[Congressional Record (Bound Edition), Volume 154 (2008), Part 12]
[House]
[Pages 17295-17327]
[From the U.S. Government Publishing Office, www.gpo.gov]




           FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

  Mr. DINGELL. Madam Speaker, I move to suspend the rules and pass the 
bill (H.R. 1108) to protect the public health by providing the Food and 
Drug Administration with certain authority to regulate tobacco 
products, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 1108

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

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``Family 
     Smoking Prevention and Tobacco Control Act''.
       (b) Table of Contents.--The table of contents of this Act 
     is as follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.

         TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION

Sec. 101. Amendment of Federal Food, Drug, and Cosmetic Act.
Sec. 102. Final rule.
Sec. 103. Conforming and other amendments to general provisions.
Sec. 104. Study on raising the minimum age to purchase tobacco 
              products.
Sec. 105. Tobacco industry concentration.
Sec. 106. Enforcement action plan for advertising and promotion 
              restrictions.

 TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT 
                               DISCLOSURE

Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Authority to revise cigarette warning label statements.
Sec. 203. State regulation of cigarette advertising and promotion.
Sec. 204. Smokeless tobacco labels and advertising warnings.
Sec. 205. Authority to revise smokeless tobacco product warning label 
              statements.
Sec. 206. Tar, nicotine, and other smoke constituent disclosure to the 
              public.

       TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS

Sec. 301. Labeling, recordkeeping, records inspection.
Sec. 302. Study and report.

               TITLE IV--THRIFT SAVINGS PLAN ENHANCEMENT

Sec. 401. Short title.
Sec. 402. Automatic enrollments.
Sec. 403. Qualified Roth contribution program.
Sec. 404. Authority to establish self-directed investment window.
Sec. 405. Reporting requirements.
Sec. 406. Acknowledgement of risk.
Sec. 407. Credit for unused sick leave.

     SEC. 2. FINDINGS.

       The Congress finds the following:
       (1) The use of tobacco products by the Nation's children is 
     a pediatric disease of considerable proportions that results 
     in new generations of tobacco-dependent children and adults.
       (2) A consensus exists within the scientific and medical 
     communities that tobacco products are inherently dangerous 
     and cause cancer, heart disease, and other serious adverse 
     health effects.
       (3) Nicotine is an addictive drug.
       (4) Virtually all new users of tobacco products are under 
     the minimum legal age to purchase such products.
       (5) Tobacco advertising and marketing contribute 
     significantly to the use of nicotine-containing tobacco 
     products by adolescents.
       (6) Because past efforts to restrict advertising and 
     marketing of tobacco products have failed adequately to curb 
     tobacco use by adolescents, comprehensive restrictions on the 
     sale, promotion, and distribution of such products are 
     needed.
       (7) Federal and State governments have lacked the legal and 
     regulatory authority and resources they need to address 
     comprehensively the public health and societal problems 
     caused by the use of tobacco products.
       (8) Federal and State public health officials, the public 
     health community, and the public at large recognize that the 
     tobacco industry should be subject to ongoing oversight.
       (9) Under article I, section 8 of the Constitution, the 
     Congress is vested with the responsibility for regulating 
     interstate commerce and commerce with Indian tribes.
       (10) The sale, distribution, marketing, advertising, and 
     use of tobacco products are activities in and substantially 
     affecting interstate commerce because they are sold, 
     marketed, advertised, and distributed in interstate commerce 
     on a nationwide basis, and have a substantial effect on the 
     Nation's economy.
       (11) The sale, distribution, marketing, advertising, and 
     use of such products substantially affect interstate commerce 
     through the health care and other costs attributable to the 
     use of tobacco products.
       (12) It is in the public interest for Congress to enact 
     legislation that provides the Food and Drug Administration 
     with the authority to regulate tobacco products and the 
     advertising and promotion of such products. The benefits to 
     the American people from enacting such legislation would be 
     significant in human and economic terms.
       (13) Tobacco use is the foremost preventable cause of 
     premature death in America. It causes over 400,000 deaths in 
     the United States each year, and approximately 8,600,000 
     Americans have chronic illnesses related to smoking.
       (14) Reducing the use of tobacco by minors by 50 percent 
     would prevent well over 10,000,000 of today's children from 
     becoming regular, daily smokers, saving over 3,000,000 of 
     them from premature death due to tobacco-induced disease. 
     Such a reduction in youth smoking would also result in 
     approximately $75,000,000,000 in savings attributable to 
     reduced health care costs.
       (15) Advertising, marketing, and promotion of tobacco 
     products have been especially directed to attract young 
     persons to use tobacco products, and these efforts have 
     resulted in increased use of such products by youth. Past 
     efforts to oversee these activities have not been successful 
     in adequately preventing such increased use.
       (16) In 2005, the cigarette manufacturers spent more than 
     $13,000,000,000 to attract new users, retain current users, 
     increase current consumption, and generate favorable long-
     term attitudes toward smoking and tobacco use.
       (17) Tobacco product advertising often misleadingly 
     portrays the use of tobacco as socially acceptable and 
     healthful to minors.
       (18) Tobacco product advertising is regularly seen by 
     persons under the age of 18, and persons under the age of 18 
     are regularly exposed to tobacco product promotional efforts.
       (19) Through advertisements during and sponsorship of 
     sporting events, tobacco has become strongly associated with 
     sports and has become portrayed as an integral part of sports 
     and the healthy lifestyle associated with rigorous sporting 
     activity.
       (20) Children are exposed to substantial and unavoidable 
     tobacco advertising that leads to favorable beliefs about 
     tobacco use, plays a role in leading young people to 
     overestimate the prevalence of tobacco use, and increases the 
     number of young people who begin to use tobacco.
       (21) The use of tobacco products in motion pictures and 
     other mass media glamorizes its use for young people and 
     encourages them to use tobacco products.
       (22) Tobacco advertising expands the size of the tobacco 
     market by increasing consumption of tobacco products 
     including tobacco use by young people.
       (23) Children are more influenced by tobacco marketing than 
     adults: more than 80 percent of youth smoke three heavily 
     marketed brands, while only 54 percent of adults, 26 and 
     older, smoke these same brands.
       (24) Tobacco company documents indicate that young people 
     are an important and often crucial segment of the tobacco 
     market.

[[Page 17296]]

     Children, who tend to be more price sensitive than adults, 
     are influenced by advertising and promotion practices that 
     result in drastically reduced cigarette prices.
       (25) Comprehensive advertising restrictions will have a 
     positive effect on the smoking rates of young people.
       (26) Restrictions on advertising are necessary to prevent 
     unrestricted tobacco advertising from undermining legislation 
     prohibiting access to young people and providing for 
     education about tobacco use.
       (27) International experience shows that advertising 
     regulations that are stringent and comprehensive have a 
     greater impact on overall tobacco use and young people's use 
     than weaker or less comprehensive ones.
       (28) Text only requirements, although not as stringent as a 
     ban, will help reduce underage use of tobacco products while 
     preserving the informational function of advertising.
       (29) It is in the public interest for Congress to adopt 
     legislation to address the public health crisis created by 
     actions of the tobacco industry.
       (30) The final regulations promulgated by the Secretary of 
     Health and Human Services in the August 28, 1996, issue of 
     the Federal Register (61 Fed. Reg. 44615-44618) for inclusion 
     as part 897 of title 21, Code of Federal Regulations, are 
     consistent with the first amendment to the United States 
     Constitution and with the standards set forth in the 
     amendments made by this subtitle for the regulation of 
     tobacco products by the Food and Drug Administration, and the 
     restriction on the sale and distribution of, including access 
     to and the advertising and promotion of, tobacco products 
     contained in such regulations are substantially related to 
     accomplishing the public health goals of this Act.
       (31) The regulations described in paragraph (30) will 
     directly and materially advance the Federal Government's 
     substantial interest in reducing the number of children and 
     adolescents who use cigarettes and smokeless tobacco and in 
     preventing the life-threatening health consequences 
     associated with tobacco use. An overwhelming majority of 
     Americans who use tobacco products begin using such products 
     while they are minors and become addicted to the nicotine in 
     those products before reaching the age of 18. Tobacco 
     advertising and promotion play a crucial role in the decision 
     of these minors to begin using tobacco products. Less 
     restrictive and less comprehensive approaches have not and 
     will not be effective in reducing the problems addressed by 
     such regulations. The reasonable restrictions on the 
     advertising and promotion of tobacco products contained in 
     such regulations will lead to a significant decrease in the 
     number of minors using and becoming addicted to those 
     products.
       (32) The regulations described in paragraph (30) impose no 
     more extensive restrictions on communication by tobacco 
     manufacturers and sellers than are necessary to reduce the 
     number of children and adolescents who use cigarettes and 
     smokeless tobacco and to prevent the life-threatening health 
     consequences associated with tobacco use. Such regulations 
     are narrowly tailored to restrict those advertising and 
     promotional practices which are most likely to be seen or 
     heard by youth and most likely to entice them into tobacco 
     use, while affording tobacco manufacturers and sellers ample 
     opportunity to convey information about their products to 
     adult consumers.
       (33) Tobacco dependence is a chronic disease, one that 
     typically requires repeated interventions to achieve long-
     term or permanent abstinence.
       (34) Because the only known safe alternative to smoking is 
     cessation, interventions should target all smokers to help 
     them quit completely.
       (35) Tobacco products have been used to facilitate and 
     finance criminal activities both domestically and 
     internationally. Illicit trade of tobacco products has been 
     linked to organized crime and terrorist groups.
       (36) It is essential that the Food and Drug Administration 
     review products sold or distributed for use to reduce risks 
     or exposures associated with tobacco products and that it be 
     empowered to review any advertising and labeling for such 
     products. It is also essential that manufacturers, prior to 
     marketing such products, be required to demonstrate that such 
     products will meet a series of rigorous criteria, and will 
     benefit the health of the population as a whole, taking into 
     account both users of tobacco products and persons who do not 
     currently use tobacco products.
       (37) Unless tobacco products that purport to reduce the 
     risks to the public of tobacco use actually reduce such 
     risks, those products can cause substantial harm to the 
     public health to the extent that the individuals, who would 
     otherwise not consume tobacco products or would consume such 
     products less, use tobacco products purporting to reduce 
     risk. Those who use products sold or distributed as modified 
     risk products that do not in fact reduce risk, rather than 
     quitting or reducing their use of tobacco products, have a 
     substantially increased likelihood of suffering disability 
     and premature death. The costs to society of the widespread 
     use of products sold or distributed as modified risk products 
     that do not in fact reduce risk or that increase risk include 
     thousands of unnecessary deaths and injuries and huge costs 
     to our health care system.
       (38) As the National Cancer Institute has found, many 
     smokers mistakenly believe that ``low tar'' and ``light'' 
     cigarettes cause fewer health problems than other cigarettes. 
     As the National Cancer Institute has also found, mistaken 
     beliefs about the health consequences of smoking ``low tar'' 
     and ``light'' cigarettes can reduce the motivation to quit 
     smoking entirely and thereby lead to disease and death.
       (39) Recent studies have demonstrated that there has been 
     no reduction in risk on a population-wide basis from ``low 
     tar'' and ``light'' cigarettes, and such products may 
     actually increase the risk of tobacco use.
       (40) The dangers of products sold or distributed as 
     modified risk tobacco products that do not in fact reduce 
     risk are so high that there is a compelling governmental 
     interest in ensuring that statements about modified risk 
     tobacco products are complete, accurate, and relate to the 
     overall disease risk of the product.
       (41) As the Federal Trade Commission has found, consumers 
     have misinterpreted advertisements in which one product is 
     claimed to be less harmful than a comparable product, even in 
     the presence of disclosures and advisories intended to 
     provide clarification.
       (42) Permitting manufacturers to make unsubstantiated 
     statements concerning modified risk tobacco products, whether 
     express or implied, even if accompanied by disclaimers would 
     be detrimental to the public health.
       (43) The only way to effectively protect the public health 
     from the dangers of unsubstantiated modified risk tobacco 
     products is to empower the Food and Drug Administration to 
     require that products that tobacco manufacturers sold or 
     distributed for risk reduction be reviewed in advance of 
     marketing, and to require that the evidence relied on to 
     support claims be fully verified.
       (44) The Food and Drug Administration is a regulatory 
     agency with the scientific expertise to identify harmful 
     substances in products to which consumers are exposed, to 
     design standards to limit exposure to those substances, to 
     evaluate scientific studies supporting claims about the 
     safety of products, and to evaluate the impact of labels, 
     labeling, and advertising on consumer behavior in order to 
     reduce the risk of harm and promote understanding of the 
     impact of the product on health. In connection with its 
     mandate to promote health and reduce the risk of harm, the 
     Food and Drug Administration routinely makes decisions about 
     whether and how products may be marketed in the United 
     States.
       (45) The Federal Trade Commission was created to protect 
     consumers from unfair or deceptive acts or practices, and to 
     regulate unfair methods of competition. Its focus is on those 
     marketplace practices that deceive or mislead consumers, and 
     those that give some competitors an unfair advantage. Its 
     mission is to regulate activities in the marketplace. Neither 
     the Federal Trade Commission nor any other Federal agency 
     except the Food and Drug Administration possesses the 
     scientific expertise needed to implement effectively all 
     provisions of the Family Smoking Prevention and Tobacco 
     Control Act.
       (46) If manufacturers state or imply in communications 
     directed to consumers through the media or through a label, 
     labeling, or advertising, that a tobacco product is approved 
     or inspected by the Food and Drug Administration or complies 
     with Food and Drug Administration standards, consumers are 
     likely to be confused and misled. Depending upon the 
     particular language used and its context, such a statement 
     could result in consumers being misled into believing that 
     the product is endorsed by the Food and Drug Administration 
     for use or in consumers being misled about the harmfulness of 
     the product because of such regulation, inspection, approval, 
     or compliance.
       (47) If manufacturers are permitted to state or imply in 
     communications directed to consumers that a tobacco product 
     is approved or inspected by the Food and Drug Administration 
     or complies with Food and Drug Administration standards, 
     consumers are likely to be confused and misled. Such a 
     statement could result in consumers being misled into 
     believing that the product is endorsed by the Food and Drug 
     Administration for use or in consumers being misled about the 
     harmfulness of the product because of such regulation, 
     inspection, or compliance.
       (48) In August 2006 a United States district court judge 
     found that the major United States cigarette companies 
     continue to target and market to youth. USA v Philip Morris, 
     USA, Inc., et al. (Civil Action No. 99-2496 (GK), August 17, 
     2006).
       (49) In August 2006 a United States district court judge 
     found that the major United States cigarette companies 
     dramatically increased their advertising and promotional 
     spending in ways that encourage youth to start smoking 
     subsequent to the signing of the Master Settlement Agreement 
     in 1998. USA v Philip Morris, USA, Inc., et al. (Civil Action 
     No. 99-2496 (GK), August 17, 2006).
       (50) In August 2006 a United States district court judge 
     found that the major United States cigarette companies have 
     designed their cigarettes to precisely control nicotine 
     delivery levels and provide doses of nicotine

[[Page 17297]]

     sufficient to create and sustain addiction while also 
     concealing much of their nicotine-related research. USA v 
     Philip Morris, USA, Inc., et al. (Civil Action No. 99-2496 
     (GK), August 17, 2006).

     SEC. 3. PURPOSE.

       The purposes of this Act are--
       (1) to provide authority to the Food and Drug 
     Administration to regulate tobacco products under the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), by 
     recognizing it as the primary Federal regulatory authority 
     with respect to the manufacture, marketing, and distribution 
     of tobacco products as provided for in this Act;
       (2) to ensure that the Food and Drug Administration has the 
     authority to address issues of particular concern to public 
     health officials, especially the use of tobacco by young 
     people and dependence on tobacco;
       (3) to authorize the Food and Drug Administration to set 
     national standards controlling the manufacture of tobacco 
     products and the identity, public disclosure, and amount of 
     ingredients used in such products;
       (4) to provide new and flexible enforcement authority to 
     ensure that there is effective oversight of the tobacco 
     industry's efforts to develop, introduce, and promote less 
     harmful tobacco products;
       (5) to vest the Food and Drug Administration with the 
     authority to regulate the levels of tar, nicotine, and other 
     harmful components of tobacco products;
       (6) in order to ensure that consumers are better informed, 
     to require tobacco product manufacturers to disclose research 
     which has not previously been made available, as well as 
     research generated in the future, relating to the health and 
     dependency effects or safety of tobacco products;
       (7) to continue to permit the sale of tobacco products to 
     adults in conjunction with measures to ensure that they are 
     not sold or accessible to underage purchasers;
       (8) to impose appropriate regulatory controls on the 
     tobacco industry;
       (9) to promote cessation to reduce disease risk and the 
     social costs associated with tobacco-related diseases; and
       (10) to strengthen legislation against illicit trade in 
     tobacco products.

     SEC. 4. SCOPE AND EFFECT.

       (a) Intended Effect.--Nothing in this Act (or an amendment 
     made by this Act) shall be construed to--
       (1) establish a precedent with regard to any other 
     industry, situation, circumstance, or legal action; or
       (2) affect any action pending in Federal, State, or Tribal 
     court, or any agreement, consent decree, or contract of any 
     kind.
       (b) Agricultural Activities.--The provisions of this Act 
     (or an amendment made by this Act) which authorize the 
     Secretary to take certain actions with regard to tobacco and 
     tobacco products shall not be construed to affect any 
     authority of the Secretary of Agriculture under existing law 
     regarding the growing, cultivation, or curing of raw tobacco.
       (c) Revenue Activities.--The provisions of this Act (or an 
     amendment made by this Act) which authorize the Secretary to 
     take certain actions with regard to tobacco products shall 
     not be construed to affect any authority of the Secretary of 
     the Treasury under chapter 52 of the Internal Revenue Code of 
     1986.

     SEC. 5. SEVERABILITY.

       If any provision of this Act, the amendments made by this 
     Act, or the application of any provision of this Act to any 
     person or circumstance is held to be invalid, the remainder 
     of this Act, the amendments made by this Act, and the 
     application of the provisions of this Act to any other person 
     or circumstance shall not be affected and shall continue to 
     be enforced to the fullest extent possible.

         TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION

     SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.

       (a) Definition of Tobacco Products.--Section 201 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is 
     amended by adding at the end the following:
       ``(rr)(1) The term `tobacco product' means any product made 
     or derived from tobacco that is intended for human 
     consumption, including any component, part, or accessory of a 
     tobacco product (except for raw materials other than tobacco 
     used in manufacturing a component, part, or accessory of a 
     tobacco product).
       ``(2) The term `tobacco product' does not mean an article 
     that is a drug under subsection (g)(1), a device under 
     subsection (h), or a combination product described in section 
     503(g).
       ``(3) The products described in paragraph (2) shall be 
     subject to chapter V of this Act.
       ``(4) A tobacco product may not be marketed in combination 
     with any other article or product regulated under this Act 
     (including a drug, biologic, food, cosmetic, medical device, 
     or a dietary supplement).''.
       (b) FDA Authority Over Tobacco Products.--The Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
       (1) by redesignating chapter IX as chapter X;
       (2) by redesignating sections 901 through 910 as sections 
     1001 through 1010; and
       (3) by inserting after chapter VIII the following:

                     ``CHAPTER IX--TOBACCO PRODUCTS

     ``SEC. 900. DEFINITIONS.

       ``In this chapter:
       ``(1) Additive.--The term `additive' means any substance 
     the intended use of which results or may reasonably be 
     expected to result, directly or indirectly, in its becoming a 
     component or otherwise affecting the characteristic of any 
     tobacco product (including any substances intended for use as 
     a flavoring or coloring or in producing, manufacturing, 
     packing, processing, preparing, treating, packaging, 
     transporting, or holding), except that such term does not 
     include tobacco or a pesticide chemical residue in or on raw 
     tobacco or a pesticide chemical.
       ``(2) Brand.--The term `brand' means a variety of tobacco 
     product distinguished by the tobacco used, tar content, 
     nicotine content, flavoring used, size, filtration, 
     packaging, logo, registered trademark, brand name, 
     identifiable pattern of colors, or any combination of such 
     attributes.
       ``(3) Cigarette.--The term `cigarette'--
       ``(A) means a product that--
       ``(i) is a tobacco product; and
       ``(ii) meets the definition of the term `cigarette' in 
     section 3(1) of the Federal Cigarette Labeling and 
     Advertising Act; and
       ``(B) includes tobacco, in any form, that is functional in 
     the product, which, because of its appearance, the type of 
     tobacco used in the filler, or its packaging and labeling, is 
     likely to be offered to, or purchased by, consumers as a 
     cigarette or as roll-your-own tobacco.
       ``(4) Cigarette tobacco.--The term `cigarette tobacco' 
     means any product that consists of loose tobacco that is 
     intended for use by consumers in a cigarette. Unless 
     otherwise stated, the requirements applicable to cigarettes 
     under this chapter shall also apply to cigarette tobacco.
       ``(5) Commerce.--The term `commerce' has the meaning given 
     that term by section 3(2) of the Federal Cigarette Labeling 
     and Advertising Act.
       ``(6) Counterfeit tobacco product.--The term `counterfeit 
     tobacco product' means a tobacco product (or the container or 
     labeling of such a product) that, without authorization, 
     bears the trademark, trade name, or other identifying mark, 
     imprint, or device, or any likeness thereof, of a tobacco 
     product listed in a registration under section 905(i)(1).
       ``(7) Distributor.--The term `distributor' as regards a 
     tobacco product means any person who furthers the 
     distribution of a tobacco product, whether domestic or 
     imported, at any point from the original place of manufacture 
     to the person who sells or distributes the product to 
     individuals for personal consumption. Common carriers are not 
     considered distributors for purposes of this chapter.
       ``(8) Illicit trade.--The term `illicit trade' means any 
     practice or conduct prohibited by law which relates to 
     production, shipment, receipt, possession, distribution, 
     sale, or purchase of tobacco products including any practice 
     or conduct intended to facilitate such activity.
       ``(9) Indian tribe.--The term `Indian tribe' has the 
     meaning given such term in section 4(e) of the Indian Self-
     Determination and Education Assistance Act.
       ``(10) Little cigar.--The term `little cigar' means a 
     product that--
       ``(A) is a tobacco product; and
       ``(B) meets the definition of the term `little cigar' in 
     section 3(7) of the Federal Cigarette Labeling and 
     Advertising Act.
       ``(11) Nicotine.--The term `nicotine' means the chemical 
     substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or 
     C[10]H[14]N[2], including any salt or complex of nicotine.
       ``(12) Package.--The term `package' means a pack, box, 
     carton, or container of any kind or, if no other container, 
     any wrapping (including cellophane), in which a tobacco 
     product is offered for sale, sold, or otherwise distributed 
     to consumers.
       ``(13) Retailer.--The term `retailer' means any person, 
     government, or entity who sells tobacco products to 
     individuals for personal consumption, or who operates a 
     facility where self-service displays of tobacco products are 
     permitted.
       ``(14) Roll-your-own tobacco.--The term `roll-your-own 
     tobacco' means any tobacco product which, because of its 
     appearance, type, packaging, or labeling, is suitable for use 
     and likely to be offered to, or purchased by, consumers as 
     tobacco for making cigarettes.
       ``(15) Small tobacco product manufacturer.--The term `small 
     tobacco product manufacturer' means a tobacco product 
     manufacturer that employs fewer than 350 employees. For 
     purposes of determining the number of employees of a 
     manufacturer under the preceding sentence, the employees of a 
     manufacturer are deemed to include the employees of each 
     entity that controls, is controlled by, or is under common 
     control with such manufacturer.
       ``(16) Smoke constituent.--The term `smoke constituent' 
     means any chemical or chemical compound in mainstream or 
     sidestream tobacco smoke that either transfers from any 
     component of the cigarette to the smoke or that is formed by 
     the combustion or heating of tobacco, additives, or other 
     component of the tobacco product.

[[Page 17298]]

       ``(17) Smokeless tobacco.--The term `smokeless tobacco' 
     means any tobacco product that consists of cut, ground, 
     powdered, or leaf tobacco and that is intended to be placed 
     in the oral or nasal cavity.
       ``(18) State; territory.--The terms `State' and `Territory' 
     shall have the meanings given to such terms in section 201.
       ``(19) Tobacco product manufacturer.--The term `tobacco 
     product manufacturer' means any person, including any 
     repacker or relabeler, who--
       ``(A) manufactures, fabricates, assembles, processes, or 
     labels a tobacco product; or
       ``(B) imports a finished tobacco product for sale or 
     distribution in the United States.
       ``(20) Tobacco warehouse.--
       ``(A) Subject to subparagraphs (B) and (C), the term 
     `tobacco warehouse' includes any person--
       ``(i) who--

       ``(I) removes foreign material from tobacco leaf through 
     nothing other than a mechanical process;
       ``(II) humidifies tobacco leaf with nothing other than 
     potable water in the form of steam or mist; or
       ``(III) de-stems, dries, and packs tobacco leaf for storage 
     and shipment;

       ``(ii) who performs no other actions with respect to 
     tobacco leaf; and
       ``(iii) who provides to any manufacturer to whom the person 
     sells tobacco all information related to the person's actions 
     described in clause (i) that is necessary for compliance with 
     this Act.
       ``(B) The term `tobacco warehouse' excludes any person 
     who--
       ``(i) reconstitutes tobacco leaf;
       ``(ii) is a manufacturer, distributor, or retailer of a 
     tobacco product; or
       ``(iii) applies any chemical, additive, or substance to the 
     tobacco leaf other than potable water in the form of steam or 
     mist.
       ``(C) The definition of the term `tobacco warehouse' in 
     subparagraph (A) shall not apply to the extent to which the 
     Secretary determines, through rulemaking, that regulation 
     under this chapter of the actions described in such 
     subparagraph is appropriate for the protection of the public 
     health.
       ``(21) United states.--The term `United States' means the 
     50 States of the United States of America and the District of 
     Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin 
     Islands, American Samoa, Wake Island, Midway Islands, Kingman 
     Reef, Johnston Atoll, the Northern Mariana Islands, and any 
     other trust territory or possession of the United States.

     ``SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.

       ``(a) In General.--Tobacco products, including modified 
     risk tobacco products for which an order has been issued in 
     accordance with section 911, shall be regulated by the 
     Secretary under this chapter and shall not be subject to the 
     provisions of chapter V.
       ``(b) Applicability.--This chapter shall apply to all 
     cigarettes, cigarette tobacco, roll-your-own tobacco, and 
     smokeless tobacco and to any other tobacco products that the 
     Secretary by regulation deems to be subject to this chapter.
       ``(c) Scope.--
       ``(1) In general.--Nothing in this chapter, or any policy 
     issued or regulation promulgated thereunder, or in sections 
     101(a), 102, or 103 of title I, title II, or title III of the 
     Family Smoking Prevention and Tobacco Control Act, shall be 
     construed to affect, expand, or limit the Secretary's 
     authority over (including the authority to determine whether 
     products may be regulated), or the regulation of, products 
     under this Act that are not tobacco products under chapter V 
     or any other chapter.
       ``(2) Limitation of authority.--
       ``(A) In general.--The provisions of this chapter shall not 
     apply to tobacco leaf that is not in the possession of a 
     manufacturer of tobacco products, or to the producers of 
     tobacco leaf, including tobacco growers, tobacco warehouses, 
     and tobacco grower cooperatives, nor shall any employee of 
     the Food and Drug Administration have any authority to enter 
     onto a farm owned by a producer of tobacco leaf without the 
     written consent of such producer.
       ``(B) Exception.--Notwithstanding subparagraph (A), if a 
     producer of tobacco leaf is also a tobacco product 
     manufacturer or controlled by a tobacco product manufacturer, 
     the producer shall be subject to this chapter in the 
     producer's capacity as a manufacturer. The exception in this 
     subparagraph shall not apply to a producer of tobacco leaf 
     who grows tobacco under a contract with a tobacco product 
     manufacturer and who is not otherwise engaged in the 
     manufacturing process.
       ``(C) Rule of construction.--Nothing in this chapter shall 
     be construed to grant the Secretary authority to promulgate 
     regulations on any matter that involves the production of 
     tobacco leaf or a producer thereof, other than activities by 
     a manufacturer affecting production.
       ``(d) Rulemaking Procedures.--Each rulemaking under this 
     chapter shall be in accordance with chapter 5 of title 5, 
     United States Code. This subsection shall not be construed to 
     affect the rulemaking provisions of section 102(a) of the 
     Family Smoking Prevention and Tobacco Control Act.
       ``(e) Center for Tobacco Products.--Not later than 90 days 
     after the date of enactment of this chapter, the Secretary 
     shall establish within the Food and Drug Administration the 
     Center for Tobacco Products, which shall report to the 
     Commissioner of Food and Drugs in the same manner as the 
     other agency centers within the Food and Drug Administration. 
     The Center shall be responsible for the implementation of 
     this chapter and related matters assigned by the 
     Commissioner.
       ``(f) Office to Assist Small Tobacco Product 
     Manufacturers.--The Secretary shall establish within the Food 
     and Drug Administration an identifiable office to provide 
     technical and other nonfinancial assistance to small tobacco 
     product manufacturers to assist them in complying with the 
     requirements of this Act.
       ``(g) Consultation Prior to Rulemaking.--Prior to 
     promulgating rules under this chapter, the Secretary shall 
     endeavor to consult with other Federal agencies as 
     appropriate.

