC71 with BILLS
87 

•HR 1108 RH

1 ‘‘(c) ACTION ON APPLICATION.— 

2 ‘‘(1) DEADLINE.— 

3 ‘‘(A) IN GENERAL.—As promptly as pos4 sible, but in no event later than 180 days after 

5 the receipt of an application under subsection 

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

7 and recommendation submitted under subsection 

8 (b)(2), shall— 

9 ‘‘(i) issue an order that the new prod10 uct may be introduced or delivered for in11 troduction into interstate commerce if the 

12 Secretary finds that none of the grounds 

13 specified in paragraph (2) of this subsection 

14 applies; or 

15 ‘‘(ii) issue an order that the new prod16 uct may not be introduced or delivered for 

17 introduction into interstate commerce if the 

18 Secretary finds (and sets forth the basis for 

19 such finding as part of or accompanying 

20 such denial) that 1 or more grounds for de21 nial specified in paragraph (2) of this sub22 section apply. 

23 ‘‘(B) RESTRICTIONS ON SALE AND DIS24 TRIBUTION.—An order under subparagraph 

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


erowe on PROD1PC71 with BILLS
88 

•HR 1108 RH

1 of the tobacco product be restricted but only to 

2 the extent that the sale and distribution of a to3 bacco product may be restricted under a regula4 tion under section 906(d). 

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

6 shall deny an application submitted under subsection 

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

8 the Secretary as part of the application and any 

9 other information before the Secretary with respect to 

10 such tobacco product, the Secretary finds that— 

11 ‘‘(A) there is a lack of a showing that per12 mitting such tobacco product to be marketed 

13 would be appropriate for the protection of the 

14 public health; 

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

16 controls used for, the manufacture, processing, or 

17 packing of such tobacco product do not conform 

18 to the requirements of section 906(e); 

19 ‘‘(C) based on a fair evaluation of all mate20 rial facts, the proposed labeling is false or mis21 leading in any particular; or 

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

23 conform in all respects to a tobacco product 

24 standard in effect under section 907, and there 


erowe on PROD1PC71 with BILLS
89 

•HR 1108 RH

1 is a lack of adequate information to justify the 

2 deviation from such standard. 

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

4 application shall, insofar as the Secretary determines 

5 to be practicable, be accompanied by a statement in6 forming the applicant of the measures required to re7 move such application from deniable form (which 

8 measures may include further research by the appli9 cant in accordance with 1 or more protocols pre10 scribed by the Secretary). 

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

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

13 tobacco product for which an application has been 

14 submitted is appropriate for the protection of the pub15 lic health shall be determined with respect to the risks 

16 and benefits to the population as a whole, including 

17 users and nonusers of the tobacco product, and taking 

18 into account— 

19 ‘‘(A) the increased or decreased likelihood 

20 that existing users of tobacco products will stop 

21 using such products; and 

22 ‘‘(B) the increased or decreased likelihood 

23 that those who do not use tobacco products will 

24 start using such products. 

25 ‘‘(5) BASIS FOR ACTION.— 


erowe on PROD1PC71 with BILLS
90 

•HR 1108 RH

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

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

3 product to be marketed would be appropriate for 

4 the protection of the public health shall, when 

5 appropriate, be determined on the basis of well6 controlled investigations, which may include 1 or 

7 more clinical investigations by experts qualified 

8 by training and experience to evaluate the to9 bacco product. 

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

11 determines that there exists valid scientific evi12 dence (other than evidence derived from inves13 tigations described in subparagraph (A)) which 

14 is sufficient to evaluate the tobacco product, the 

15 Secretary may authorize that the determination 

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

17 basis of such evidence. 

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

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

20 obtaining, where appropriate, advice on scientific 

21 matters from the Tobacco Products Scientific Advi22 sory Committee, and after due notice and opportunity 

23 for informal hearing for a tobacco product for which 

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


erowe on PROD1PC71 with BILLS
91 

•HR 1108 RH

1 issue an order withdrawing the order if the Secretary 

2 finds— 

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

4 tobacco product no longer is appropriate for the 

5 protection of the public health; 

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

7 accompanied by an untrue statement of a mate8 rial fact; 

9 ‘‘(C) that the applicant— 

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

11 maintaining records, or has repeatedly or 

12 deliberately failed to maintain records or to 

13 make reports, required by an applicable reg14 ulation under section 909; 

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

16 copying or verification of, such records as 

17 required by section 704; or 

18 ‘‘(iii) has not complied with the re19 quirements of section 905; 

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

21 the Secretary with respect to such tobacco prod22 uct, evaluated together with the evidence before 

23 the Secretary when the application was reviewed, 

24 that the methods used in, or the facilities and 

25 controls used for, the manufacture, processing, 


erowe on PROD1PC71 with BILLS
92 

•HR 1108 RH

1 packing, or installation of such tobacco product 

2 do not conform with the requirements of section 

3 906(e) and were not brought into conformity 

4 with such requirements within a reasonable time 

5 after receipt of written notice from the Secretary 

6 of nonconformity; 

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

8 the Secretary, evaluated together with the evi9 dence before the Secretary when the application 

10 was reviewed, that the labeling of such tobacco 

11 product, based on a fair evaluation of all mate12 rial facts, is false or misleading in any par13 ticular and was not corrected within a reason14 able time after receipt of written notice from the 

15 Secretary of such fact; or 

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

17 the Secretary, evaluated together with the evi18 dence before the Secretary when such order was 

19 issued, that such tobacco product is not shown to 

20 conform in all respects to a tobacco product 

21 standard which is in effect under section 907, 

22 compliance with which was a condition to the 

23 issuance of an order relating to the application, 

24 and that there is a lack of adequate information 

25 to justify the deviation from such standard. 


erowe on PROD1PC71 with BILLS
93 

•HR 1108 RH

1 ‘‘(2) APPEAL.—The holder of an application sub2 ject to an order issued under paragraph (1) with3 drawing an order issued pursuant to subsection 

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

5 30th day after the date upon which such holder re6 ceives notice of such withdrawal, obtain review thereof 

7 in accordance with section 912. 

8 ‘‘(3) TEMPORARY SUSPENSION.—If, after pro9 viding an opportunity for an informal hearing, the 

10 Secretary determines there is reasonable probability 

11 that the continuation of distribution of a tobacco 

12 product under an order would cause serious, adverse 

13 health consequences or death, that is greater than or14 dinarily caused by tobacco products on the market, 

15 the Secretary shall by order temporarily suspend the 

16 authority of the manufacturer to market the product. 

17 If the Secretary issues such an order, the Secretary 

18 shall proceed expeditiously under paragraph (1) to 

19 withdraw such application. 

20 ‘‘(e) SERVICE OF ORDER.—An order issued by the Sec21 retary under this section shall be served— 

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

23 department designated by the Secretary; or 

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

25 certified mail addressed to the applicant at the appliVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00093 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
94 

•HR 1108 RH

1 cant’s last known address in the records of the Sec2 retary. 

3 ‘‘(f) RECORDS.— 

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

5 any tobacco product for which an order issued pursu6 ant to subsection (c)(1)(A)(i) for an application filed 

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

8 establish and maintain such records, and make such 

9 reports to the Secretary, as the Secretary may by reg10 ulation, or by order with respect to such application, 

11 prescribe on the basis of a finding that such records 

12 and reports are necessary in order to enable the Sec13 retary to determine, or facilitate a determination of, 

14 whether there is or may be grounds for withdrawing 

15 or temporarily suspending such order. 

16 ‘‘(2) ACCESS TO RECORDS.—Each person re17 quired under this section to maintain records, and 

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

19 request of an officer or employee designated by the 

20 Secretary, permit such officer or employee at all rea21 sonable times to have access to and copy and verify 

22 such records. 

23 ‘‘(g) INVESTIGATIONAL TOBACCO PRODUCT EXEMP24 TION FOR INVESTIGATIONAL USE.—The Secretary may ex25 empt tobacco products intended for investigational use from 


erowe on PROD1PC71 with BILLS
95 

•HR 1108 RH

1 the provisions of this chapter under such conditions as the 

2 Secretary may by regulation prescribe. 

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

4 ‘‘(a) IN GENERAL.—No person may introduce or de5 liver for introduction into interstate commerce any modi6 fied risk tobacco product unless an order issued pursuant 

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

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

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

10 term ‘modified risk tobacco product’ means any to11 bacco product that is sold or distributed for use to re12 duce harm or the risk of tobacco-related disease asso13 ciated with commercially marketed tobacco products. 

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-related 

18 disease associated with commercially marketed 

19 tobacco products’ means a tobacco product— 

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

21 of which represents explicitly or implicitly 

22 that— 

23 ‘‘(I) the tobacco product presents 

24 a lower risk of tobacco-related disease 

25 or is less harmful than one or more 


erowe on PROD1PC71 with BILLS
96 

•HR 1108 RH

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 directed 

15 to consumers through the media or other16 wise, other than by means of the tobacco 

17 product’s label, labeling, or advertising, 

18 after the date of enactment of the Family 

19 Smoking Prevention and Tobacco Control 

20 Act, respecting the product that would be 

21 reasonably expected to result in consumers 

22 believing that the tobacco product or its 

23 smoke may present a lower risk of disease 

24 or is less harmful than one or more com25 mercially marketed tobacco products, or 


erowe on PROD1PC71 with BILLS
97 

•HR 1108 RH

1 presents a reduced exposure to, or does not 

2 contain or is free of, a substance or sub3 stances. 

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-related 

7 disease associated with commercially marketed 

8 tobacco products’, except as described in sub9 paragraph (A). 

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

11 smokeless tobacco product shall be considered to 

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

13 the risk of tobacco-related disease associated with 

14 commercially marketed tobacco products’ solely 

15 because its label, labeling, or advertising uses the 

16 following phrases to describe such product and 

17 its use: ‘smokeless tobacco’, ‘smokeless tobacco 

18 product’, ‘not consumed by smoking’, ‘does not 

19 produce smoke’, ‘smokefree’, ‘smoke-free’, ‘without 

20 smoke’, ‘no smoke’, or ‘not smoke’. 

21 ‘‘(3) EFFECTIVE DATE.—The provisions of para22 graph (2)(A)(ii) shall take effect 12 months after the 

23 date of enactment of the Family Smoking Prevention 

24 and Tobacco Control Act for those products whose 

25 label, labeling, or advertising contains the terms deVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00097 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
98 

•HR 1108 RH

1 scribed in such paragraph on such date of enactment. 

2 The effective date shall be with respect to the date of 

3 manufacture, provided that, in any case, 30 days 

4 after such effective date, a manufacturer shall not in5 troduce into the domestic commerce of the United 

6 States any product that is not in conformance with 

7 paragraph (2)(A)(ii). 

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

9 that is intended to be used for the treatment of tobacco de10 pendence, including smoking cessation, is not a modified 

11 risk tobacco product under this section if it has been ap12 proved as a drug or device by the Food and Drug Adminis13 tration and is subject to the requirements of chapter V. 

14 ‘‘(d) FILING.—Any person may file with the Secretary 

15 an application for a modified risk tobacco product. Such 

16 application shall include— 

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

18 any proposed advertising and labeling; 

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

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

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

22 ‘‘(5) all documents (including underlying sci23 entific information) relating to research findings con24 ducted, supported, or possessed by the tobacco product 

25 manufacturer relating to the effect of the product on 


erowe on PROD1PC71 with BILLS
99 

•HR 1108 RH

1 tobacco-related diseases and health-related conditions, 

2 including information both favorable and unfavorable 

3 to the ability of the product to reduce risk or exposure 

4 and relating to human health; 

5 ‘‘(6) data and information on how consumers ac6 tually use the tobacco product; and 

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

8 may require. 

9 ‘‘(e) PUBLIC AVAILABILITY.—The Secretary shall make 

10 the application described in subsection (d) publicly avail11 able (except matters in the application which are trade se12 crets or otherwise confidential, commercial information) 

13 and shall request comments by interested persons on the in14 formation contained in the application and on the label, 

15 labeling, and advertising accompanying such application. 

16 ‘‘(f) ADVISORY COMMITTEE.— 

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

18 the Tobacco Products Scientific Advisory Committee 

19 any application submitted under this section. 

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

21 days after the date an application is referred to the 

22 Tobacco Products Scientific Advisory Committee 

23 under paragraph (1), the Advisory Committee shall 

24 report its recommendations on the application to the 

25 Secretary. 


erowe on PROD1PC71 with BILLS
100 

•HR 1108 RH

1 ‘‘(g) MARKETING.— 

2 ‘‘(1) MODIFIED RISK PRODUCTS.—Except as pro3 vided in paragraph (2), the Secretary shall, with re4 spect to an application submitted under this section, 

5 issue an order that a modified risk product may be 

6 commercially marketed only if the Secretary deter7 mines that the applicant has demonstrated that such 

8 product, as it is actually used by consumers, will— 

9 ‘‘(A) significantly reduce harm and the risk 

10 of tobacco-related disease to individual tobacco 

11 users; and 

12 ‘‘(B) benefit the health of the population as 

13 a whole taking into account both users of tobacco 

14 products and persons who do not currently use 

15 tobacco products. 

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

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

18 issue an order that a tobacco product may be in19 troduced or delivered for introduction into inter20 state commerce, pursuant to an application 

21 under this section, with respect to a tobacco 

22 product that may not be commercially marketed 

23 under paragraph (1) if the Secretary makes the 

24 findings required under this paragraph and deVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00100 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
101 

•HR 1108 RH

1 termines that the applicant has demonstrated 

2 that— 

3 ‘‘(i) such order would be appropriate 

4 to promote the public health; 

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

6 and advertising for such product that would 

7 cause the tobacco product to be a modified 

8 risk tobacco product under subsection (b) is 

9 limited to an explicit or implicit represen10 tation that such tobacco product or its 

11 smoke does not contain or is free of a sub12 stance or contains a reduced level of a sub13 stance, or presents a reduced exposure to a 

14 substance in tobacco smoke; 

15 ‘‘(iii) scientific evidence is not avail16 able and, using the best available scientific 

17 methods, cannot be made available without 

18 conducting long-term epidemiological stud19 ies for an application to meet the standards 

20 set forth in paragraph (1); and 

21 ‘‘(iv) the scientific evidence that is 

22 available without conducting long-term epi23 demiological studies demonstrates that a 

24 measurable and substantial reduction in 

25 morbidity or mortality among individual 


erowe on PROD1PC71 with BILLS
102 

•HR 1108 RH

1 tobacco users is reasonably likely in subse2 quent studies. 

3 ‘‘(B) ADDITIONAL FINDINGS REQUIRED.— 

4 To issue an order under subparagraph (A) the 

5 Secretary must also find that the applicant has 

6 demonstrated that— 

7 ‘‘(i) the magnitude of the overall reduc8 tions in exposure to the substance or sub9 stances which are the subject of the applica10 tion is substantial, such substance or sub11 stances are harmful, and the product as ac12 tually used exposes consumers to the speci13 fied reduced level of the substance or sub14 stances; 

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

16 consumers will not expose them to higher 

17 levels of other harmful substances compared 

18 to the similar types of tobacco products then 

19 on the market unless such increases are 

20 minimal and the reasonably likely overall 

21 impact of use of the product remains a sub22 stantial and measurable reduction in over23 all morbidity and mortality among indi24 vidual tobacco users; 


erowe on PROD1PC71 with BILLS
103 

•HR 1108 RH

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

5 the product— 

6 ‘‘(I) is or has been demonstrated 

7 to be less harmful; or 

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

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

12 ‘‘(iv) issuance of an order with respect 

13 to the application is expected to benefit the 

14 health of the population as a whole taking 

15 into account both users of tobacco products 

16 and persons who do not currently use to17 bacco products. 

18 ‘‘(C) CONDITIONS OF MARKETING.— 

19 ‘‘(i) IN GENERAL.—Applications sub20 ject to an order under this paragraph shall 

21 be limited to a term of not more than 5 

22 years, but may be renewed upon a finding 

23 by the Secretary that the requirements of 

24 this paragraph continue to be satisfied 

25 based on the filing of a new application. 


erowe on PROD1PC71 with BILLS
104 

•HR 1108 RH

1 ‘‘(ii) AGREEMENTS BY APPLICANT.— 

2 An order under this paragraph shall be con3 ditioned on the applicant’s agreement to 

4 conduct postmarket surveillance and studies 

5 and to submit to the Secretary the results of 

6 such surveillance and studies to determine 

7 the impact of the order on consumer percep8 tion, behavior, and health and to enable the 

9 Secretary to review the accuracy of the de10 terminations upon which the order was 

11 based in accordance with a protocol ap12 proved by the Secretary. 

13 ‘‘(iii) ANNUAL SUBMISSION.—The re14 sults of such postmarket surveillance and 

15 studies described in clause (ii) shall be sub16 mitted annually. 

17 ‘‘(3) BASIS.—The determinations under para18 graphs (1) and (2) shall be based on— 

19 ‘‘(A) the scientific evidence submitted by the 

20 applicant; and 

21 ‘‘(B) scientific evidence and other informa22 tion that is made available to the Secretary. 

23 ‘‘(4) BENEFIT TO HEALTH OF INDIVIDUALS AND

24 OF POPULATION AS A WHOLE.—In making the deterVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00104 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
105 

•HR 1108 RH

1 minations under paragraphs (1) and (2), the Sec2 retary shall take into account— 

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

4 of the tobacco product that is the subject of the 

5 application; 

6 ‘‘(B) the increased or decreased likelihood 

7 that existing users of tobacco products who would 

8 otherwise stop using such products will switch to 

9 the tobacco product that is the subject of the ap10 plication; 

11 ‘‘(C) the increased or decreased likelihood 

12 that persons who do not use tobacco products 

13 will start using the tobacco product that is the 

14 subject of the application; 

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

16 the use of the tobacco product that is the subject 

17 of the application as compared to the use of 

18 products for smoking cessation approved under 

19 chapter V to treat nicotine dependence; and 

20 ‘‘(E) comments, data, and information sub21 mitted by interested persons. 

22 ‘‘(h) ADDITIONAL CONDITIONS FOR MARKETING.— 

23 ‘‘(1) MODIFIED RISK PRODUCTS.—The Secretary 

24 shall require for the marketing of a product under 

25 this section that any advertising or labeling conVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00105 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
106 

•HR 1108 RH

1 cerning modified risk products enable the public to 

2 comprehend the information concerning modified risk 

3 and to understand the relative significance of such in4 formation in the context of total health and in rela5 tion to all of the diseases and health-related condi6 tions associated with the use of tobacco products. 

7 ‘‘(2) COMPARATIVE CLAIMS.— 

8 ‘‘(A) IN GENERAL.—The Secretary may re9 quire for the marketing of a product under this 

10 subsection that a claim comparing a tobacco 

11 product to 1 or more other commercially mar12 keted tobacco products shall compare the tobacco 

13 product to a commercially marketed tobacco 

14 product that is representative of that type of to15 bacco product on the market (for example the av16 erage value of the top 3 brands of an established 

17 regular tobacco product). 

18 ‘‘(B) QUANTITATIVE COMPARISONS.—The 

19 Secretary may also require, for purposes of sub20 paragraph (A), that the percent (or fraction) of 

21 change and identity of the reference tobacco 

22 product and a quantitative comparison of the 

23 amount of the substance claimed to be reduced 

24 shall be stated in immediate proximity to the 

25 most prominent claim. 


erowe on PROD1PC71 with BILLS
107 

•HR 1108 RH

1 ‘‘(3) LABEL DISCLOSURE.— 

2 ‘‘(A) IN GENERAL.—The Secretary may re3 quire the disclosure on the label of other sub4 stances in the tobacco product, or substances that 

5 may be produced by the consumption of that to6 bacco product, that may affect a disease or 

7 health-related condition or may increase the risk 

8 of other diseases or health-related conditions as9 sociated with the use of tobacco products. 

10 ‘‘(B) CONDITIONS OF USE.—If the condi11 tions of use of the tobacco product may affect the 

12 risk of the product to human health, the Sec13 retary may require the labeling of conditions of 

14 use. 

15 ‘‘(4) TIME.—An order issued under subsection 

16 (g)(1) shall be effective for a specified period of time. 

17 ‘‘(5) ADVERTISING.—The Secretary may require, 

18 with respect to a product for which an applicant ob19 tained an order under subsection (g)(1), that the 

20 product comply with requirements relating to adver21 tising and promotion of the tobacco product. 

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

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

24 with respect to a product for which an applicant ob25 tained an order under subsection (g)(1), that the apVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00107 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
108 

•HR 1108 RH

1 plicant conduct postmarket surveillance and studies 

2 for such a tobacco product to determine the impact of 

3 the order issuance on consumer perception, behavior, 

4 and health, to enable the Secretary to review the accu5 racy of the determinations upon which the order was 

6 based, and to provide information that the Secretary 

7 determines is otherwise necessary regarding the use or 

8 health risks involving the tobacco product. The results 

9 of postmarket surveillance and studies shall be sub10 mitted to the Secretary on an annual basis. 

11 ‘‘(2) SURVEILLANCE PROTOCOL.—Each appli12 cant required to conduct a surveillance of a tobacco 

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

14 after receiving notice that the applicant is required to 

15 conduct such surveillance, submit, for the approval of 

16 the Secretary, a protocol for the required surveillance. 

17 The Secretary, within 60 days of the receipt of such 

18 protocol, shall determine if the principal investigator 

19 proposed to be used in the surveillance has sufficient 

20 qualifications and experience to conduct such surveil21 lance and if such protocol will result in collection of 

22 the data or other information designated by the Sec23 retary as necessary to protect the public health. 

24 ‘‘(j) WITHDRAWAL OF AUTHORIZATION.—The Sec25 retary, after an opportunity for an informal hearing, shall 


erowe on PROD1PC71 with BILLS
109 

•HR 1108 RH

1 withdraw an order under subsection (g) if the Secretary de2 termines that— 

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

4 can no longer make the demonstrations required 

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

6 make the determinations required under subsection 

7 (g); 

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

9 information or included any untrue statement of ma10 terial fact; 

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

12 the product reduces risk or exposure is no longer 

13 valid, including if— 

14 ‘‘(A) a tobacco product standard is estab15 lished pursuant to section 907; 

16 ‘‘(B) an action is taken that affects the risks 

17 presented by other commercially marketed to18 bacco products that were compared to the prod19 uct that is the subject of the application; or 

20 ‘‘(C) any postmarket surveillance or studies 

21 reveal that the order is no longer consistent with 

22 the protection of the public health; 

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

24 the postmarket surveillance and studies required 

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


erowe on PROD1PC71 with BILLS
110 

•HR 1108 RH

1 ‘‘(5) the applicant failed to meet a condition im2 posed under subsection (h). 

3 ‘‘(k) CHAPTER IV OR V.—A product for which the Sec4 retary has issued an order pursuant to subsection (g) shall 

5 not be subject to chapter IV or V. 

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

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

8 years after the date of enactment of the Family Smok9 ing Prevention and Tobacco Control Act, the Sec10 retary shall issue regulations or guidance (or any 

11 combination thereof) on the scientific evidence re12 quired for assessment and ongoing review of modified 

13 risk tobacco products. Such regulations or guidance 

14 shall— 

15 ‘‘(A) to the extent that adequate scientific 

16 evidence exists, establish minimum standards for 

17 scientific studies needed prior to issuing an 

18 order under subsection (g) to show that a sub19 stantial reduction in morbidity or mortality 

20 among individual tobacco users occurs for prod21 ucts described in subsection (g)(1) or is reason22 ably likely for products described in subsection 

23 (g)(2); 


erowe on PROD1PC71 with BILLS
111 

•HR 1108 RH

1 ‘‘(B) include validated biomarkers, inter2 mediate clinical endpoints, and other feasible 

3 outcome measures, as appropriate; 

4 ‘‘(C) establish minimum standards for 

5 postmarket studies, that shall include regular 

6 and long-term assessments of health outcomes 

7 and mortality, intermediate clinical endpoints, 

8 consumer perception of harm reduction, and the 

9 impact on quitting behavior and new use of to10 bacco products, as appropriate; 

11 ‘‘(D) establish minimum standards for re12 quired postmarket surveillance, including ongo13 ing assessments of consumer perception; 

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

15 studies and surveillance be made available to the 

16 Secretary prior to the decision on renewal of a 

17 modified risk tobacco product; and 

18 ‘‘(F) establish a reasonable timetable for the 

19 Secretary to review an application under this 

20 section. 

21 ‘‘(2) CONSULTATION.—The regulations or guid22 ance issued under paragraph (1) shall be developed in 

23 consultation with the Institute of Medicine, and with 

24 the input of other appropriate scientific and medical 


erowe on PROD1PC71 with BILLS
112 

•HR 1108 RH

1 experts, on the design and conduct of such studies and 

2 surveillance. 

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

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

5 basis as new scientific information becomes available. 

6 ‘‘(4) NEW TOBACCO PRODUCTS.—Not later than 

7 2 years after the date of enactment of the Family 

8 Smoking Prevention and Tobacco Control Act, the 

9 Secretary shall issue a regulation or guidance that 

10 permits the filing of a single application for any to11 bacco product that is a new tobacco product under 

12 section 910 and which the applicant seeks to commer13 cially market under this section. 

14 ‘‘(m) DISTRIBUTORS.—Except as provided in this sec15 tion, no distributor may take any action, after the date of 

16 enactment of the Family Smoking Prevention and Tobacco 

17 Control Act, with respect to a tobacco product that would 

18 reasonably be expected to result in consumers believing that 

19 the tobacco product or its smoke may present a lower risk 

20 of disease or is less harmful than one or more commercially 

21 marketed tobacco products, or presents a reduced exposure 

22 to, or does not contain or is free of, a substance or sub23 stances. 

24 ‘‘SEC. 912. JUDICIAL REVIEW. 

25 ‘‘(a) RIGHT TO REVIEW.— 


erowe on PROD1PC71 with BILLS
113 

•HR 1108 RH

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

2 after— 

3 ‘‘(A) the promulgation of a regulation 

4 under section 907 establishing, amending, or re5 voking a tobacco product standard; or 

6 ‘‘(B) a denial of an application under sec7 tion 910(c), 

8 any person adversely affected by such regulation or 

9 denial may file a petition for judicial review of such 

10 regulation or denial with the United States Court of 

11 Appeals for the District of Columbia Circuit or for 

12 the circuit in which such person resides or has their 

13 principal place of business. 

14 ‘‘(2) REQUIREMENTS.— 

15 ‘‘(A) COPY OF PETITION.—A copy of the pe16 tition filed under paragraph (1) shall be trans17 mitted by the clerk of the court involved to the 

18 Secretary. 

19 ‘‘(B) RECORD OF PROCEEDINGS.—On re20 ceipt of a petition under subparagraph (A), the 

21 Secretary shall file in the court in which such 

22 petition was filed— 

23 ‘‘(i) the record of the proceedings on 

24 which the regulation or order was based; 

25 and 


erowe on PROD1PC71 with BILLS
114 

•HR 1108 RH

1 ‘‘(ii) a statement of the reasons for the 

2 issuance of such a regulation or order. 

3 ‘‘(C) DEFINITION OF RECORD.—In this sec4 tion, the term ‘record’ means— 

5 ‘‘(i) all notices and other matter pub6 lished in the Federal Register with respect 

7 to the regulation or order reviewed; 

8 ‘‘(ii) all information submitted to the 

9 Secretary with respect to such regulation or 

10 order; 

11 ‘‘(iii) proceedings of any panel or ad12 visory committee with respect to such regu13 lation or order; 

14 ‘‘(iv) any hearing held with respect to 

15 such regulation or order; and 

16 ‘‘(v) any other information identified 

17 by the Secretary, in the administrative pro18 ceeding held with respect to such regulation 

19 or order, as being relevant to such regula20 tion or order. 

21 ‘‘(b) STANDARD OF REVIEW.—Upon the filing of the 

22 petition under subsection (a) for judicial review of a regula23 tion or order, the court shall have jurisdiction to review 

24 the regulation or order in accordance with chapter 7 of title 

25 5, United States Code, and to grant appropriate relief, inVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00114 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
115 

•HR 1108 RH

1 cluding interim relief, as provided for in such chapter. A 

2 regulation or denial described in subsection (a) shall be re3 viewed in accordance with section 706(2)(A) of title 5, 

4 United States Code. 

5 ‘‘(c) FINALITY OF JUDGMENT.—The judgment of the 

6 court affirming or setting aside, in whole or in part, any 

7 regulation or order shall be final, subject to review by the 

8 Supreme Court of the United States upon certiorari or cer9 tification, as provided in section 1254 of title 28, United 

10 States Code. 

11 ‘‘(d) OTHER REMEDIES.—The remedies provided for 

12 in this section shall be in addition to, and not in lieu of, 

13 any other remedies provided by law. 

14 ‘‘(e) REGULATIONS AND ORDERS MUST RECITE BASIS

15 IN RECORD.—To facilitate judicial review, a regulation or 

16 order issued under section 906, 907, 908, 909, 910, or 916 

17 shall contain a statement of the reasons for the issuance 

18 of such regulation or order in the record of the proceedings 

19 held in connection with its issuance. 

20 ‘‘SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS. 

21 ‘‘The Secretary shall issue regulations to require that 

22 retail establishments for which the predominant business is 

23 the sale of tobacco products comply with any advertising 

24 restrictions applicable to retail establishments accessible to 

25 individuals under the age of 18. 


erowe on PROD1PC71 with BILLS
116 

•HR 1108 RH

1 ‘‘SEC. 914. JURISDICTION OF AND COORDINATION WITH 

2 THE FEDERAL TRADE COMMISSION. 

3 ‘‘(a) JURISDICTION.— 

4 ‘‘(1) IN GENERAL.—Except where expressly pro5 vided in this chapter, nothing in this chapter shall be 

6 construed as limiting or diminishing the authority of 

7 the Federal Trade Commission to enforce the laws 

8 under its jurisdiction with respect to the advertising, 

9 sale, or distribution of tobacco products. 