     ``SEC. 902. ADULTERATED TOBACCO PRODUCTS.

       ``A tobacco product shall be deemed to be adulterated if--
       ``(1) it consists in whole or in part of any filthy, 
     putrid, or decomposed substance, or is otherwise contaminated 
     by any added poisonous or added deleterious substance that 
     may render the product injurious to health;
       ``(2) it has been prepared, packed, or held under 
     insanitary conditions whereby it may have been contaminated 
     with filth, or whereby it may have been rendered injurious to 
     health;
       ``(3) its package is composed, in whole or in part, of any 
     poisonous or deleterious substance which may render the 
     contents injurious to health;
       ``(4) the manufacturer or importer of the tobacco product 
     fails to pay a user fee assessed to such manufacturer or 
     importer pursuant to section 919 by the date specified in 
     section 919 or by the 30th day after final agency action on a 
     resolution of any dispute as to the amount of such fee;
       ``(5) it is, or purports to be or is represented as, a 
     tobacco product which is subject to a tobacco product 
     standard established under section 907 unless such tobacco 
     product is in all respects in conformity with such standard;
       ``(6)(A) it is required by section 910(a) to have premarket 
     review and does not have an order in effect under section 
     910(c)(1)(A)(i); or
       ``(B) it is in violation of an order under section 
     910(c)(1)(A);
       ``(7) the methods used in, or the facilities or controls 
     used for, its manufacture, packing, or storage are not in 
     conformity with applicable requirements under section 
     906(e)(1) or an applicable condition prescribed by an order 
     under section 906(e)(2); or
       ``(8) it is in violation of section 911.

     ``SEC. 903. MISBRANDED TOBACCO PRODUCTS.

       ``(a) In General.--A tobacco product shall be deemed to be 
     misbranded--
       ``(1) if its labeling is false or misleading in any 
     particular;
       ``(2) if in package form unless it bears a label 
     containing--
       ``(A) the name and place of business of the tobacco product 
     manufacturer, packer, or distributor;
       ``(B) an accurate statement of the quantity of the contents 
     in terms of weight, measure, or numerical count;
       ``(C) an accurate statement of the percentage of the 
     tobacco used in the product that is domestically grown 
     tobacco and the percentage that is foreign grown tobacco; and
       ``(D) the statement required under section 920(a),

     except that under subparagraph (B) reasonable variations 
     shall be permitted, and exemptions as to small packages shall 
     be established, by regulations prescribed by the Secretary;
       ``(3) if any word, statement, or other information required 
     by or under authority of this chapter to appear on the label 
     or labeling is not prominently placed thereon with such 
     conspicuousness (as compared with other words, statements, or 
     designs in the labeling) and in such terms as to render it 
     likely to be read and understood by the ordinary individual 
     under customary conditions of purchase and use;
       ``(4) if it has an established name, unless its label 
     bears, to the exclusion of any other nonproprietary name, its 
     established name prominently printed in type as required by 
     the Secretary by regulation;
       ``(5) if the Secretary has issued regulations requiring 
     that its labeling bear adequate directions for use, or 
     adequate warnings against use by children, that are necessary 
     for the protection of users unless its labeling conforms in 
     all respects to such regulations;
       ``(6) if it was manufactured, prepared, propagated, 
     compounded, or processed in an establishment not duly 
     registered under section 905(b), 905(c), 905(d), or 905(h), 
     if it was not included in a list required by section 905(i), 
     if a notice or other information respecting it was not 
     provided as required by such section or section 905(j), or if 
     it does not bear such symbols from the uniform system for 
     identification of tobacco products prescribed under section 
     905(e) as the Secretary by regulation requires;
       ``(7) if, in the case of any tobacco product distributed or 
     offered for sale in any State--

[[Page 17299]]

       ``(A) its advertising is false or misleading in any 
     particular; or
       ``(B) it is sold or distributed in violation of regulations 
     prescribed under section 906(d);
       ``(8) unless, in the case of any tobacco product 
     distributed or offered for sale in any State, the 
     manufacturer, packer, or distributor thereof includes in all 
     advertisements and other descriptive printed matter issued or 
     caused to be issued by the manufacturer, packer, or 
     distributor with respect to that tobacco product--
       ``(A) a true statement of the tobacco product's established 
     name as described in paragraph (4), printed prominently; and
       ``(B) a brief statement of--
       ``(i) the uses of the tobacco product and relevant 
     warnings, precautions, side effects, and contraindications; 
     and
       ``(ii) in the case of specific tobacco products made 
     subject to a finding by the Secretary after notice and 
     opportunity for comment that such action is appropriate to 
     protect the public health, a full description of the 
     components of such tobacco product or the formula showing 
     quantitatively each ingredient of such tobacco product to the 
     extent required in regulations which shall be issued by the 
     Secretary after an opportunity for a hearing;
       ``(9) if it is a tobacco product subject to a tobacco 
     product standard established under section 907, unless it 
     bears such labeling as may be prescribed in such tobacco 
     product standard; or
       ``(10) if there was a failure or refusal--
       ``(A) to comply with any requirement prescribed under 
     section 904 or 908; or
       ``(B) to furnish any material or information required under 
     section 909.
       ``(b) Prior Approval of Label Statements.--The Secretary 
     may, by regulation, require prior approval of statements made 
     on the label of a tobacco product. No regulation issued under 
     this subsection may require prior approval by the Secretary 
     of the content of any advertisement, except for modified risk 
     tobacco products as provided in section 911. No advertisement 
     of a tobacco product published after the date of enactment of 
     the Family Smoking Prevention and Tobacco Control Act shall, 
     with respect to the language of label statements as 
     prescribed under section 4 of the Federal Cigarette Labeling 
     and Advertising Act and section 3 of the Comprehensive 
     Smokeless Tobacco Health Education Act of 1986 or the 
     regulations issued under such sections, be subject to the 
     provisions of sections 12 through 15 of the Federal Trade 
     Commission Act.

     ``SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE 
                   SECRETARY.

       ``(a) Requirement.--Each tobacco product manufacturer or 
     importer, or agents thereof, shall submit to the Secretary 
     the following information:
       ``(1) Not later than 6 months after the date of enactment 
     of the Family Smoking Prevention and Tobacco Control Act, a 
     listing of all ingredients, including tobacco, substances, 
     compounds, and additives that are, as of such date, added by 
     the manufacturer to the tobacco, paper, filter, or other part 
     of each tobacco product by brand and by quantity in each 
     brand and subbrand.
       ``(2) A description of the content, delivery, and form of 
     nicotine in each tobacco product measured in milligrams of 
     nicotine in accordance with regulations promulgated by the 
     Secretary in accordance with section 4(e) of the Federal 
     Cigarette Labeling and Advertising Act.
       ``(3) Beginning 3 years after the date of enactment of this 
     Act, a listing of all constituents, including smoke 
     constituents as applicable, identified by the Secretary as 
     harmful or potentially harmful to health in each tobacco 
     product, and as applicable in the smoke of each tobacco 
     product, by brand and by quantity in each brand and subbrand. 
     Effective beginning 3 years after the date of enactment of 
     this chapter, the manufacturer, importer, or agent shall 
     comply with regulations promulgated under section 915 in 
     reporting information under this paragraph, where applicable.
       ``(4) Beginning 6 months after the date of enactment of the 
     Family Smoking Prevention and Tobacco Control Act, all 
     documents developed after the date of enactment of the Family 
     Smoking Prevention and Tobacco Control Act that relate to 
     health, toxicological, behavioral, or physiologic effects of 
     current or future tobacco products, their constituents 
     (including smoke constituents), ingredients, components, and 
     additives.
       ``(b) Data Submission.--At the request of the Secretary, 
     each tobacco product manufacturer or importer of tobacco 
     products, or agents thereof, shall submit the following:
       ``(1) Any or all documents (including underlying scientific 
     information) relating to research activities, and research 
     findings, conducted, supported, or possessed by the 
     manufacturer (or agents thereof) on the health, 
     toxicological, behavioral, or physiologic effects of tobacco 
     products and their constituents (including smoke 
     constituents), ingredients, components, and additives.
       ``(2) Any or all documents (including underlying scientific 
     information) relating to research activities, and research 
     findings, conducted, supported, or possessed by the 
     manufacturer (or agents thereof) that relate to the issue of 
     whether a reduction in risk to health from tobacco products 
     can occur upon the employment of technology available or 
     known to the manufacturer.
       ``(3) Any or all documents (including underlying scientific 
     or financial information) relating to marketing research 
     involving the use of tobacco products or marketing practices 
     and the effectiveness of such practices used by tobacco 
     manufacturers and distributors.

     An importer of a tobacco product not manufactured in the 
     United States shall supply the information required of a 
     tobacco product manufacturer under this subsection.
       ``(c) Time for Submission.--
       ``(1) In general.--At least 90 days prior to the delivery 
     for introduction into interstate commerce of a tobacco 
     product not on the market on the date of enactment of the 
     Family Smoking Prevention and Tobacco Control Act, the 
     manufacturer of such product shall provide the information 
     required under subsection (a).
       ``(2) Disclosure of additive.--If at any time a tobacco 
     product manufacturer adds to its tobacco products a new 
     tobacco additive or increases the quantity of an existing 
     tobacco additive, the manufacturer shall, except as provided 
     in paragraph (3), at least 90 days prior to such action so 
     advise the Secretary in writing.
       ``(3) Disclosure of other actions.--If at any time a 
     tobacco product manufacturer eliminates or decreases an 
     existing additive, or adds or increases an additive that has 
     by regulation been designated by the Secretary as an additive 
     that is not a human or animal carcinogen, or otherwise 
     harmful to health under intended conditions of use, the 
     manufacturer shall within 60 days of such action so advise 
     the Secretary in writing.
       ``(d) Data List.--
       ``(1) In general.--Not later than 3 years after the date of 
     enactment of the Family Smoking Prevention and Tobacco 
     Control Act, and annually thereafter, the Secretary shall 
     publish in a format that is understandable and not misleading 
     to a lay person, and place on public display (in a manner 
     determined by the Secretary) the list established under 
     subsection (e).
       ``(2) Consumer research.--The Secretary shall conduct 
     periodic consumer research to ensure that the list published 
     under paragraph (1) is not misleading to lay persons. Not 
     later than 5 years after the date of enactment of the Family 
     Smoking Prevention and Tobacco Control Act, the Secretary 
     shall submit to the appropriate committees of Congress a 
     report on the results of such research, together with 
     recommendations on whether such publication should be 
     continued or modified.
       ``(e) Data Collection.--Not later than 24 months after the 
     date of enactment of the Family Smoking Prevention and 
     Tobacco Control Act, the Secretary shall establish, and 
     periodically revise as appropriate, a list of harmful and 
     potentially harmful constituents, including smoke 
     constituents, to health in each tobacco product by brand and 
     by quantity in each brand and subbrand. The Secretary shall 
     publish a public notice requesting the submission by 
     interested persons of scientific and other information 
     concerning the harmful and potentially harmful constituents 
     in tobacco products and tobacco smoke.

     ``SEC. 905. ANNUAL REGISTRATION.

       ``(a) Definitions.--In this section:
       ``(1) Manufacture, preparation, compounding, or 
     processing.--The term `manufacture, preparation, compounding, 
     or processing' shall include repackaging or otherwise 
     changing the container, wrapper, or labeling of any tobacco 
     product package in furtherance of the distribution of the 
     tobacco product from the original place of manufacture to the 
     person who makes final delivery or sale to the ultimate 
     consumer or user.
       ``(2) Name.--The term `name' shall include in the case of a 
     partnership the name of each partner and, in the case of a 
     corporation, the name of each corporate officer and director, 
     and the State of incorporation.
       ``(b) Registration by Owners and Operators.--On or before 
     December 31 of each year, every person who owns or operates 
     any establishment in any State engaged in the manufacture, 
     preparation, compounding, or processing of a tobacco product 
     or tobacco products shall register with the Secretary the 
     name, places of business, and all such establishments of that 
     person. If the enactment of this Act occurs in the second 
     half of the calendar year, the Secretary shall designate a 
     date no later than 6 months into the subsequent calendar year 
     by which registration pursuant to this subsection shall 
     occur.
       ``(c) Registration by New Owners and Operators.--Every 
     person upon first engaging in the manufacture, preparation, 
     compounding, or processing of a tobacco product or tobacco 
     products in any establishment owned or operated in any State 
     by that person shall immediately register with the Secretary 
     that person's name, place of business, and such 
     establishment.
       ``(d) Registration of Added Establishments.--Every person 
     required to register under subsection (b) or (c) shall 
     immediately register with the Secretary any additional 
     establishment which that person owns or operates in any State 
     and in which that person begins the manufacture, preparation, 
     compounding, or processing of a tobacco product or tobacco 
     products.

[[Page 17300]]

       ``(e) Uniform Product Identification System.--The Secretary 
     may by regulation prescribe a uniform system for the 
     identification of tobacco products and may require that 
     persons who are required to list such tobacco products under 
     subsection (i) shall list such tobacco products in accordance 
     with such system.
       ``(f) Public Access to Registration Information.--The 
     Secretary shall make available for inspection, to any person 
     so requesting, any registration filed under this section.
       ``(g) Biennial Inspection of Registered Establishments.--
     Every establishment registered with the Secretary under this 
     section shall be subject to inspection under section 704 or 
     subsection (h), and every such establishment engaged in the 
     manufacture, compounding, or processing of a tobacco product 
     or tobacco products shall be so inspected by 1 or more 
     officers or employees duly designated by the Secretary at 
     least once in the 2-year period beginning with the date of 
     registration of such establishment under this section and at 
     least once in every successive 2-year period thereafter.
       ``(h) Registration by Foreign Establishments.--Any 
     establishment within any foreign country engaged in the 
     manufacture, preparation, compounding, or processing of a 
     tobacco product or tobacco products, shall register under 
     this section under regulations promulgated by the Secretary. 
     Such regulations shall require such establishment to provide 
     the information required by subsection (i) and shall include 
     provisions for registration of any such establishment upon 
     condition that adequate and effective means are available, by 
     arrangement with the government of such foreign country or 
     otherwise, to enable the Secretary to determine from time to 
     time whether tobacco products manufactured, prepared, 
     compounded, or processed in such establishment, if imported 
     or offered for import into the United States, shall be 
     refused admission on any of the grounds set forth in section 
     801(a).
       ``(i) Registration Information.--
       ``(1) Product list.--Every person who registers with the 
     Secretary under subsection (b), (c), (d), or (h) shall, at 
     the time of registration under any such subsection, file with 
     the Secretary a list of all tobacco products which are being 
     manufactured, prepared, compounded, or processed by that 
     person for commercial distribution and which have not been 
     included in any list of tobacco products filed by that person 
     with the Secretary under this paragraph or paragraph (2) 
     before such time of registration. Such list shall be prepared 
     in such form and manner as the Secretary may prescribe and 
     shall be accompanied by--
       ``(A) in the case of a tobacco product contained in the 
     applicable list with respect to which a tobacco product 
     standard has been established under section 907 or which is 
     subject to section 910, a reference to the authority for the 
     marketing of such tobacco product and a copy of all labeling 
     for such tobacco product;
       ``(B) in the case of any other tobacco product contained in 
     an applicable list, a copy of all consumer information and 
     other labeling for such tobacco product, a representative 
     sampling of advertisements for such tobacco product, and, 
     upon request made by the Secretary for good cause, a copy of 
     all advertisements for a particular tobacco product; and
       ``(C) if the registrant filing a list has determined that a 
     tobacco product contained in such list is not subject to a 
     tobacco product standard established under section 907, a 
     brief statement of the basis upon which the registrant made 
     such determination if the Secretary requests such a statement 
     with respect to that particular tobacco product.
       ``(2) Consultation with respect to forms.--The Secretary 
     shall consult with the Secretary of the Treasury in 
     developing the forms to be used for registration under this 
     section to minimize the burden on those persons required to 
     register with both the Secretary and the Tax and Trade Bureau 
     of the Department of the Treasury.
       ``(3) Biannual report of any change in product list.--Each 
     person who registers with the Secretary under this section 
     shall report to the Secretary once during the month of June 
     of each year and once during the month of December of each 
     year the following:
       ``(A) A list of each tobacco product introduced by the 
     registrant for commercial distribution which has not been 
     included in any list previously filed by that person with the 
     Secretary under this subparagraph or paragraph (1). A list 
     under this subparagraph shall list a tobacco product by its 
     established name and shall be accompanied by the other 
     information required by paragraph (1).
       ``(B) If since the date the registrant last made a report 
     under this paragraph that person has discontinued the 
     manufacture, preparation, compounding, or processing for 
     commercial distribution of a tobacco product included in a 
     list filed under subparagraph (A) or paragraph (1), notice of 
     such discontinuance, the date of such discontinuance, and the 
     identity of its established name.
       ``(C) If since the date the registrant reported under 
     subparagraph (B) a notice of discontinuance that person has 
     resumed the manufacture, preparation, compounding, or 
     processing for commercial distribution of the tobacco product 
     with respect to which such notice of discontinuance was 
     reported, notice of such resumption, the date of such 
     resumption, the identity of such tobacco product by 
     established name, and other information required by paragraph 
     (1), unless the registrant has previously reported such 
     resumption to the Secretary under this subparagraph.
       ``(D) Any material change in any information previously 
     submitted under this paragraph or paragraph (1).
       ``(j) Report Preceding Introduction of Certain 
     Substantially Equivalent Products Into Interstate Commerce.--
       ``(1) In general.--Each person who is required to register 
     under this section and who proposes to begin the introduction 
     or delivery for introduction into interstate commerce for 
     commercial distribution of a tobacco product intended for 
     human use that was not commercially marketed (other than for 
     test marketing) in the United States as of February 15, 2007, 
     shall, at least 90 days prior to making such introduction or 
     delivery, report to the Secretary (in such form and manner as 
     the Secretary shall prescribe)--
       ``(A) the basis for such person's determination that--
       ``(i) the tobacco product is substantially equivalent, 
     within the meaning of section 910, to a tobacco product 
     commercially marketed (other than for test marketing) in the 
     United States as of February 15, 2007, or to a tobacco 
     product that the Secretary has previously determined, 
     pursuant to subsection (a)(3) of section 910, is 
     substantially equivalent and that is in compliance with the 
     requirements of this Act; or
       ``(ii) the tobacco product is modified within the meaning 
     of paragraph (3), the modifications are to a product that is 
     commercially marketed and in compliance with the requirements 
     of this Act, and all of the modifications are covered by 
     exemptions granted by the Secretary pursuant to paragraph 
     (3); and
       ``(B) action taken by such person to comply with the 
     requirements under section 907 that are applicable to the 
     tobacco product.
       ``(2) Application to certain post-february 15, 2007, 
     products.--A report under this subsection for a tobacco 
     product that was first introduced or delivered for 
     introduction into interstate commerce for commercial 
     distribution in the United States after February 15, 2007, 
     and prior to the date that is 21 months after the date of 
     enactment of the Family Smoking Prevention and Tobacco 
     Control Act shall be submitted to the Secretary not later 
     than 21 months after such date of enactment.
       ``(3) Exemptions.--
       ``(A) In general.--The Secretary may exempt from the 
     requirements of this subsection relating to the demonstration 
     that a tobacco product is substantially equivalent within the 
     meaning of section 910, tobacco products that are modified by 
     adding or deleting a tobacco additive, or increasing or 
     decreasing the quantity of an existing tobacco additive, if 
     the Secretary determines that--
       ``(i) such modification would be a minor modification of a 
     tobacco product that can be sold under this Act;
       ``(ii) a report under this subsection is not necessary to 
     ensure that permitting the tobacco product to be marketed 
     would be appropriate for protection of the public health; and
       ``(iii) an exemption is otherwise appropriate.
       ``(B) Regulations.--Not later than 15 months after the date 
     of enactment of the Family Smoking Prevention and Tobacco 
     Control Act, the Secretary shall issue regulations to 
     implement this paragraph.

     ``SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO 
                   PRODUCTS.

       ``(a) In General.--Any requirement established by or under 
     section 902, 903, 905, or 909 applicable to a tobacco product 
     shall apply to such tobacco product until the applicability 
     of the requirement to the tobacco product has been changed by 
     action taken under section 907, section 910, section 911, or 
     subsection (d) of this section, and any requirement 
     established by or under section 902, 903, 905, or 909 which 
     is inconsistent with a requirement imposed on such tobacco 
     product under section 907, section 910, section 911, or 
     subsection (d) of this section shall not apply to such 
     tobacco product.
       ``(b) Information on Public Access and Comment.--Each 
     notice of proposed rulemaking or other notification under 
     section 907, 908, 909, 910, or 911 or under this section, any 
     other notice which is published in the Federal Register with 
     respect to any other action taken under any such section and 
     which states the reasons for such action, and each 
     publication of findings required to be made in connection 
     with rulemaking under any such section shall set forth--
       ``(1) the manner in which interested persons may examine 
     data and other information on which the notice or findings is 
     based; and
       ``(2) the period within which interested persons may 
     present their comments on the notice or findings (including 
     the need therefore) orally or in writing, which period shall 
     be at least 60 days but may not exceed 90 days unless the 
     time is extended by the Secretary by a notice published in 
     the Federal Register stating good cause therefore.

[[Page 17301]]

       ``(c) Limited Confidentiality of Information.--Any 
     information reported to or otherwise obtained by the 
     Secretary or the Secretary's representative under section 
     903, 904, 907, 908, 909, 910, 911, or 704, or under 
     subsection (e) or (f) of this section, which is exempt from 
     disclosure under subsection (a) of section 552 of title 5, 
     United States Code, by reason of subsection (b)(4) of that 
     section shall be considered confidential and shall not be 
     disclosed, except that the information may be disclosed to 
     other officers or employees concerned with carrying out this 
     chapter, or when relevant in any proceeding under this 
     chapter.
       ``(d) Restrictions.--
       ``(1) In general.--The Secretary may by regulation require 
     restrictions on the sale and distribution of a tobacco 
     product, including restrictions on the access to, and the 
     advertising and promotion of, the tobacco product, if the 
     Secretary determines that such regulation would be 
     appropriate for the protection of the public health. The 
     Secretary may by regulation impose restrictions on the 
     advertising and promotion of a tobacco product consistent 
     with and to full extent permitted by the first amendment to 
     the Constitution. The finding as to whether such regulation 
     would be appropriate for the protection of the public health 
     shall be determined with respect to the risks and benefits to 
     the population as a whole, including users and nonusers of 
     the tobacco product, and taking into account--
       ``(A) the increased or decreased likelihood that existing 
     users of tobacco products will stop using such products; and
       ``(B) the increased or decreased likelihood that those who 
     do not use tobacco products will start using such products.

     No such regulation may require that the sale or distribution 
     of a tobacco product be limited to the written or oral 
     authorization of a practitioner licensed by law to prescribe 
     medical products.
       ``(2) Label statements.--The label of a tobacco product 
     shall bear such appropriate statements of the restrictions 
     required by a regulation under subsection (a) as the 
     Secretary may in such regulation prescribe.
       ``(3) Limitations.--
       ``(A) In general.--No restrictions under paragraph (1) 
     may--
       ``(i) prohibit the sale of any tobacco product in face-to-
     face transactions by a specific category of retail outlets; 
     or
       ``(ii) establish a minimum age of sale of tobacco products 
     to any person older than 18 years of age.
       ``(B) Matchbooks.--For purposes of any regulations issued 
     by the Secretary, matchbooks of conventional size containing 
     not more than 20 paper matches, and which are customarily 
     given away for free with the purchase of tobacco products, 
     shall be considered as adult-written publications which shall 
     be permitted to contain advertising. Notwithstanding the 
     preceding sentence, if the Secretary finds that such 
     treatment of matchbooks is not appropriate for the protection 
     of the public health, the Secretary may determine by 
     regulation that matchbooks shall not be considered adult-
     written publications.
       ``(4) Remote sales.--
       ``(A) In general.--The Secretary shall--
       ``(i) within 18 months after the date of enactment of this 
     chapter, promulgate regulations regarding the sale and 
     distribution of tobacco products that occur through means 
     other than a direct, face-to-face exchange between a retailer 
     and a consumer in order to prevent the sale and distribution 
     of tobacco products to individuals who have not attained the 
     minimum age established by applicable law for the purchase of 
     such products, including requirements for age verification; 
     and
       ``(ii) within 2 years after such date of enactment, issue 
     regulations to address the promotion and marketing of tobacco 
     products that are sold or distributed through means other 
     than a direct, face-to-face exchange between a retailer and a 
     consumer in order to protect individuals who have not 
     attained the minimum age established by applicable law for 
     the purchase of such products.
       ``(B) Relation to other authority.--Nothing in this 
     paragraph limits the authority of the Secretary to take 
     additional actions under the other paragraphs of this 
     subsection.
       ``(e) Good Manufacturing Practice Requirements.--
       ``(1) Methods, facilities, and controls to conform.--
       ``(A) In general.--In applying manufacturing restrictions 
     to tobacco, the Secretary shall, in accordance with 
     subparagraph (B), prescribe regulations (which may differ 
     based on the type of tobacco product involved) requiring that 
     the methods used in, and the facilities and controls used 
     for, the manufacture, preproduction design validation 
     (including a process to assess the performance of a tobacco 
     product), packing, and storage of a tobacco product conform 
     to current good manufacturing practice, or hazard analysis 
     and critical control point methodology, as prescribed in such 
     regulations to assure that the public health is protected and 
     that the tobacco product is in compliance with this chapter. 
     Such regulations may provide for the testing of raw tobacco 
     for pesticide chemical residues regardless of whether a 
     tolerance for such chemical residues has been established.
       ``(B) Requirements.--The Secretary shall--
       ``(i) before promulgating any regulation under subparagraph 
     (A), afford the Tobacco Products Scientific Advisory 
     Committee an opportunity to submit recommendations with 
     respect to the regulation proposed to be promulgated;
       ``(ii) before promulgating any regulation under 
     subparagraph (A), afford opportunity for an oral hearing;
       ``(iii) provide the Tobacco Products Scientific Advisory 
     Committee a reasonable time to make its recommendation with 
     respect to proposed regulations under subparagraph (A);
       ``(iv) in establishing the effective date of a regulation 
     promulgated under this subsection, take into account the 
     differences in the manner in which the different types of 
     tobacco products have historically been produced, the 
     financial resources of the different tobacco product 
     manufacturers, and the state of their existing manufacturing 
     facilities, and shall provide for a reasonable period of time 
     for such manufacturers to conform to good manufacturing 
     practices; and
       ``(v) not require any small tobacco product manufacturer to 
     comply with a regulation under subparagraph (A) for at least 
     4 years following the effective date established by the 
     Secretary for such regulation.
       ``(2) Exemptions; variances.--
       ``(A) Petition.--Any person subject to any requirement 
     prescribed under paragraph (1) may petition the Secretary for 
     a permanent or temporary exemption or variance from such 
     requirement. Such a petition shall be submitted to the 
     Secretary in such form and manner as the Secretary shall 
     prescribe and shall--
       ``(i) in the case of a petition for an exemption from a 
     requirement, set forth the basis for the petitioner's 
     determination that compliance with the requirement is not 
     required to assure that the tobacco product will be in 
     compliance with this chapter;
       ``(ii) in the case of a petition for a variance from a 
     requirement, set forth the methods proposed to be used in, 
     and the facilities and controls proposed to be used for, the 
     manufacture, packing, and storage of the tobacco product in 
     lieu of the methods, facilities, and controls prescribed by 
     the requirement; and
       ``(iii) contain such other information as the Secretary 
     shall prescribe.
       ``(B) Referral to the tobacco products scientific advisory 
     committee.--The Secretary may refer to the Tobacco Products 
     Scientific Advisory Committee any petition submitted under 
     subparagraph (A). The Tobacco Products Scientific Advisory 
     Committee shall report its recommendations to the Secretary 
     with respect to a petition referred to it within 60 days 
     after the date of the petition's referral. Within 60 days 
     after--
       ``(i) the date the petition was submitted to the Secretary 
     under subparagraph (A); or
       ``(ii) the day after the petition was referred to the 
     Tobacco Products Scientific Advisory Committee,

     whichever occurs later, the Secretary shall by order either 
     deny the petition or approve it.
       ``(C) Approval.--The Secretary may approve--
       ``(i) a petition for an exemption for a tobacco product 
     from a requirement if the Secretary determines that 
     compliance with such requirement is not required to assure 
     that the tobacco product will be in compliance with this 
     chapter; and
       ``(ii) a petition for a variance for a tobacco product from 
     a requirement if the Secretary determines that the methods to 
     be used in, and the facilities and controls to be used for, 
     the manufacture, packing, and storage of the tobacco product 
     in lieu of the methods, facilities, and controls prescribed 
     by the requirement are sufficient to assure that the tobacco 
     product will be in compliance with this chapter.
       ``(D) Conditions.--An order of the Secretary approving a 
     petition for a variance shall prescribe such conditions 
     respecting the methods used in, and the facilities and 
     controls used for, the manufacture, packing, and storage of 
     the tobacco product to be granted the variance under the 
     petition as may be necessary to assure that the tobacco 
     product will be in compliance with this chapter.
       ``(E) Hearing.--After the issuance of an order under 
     subparagraph (B) respecting a petition, the petitioner shall 
     have an opportunity for an informal hearing on such order.
       ``(3) Compliance.--Compliance with requirements under this 
     subsection shall not be required before the end of the 3-year 
     period following the date of enactment of the Family Smoking 
     Prevention and Tobacco Control Act.
       ``(f) Research and Development.--The Secretary may enter 
     into contracts for research, testing, and demonstrations 
     respecting tobacco products and may obtain tobacco products 
     for research, testing, and demonstration purposes.