10 ‘‘(2) ENFORCEMENT.—Any advertising that vio11 lates this chapter or a provision of the regulations re12 ferred to in section 102 of the Family Smoking Pre13 vention and Tobacco Control Act, is an unfair or de14 ceptive act or practice under section 5(a) of the Fed15 eral Trade Commission Act and shall be considered a 

16 violation of a rule promulgated under section 18 of 

17 that Act. 

18 ‘‘(b) COORDINATION.—With respect to the requirements 

19 of section 4 of the Federal Cigarette Labeling and Adver20 tising Act and section 3 of the Comprehensive Smokeless 

21 Tobacco Health Education Act of 1986— 

22 ‘‘(1) the Chairman of the Federal Trade Com23 mission shall coordinate with the Secretary con24 cerning the enforcement of such Act as such enforce25 ment relates to unfair or deceptive acts or practices 


erowe on PROD1PC71 with BILLS
117 

•HR 1108 RH

1 in the advertising of cigarettes or smokeless tobacco; 

2 and 

3 ‘‘(2) the Secretary shall consult with the Chair4 man of such Commission in revising the label state5 ments and requirements under such sections. 

6 ‘‘SEC. 915. REGULATION REQUIREMENT. 

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

8 later than 36 months after the date of enactment of the 

9 Family Smoking Prevention and Tobacco Control Act, the 

10 Secretary shall promulgate regulations under this Act that 

11 meet the requirements of subsection (b). 

12 ‘‘(b) CONTENTS OF RULES.—The regulations promul13 gated under subsection (a)— 

14 ‘‘(1) shall require testing and reporting of to15 bacco product constituents, ingredients, and additives, 

16 including smoke constituents, by brand and subbrand 

17 that the Secretary determines should be tested to pro18 tect the public health; and 

19 ‘‘(2) may require that tobacco product manufac20 turers, packagers, or importers make disclosures relat21 ing to the results of the testing of tar and nicotine 

22 through labels or advertising or other appropriate 

23 means, and make disclosures regarding the results of 

24 the testing of other constituents, including smoke con25 stituents, ingredients, or additives, that the Secretary 


erowe on PROD1PC71 with BILLS
118 

•HR 1108 RH

1 determines should be disclosed to the public to protect 

2 the public health and will not mislead consumers 

3 about the risk of tobacco-related disease. 

4 ‘‘(c) AUTHORITY.—The Secretary shall have the au5 thority under this chapter to conduct or to require the test6 ing, reporting, or disclosure of tobacco product constituents, 

7 including smoke constituents. 

8 ‘‘(d) SMALL TOBACCO PRODUCT MANUFACTURERS.— 

9 ‘‘(1) FIRST COMPLIANCE DATE.—The initial reg10 ulations promulgated under subsection (a) shall not 

11 impose requirements on small tobacco product manu12 facturers before the later of— 

13 ‘‘(A) the end of the 2-year period following 

14 the final promulgation of such regulations; and 

15 ‘‘(B) the initial date set by the Secretary for 

16 compliance with such regulations by manufac17 turers that are not small tobacco product manu18 facturers. 

19 ‘‘(2) TESTING AND REPORTING INITIAL COMPLI20 ANCE PERIOD.— 

21 ‘‘(A) 4-YEAR PERIOD.—The initial regula22 tions promulgated under subsection (a) shall give 

23 each small tobacco product manufacturer a 4- 

24 year period over which to conduct testing and re25 porting for all of its tobacco products. Subject to 


erowe on PROD1PC71 with BILLS
119 

•HR 1108 RH

1 paragraph (1), the end of the first year of such 

2 4-year period shall coincide with the initial date 

3 of compliance under this section set by the Sec4 retary with respect to manufacturers that are 

5 not small tobacco product manufacturers or the 

6 end of the 2-year period following the final pro7 mulgation of such regulations, as described in 

8 paragraph (1)(A). A small tobacco product man9 ufacturer shall be required— 

10 ‘‘(i) to conduct such testing and report11 ing for 25 percent of its tobacco products 

12 during each year of such 4-year period; and 

13 ‘‘(ii) to conduct such testing and re14 porting for its largest-selling tobacco prod15 ucts (as determined by the Secretary) before 

16 its other tobacco products, or in such other 

17 order of priority as determined by the Sec18 retary. 

19 ‘‘(B) CASE-BY-CASE DELAY.—Notwith20 standing subparagraph (A), the Secretary may, 

21 on a case-by-case basis, delay the date by which 

22 an individual small tobacco product manufac23 turer must conduct testing and reporting for its 

24 tobacco products under this section based upon a 

25 showing of undue hardship to such manufacVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00119 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
120 

•HR 1108 RH

1 turer. Notwithstanding the preceding sentence, 

2 the Secretary shall not extend the deadline for a 

3 small tobacco product manufacturer to conduct 

4 testing and reporting for all of its tobacco prod5 ucts beyond a total of 5 years after the initial 

6 date of compliance under this section set by the 

7 Secretary with respect to manufacturers that are 

8 not small tobacco product manufacturers. 

9 ‘‘(3) SUBSEQUENT AND ADDITIONAL TESTING

10 AND REPORTING.—The regulations promulgated under 

11 subsection (a) shall provide that, with respect to any 

12 subsequent or additional testing and reporting of to13 bacco products required under this section, such test14 ing and reporting by a small tobacco product manu15 facturer shall be conducted in accordance with the 

16 timeframes described in paragraph (2)(A), except 

17 that, in the case of a new product, or if there has been 

18 a modification described in section 910(a)(1)(B) of 

19 any product of a small tobacco product manufacturer 

20 since the last testing and reporting required under 

21 this section, the Secretary shall require that any sub22 sequent or additional testing and reporting be con23 ducted in accordance with the same timeframe appli24 cable to manufacturers that are not small tobacco 

25 product manufacturers. 


erowe on PROD1PC71 with BILLS
121 

•HR 1108 RH

1 ‘‘(4) JOINT LABORATORY TESTING SERVICES.— 

2 The Secretary shall allow any 2 or more small to3 bacco product manufacturers to join together to pur4 chase laboratory testing services required by this sec5 tion on a group basis in order to ensure that such 

6 manufacturers receive access to, and fair pricing of, 

7 such testing services. 

8 ‘‘(e) EXTENSIONS FOR LIMITED LABORATORY CAPAC9 ITY.— 

10 ‘‘(1) IN GENERAL.—The regulations promulgated 

11 under subsection (a) shall provide that a small to12 bacco product manufacturer shall not be considered to 

13 be in violation of this section before the deadline ap14 plicable under paragraphs (3) and (4), if— 

15 ‘‘(A) the tobacco products of such manufac16 turer are in compliance with all other require17 ments of this chapter; and 

18 ‘‘(B) the conditions described in paragraph 

19 (2) are met. 

20 ‘‘(2) CONDITIONS.—Notwithstanding the require21 ments of this section, the Secretary may delay the 

22 date by which a small tobacco product manufacturer 

23 must be in compliance with the testing and reporting 

24 required by this section until such time as the testing 

25 is reported if, not later than 90 days before the deadVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00121 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
122 

•HR 1108 RH

1 line for reporting in accordance with this section, a 

2 small tobacco product manufacturer provides evidence 

3 to the Secretary demonstrating that— 

4 ‘‘(A) the manufacturer has submitted the re5 quired products for testing to a laboratory and 

6 has done so sufficiently in advance of the dead7 line to create a reasonable expectation of comple8 tion by the deadline; 

9 ‘‘(B) the products currently are awaiting 

10 testing by the laboratory; and 

11 ‘‘(C) neither that laboratory nor any other 

12 laboratory is able to complete testing by the 

13 deadline at customary, nonexpedited testing fees. 

14 ‘‘(3) EXTENSION.—The Secretary, taking into 

15 account the laboratory testing capacity that is avail16 able to tobacco product manufacturers, shall review 

17 and verify the evidence submitted by a small tobacco 

18 product manufacturer in accordance with paragraph 

19 (2). If the Secretary finds that the conditions de20 scribed in such paragraph are met, the Secretary 

21 shall notify the small tobacco product manufacturer 

22 that the manufacturer shall not be considered to be in 

23 violation of the testing and reporting requirements of 

24 this section until the testing is reported or until 1 

25 year after the reporting deadline has passed, whichVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00122 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
123 

•HR 1108 RH

1 ever occurs sooner. If, however, the Secretary has not 

2 made a finding before the reporting deadline, the 

3 manufacturer shall not be considered to be in viola4 tion of such requirements until the Secretary finds 

5 that the conditions described in paragraph (2) have 

6 not been met, or until 1 year after the reporting dead7 line, whichever occurs sooner. 

8 ‘‘(4) ADDITIONAL EXTENSION.—In addition to 

9 the time that may be provided under paragraph (3), 

10 the Secretary may provide further extensions of time, 

11 in increments of no more than 1 year, for required 

12 testing and reporting to occur if the Secretary deter13 mines, based on evidence properly and timely sub14 mitted by a small tobacco product manufacturer in 

15 accordance with paragraph (2), that a lack of avail16 able laboratory capacity prevents the manufacturer 

17 from completing the required testing during the pe18 riod described in paragraph (3). 

19 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in subsection 

20 (d) or (e) shall be construed to authorize the extension of 

21 any deadline, or to otherwise affect any timeframe, under 

22 any provision of this Act or the Family Smoking Preven23 tion and Tobacco Control Act other than this section. 


erowe on PROD1PC71 with BILLS
124 

•HR 1108 RH

1 ‘‘SEC. 916. PRESERVATION OF STATE AND LOCAL AUTHOR2 ITY. 

3 ‘‘(a) IN GENERAL.— 

4 ‘‘(1) PRESERVATION.—Except as provided in 

5 paragraph (2)(A), nothing in this chapter, or rules 

6 promulgated under this chapter, shall be construed to 

7 limit the authority of a Federal agency (including the 

8 Armed Forces), a State or political subdivision of a 

9 State, or the government of an Indian tribe to enact, 

10 adopt, promulgate, and enforce any law, rule, regula11 tion, or other measure with respect to tobacco prod12 ucts that is in addition to, or more stringent than, 

13 requirements established under this chapter, including 

14 a law, rule, regulation, or other measure relating to 

15 or prohibiting the sale, distribution, possession, expo16 sure to, access to, advertising and promotion of, or 

17 use of tobacco products by individuals of any age, in18 formation reporting to the State, or measures relating 

19 to fire safety standards for tobacco products. No pro20 vision of this chapter shall limit or otherwise affect 

21 any State, tribal, or local taxation of tobacco prod22 ucts. 

23 ‘‘(2) PREEMPTION OF CERTAIN STATE AND LOCAL

24 REQUIREMENTS.— 

25 ‘‘(A) IN GENERAL.—No State or political 

26 subdivision of a State may establish or continue 


erowe on PROD1PC71 with BILLS
125 

•HR 1108 RH

1 in effect with respect to a tobacco product any 

2 requirement which is different from, or in addi3 tion to, any requirement under the provisions of 

4 this chapter relating to tobacco product stand5 ards, premarket review, adulteration, mis6 branding, labeling, registration, good manufac7 turing standards, or modified risk tobacco prod8 ucts. 

9 ‘‘(B) EXCEPTION.—Subparagraph (A) does 

10 not apply to requirements relating to the sale, 

11 distribution, possession, information reporting to 

12 the State, exposure to, access to, the advertising 

13 and promotion of, or use of, tobacco products by 

14 individuals of any age, or relating to fire safety 

15 standards for tobacco products. Information dis16 closed to a State under subparagraph (A) that is 

17 exempt from disclosure under section 552(b)(4) 

18 of title 5, United States Code, shall be treated as 

19 a trade secret and confidential information by 

20 the State. 

21 ‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT

22 LIABILITY.—No provision of this chapter relating to a to23 bacco product shall be construed to modify or otherwise af24 fect any action or the liability of any person under the 

25 product liability law of any State. 


erowe on PROD1PC71 with BILLS
126 

•HR 1108 RH

1 ‘‘SEC. 917. TOBACCO PRODUCTS SCIENTIFIC ADVISORY 

2 COMMITTEE. 

3 ‘‘(a) ESTABLISHMENT.—Not later than 1 year after the 

4 date of enactment of the Family Smoking Prevention and 

5 Tobacco Control Act, the Secretary shall establish a 12- 

6 member advisory committee, to be known as the Tobacco 

7 Products Scientific Advisory Committee (in this section re8 ferred to as the ‘Advisory Committee’). 

9 ‘‘(b) MEMBERSHIP.— 

10 ‘‘(1) IN GENERAL.— 

11 ‘‘(A) MEMBERS.—The Secretary shall ap12 point as members of the Tobacco Products Sci13 entific Advisory Committee individuals who are 

14 technically qualified by training and experience 

15 in medicine, medical ethics, science, or tech16 nology involving the manufacture, evaluation, or 

17 use of tobacco products, who are of appropriately 

18 diversified professional backgrounds. The com19 mittee shall be composed of— 

20 ‘‘(i) 7 individuals who are physicians, 

21 dentists, scientists, or health care profes22 sionals practicing in the area of oncology, 

23 pulmonology, cardiology, toxicology, phar24 macology, addiction, or any other relevant 

25 specialty; 


erowe on PROD1PC71 with BILLS
127 

•HR 1108 RH

1 ‘‘(ii) 1 individual who is an officer or 

2 employee of a State or local government or 

3 of the Federal Government; 

4 ‘‘(iii) 1 individual as a representative 

5 of the general public; 

6 ‘‘(iv) 1 individual as a representative 

7 of the interests of the tobacco manufacturing 

8 industry; 

9 ‘‘(v) 1 individual as a representative of 

10 the interests of the small business tobacco 

11 manufacturing industry, which position 

12 may be filled on a rotating, sequential basis 

13 by representatives of different small business 

14 tobacco manufacturers based on areas of ex15 pertise relevant to the topics being consid16 ered by the Advisory Committee; and 

17 ‘‘(vi) 1 individual as a representative 

18 of the interests of the tobacco growers. 

19 ‘‘(B) NONVOTING MEMBERS.—The members 

20 of the committee appointed under clauses (iv), 

21 (v), and (vi) of subparagraph (A) shall serve as 

22 consultants to those described in clauses (i) 

23 through (iii) of subparagraph (A) and shall be 

24 nonvoting representatives. 


erowe on PROD1PC71 with BILLS
128 

•HR 1108 RH

1 ‘‘(C) CONFLICTS OF INTEREST.—No mem2 bers of the committee, other than members ap3 pointed pursuant to clauses (iv), (v), and (vi) of 

4 subparagraph (A) shall, during the member’s 

5 tenure on the committee or for the 18-month pe6 riod prior to becoming such a member, receive 

7 any salary, grants, or other payments or support 

8 from any business that manufactures, distrib9 utes, markets, or sells cigarettes or other tobacco 

10 products. 