     ``SEC. 907. TOBACCO PRODUCT STANDARDS.

       ``(a) In General.--
       ``(1) Special rules.--

[[Page 17302]]

       ``(A) Special rule for cigarettes.--Beginning 3 months 
     after the date of enactment of the Family Smoking Prevention 
     and Tobacco Control Act, a cigarette or any of its component 
     parts (including the tobacco, filter, or paper) shall not 
     contain, as a constituent (including a smoke constituent) or 
     additive, an artificial or natural flavor (other than tobacco 
     or menthol) or an herb or spice, including strawberry, grape, 
     orange, clove, cinnamon, pineapple, vanilla, coconut, 
     licorice, cocoa, chocolate, cherry, or coffee, that is a 
     characterizing flavor of the tobacco product or tobacco 
     smoke. Nothing in this subparagraph shall be construed to 
     limit the Secretary's authority to take action under this 
     section or other sections of this Act applicable to menthol 
     or any artificial or natural flavor, herb, or spice not 
     specified in this subparagraph.
       ``(B) Additional special rule.--A tobacco product 
     manufactured in or imported into the United States shall not 
     contain foreign-grown tobacco that--
       ``(i) was grown or processed using a pesticide chemical 
     that is not approved under applicable Federal law for use in 
     domestic tobacco farming and processing; or
       ``(ii) in the case of a pesticide chemical that is so 
     approved, was grown or processed using the pesticide chemical 
     in a manner inconsistent with the approved labeling for use 
     of the pesticide chemical in domestic tobacco farming and 
     processing.
       ``(2) Revision of tobacco product standards.--The Secretary 
     may revise the tobacco product standards in paragraph (1) in 
     accordance with subsection (c).
       ``(3) Tobacco product standards.--
       ``(A) In general.--The Secretary may adopt tobacco product 
     standards in addition to those in paragraph (1) if the 
     Secretary finds that a tobacco product standard is 
     appropriate for the protection of the public health.
       ``(B) Determinations.--
       ``(i) Considerations.--In making a finding described in 
     subparagraph (A), the Secretary shall consider scientific 
     evidence concerning--

       ``(I) the risks and benefits to the population as a whole, 
     including users and nonusers of tobacco products, of the 
     proposed standard;
       ``(II) the increased or decreased likelihood that existing 
     users of tobacco products will stop using such products; and
       ``(III) the increased or decreased likelihood that those 
     who do not use tobacco products will start using such 
     products.

       ``(ii) Additional considerations.--In the event that the 
     Secretary makes a determination, set forth in a proposed 
     tobacco product standard in a proposed rule, that it is 
     appropriate for the protection of public health to require 
     the reduction or elimination of an additive, constituent 
     (including a smoke constituent), or other component of a 
     tobacco product because the Secretary has found that the 
     additive, constituent, or other component is or may be 
     harmful, any party objecting to the proposed standard on the 
     ground that the proposed standard will not reduce or 
     eliminate the risk of illness or injury may provide for the 
     Secretary's consideration scientific evidence that 
     demonstrates that the proposed standard will not reduce or 
     eliminate the risk of illness or injury.
       ``(4) Content of tobacco product standards.--A tobacco 
     product standard established under this section for a tobacco 
     product--
       ``(A) shall include provisions that are appropriate for the 
     protection of the public health, including provisions, where 
     appropriate--
       ``(i) for nicotine yields of the product;
       ``(ii) for the reduction or elimination of other 
     constituents, including smoke constituents, or harmful 
     components of the product; or
       ``(iii) relating to any other requirement under 
     subparagraph (B);
       ``(B) shall, where appropriate for the protection of the 
     public health, include--
       ``(i) provisions respecting the construction, components, 
     ingredients, additives, constituents, including smoke 
     constituents, and properties of the tobacco product;
       ``(ii) provisions for the testing (on a sample basis or, if 
     necessary, on an individual basis) of the tobacco product;
       ``(iii) provisions for the measurement of the tobacco 
     product characteristics of the tobacco product;
       ``(iv) provisions requiring that the results of each or of 
     certain of the tests of the tobacco product required to be 
     made under clause (ii) show that the tobacco product is in 
     conformity with the portions of the standard for which the 
     test or tests were required; and
       ``(v) a provision requiring that the sale and distribution 
     of the tobacco product be restricted but only to the extent 
     that the sale and distribution of a tobacco product may be 
     restricted under a regulation under section 906(d);
       ``(C) shall, where appropriate, require the use and 
     prescribe the form and content of labeling for the proper use 
     of the tobacco product; and
       ``(D) shall require tobacco products containing foreign-
     grown tobacco to meet the same standards applicable to 
     tobacco products containing domestically grown tobacco.
       ``(5) Periodic reevaluation of tobacco product standards.--
     The Secretary shall provide for periodic evaluation of 
     tobacco product standards established under this section to 
     determine whether such standards should be changed to reflect 
     new medical, scientific, or other technological data. The 
     Secretary may provide for testing under paragraph (4)(B) by 
     any person.
       ``(6) Involvement of other agencies; informed persons.--In 
     carrying out duties under this section, the Secretary shall 
     endeavor to--
       ``(A) use personnel, facilities, and other technical 
     support available in other Federal agencies;
       ``(B) consult with other Federal agencies concerned with 
     standard setting and other nationally or internationally 
     recognized standard-setting entities; and
       ``(C) invite appropriate participation, through joint or 
     other conferences, workshops, or other means, by informed 
     persons representative of scientific, professional, industry, 
     agricultural, or consumer organizations who in the 
     Secretary's judgment can make a significant contribution.
       ``(b) Considerations by Secretary.--
       ``(1) Technical achievability.--The Secretary shall 
     consider information submitted in connection with a proposed 
     standard regarding the technical achievability of compliance 
     with such standard.
       ``(2) Other considerations.--The Secretary shall consider 
     all other information submitted in connection with a proposed 
     standard, including information concerning the countervailing 
     effects of the tobacco product standard on the health of 
     adolescent tobacco users, adult tobacco users, or nontobacco 
     users, such as the creation of a significant demand for 
     contraband or other tobacco products that do not meet the 
     requirements of this chapter and the significance of such 
     demand.
       ``(c) Proposed Standards.--
       ``(1) In general.--The Secretary shall publish in the 
     Federal Register a notice of proposed rulemaking for the 
     establishment, amendment, or revocation of any tobacco 
     product standard.
       ``(2) Requirements of notice.--A notice of proposed 
     rulemaking for the establishment or amendment of a tobacco 
     product standard for a tobacco product shall--
       ``(A) set forth a finding with supporting justification 
     that the tobacco product standard is appropriate for the 
     protection of the public health;
       ``(B) invite interested persons to submit a draft or 
     proposed tobacco product standard for consideration by the 
     Secretary;
       ``(C) invite interested persons to submit comments on 
     structuring the standard so that it does not advantage 
     foreign-grown tobacco over domestically grown tobacco; and
       ``(D) invite the Secretary of Agriculture to provide any 
     information or analysis which the Secretary of Agriculture 
     believes is relevant to the proposed tobacco product 
     standard.
       ``(3) Finding.--A notice of proposed rulemaking for the 
     revocation of a tobacco product standard shall set forth a 
     finding with supporting justification that the tobacco 
     product standard is no longer appropriate for the protection 
     of the public health.
       ``(4) Comment.--The Secretary shall provide for a comment 
     period of not less than 60 days.
       ``(d) Promulgation.--
       ``(1) In general.--After the expiration of the period for 
     comment on a notice of proposed rulemaking published under 
     subsection (c) respecting a tobacco product standard and 
     after consideration of comments submitted under subsections 
     (b) and (c) and any report from the Tobacco Products 
     Scientific Advisory Committee, if the Secretary determines 
     that the standard would be appropriate for the protection of 
     the public health, the Secretary shall--
       ``(A) promulgate a regulation establishing a tobacco 
     product standard and publish in the Federal Register findings 
     on the matters referred to in subsection (c); or
       ``(B) publish a notice terminating the proceeding for the 
     development of the standard together with the reasons for 
     such termination.
       ``(2) Effective date.--A regulation establishing a tobacco 
     product standard shall set forth the date or dates upon which 
     the standard shall take effect, but no such regulation may 
     take effect before 1 year after the date of its publication 
     unless the Secretary determines that an earlier effective 
     date is necessary for the protection of the public health. 
     Such date or dates shall be established so as to minimize, 
     consistent with the public health, economic loss to, and 
     disruption or dislocation of, domestic and international 
     trade. In establishing such effective date or dates, the 
     Secretary shall consider information submitted in connection 
     with a proposed product standard by interested parties, 
     including manufacturers and tobacco growers, regarding the 
     technical achievability of compliance with the standard, and 
     including information concerning the existence of patents 
     that make it impossible to comply in the timeframe envisioned 
     in the proposed standard. If the Secretary determines, based 
     on the Secretary's evaluation of submitted comments, that a 
     product standard can be met only by manufacturers

[[Page 17303]]

     requiring substantial changes to the methods of farming the 
     domestically grown tobacco used by the manufacturer, the 
     effective date of that product standard shall be not less 
     than 2 years after the date of publication of the final 
     regulation establishing the standard.
       ``(3) Limitation on power granted to the food and drug 
     administration.--Because of the importance of a decision of 
     the Secretary to issue a regulation--
       ``(A) banning all cigarettes, all smokeless tobacco 
     products, all little cigars, all cigars other than little 
     cigars, all pipe tobacco, or all roll-your-own tobacco 
     products; or
       ``(B) requiring the reduction of nicotine yields of a 
     tobacco product to zero,
     the Secretary is prohibited from taking such actions under 
     this Act.
       ``(4) Amendment; revocation.--
       ``(A) Authority.--The Secretary, upon the Secretary's own 
     initiative or upon petition of an interested person, may by a 
     regulation, promulgated in accordance with the requirements 
     of subsection (c) and paragraph (2), amend or revoke a 
     tobacco product standard.
       ``(B) Effective date.--The Secretary may declare a proposed 
     amendment of a tobacco product standard to be effective on 
     and after its publication in the Federal Register and until 
     the effective date of any final action taken on such 
     amendment if the Secretary determines that making it so 
     effective is in the public interest.
       ``(5) Referral to advisory committee.--
       ``(A) In general.--The Secretary may refer a proposed 
     regulation for the establishment, amendment, or revocation of 
     a tobacco product standard to the Tobacco Products Scientific 
     Advisory Committee for a report and recommendation with 
     respect to any matter involved in the proposed regulation 
     which requires the exercise of scientific judgment.
       ``(B) Initiation of referral.--The Secretary may make a 
     referral under this paragraph--
       ``(i) on the Secretary's own initiative; or
       ``(ii) upon the request of an interested person that--

       ``(I) demonstrates good cause for the referral; and
       ``(II) is made before the expiration of the period for 
     submission of comments on the proposed regulation.

       ``(C) Provision of data.--If a proposed regulation is 
     referred under this paragraph to the Tobacco Products 
     Scientific Advisory Committee, the Secretary shall provide 
     the Advisory Committee with the data and information on which 
     such proposed regulation is based.
       ``(D) Report and recommendation.--The Tobacco Products 
     Scientific Advisory Committee shall, within 60 days after the 
     referral of a proposed regulation under this paragraph and 
     after independent study of the data and information furnished 
     to it by the Secretary and other data and information before 
     it, submit to the Secretary a report and recommendation 
     respecting such regulation, together with all underlying data 
     and information and a statement of the reason or basis for 
     the recommendation.
       ``(E) Public availability.--The Secretary shall make a copy 
     of each report and recommendation under subparagraph (D) 
     publicly available.
       ``(e) Menthol Cigarettes.--
       ``(1) Referral; considerations.--Immediately upon the 
     establishment of the Tobacco Products Scientific Advisory 
     Committee under section 917(a), the Secretary shall refer to 
     the Committee for report and recommendation, under section 
     917(c)(4), the issue of the impact of the use of menthol in 
     cigarettes on the public health, including such use among 
     African Americans, Hispanics, and other racial and ethnic 
     minorities. In its review, the Tobacco Products Scientific 
     Advisory Committee shall address the considerations listed in 
     subsections (a)(3)(B)(i) and (b).
       ``(2) Report and recommendation.--Not later than 1 year 
     after its establishment, the Tobacco Product Scientific 
     Advisory Committee shall submit to the Secretary the report 
     and recommendations required pursuant to paragraph (1).
       ``(3) Rule of construction.--Nothing in this subsection 
     shall be construed to limit the Secretary's authority to take 
     action under this section or other sections of this Act 
     applicable to menthol.

     ``SEC. 908. NOTIFICATION AND OTHER REMEDIES.

       ``(a) Notification.--If the Secretary determines that--
       ``(1) a tobacco product which is introduced or delivered 
     for introduction into interstate commerce for commercial 
     distribution presents an unreasonable risk of substantial 
     harm to the public health; and
       ``(2) notification under this subsection is necessary to 
     eliminate the unreasonable risk of such harm and no more 
     practicable means is available under the provisions of this 
     chapter (other than this section) to eliminate such risk,

     the Secretary may issue such order as may be necessary to 
     assure that adequate notification is provided in an 
     appropriate form, by the persons and means best suited under 
     the circumstances involved, to all persons who should 
     properly receive such notification in order to eliminate such 
     risk. The Secretary may order notification by any appropriate 
     means, including public service announcements. Before issuing 
     an order under this subsection, the Secretary shall consult 
     with the persons who are to give notice under the order.
       ``(b) No Exemption From Other Liability.--Compliance with 
     an order issued under this section shall not relieve any 
     person from liability under Federal or State law. In awarding 
     damages for economic loss in an action brought for the 
     enforcement of any such liability, the value to the plaintiff 
     in such action of any remedy provided under such order shall 
     be taken into account.
       ``(c) Recall Authority.--
       ``(1) In general.--If the Secretary finds that there is a 
     reasonable probability that a tobacco product contains a 
     manufacturing or other defect not ordinarily contained in 
     tobacco products on the market that would cause serious, 
     adverse health consequences or death, the Secretary shall 
     issue an order requiring the appropriate person (including 
     the manufacturers, importers, distributors, or retailers of 
     the tobacco product) to immediately cease distribution of 
     such tobacco product. The order shall provide the person 
     subject to the order with an opportunity for an informal 
     hearing, to be held not later than 10 days after the date of 
     the issuance of the order, on the actions required by the 
     order and on whether the order should be amended to require a 
     recall of such tobacco product. If, after providing an 
     opportunity for such a hearing, the Secretary determines that 
     inadequate grounds exist to support the actions required by 
     the order, the Secretary shall vacate the order.
       ``(2) Amendment of order to require recall.--
       ``(A) In general.--If, after providing an opportunity for 
     an informal hearing under paragraph (1), the Secretary 
     determines that the order should be amended to include a 
     recall of the tobacco product with respect to which the order 
     was issued, the Secretary shall, except as provided in 
     subparagraph (B), amend the order to require a recall. The 
     Secretary shall specify a timetable in which the tobacco 
     product recall will occur and shall require periodic reports 
     to the Secretary describing the progress of the recall.
       ``(B) Notice.--An amended order under subparagraph (A)--
       ``(i) shall not include recall of a tobacco product from 
     individuals; and
       ``(ii) shall provide for notice to persons subject to the 
     risks associated with the use of such tobacco product.

     In providing the notice required by clause (ii), the 
     Secretary may use the assistance of retailers and other 
     persons who distributed such tobacco product. If a 
     significant number of such persons cannot be identified, the 
     Secretary shall notify such persons under section 705(b).
       ``(3) Remedy not exclusive.--The remedy provided by this 
     subsection shall be in addition to remedies provided by 
     subsection (a).

     ``SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS.

       ``(a) In General.--Every person who is a tobacco product 
     manufacturer or importer of a tobacco product shall establish 
     and maintain such records, make such reports, and provide 
     such information, as the Secretary may by regulation 
     reasonably require to assure that such tobacco product is not 
     adulterated or misbranded and to otherwise protect public 
     health. Regulations prescribed under the preceding sentence--
       ``(1) may require a tobacco product manufacturer or 
     importer to report to the Secretary whenever the manufacturer 
     or importer receives or otherwise becomes aware of 
     information that reasonably suggests that one of its marketed 
     tobacco products may have caused or contributed to a serious 
     unexpected adverse experience associated with the use of the 
     product or any significant increase in the frequency of a 
     serious, expected adverse product experience;
       ``(2) shall require reporting of other significant adverse 
     tobacco product experiences as determined by the Secretary to 
     be necessary to be reported;
       ``(3) shall not impose requirements unduly burdensome to a 
     tobacco product manufacturer or importer, taking into account 
     the cost of complying with such requirements and the need for 
     the protection of the public health and the implementation of 
     this chapter;
       ``(4) when prescribing the procedure for making requests 
     for reports or information, shall require that each request 
     made under such regulations for submission of a report or 
     information to the Secretary state the reason or purpose for 
     such request and identify to the fullest extent practicable 
     such report or information;
       ``(5) when requiring submission of a report or information 
     to the Secretary, shall state the reason or purpose for the 
     submission of such report or information and identify to the 
     fullest extent practicable such report or information; and
       ``(6) may not require that the identity of any patient or 
     user be disclosed in records, reports, or information 
     required under this subsection unless required for the 
     medical welfare of an individual, to determine risks to 
     public health of a tobacco product, or to verify a record, 
     report, or information submitted under this chapter.

     In prescribing regulations under this subsection, the 
     Secretary shall have due regard

[[Page 17304]]

     for the professional ethics of the medical profession and the 
     interests of patients. The prohibitions of paragraph (6) 
     continue to apply to records, reports, and information 
     concerning any individual who has been a patient, 
     irrespective of whether or when he ceases to be a patient.
       ``(b) Reports of Removals and Corrections.--
       ``(1) In general.--Except as provided in paragraph (2), the 
     Secretary shall by regulation require a tobacco product 
     manufacturer or importer of a tobacco product to report 
     promptly to the Secretary any corrective action taken or 
     removal from the market of a tobacco product undertaken by 
     such manufacturer or importer if the removal or correction 
     was undertaken--
       ``(A) to reduce a risk to health posed by the tobacco 
     product; or
       ``(B) to remedy a violation of this chapter caused by the 
     tobacco product which may present a risk to health.

     A tobacco product manufacturer or importer of a tobacco 
     product who undertakes a corrective action or removal from 
     the market of a tobacco product which is not required to be 
     reported under this subsection shall keep a record of such 
     correction or removal.
       ``(2) Exception.--No report of the corrective action or 
     removal of a tobacco product may be required under paragraph 
     (1) if a report of the corrective action or removal is 
     required and has been submitted under subsection (a).

     ``SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TOBACCO 
                   PRODUCTS.

       ``(a) In General.--
       ``(1) New tobacco product defined.--For purposes of this 
     section the term `new tobacco product' means--
       ``(A) any tobacco product (including those products in test 
     markets) that was not commercially marketed in the United 
     States as of February 15, 2007; or
       ``(B) any modification (including a change in design, any 
     component, any part, or any constituent, including a smoke 
     constituent, or in the content, delivery or form of nicotine, 
     or any other additive or ingredient) of a tobacco product 
     where the modified product was commercially marketed in the 
     United States after February 15, 2007.
       ``(2) Premarket review required.--
       ``(A) New products.--An order under subsection (c)(1)(A)(i) 
     for a new tobacco product is required unless--
       ``(i) the manufacturer has submitted a report under section 
     905(j); and the Secretary has issued an order that the 
     tobacco product--

       ``(I) is substantially equivalent to a tobacco product 
     commercially marketed (other than for test marketing) in the 
     United States as of February 15, 2007; and
       ``(II) is in compliance with the requirements of this Act; 
     or

       ``(ii) the tobacco product is exempt from the requirements 
     of section 905(j) pursuant to a regulation issued under 
     section 905(j)(3).
       ``(B) Application to certain post-february 15, 2007, 
     products.--Subparagraph (A) shall not apply to a tobacco 
     product--
       ``(i) that was first introduced or delivered for 
     introduction into interstate commerce for commercial 
     distribution in the United States after February 15, 2007, 
     and prior to the date that is 21 months after the date of 
     enactment of the Family Smoking Prevention and Tobacco 
     Control Act; and
       ``(ii) for which a report was submitted under section 
     905(j) within such 21-month period,

     except that subparagraph (A) shall apply to the tobacco 
     product if the Secretary issues an order that the tobacco 
     product is not substantially equivalent.
       ``(3) Substantially equivalent defined.--
       ``(A) In general.--In this section and section 905(j), the 
     term `substantially equivalent' or `substantial equivalence' 
     means, with respect to the tobacco product being compared to 
     the predicate tobacco product, that the Secretary by order 
     has found that the tobacco product--
       ``(i) has the same characteristics as the predicate tobacco 
     product; or
       ``(ii) has different characteristics and the information 
     submitted contains information, including clinical data if 
     deemed necessary by the Secretary, that demonstrates that it 
     is not appropriate to regulate the product under this section 
     because the product does not raise different questions of 
     public health.
       ``(B) Characteristics.--In subparagraph (A), the term 
     `characteristics' means the materials, ingredients, design, 
     composition, heating source, or other features of a tobacco 
     product.
       ``(C) Limitation.--A tobacco product may not be found to be 
     substantially equivalent to a predicate tobacco product that 
     has been removed from the market at the initiative of the 
     Secretary or that has been determined by a judicial order to 
     be misbranded or adulterated.
       ``(4) Health information.--
       ``(A) Summary.--As part of a submission under section 
     905(j) respecting a tobacco product, the person required to 
     file a premarket notification under such section shall 
     provide an adequate summary of any health information related 
     to the tobacco product or state that such information will be 
     made available upon request by any person.
       ``(B) Required information.--Any summary under subparagraph 
     (A) respecting a tobacco product shall contain detailed 
     information regarding data concerning adverse health effects 
     and shall be made available to the public by the Secretary 
     within 30 days of the issuance of a determination that such 
     tobacco product is substantially equivalent to another 
     tobacco product.
       ``(b) Application.--
       ``(1) Contents.--An application under this section shall 
     contain--
       ``(A) full reports of all information, published or known 
     to, or which should reasonably be known to, the applicant, 
     concerning investigations which have been made to show the 
     health risks of such tobacco product and whether such tobacco 
     product presents less risk than other tobacco products;
       ``(B) a full statement of the components, ingredients, 
     additives, and properties, and of the principle or principles 
     of operation, of such tobacco product;
       ``(C) a full description of the methods used in, and the 
     facilities and controls used for, the manufacture, 
     processing, and, when relevant, packing and installation of, 
     such tobacco product;
       ``(D) an identifying reference to any tobacco product 
     standard under section 907 which would be applicable to any 
     aspect of such tobacco product, and either adequate 
     information to show that such aspect of such tobacco product 
     fully meets such tobacco product standard or adequate 
     information to justify any deviation from such standard;
       ``(E) such samples of such tobacco product and of 
     components thereof as the Secretary may reasonably require;
       ``(F) specimens of the labeling proposed to be used for 
     such tobacco product; and
       ``(G) such other information relevant to the subject matter 
     of the application as the Secretary may require.
       ``(2) Referral to tobacco products scientific advisory 
     committee.--Upon receipt of an application meeting the 
     requirements set forth in paragraph (1), the Secretary--
       ``(A) may, on the Secretary's own initiative; or
       ``(B) may, upon the request of an applicant,

     refer such application to the Tobacco Products Scientific 
     Advisory Committee for reference and for submission (within 
     such period as the Secretary may establish) of a report and 
     recommendation respecting the application, together with all 
     underlying data and the reasons or basis for the 
     recommendation.
       ``(c) Action on Application.--
       ``(1) Deadline.--
       ``(A) In general.--As promptly as possible, but in no event 
     later than 180 days after the receipt of an application under 
     subsection (b), the Secretary, after considering the report 
     and recommendation submitted under subsection (b)(2), shall--
       ``(i) issue an order that the new product may be introduced 
     or delivered for introduction into interstate commerce if the 
     Secretary finds that none of the grounds specified in 
     paragraph (2) of this subsection applies; or
       ``(ii) issue an order that the new product may not be 
     introduced or delivered for introduction into interstate 
     commerce if the Secretary finds (and sets forth the basis for 
     such finding as part of or accompanying such denial) that 1 
     or more grounds for denial specified in paragraph (2) of this 
     subsection apply.
       ``(B) Restrictions on sale and distribution.--An order 
     under subparagraph (A)(i) may require that the sale and 
     distribution of the tobacco product be restricted but only to 
     the extent that the sale and distribution of a tobacco 
     product may be restricted under a regulation under section 
     906(d).
       ``(2) Denial of application.--The Secretary shall deny an 
     application submitted under subsection (b) if, upon the basis 
     of the information submitted to the Secretary as part of the 
     application and any other information before the Secretary 
     with respect to such tobacco product, the Secretary finds 
     that--
       ``(A) there is a lack of a showing that permitting such 
     tobacco product to be marketed would be appropriate for the 
     protection of the public health;
       ``(B) the methods used in, or the facilities or controls 
     used for, the manufacture, processing, or packing of such 
     tobacco product do not conform to the requirements of section 
     906(e);
       ``(C) based on a fair evaluation of all material facts, the 
     proposed labeling is false or misleading in any particular; 
     or
       ``(D) such tobacco product is not shown to conform in all 
     respects to a tobacco product standard in effect under 
     section 907, and there is a lack of adequate information to 
     justify the deviation from such standard.
       ``(3) Denial information.--Any denial of an application 
     shall, insofar as the Secretary determines to be practicable, 
     be accompanied by a statement informing the applicant of the 
     measures required to remove such application from deniable 
     form (which measures may include further research by the 
     applicant in accordance with 1 or more protocols prescribed 
     by the Secretary).
       ``(4) Basis for finding.--For purposes of this section, the 
     finding as to whether the marketing of a tobacco product for 
     which an

[[Page 17305]]

     application has been submitted is appropriate for the 
     protection of the public health shall be determined with 
     respect to the risks and benefits to the population as a 
     whole, including users and nonusers of the tobacco product, 
     and taking into account--
       ``(A) the increased or decreased likelihood that existing 
     users of tobacco products will stop using such products; and
       ``(B) the increased or decreased likelihood that those who 
     do not use tobacco products will start using such products.
       ``(5) Basis for action.--
       ``(A) Investigations.--For purposes of paragraph (2)(A), 
     whether permitting a tobacco product to be marketed would be 
     appropriate for the protection of the public health shall, 
     when appropriate, be determined on the basis of well-
     controlled investigations, which may include 1 or more 
     clinical investigations by experts qualified by training and 
     experience to evaluate the tobacco product.
       ``(B) Other evidence.--If the Secretary determines that 
     there exists valid scientific evidence (other than evidence 
     derived from investigations described in subparagraph (A)) 
     which is sufficient to evaluate the tobacco product, the 
     Secretary may authorize that the determination for purposes 
     of paragraph (2)(A) be made on the basis of such evidence.
       ``(d) Withdrawal and Temporary Suspension.--
       ``(1) In general.--The Secretary shall, upon obtaining, 
     where appropriate, advice on scientific matters from the 
     Tobacco Products Scientific Advisory Committee, and after due 
     notice and opportunity for informal hearing for a tobacco 
     product for which an order was issued under subsection 
     (c)(1)(A)(i), issue an order withdrawing the order if the 
     Secretary finds--
       ``(A) that the continued marketing of such tobacco product 
     no longer is appropriate for the protection of the public 
     health;
       ``(B) that the application contained or was accompanied by 
     an untrue statement of a material fact;
       ``(C) that the applicant--
       ``(i) has failed to establish a system for maintaining 
     records, or has repeatedly or deliberately failed to maintain 
     records or to make reports, required by an applicable 
     regulation under section 909;
       ``(ii) has refused to permit access to, or copying or 
     verification of, such records as required by section 704; or
       ``(iii) has not complied with the requirements of section 
     905;
       ``(D) on the basis of new information before the Secretary 
     with respect to such tobacco product, evaluated together with 
     the evidence before the Secretary when the application was 
     reviewed, that the methods used in, or the facilities and 
     controls used for, the manufacture, processing, packing, or 
     installation of such tobacco product do not conform with the 
     requirements of section 906(e) and were not brought into 
     conformity with such requirements within a reasonable time 
     after receipt of written notice from the Secretary of 
     nonconformity;
       ``(E) on the basis of new information before the Secretary, 
     evaluated together with the evidence before the Secretary 
     when the application was reviewed, that the labeling of such 
     tobacco product, based on a fair evaluation of all material 
     facts, is false or misleading in any particular and was not 
     corrected within a reasonable time after receipt of written 
     notice from the Secretary of such fact; or
       ``(F) on the basis of new information before the Secretary, 
     evaluated together with the evidence before the Secretary 
     when such order was issued, that such tobacco product is not 
     shown to conform in all respects to a tobacco product 
     standard which is in effect under section 907, compliance 
     with which was a condition to the issuance of an order 
     relating to the application, and that there is a lack of 
     adequate information to justify the deviation from such 
     standard.
       ``(2) Appeal.--The holder of an application subject to an 
     order issued under paragraph (1) withdrawing an order issued 
     pursuant to subsection (c)(1)(A)(i) may, by petition filed on 
     or before the 30th day after the date upon which such holder 
     receives notice of such withdrawal, obtain review thereof in 
     accordance with section 912.
       ``(3) Temporary suspension.--If, after providing an 
     opportunity for an informal hearing, the Secretary determines 
     there is reasonable probability that the continuation of 
     distribution of a tobacco product under an order would cause 
     serious, adverse health consequences or death, that is 
     greater than ordinarily caused by tobacco products on the 
     market, the Secretary shall by order temporarily suspend the 
     authority of the manufacturer to market the product. If the 
     Secretary issues such an order, the Secretary shall proceed 
     expeditiously under paragraph (1) to withdraw such 
     application.
       ``(e) Service of Order.--An order issued by the Secretary 
     under this section shall be served--
       ``(1) in person by any officer or employee of the 
     department designated by the Secretary; or
       ``(2) by mailing the order by registered mail or certified 
     mail addressed to the applicant at the applicant's last known 
     address in the records of the Secretary.
       ``(f) Records.--
       ``(1) Additional information.--In the case of any tobacco 
     product for which an order issued pursuant to subsection 
     (c)(1)(A)(i) for an application filed under subsection (b) is 
     in effect, the applicant shall establish and maintain such 
     records, and make such reports to the Secretary, as the 
     Secretary may by regulation, or by order with respect to such 
     application, prescribe on the basis of a finding that such 
     records and reports are necessary in order to enable the 
     Secretary to determine, or facilitate a determination of, 
     whether there is or may be grounds for withdrawing or 
     temporarily suspending such order.
       ``(2) Access to records.--Each person required under this 
     section to maintain records, and each person in charge of 
     custody thereof, shall, upon request of an officer or 
     employee designated by the Secretary, permit such officer or 
     employee at all reasonable times to have access to and copy 
     and verify such records.
       ``(g) Investigational Tobacco Product Exemption for 
     Investigational Use.--The Secretary may exempt tobacco 
     products intended for investigational use from the provisions 
     of this chapter under such conditions as the Secretary may by 
     regulation prescribe.

     ``SEC. 911. MODIFIED RISK TOBACCO PRODUCTS.

       ``(a) In General.--No person may introduce or deliver for 
     introduction into interstate commerce any modified risk 
     tobacco product unless an order issued pursuant to subsection 
     (g) is effective with respect to such product.
       ``(b) Definitions.--In this section:
       ``(1) Modified risk tobacco product.--The term `modified 
     risk tobacco product' means any tobacco product that is sold 
     or distributed for use to reduce harm or the risk of tobacco-
     related disease associated with commercially marketed tobacco 
     products.
       ``(2) Sold or distributed.--
       ``(A) In general.--With respect to a tobacco product, the 
     term `sold or distributed for use to reduce harm or the risk 
     of tobacco-related disease associated with commercially 
     marketed tobacco products' means a tobacco product--
       ``(i) the label, labeling, or advertising of which 
     represents explicitly or implicitly that--

       ``(I) the tobacco product presents a lower risk of tobacco-
     related disease or is less harmful than one or more other 
     commercially marketed tobacco products;
       ``(II) the tobacco product or its smoke contains a reduced 
     level of a substance or presents a reduced exposure to a 
     substance; or
       ``(III) the tobacco product or its smoke does not contain 
     or is free of a substance;

       ``(ii) the label, labeling, or advertising of which uses 
     the descriptors `light', `mild', or `low' or similar 
     descriptors; or
       ``(iii) the tobacco product manufacturer of which has taken 
     any action directed to consumers through the media or 
     otherwise, other than by means of the tobacco product's 
     label, labeling, or advertising, after the date of enactment 
     of the Family Smoking Prevention and Tobacco Control Act, 
     respecting the product that would be reasonably expected to 
     result in consumers believing that the tobacco product or its 
     smoke may present a lower risk of disease or is less harmful 
     than one or more commercially marketed tobacco products, or 
     presents a reduced exposure to, or does not contain or is 
     free of, a substance or substances.
       ``(B) Limitation.--No tobacco product shall be considered 
     to be `sold or distributed for use to reduce harm or the risk 
     of tobacco-related disease associated with commercially 
     marketed tobacco products', except as described in 
     subparagraph (A).
       ``(C) Smokeless tobacco product.--No smokeless tobacco 
     product shall be considered to be `sold or distributed for 
     use to reduce harm or the risk of tobacco-related disease 
     associated with commercially marketed tobacco products' 
     solely because its label, labeling, or advertising uses the 
     following phrases to describe such product and its use: 
     `smokeless tobacco', `smokeless tobacco product', `not 
     consumed by smoking', `does not produce smoke', `smokefree', 
     `smoke-free', `without smoke', `no smoke', or `not smoke'.
       ``(3) Effective date.--The provisions of paragraph 
     (2)(A)(ii) shall take effect 12 months after the date of 
     enactment of the Family Smoking Prevention and Tobacco 
     Control Act for those products whose label, labeling, or 
     advertising contains the terms described in such paragraph on 
     such date of enactment. The effective date shall be with 
     respect to the date of manufacture, provided that, in any 
     case, beginning 30 days after such effective date, a 
     manufacturer shall not introduce into the domestic commerce 
     of the United States any product, irrespective of the date of 
     manufacture, that is not in conformance with paragraph 
     (2)(A)(ii).
       ``(c) Tobacco Dependence Products.--A product that is 
     intended to be used for the treatment of tobacco dependence, 
     including smoking cessation, is not a modified risk tobacco 
     product under this section if it has been approved as a drug 
     or device by the Food and Drug Administration and is subject 
     to the requirements of chapter V.
       ``(d) Filing.--Any person may file with the Secretary an 
     application for a modified risk tobacco product. Such 
     application shall include--

[[Page 17306]]

       ``(1) a description of the proposed product and any 
     proposed advertising and labeling;
       ``(2) the conditions for using the product;
       ``(3) the formulation of the product;
       ``(4) sample product labels and labeling;
       ``(5) all documents (including underlying scientific 
     information) relating to research findings conducted, 
     supported, or possessed by the tobacco product manufacturer 
     relating to the effect of the product on tobacco-related 
     diseases and health-related conditions, including information 
     both favorable and unfavorable to the ability of the product 
     to reduce risk or exposure and relating to human health;
       ``(6) data and information on how consumers actually use 
     the tobacco product; and
       ``(7) such other information as the Secretary may require.
       ``(e) Public Availability.--The Secretary shall make the 
     application described in subsection (d) publicly available 
     (except matters in the application which are trade secrets or 
     otherwise confidential, commercial information) and shall 
     request comments by interested persons on the information 
     contained in the application and on the label, labeling, and 
     advertising accompanying such application.
       ``(f) Advisory Committee.--
       ``(1) In general.--The Secretary shall refer to the Tobacco 
     Products Scientific Advisory Committee any application 
     submitted under this section.
       ``(2) Recommendations.--Not later than 60 days after the 
     date an application is referred to the Tobacco Products 
     Scientific Advisory Committee under paragraph (1), the 
     Advisory Committee shall report its recommendations on the 
     application to the Secretary.
       ``(g) Marketing.--
       ``(1) Modified risk products.--Except as provided in 
     paragraph (2), the Secretary shall, with respect to an 
     application submitted under this section, issue an order that 
     a modified risk product may be commercially marketed only if 
     the Secretary determines that the applicant has demonstrated 
     that such product, as it is actually used by consumers, 
     will--
       ``(A) significantly reduce harm and the risk of tobacco-
     related disease to individual tobacco users; and
       ``(B) benefit the health of the population as a whole 
     taking into account both users of tobacco products and 
     persons who do not currently use tobacco products.
       ``(2) Special rule for certain products.--
       ``(A) In general.--The Secretary may issue an order that a 
     tobacco product may be introduced or delivered for 
     introduction into interstate commerce, pursuant to an 
     application under this section, with respect to a tobacco 
     product that may not be commercially marketed under paragraph 
     (1) if the Secretary makes the findings required under this 
     paragraph and determines that the applicant has demonstrated 
     that--
       ``(i) such order would be appropriate to promote the public 
     health;
       ``(ii) any aspect of the label, labeling, and advertising 
     for such product that would cause the tobacco product to be a 
     modified risk tobacco product under subsection (b) is limited 
     to an explicit or implicit representation that such tobacco 
     product or its smoke does not contain or is free of a 
     substance or contains a reduced level of a substance, or 
     presents a reduced exposure to a substance in tobacco smoke;
       ``(iii) scientific evidence is not available and, using the 
     best available scientific methods, cannot be made available 
     without conducting long-term epidemiological studies for an 
     application to meet the standards set forth in paragraph (1); 
     and
       ``(iv) the scientific evidence that is available without 
     conducting long-term epidemiological studies demonstrates 
     that a measurable and substantial reduction in morbidity or 
     mortality among individual tobacco users is reasonably likely 
     in subsequent studies.
       ``(B) Additional findings required.--To issue an order 
     under subparagraph (A) the Secretary must also find that the 
     applicant has demonstrated that--
       ``(i) the magnitude of the overall reductions in exposure 
     to the substance or substances which are the subject of the 
     application is substantial, such substance or substances are 
     harmful, and the product as actually used exposes consumers 
     to the specified reduced level of the substance or 
     substances;
       ``(ii) the product as actually used by consumers will not 
     expose them to higher levels of other harmful substances 
     compared to the similar types of tobacco products then on the 
     market unless such increases are minimal and the reasonably 
     likely overall impact of use of the product remains a 
     substantial and measurable reduction in overall morbidity and 
     mortality among individual tobacco users;
       ``(iii) testing of actual consumer perception shows that, 
     as the applicant proposes to label and market the product, 
     consumers will not be misled into believing that the 
     product--

       ``(I) is or has been demonstrated to be less harmful; or
       ``(II) presents or has been demonstrated to present less of 
     a risk of disease than 1 or more other commercially marketed 
     tobacco products; and

       ``(iv) issuance of an order with respect to the application 
     is expected to benefit the health of the population as a 
     whole taking into account both users of tobacco products and 
     persons who do not currently use tobacco products.
       ``(C) Conditions of marketing.--
       ``(i) In general.--Applications subject to an order under 
     this paragraph shall be limited to a term of not more than 5 
     years, but may be renewed upon a finding by the Secretary 
     that the requirements of this paragraph continue to be 
     satisfied based on the filing of a new application.
       ``(ii) Agreements by applicant.--An order under this 
     paragraph shall be conditioned on the applicant's agreement 
     to conduct postmarket surveillance and studies and to submit 
     to the Secretary the results of such surveillance and studies 
     to determine the impact of the order on consumer perception, 
     behavior, and health and to enable the Secretary to review 
     the accuracy of the determinations upon which the order was 
     based in accordance with a protocol approved by the 
     Secretary.
       ``(iii) Annual submission.--The results of such postmarket 
     surveillance and studies described in clause (ii) shall be 
     submitted annually.
       ``(3) Basis.--The determinations under paragraphs (1) and 
     (2) shall be based on--
       ``(A) the scientific evidence submitted by the applicant; 
     and
       ``(B) scientific evidence and other information that is 
     made available to the Secretary.
       ``(4) Benefit to health of individuals and of population as 
     a whole.--In making the determinations under paragraphs (1) 
     and (2), the Secretary shall take into account--
       ``(A) the relative health risks to individuals of the 
     tobacco product that is the subject of the application;
       ``(B) the increased or decreased likelihood that existing 
     users of tobacco products who would otherwise stop using such 
     products will switch to the tobacco product that is the 
     subject of the application;
       ``(C) the increased or decreased likelihood that persons 
     who do not use tobacco products will start using the tobacco 
     product that is the subject of the application;
       ``(D) the risks and benefits to persons from the use of the 
     tobacco product that is the subject of the application as 
     compared to the use of products for smoking cessation 
     approved under chapter V to treat nicotine dependence; and
       ``(E) comments, data, and information submitted by 
     interested persons.
       ``(h) Additional Conditions for Marketing.--
       ``(1) Modified risk products.--The Secretary shall require 
     for the marketing of a product under this section that any 
     advertising or labeling concerning modified risk products 
     enable the public to comprehend the information concerning 
     modified risk and to understand the relative significance of 
     such information in the context of total health and in 
     relation to all of the diseases and health-related conditions 
     associated with the use of tobacco products.
       ``(2) Comparative claims.--
       ``(A) In general.--The Secretary may require for the 
     marketing of a product under this subsection that a claim 
     comparing a tobacco product to 1 or more other commercially 
     marketed tobacco products shall compare the tobacco product 
     to a commercially marketed tobacco product that is 
     representative of that type of tobacco product on the market 
     (for example the average value of the top 3 brands of an 
     established regular tobacco product).
       ``(B) Quantitative comparisons.--The Secretary may also 
     require, for purposes of subparagraph (A), that the percent 
     (or fraction) of change and identity of the reference tobacco 
     product and a quantitative comparison of the amount of the 
     substance claimed to be reduced shall be stated in immediate 
     proximity to the most prominent claim.
       ``(3) Label disclosure.--
       ``(A) In general.--The Secretary may require the disclosure 
     on the label of other substances in the tobacco product, or 
     substances that may be produced by the consumption of that 
     tobacco product, that may affect a disease or health-related 
     condition or may increase the risk of other diseases or 
     health-related conditions associated with the use of tobacco 
     products.
       ``(B) Conditions of use.--If the conditions of use of the 
     tobacco product may affect the risk of the product to human 
     health, the Secretary may require the labeling of conditions 
     of use.
       ``(4) Time.--An order issued under subsection (g)(1) shall 
     be effective for a specified period of time.
       ``(5) Advertising.--The Secretary may require, with respect 
     to a product for which an applicant obtained an order under 
     subsection (g)(1), that the product comply with requirements 
     relating to advertising and promotion of the tobacco product.
       ``(i) Postmarket Surveillance and Studies.--
       ``(1) In general.--The Secretary shall require, with 
     respect to a product for which an applicant obtained an order 
     under subsection (g)(1), that the applicant conduct 
     postmarket surveillance and studies for such a tobacco 
     product to determine the impact of the order issuance on 
     consumer perception, behavior, and health, to enable the 
     Secretary to review

[[Page 17307]]

     the accuracy of the determinations upon which the order was 
     based, and to provide information that the Secretary 
     determines is otherwise necessary regarding the use or health 
     risks involving the tobacco product. The results of 
     postmarket surveillance and studies shall be submitted to the 
     Secretary on an annual basis.
       ``(2) Surveillance protocol.--Each applicant required to 
     conduct a surveillance of a tobacco product under paragraph 
     (1) shall, within 30 days after receiving notice that the 
     applicant is required to conduct such surveillance, submit, 
     for the approval of the Secretary, a protocol for the 
     required surveillance. The Secretary, within 60 days of the 
     receipt of such protocol, shall determine if the principal 
     investigator proposed to be used in the surveillance has 
     sufficient qualifications and experience to conduct such 
     surveillance and if such protocol will result in collection 
     of the data or other information designated by the Secretary 
     as necessary to protect the public health.
       ``(j) Withdrawal of Authorization.--The Secretary, after an 
     opportunity for an informal hearing, shall withdraw an order 
     under subsection (g) if the Secretary determines that--
       ``(1) the applicant, based on new information, can no 
     longer make the demonstrations required under subsection (g), 
     or the Secretary can no longer make the determinations 
     required under subsection (g);
       ``(2) the application failed to include material 
     information or included any untrue statement of material 
     fact;
       ``(3) any explicit or implicit representation that the 
     product reduces risk or exposure is no longer valid, 
     including if--
       ``(A) a tobacco product standard is established pursuant to 
     section 907;
       ``(B) an action is taken that affects the risks presented 
     by other commercially marketed tobacco products that were 
     compared to the product that is the subject of the 
     application; or
       ``(C) any postmarket surveillance or studies reveal that 
     the order is no longer consistent with the protection of the 
     public health;
       ``(4) the applicant failed to conduct or submit the 
     postmarket surveillance and studies required under subsection 
     (g)(2)(C)(ii) or subsection (i); or
       ``(5) the applicant failed to meet a condition imposed 
     under subsection (h).
       ``(k) Chapter IV or V.--A product for which the Secretary 
     has issued an order pursuant to subsection (g) shall not be 
     subject to chapter IV or V.
       ``(l) Implementing Regulations or Guidance.--
       ``(1) Scientific evidence.--Not later than 2 years after 
     the date of enactment of the Family Smoking Prevention and 
     Tobacco Control Act, the Secretary shall issue regulations or 
     guidance (or any combination thereof) on the scientific 
     evidence required for assessment and ongoing review of 
     modified risk tobacco products. Such regulations or guidance 
     shall--
       ``(A) to the extent that adequate scientific evidence 
     exists, establish minimum standards for scientific studies 
     needed prior to issuing an order under subsection (g) to show 
     that a substantial reduction in morbidity or mortality among 
     individual tobacco users occurs for products described in 
     subsection (g)(1) or is reasonably likely for products 
     described in subsection (g)(2);
       ``(B) include validated biomarkers, intermediate clinical 
     endpoints, and other feasible outcome measures, as 
     appropriate;
       ``(C) establish minimum standards for postmarket studies, 
     that shall include regular and long-term assessments of 
     health outcomes and mortality, intermediate clinical 
     endpoints, consumer perception of harm reduction, and the 
     impact on quitting behavior and new use of tobacco products, 
     as appropriate;
       ``(D) establish minimum standards for required postmarket 
     surveillance, including ongoing assessments of consumer 
     perception;
       ``(E) require that data from the required studies and 
     surveillance be made available to the Secretary prior to the 
     decision on renewal of a modified risk tobacco product; and
       ``(F) establish a reasonable timetable for the Secretary to 
     review an application under this section.
       ``(2) Consultation.--The regulations or guidance issued 
     under paragraph (1) shall be developed in consultation with 
     the Institute of Medicine, and with the input of other 
     appropriate scientific and medical experts, on the design and 
     conduct of such studies and surveillance.
       ``(3) Revision.--The regulations or guidance under 
     paragraph (1) shall be revised on a regular basis as new 
     scientific information becomes available.
       ``(4) New tobacco products.--Not later than 2 years after 
     the date of enactment of the Family Smoking Prevention and 
     Tobacco Control Act, the Secretary shall issue a regulation 
     or guidance that permits the filing of a single application 
     for any tobacco product that is a new tobacco product under 
     section 910 and which the applicant seeks to commercially 
     market under this section.
       ``(m) Distributors.--Except as provided in this section, no 
     distributor may take any action, after the date of enactment 
     of the Family Smoking Prevention and Tobacco Control Act, 
     with respect to a tobacco product that would reasonably be 
     expected to result in consumers believing that the tobacco 
     product or its smoke may present a lower risk of disease or 
     is less harmful than one or more commercially marketed 
     tobacco products, or presents a reduced exposure to, or does 
     not contain or is free of, a substance or substances.

     ``SEC. 912. JUDICIAL REVIEW.

       ``(a) Right To Review.--
       ``(1) In general.--Not later than 30 days after--
       ``(A) the promulgation of a regulation under section 907 
     establishing, amending, or revoking a tobacco product 
     standard; or
       ``(B) a denial of an application under section 910(c),

     any person adversely affected by such regulation or denial 
     may file a petition for judicial review of such regulation or 
     denial with the United States Court of Appeals for the 
     District of Columbia or for the circuit in which such person 
     resides or has their principal place of business.
       ``(2) Requirements.--
       ``(A) Copy of petition.--A copy of the petition filed under 
     paragraph (1) shall be transmitted by the clerk of the court 
     involved to the Secretary.
       ``(B) Record of proceedings.--On receipt of a petition 
     under subparagraph (A), the Secretary shall file in the court 
     in which such petition was filed--
       ``(i) the record of the proceedings on which the regulation 
     or order was based; and
       ``(ii) a statement of the reasons for the issuance of such 
     a regulation or order.
       ``(C) Definition of record.--In this section, the term 
     `record' means--
       ``(i) all notices and other matter published in the Federal 
     Register with respect to the regulation or order reviewed;
       ``(ii) all information submitted to the Secretary with 
     respect to such regulation or order;
       ``(iii) proceedings of any panel or advisory committee with 
     respect to such regulation or order;
       ``(iv) any hearing held with respect to such regulation or 
     order; and
       ``(v) any other information identified by the Secretary, in 
     the administrative proceeding held with respect to such 
     regulation or order, as being relevant to such regulation or 
     order.
       ``(b) Standard of Review.--Upon the filing of the petition 
     under subsection (a) for judicial review of a regulation or 
     order, the court shall have jurisdiction to review the 
     regulation or order in accordance with chapter 7 of title 5, 
     United States Code, and to grant appropriate relief, 
     including interim relief, as provided for in such chapter. A 
     regulation or denial described in subsection (a) shall be 
     reviewed in accordance with section 706(2)(A) of title 5, 
     United States Code.
       ``(c) Finality of Judgment.--The judgment of the court 
     affirming or setting aside, in whole or in part, any 
     regulation or order shall be final, subject to review by the 
     Supreme Court of the United States upon certiorari or 
     certification, as provided in section 1254 of title 28, 
     United States Code.
       ``(d) Other Remedies.--The remedies provided for in this 
     section shall be in addition to, and not in lieu of, any 
     other remedies provided by law.
       ``(e) Regulations and Orders Must Recite Basis in Record.--
     To facilitate judicial review, a regulation or order issued 
     under section 906, 907, 908, 909, 910, or 916 shall contain a 
     statement of the reasons for the issuance of such regulation 
     or order in the record of the proceedings held in connection 
     with its issuance.

     ``SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS.

       ``The Secretary shall issue regulations to require that 
     retail establishments for which the predominant business is 
     the sale of tobacco products comply with any advertising 
     restrictions applicable to retail establishments accessible 
     to individuals under the age of 18.

     ``SEC. 914. JURISDICTION OF AND COORDINATION WITH THE FEDERAL 
                   TRADE COMMISSION.

       ``(a) Jurisdiction.--
       ``(1) In general.--Except where expressly provided in this 
     chapter, nothing in this chapter shall be construed as 
     limiting or diminishing the authority of the Federal Trade 
     Commission to enforce the laws under its jurisdiction with 
     respect to the advertising, sale, or distribution of tobacco 
     products.
       ``(2) Enforcement.--Any advertising that violates this 
     chapter or a provision of the regulations referred to in 
     section 102 of the Family Smoking Prevention and Tobacco 
     Control Act, is an unfair or deceptive act or practice under 
     section 5(a) of the Federal Trade Commission Act and shall be 
     considered a violation of a rule promulgated under section 18 
     of that Act.
       ``(b) Coordination.--With respect to the requirements of 
     section 4 of the Federal Cigarette Labeling and Advertising 
     Act and section 3 of the Comprehensive Smokeless Tobacco 
     Health Education Act of 1986--
       ``(1) the Chairman of the Federal Trade Commission shall 
     coordinate with the Secretary concerning the enforcement of 
     such Act as such enforcement relates to unfair or

[[Page 17308]]

     deceptive acts or practices in the advertising of cigarettes 
     or smokeless tobacco; and
       ``(2) the Secretary shall consult with the Chairman of such 
     Commission in revising the label statements and requirements 
     under such sections.

     ``SEC. 915. REGULATION REQUIREMENT.