11 ‘‘(2) LIMITATION.—The Secretary may not ap12 point to the Advisory Committee any individual who 

13 is in the regular full-time employ of the Food and 

14 Drug Administration or any agency responsible for 

15 the enforcement of this Act. The Secretary may ap16 point Federal officials as ex officio members. 

17 ‘‘(3) CHAIRPERSON.—The Secretary shall des18 ignate 1 of the members appointed under clauses (i), 

19 (ii), and (iii) of paragraph (1)(A) to serve as chair20 person. 

21 ‘‘(c) DUTIES.—The Tobacco Products Scientific Advi22 sory Committee shall provide advice, information, and rec23 ommendations to the Secretary— 

24 ‘‘(1) as provided in this chapter; 


erowe on PROD1PC71 with BILLS
129 

•HR 1108 RH

1 ‘‘(2) on the effects of the alteration of the nicotine 

2 yields from tobacco products; 

3 ‘‘(3) on whether there is a threshold level below 

4 which nicotine yields do not produce dependence on 

5 the tobacco product involved; and 

6 ‘‘(4) on its review of other safety, dependence, or 

7 health issues relating to tobacco products as requested 

8 by the Secretary. 

9 ‘‘(d) COMPENSATION; SUPPORT; FACA.— 

10 ‘‘(1) COMPENSATION AND TRAVEL.—Members of 

11 the Advisory Committee who are not officers or em12 ployees of the United States, while attending con13 ferences or meetings of the committee or otherwise en14 gaged in its business, shall be entitled to receive com15 pensation at rates to be fixed by the Secretary, which 

16 may not exceed the daily equivalent of the rate in ef17 fect under the Senior Executive Schedule under sec18 tion 5382 of title 5, United States Code, for each day 

19 (including travel time) they are so engaged; and while 

20 so serving away from their homes or regular places of 

21 business each member may be allowed travel expenses, 

22 including per diem in lieu of subsistence, as author23 ized by section 5703 of title 5, United States Code, for 

24 persons in the Government service employed intermit25 tently. 


erowe on PROD1PC71 with BILLS
130 

•HR 1108 RH

1 ‘‘(2) ADMINISTRATIVE SUPPORT.—The Secretary 

2 shall furnish the Advisory Committee clerical and 

3 other assistance. 

4 ‘‘(3) NONAPPLICATION OF FACA.—Section 14 of 

5 the Federal Advisory Committee Act does not apply 

6 to the Advisory Committee. 

7 ‘‘(e) PROCEEDINGS OF ADVISORY PANELS AND COM8 MITTEES.—The Advisory Committee shall make and main9 tain a transcript of any proceeding of the panel or com10 mittee. Each such panel and committee shall delete from 

11 any transcript made under this subsection information 

12 which is exempt from disclosure under section 552(b) of title 

13 5, United States Code. 

14 ‘‘SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DE15 PENDENCE. 

16 ‘‘(a) IN GENERAL.—The Secretary shall— 

17 ‘‘(1) at the request of the applicant, consider des18 ignating products for smoking cessation, including 

19 nicotine replacement products as fast track research 

20 and approval products within the meaning of section 

21 506; 

22 ‘‘(2) consider approving the extended use of nico23 tine replacement products (such as nicotine patches, 

24 nicotine gum, and nicotine lozenges) for the treatment 

25 of tobacco dependence; and 


erowe on PROD1PC71 with BILLS
131 

•HR 1108 RH

1 ‘‘(3) review and consider the evidence for addi2 tional indications for nicotine replacement products, 

3 such as for craving relief or relapse prevention. 

4 ‘‘(b) REPORT ON INNOVATIVE PRODUCTS.— 

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

6 the date of enactment of the Family Smoking Preven7 tion and Tobacco Control Act, the Secretary, after 

8 consultation with recognized scientific, medical, and 

9 public health experts (including both Federal agencies 

10 and nongovernmental entities, the Institute of Medi11 cine of the National Academy of Sciences, and the So12 ciety for Research on Nicotine and Tobacco), shall 

13 submit to the Congress a report that examines how 

14 best to regulate, promote, and encourage the develop15 ment of innovative products and treatments (includ16 ing nicotine-based and non-nicotine-based products 

17 and treatments) to better achieve, in a manner that 

18 best protects and promotes the public health— 

19 ‘‘(A) total abstinence from tobacco use; 

20 ‘‘(B) reductions in consumption of tobacco; 

21 and 

22 ‘‘(C) reductions in the harm associated with 

23 continued tobacco use. 

24 ‘‘(2) RECOMMENDATIONS.—The report under 

25 paragraph (1) shall include the recommendations of 


erowe on PROD1PC71 with BILLS
132 

•HR 1108 RH

1 the Secretary on how the Food and Drug Administra2 tion should coordinate and facilitate the exchange of 

3 information on such innovative products and treat4 ments among relevant offices and centers within the 

5 Administration and within the National Institutes of 

6 Health, the Centers for Disease Control and Preven7 tion, and other relevant agencies. 

8 ‘‘SEC. 919. USER FEE. 

9 ‘‘(a) ESTABLISHMENT OF QUARTERLY USER FEE.— 

10 The Secretary shall assess a quarterly user fee with respect 

11 to every quarter of each fiscal year commencing fiscal year 

12 2008, calculated in accordance with this section, upon each 

13 manufacturer and importer of tobacco products subject to 

14 this chapter. 

15 ‘‘(b) FUNDING OF FDA REGULATION OF TOBACCO

16 PRODUCTS.— 

17 ‘‘(1) IN GENERAL.—The Secretary shall make 

18 user fees collected pursuant to subsection (c)(1) avail19 able to pay, in each fiscal year beginning with fiscal 

20 year 2008, for the costs of the activities of the Food 

21 and Drug Administration related to the regulation of 

22 tobacco products under this chapter and the Family 

23 Smoking Prevention and Tobacco Control Act. No fees 

24 collected pursuant to subsection (c)(1) may be used by 

25 the Secretary for any other costs. 


erowe on PROD1PC71 with BILLS
133 

•HR 1108 RH

1 ‘‘(2) AVAILABILITY.—Subject to paragraph (1), 

2 fees collected pursuant to subsection (c)(1) shall be 

3 available to the Secretary without further appropria4 tion in the following amounts: 

5 ‘‘(A) For fiscal year 2008, $85,000,000. 

6 ‘‘(B) For fiscal year 2009, $235,000,000. 

7 ‘‘(C) For fiscal year 2010, $450,000,000. 

8 ‘‘(D) For fiscal year 2011, $477,000,000. 

9 ‘‘(E) For fiscal year 2012, $505,000,000. 

10 ‘‘(F) For fiscal year 2013, $534,000,000. 

11 ‘‘(G) For fiscal year 2014, $566,000,000. 

12 ‘‘(H) For fiscal year 2015, $599,000,000. 

13 ‘‘(I) For fiscal year 2016, $635,000,000. 

14 ‘‘(J) For fiscal year 2017, $672,000,000. 

15 ‘‘(K) For fiscal year 2018 and each subse16 quent fiscal year, $712,000,000. 

17 Fees made available to the Secretary under this para18 graph shall remain available until expended. 

19 ‘‘(3) OFFSETTING RECEIPTS.—Fees collected pur20 suant to subsection (c)(1) shall be recorded as offset21 ting receipts. 

22 ‘‘(4) PROHIBITION AGAINST USE OF OTHER

23 FUNDS.— 

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

25 subparagraph (B), fees collected pursuant to this 


erowe on PROD1PC71 with BILLS
134 

•HR 1108 RH

1 section shall be the only funds used to pay the 

2 costs of the activities of the Food and Drug Ad3 ministration related to the regulation of tobacco 

4 products under this chapter and the Family 

5 Smoking Prevention and Tobacco Control Act. 

6 ‘‘(B) STARTUP COSTS.—Subparagraph (A) 

7 shall not apply until the date on which the Sec8 retary has collected fees pursuant to this section 

9 for 2 fiscal year quarters. Until such date, 

10 amounts available to the Food and Drug Admin11 istration (other than fees collected pursuant to 

12 this section) may be used to pay the costs de13 scribed in subparagraph (A), provided that such 

14 amounts are reimbursed through such fees. 

15 ‘‘(c) ASSESSMENT OF USER FEE.— 

16 ‘‘(1) AMOUNT OF ASSESSMENT.—The assessment 

17 under this section for— 

18 ‘‘(A) fiscal year 2008 shall be $90,100,000; 

19 ‘‘(B) fiscal year 2009 shall be $249,100,000; 

20 ‘‘(C) fiscal year 2010 shall be $477,000,000; 

21 ‘‘(D) fiscal year 2011 shall be $505,620,000; 

22 ‘‘(E) fiscal year 2012 shall be $535,300,000; 

23 ‘‘(F) fiscal year 2013 shall be $566,040,000; 

24 ‘‘(G) fiscal year 2014 shall be $599,960,000; 

25 ‘‘(H) fiscal year 2015 shall be $634,940,000; 


erowe on PROD1PC71 with BILLS
135 

•HR 1108 RH

1 ‘‘(I) fiscal year 2016 shall be $673,100,000; 

2 ‘‘(J) fiscal year 2017 shall be $712,320,000; 

3 and 

4 ‘‘(K) fiscal year 2018 and each subsequent 

5 fiscal year shall be $754,720,000. 

6 ‘‘(2) ALLOCATIONS OF ASSESSMENT BY CLASS OF

7 TOBACCO PRODUCTS.— 

8 ‘‘(A) IN GENERAL.—The total user fees as9 sessed each fiscal year with respect to each class 

10 of tobacco products shall be an amount that is 

11 equal to the applicable percentage of each class 

12 multiplied by the amount specified in paragraph 

13 (1) for each fiscal year. 

14 ‘‘(B) APPLICABLE PERCENTAGE.— 

15 ‘‘(i) IN GENERAL.—For purposes of 

16 subparagraph (A), the applicable percentage 

17 for a fiscal year for each of the following 

18 classes of tobacco products shall be deter19 mined in accordance with clause (ii): 

20 ‘‘(I) Cigarettes. 

21 ‘‘(II) Cigars, including small ci22 gars and cigars other than small ci23 gars. 

24 ‘‘(III) Snuff. 

25 ‘‘(IV) Chewing tobacco. 


erowe on PROD1PC71 with BILLS
136 

•HR 1108 RH

1 ‘‘(V) Pipe tobacco. 

2 ‘‘(VI) Roll-your-own tobacco. 

3 ‘‘(ii) ALLOCATIONS.—The applicable 

4 percentage of each class of tobacco product 

5 described in clause (i) for a fiscal year shall 

6 be the percentage determined under section 

7 625(c) of Public Law 108–357 for each such 

8 class of product for such fiscal year. 

9 ‘‘(iii) REQUIREMENT OF REGULA10 TIONS.—Notwithstanding clause (ii), no 

11 user fees shall be assessed on a class of to12 bacco products unless such class of tobacco 

13 products is listed in section 901(b) or is 

14 deemed by the Secretary in a regulation 

15 under section 901(b) to be subject to this 

16 chapter. 

17 ‘‘(iv) REALLOCATIONS.—In the case of 

18 a class of tobacco products that is not listed 

19 in section 901(b) or deemed by the Sec20 retary in a regulation under section 901(b) 

21 to be subject to this chapter, the amount of 

22 user fees that would otherwise be assessed to 

23 such class of tobacco products shall be re24 allocated to such other classes of tobacco 

25 products that are subject to this chapter in 


erowe on PROD1PC71 with BILLS
137 

•HR 1108 RH

1 the same manner and based on the same 

2 relative percentages otherwise determined 

3 under clause (ii). 

4 ‘‘(3) DETERMINATION OF USER FEE BY COM5 PANY.— 

6 ‘‘(A) IN GENERAL.—The total user fee to be 

7 paid by each manufacturer or importer of a par8 ticular class of tobacco products shall be deter9 mined in each quarter by multiplying— 

10 ‘‘(i) such manufacturer’s or importer’s 

11 percentage share as determined under para12 graph (4); by 

13 ‘‘(ii) the portion of the user fee amount 

14 for the current quarter to be assessed on all 

15 manufacturers and importers of such class 

16 of tobacco products as determined under 

17 paragraph (2). 

18 ‘‘(B) NO FEE IN EXCESS OF PERCENTAGE

19 SHARE.—No manufacturer or importer of to20 bacco products shall be required to pay a user fee 

21 in excess of the percentage share of such manu22 facturer or importer. 

23 ‘‘(4) ALLOCATION OF ASSESSMENT WITHIN EACH

24 CLASS OF TOBACCO PRODUCT.—The percentage share 

25 of each manufacturer or importer of a particular 


erowe on PROD1PC71 with BILLS
138 

•HR 1108 RH

1 class of tobacco products of the total user fee to be 

2 paid by all manufacturers or importers of that class 

3 of tobacco products shall be the percentage determined 

4 for purposes of allocations under subsections (e) 

5 through (h) of section 625 of Public Law 108–357. 

6 ‘‘(5) ALLOCATION FOR CIGARS.—Notwith7 standing paragraph (4), if a user fee assessment is 

8 imposed on cigars, the percentage share of each manu9 facturer or importer of cigars shall be based on the ex10 cise taxes paid by such manufacturer or importer 

11 during the prior fiscal year. 

12 ‘‘(d) TIMING OF USER FEE ASSESSMENT.—The Sec13 retary shall notify each manufacturer and importer of to14 bacco products subject to this section of the amount of the 

15 quarterly assessment imposed on such manufacturer or im16 porter under subsection (c) during each quarter of each fis17 cal year. Such notifications shall occur not later than 30 

18 days prior to the end of the quarter for which such assess19 ment is made, and payments of all assessments shall be 

20 made by the last day of the quarter involved. 

21 ‘‘(e) MEMORANDUM OF UNDERSTANDING.— 

22 ‘‘(1) IN GENERAL.—The Secretary shall request 

23 the appropriate Federal agency to enter into a memo24 randum of understanding that provides for the reg25 ular and timely transfer from the head of such agency 


erowe on PROD1PC71 with BILLS
139 

•HR 1108 RH

1 to the Secretary of the information described in para2 graphs (2)(B)(ii) and (4) of subsection (c) and all 

3 necessary information regarding all tobacco product 

4 manufacturers and importers required to pay user 

5 fees. The Secretary shall maintain all disclosure re6 strictions established by the head of such agency re7 garding the information provided under the memo8 randum of understanding. 

9 ‘‘(2) ASSURANCES.—Beginning not later than 

10 fiscal year 2015, and for each subsequent fiscal year, 

11 the Secretary shall ensure that the Food and Drug 

12 Administration is able to determine the applicable 

13 percentages described in subsection (c)(2) and the per14 centage shares described in subsection (c)(4). The Sec15 retary may carry out this paragraph by entering into 

16 a contract with the head of the Federal agency re17 ferred to in paragraph (1) to continue to provide the 

18 necessary information. 