       ``(a) Testing, Reporting, and Disclosure.--Not later than 
     36 months after the date of enactment of the Family Smoking 
     Prevention and Tobacco Control Act, the Secretary shall 
     promulgate regulations under this Act that meet the 
     requirements of subsection (b).
       ``(b) Contents of Rules.--The regulations promulgated under 
     subsection (a)--
       ``(1) shall require testing and reporting of tobacco 
     product constituents, ingredients, and additives, including 
     smoke constituents, by brand and subbrand that the Secretary 
     determines should be tested to protect the public health, 
     provided that, for purposes of the testing requirements of 
     this paragraph, tobacco products manufactured and sold by a 
     single tobacco product manufacturer that are identical in all 
     respects except the labels, packaging design, logo, trade 
     dress, trademark, brand name, or any combination thereof, 
     shall be considered as a single brand; and
       ``(2) may require that tobacco product manufacturers, 
     packagers, or importers make disclosures relating to the 
     results of the testing of tar and nicotine through labels or 
     advertising or other appropriate means, and make disclosures 
     regarding the results of the testing of other constituents, 
     including smoke constituents, ingredients, or additives, that 
     the Secretary determines should be disclosed to the public to 
     protect the public health and will not mislead consumers 
     about the risk of tobacco-related disease.
       ``(c) Authority.--The Secretary shall have the authority 
     under this chapter to conduct or to require the testing, 
     reporting, or disclosure of tobacco product constituents, 
     including smoke constituents.
       ``(d) Small Tobacco Product Manufacturers.--
       ``(1) First compliance date.--The initial regulations 
     promulgated under subsection (a) shall not impose 
     requirements on small tobacco product manufacturers before 
     the later of--
       ``(A) the end of the 2-year period following the final 
     promulgation of such regulations; and
       ``(B) the initial date set by the Secretary for compliance 
     with such regulations by manufacturers that are not small 
     tobacco product manufacturers.
       ``(2) Testing and reporting initial compliance period.--
       ``(A) 4-year period.--The initial regulations promulgated 
     under subsection (a) shall give each small tobacco product 
     manufacturer a 4-year period over which to conduct testing 
     and reporting for all of its tobacco products. Subject to 
     paragraph (1), the end of the first year of such 4-year 
     period shall coincide with the initial date of compliance 
     under this section set by the Secretary with respect to 
     manufacturers that are not small tobacco product 
     manufacturers or the end of the 2-year period following the 
     final promulgation of such regulations, as described in 
     paragraph (1)(A). A small tobacco product manufacturer shall 
     be required--
       ``(i) to conduct such testing and reporting for 25 percent 
     of its tobacco products during each year of such 4-year 
     period; and
       ``(ii) to conduct such testing and reporting for its 
     largest-selling tobacco products (as determined by the 
     Secretary) before its other tobacco products, or in such 
     other order of priority as determined by the Secretary.
       ``(B) Case-by-case delay.--Notwithstanding subparagraph 
     (A), the Secretary may, on a case-by-case basis, delay the 
     date by which an individual small tobacco product 
     manufacturer must conduct testing and reporting for its 
     tobacco products under this section based upon a showing of 
     undue hardship to such manufacturer. Notwithstanding the 
     preceding sentence, the Secretary shall not extend the 
     deadline for a small tobacco product manufacturer to conduct 
     testing and reporting for all of its tobacco products beyond 
     a total of 5 years after the initial date of compliance under 
     this section set by the Secretary with respect to 
     manufacturers that are not small tobacco product 
     manufacturers.
       ``(3) Subsequent and additional testing and reporting.--The 
     regulations promulgated under subsection (a) shall provide 
     that, with respect to any subsequent or additional testing 
     and reporting of tobacco products required under this 
     section, such testing and reporting by a small tobacco 
     product manufacturer shall be conducted in accordance with 
     the timeframes described in paragraph (2)(A), except that, in 
     the case of a new product, or if there has been a 
     modification described in section 910(a)(1)(B) of any product 
     of a small tobacco product manufacturer since the last 
     testing and reporting required under this section, the 
     Secretary shall require that any subsequent or additional 
     testing and reporting be conducted in accordance with the 
     same timeframe applicable to manufacturers that are not small 
     tobacco product manufacturers.
       ``(4) Joint laboratory testing services.--The Secretary 
     shall allow any 2 or more small tobacco product manufacturers 
     to join together to purchase laboratory testing services 
     required by this section on a group basis in order to ensure 
     that such manufacturers receive access to, and fair pricing 
     of, such testing services.
       ``(e) Extensions for Limited Laboratory Capacity.--
       ``(1) In general.--The regulations promulgated under 
     subsection (a) shall provide that a small tobacco product 
     manufacturer shall not be considered to be in violation of 
     this section before the deadline applicable under paragraphs 
     (3) and (4), if--
       ``(A) the tobacco products of such manufacturer are in 
     compliance with all other requirements of this chapter; and
       ``(B) the conditions described in paragraph (2) are met.
       ``(2) Conditions.--Notwithstanding the requirements of this 
     section, the Secretary may delay the date by which a small 
     tobacco product manufacturer must be in compliance with the 
     testing and reporting required by this section until such 
     time as the testing is reported if, not later than 90 days 
     before the deadline for reporting in accordance with this 
     section, a small tobacco product manufacturer provides 
     evidence to the Secretary demonstrating that--
       ``(A) the manufacturer has submitted the required products 
     for testing to a laboratory and has done so sufficiently in 
     advance of the deadline to create a reasonable expectation of 
     completion by the deadline;
       ``(B) the products currently are awaiting testing by the 
     laboratory; and
       ``(C) neither that laboratory nor any other laboratory is 
     able to complete testing by the deadline at customary, 
     nonexpedited testing fees.
       ``(3) Extension.--The Secretary, taking into account the 
     laboratory testing capacity that is available to tobacco 
     product manufacturers, shall review and verify the evidence 
     submitted by a small tobacco product manufacturer in 
     accordance with paragraph (2). If the Secretary finds that 
     the conditions described in such paragraph are met, the 
     Secretary shall notify the small tobacco product manufacturer 
     that the manufacturer shall not be considered to be in 
     violation of the testing and reporting requirements of this 
     section until the testing is reported or until 1 year after 
     the reporting deadline has passed, whichever occurs sooner. 
     If, however, the Secretary has not made a finding before the 
     reporting deadline, the manufacturer shall not be considered 
     to be in violation of such requirements until the Secretary 
     finds that the conditions described in paragraph (2) have not 
     been met, or until 1 year after the reporting deadline, 
     whichever occurs sooner.
       ``(4) Additional extension.--In addition to the time that 
     may be provided under paragraph (3), the Secretary may 
     provide further extensions of time, in increments of no more 
     than 1 year, for required testing and reporting to occur if 
     the Secretary determines, based on evidence properly and 
     timely submitted by a small tobacco product manufacturer in 
     accordance with paragraph (2), that a lack of available 
     laboratory capacity prevents the manufacturer from completing 
     the required testing during the period described in paragraph 
     (3).
       ``(f) Rule of Construction.--Nothing in subsection (d) or 
     (e) shall be construed to authorize the extension of any 
     deadline, or to otherwise affect any timeframe, under any 
     provision of this Act or the Family Smoking Prevention and 
     Tobacco Control Act other than this section.

     ``SEC. 916. PRESERVATION OF STATE AND LOCAL AUTHORITY.

       ``(a) In General.--
       ``(1) Preservation.--Except as provided in paragraph 
     (2)(A), nothing in this chapter, or rules promulgated under 
     this chapter, shall be construed to limit the authority of a 
     Federal agency (including the Armed Forces), a State or 
     political subdivision of a State, or the government of an 
     Indian tribe to enact, adopt, promulgate, and enforce any 
     law, rule, regulation, or other measure with respect to 
     tobacco products that is in addition to, or more stringent 
     than, requirements established under this chapter, including 
     a law, rule, regulation, or other measure relating to or 
     prohibiting the sale, distribution, possession, exposure to, 
     access to, advertising and promotion of, or use of tobacco 
     products by individuals of any age, information reporting to 
     the State, or measures relating to fire safety standards for 
     tobacco products. No provision of this chapter shall limit or 
     otherwise affect any State, Tribal, or local taxation of 
     tobacco products.
       ``(2) Preemption of certain state and local requirements.--
       ``(A) In general.--No State or political subdivision of a 
     State may establish or continue in effect with respect to a 
     tobacco product any requirement which is different from, or 
     in addition to, any requirement under the provisions of this 
     chapter relating to tobacco product standards, premarket 
     review, adulteration, misbranding, labeling, registration, 
     good manufacturing standards, or modified risk tobacco 
     products.
       ``(B) Exception.--Subparagraph (A) does not apply to 
     requirements relating to the sale, distribution, possession, 
     information reporting to the State, exposure to, access to, 
     the advertising and promotion of, or use of, tobacco products 
     by individuals of any

[[Page 17309]]

     age, or relating to fire safety standards for tobacco 
     products. Information disclosed to a State under subparagraph 
     (A) that is exempt from disclosure under section 552(b)(4) of 
     title 5, United States Code, shall be treated as a trade 
     secret and confidential information by the State.
       ``(b) Rule of Construction Regarding Product Liability.--No 
     provision of this chapter relating to a tobacco product shall 
     be construed to modify or otherwise affect any action or the 
     liability of any person under the product liability law of 
     any State.

     ``SEC. 917. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.

       ``(a) Establishment.--Not later than 6 months after the 
     date of enactment of the Family Smoking Prevention and 
     Tobacco Control Act, the Secretary shall establish a 12-
     member advisory committee, to be known as the Tobacco 
     Products Scientific Advisory Committee (in this section 
     referred to as the `Advisory Committee').
       ``(b) Membership.--
       ``(1) In general.--
       ``(A) Members.--The Secretary shall appoint as members of 
     the Tobacco Products Scientific Advisory Committee 
     individuals who are technically qualified by training and 
     experience in medicine, medical ethics, science, or 
     technology involving the manufacture, evaluation, or use of 
     tobacco products, who are of appropriately diversified 
     professional backgrounds. The committee shall be composed 
     of--
       ``(i) 7 individuals who are physicians, dentists, 
     scientists, or health care professionals practicing in the 
     area of oncology, pulmonology, cardiology, toxicology, 
     pharmacology, addiction, or any other relevant specialty;
       ``(ii) 1 individual who is an officer or employee of a 
     State or local government or of the Federal Government;
       ``(iii) 1 individual as a representative of the general 
     public;
       ``(iv) 1 individual as a representative of the interests of 
     the tobacco manufacturing industry;
       ``(v) 1 individual as a representative of the interests of 
     the small business tobacco manufacturing industry, which 
     position may be filled on a rotating, sequential basis by 
     representatives of different small business tobacco 
     manufacturers based on areas of expertise relevant to the 
     topics being considered by the Advisory Committee; and
       ``(vi) 1 individual as a representative of the interests of 
     the tobacco growers.
       ``(B) Nonvoting members.--The members of the committee 
     appointed under clauses (iv), (v), and (vi) of subparagraph 
     (A) shall serve as consultants to those described in clauses 
     (i) through (iii) of subparagraph (A) and shall be nonvoting 
     representatives.
       ``(C) Conflicts of interest.--No members of the committee, 
     other than members appointed pursuant to clauses (iv), (v), 
     and (vi) of subparagraph (A) shall, during the member's 
     tenure on the committee or for the 18-month period prior to 
     becoming such a member, receive any salary, grants, or other 
     payments or support from any business that manufactures, 
     distributes, markets, or sells cigarettes or other tobacco 
     products.
       ``(2) Limitation.--The Secretary may not appoint to the 
     Advisory Committee any individual who is in the regular full-
     time employ of the Food and Drug Administration or any agency 
     responsible for the enforcement of this Act. The Secretary 
     may appoint Federal officials as ex officio members.
       ``(3) Chairperson.--The Secretary shall designate 1 of the 
     members appointed under clauses (i), (ii), and (iii) of 
     paragraph (1)(A) to serve as chairperson.
       ``(c) Duties.--The Tobacco Products Scientific Advisory 
     Committee shall provide advice, information, and 
     recommendations to the Secretary--
       ``(1) as provided in this chapter;
       ``(2) on the effects of the alteration of the nicotine 
     yields from tobacco products;
       ``(3) on whether there is a threshold level below which 
     nicotine yields do not produce dependence on the tobacco 
     product involved; and
       ``(4) on its review of other safety, dependence, or health 
     issues relating to tobacco products as requested by the 
     Secretary.
       ``(d) Compensation; Support; FACA.--
       ``(1) Compensation and travel.--Members of the Advisory 
     Committee who are not officers or employees of the United 
     States, while attending conferences or meetings of the 
     committee or otherwise engaged in its business, shall be 
     entitled to receive compensation at rates to be fixed by the 
     Secretary, which may not exceed the daily equivalent of the 
     rate in effect under the Senior Executive Schedule under 
     section 5382 of title 5, United States Code, for each day 
     (including travel time) they are so engaged; and while so 
     serving away from their homes or regular places of business 
     each member may be allowed travel expenses, including per 
     diem in lieu of subsistence, as authorized by section 5703 of 
     title 5, United States Code, for persons in the Government 
     service employed intermittently.
       ``(2) Administrative support.--The Secretary shall furnish 
     the Advisory Committee clerical and other assistance.
       ``(3) Nonapplication of faca.--Section 14 of the Federal 
     Advisory Committee Act does not apply to the Advisory 
     Committee.
       ``(e) Proceedings of Advisory Panels and Committees.--The 
     Advisory Committee shall make and maintain a transcript of 
     any proceeding of the panel or committee. Each such panel and 
     committee shall delete from any transcript made under this 
     subsection information which is exempt from disclosure under 
     section 552(b) of title 5, United States Code.

     ``SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.

       ``(a) In General.--The Secretary shall--
       ``(1) at the request of the applicant, consider designating 
     products for smoking cessation, including nicotine 
     replacement products as fast track research and approval 
     products within the meaning of section 506;
       ``(2) consider approving the extended use of nicotine 
     replacement products (such as nicotine patches, nicotine gum, 
     and nicotine lozenges) for the treatment of tobacco 
     dependence; and
       ``(3) review and consider the evidence for additional 
     indications for nicotine replacement products, such as for 
     craving relief or relapse prevention.
       ``(b) Report on Innovative Products.--
       ``(1) In general.--Not later than 3 years after the date of 
     enactment of the Family Smoking Prevention and Tobacco 
     Control Act, the Secretary, after consultation with 
     recognized scientific, medical, and public health experts 
     (including both Federal agencies and nongovernmental 
     entities, the Institute of Medicine of the National Academy 
     of Sciences, and the Society for Research on Nicotine and 
     Tobacco), shall submit to the Congress a report that examines 
     how best to regulate, promote, and encourage the development 
     of innovative products and treatments (including nicotine-
     based and non-nicotine-based products and treatments) to 
     better achieve, in a manner that best protects and promotes 
     the public health--
       ``(A) total abstinence from tobacco use;
       ``(B) reductions in consumption of tobacco; and
       ``(C) reductions in the harm associated with continued 
     tobacco use.
       ``(2) Recommendations.--The report under paragraph (1) 
     shall include the recommendations of the Secretary on how the 
     Food and Drug Administration should coordinate and facilitate 
     the exchange of information on such innovative products and 
     treatments among relevant offices and centers within the 
     Administration and within the National Institutes of Health, 
     the Centers for Disease Control and Prevention, and other 
     relevant agencies.

     ``SEC. 919. USER FEES.

       ``(a) Establishment of Quarterly Fee.--Beginning on the 
     date of the enactment of the Family Smoking Prevention and 
     Tobacco Control Act, the Secretary shall in accordance with 
     this section assess user fees on, and collect such fees from, 
     each manufacturer and importer of tobacco products subject to 
     this chapter. The fees shall be assessed and collected with 
     respect to each quarter of each fiscal year, and the total 
     amount assessed and collected for a fiscal year shall be the 
     amount specified in subsection (b)(1) for such year, subject 
     to subsection (c).
       ``(b) Assessment of User Fee.--
       ``(1) Amount of assessment.--The total amount of user fees 
     authorized to be assessed and collected under subsection (a) 
     for a fiscal year is the following, as applicable to the 
     fiscal year involved:
       ``(A) For fiscal year 2009, $85,000,000 (subject to 
     subsection (e)).
       ``(B) For fiscal year 2010, $235,000,000.
       ``(C) For fiscal year 2011, $450,000,000.
       ``(D) For fiscal year 2012, $477,000,000.
       ``(E) For fiscal year 2013, $505,000,000.
       ``(F) For fiscal year 2014, $534,000,000.
       ``(G) For fiscal year 2015, $566,000,000.
       ``(H) For fiscal year 2016, $599,000,000.
       ``(I) For fiscal year 2017, $635,000,000.
       ``(J) For fiscal year 2018, $672,000,000.
       ``(K) For fiscal year 2019 and each subsequent fiscal year, 
     $712,000,000.
       ``(2) Allocations of assessment by class of tobacco 
     products.--
       ``(A) In general.--The total user fees assessed and 
     collected under subsection (a) each fiscal year with respect 
     to each class of tobacco products shall be an amount that is 
     equal to the applicable percentage of each class for the 
     fiscal year multiplied by the amount specified in paragraph 
     (1) for the fiscal year.
       ``(B) Applicable percentage.--
       ``(i) In general.--For purposes of subparagraph (A), the 
     applicable percentage for a fiscal year for each of the 
     following classes of tobacco products shall be determined in 
     accordance with clause (ii):

       ``(I) Cigarettes.
       ``(II) Cigars, including small cigars and cigars other than 
     small cigars.
       ``(III) Snuff.
       ``(IV) Chewing tobacco.
       ``(V) Pipe tobacco.
       ``(VI) Roll-your-own tobacco.

       ``(ii) Allocations.--The applicable percentage of each 
     class of tobacco product described in clause (i) for a fiscal 
     year shall be the percentage determined under section 625(c) 
     of Public Law 108-357 for each such class of product for such 
     fiscal year.
       ``(iii) Requirement of regulations.--Notwithstanding clause 
     (ii), no user fees shall be assessed on a class of tobacco 
     products unless such class of tobacco products is listed

[[Page 17310]]

     in section 901(b) or is deemed by the Secretary in a 
     regulation under section 901(b) to be subject to this 
     chapter.
       ``(iv) Reallocations.--In the case of a class of tobacco 
     products that is not listed in section 901(b) or deemed by 
     the Secretary in a regulation under section 901(b) to be 
     subject to this chapter, the amount of user fees that would 
     otherwise be assessed to such class of tobacco products shall 
     be reallocated to the classes of tobacco products that are 
     subject to this chapter in the same manner and based on the 
     same relative percentages otherwise determined under clause 
     (ii).
       ``(3) Determination of user fee by company.--
       ``(A) In general.--The total user fee to be paid by each 
     manufacturer or importer of a particular class of tobacco 
     products shall be determined for each quarter by 
     multiplying--
       ``(i) such manufacturer's or importer's percentage share as 
     determined under paragraph (4); by
       ``(ii) the portion of the user fee amount for the current 
     quarter to be assessed on all manufacturers and importers of 
     such class of tobacco products as determined under paragraph 
     (2).
       ``(B) No fee in excess of percentage share.--No 
     manufacturer or importer of tobacco products shall be 
     required to pay a user fee in excess of the percentage share 
     of such manufacturer or importer.
       ``(4) Allocation of assessment within each class of tobacco 
     product.--The percentage share of each manufacturer or 
     importer of a particular class of tobacco products of the 
     total user fee to be paid by all manufacturers or importers 
     of that class of tobacco products shall be the percentage 
     determined for purposes of allocations under subsections (e) 
     through (h) of section 625 of Public Law 108-357.
       ``(5) Allocation for cigars.--Notwithstanding paragraph 
     (4), if a user fee assessment is imposed on cigars, the 
     percentage share of each manufacturer or importer of cigars 
     shall be based on the excise taxes paid by such manufacturer 
     or importer during the prior fiscal year.
       ``(6) Timing of assessment.--The Secretary shall notify 
     each manufacturer and importer of tobacco products subject to 
     this section of the amount of the quarterly assessment 
     imposed on such manufacturer or importer under this 
     subsection for each quarter of each fiscal year. Such 
     notifications shall occur not later than 30 days prior to the 
     end of the quarter for which such assessment is made, and 
     payments of all assessments shall be made by the last day of 
     the quarter involved.
       ``(7) Memorandum of understanding.--
       ``(A) In general.--The Secretary shall request the 
     appropriate Federal agency to enter into a memorandum of 
     understanding that provides for the regular and timely 
     transfer from the head of such agency to the Secretary of the 
     information described in paragraphs (2)(B)(ii) and (4) and 
     all necessary information regarding all tobacco product 
     manufacturers and importers required to pay user fees. The 
     Secretary shall maintain all disclosure restrictions 
     established by the head of such agency regarding the 
     information provided under the memorandum of understanding.
       ``(B) Assurances.--Beginning not later than fiscal year 
     2015, and for each subsequent fiscal year, the Secretary 
     shall ensure that the Food and Drug Administration is able to 
     determine the applicable percentages described in paragraph 
     (2) and the percentage shares described in paragraph (4). The 
     Secretary may carry out this subparagraph by entering into a 
     contract with the head of the Federal agency referred to in 
     subparagraph (A) to continue to provide the necessary 
     information.
       ``(c) Crediting and Availability of Fees.--
       ``(1) In general.--Fees authorized under subsection (a) 
     shall be collected and available for obligation only to the 
     extent and in the amount provided in advance in 
     appropriations Acts. Such fees are authorized to remain 
     available until expended. Such sums as may be necessary may 
     be transferred from the Food and Drug Administration salaries 
     and expenses appropriation account without fiscal year 
     limitation to such appropriation account for salaries and 
     expenses with such fiscal year limitation.
       ``(2) Availability.--
       ``(A) In general.--Fees appropriated under paragraph (3) 
     are available only for the purpose of paying the costs of the 
     activities of the Food and Drug Administration related to the 
     regulation of tobacco products under this chapter and the 
     Family Smoking Prevention and Tobacco Control Act. No fees 
     collected under subsection (a) may be used for any other 
     costs.
       ``(B) Prohibition against use of other funds.--
       ``(i) In general.--Except as provided in clause (ii), fees 
     collected under subsection (a) are the only funds authorized 
     to be made available for the purpose described in 
     subparagraph (A).
       ``(ii) Startup costs.--Clause (i) does not apply until the 
     date on which the Secretary has collected fees under 
     subsection (a) for 2 fiscal year quarters. Until such date, 
     other amounts available to the Food and Drug Administration 
     (excluding fees collected under subsection (a)) are 
     authorized to be made available to pay the costs described in 
     subparagraph (A), provided that such amounts are reimbursed 
     through fees collected under subsection (a).
       ``(3) Authorization of appropriations.--For fiscal year 
     2009 and each subsequent fiscal year, there is authorized to 
     be appropriated for fees under this section an amount equal 
     to the amount specified in subsection (b)(1) for the fiscal 
     year.
       ``(d) Collection of Unpaid Fees.--In any case where the 
     Secretary does not receive payment of a fee assessed under 
     subsection (a) within 30 days after it is due, such fee shall 
     be treated as a claim of the United States Government subject 
     to subchapter II of chapter 37 of title 31, United States 
     Code.
       ``(e) Applicability to Fiscal Year 2009.--If the date of 
     the enactment of the Family Smoking Prevention and Tobacco 
     Control Act occurs during fiscal year 2009, the following 
     applies, subject to subsection (c):
       ``(1) The Secretary shall determine the fees that would 
     apply for a single quarter of such fiscal year according to 
     the application of subsection (b) to the amount specified in 
     paragraph (1)(A) of such subsection (referred to in this 
     subsection as the `quarterly fee amounts').
       ``(2) For the quarter in which such date of enactment 
     occurs, the amount of fees assessed shall be a pro rata 
     amount, determined according to the number of days remaining 
     in the quarter (including such date of enactment) and 
     according to the daily equivalent of the quarterly fee 
     amounts. Fees assessed under the preceding sentence shall not 
     be collected until the next quarter.
       ``(3) For the quarter following the quarter to which 
     paragraph (2) applies, the full quarterly fee amounts shall 
     be assessed and collected, in addition to collection of the 
     pro rata fees assessed under paragraph (2).
       ``(f) Study by GAO.--
       ``(1) In general.--The Comptroller General of the United 
     States shall conduct a study on--
       ``(A) the prevalence of youth tobacco use and the brands 
     and subbrands that individuals under the age of 18 consume;
       ``(B) the feasibility of structuring the user fees or a 
     portion of the user fees collected under this section on the 
     youth market share of a manufacturer or year to year changes 
     in a manufacturer's share of youth market; and
       ``(C) the potential effects of tobacco marketing to youth 
     audiences if user fees were calculated in whole or in part on 
     youth market share.
       ``(2) Report.--The Comptroller General shall submit to the 
     Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate a report on the study 
     conducted under paragraph (1) by not later than 3 years after 
     the date of enactment of the Family Smoking Prevention and 
     Tobacco Control Act.''.

     SEC. 102. FINAL RULE.

       (a) Cigarettes and Smokeless Tobacco.--
       (1) In general.--On the first day of publication of the 
     Federal Register that is 180 days or more after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall publish in the Federal Register a final rule 
     regarding cigarettes and smokeless tobacco, which--
       (A) is deemed to be issued under chapter 9 of the Federal 
     Food, Drug, and Cosmetic Act, as added by section 101 of this 
     Act; and
       (B) shall be deemed to be in compliance with all applicable 
     provisions of chapter 5 of title 5, United States Code, and 
     all other provisions of law relating to rulemaking 
     procedures.
       (2) Contents of rule.--Except as provided in this 
     subsection, the final rule published under paragraph (1), 
     shall be identical in its provisions to part 897 of the 
     regulations promulgated by the Secretary of Health and Human 
     Services in the August 28, 1996, issue of the Federal 
     Register (61 Fed. Reg., 44615-44618). Such rule shall--
       (A) provide for the designation of jurisdictional authority 
     that is in accordance with this subsection in accordance with 
     this Act and the amendments made by this Act;
       (B) strike Subpart C--Labels and section 897.32(c);
       (C) strike paragraphs (a), (b), and (i) of section 897.3 
     and insert definitions of the terms ``cigarette'', 
     ``cigarette tobacco,'', and ``smokeless tobacco'' as defined 
     in section 900 of the Federal Food, Drug, and Cosmetic Act;
       (D) insert ``or roll-your-own paper'' in section 897.34(a) 
     after ``other than cigarettes or smokeless tobacco'';
       (E) become effective on the date that is 1 year after the 
     date of enactment of this Act; and
       (F) amend paragraph (d) of section 897.16 to read as 
     follows:
       ``(d)(1) Except as provided in subparagraph (2), no 
     manufacturer, distributor, or retailer may distribute or 
     cause to be distributed any free samples of cigarettes, 
     smokeless tobacco, or other tobacco products (as such term is 
     defined in section 201 of the Federal Food, Drug, and 
     Cosmetic Act).
       ``(2)(A) Subparagraph (1) does not prohibit a manufacturer, 
     distributor, or retailer from distributing or causing to be 
     distributed free

[[Page 17311]]

     samples of smokeless tobacco in a qualified adult-only 
     facility.
       ``(B) This subparagraph does not affect the authority of a 
     State or local government to prohibit or otherwise restrict 
     the distribution of free samples of smokeless tobacco.
       ``(C) For purposes of this paragraph, the term `qualified 
     adult-only facility' means a facility or restricted area 
     that--
       ``(i) requires each person present to provide to a law 
     enforcement officer (whether on or off duty) or to a security 
     guard licensed by a governmental entity government-issued 
     identification showing a photograph and at least the minimum 
     age established by applicable law for the purchase of 
     smokeless tobacco;
       ``(ii) does not sell, serve, or distribute alcohol;
       ``(iii) is not located adjacent to or immediately across 
     from (in any direction) a space that is used primarily for 
     youth-oriented marketing, promotional, or other activities;
       ``(iv) is a temporary structure constructed, designated, 
     and operated as a distinct enclosed area for the purpose of 
     distributing free samples of smokeless tobacco in accordance 
     with this subparagraph; and
       ``(v) is enclosed by a barrier that--
       ``(I) is constructed of, or covered with, an opaque 
     material (except for entrances and exits);
       ``(II) extends from no more than 12 inches above the ground 
     or floor (which area at the bottom of the barrier must be 
     covered with material that restricts visibility but may allow 
     airflow) to at least 8 feet above the ground or floor (or to 
     the ceiling); and
       ``(III) prevents persons outside the qualified adult-only 
     facility from seeing into the qualified adult-only facility, 
     unless they make unreasonable efforts to do so; and
       ``(vi) does not display on its exterior--
       ``(I) any tobacco product advertising;
       ``(II) a brand name other than in conjunction with words 
     for an area or enclosure to identify an adult-only facility; 
     or
       ``(III) any combination of words that would imply to a 
     reasonable observer that the manufacturer, distributor, or 
     retailer has a sponsorship that would violate section 
     897.34(c).
       ``(D) Distribution of samples of smokeless tobacco under 
     this subparagraph permitted to be taken out of the qualified 
     adult-only facility shall be limited to 1 package per adult 
     consumer containing no more than 0.53 ounces (15 grams) of 
     smokeless tobacco. If such package of smokeless tobacco 
     contains individual portions of smokeless tobacco, the 
     individual portions of smokeless tobacco shall not exceed 8 
     individual portions and the collective weight of such 
     individual portions shall not exceed 0.53 ounces (15 grams). 
     Any manufacturer, distributor, or retailer who distributes or 
     causes to be distributed free samples also shall take 
     reasonable steps to ensure that the above amounts are limited 
     to one such package per adult consumer per day.
       ``(3) Notwithstanding subparagraph (2), no manufacturer, 
     distributor, or retailer may distribute or cause to be 
     distributed any free samples of smokeless tobacco--
       ``(A) to a sports team or entertainment group; or
       ``(B) at any football, basketball, baseball, soccer, or 
     hockey event or any other sporting or entertainment event 
     determined by the Secretary to be covered by this 
     subparagraph.
       ``(4) The Secretary shall implement a program to ensure 
     compliance with this paragraph and submit a report to the 
     Congress on such compliance not later than 18 months after 
     the date of enactment of the Family Smoking Prevention and 
     Tobacco Control Act.
       ``(5) Nothing in this paragraph shall be construed to 
     authorize any person to distribute or cause to be distributed 
     any sample of a tobacco product to any individual who has not 
     attained the minimum age established by applicable law for 
     the purchase of such product.''.
       (3) Amendments to rule.--Prior to making amendments to the 
     rule published under paragraph (1), the Secretary shall 
     promulgate a proposed rule in accordance with chapter 5 of 
     title 5, United States Code.
       (4) Rule of construction.--Except as provided in paragraph 
     (3), nothing in this section shall be construed to limit the 
     authority of the Secretary to amend, in accordance with 
     chapter 5 of title 5, United States Code, the regulation 
     promulgated pursuant to this section, including the 
     provisions of such regulation relating to distribution of 
     free samples.
       (5) Enforcement of retail sale provisions.--The Secretary 
     of Health and Human Services shall ensure that the provisions 
     of this Act, the amendments made by this Act, and the 
     implementing regulations (including such provisions, 
     amendments, and regulations relating to the retail sale of 
     tobacco products) are enforced with respect to the United 
     States and Indian tribes.
       (6) Qualified adult-only facility.--A qualified adult-only 
     facility (as such term is defined in section 897.16(d) of the 
     final rule published under paragraph (1)) that is also a 
     retailer and that commits a violation as a retailer shall not 
     be subject to the limitations in section 103(q) and shall be 
     subject to penalties applicable to a qualified adult-only 
     facility.
       (7) Congressional review provisions.--Section 801 of title 
     5, United States Code, shall not apply to the final rule 
     published under paragraph (1).
       (b) Limitation on Advisory Opinions.--As of the date of 
     enactment of this Act, the following documents issued by the 
     Food and Drug Administration shall not constitute advisory 
     opinions under section 10.85(d)(1) of title 21, Code of 
     Federal Regulations, except as they apply to tobacco 
     products, and shall not be cited by the Secretary of Health 
     and Human Services or the Food and Drug Administration as 
     binding precedent:
       (1) The preamble to the proposed rule in the document 
     titled ``Regulations Restricting the Sale and Distribution of 
     Cigarettes and Smokeless Tobacco Products to Protect Children 
     and Adolescents'' (60 Fed. Reg. 41314-41372 (August 11, 
     1995)).
       (2) The document titled ``Nicotine in Cigarettes and 
     Smokeless Tobacco Products is a Drug and These Products Are 
     Nicotine Delivery Devices Under the Federal Food, Drug, and 
     Cosmetic Act'' (60 Fed. Reg. 41453-41787 (August 11, 1995)).
       (3) The preamble to the final rule in the document titled 
     ``Regulations Restricting the Sale and Distribution of 
     Cigarettes and Smokeless Tobacco to Protect Children and 
     Adolescents'' (61 Fed. Reg. 44396-44615 (August 28, 1996)).
       (4) The document titled ``Nicotine in Cigarettes and 
     Smokeless Tobacco is a Drug and These Products are Nicotine 
     Delivery Devices Under the Federal Food, Drug, and Cosmetic 
     Act; Jurisdictional Determination'' (61 Fed. Reg. 44619-45318 
     (August 28, 1996)).

     SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL 
                   PROVISIONS.

       (a) Amendment of Federal Food, Drug, and Cosmetic Act.--
     Except as otherwise expressly provided, whenever in this 
     section an amendment is expressed in terms of an amendment 
     to, or repeal of, a section or other provision, the reference 
     is to a section or other provision of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 301 et seq.).
       (b) Section 301.--Section 301 (21 U.S.C. 331) is amended--
       (1) in subsection (a), by inserting ``tobacco product,'' 
     after ``device,'';
       (2) in subsection (b), by inserting ``tobacco product,'' 
     after ``device,'';
       (3) in subsection (c), by inserting ``tobacco product,'' 
     after ``device,'';
       (4) in subsection (e)--
       (A) by striking the period after ``572(i)''; and
       (B) by striking ``or 761 or the refusal to permit access 
     to'' and inserting ``761, 909, or 920 or the refusal to 
     permit access to'';
       (5) in subsection (g), by inserting ``tobacco product,'' 
     after ``device,'';
       (6) in subsection (h), by inserting ``tobacco product,'' 
     after ``device,'';
       (7) in subsection (j)--
       (A) by striking the period after ``573''; and
       (B) by striking ``708, or 721'' and inserting ``708, 721, 
     904, 905, 906, 907, 908, 909, or 920(b)'';
       (8) in subsection (k), by inserting ``tobacco product,'' 
     after ``device,'';
       (9) by striking subsection (p) and inserting the following:
       ``(p) The failure to register in accordance with section 
     510 or 905, the failure to provide any information required 
     by section 510(j), 510(k), 905(i), or 905(j), or the failure 
     to provide a notice required by section 510(j)(2) or 
     905(i)(3).'';
       (10) by striking subsection (q)(1) and inserting the 
     following:
       ``(q)(1) The failure or refusal--
       ``(A) to comply with any requirement prescribed under 
     section 518, 520(g), 903(b), 907, 908, or 916;
       ``(B) to furnish any notification or other material or 
     information required by or under section 519, 520(g), 904, 
     909, or 920; or
       ``(C) to comply with a requirement under section 522 or 
     913.'';
       (11) in subsection (q)(2), by striking ``device,'' and 
     inserting ``device or tobacco product,'';
       (12) in subsection (r), by inserting ``or tobacco product'' 
     after the term ``device'' each time that such term appears; 
     and
       (13) by adding at the end the following:
       ``(oo) The sale of tobacco products in violation of a no-
     tobacco-sale order issued under section 303(f).
       ``(pp) The introduction or delivery for introduction into 
     interstate commerce of a tobacco product in violation of 
     section 911.
       ``(qq)(1) Forging, counterfeiting, simulating, or falsely 
     representing, or without proper authority using any mark, 
     stamp (including tax stamp), tag, label, or other 
     identification device upon any tobacco product or container 
     or labeling thereof so as to render such tobacco product a 
     counterfeit tobacco product.
       ``(2) Making, selling, disposing of, or keeping in 
     possession, control, or custody, or concealing any punch, 
     die, plate, stone, or other item that is designed to print, 
     imprint, or reproduce the trademark, trade name, or other 
     identifying mark, imprint, or device of another or any 
     likeness of any of the foregoing upon any tobacco product or 
     container or labeling thereof so as to render such tobacco 
     product a counterfeit tobacco product.
       ``(3) The doing of any act that causes a tobacco product to 
     be a counterfeit tobacco product, or the sale or dispensing, 
     or the holding for sale or dispensing, of a counterfeit 
     tobacco product.

[[Page 17312]]

       ``(rr) The charitable distribution of tobacco products.
       ``(ss) The failure of a manufacturer or distributor to 
     notify the Attorney General and the Secretary of the Treasury 
     of their knowledge of tobacco products used in illicit trade.
       ``(tt) With respect to a tobacco product, any statement 
     directed to consumers through the media or through the label, 
     labeling, or advertising that would reasonably be expected to 
     result in consumers believing that the product is regulated, 
     inspected or approved by the Food and Drug Administration, or 
     that the product complies with the requirements of the Food 
     and Drug Administration, including a statement or implication 
     in the label, labeling, or advertising of such product, and 
     that could result in consumers believing that the product is 
     endorsed for use by the Food and Drug Administration or in 
     consumers being misled about the harmfulness of the product 
     because of such regulation, inspection, or compliance.''.
       (c) Section 303.--Section 303(f) (21 U.S.C. 333(f)) is 
     amended--
       (1) in paragraph (1)(A), by inserting ``or tobacco 
     products'' after the term ``devices'' each place such term 
     appears;
       (2) in paragraph (5)--
       (A) in subparagraph (A)--
       (i) by striking ``assessed'' the first time it appears and 
     inserting ``assessed, or a no-tobacco-sale order may be 
     imposed,''; and
       (ii) by striking ``penalty'' the second time it appears and 
     inserting ``penalty, or upon whom a no-tobacco-sale order is 
     to be imposed,'';
       (B) in subparagraph (B)--
       (i) by inserting after ``penalty,'' the following: ``or the 
     period to be covered by a no-tobacco-sale order,''; and
       (ii) by adding at the end the following: ``A no-tobacco-
     sale order permanently prohibiting an individual retail 
     outlet from selling tobacco products shall include provisions 
     that allow the outlet, after a specified period of time, to 
     request that the Secretary compromise, modify, or terminate 
     the order.''; and
       (C) by adding at the end the following:
       ``(D) The Secretary may compromise, modify, or terminate, 
     with or without conditions, any no-tobacco-sale order.'';
       (3) in paragraph (6)--
       (A) by inserting ``or the imposition of a no-tobacco-sale 
     order'' after the term ``penalty'' each place such term 
     appears; and
       (B) by striking ``issued.'' and inserting ``issued, or on 
     which the no-tobacco-sale order was imposed, as the case may 
     be.''; and
       (4) by adding at the end the following:
       ``(8) If the Secretary finds that a person has committed 
     repeated violations of restrictions promulgated under section 
     906(d) at a particular retail outlet then the Secretary may 
     impose a no-tobacco-sale order on that person prohibiting the 
     sale of tobacco products in that outlet. A no-tobacco-sale 
     order may be imposed with a civil penalty under paragraph 
     (1). Prior to the entry of a no-sale order under this 
     paragraph, a person shall be entitled to a hearing pursuant 
     to the procedures established through regulations of the Food 
     and Drug Administration for assessing civil money penalties, 
     including at a retailer's request a hearing by telephone, or 
     at the nearest regional or field office of the Food and Drug 
     Administration, or at a Federal, State, or county facility 
     within 100 miles from the location of the retail outlet, if 
     such a facility is available.''.
       (d) Section 304.--Section 304 (21 U.S.C. 334) is amended--
       (1) in subsection (a)(2)--
       (A) by striking ``and'' before ``(D)''; and
       (B) by striking ``device.'' and inserting the following: 
     ``device, and (E) Any adulterated or misbranded tobacco 
     product.'';
       (2) in subsection (d)(1), by inserting ``tobacco product,'' 
     after ``device,'';
       (3) in subsection (g)(1), by inserting ``or tobacco 
     product'' after the term ``device'' each place such term 
     appears; and
       (4) in subsection (g)(2)(A), by inserting ``or tobacco 
     product'' after ``device''.
       (e) Section 505.--Section 505(n)(2) (21 U.S.C. 355(n)(2)) 
     is amended by striking ``section 904'' and inserting 
     ``section 1004''.
       (f) Section 523.--Section 523(b)(2)(D) (21 U.S.C. 
     360m(b)(2)(D)) is amended by striking ``section 903(g)'' and 
     inserting ``section 1003(g)''.
       (g) Section 702.--Section 702(a)(1) (U.S.C. 372(a)(1)) is 
     amended--
       (1) by striking ``(a)(1)'' and inserting ``(a)(1)(A)''; and
       (2) by adding at the end the following:
       ``(B)(i) For a tobacco product, to the extent feasible, the 
     Secretary shall contract with the States in accordance with 
     this paragraph to carry out inspections of retailers within 
     that State in connection with the enforcement of this Act.
       ``(ii) The Secretary shall not enter into any contract 
     under clause (i) with the government of any of the several 
     States to exercise enforcement authority under this Act on 
     Indian lands without the express written consent of the 
     Indian tribe involved.''.
       (h) Section 703.--Section 703 (21 U.S.C. 373) is amended--
       (1) by inserting ``tobacco product,'' after the term 
     ``device,'' each place such term appears; and
       (2) by inserting ``tobacco products,'' after the term 
     ``devices,'' each place such term appears.
       (i) Section 704.--Section 704 (21 U.S.C. 374) is amended--
       (1) in subsection (a)(1)(A), by inserting ``tobacco 
     products,'' after the term ``devices,'' each place such term 
     appears;
       (2) in subsection (a)(1)(B), by inserting ``or tobacco 
     products'' after the term ``restricted devices'' each place 
     such term appears;
       (3) in subsection (b), by inserting ``tobacco product,'' 
     after ``device,''; and
       (4) in subsection (g)(13), by striking ``section 903(g)'' 
     and inserting ``section 1003(g)''.
       (j) Section 705.--Section 705(b) (21 U.S.C. 375(b)) is 
     amended by inserting ``tobacco products,'' after 
     ``devices,''.
       (k) Section 709.--Section 709 (21 U.S.C. 379a) is amended 
     by inserting ``tobacco product,'' after ``device,''.
       (l) Section 801.--Section 801 (21 U.S.C. 381) is amended--
       (1) in subsection (a)--
       (A) by inserting ``tobacco products,'' after the term 
     ``devices,'' ;
       (B) by inserting ``or section 905(h)'' after ``section 
     510''; and
       (C) by striking the term ``drugs or devices'' each time 
     such term appears and inserting ``drugs, devices, or tobacco 
     products'';
       (2) in subsection (e)(1), by inserting ``tobacco product,'' 
     after ``device,''; and
       (3) by adding at the end the following:
       ``(p)(1) Not later than 36 months after the date of 
     enactment of the Family Smoking Prevention and Tobacco 
     Control Act, and annually thereafter, the Secretary shall 
     submit to the Committee on Health, Education, Labor, and 
     Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives, a report 
     regarding--
       ``(A) the nature, extent, and destination of United States 
     tobacco product exports that do not conform to tobacco 
     product standards established pursuant to this Act;
       ``(B) the public health implications of such exports, 
     including any evidence of a negative public health impact; 
     and
       ``(C) recommendations or assessments of policy alternatives 
     available to Congress and the executive branch to reduce any 
     negative public health impact caused by such exports.
       ``(2) The Secretary is authorized to establish appropriate 
     information disclosure requirements to carry out this 
     subsection.''.
       (m) Section 1003.--Section 1003(d)(2)(C) (as redesignated 
     by section 101(b)) is amended--
       (1) by striking ``and'' after ``cosmetics,''; and
       (2) inserting ``, and tobacco products'' after ``devices''.
       (n) Section 1009.--Section 1009(b) (as redesignated by 
     section 101(b)) is amended by striking ``section 908'' and 
     inserting ``section 1008''.
       (o) Section 409 of the Federal Meat Inspection Act.--
     Section 409(a) of the Federal Meat Inspection Act (21 U.S.C. 
     679(a)) is amended by striking ``section 902(b)'' and 
     inserting ``section 1002(b)''.
       (p) Rule of Construction.--Nothing in this section is 
     intended or shall be construed to expand, contract, or 
     otherwise modify or amend the existing limitations on State 
     government authority over tribal restricted fee or trust 
     lands.
       (q) Guidance and Effective Dates.--
       (1) In general.--The Secretary of Health and Human Services 
     shall issue guidance--
       (A) defining the term ``repeated violation'', as used in 
     section 303(f)(8) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 333(f)(8)) as amended by subsection (c), as 
     including at least 5 violations of particular requirements 
     over a 36-month period at a particular retail outlet that 
     constitute a repeated violation and providing for civil 
     penalties in accordance with paragraph (2);
       (B) providing for timely and effective notice by certified 
     or registered mail or personal delivery to the retailer of 
     each alleged violation at a particular retail outlet prior to 
     conducting a followup compliance check, such notice to be 
     sent to the location specified on the retailer's registration 
     or to the retailer's registered agent if the retailer has 
     provider such agent information to the Food and Drug 
     Administration prior to the violation;
       (C) providing for a hearing pursuant to the procedures 
     established through regulations of the Food and Drug 
     Administration for assessing civil money penalties, including 
     at a retailer's request a hearing by telephone or at the 
     nearest regional or field office of the Food and Drug 
     Administration, and providing for an expedited procedure for 
     the administrative appeal of an alleged violation;
       (D) providing that a person may not be charged with a 
     violation at a particular retail outlet unless the Secretary 
     has provided notice to the retailer of all previous 
     violations at that outlet;
       (E) establishing that civil money penalties for multiple 
     violations shall increase from one violation to the next 
     violation pursuant to paragraph (2) within the time periods 
     provided for in such paragraph;
       (F) providing that good faith reliance on the presentation 
     of a false government-issued photographic identification that 
     contains a date of birth does not constitute a violation of 
     any minimum age requirement for the sale of tobacco products 
     if the retailer has taken effective steps to prevent such 
     violations, including--

[[Page 17313]]

       (i) adopting and enforcing a written policy against sales 
     to minors;
       (ii) informing its employees of all applicable laws;
       (iii) establishing disciplinary sanctions for employee 
     noncompliance; and
       (iv) requiring its employees to verify age by way of 
     photographic identification or electronic scanning device; 
     and
       (G) providing for the Secretary, in determining whether to 
     impose a no-tobacco-sale order and in determining whether to 
     compromise, modify, or terminate such an order, to consider 
     whether the retailer has taken effective steps to prevent 
     violations of the minimum age requirements for the sale of 
     tobacco products, including the steps listed in subparagraph 
     (F).
       (2) Penalties for violations.--
       (A) In general.--The amount of the civil penalty to be 
     applied for violations of restrictions promulgated under 
     section 906(d), as described in paragraph (1), shall be as 
     follows:
       (i) With respect to a retailer with an approved training 
     program, the amount of the civil penalty shall not exceed--

       (I) in the case of the first violation, $0.00 together with 
     the issuance of a warning letter to the retailer;
       (II) in the case of a second violation within a 12-month 
     period, $250;
       (III) in the case of a third violation within a 24-month 
     period, $500;
       (IV) in the case of a fourth violation within a 24-month 
     period, $2,000;
       (V) in the case of a fifth violation within a 36-month 
     period, $5,000; and
       (VI) in the case of a sixth or subsequent violation within 
     a 48-month period, $10,000 as determined by the Secretary on 
     a case-by-case basis.

       (ii) With respect to a retailer that does not have an 
     approved training program, the amount of the civil penalty 
     shall not exceed--

       (I) in the case of the first violation, $250;
       (II) in the case of a second violation within a 12-month 
     period, $500;
       (III) in the case of a third violation within a 24-month 
     period, $1,000;
       (IV) in the case of a fourth violation within a 24-month 
     period, $2,000;
       (V) in the case of a fifth violation within a 36-month 
     period, $5,000; and
       (VI) in the case of a sixth or subsequent violation within 
     a 48-month period, $10,000 as determined by the Secretary on 
     a case-by-case basis.

       (B) Training program.--For purposes of subparagraph (A), 
     the term ``approved training program'' means a training 
     program that complies with standards developed by the Food 
     and Drug Administration for such programs.
       (C) Consideration of state penalties.--The Secretary shall 
     coordinate with the States in enforcing the provisions of 
     this Act and, for purposes of mitigating a civil penalty to 
     be applied for a violation by a retailer of any restriction 
     promulgated under section 906(d), shall consider the amount 
     of any penalties paid by the retailer to a State for the same 
     violation.
       (3) General effective date.--The amendments made by 
     paragraphs (2), (3), and (4) of subsection (c) shall take 
     effect upon the issuance of guidance described in paragraph 
     (1) of this subsection.
       (4) Special effective date.--The amendment made by 
     subsection (c)(1) shall take effect on the date of enactment 
     of this Act.
       (5) Package label requirements.--The package label 
     requirements of paragraphs (2), (3), and (4) of section 
     903(a) of the Federal Food, Drug, and Cosmetic Act (as 
     amended by this Act) shall take effect on the date that is 12 
     months after the date of enactment of this Act. The effective 
     date shall be with respect to the date of manufacture, 
     provided that, in any case, beginning 30 days after such 
     effective date, a manufacturer shall not introduce into the 
     domestic commerce of the United States any product, 
     irrespective of the date of manufacture, that is not in 
     conformance with section 903(a)(2), (3), and (4) and section 
     920(a) of the Federal Food, Drug, and Cosmetic Act.
       (6) Advertising requirements.--The advertising requirements 
     of section 903(a)(8) of the Federal Food, Drug, and Cosmetic 
     Act (as amended by this Act) shall take effect on the date 
     that is 12 months after the date of enactment of this Act.

     SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PURCHASE 
                   TOBACCO PRODUCTS.

       The Secretary of Health and Human Services shall--
       (1) convene an expert panel to conduct a study on the 
     public health implications of raising the minimum age to 
     purchase tobacco products; and
       (2) not later than 5 years after the date of the enactment 
     of this Act, submit a report to the Congress on the results 
     of such study.

     SEC. 105. TOBACCO INDUSTRY CONCENTRATION.

       (a) Study.--The Federal Trade Commission shall conduct a 
     study on the causes and effects of concentration in the 
     tobacco industry.
       (b) Public Report.--The Federal Trade Commission shall 
     transmit to Congress a report not later than 5 years after 
     the date of enactment of this Act, and a subsequent report on 
     the date that is 10 years after the date of enactment of this 
     Act. Such reports shall include--
       (1) an analysis of trends in the market share of any 
     dominant tobacco product manufacturer in any class of tobacco 
     products; or
       (2) an analysis of trends in competition or the emergence 
     of a monopoly; and
       (3) recommendations to Congress on any corrective actions 
     that should be taken to address tobacco industry 
     concentration.

     SEC. 106. ENFORCEMENT ACTION PLAN FOR ADVERTISING AND 
                   PROMOTION RESTRICTIONS.

       (a) Action Plan.--
       (1) Development.--Not later than 6 months after the date of 
     the enactment of this Act, the Secretary of Health and Human 
     Services (in this section referred to as the ``Secretary'') 
     shall develop and publish an action plan to enforce 
     restrictions adopted pursuant to section 906 of the Federal 
     Food, Drug, and Cosmetic Act, as added by section 101(b) of 
     this Act, or pursuant to section 102(a) of this Act, on 
     promotion and advertising of menthol and other cigarettes to 
     youth.
       (2) Consultation.--The action plan required by paragraph 
     (1) shall be developed in consultation with public health 
     organizations and other stakeholders with demonstrated 
     expertise and experience in serving minority communities.
       (3) Priority.--The action plan required by paragraph (1) 
     shall include provisions designed to ensure enforcement of 
     the restrictions described in paragraph (1) in minority 
     communities.
       (b) State and Local Activities.--
       (1) Information on authority.--Not later than 3 months 
     after the date of the enactment of this Act, the Secretary 
     shall inform State, local, and tribal governments of the 
     authority provided to such entities under section 5(c) of the 
     Federal Cigarette Labeling and Advertising Act, as added by 
     section 203 of this Act, or preserved by such entities under 
     section 916 of the Federal Food, Drug, and Cosmetic Act, as 
     added by section 101(b) of this Act.
       (2) Community assistance.--At the request of communities 
     seeking assistance to prevent underage tobacco use, the 
     Secretary shall provide such assistance, including assistance 
     with strategies to address the prevention of underage tobacco 
     use in communities with a disproportionate use of menthol 
     cigarettes by minors.

 TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT 
                               DISCLOSURE

     SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.

       (a) Amendment.--Section 4 of the Federal Cigarette Labeling 
     and Advertising Act (15 U.S.C. 1333) is amended to read as 
     follows:

     ``SEC. 4. LABELING.

       ``(a) Label Requirements.--
       ``(1) In general.--It shall be unlawful for any person to 
     manufacture, package, sell, offer to sell, distribute, or 
     import for sale or distribution within the United States any 
     cigarettes the package of which fails to bear, in accordance 
     with the requirements of this section, one of the following 
     labels:
       ``WARNING: Cigarettes are addictive.
       ``WARNING: Tobacco smoke can harm your children.
       ``WARNING: Cigarettes cause fatal lung disease.
       ``WARNING: Cigarettes cause cancer.
       ``WARNING: Cigarettes cause strokes and heart disease.
       ``WARNING: Smoking during pregnancy can harm your baby.
       ``WARNING: Smoking can kill you.
       ``WARNING: Tobacco smoke causes fatal lung disease in 
     nonsmokers.
       ``WARNING: Quitting smoking now greatly reduces serious 
     risks to your health.
       ``(2) Placement; typography; etc.--Each label statement 
     required by paragraph (1) shall be located in the upper 
     portion of the front and rear panels of the package, directly 
     on the package underneath the cellophane or other clear 
     wrapping. Each label statement shall comprise at least the 
     top 30 percent of the front and rear panels of the package. 
     The word `WARNING' shall appear in capital letters and all 
     text shall be in conspicuous and legible 17-point type, 
     unless the text of the label statement would occupy more than 
     70 percent of such area, in which case the text may be in a 
     smaller conspicuous and legible type size, provided that at 
     least 60 percent of such area is occupied by required text. 
     The text shall be black on a white background, or white on a 
     black background, in a manner that contrasts, by typography, 
     layout, or color, with all other printed material on the 
     package, in an alternating fashion under the plan submitted 
     under subsection (c).
       ``(3) Does not apply to foreign distribution.--The 
     provisions of this subsection do not apply to a tobacco 
     product manufacturer or distributor of cigarettes which does 
     not manufacture, package, or import cigarettes for sale or 
     distribution within the United States.
       ``(4) Applicability to retailers.--A retailer of cigarettes 
     shall not be in violation of this subsection for packaging 
     that--
       ``(A) contains a warning label;
       ``(B) is supplied to the retailer by a license- or permit-
     holding tobacco product manufacturer, importer, or 
     distributor; and

[[Page 17314]]

       ``(C) is not altered by the retailer in a way that is 
     material to the requirements of this subsection.
       ``(b) Advertising Requirements.--
       ``(1) In general.--It shall be unlawful for any tobacco 
     product manufacturer, importer, distributor, or retailer of 
     cigarettes to advertise or cause to be advertised within the 
     United States any cigarette unless its advertising bears, in 
     accordance with the requirements of this section, one of the 
     labels specified in subsection (a).
       ``(2) Typography, etc.--Each label statement required by 
     subsection (a) in cigarette advertising shall comply with the 
     standards set forth in this paragraph. For press and poster 
     advertisements, each such statement and (where applicable) 
     any required statement relating to tar, nicotine, or other 
     constituent (including a smoke constituent) yield shall 
     comprise at least 20 percent of the area of the advertisement 
     and shall appear in a conspicuous and prominent format and 
     location at the top of each advertisement within the trim 
     area. The Secretary may revise the required type sizes in 
     such area in such manner as the Secretary determines 
     appropriate. The word `WARNING' shall appear in capital 
     letters, and each label statement shall appear in conspicuous 
     and legible type. The text of the label statement shall be 
     black if the background is white and white if the background 
     is black, under the plan submitted under subsection (c). The 
     label statements shall be enclosed by a rectangular border 
     that is the same color as the letters of the statements and 
     that is the width of the first downstroke of the capital `W' 
     of the word `WARNING' in the label statements. The text of 
     such label statements shall be in a typeface pro rata to the 
     following requirements: 45-point type for a whole-page 
     broadsheet newspaper advertisement; 39-point type for a half-
     page broadsheet newspaper advertisement; 39-point type for a 
     whole-page tabloid newspaper advertisement; 27-point type for 
     a half-page tabloid newspaper advertisement; 31.5-point type 
     for a double page spread magazine or whole-page magazine 
     advertisement; 22.5-point type for a 28 centimeter by 3 
     column advertisement; and 15-point type for a 20 centimeter 
     by 2 column advertisement. The label statements shall be in 
     English, except that--
       ``(A) in the case of an advertisement that appears in a 
     newspaper, magazine, periodical, or other publication that is 
     not in English, the statements shall appear in the 
     predominant language of the publication; and
       ``(B) in the case of any other advertisement that is not in 
     English, the statements shall appear in the same language as 
     that principally used in the advertisement.
       ``(3) Matchbooks.--Notwithstanding paragraph (2), for 
     matchbooks (defined as containing not more than 20 matches) 
     customarily given away with the purchase of tobacco products, 
     each label statement required by subsection (a) may be 
     printed on the inside cover of the matchbook.
       ``(4) Adjustment by secretary.--The Secretary may, through 
     a rulemaking under section 553 of title 5, United States 
     Code, adjust the format and type sizes for the label 
     statements required by this section; the text, format, and 
     type sizes of any required tar, nicotine yield, or other 
     constituent (including smoke constituent) disclosures; or the 
     text, format, and type sizes for any other disclosures 
     required under the Federal Food, Drug, and Cosmetic Act. The 
     text of any such label statements or disclosures shall be 
     required to appear only within the 20 percent area of 
     cigarette advertisements provided by paragraph (2). The 
     Secretary shall promulgate regulations which provide for 
     adjustments in the format and type sizes of any text required 
     to appear in such area to ensure that the total text required 
     to appear by law will fit within such area.
       ``(c) Marketing Requirements.--
       ``(1) Random display.--The label statements specified in 
     subsection (a)(1) shall be randomly displayed in each 12-
     month period, in as equal a number of times as is possible on 
     each brand of the product and be randomly distributed in all 
     areas of the United States in which the product is marketed 
     in accordance with a plan submitted by the tobacco product 
     manufacturer, importer, distributor, or retailer and approved 
     by the Secretary.
       ``(2) Rotation.--The label statements specified in 
     subsection (a)(1) shall be rotated quarterly in alternating 
     sequence in advertisements for each brand of cigarettes in 
     accordance with a plan submitted by the tobacco product 
     manufacturer, importer, distributor, or retailer to, and 
     approved by, the Secretary.
       ``(3) Review.--The Secretary shall review each plan 
     submitted under paragraph (2) and approve it if the plan--
       ``(A) will provide for the equal distribution and display 
     on packaging and the rotation required in advertising under 
     this subsection; and
       ``(B) assures that all of the labels required under this 
     section will be displayed by the tobacco product 
     manufacturer, importer, distributor, or retailer at the same 
     time.
       ``(4) Applicability to retailers.--This subsection and 
     subsection (b) apply to a retailer only if that retailer is 
     responsible for or directs the label statements required 
     under this section except that this paragraph shall not 
     relieve a retailer of liability if the retailer displays, in 
     a location open to the public, an advertisement that does not 
     contain a warning label or has been altered by the retailer 
     in a way that is material to the requirements of this 
     subsection and subsection (b).''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall take effect 12 months after the date of enactment of 
     this Act. Such effective date shall be with respect to the 
     date of manufacture, provided that, in any case, beginning 30 
     days after such effective date, a manufacturer shall not 
     introduce into the domestic commerce of the United States any 
     product, irrespective of the date of manufacture, that is not 
     in conformance with section 4 of the Federal Cigarette 
     Labeling and Advertising Act (15 U.S.C. 1333), as amended by 
     subsection (a).

     SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING LABEL 
                   STATEMENTS.

       (a) Preemption.--Section 5(a) of the Federal Cigarette 
     Labeling and Advertising Act (15 U.S.C. 1334(a)) is amended 
     by striking ``No'' and inserting ``Except to the extent the 
     Secretary requires additional or different statements on any 
     cigarette package by a regulation, by an order, by a 
     standard, by an authorization to market a product, or by a 
     condition of marketing a product, pursuant to the Family 
     Smoking Prevention and Tobacco Control Act (and the 
     amendments made by that Act), or as required under section 
     903(a)(2) or section 920(a) of the Federal Food, Drug, and 
     Cosmetic Act, no''.
       (b) Change in Required Statements.--Section 4 of the 
     Federal Cigarette Labeling and Advertising Act (15 U.S.C. 
     1333), as amended by section 201, is further amended by 
     adding at the end the following:
       ``(d) Change in Required Statements.--The Secretary may, by 
     a rulemaking conducted under section 553 of title 5, United 
     States Code, adjust the format, type size, and text of any of 
     the label requirements, require color graphics to accompany 
     the text, increase the required label area from 30 percent up 
     to 50 percent of the front and rear panels of the package, or 
     establish the format, type size, and text of any other 
     disclosures required under the Federal Food, Drug, and 
     Cosmetic Act, if the Secretary finds that such a change would 
     promote greater public understanding of the risks associated 
     with the use of tobacco products.''.

     SEC. 203. STATE REGULATION OF CIGARETTE ADVERTISING AND 
                   PROMOTION.

       Section 5 of the Federal Cigarette Labeling and Advertising 
     Act (15 U.S.C. 1334) is amended by adding at the end the 
     following:
       ``(c) Exception.--Notwithstanding subsection (b), a State 
     or locality may enact statutes and promulgate regulations, 
     based on smoking and health, that take effect after the 
     effective date of the Family Smoking Prevention and Tobacco 
     Control Act, imposing specific bans or restrictions on the 
     time, place, and manner, but not content, of the advertising 
     or promotion of any cigarettes.''.

     SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING WARNINGS.

       (a) Amendment.--Section 3 of the Comprehensive Smokeless 
     Tobacco Health Education Act of 1986 (15 U.S.C. 4402) is 
     amended to read as follows:

     ``SEC. 3. SMOKELESS TOBACCO WARNING.

       ``(a) General Rule.--
       ``(1) It shall be unlawful for any person to manufacture, 
     package, sell, offer to sell, distribute, or import for sale 
     or distribution within the United States any smokeless 
     tobacco product unless the product package bears, in 
     accordance with the requirements of this Act, one of the 
     following labels:
       ``WARNING: This product can cause mouth cancer.
       ``WARNING: This product can cause gum disease and tooth 
     loss.
       ``WARNING: This product is not a safe alternative to 
     cigarettes.
       ``WARNING: Smokeless tobacco is addictive.
       ``(2) Each label statement required by paragraph (1) shall 
     be--
       ``(A) located on the 2 principal display panels of the 
     package, and each label statement shall comprise at least 30 
     percent of each such display panel; and
       ``(B) in 17-point conspicuous and legible type and in black 
     text on a white background, or white text on a black 
     background, in a manner that contrasts by typography, layout, 
     or color, with all other printed material on the package, in 
     an alternating fashion under the plan submitted under 
     subsection (b)(3), except that if the text of a label 
     statement would occupy more than 70 percent of the area 
     specified by subparagraph (A), such text may appear in a 
     smaller type size, so long as at least 60 percent of such 
     warning area is occupied by the label statement.
       ``(3) The label statements required by paragraph (1) shall 
     be introduced by each tobacco product manufacturer, packager, 
     importer, distributor, or retailer of smokeless tobacco 
     products concurrently into the distribution chain of such 
     products.
       ``(4) The provisions of this subsection do not apply to a 
     tobacco product manufacturer or distributor of any smokeless 
     tobacco product that does not manufacture, package, or import 
     smokeless tobacco products for sale or distribution within 
     the United States.

[[Page 17315]]

       ``(5) A retailer of smokeless tobacco products shall not be 
     in violation of this subsection for packaging that--
       ``(A) contains a warning label;
       ``(B) is supplied to the retailer by a license- or permit-
     holding tobacco product manufacturer, importer, or 
     distributor; and
       ``(C) is not altered by the retailer in a way that is 
     material to the requirements of this subsection.
       ``(b) Required Labels.--
       ``(1) It shall be unlawful for any tobacco product 
     manufacturer, packager, importer, distributor, or retailer of 
     smokeless tobacco products to advertise or cause to be 
     advertised within the United States any smokeless tobacco 
     product unless its advertising bears, in accordance with the 
     requirements of this section, one of the labels specified in 
     subsection (a).
       ``(2)(A) Each label statement required by subsection (a) in 
     smokeless tobacco advertising shall comply with the standards 
     set forth in this paragraph.
       ``(B) For press and poster advertisements, each such 
     statement and (where applicable) any required statement 
     relating to tar, nicotine, or other constituent yield shall 
     comprise at least 20 percent of the area of the 
     advertisement.
       ``(C) The word `WARNING' shall appear in capital letters, 
     and each label statement shall appear in conspicuous and 
     legible type.
       ``(D) The text of the label statement shall be black on a 
     white background, or white on a black background, in an 
     alternating fashion under the plan submitted under paragraph 
     (3).
       ``(E) The label statements shall be enclosed by a 
     rectangular border that is the same color as the letters of 
     the statements and that is the width of the first downstroke 
     of the capital `W' of the word `WARNING' in the label 
     statements.
       ``(F) The text of such label statements shall be in a 
     typeface pro rata to the following requirements: 45-point 
     type for a whole-page broadsheet newspaper advertisement; 39-
     point type for a half-page broadsheet newspaper 
     advertisement; 39-point type for a whole-page tabloid 
     newspaper advertisement; 27-point type for a half-page 
     tabloid newspaper advertisement; 31.5-point type for a double 
     page spread magazine or whole-page magazine advertisement; 
     22.5-point type for a 28 centimeter by 3 column 
     advertisement; and 15-point type for a 20 centimeter by 2 
     column advertisement.
       ``(G) The label statements shall be in English, except 
     that--
       ``(i) in the case of an advertisement that appears in a 
     newspaper, magazine, periodical, or other publication that is 
     not in English, the statements shall appear in the 
     predominant language of the publication; and
       ``(ii) in the case of any other advertisement that is not 
     in English, the statements shall appear in the same language 
     as that principally used in the advertisement.
       ``(3)(A) The label statements specified in subsection 
     (a)(1) shall be randomly displayed in each 12-month period, 
     in as equal a number of times as is possible on each brand of 
     the product and be randomly distributed in all areas of the 
     United States in which the product is marketed in accordance 
     with a plan submitted by the tobacco product manufacturer, 
     importer, distributor, or retailer and approved by the 
     Secretary.
       ``(B) The label statements specified in subsection (a)(1) 
     shall be rotated quarterly in alternating sequence in 
     advertisements for each brand of smokeless tobacco product in 
     accordance with a plan submitted by the tobacco product 
     manufacturer, importer, distributor, or retailer to, and 
     approved by, the Secretary.
       ``(C) The Secretary shall review each plan submitted under 
     subparagraphs (A) and (B) and approve it if the plan--
       ``(i) will provide for the equal distribution and display 
     on packaging and the rotation required in advertising under 
     this subsection; and
       ``(ii) assures that all of the labels required under this 
     section will be displayed by the tobacco product 
     manufacturer, importer, distributor, or retailer at the same 
     time.
       ``(D) This paragraph applies to a retailer only if that 
     retailer is responsible for or directs the label statements 
     under this section, unless the retailer displays, in a 
     location open to the public, an advertisement that does not 
     contain a warning label or has been altered by the retailer 
     in a way that is material to the requirements of this 
     subsection.
       ``(4) The Secretary may, through a rulemaking under section 
     553 of title 5, United States Code, adjust the format and 
     type sizes for the label statements required by this section; 
     the text, format, and type sizes of any required tar, 
     nicotine yield, or other constituent disclosures; or the 
     text, format, and type sizes for any other disclosures 
     required under the Federal Food, Drug, and Cosmetic Act. The 
     text of any such label statements or disclosures shall be 
     required to appear only within the 20 percent area of 
     advertisements provided by paragraph (2). The Secretary shall 
     promulgate regulations which provide for adjustments in the 
     format and type sizes of any text required to appear in such 
     area to ensure that the total text required to appear by law 
     will fit within such area.
       ``(c) Television and Radio Advertising.--It is unlawful to 
     advertise smokeless tobacco on any medium of electronic 
     communications subject to the jurisdiction of the Federal 
     Communications Commission.''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall take effect 12 months after the date of enactment of 
     this Act. Such effective date shall be with respect to the 
     date of manufacture, provided that, in any case, beginning 30 
     days after such effective date, a manufacturer shall not 
     introduce into the domestic commerce of the United States any 
     product, irrespective of the date of manufacture, that is not 
     in conformance with section 3 of the Comprehensive Smokeless 
     Tobacco Health Education Act of 1986 (15 U.S.C. 4402), as 
     amended by subsection (a)

     SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT 
                   WARNING LABEL STATEMENTS.

       (a) In General.--Section 3 of the Comprehensive Smokeless 
     Tobacco Health Education Act of 1986 (15 U.S.C. 4402), as 
     amended by section 204, is further amended by adding at the 
     end the following:
       ``(d) Authority To Revise Warning Label Statements.--The 
     Secretary may, by a rulemaking conducted under section 553 of 
     title 5, United States Code, adjust the format, type size, 
     and text of any of the label requirements, require color 
     graphics to accompany the text, increase the required label 
     area from 30 percent up to 50 percent of the front and rear 
     panels of the package, or establish the format, type size, 
     and text of any other disclosures required under the Federal 
     Food, Drug, and Cosmetic Act, if the Secretary finds that 
     such a change would promote greater public understanding of 
     the risks associated with the use of smokeless tobacco 
     products.''.
       (b) Preemption.--Section 7(a) of the Comprehensive 
     Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 
     4406(a)) is amended by striking ``No'' and inserting ``Except 
     as provided in the Family Smoking Prevention and Tobacco 
     Control Act (and the amendments made by that Act), no''.

     SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT 
                   DISCLOSURE TO THE PUBLIC.

       Section 4 of the Federal Cigarette Labeling and Advertising 
     Act (15 U.S.C. 1333), as amended by sections 201 and 202, is 
     further amended by adding at the end the following:
       ``(e) Tar, Nicotine, and Other Smoke Constituent 
     Disclosure.--
       ``(1) In general.--The Secretary shall, by a rulemaking 
     conducted under section 553 of title 5, United States Code, 
     determine (in the Secretary's sole discretion) whether 
     cigarette and other tobacco product manufacturers shall be 
     required to include in the area of each cigarette 
     advertisement specified by subsection (b) of this section, or 
     on the package label, or both, the tar and nicotine yields of 
     the advertised or packaged brand. Any such disclosure shall 
     be in accordance with the methodology established under such 
     regulations, shall conform to the type size requirements of 
     subsection (b) of this section, and shall appear within the 
     area specified in subsection (b) of this section.
       ``(2) Resolution of differences.--Any differences between 
     the requirements established by the Secretary under paragraph 
     (1) and tar and nicotine yield reporting requirements 
     established by the Federal Trade Commission shall be resolved 
     by a memorandum of understanding between the Secretary and 
     the Federal Trade Commission.
       ``(3) Cigarette and other tobacco product constituents.--In 
     addition to the disclosures required by paragraph (1), the 
     Secretary may, under a rulemaking conducted under section 553 
     of title 5, United States Code, prescribe disclosure 
     requirements regarding the level of any cigarette or other 
     tobacco product constituent including any smoke constituent. 
     Any such disclosure may be required if the Secretary 
     determines that disclosure would be of benefit to the public 
     health, or otherwise would increase consumer awareness of the 
     health consequences of the use of tobacco products, except 
     that no such prescribed disclosure shall be required on the 
     face of any cigarette package or advertisement. Nothing in 
     this section shall prohibit the Secretary from requiring such 
     prescribed disclosure through a cigarette or other tobacco 
     product package or advertisement insert, or by any other 
     means under the Federal Food, Drug, and Cosmetic Act.
       ``(4) Retailers.--This subsection applies to a retailer 
     only if that retailer is responsible for or directs the label 
     statements required under this section.''.

       TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS

     SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPECTION.

       Chapter IX of the Federal Food, Drug, and Cosmetic Act, as 
     added by section 101, is further amended by adding at the end 
     the following:

     ``SEC. 920. LABELING, RECORDKEEPING, RECORDS INSPECTION.

       ``(a) Origin Labeling.--
       ``(1) Requirement.--Beginning 1 year after the date of 
     enactment of the Family Smoking Prevention and Tobacco 
     Control Act, the label, packaging, and shipping containers of 
     tobacco products for introduction or delivery for 
     introduction into interstate commerce in

[[Page 17316]]

     the United States shall bear the statement `sale only allowed 
     in the United States'.
       ``(2) Effective date.--The effective date specified in 
     paragraph (1) shall be with respect to the date of 
     manufacture, provided that, in any case, beginning 30 days 
     after such effective date, a manufacturer shall not introduce 
     into the domestic commerce of the United States any product, 
     irrespective of the date of manufacture, that is not in 
     conformance with such paragraph.
       ``(b) Regulations Concerning Recordkeeping for Tracking and 
     Tracing.--
       ``(1) In general.--The Secretary shall promulgate 
     regulations regarding the establishment and maintenance of 
     records by any person who manufactures, processes, 
     transports, distributes, receives, packages, holds, exports, 
     or imports tobacco products.
       ``(2) Inspection.--In promulgating the regulations 
     described in paragraph (1), the Secretary shall consider 
     which records are needed for inspection to monitor the 
     movement of tobacco products from the point of manufacture 
     through distribution to retail outlets to assist in 
     investigating potential illicit trade, smuggling, or 
     counterfeiting of tobacco products.
       ``(3) Codes.--The Secretary may require codes on the labels 
     of tobacco products or other designs or devices for the 
     purpose of tracking or tracing the tobacco product through 
     the distribution system.
       ``(4) Size of business.--The Secretary shall take into 
     account the size of a business in promulgating regulations 
     under this section.
       ``(5) Recordkeeping by retailers.--The Secretary shall not 
     require any retailer to maintain records relating to 
     individual purchasers of tobacco products for personal 
     consumption.
       ``(c) Records Inspection.--If the Secretary has a 
     reasonable belief that a tobacco product is part of an 
     illicit trade or smuggling or is a counterfeit product, each 
     person who manufactures, processes, transports, distributes, 
     receives, holds, packages, exports, or imports tobacco 
     products shall, at the request of an officer or employee duly 
     designated by the Secretary, permit such officer or employee, 
     at reasonable times and within reasonable limits and in a 
     reasonable manner, upon the presentation of appropriate 
     credentials and a written notice to such person, to have 
     access to and copy all records (including financial records) 
     relating to such article that are needed to assist the 
     Secretary in investigating potential illicit trade, 
     smuggling, or counterfeiting of tobacco products. The 
     Secretary shall not authorize an officer or employee of the 
     government of any of the several States to exercise authority 
     under the preceding sentence on Indian lands without the 
     express written consent of the Indian tribe involved.
       ``(d) Knowledge of Illegal Transaction.--
       ``(1) Notification.--If the manufacturer or distributor of 
     a tobacco product has knowledge which reasonably supports the 
     conclusion that a tobacco product manufactured or distributed 
     by such manufacturer or distributor that has left the control 
     of such person may be or has been--
       ``(A) imported, exported, distributed, or offered for sale 
     in interstate commerce by a person without paying duties or 
     taxes required by law; or
       ``(B) imported, exported, distributed, or diverted for 
     possible illicit marketing,
     the manufacturer or distributor shall promptly notify the 
     Attorney General and the Secretary of the Treasury of such 
     knowledge.
       ``(2) Knowledge defined.--For purposes of this subsection, 
     the term `knowledge' as applied to a manufacturer or 
     distributor means--
       ``(A) the actual knowledge that the manufacturer or 
     distributor had; or
       ``(B) the knowledge which a reasonable person would have 
     had under like circumstances or which would have been 
     obtained upon the exercise of due care.''.

     SEC. 302. STUDY AND REPORT.

       (a) Study.--The Comptroller General of the United States 
     shall conduct a study of cross-border trade in tobacco 
     products to--
       (1) collect data on cross-border trade in tobacco products, 
     including illicit trade and trade of counterfeit tobacco 
     products and make recommendations on the monitoring of such 
     trade;
       (2) collect data on cross-border advertising (any 
     advertising intended to be broadcast, transmitted, or 
     distributed from the United States to another country) of 
     tobacco products and make recommendations on how to prevent 
     or eliminate, and what technologies could help facilitate the 
     elimination of, cross-border advertising; and
       (3) collect data on the health effects (particularly with 
     respect to individuals under 18 years of age) resulting from 
     cross-border trade in tobacco products, including the health 
     effects resulting from--
       (A) the illicit trade of tobacco products and the trade of 
     counterfeit tobacco products; and
       (B) the differing tax rates applicable to tobacco products.
       (b) Report.--Not later than 18 months after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall submit to the Committee on Health, Education, 
     Labor, and Pensions of the Senate and the Committee on Energy 
     and Commerce of the House of Representatives a report on the 
     study described in subsection (a).
       (c) Definition.--In this section:
       (1) The term ``cross-border trade'' means trade across a 
     border of the United States, a State or Territory, or Indian 
     country.
       (2) The term ``Indian country'' has the meaning given to 
     that term in section 1151 of title 18, United States Code.
       (3) The terms ``State'' and ``Territory'' have the meanings 
     given to those terms in section 201 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 321).

               TITLE IV--THRIFT SAVINGS PLAN ENHANCEMENT

     SEC. 401. SHORT TITLE.

       This title may be cited as the ``Thrift Savings Plan 
     Enhancement Act of 2008''.

     SEC. 402. AUTOMATIC ENROLLMENTS.

       (a) Automatic Enrollments.--
       (1) In general.--Section 8432(b) of title 5, United States 
     Code, is amended by striking paragraphs (2) through (4) and 
     inserting the following:
       ``(2)(A) The Board shall by regulation provide for an 
     eligible individual to be automatically enrolled to make 
     contributions under subsection (a) at the default percentage 
     of basic pay.
       ``(B) For purposes of this paragraph, the default 
     percentage shall be equal to 3 percent or such other 
     percentage, not less than 2 percent nor more than 5 percent, 
     as the Board may by regulation prescribe.
       ``(C) The regulations shall include provisions under which 
     any individual who would otherwise be automatically enrolled 
     in accordance with subparagraph (A) may--
       ``(i) modify the percentage or amount to be contributed 
     pursuant to automatic enrollment, effective from the start of 
     such enrollment; or
       ``(ii) decline automatic enrollment altogether.
       ``(D) For purposes of this paragraph, the term `eligible 
     individual' means any individual who, after any regulations 
     under subparagraph (A) first take effect, is appointed, 
     transferred, or reappointed to a position in which that 
     individual is eligible to contribute to the Thrift Savings 
     Fund.
       ``(E) Sections 8351(a)(1), 8440a(a)(1), 8440b(a)(1), 
     8440c(a)(1), 8440d(a)(1), and 8440e(a)(1) shall be applied in 
     a manner consistent with the purposes of this paragraph.''.
       (2) Technical amendment.--Section 8432(b)(1) of title 5, 
     United States Code, is amended by striking the parenthetical 
     matter in subparagraph (B).
       (b) Default Investments.--Section 8438(c)(2) of title 5, 
     United States Code, is amended to read as follows:
       ``(2) If an election has not been made with respect to any 
     sums in the Thrift Savings Fund which are available for 
     investment, the Executive Director shall invest such sums 
     in--
       ``(A) the Government Securities Investment Fund; or
       ``(B) such alternative fund or funds (in lieu of the fund 
     under subparagraph (A)) as the Board may designate in 
     regulations.

     The designation of an alternative fund by regulations under 
     subparagraph (B) may be made only if, in the judgment of the 
     Board, such designation would be in the best interests of 
     participants. Any decision under the preceding sentence shall 
     be made after consultation with the Employee Thrift Advisory 
     Council (established under section 8473).''.

     SEC. 403. QUALIFIED ROTH CONTRIBUTION PROGRAM.

       (a) In General.--Subchapter III of chapter 84 of title 5, 
     United States Code, is amended by inserting after section 
     8432c the following:

     ``Sec. 8432d. Qualified Roth contribution program

       ``(a) Definitions.--For purposes of this section--
       ``(1) the term `qualified Roth contribution program' means 
     a program described in paragraph (1) of section 402A(b) of 
     the Internal Revenue Code of 1986 which meets the 
     requirements of paragraph (2) of such section; and
       ``(2) the terms `designated Roth contribution' and 
     `elective deferral' have the meanings given such terms in 
     section 402A of the Internal Revenue Code of 1986.
       ``(b) Authority To Establish.--The Board shall by 
     regulation provide for the inclusion in the Thrift Savings 
     Plan of a qualified Roth contribution program, under such 
     terms and conditions as the Board may prescribe.
       ``(c) Required Provisions.--The regulations under 
     subsection (b) shall include--
       ``(1) provisions under which an election to make designated 
     Roth contributions may be made--
       ``(A) by any individual who is eligible to make 
     contributions under section 8351, 8432(a), 8440a, 8440b, 
     8440c, 8440d, or 8440e; and
       ``(B) by any individual, not described in subparagraph (A), 
     who is otherwise eligible to make elective deferrals under 
     the Thrift Savings Plan;
       ``(2) any provisions which may, as a result of the 
     enactment of this section, be necessary in order to clarify 
     the meaning of any reference to an `account' made in section 
     8432(f), 8433, 8434(d), 8435, 8437, or any other provision of 
     law; and

[[Page 17317]]

       ``(3) any other provisions which may be necessary to carry 
     out this section.''.
       (b) Clerical Amendment.--The analysis for chapter 84 of 
     title 5, United States Code, is amended by inserting after 
     the item relating to section 8432c the following:

``8432d. Qualified Roth contribution program.''.

     SEC. 404. AUTHORITY TO ESTABLISH SELF-DIRECTED INVESTMENT 
                   WINDOW.

       (a) In General.--Section 8438(b)(1) of title 5, United 
     States Code, is amended--
       (1) in subparagraph (D), by striking ``and'' at the end;
       (2) in subparagraph (E), by striking the period and 
     inserting ``; and''; and
       (3) by adding after subparagraph (E) the following:
       ``(F) a self-directed investment window, if the Board 
     authorizes such window under paragraph (5).''.
       (b) Requirements.--Section 8438(b) of title 5, United 
     States Code, is amended by adding at the end the following:
       ``(5)(A) The Board may authorize the addition of a self-
     directed investment window under the Thrift Savings Plan if 
     the Board determines that such addition would be in the best 
     interests of participants.
       ``(B) The self-directed investment window shall be limited 
     to--
       ``(i) low-cost, passively-managed index funds that offer 
     diversification benefits; and
       ``(ii) other investment options, if the Board determines 
     the options to be appropriate retirement investment vehicles 
     for participants.
       ``(C) The Board shall ensure that any administrative 
     expenses related to use of the self-directed investment 
     window are borne solely by the participants who use such 
     window.
       ``(D) The Board may establish such other terms and 
     conditions for the self-directed investment window as the 
     Board considers appropriate to protect the interests of 
     participants, including requirements relating to risk 
     disclosure.
       ``(E) The Board shall consult with the Employee Thrift 
     Advisory Council (established under section 8473) before 
     establishing any self-directed investment window.''.

     SEC. 405. REPORTING REQUIREMENTS.

       (a) Annual Report.--The Board shall, not later than June 30 
     of each year, submit to Congress an annual report on the 
     operations of the Thrift Savings Plan. Such report shall 
     include, for the prior calendar year, information on the 
     number of participants as of the last day of such prior 
     calendar year, the median balance in participants' accounts 
     as of such last day, demographic information on participants, 
     the percentage allocation of amounts among investment funds 
     or options, the status of the development and implementation 
     of the self-directed investment window, the diversity 
     demographics of any company, investment adviser, or other 
     entity retained to invest and manage the assets of the Thrift 
     Savings Fund, and such other information as the Board 
     considers appropriate. A copy of each annual report under 
     this subsection shall be made available to the public through 
     an Internet website.
       (b) Reporting of Fees and Other Information.--
       (1) In general.--The Board shall include in the periodic 
     statements provided to participants under section 8439(c) the 
     amount of the investment management fees, administrative 
     expenses, and any other fees or expenses paid with respect to 
     each investment fund and option under the Thrift Savings 
     Plan. Any such statement shall also provide a statement 
     notifying participants as to how they may access the annual 
     report described in subsection (a), as well as any other 
     information concerning the Thrift Savings Plan that might be 
     useful.
       (2) Use of estimates.--For purposes of providing the 
     information required under this subsection, the Executive 
     Director may provide a reasonable and representative estimate 
     of any fees or expenses described in paragraph (1) and shall 
     indicate any such estimate as being such an estimate. Any 
     such estimate shall be based on the previous year's 
     experience.
       (c) Definitions.--For purposes of this section--
       (1) the term ``Board'' has the meaning given such term by 
     8401(5) of title 5, United States Code;
       (2) the term ``participant'' has the meaning given such 
     term by section 8471(3) of title 5, United States Code; and
       (3) the term ``account'' means an account established under 
     section 8439 of title 5, United States Code.

     SEC. 406. ACKNOWLEDGEMENT OF RISK.

       (a) In General.--Section 8439(d) of title 5, United States 
     Code, is amended--
       (1) by striking the matter after ``who elects to invest 
     in'' and before ``shall sign an acknowledgement'' and 
     inserting ``any investment fund or option under this chapter, 
     other than the Government Securities Investment Fund,''; and
       (2) by striking ``either such Fund'' and inserting ``any 
     such fund or option''.
       (b) Coordination With Provisions Relating to Investments in 
     the Absence of an Election.--Subsection (d) of section 8439 
     of title 5, United States Code (as amended by subsection (a)) 
     is further amended--
       (1) by redesignating subsection (d) as subsection (d)(1); 
     and
       (2) by adding at the end the following:
       ``(2)(A) In the case of an investment made under section 
     8438(c)(2) in any fund or option to which paragraph (1) would 
     otherwise apply, the participant involved shall, for purposes 
     of this subsection, be deemed--
       ``(i) to have elected to invest in such fund or option; and
       ``(ii) to have executed the acknowledgement required under 
     paragraph (1).
       ``(B)(i) The Executive Director shall prescribe regulations 
     under which written notice shall be provided to a participant 
     whenever an investment is made under section 8438(c)(2)(B) on 
     behalf of such participant in the absence of an affirmative 
     election described in section 8438(c)(1).
       ``(ii) The regulations shall ensure that any such notice 
     shall be provided to the participant within 7 calendar days 
     after the effective date of the default election.
       ``(C) For purposes of this paragraph, the term 
     `participant' has the meaning given such term by section 
     8471(3).''.
       (c) Coordination With Provisions Relating to Fiduciary 
     Responsibilities, Liabilities, and Penalties.--Section 
     8477(e)(1)(C) of title 5, United States Code, is amended--
       (1) by redesignating subparagraph (C) as subparagraph 
     (C)(i); and
       (2) by adding at the end the following:
       ``(ii) A fiduciary shall not be liable under subparagraph 
     (A), and no civil action may be brought against a fiduciary--
       ``(I) for providing for the automatic enrollment of a 
     participant in accordance with section 8432(b)(2)(A);
       ``(II) for enrolling a participant in a default investment 
     fund in accordance with section 8438(c)(2)(B); or
       ``(III) for allowing a participant to invest through the 
     self-directed investment window or for establishing 
     restrictions applicable to participants' ability to invest 
     through the self-directed investment window.''.

     SEC. 407. CREDIT FOR UNUSED SICK LEAVE.