19 ‘‘(f) EFFECTIVE DATE.— 

20 ‘‘(1) IN GENERAL.—The user fees prescribed by 

21 this section shall be assessed in fiscal year 2008, and 

22 shall be assessed in each fiscal year thereafter. 

23 ‘‘(2) SPECIAL RULE.—If the date of enactment of 

24 the Family Smoking Prevention and Tobacco Control 

25 Act occurs during a quarter of fiscal year 2008, the 


erowe on PROD1PC71 with BILLS
140 

•HR 1108 RH

1 user fees for the portion of the quarter that occurs 

2 after such date of enactment shall be assessed during 

3 the next full quarter. 

4 ‘‘(g) STUDY BY GAO.— 

5 ‘‘(1) IN GENERAL.—The Comptroller General of 

6 the United States shall conduct a study on— 

7 ‘‘(A) the prevalence of youth tobacco use 

8 and the brands and subbrands that individuals 

9 under the age of 18 consume; 

10 ‘‘(B) the feasibility of structuring the user 

11 fees or a portion of the user fees collected under 

12 this section on the youth market share of a man13 ufacturer or year to year changes in a manufac14 turer’s share of youth market; and 

15 ‘‘(C) the potential effects of tobacco mar16 keting to youth audiences if user fees were cal17 culated in whole or in part on youth market 

18 share. 

19 ‘‘(2) REPORT.—The Comptroller General shall 

20 submit to the Energy and Commerce Committee of the 

21 House of Representatives and the Health, Education, 

22 Labor, and Pensions Committee of the Senate a re23 port on the study conducted under paragraph (1) by 

24 not later than 3 years after the date of enactment of 


erowe on PROD1PC71 with BILLS
141 

•HR 1108 RH

1 the Family Smoking Prevention and Tobacco Control 

2 Act.’’. 

3 SEC. 102. FINAL RULE. 

4 (a) CIGARETTES AND SMOKELESS TOBACCO.— 

5 (1) IN GENERAL.—On the first day of publica6 tion of the Federal Register that is 180 days or more 

7 after the date of enactment of this Act, the Secretary 

8 of Health and Human Services shall publish in the 

9 Federal Register a final rule regarding cigarettes and 

10 smokeless tobacco, which— 

11 (A) is deemed to be issued under chapter 9 

12 of the Federal Food, Drug, and Cosmetic Act, as 

13 added by section 101 of this Act; and 

14 (B) shall be deemed to be in compliance 

15 with all applicable provisions of chapter 5 of 

16 title 5, United States Code, and all other provi17 sions of law relating to rulemaking procedures. 

18 (2) CONTENTS OF RULE.—Except as provided in 

19 this subsection, the final rule published under para20 graph (1), shall be identical in its provisions to part 

21 897 of the regulations promulgated by the Secretary 

22 of Health and Human Services in the August 28, 

23 1996, issue of the Federal Register (61 Fed. Reg., 

24 44615–44618). Such rule shall— 


erowe on PROD1PC71 with BILLS
142 

•HR 1108 RH

1 (A) provide for the designation of jurisdic2 tional authority that is in accordance with this 

3 subsection in accordance with this Act and the 

4 amendments made by this Act; 

5 (B) strike Subpart C—Labels and section 

6 897.32(c); 

7 (C) strike paragraphs (a), (b), and (i) of 

8 section 897.3 and insert definitions of the terms 

9 ‘‘cigarette’’, ‘‘cigarette tobacco,’’, and ‘‘smokeless 

10 tobacco’’ as defined in section 900 of the Federal 

11 Food, Drug, and Cosmetic Act; 

12 (D) insert ‘‘or roll-your-own paper’’ in sec13 tion 897.34(a) after ‘‘other than cigarettes or 

14 smokeless tobacco’’; 

15 (E) become effective on the date that is 1 

16 year after the date of enactment of this Act; and 

17 (F) amend paragraph (d) of section 897.16 

18 to read as follows: 

19 ‘‘(d)(1) Except as provided in subparagraph (2), no 

20 manufacturer, distributor, or retailer may distribute or 

21 cause to be distributed any free samples of cigarettes, smoke22 less tobacco, or other tobacco products (as such term is de23 fined in section 201 of the Federal Food, Drug, and Cos24 metic Act). 


erowe on PROD1PC71 with BILLS
143 

•HR 1108 RH

1 ‘‘(2)(A) Subparagraph (1) does not prohibit a manu2 facturer, distributor, or retailer from distributing or caus3 ing to be distributed free samples of smokeless tobacco in 

4 a qualified adult-only facility. 

5 ‘‘(B) This subparagraph does not affect the authority 

6 of a State or local government to prohibit or otherwise re7 strict the distribution of free samples of smokeless tobacco. 

8 ‘‘(C) For purposes of this paragraph, the term ‘quali9 fied adult-only facility’ means a facility or restricted area 

10 that— 

11 ‘‘(i) requires each person present to provide to a 

12 law enforcement officer (whether on or off duty) or to 

13 a security guard licensed by a governmental entity 

14 government-issued identification showing a photo15 graph and at least the minimum age established by 

16 applicable law for the purchase of smokeless tobacco; 

17 ‘‘(ii) does not sell, serve, or distribute alcohol; 

18 ‘‘(iii) is not located adjacent to or immediately 

19 across from (in any direction) a space that is used 

20 primarily for youth-oriented marketing, promotional, 

21 or other activities; 

22 ‘‘(iv) is a temporary structure constructed, des23 ignated, and operated as a distinct enclosed area for 

24 the purpose of distributing free samples of smokeless 

25 tobacco in accordance with this subparagraph; and 


erowe on PROD1PC71 with BILLS
144 

•HR 1108 RH

1 ‘‘(v) is enclosed by a barrier that— 

2 ‘‘(I) is constructed of, or covered with, an 

3 opaque material (except for entrances and exits); 

4 ‘‘(II) extends from no more than 12 inches 

5 above the ground or floor (which area at the bot6 tom of the barrier must be covered with material 

7 that restricts visibility but may allow airflow) to 

8 at least 8 feet above the ground or floor (or to 

9 the ceiling); and 

10 ‘‘(III) prevents persons outside the qualified 

11 adult-only facility from seeing into the qualified 

12 adult-only facility, unless they make unreason13 able efforts to do so; and 

14 ‘‘(vi) does not display on its exterior— 

15 ‘‘(I) any tobacco product advertising; 

16 ‘‘(II) a brand name other than in conjunc17 tion with words for an area or enclosure to iden18 tify an adult-only facility; or 

19 ‘‘(III) any combination of words that would 

20 imply to a reasonable observer that the manufac21 turer, distributor, or retailer has a sponsorship 

22 that would violate section 897.34(c). 

23 ‘‘(D) Distribution of samples of smokeless tobacco 

24 under this subparagraph permitted to be taken out of the 

25 qualified adult-only facility shall be limited to 1 package 


erowe on PROD1PC71 with BILLS
145 

•HR 1108 RH

1 per adult consumer containing no more than 0.53 ounces 

2 (15 grams) of smokeless tobacco. If such package of smoke3 less tobacco contains individual portions of smokeless to4 bacco, the individual portions of smokeless tobacco shall not 

5 exceed 8 individual portions and the collective weight of 

6 such individual portions shall not exceed 0.53 ounces (15 

7 grams). Any manufacturer, distributor, or retailer who dis8 tributes or causes to be distributed free samples also shall 

9 take reasonable steps to ensure that the above amounts are 

10 limited to one such package per adult consumer per day. 

11 ‘‘(3) Notwithstanding subparagraph (2), no manufac12 turer, distributor, or retailer may distribute or cause to be 

13 distributed any free samples of smokeless tobacco— 

14 ‘‘(A) to a sports team or entertainment group; or 

15 ‘‘(B) at any football, basketball, baseball, soccer, 

16 or hockey event or any other sporting or entertain17 ment event determined by the Secretary to be covered 

18 by this subparagraph. 

19 ‘‘(4) The Secretary shall implement a program to en20 sure compliance with this paragraph and submit a report 

21 to the Congress on such compliance not later than 18 

22 months after the date of enactment of the Family Smoking 

23 Prevention and Tobacco Control Act. 

24 ‘‘(5) Nothing in this paragraph shall be construed to 

25 authorize any person to distribute or cause to be distributed 


erowe on PROD1PC71 with BILLS
146 

•HR 1108 RH

1 any sample of a tobacco product to any individual who has 

2 not attained the minimum age established by applicable 

3 law for the purchase of such product.’’. 

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

5 amendments to the rule published under paragraph 

6 (1), the Secretary shall promulgate a proposed rule in 

7 accordance with chapter 5 of title 5, United States 

8 Code. 

9 (4) RULE OF CONSTRUCTION.—Except as pro10 vided in paragraph (3), nothing in this section shall 

11 be construed to limit the authority of the Secretary to 

12 amend, in accordance with chapter 5 of title 5, 

13 United States Code, the regulation promulgated pur14 suant to this section, including the provisions of such 

15 regulation relating to distribution of free samples. 

16 (5) ENFORCEMENT OF RETAIL SALE PROVI17 SIONS.—The Secretary of Health and Human Serv18 ices shall ensure that the provisions of this Act, the 

19 amendments made by this Act, and the implementing 

20 regulations (including such provisions, amendments, 

21 and regulations relating to the retail sale of tobacco 

22 products) are enforced with respect to the United 

23 States and Indian tribes. 

24 (6) QUALIFIED ADULT-ONLY FACILITY.—A quali25 fied adult-only facility (as such term is defined in 


erowe on PROD1PC71 with BILLS
147 

•HR 1108 RH

1 section 897.16(d) of the final rule published under 

2 paragraph (1)) that is also a retailer and that com3 mits a violation as a retailer shall not be subject to 

4 the limitations in section 103(q) and shall be subject 

5 to penalties applicable to a qualified adult-only facil6 ity. 

7 (7) CONGRESSIONAL REVIEW PROVISIONS.—Sec8 tion 801 of title 5, United States Code, shall not 

9 apply to the final rule published under paragraph 

10 (1). 

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

12 date of enactment of this Act, the following documents 

13 issued by the Food and Drug Administration shall not con14 stitute advisory opinions under section 10.85(d)(1) of title 

15 21, Code of Federal Regulations, except as they apply to 

16 tobacco products, and shall not be cited by the Secretary 

17 of Health and Human Services or the Food and Drug Ad18 ministration as binding precedent: 

19 (1) The preamble to the proposed rule in the doc20 ument titled ‘‘Regulations Restricting the Sale and 

21 Distribution of Cigarettes and Smokeless Tobacco 

22 Products to Protect Children and Adolescents’’ (60 

23 Fed. Reg. 41314–41372 (August 11, 1995)). 

24 (2) The document titled ‘‘Nicotine in Cigarettes 

25 and Smokeless Tobacco Products is a Drug and These 


erowe on PROD1PC71 with BILLS
148 

•HR 1108 RH

1 Products Are Nicotine Delivery Devices Under the 

2 Federal Food, Drug, and Cosmetic Act’’ (60 Fed. Reg. 

3 41453–41787 (August 11, 1995)). 

4 (3) The preamble to the final rule in the docu5 ment titled ‘‘Regulations Restricting the Sale and 

6 Distribution of Cigarettes and Smokeless Tobacco to 

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

8 44396–44615 (August 28, 1996)). 

9 (4) The document titled ‘‘Nicotine in Cigarettes 

10 and Smokeless Tobacco is a Drug and These Products 

11 are Nicotine Delivery Devices Under the Federal 

12 Food, Drug, and Cosmetic Act; Jurisdictional Deter13 mination’’ (61 Fed. Reg. 44619–45318 (August 28, 

14 1996)). 

15 SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GEN16 ERAL PROVISIONS. 

17 (a) AMENDMENT OF FEDERAL FOOD, DRUG, AND COS18 METIC ACT.—Except as otherwise expressly provided, when19 ever in this section an amendment is expressed in terms 

20 of an amendment to, or repeal of, a section or other provi21 sion, the reference is to a section or other provision of the 

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

23 seq.). 

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

25 amended— 


erowe on PROD1PC71 with BILLS
149 

•HR 1108 RH

1 (1) in subsection (a), by inserting ‘‘tobacco prod2 uct,’’ after ‘‘device,’’; 

3 (2) in subsection (b), by inserting ‘‘tobacco prod4 uct,’’ after ‘‘device,’’; 

5 (3) in subsection (c), by inserting ‘‘tobacco prod6 uct,’’ after ‘‘device,’’; 

7 (4) in subsection (e)— 

8 (A) by striking the period after ‘‘572(i)’’; 

9 and 

10 (B) by striking ‘‘or 761 or the refusal to 

11 permit access to’’ and inserting ‘‘761, 909, or 

12 921 or the refusal to permit access to’’; 

13 (5) in subsection (g), by inserting ‘‘tobacco prod14 uct,’’ after ‘‘device,’’; 

15 (6) in subsection (h), by inserting ‘‘tobacco prod16 uct,’’ after ‘‘device,’’; 

17 (7) in subsection (j)— 

18 (A) by striking the period after ‘‘573’’; and 

19 (B) by striking ‘‘708, or 721’’ and inserting 

20 ‘‘708, 721, 904, 905, 906, 907, 908, 909, or 

21 921(b)’’; 

22 (8) in subsection (k), by inserting ‘‘tobacco prod23 uct,’’ after ‘‘device,’’; 

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

25 following: 


erowe on PROD1PC71 with BILLS
150 

•HR 1108 RH

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

2 510 or 905, the failure to provide any information required 

3 by section 510(j), 510(k), 905(i), or 905(j), or the failure 

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

5 905(i)(3).’’; 

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), 907, 908, or 916; 

11 ‘‘(B) to furnish any notification or other mate12 rial or information required by or under section 519, 

13 520(g), 904, 909, or 921; or 

14 ‘‘(C) to comply with a requirement under section 

15 522 or 913.’’; 

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

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

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

19 product’’ after the term ‘‘device’’ each time that such 

20 term appears; and 

21 (13) by adding at the end the following: 

22 ‘‘(oo) The sale of tobacco products in violation of a 

23 no-tobacco-sale order issued under section 303(f). 


erowe on PROD1PC71 with BILLS
151 

•HR 1108 RH

1 ‘‘(pp) The introduction or delivery for introduction 

2 into interstate commerce of a tobacco product in violation 

3 of section 911. 

4 ‘‘(qq)(1) Forging, counterfeiting, simulating, or falsely 

5 representing, or without proper authority using any mark, 

6 stamp (including tax stamp), tag, label, or other identifica7 tion device upon any tobacco product or container or label8 ing thereof so as to render such tobacco product a counterfeit 

9 tobacco product. 

10 ‘‘(2) Making, selling, disposing of, or keeping in posses11 sion, control, or custody, or concealing any punch, die, 

12 plate, stone, or other item that is designed to print, imprint, 

13 or reproduce the trademark, trade name, or other identi14 fying mark, imprint, or device of another or any likeness 

15 of any of the foregoing upon any tobacco product or con16 tainer or labeling thereof so as to render such tobacco prod17 uct a counterfeit tobacco product. 

18 ‘‘(3) The doing of any act that causes a tobacco prod19 uct to be a counterfeit tobacco product, or the sale or dis20 pensing, or the holding for sale or dispensing, of a counter21 feit tobacco product. 

22 ‘‘(rr) The charitable distribution of tobacco products. 

23 ‘‘(ss) The failure of a manufacturer or distributor to 

24 notify the Attorney General and the Secretary of the TreasVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00151 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
152 

•HR 1108 RH

1 ury of their knowledge of tobacco products used in illicit 

2 trade. 

3 ‘‘(tt) With respect to a tobacco product, any statement 

4 directed to consumers through the media or through the 

5 label, labeling, or advertising that would reasonably be ex6 pected to result in consumers believing that the product is 

7 regulated, inspected or approved by the Food and Drug Ad8 ministration, or that the product complies with the require9 ments of the Food and Drug Administration, including a 

10 statement or implication in the label, labeling, or adver11 tising of such product, and that could result in consumers 

12 believing that the product is endorsed for use by the Food 

13 and Drug Administration or in consumers being misled 

14 about the harmfulness of the product because of such regula15 tion, inspection, or compliance.’’. 

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

17 is amended— 

18 (1) in paragraph (1)(A), by inserting ‘‘or to19 bacco products’’ after the term ‘‘devices’’ each place 

20 such term appears; 

21 (2) in paragraph (5)— 

22 (A) in subparagraph (A)— 

23 (i) by striking ‘‘assessed’’ the first time 

24 it appears and inserting ‘‘assessed, or a no25 tobacco-sale order may be imposed,’’; and 


erowe on PROD1PC71 with BILLS
153 

•HR 1108 RH

1 (ii) by striking ‘‘penalty’’ the second 

2 time it appears and inserting ‘‘penalty, or 

3 upon whom a no-tobacco-sale order is to be 

4 imposed,’’; 

5 (B) in subparagraph (B)— 

6 (i) by inserting after ‘‘penalty,’’ the 

7 following: ‘‘or the period to be covered by a 

8 no-tobacco-sale order,’’; and 

9 (ii) by adding at the end the following: 

10 ‘‘A no-tobacco-sale order permanently pro11 hibiting an individual retail outlet from 

12 selling tobacco products shall include provi13 sions that allow the outlet, after a specified 

14 period of time, to request that the Secretary 

15 compromise, modify, or terminate the 

16 order.’’; and 

17 (C) by adding at the end the following: 

18 ‘‘(D) The Secretary may compromise, modify, or ter19 minate, with or without conditions, any no-tobacco-sale 

20 order.’’; 

21 (3) in paragraph (6)— 

22 (A) by inserting ‘‘or the imposition of a no23 tobacco-sale order’’ after the term ‘‘penalty’’ each 

24 place such term appears; and 


erowe on PROD1PC71 with BILLS
154 

•HR 1108 RH

1 (B) by striking ‘‘issued.’’ and inserting 

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

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

4 (4) by adding at the end the following: 

5 ‘‘(8) If the Secretary finds that a person has 

6 committed repeated violations of restrictions promul7 gated under section 906(d) at a particular retail out8 let then the Secretary may impose a no-tobacco-sale 

9 order on that person prohibiting the sale of tobacco 

10 products in that outlet. A no-tobacco-sale order may 

11 be imposed with a civil penalty under paragraph (1). 

12 Prior to the entry of a no-sale order under this para13 graph, a person shall be entitled to a hearing pursu14 ant to the procedures established through regulations 

15 of the Food and Drug Administration for assessing 

16 civil money penalties, including at a retailer’s request 

17 a hearing by telephone, or at the nearest regional or 

18 field office of the Food and Drug Administration, or 

19 at a Federal, State, or county facility within 100 

20 miles from the location of the retail outlet, if such a 

21 facility is available.’’. 

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

23 amended— 

24 (1) in subsection (a)(2)— 

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


erowe on PROD1PC71 with BILLS
155 

•HR 1108 RH

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

2 following: ‘‘device, and (E) Any adulterated or 

3 misbranded tobacco product.’’; 

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

5 product,’’ after ‘‘device,’’; 

6 (3) in subsection (g)(1), by inserting ‘‘or tobacco 

7 product’’ after the term ‘‘device’’ each place such term 

8 appears; and 

9 (4) in subsection (g)(2)(A), by inserting ‘‘or to10 bacco product’’ after ‘‘device’’. 

11 (e) SECTION 505.—Section 505(n)(2) (21 U.S.C. 

12 355(n)(2)) is amended by striking ‘‘section 904’’ and insert13 ing ‘‘section 1004’’. 

14 (f) SECTION 523.—Section 523(b)(2)(D) (21 U.S.C. 

15 360m(b)(2)(D)) is amended by striking ‘‘section 903(g)’’ 

16 and inserting ‘‘section 1003(g)’’. 

17 (g) SECTION 702.—Section 702(a) (21 U.S.C. 372(a)) 

18 is amended by adding at the end of paragraph (1) the fol19 lowing: ‘‘For a tobacco product, to the extent feasible, the 

20 Secretary shall contract with the States in accordance with 

21 this paragraph to carry out inspections of retailers within 

22 that State in connection with the enforcement of this Act.’’. 

23 (h) SECTION 703.—Section 703 (21 U.S.C. 373) is 

24 amended— 


erowe on PROD1PC71 with BILLS
156 

•HR 1108 RH

1 (1) by inserting ‘‘tobacco product,’’ after the 

2 term ‘‘device,’’ each place such term appears; and 

3 (2) by inserting ‘‘tobacco products,’’ after the 

4 term ‘‘devices,’’ each place such term appears. 

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

6 amended— 

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

8 products,’’ after the term ‘‘devices,’’ each place such 

9 term appears; 

10 (2) in subsection (a)(1)(B), by inserting ‘‘or to11 bacco products’’ after the term ‘‘restricted devices’’ 

12 each place such term appears; 

13 (3) in subsection (b), by inserting ‘‘tobacco prod14 uct,’’ after ‘‘device,’’; and 

15 (4) in subsection (g)(13), by striking ‘‘section 

16 903(g)’’ and inserting ‘‘section 1003(g)’’. 

17 (j) SECTION 705.—Section 705(b) (21 U.S.C. 375(b)) 

18 is amended by inserting ‘‘tobacco products,’’ after ‘‘de19 vices,’’. 

20 (k) SECTION 709.—Section 709 (21 U.S.C. 379a) is 

21 amended by inserting ‘‘tobacco product,’’ after ‘‘device,’’. 

22 (l) SECTION 801.—Section 801 (21 U.S.C. 381) is 

23 amended— 

24 (1) in subsection (a)— 


erowe on PROD1PC71 with BILLS
157 

•HR 1108 RH

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

2 the term ‘‘devices,’’ ; 

3 (B) by inserting ‘‘or section 905(h)’’ after 

4 ‘‘section 510’’; and 

5 (C) by striking the term ‘‘drugs or devices’’ 

6 each time such term appears and inserting 

7 ‘‘drugs, devices, or tobacco products’’; 

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

9 product,’’ after ‘‘device,’’; and 

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

11 ‘‘(p)(1) Not later than 36 months after the date of en12 actment of the Family Smoking Prevention and Tobacco 

13 Control Act, and annually thereafter, the Secretary shall 

14 submit to the Committee on Health, Education, Labor, and 

15 Pensions of the Senate and the Committee on Energy and 

16 Commerce of the House of Representatives, a report regard17 ing— 

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

19 United States tobacco product exports that do not 

20 conform to tobacco product standards established pur21 suant to this Act; 

22 ‘‘(B) the public health implications of such ex23 ports, including any evidence of a negative public 

24 health impact; and 


erowe on PROD1PC71 with BILLS
158 

•HR 1108 RH

1 ‘‘(C) recommendations or assessments of policy 

2 alternatives available to Congress and the executive 

3 branch to reduce any negative public health impact 

4 caused by such exports. 

5 ‘‘(2) The Secretary is authorized to establish appro6 priate information disclosure requirements to carry out this 

7 subsection.’’. 

8 (m) SECTION 1003.—Section 1003(d)(2)(C) (as redes9 ignated by section 101(b)) is amended— 

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

11 (2) inserting ‘‘, and tobacco products’’ after ‘‘de12 vices’’. 

13 (n) SECTION 1009.—Section 1009(b) (as redesignated 

14 by section 101(b)) is amended by striking ‘‘section 908’’ and 

15 inserting ‘‘section 1008’’. 

16 (o) SECTION 409 OF THE FEDERAL MEAT INSPECTION

17 ACT.—Section 409(a) of the Federal Meat Inspection Act 

18 (21 U.S.C. 679(a)) is amended by striking ‘‘section 902(b)’’ 

19 and inserting ‘‘section 1002(b)’’. 

20 (p) RULE OF CONSTRUCTION.—Nothing in this section 

21 is intended or shall be construed to expand, contract, or 

22 otherwise modify or amend the existing limitations on State 

23 government authority over tribal restricted fee or trust 

24 lands. 

25 (q) GUIDANCE AND EFFECTIVE DATES.— 


erowe on PROD1PC71 with BILLS
159 

•HR 1108 RH

1 (1) IN GENERAL.—The Secretary of Health and 

2 Human Services shall issue guidance— 

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

4 as used in section 303(f)(8) of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 333(f)(8)) as 

6 amended by subsection (c), as including at least 

7 5 violations of particular requirements over a 

8 36-month period at a particular retail outlet 

9 that constitute a repeated violation and pro10 viding for civil penalties in accordance with 

11 paragraph (2); 

12 (B) providing for timely and effective notice 

13 by certified or registered mail or personal deliv14 ery to the retailer of each alleged violation at a 

15 particular retail outlet prior to conducting a fol16 lowup compliance check, such notice to be sent to 

17 the location specified on the retailer’s registra18 tion or to the retailer’s registered agent if the re19 tailer has provider such agent information to the 

20 Food and Drug Administration prior to the vio21 lation; 

22 (C) providing for a hearing pursuant to the 

23 procedures established through regulations of the 

24 Food and Drug Administration for assessing 

25 civil money penalties, including at a retailer’s 


erowe on PROD1PC71 with BILLS
160 

•HR 1108 RH

1 request a hearing by telephone or at the nearest 

2 regional or field office of the Food and Drug Ad3 ministration, and providing for an expedited 

4 procedure for the administrative appeal of an al5 leged violation; 

6 (D) providing that a person may not be 

7 charged with a violation at a particular retail 

8 outlet unless the Secretary has provided notice to 

9 the retailer of all previous violations at that out10 let; 

11 (E) establishing that civil money penalties 

12 for multiple violations shall increase from one 

13 violation to the next violation pursuant to para14 graph (2) within the time periods provided for 

15 in such paragraph; 

16 (F) providing that good faith reliance on 

17 the presentation of a false government-issued 

18 photographic identification that contains a date 

19 of birth does not constitute a violation of any 

20 minimum age requirement for the sale of tobacco 

21 products if the retailer has taken effective steps 

22 to prevent such violations, including— 

23 (i) adopting and enforcing a written 

24 policy against sales to minors; 


erowe on PROD1PC71 with BILLS
161 

•HR 1108 RH

1 (ii) informing its employees of all ap2 plicable laws; 

3 (iii) establishing disciplinary sanctions 

4 for employee noncompliance; and 

5 (iv) requiring its employees to verify 

6 age by way of photographic identification 

7 or electronic scanning device; and 

8 (G) providing for the Secretary, in deter9 mining whether to impose a no-tobacco-sale order 

10 and in determining whether to compromise, 

11 modify, or terminate such an order, to consider 

12 whether the retailer has taken effective steps to 

13 prevent violations of the minimum age require14 ments for the sale of tobacco products, including 

15 the steps listed in subparagraph (F). 

16 (2) PENALTIES FOR VIOLATIONS.— 

17 (A) IN GENERAL.—The amount of the civil 

18 penalty to be applied for violations of restric19 tions promulgated under section 906(d), as de20 scribed in paragraph (1), shall be as follows: 

21 (i) With respect to a retailer with an 

22 approved training program, the amount of 

23 the civil penalty shall not exceed— 


erowe on PROD1PC71 with BILLS
162 

•HR 1108 RH

1 (I) in the case of the first viola2 tion, $0.00 together with the issuance 

3 of a warning letter to the retailer; 

4 (II) in the case of a second viola5 tion within a 12-month period, $250; 

6 (III) in the case of a third viola7 tion within a 24-month period, $500; 

8 (IV) in the case of a fourth viola9 tion within a 24-month period, $2,000; 

10 (V) in the case of a fifth violation 

11 within a 36-month period, $5,000; and 

12 (VI) in the case of a sixth or sub13 sequent violation within a 48-month 

14 period, $10,000 as determined by the 

15 Secretary on a case-by-case basis. 

16 (ii) With respect to a retailer that does 

17 not have an approved training program, the 

18 amount of the civil penalty shall not ex19 ceed— 

20 (I) in the case of the first viola21 tion, $250; 

22 (II) in the case of a second viola23 tion within a 12-month period, $500; 

24 (III) in the case of a third viola25 tion within a 24-month period, $1,000; 


erowe on PROD1PC71 with BILLS
163 

•HR 1108 RH

1 (IV) in the case of a fourth viola2 tion within a 24-month period, $2,000; 

3 (V) in the case of a fifth violation 

4 within a 36-month period, $5,000; and 

5 (VI) in the case of a sixth or sub6 sequent violation within a 48-month 

7 period, $10,000 as determined by the 

8 Secretary on a case-by-case basis. 

9 (B) TRAINING PROGRAM.—For purposes of 

10 subparagraph (A), the term ‘‘approved training 

11 program’’ means a training program that com12 plies with standards developed by the Food and 

13 Drug Administration for such programs. 

14 (C) CONSIDERATION OF STATE PEN15 ALTIES.—The Secretary shall coordinate with the 

16 States in enforcing the provisions of this Act 

17 and, for purposes of mitigating a civil penalty 

18 to be applied for a violation by a retailer of any 

19 restriction promulgated under section 906(d), 

20 shall consider the amount of any penalties paid 

21 by the retailer to a State for the same violation. 

22 (3) GENERAL EFFECTIVE DATE.—The amend23 ments made by paragraphs (2), (3), and (4) of sub24 section (c) shall take effect upon the issuance of guid25 ance described in paragraph (1) of this subsection. 


erowe on PROD1PC71 with BILLS
164 

•HR 1108 RH

1 (4) SPECIAL EFFECTIVE DATE.—The amendment 

2 made by subsection (c)(1) shall take effect on the date 

3 of enactment of this Act. 

4 (5) PACKAGE LABEL REQUIREMENTS.—The pack5 age label requirements of paragraphs (2), (3), and (4) 

6 of section 903(a) of the Federal Food, Drug, and Cos7 metic Act (as amended by this Act) shall take effect 

8 on the date that is 12 months after the date of enact9 ment of this Act. The effective date shall be with re10 spect to the date of manufacture, provided that, in 

11 any case, 30 days after such effective date, a manu12 facturer shall not introduce into the domestic com13 merce of the United States any product that is not in 

14 conformance with section 903(a)(2), (3), and (4) and 

15 section 920(a) of the Federal Food, Drug, and Cos16 metic Act. 

17 (6) ADVERTISING REQUIREMENTS.—The adver18 tising requirements of section 903(a)(8) of the Federal 

19 Food, Drug, and Cosmetic Act (as amended by this 

20 Act) shall take effect on the date that is 12 months 

21 after the date of enactment of this Act. 

22 SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PUR23 CHASE TOBACCO PRODUCTS. 

24 The Secretary of Health and Human Services shall— 


erowe on PROD1PC71 with BILLS
165 

•HR 1108 RH

1 (1) convene an expert panel to conduct a study 

2 on the public health implications of raising the min3 imum age to purchase tobacco products; and 

4 (2) not later than 5 years after the date of the 

5 enactment of this Act, submit a report to the Congress 

6 on the results of such study. 

7 SEC. 105. TOBACCO INDUSTRY CONCENTRATION. 

8 (a) STUDY.—The Federal Trade Commission shall 

9 conduct a study on the causes and effects of concentration 

10 in the tobacco industry. 

11 (b) PUBLIC REPORT.—The Federal Trade Commission 

12 shall transmit to Congress a report not later than 5 years 

13 after the date of enactment of this Act, and a subsequent 

14 report on the date that is 10 years after the date of enact15 ment of this Act. Such reports shall include— 

16 (1) an analysis of trends in the market share of 

17 any dominant tobacco product manufacturer in any 

18 class of tobacco products; or 

19 (2) an analysis of trends in competition or the 

20 emergence of a monopoly; and 

21 (3) recommendations to Congress on any correc22 tive actions that should be taken to address tobacco 

23 industry concentration. 


erowe on PROD1PC71 with BILLS
166 

•HR 1108 RH

1 TITLE II—TOBACCO PRODUCT 

2 WARNINGS; CONSTITUENT 

3 AND SMOKE CONSTITUENT 

4 DISCLOSURE 

5 SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS. 

6 (a) AMENDMENT.—Section 4 of the Federal Cigarette 

7 Labeling and Advertising Act (15 U.S.C. 1333) is amended 

8 to read as follows: 

9 ‘‘SEC. 4. LABELING. 

10 ‘‘(a) LABEL REQUIREMENTS.— 

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

12 person to manufacture, package, sell, offer to sell, dis13 tribute, or import for sale or distribution within the 

14 United States any cigarettes the package of which 

15 fails to bear, in accordance with the requirements of 

16 this section, one of the following labels: 

17 ‘‘WARNING: Cigarettes are addictive. 

18 ‘‘WARNING: Tobacco smoke can harm your 

19 children. 

20 ‘‘WARNING: Cigarettes cause fatal lung 

21 disease. 

22 ‘‘WARNING: Cigarettes cause cancer. 

23 ‘‘WARNING: Cigarettes cause strokes and 

24 heart disease. 


erowe on PROD1PC71 with BILLS
167 

•HR 1108 RH

1 ‘‘WARNING: Smoking during pregnancy 

2 can harm your baby. 

3 ‘‘WARNING: Smoking can kill you. 

4 ‘‘WARNING: Tobacco smoke causes fatal 

5 lung disease in nonsmokers. 

6 ‘‘WARNING: Quitting smoking now greatly 

7 reduces serious risks to your health. 

8 ‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—Each 

9 label statement required by paragraph (1) shall be lo10 cated in the upper portion of the front and rear pan11 els of the package, directly on the package underneath 

12 the cellophane or other clear wrapping. Each label 

13 statement shall comprise at least the top 30 percent 

14 of the front and rear panels of the package. The word 

15 ‘WARNING’ shall appear in capital letters and all 

16 text shall be in conspicuous and legible 17-point type, 

17 unless the text of the label statement would occupy 

18 more than 70 percent of such area, in which case the 

19 text may be in a smaller conspicuous and legible type 

20 size, provided that at least 60 percent of such area is 

21 occupied by required text. The text shall be black on 

22 a white background, or white on a black background, 

23 in a manner that contrasts, by typography, layout, or 

24 color, with all other printed material on the package, 


erowe on PROD1PC71 with BILLS
168 

•HR 1108 RH

1 in an alternating fashion under the plan submitted 

2 under subsection (c). 

3 ‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU4 TION.—The provisions of this subsection do not apply 

5 to a tobacco product manufacturer or distributor of 

6 cigarettes which does not manufacture, package, or 

7 import cigarettes for sale or distribution within the 

8 United States. 

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

10 of cigarettes shall not be in violation of this subsection 

11 for packaging that— 

12 ‘‘(A) contains a warning label; 

13 ‘‘(B) is supplied to the retailer by a license14 or permit-holding tobacco product manufacturer, 

15 importer, or distributor; and 

16 ‘‘(C) is not altered by the retailer in a way 

17 that is material to the requirements of this sub18 section. 

19 ‘‘(b) ADVERTISING REQUIREMENTS.— 

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

21 tobacco product manufacturer, importer, distributor, 

22 or retailer of cigarettes to advertise or cause to be ad23 vertised within the United States any cigarette unless 

24 its advertising bears, in accordance with the requireVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00168 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
169 

•HR 1108 RH

1 ments of this section, one of the labels specified in 

2 subsection (a). 

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

4 required by subsection (a) in cigarette advertising 

5 shall comply with the standards set forth in this 

6 paragraph. For press and poster advertisements, each 

7 such statement and (where applicable) any required 

8 statement relating to tar, nicotine, or other con9 stituent (including a smoke constituent) yield shall 

10 comprise at least 20 percent of the area of the adver11 tisement and shall appear in a conspicuous and 

12 prominent format and location at the top of each ad13 vertisement within the trim area. The Secretary may 

14 revise the required type sizes in such area in such 

15 manner as the Secretary determines appropriate. The 

16 word ‘WARNING’ shall appear in capital letters, and 

17 each label statement shall appear in conspicuous and 

18 legible type. The text of the label statement shall be 

19 black if the background is white and white if the 

20 background is black, under the plan submitted under 

21 subsection (c). The label statements shall be enclosed 

22 by a rectangular border that is the same color as the 

23 letters of the statements and that is the width of the 

24 first downstroke of the capital ‘W’ of the word 

25 ‘WARNING’ in the label statements. The text of such 


erowe on PROD1PC71 with BILLS
170 

•HR 1108 RH

1 label statements shall be in a typeface pro rata to the 

2 following requirements: 45-point type for a whole3 page broadsheet newspaper advertisement; 39-point 

4 type for a half-page broadsheet newspaper advertise5 ment; 39-point type for a whole-page tabloid news6 paper advertisement; 27-point type for a half-page 

7 tabloid newspaper advertisement; 31.5-point type for 

8 a double page spread magazine or whole-page maga9 zine advertisement; 22.5-point type for a 28 centi10 meter by 3 column advertisement; and 15-point type 

11 for a 20 centimeter by 2 column advertisement. The 

12 label statements shall be in English, except that— 

13 ‘‘(A) in the case of an advertisement that 

14 appears in a newspaper, magazine, periodical, 

15 or other publication that is not in English, the 

16 statements shall appear in the predominant lan17 guage of the publication; and 

18 ‘‘(B) in the case of any other advertisement 

19 that is not in English, the statements shall ap20 pear in the same language as that principally 

21 used in the advertisement. 

22 ‘‘(3) MATCHBOOKS.—Notwithstanding para23 graph (2), for matchbooks (defined as containing not 

24 more than 20 matches) customarily given away with 

25 the purchase of tobacco products, each label statement 


erowe on PROD1PC71 with BILLS
171 

•HR 1108 RH

1 required by subsection (a) may be printed on the in2 side cover of the matchbook. 

3 ‘‘(4) ADJUSTMENT BY SECRETARY.—The Sec4 retary may, through a rulemaking under section 553 

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

6 type sizes for the label statements required by this sec7 tion; the text, format, and type sizes of any required 

8 tar, nicotine yield, or other constituent (including 

9 smoke constituent) disclosures; or the text, format, 

10 and type sizes for any other disclosures required 

11 under the Federal Food, Drug, and Cosmetic Act. The 

12 text of any such label statements or disclosures shall 

13 be required to appear only within the 20 percent area 

14 of cigarette advertisements provided by paragraph 

15 (2). The Secretary shall promulgate regulations which 

16 provide for adjustments in the format and type sizes 

17 of any text required to appear in such area to ensure 

18 that the total text required to appear by law will fit 

19 within such area. 

20 ‘‘(c) MARKETING REQUIREMENTS.— 

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

22 specified in subsection (a)(1) shall be randomly dis23 played in each 12-month period, in as equal a num24 ber of times as is possible on each brand of the prod25 uct and be randomly distributed in all areas of the 


erowe on PROD1PC71 with BILLS
172 

•HR 1108 RH

1 United States in which the product is marketed in ac2 cordance with a plan submitted by the tobacco prod3 uct manufacturer, importer, distributor, or retailer 

4 and approved by the Secretary. 

5 ‘‘(2) ROTATION.—The label statements specified 

6 in subsection (a)(1) shall be rotated quarterly in al7 ternating sequence in advertisements for each brand 

8 of cigarettes in accordance with a plan submitted by 

9 the tobacco product manufacturer, importer, dis10 tributor, or retailer to, and approved by, the Sec11 retary. 

12 ‘‘(3) REVIEW.—The Secretary shall review each 

13 plan submitted under paragraph (2) and approve it 

14 if the plan— 

15 ‘‘(A) will provide for the equal distribution 

16 and display on packaging and the rotation re17 quired in advertising under this subsection; and 

18 ‘‘(B) assures that all of the labels required 

19 under this section will be displayed by the to20 bacco product manufacturer, importer, dis21 tributor, or retailer at the same time. 

22 ‘‘(4) APPLICABILITY TO RETAILERS.—This sub23 section and subsection (b) apply to a retailer only if 

24 that retailer is responsible for or directs the label 

25 statements required under this section except that this 


erowe on PROD1PC71 with BILLS
173 

•HR 1108 RH

1 paragraph shall not relieve a retailer of liability if 

2 the retailer displays, in a location open to the public, 

3 an advertisement that does not contain a warning 

4 label or has been altered by the retailer in a way that 

5 is material to the requirements of this subsection and 

6 subsection (b).’’. 

7 (b) EFFECTIVE DATE.—The amendments made by this 

8 title to section 4 of the Federal Cigarette Labeling and Ad9 vertising Act (15 U.S.C. 1333) shall take effect on the date 

10 that is 1 year after the date of enactment of this Act. 

11 SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING 

12 LABEL STATEMENTS. 

13 Section 4 of the Federal Cigarette Labeling and Adver14 tising Act (15 U.S.C. 1333), as amended by section 201, 

15 is further amended by adding at the end the following: 

16 ‘‘(d) CHANGE IN REQUIRED STATEMENTS.—The Sec17 retary may, by a rulemaking conducted under section 553 

18 of title 5, United States Code, adjust the format, type size, 

19 and text of any of the label requirements, require color 

20 graphics to accompany the text, increase the required label 

21 area from 30 percent up to 50 percent of the front and rear 

22 panels of the package, or establish the format, type size, and 

23 text of any other disclosures required under the Federal 

24 Food, Drug, and Cosmetic Act, if the Secretary finds that 


erowe on PROD1PC71 with BILLS
174 

•HR 1108 RH

1 such a change would promote greater public understanding 

2 of the risks associated with the use of tobacco products.’’. 

3 SEC. 203. STATE REGULATION OF CIGARETTE ADVERTISING 

4 AND PROMOTION. 

5 Section 5 of the Federal Cigarette Labeling and Adver6 tising Act (15 U.S.C. 1334) is amended by adding at the 

7 end the following: 

8 ‘‘(c) EXCEPTION.—Notwithstanding subsection (b), a 

9 State or locality may enact statutes and promulgate regula10 tions, based on smoking and health, that take effect after 

11 the effective date of the Family Smoking Prevention and 

12 Tobacco Control Act, imposing specific bans or restrictions 

13 on the time, place, and manner, but not content, of the ad14 vertising or promotion of any cigarettes.’’. 

15 SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING 

16 WARNINGS. 

17 (a) AMENDMENT.—Section 3 of the Comprehensive 

18 Smokeless Tobacco Health Education Act of 1986 (15 

19 U.S.C. 4402) is amended to read as follows: 

20 ‘‘SEC. 3. SMOKELESS TOBACCO WARNING. 

21 ‘‘(a) GENERAL RULE.— 

22 ‘‘(1) It shall be unlawful for any person to man23 ufacture, package, sell, offer to sell, distribute, or im24 port for sale or distribution within the United States 

25 any smokeless tobacco product unless the product 


erowe on PROD1PC71 with BILLS
175 

•HR 1108 RH

1 package bears, in accordance with the requirements of 

2 this Act, one of the following labels: 

3 ‘‘WARNING: This product can cause mouth 

4 cancer. 

5 ‘‘WARNING: This product can cause gum 

6 disease and tooth loss. 

7 ‘‘WARNING: This product is not a safe al8 ternative to cigarettes. 

9 ‘‘WARNING: Smokeless tobacco is addictive. 

10 ‘‘(2) Each label statement required by paragraph 

11 (1) shall be— 

12 ‘‘(A) located on the 2 principal display 

13 panels of the package, and each label statement 

14 shall comprise at least 30 percent of each such 

15 display panel; and 

16 ‘‘(B) in 17-point conspicuous and legible 

17 type and in black text on a white background, or 

18 white text on a black background, in a manner 

19 that contrasts by typography, layout, or color, 

20 with all other printed material on the package, 

21 in an alternating fashion under the plan sub22 mitted under subsection (b)(3), except that if the 

23 text of a label statement would occupy more than 

24 70 percent of the area specified by subparagraph 

25 (A), such text may appear in a smaller type size, 


erowe on PROD1PC71 with BILLS
176 

•HR 1108 RH

1 so long as at least 60 percent of such warning 

2 area is occupied by the label statement. 

3 ‘‘(3) The label statements required by paragraph 

4 (1) shall be introduced by each tobacco product manu5 facturer, packager, importer, distributor, or retailer of 

6 smokeless tobacco products concurrently into the dis7 tribution chain of such products. 

8 ‘‘(4) The provisions of this subsection do not 

9 apply to a tobacco product manufacturer or dis10 tributor of any smokeless tobacco product that does 

11 not manufacture, package, or import smokeless to12 bacco products for sale or distribution within the 

13 United States. 

14 ‘‘(5) A retailer of smokeless tobacco products 

15 shall not be in violation of this subsection for pack16 aging that— 

17 ‘‘(A) contains a warning label; 

18 ‘‘(B) is supplied to the retailer by a license19 or permit-holding tobacco product manufacturer, 

20 importer, or distributor; and 

21 ‘‘(C) is not altered by the retailer in a way 

22 that is material to the requirements of this sub23 section. 

24 ‘‘(b) REQUIRED LABELS.— 


erowe on PROD1PC71 with BILLS
177 

•HR 1108 RH

1 ‘‘(1) It shall be unlawful for any tobacco product 

2 manufacturer, packager, importer, distributor, or re3 tailer of smokeless tobacco products to advertise or 

4 cause to be advertised within the United States any 

5 smokeless tobacco product unless its advertising bears, 

6 in accordance with the requirements of this section, 

7 one of the labels specified in subsection (a). 

8 ‘‘(2) Each label statement required by subsection 

9 (a) in smokeless tobacco advertising shall comply with 

10 the standards set forth in this paragraph. For press 

11 and poster advertisements, each such statement and 

12 (where applicable) any required statement relating to 

13 tar, nicotine, or other constituent yield shall— 

14 ‘‘(A) comprise at least 20 percent of the 

15 area of the advertisement, and the warning area 

16 shall be delineated by a dividing line of con17 trasting color from the advertisement; and 

18 ‘‘(B) the word ‘WARNING’ shall appear in 

19 capital letters and each label statement shall ap20 pear in conspicuous and legible type. The text of 

21 the label statement shall be black on a white 

22 background, or white on a black background, in 

23 an alternating fashion under the plan submitted 

24 under paragraph (3). 


erowe on PROD1PC71 with BILLS
178 

•HR 1108 RH

1 ‘‘(3)(A) The label statements specified in sub2 section (a)(1) shall be randomly displayed in each 12- 

3 month period, in as equal a number of times as is 

4 possible on each brand of the product and be ran5 domly distributed in all areas of the United States in 

6 which the product is marketed in accordance with a 

7 plan submitted by the tobacco product manufacturer, 

8 importer, distributor, or retailer and approved by the 

9 Secretary. 

10 ‘‘(B) The label statements specified in subsection 

11 (a)(1) shall be rotated quarterly in alternating se12 quence in advertisements for each brand of smokeless 

13 tobacco product in accordance with a plan submitted 

14 by the tobacco product manufacturer, importer, dis15 tributor, or retailer to, and approved by, the Sec16 retary. 

17 ‘‘(C) The Secretary shall review each plan sub18 mitted under subparagraphs (A) and (B) and ap19 prove it if the plan— 

20 ‘‘(i) will provide for the equal distribution 

21 and display on packaging and the rotation re22 quired in advertising under this subsection; and 

23 ‘‘(ii) assures that all of the labels required 

24 under this section will be displayed by the toVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00178 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
179 

•HR 1108 RH

1 bacco product manufacturer, importer, dis2 tributor, or retailer at the same time. 

3 ‘‘(D) This paragraph applies to a retailer only 

4 if that retailer is responsible for or directs the label 

5 statements under this section, unless the retailer dis6 plays, in a location open to the public, an advertise7 ment that does not contain a warning label or has 

8 been altered by the retailer in a way that is material 

9 to the requirements of this subsection. 

10 ‘‘(4) The Secretary may, through a rulemaking 

11 under section 553 of title 5, United States Code, ad12 just the format and type sizes for the label statements 

13 required by this section; the text, format, and type 

14 sizes of any required tar, nicotine yield, or other con15 stituent disclosures; or the text, format, and type sizes 

16 for any other disclosures required under the Federal 

17 Food, Drug, and Cosmetic Act. The text of any such 

18 label statements or disclosures shall be required to ap19 pear only within the 20 percent area of advertise20 ments provided by paragraph (2). The Secretary shall 

21 promulgate regulations which provide for adjustments 

22 in the format and type sizes of any text required to 

23 appear in such area to ensure that the total text re24 quired to appear by law will fit within such area. 


erowe on PROD1PC71 with BILLS
180 

•HR 1108 RH

1 ‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is un2 lawful to advertise smokeless tobacco on any medium of elec3 tronic communications subject to the jurisdiction of the 

4 Federal Communications Commission.’’. 

5 (b) EFFECTIVE DATE.—The amendments made by this 

6 title to section 3 of the Comprehensive Smokeless Tobacco 

7 Health Education Act of 1986 (15 U.S.C. 4402) shall take 

8 effect on the date that is 1 year after the date of enactment 

9 of this Act. 

10 SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO 

11 PRODUCT WARNING LABEL STATEMENTS. 

12 (a) IN GENERAL.—Section 3 of the Comprehensive 

13 Smokeless Tobacco Health Education Act of 1986 (15 

14 U.S.C. 4402), as amended by section 204, is further amend15 ed by adding at the end the following: 

16 ‘‘(d) AUTHORITY TO REVISE WARNING LABEL STATE17 MENTS.—The Secretary may, by a rulemaking conducted 

18 under section 553 of title 5, United States Code, adjust the 

19 format, type size, and text of any of the label requirements, 

20 require color graphics to accompany the text, increase the 

21 required label area from 30 percent up to 50 percent of the 

22 front and rear panels of the package, or establish the format, 

23 type size, and text of any other disclosures required under 

24 the Federal Food, Drug, and Cosmetic Act, if the Secretary 

25 finds that such a change would promote greater public unVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00180 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
181 

•HR 1108 RH

1 derstanding of the risks associated with the use of smokeless 

2 tobacco products.’’. 

3 (b) PREEMPTION.—Section 7(a) of the Comprehensive 

4 Smokeless Tobacco Health Education Act of 1986 (15 

5 U.S.C. 4406(a)) is amended by striking ‘‘No’’ and inserting 

6 ‘‘Except as provided in the Family Smoking Prevention 

7 and Tobacco Control Act (and the amendments made by 

8 that Act), no’’. 

9 SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CON10 STITUENT DISCLOSURE TO THE PUBLIC. 

11 Section 4 of the Federal Cigarette Labeling and Adver12 tising Act (15 U.S.C. 1333), as amended by sections 201 

13 and 202, is further amended by adding at the end the fol14 lowing: 

15 ‘‘(e) TAR, NICOTINE, AND OTHER SMOKE CON16 STITUENT DISCLOSURE.— 

17 ‘‘(1) IN GENERAL.—The Secretary shall, by a 

18 rulemaking conducted under section 553 of title 5, 

19 United States Code, determine (in the Secretary’s sole 

20 discretion) whether cigarette and other tobacco prod21 uct manufacturers shall be required to include in the 

22 area of each cigarette advertisement specified by sub23 section (b) of this section, or on the package label, or 

24 both, the tar and nicotine yields of the advertised or 

25 packaged brand. Any such disclosure shall be in acVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00181 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
182 

•HR 1108 RH

1 cordance with the methodology established under such 

2 regulations, shall conform to the type size require3 ments of subsection (b) of this section, and shall ap4 pear within the area specified in subsection (b) of this 

5 section. 

6 ‘‘(2) RESOLUTION OF DIFFERENCES.—Any dif7 ferences between the requirements established by the 

8 Secretary under paragraph (1) and tar and nicotine 

9 yield reporting requirements established by the Fed10 eral Trade Commission shall be resolved by a memo11 randum of understanding between the Secretary and 

12 the Federal Trade Commission. 

13 ‘‘(3) CIGARETTE AND OTHER TOBACCO PRODUCT

14 CONSTITUENTS.—In addition to the disclosures re15 quired by paragraph (1), the Secretary may, under a 

16 rulemaking conducted under section 553 of title 5, 

17 United States Code, prescribe disclosure requirements 

18 regarding the level of any cigarette or other tobacco 

19 product constituent including any smoke constituent. 

20 Any such disclosure may be required if the Secretary 

21 determines that disclosure would be of benefit to the 

22 public health, or otherwise would increase consumer 

23 awareness of the health consequences of the use of to24 bacco products, except that no such prescribed disclo25 sure shall be required on the face of any cigarette 


erowe on PROD1PC71 with BILLS
183 

•HR 1108 RH

1 package or advertisement. Nothing in this section 

2 shall prohibit the Secretary from requiring such pre3 scribed disclosure through a cigarette or other tobacco 

4 product package or advertisement insert, or by any 

5 other means under the Federal Food, Drug, and Cos6 metic Act. 

7 ‘‘(4) RETAILERS.—This subsection applies to a 

8 retailer only if that retailer is responsible for or di9 rects the label statements required under this sec10 tion.’’. 

11 TITLE III—PREVENTION OF IL12 LICIT TRADE IN TOBACCO 

13 PRODUCTS 

14 SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPEC15 TION. 

16 Chapter IX of the Federal Food, Drug, and Cosmetic 

17 Act, as added by section 101, is further amended by adding 

18 at the end the following: 

19 ‘‘SEC. 920. LABELING, RECORDKEEPING, RECORDS INSPEC20 TION. 

21 ‘‘(a) ORIGIN LABELING.—Beginning 1 year after the 

22 date of enactment of the Family Smoking Prevention and 

23 Tobacco Control Act, the label, packaging, and shipping 

24 containers of tobacco products for introduction or delivery 

25 for introduction into interstate commerce in the United 


erowe on PROD1PC71 with BILLS
184 

•HR 1108 RH

1 States shall bear the statement ‘sale only allowed in the 

2 United States’. 

3 ‘‘(b) REGULATIONS CONCERNING RECORDKEEPING

4 FOR TRACKING AND TRACING.— 

5 ‘‘(1) IN GENERAL.—The Secretary shall promul6 gate regulations regarding the establishment and 

7 maintenance of records by any person who manufac8 tures, processes, transports, distributes, receives, pack9 ages, holds, exports, or imports tobacco products. 

10 ‘‘(2) INSPECTION.—In promulgating the regula11 tions described in paragraph (1), the Secretary shall 

12 consider which records are needed for inspection to 

13 monitor the movement of tobacco products from the 

14 point of manufacture through distribution to retail 

15 outlets to assist in investigating potential illicit 

16 trade, smuggling, or counterfeiting of tobacco prod17 ucts. 

18 ‘‘(3) CODES.—The Secretary may require codes 

19 on the labels of tobacco products or other designs or 

20 devices for the purpose of tracking or tracing the to21 bacco product through the distribution system. 

22 ‘‘(4) SIZE OF BUSINESS.—The Secretary shall 

23 take into account the size of a business in promul24 gating regulations under this section. 


erowe on PROD1PC71 with BILLS
185 

•HR 1108 RH

1 ‘‘(5) RECORDKEEPING BY RETAILERS.—The Sec2 retary shall not require any retailer to maintain 

3 records relating to individual purchasers of tobacco 

4 products for personal consumption. 

5 ‘‘(c) RECORDS INSPECTION.—If the Secretary has a 

6 reasonable belief that a tobacco product is part of an illicit 

7 trade or smuggling or is a counterfeit product, each person 

8 who manufactures, processes, transports, distributes, re9 ceives, holds, packages, exports, or imports tobacco products 

10 shall, at the request of an officer or employee duly des11 ignated by the Secretary, permit such officer or employee, 

12 at reasonable times and within reasonable limits and in 

13 a reasonable manner, upon the presentation of appropriate 

14 credentials and a written notice to such person, to have ac15 cess to and copy all records (including financial records) 

16 relating to such article that are needed to assist the Sec17 retary in investigating potential illicit trade, smuggling, or 

18 counterfeiting of tobacco products. 

19 ‘‘(d) KNOWLEDGE OF ILLEGAL TRANSACTION.— 

20 ‘‘(1) NOTIFICATION.—If the manufacturer or dis21 tributor of a tobacco product has knowledge which 

22 reasonably supports the conclusion that a tobacco 

23 product manufactured or distributed by such manu24 facturer or distributor that has left the control of such 

25 person may be or has been— 


erowe on PROD1PC71 with BILLS
186 

•HR 1108 RH

1 ‘‘(A) imported, exported, distributed, or of2 fered for sale in interstate commerce by a person 

3 without paying duties or taxes required by law; 

4 or 

5 ‘‘(B) imported, exported, distributed, or di6 verted for possible illicit marketing, 

7 the manufacturer or distributor shall promptly notify 

8 the Attorney General and the Secretary of the Treas9 ury of such knowledge. 

10 ‘‘(2) KNOWLEDGE DEFINED.—For purposes of 

11 this subsection, the term ‘knowledge’ as applied to a 

12 manufacturer or distributor means— 

13 ‘‘(A) the actual knowledge that the manu14 facturer or distributor had; or 

15 ‘‘(B) the knowledge which a reasonable per16 son would have had under like circumstances or 

17 which would have been obtained upon the exer18 cise of due care.’’. 

19 SEC. 302. STUDY AND REPORT. 

20 (a) STUDY.—The Comptroller General of the United 

21 States shall conduct a study of cross-border trade in tobacco 

22 products to— 

23 (1) collect data on cross-border trade in tobacco 

24 products, including illicit trade and trade of counterVerDate Aug 31 2005 23:01 Jul 17, 2008 Jkt 069200 PO 00000 Frm 00186 Fmt 6652 Sfmt 6203 E:\BILLS\H1108.RH H1108

erowe on PROD1PC71 with BILLS
187 

•HR 1108 RH

1 feit tobacco products and make recommendations on 

2 the monitoring of such trade; 

3 (2) collect data on cross-border advertising (any 

4 advertising intended to be broadcast, transmitted, or 

5 distributed from the United States to another coun6 try) of tobacco products and make recommendations 

7 on how to prevent or eliminate, and what technologies 

8 could help facilitate the elimination of, cross-border 

9 advertising; and 

10 (3) collect data on the health effects (particularly 

11 with respect to individuals under 18 years of age) re12 sulting from cross-border trade in tobacco products, 

13 including the health effects resulting from— 

14 (A) the illicit trade of tobacco products and 

15 the trade of counterfeit tobacco products; and 

16 (B) the differing tax rates applicable to to17 bacco products. 

18 (b) REPORT.—Not later than 18 months after the date 

19 of enactment of this Act, the Comptroller General of the 

20 United States shall submit to the Committee on Health, 

21 Education, Labor, and Pensions of the Senate and the Com22 mittee on Energy and Commerce of the House of Represent23 atives a report on the study described in subsection (a). 

24 (c) DEFINITION.—In this section: 


erowe on PROD1PC71 with BILLS
188 

•HR 1108 RH

1 (1) The term ‘‘cross-border trade’’ means trade 

2 across a border of the United States, a State or Terri3 tory, or Indian country. 

4 (2) The term ‘‘Indian country’’ has the meaning 

5 given to that term in section 1151 of title 18, United 

6 States Code. 

7 (3) The terms ‘‘State’’ and ‘‘Territory’’ have the 

8 meanings given to those terms in section 201 of the 

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

10 321). 


erowe on PROD1PC71 with BILLS

erowe on PROD1PC71 with BILLS
Union Calendar No. 485 

110TH CONGRESS 

2D SESSION H. R. 1108 

[Report No. 110

–762] 

A BILL 

To protect the public health by providing the Food 

to regulate tobacco products. and Drug Administration with certain authority 

JULY 17, 2008 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 


erowe on PROD1PC71 with BILLS