       (a) In General.--Section 8415 of title 5, United States 
     Code, is amended--
       (1) by redesignating the second subsection (k) and 
     subsection (l) as subsections (l) and (m), respectively; and
       (2) in subsection (l) (as so redesignated by paragraph 
     (1))--
       (A) by striking ``(l) In computing'' and inserting ``(l)(1) 
     In computing''; and
       (B) by adding at the end the following:
       ``(2) Except as provided in paragraph (1), in computing an 
     annuity under this subchapter, the total service of an 
     employee who retires on an immediate annuity or who dies 
     leaving a survivor or survivors entitled to annuity 
     includes--
       ``(A) for an employee who retires within 3 years after the 
     date of enactment of this paragraph, \3/4\ of the days, and
       ``(B) for an employee who retires after 3 years after the 
     date of enactment of this paragraph, the days

     of unused sick leave to his credit under a formal leave 
     system, except that these days will not be counted in 
     determining average pay or annuity eligibility under this 
     subchapter. For purposes of this subsection, in the case of 
     any such employee who is excepted from subchapter I of 
     chapter 63 under section 6301(2)(x)-(xiii), the days of 
     unused sick leave to his credit include any unused sick leave 
     standing to his credit when he was excepted from such 
     subchapter.''.
       (b) Exception From Deposit Requirement.--Section 8422(d)(2) 
     of title 5, United States Code, is amended by striking 
     ``section 8415(k)'' and inserting ``paragraph (1) or (2) of 
     section 8415(l)''.
       (c) Effective Date.--The amendments made by this section 
     shall apply with respect to annuities computed based on 
     separations occurring on or after the date of the enactment 
     of this Act.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Michigan (Mr. Dingell) and the gentleman from Texas (Mr. Barton) each 
will control 20 minutes.
  The Chair recognizes the gentleman from Michigan.


                             General Leave

  Mr. DINGELL. Madam Speaker, I ask unanimous consent that all Members 
have 5 legislative days in which to revise and extend their remarks and 
to insert extraneous materials on the bill under consideration.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Michigan?
  There was no objection.
  Mr. DINGELL. Madam Speaker, I want to place the legislation we are 
about to consider in its proper historical context.
  Fifty-one years ago, the Surgeon General first stated that tobacco 
smoking was linked to cancer.
  Forty-three years ago, in 1965, tobacco products were for the first 
time required to carry labels warning of the health hazards to 
consumers who used them.
  Fourteen years ago, the chief executives of the tobacco companies 
were

[[Page 17318]]

summoned to appear before the Committee on Energy and Commerce to 
answer questions about their knowledge of the dangers to human health 
caused by tobacco and their reluctance or refusal to disclose what they 
knew.
  Ten years ago, the tobacco companies entered into a master settlement 
with the attorneys general of the States, under which they would pay 
out billions of dollars to address the costs of smoking, amongst other 
purposes.
  Today, the House will consider H.R. 1108, the Family Smoking 
Prevention and Tobacco Control Act. This landmark legislation will, for 
the first time, grant the Food and Drug Administration the authority to 
regulate tobacco products and to protect consumers on this particular, 
difficult matter.
  It is hard to believe that 51 years after we first became aware of 
the harmful effects of smoking--and three years after a United Nations 
tobacco control treaty was enacted--the U.S. government has been unable 
to take the steps necessary to stem the tide of smoking. With this 
legislation, we can change that.
  Cigarette smoking accounts for about one in five deaths annually, or 
about 435,000 deaths each year. Each day, more than 4,000 young 
Americans try a cigarette for the first time, and each day 1,000 of 
these become addicted to tobacco. One in every three of these smokers 
will die prematurely.
  With this legislation, we will place sharp and sorely needed limits 
on access to tobacco products and on tobacco advertising and marketing.
  Public health organizations have fought for this legislation for 20 
years, and I want to commend in particular the Campaign for Tobacco-
Free Kids, the American Lung Association, the American Heart 
Association, the American Cancer Society, and other of our colleagues 
in particular, Representatives Waxman, Davis and Pallone, who deserve 
great credit for their diligence and persistence in bringing this 
legislation to the point where it is.
  Passage of H.R. 1108 will stand as an historic achievement. I urge my 
colleagues in the strongest terms to vote for the health of America's 
children and to vote for the health of the American people.
  I reserve the balance of my time.
  Mr. BARTON of Texas. Madam Speaker, I yield myself such time as I may 
consume.
  Madam Speaker, on the next bill, the Consumer Product Safety 
Commission reauthorization bill, I will be standing in this very spot 
saying extremely complimentary things about Chairman Dingell, the 
process that he has used and that Speaker Pelosi has used to bring the 
Consumer Product Safety Commission reauthorization bill to the floor of 
the House of Representatives. But that's the next bill.
  On this bill, I must say I still have the greatest personal respect 
for our distinguished chairman, Mr. Dingell, and our subcommittee 
chairman, Mr. Pallone, but I cannot say anything kind about the product 
of the legislation that they're bringing to the body today.
  At the beginning of this Congress, Madam Speaker, our Speaker for the 
entire full House of Representatives, Speaker  Nancy Pelosi said, 
``Bills should generally come to floor under a procedure that allows 
open, full and fair debate consisting of a full amendment process that 
grants the Minority the right to offer its alternatives.''
  That's not the case with this bill, Madam Speaker. The final product 
that's before us was given to the minority at about 1:05 this 
afternoon, which is approximately 3 hours and 5 minutes ago. We did 
have a committee markup. We did have some process. We did have some 
hearings in Mr. Pallone's subcommittee. We did have a legislative 
hearing on the bill, but once that was concluded, the bill disappeared 
into a sinkhole, only to reemerge today as a suspension bill.
  As you know, Madam Speaker, suspensions are theoretically about 
noncontroversial items in which there is little controversy and no 
disagreement between Members of the body on either side of the aisle. 
It's not the case on this bill, Madam Speaker.
  This bill will cost jobs in the agricultural sector. This bill has 
been so controversial that we, as I said earlier, didn't even get a 
work product until early this afternoon.
  On the substance of the bill, I disagree with the central premise, 
that the Food and Drug Administration should have the authority under 
this bill that actually certifies that tobacco is a responsible 
product. Isn't that an ironic thing? This bill is, in my opinion, a 
marketing allocation bill more than it is a regulation bill.
  The FDA does not have the resources to do this new responsibility. 
The FDA is not the tobacco police. The FDA should not be responsible 
for going into every convenience store and grocery store and tobacco 
shop in America making sure that the tobacco products are sold exactly 
as required.
  I could go on and on. I could quote Chairman Dingell and Subcommittee 
Chairman Pallone and Chairman Waxman of the Government Reform Committee 
where in a letter they said back in January about how short the FDA was 
of resources. I'm not going to do that. I might put it in the Record, 
but I won't quote them at this time.
  The FDA has only increased its total number of employees in the last 
decade by 646. Its appropriations in adjusted dollars is about $300 
million less than the inflation-adjusted dollars that the FDA says it 
needs. Yet we're going to give the FDA another huge responsibility and 
not give them the resources to do the work that the bill says they 
should do.
  If we really need to do more to restrict advertising for tobacco 
products or to prevent marketing to children, we can do that by going 
to other agencies that have that responsibility in the marketplace 
right now. If there should be more enforcement to prevent children from 
buying cigarettes because they're under age, we should bring a bill to 
the floor that would strengthen the Synar amendment, a former 
congressman from Oklahoma and a former member of the Energy and 
Commerce Committee.
  We could certainly encourage States to actually use their master 
settlement agreement funds to do things like the smoking cessation 
programs. It's ironic to me that less than 30 percent of the funds that 
have been given to the States under the master settlement agreement are 
being used for anti-smoking campaigns. That would be one area where I 
think both sides of the aisle, Republicans and the Democrats, could 
have bipartisan agreement.
  In short, Madam Speaker, what we don't need is creating at the FDA a 
new, Draconian bureaucracy since they're already overburdened and have 
more work than they know what to do with.
  I do agree that cigarettes are bad for people's health. I have never 
smoked a cigarette. I don't allow smoking in my office. I don't take 
any kind of campaign funds from tobacco companies. So I do practice 
what I preach, Madam Speaker, but I do not believe that this bill 
addresses the underlying problem in a satisfactory way.
  And for that purpose, I will strongly urge a ``no'' vote--again, 
since this is a suspension bill which on process alone, it shouldn't be 
but it is--it only takes one-third vote to defeat the bill.

                              {time}  1615

  That would be the perfect solution to this bill, would be to send it 
to the boneyard of other suspension bills that shouldn't be on the 
suspension calendar in the first place.
  Madam Speaker, it is getting a little tiresome to keep saying here we 
go again, but here we go again.
  Once again we come to the House floor to consider a major piece of 
legislation under suspension of the rules. Traditionally, we suspend 
the normal rules for things like naming post offices and other 
noncontroversial bills. For those watching on C-SPAN, suspension of the 
rules means limited debate and no amendments. We all remember that 
Speaker Pelosi told us that--and I'm quoting here--``bills should 
generally come to the floor under a procedure that allows open, full 
and fair debate consisting of a full amendment process that grants the 
minority the right to offer its alternatives.'' The reality has been 
different. Promise made, promise unmade.

[[Page 17319]]

  Madam Speaker, this bill is hardly ordinary. Honestly 
noncontroversial bills do not require committee mark-ups that stretch 
over multiple days. Noncontroversial bills do not contain billion-
dollar tax hikes. Noncontroversial bills do not cause working people to 
lose their jobs or their farms. In fact, the provisions of the bill 
were so controversial that the majority could not even produce a bill 
to be seen in public until this morning because they couldn't agree 
among themselves about what should be in it. Madam Speaker, handling 
legislation of this importance in this way is not the open and 
transparent process that was promised. It is the opposite.
  Now, on the substance of the bill, I disagree with the central 
premise of the bill that the Food and Drug Administration should be 
given this responsibility. The FDA is tasked with protecting the safety 
of the food we eat, and ensuring the drugs we take, and the medical 
devices we use are safe and effective. It is an agency that we have 
held numerous hearings on and have come to a bipartisan conclusion that 
the agency lacks sufficient resources to do its current mission. 
Congress affirmed that conclusion when we appropriated an additional 
$150 million in the Emergency Supplemental Appropriations for the FDA. 
Speaker, the FDA is still the wrong agency, at the wrong time, to 
become the tobacco police. They need to focus on their current mission.
  Here's what Chairman Dingell, Chairman Pallone and Chairman Waxman 
said about the current problem in a January 23, 2008 letter to FDA:

       Experts from every affected sector agree that this 
     desperate funding situation has rendered FDA unable to 
     protect the American public from even the most basic threats, 
     including contaminated food, tainted and dangerous drugs, and 
     faulty medical devices. According to FDA's own Science Board 
     . . . American lives are now at risk.

  FDA has plenty to do just to save those lives that are at risk. We, 
the Congress, have passed 125 laws over the last 20 years that directly 
impact FDA's regulatory responsibilities, yet our appropriated 
resources to the agency have not kept pace. During the same time 
period, FDA has only increased its total number of employees by 646 
people; and its appropriations are about $300 million less now in 
inflation-adjusted dollars. We're pretty good at telling FDA what to do 
and how to do it, but not so good at paying for what we order. And here 
we go again. Instead of making it possible for FDA to do the jobs we've 
already given it, we are here today adding new regulatory 
responsibilities that dwarf any of those given to the FDA in the past 
two decades.
  If we need to do more to restrict advertising or prevent marketing to 
children, we can find the right agency to do that. If there should be 
more enforcement to prevent children from buying cigarettes, we can 
strengthen the Synar amendment. The best way to reduce smoking is for 
States to use more of their Master Settlement Agreement funds on things 
like smoking cessation products. So let's talk about encouraging States 
to use more of their MSA funds for this purpose.
  These are problems we can solve without creating a new, draconian 
bureaucracy at an already over-burdened agency that Members on both 
sides of the aisle agree needs to do a much better job at conducting 
its current mission.
  Cigarettes are bad for people's health, period. Madam Speaker, if 
people believe there should be an increased Federal role in tobacco 
regulation, we can do better than this deceptive process and we can do 
better than this bill. I urge my colleagues to vote ``no'' and send a 
message that promises are meant to be kept.
  With that, Madam Speaker, I reserve the balance of my time.
  Mr. DINGELL. Madam Speaker, I yield to my dear and valued friend from 
West Virginia, the chairman of the Natural Resources Committee, 1 
minute for the purposes of a colloquy.
  Mr. RAHALL. Mr. Chairman, thank you very much for yielding. I want to 
thank you for the very accommodating and congenial manner in which you 
have accommodated the interests and the jurisdiction of the House of 
Natural Resources Committee on this issue.
  I would like to ask the distinguished chairman, the gentleman from 
Michigan, a question about the provision of the bill that requires the 
FDA, to the extent feasible, to enter into contracts with States for 
the inspection of tobacco retailers within their borders. It is my 
understanding that this contracting provision applies to Indian tribes 
in the same way as the provision applies to States.
  I would yield to the distinguished chairman to clarify.
  Mr. DINGELL. My good friend from West Virginia is correct. The FDA is 
required in the legislation, to the extent feasible, to enter into 
contracts with Indian tribes for the inspection of tobacco retailers 
located on Indian lands.
  Mr. RAHALL. I thank the distinguished chairman.
  Mr. DINGELL. I thank my good friend.
  Mr. BARTON of Texas. Madam Speaker, I want to yield 1 minute to our 
distinguished minority leader from the Buckeye State of Ohio (Mr. 
Boehner).
  Mr. BOEHNER. Let me thank my colleague for yielding and say to my 
colleagues that we don't have time to have a vote this week on our All-
American Energy Plan that would actually bring down gas prices in 
America, but we've got time to regulate tobacco.
  Now this bill has been hanging around here for 15 years. For 15 
years, we've been trying to move this piece of legislation. We're going 
to charge the tobacco companies about $5 billion over the next few 
years to pay for a bureaucracy here in Washington so we can regulate 
tobacco.
  Now, listen. Most of my colleagues know that I smoke. I know that 
smoking is probably not good for my health. Most people who smoke in 
America know that smoking is probably not good for their health. Do we 
need the Federal Government to tell us? Do we need to spend $5 billion 
of smokers' money for the government to tell us that smoking is not 
good for us? I don't think so. This bill has not been through the 
legislative process as everything was promised that it should be. 
Frankly, the whole idea that the Federal Government ought to regulate 
more and more and more of our lives just gets under my skin.
  I have great respect for my colleague from Michigan. He is a great 
Member of Congress, and we've worked together on a lot of issues, but 
this is a boneheaded idea. I mean, how much is enough? How much 
government do we need? More and more and more. There is not a smoker in 
America who doesn't understand that smoking isn't good for you, but now 
we're going to have the Federal Government, a big agency, set up under 
this bill where the FDA is going to be required to have this whole 
bureaucracy. It will have all of these new buildings. It will hire all 
of these people to issue all of these regulations that the tobacco 
companies are going to have to comply with and that smokers will pay 
for so that we can, out of all of this, understand that smoking is not 
good for you.
  We've already got labels on cigarettes. You've got some companies 
that might as well put a billboard on a pack of cigarettes so that you 
know that it's bad for you. I can imagine what will happen after we get 
more government regulations on this issue. I would just ask my 
colleagues: How much is enough? How much regulation and how much 
government and how much bureaucracy do we need before we finally say, 
Enough is enough? Let's stop. Let's vote against this bill.
  Mr. DINGELL. Madam Speaker, I yield myself 15 seconds for the purpose 
of responding to my beloved friend, the minority leader.
  This legislation is on the floor because people are killing 
themselves by smoking these evil cigarettes. The distinguished 
gentleman, the minority leader, is going to be amongst the next to die. 
I am trying to save him, as the rest of us are, because he is 
committing suicide every time he puffs on one of those things.
  Mr. BOEHNER. Would the gentleman be kind enough to yield?
  Mr. DINGELL. I didn't yield to the gentleman.
  The SPEAKER pro tempore. The time of the gentleman from Michigan has 
expired.
  Mr. DINGELL. At this time, Madam Speaker, I yield 2 minutes to my 
good friend from New Jersey (Mr. Pallone).
  Mr. PALLONE. Madam Speaker, I couldn't agree more with what Mr. 
Dingell said, but I do also want to point out to the minority leader 
that this is about kids.
  In fact, many adults smoke, and I'm sure they're very much aware of 
what they're doing. I suppose you could

[[Page 17320]]

argue that, if people want to kill themselves and they're adults, then 
let them do so, but every day, approximately 4,000 kids, children, try 
a cigarette for the first time, of which 1,140 become new daily 
smokers.
  According to my calculations, this means that since 1996 almost 5 
million children have become tobacco addicts and that one-third of 
those kids will end up dying prematurely from tobacco-related 
illnesses.
  So I say to the minority leader: Forget about the adults for the time 
being. We've got to stop the kids who are not aware and who don't 
understand the dangers of tobacco. They shouldn't start smoking. I 
think that's really what this is all about. This is a very important 
day, and I do resent the fact that the minority leader is belittling it 
by saying this is a boneheaded idea.
  I want to thank Mr. Waxman. He has been at this for I don't know how 
many years--12, 15, 20 years.
  Twelve years after the FDA first published a comprehensive rule that 
would protect children from the harmful effects of tobacco, we are 
finally one step closer to actually implementing its provisions and 
protecting millions of Americans, and particularly the children, from a 
lifetime of addiction and of poor health.
  Madam Speaker, it's hard to believe that tobacco products are exempt 
from the basic health and safety regulations that apply to other 
consumer products, but in fact, they are. Presently, the FDA is 
prohibited from regulating tobacco products, one of the most dangerous 
products available to consumers, and that's why we have to act today. 
Imagine that the FDA regulates toothpaste but not cigarettes. They 
monitor cereal but not chewing tobacco. Ironically, the FDA regulates 
both over-the-counter and prescription medications to help people quit 
smoking; yet it has no authority over the cause of the addiction. By 
passing this bill today, we're one step closer to changing all of that.
  In closing, I just want to say that this is a very important bill, 
and I urge its passage.
  The SPEAKER pro tempore. Without objection, the gentleman from New 
Jersey (Mr. Pallone) will control the balance of the majority's time.
  There was no objection.
  Mr. BARTON of Texas. I would yield to the gentleman from Indiana (Mr. 
Buyer), a member of the committee, for a unanimous consent request.
  Mr. BUYER. Madam Speaker, I rise in opposition to this bill.
  As we discuss H.R. 1108, the Family Smoking Prevention and Tobacco 
Control Act, the question before the House is not whether we want to 
decrease youth smoking as the bill is purported to do. The question is, 
after years of headlines and alarming stories about the FDA's failure 
to protect our Nation's food and drug supplies, do we in Congress 
believe that the FDA is in a place to take on a multi-billion dollar 
tobacco industry?
  I believe that each one of us agrees that the FDA is under-funded and 
cannot perform its current functions. Over the past 2 years, this 
Congress has spent enormous amounts of time negotiating legislation to 
reauthorize programs such as the Prescription Drug User Fee Act and the 
Medical Device User Fee Act. Not only did we reauthorize the programs 
as they existed, but we added to these programs and increased the FDA's 
workload.
  In the past several months, there have been numerous hearings in the 
Energy and Commerce Committee to try to determine what needs to be 
fixed at the FDA so that we can assure the American people that their 
food, their drugs, and their medical devices are safe.
  Unfortunately, we all understand the realities that exist within the 
FDA. Foreign drug manufacturing facilities are mostly going uninspected 
by the FDA, and the inspections that take place are not effective. 
FDA's surveillance over the drugs on our market today is not where it 
should be. Bad actors are getting into our drug supply chain and 
diverting good drugs out of the supply chain and bad drugs into the 
chain. Hundreds of thousands of unregulated and potentially harmful 
drugs are streaming into our country's international mail facilities 
every day and being sent to American homes with no FDA inspection or 
testing whatsoever. And, these problems only cover the problems with 
FDA's oversight over our Nation's prescription drug supply. We could go 
on about the problems that exist with our Nation's food supply.
  It is important that we look back at our discussions over the past 
year in this Congress and the discussions that we have before us over 
the FDA's lack of resources and ability to fulfill the duties that we 
have vested in the Agency.
  Every morning when I pick up the paper there is a new article about 
the dangers facing our country due to an underfunded and ill-equipped 
FDA. A few recent headlines have read:
  ``FDA inspections lag in overseas drug factories.''--Washington Times 
(2/28/08)
  ``FDA Chief is in a Budget Bind.''--WSJ (2/27/08)
  ``FDA Needs $375 million more to address shortcomings.''--Congress 
Daily (2/27/08)
  In fact, just this morning in an article in the Wall Street Journal, 
the Chairman of the Energy and Commerce Committee is quoted as saying, 
``There's a total inability of the FDA to carry out its mission.''
  Many of my colleagues on the Energy and Commerce Committee have been 
vocal about the FDA's ineffectiveness in recent congressional 
testimonies.
  The FDA is ``a sorry mess.''--Chairman Dingell (7/17/07)
  ``The warning signs are clear: FDA is an agency in crisis.''--Henry 
Waxman (author of the tobacco bill) (5/5/07)
  ``Unfortunately, as this Committee under both Republican and Democrat 
leadership has documented, FDA's resources have become woefully 
inadequate given the agency's expansive mission. Accordingly, the 
agency's ability to protect American families from unsafe foods, drugs, 
medical devices, and other products has radically deteriorated.''--Bart 
Stupak (1/29/08)
  Despite these strong statements, these very members want to put a 
multi-billion dollar industry under an Agency that is not adequately 
performing its current functions.
  The FDA itself has expressed its concerns about being mandated to 
regulate tobacco. The current FDA Commissioner, Andrew von Eschenbach, 
outlined his concerns in a recent letter to Members of Congress. 
Commissioner von Eschenbach wrote, ``Enactment of H.R. 1108 would 
redirect Agency priorities and resources to a new regulatory area, 
which is not only inconsistent with FDA's mission, but also diverts 
attention from the significant public health matters of the safety of 
food, drugs, biologics and medical devices.''
  And, if I remember correctly, none of the last few FDA Commissioners 
has supported FDA regulating tobacco.
  Madam Speaker, I ask that we all think long and hard about that one 
big question before us today. Is the FDA ready to take on this multi-
billion dollar industry in the midst of the challenges already before 
the Agency today?
  I agree that we need to keep tobacco out of the hands of our youth. I 
agree with the statistics that show that people become addicted to 
tobacco while they are in their youth. I am concerned about the growing 
prevalence of disease and death attributable to tobacco in our country.
  However, I believe that we have means to increase enforcement in our 
States to keep tobacco out of our children's hands. We do not need a 
new government bureaucracy which will inevitably be underfunded and 
ill-equipped to effectively regulate the tobacco market.
  Mr. BARTON of Texas. I now want to yield to the distinguished tri-
captain of the victorious congressional Republican baseball team, the 
gentleman from Virginia (Mr. Davis), 1 minute.
  Mr. DAVIS of Virginia. Could I have 1 minute from the other side as 
well?
  Mr. PALLONE. Madam Speaker, I yield 1 minute to the gentleman from 
Virginia.
  The SPEAKER pro tempore. The gentleman from Virginia is recognized 
for 2 minutes.
  Mr. DAVIS of Virginia. Four hundred thousand Americans die every year 
from tobacco-related diseases. That's why we're here today.
  For the past 8 years, I've sought to pass legislation like this, 
giving the FDA authority to regulate tobacco. For the past 6, my good 
friend and esteemed colleague Henry Waxman and I have partnered on 
legislation to this end. Today's hopeful passage of H.R. 1108 marks a 
milestone in our efforts, and I'm honored and proud to be here with him 
and with the distinguished chairman of the committee to take this vital 
step in protecting the public health.
  In my view, the primary focus of our tobacco control policy should be 
to stem the flow of new tobacco users. Regrettably, this equates to 
keeping children away from tobacco since most of

[[Page 17321]]

the new users are under the age of 18. Among this group, tobacco use 
has become synonymous with a rugged independence, of a refutation of 
authority and of an arrogant disregard for one's personal well-being--
the traits that many teenagers desire.
  How did this most self-destructive behavior, short of actual suicide, 
take hold in the collective psyche of our young people?
  In large part, the marketing tactics by tobacco manufacturers fanned 
the flames of youthful angst. The entertainment industry added further 
fuel with innumerable cigarette-smoking heroes on movie screens and on 
television. If only the Marlboro Man had been holding a slide rule 
instead of a cigarette.
  H.R. 1108 gives the FDA appropriate tools to restrict marketing and 
access so that children will have less interest in tobacco and less 
ability to purchase it. Tobacco can be more addictive than heroin, so 
it is important that the tobacco policy espoused in this legislation 
also addresses the needs of current users. It calls on the Secretary to 
closely examine innovative products that would help users end their 
dependence. I'm hopeful the result will be the expedited approval of 
cessation products and of a more vibrant market for them. H.R. 1108 
also allows for the development of modified risk products.
  I urge the adoption of this legislation.
  Mr. PALLONE. Madam Speaker, I yield 3 minutes to the sponsor of the 
legislation, who has worked tirelessly on this for so many years, Mr. 
Waxman.
  Mr. WAXMAN. I thank the gentleman for yielding to me.
  Madam Speaker, this is truly an historic day in the fight against 
tobacco, but it took us far too long to get here.
  In 1994, the tobacco executives stood before my subcommittee, held 
their hands up, swore to tell the truth, and then immediately lied 
under oath and said, ``Nicotine, it's not addictive. Children, we don't 
try to market to children.'' Of course, the opposite was true.
  In 1996, the FDA tried to regulate tobacco products, but the Supreme 
Court told them they needed specific congressional language to give 
them that authority. Now, 12 years later, here we are, finally giving 
the FDA that authority to regulate the leading preventable cause of 
death in America.
  Every one of us knows the tragic consequences of cigarette smoking. 
We've seen loved ones die, suffer. We've watched others grow sick. Many 
of us have felt the grip firsthand of addiction, but the worst of all 
is what happens to children. One thousand children start smoking each 
and every day. Four hundred thousand Americans die every year.
  The minority leader said: When is enough enough?
  Well, cigarettes, one of the most dangerous products on sale today, 
is not regulated at all. This bill would give the FDA, the only agency 
with the right combination of scientific expertise, with regulatory 
experience and with a public health mission, the ability to oversee the 
products effectively.
  The FDA can stop that marketing to kids. They can prevent 
manufacturers from misrepresenting their products as ``light'' or as 
``safer.'' They can require changes in cigarettes. They can change the 
level of nicotine so that people who smoke and who want to give up 
smoking will have a fighting chance. They can regulate ingredients such 
as formaldehyde or benzene or radioactive elements or any other deadly 
chemical.
  Now, some have argued that the FDA is overburdened, that they can't 
do another job. Well, they are overburdened, and they're not well 
funded, but this bill has a user fee built into it to raise the money 
from the tobacco companies to give the FDA the ability to go and 
regulate this product.
  The breadth of support for this bill is from the AARP to the American 
Academy of Pediatrics and from the Southern Baptist Convention to the 
Islamic Society of North America. It is supported by the American Lung 
Association, by the American Heart Association and by the American 
Cancer Society--the groups that are best situated to understand the 
damage caused by tobacco. We've tried to accommodate specific concerns 
we've heard about this bill to provide fairness and flexibility for 
convenient stores and for others.
  Join in support of this legislation. It is a bipartisan bill, and I 
urge its adoption.
  Mr. BARTON of Texas. Madam Speaker, can I inquire as to the time on 
each side that is remaining, please.
  The SPEAKER pro tempore. The gentleman from Texas controls 12 
minutes, and the gentleman from New Jersey controls 9\1/2\ minutes.
  Mr. BARTON of Texas. Madam Speaker, I wish to yield 2 minutes to the 
distinguished gentleman from North Carolina (Mr. Coble).
  Mr. COBLE. I thank the gentleman from Texas.
  Madam Speaker, during my tenure in Congress, I have consistently 
opposed granting the Food and Drug Administration the authority to 
regulate tobacco. As I have stated on many occasions, I believe 
allowing the FDA to regulate tobacco in any capacity would inevitably 
lead to the FDA's regulating the family farm.

                              {time}  1630

  Let's be candid, Madam Speaker; should the FDA spend its time 
regulating tobacco on the farm and in manufacturing facilities, despite 
warnings on cigarette labels which alert consumers to their danger, or 
should it focus on the core mission of ensuring the safety and 
soundness of our food, drugs and cosmetics?
  I also have concerns with the impact this legislation would have upon 
tobacco manufacturers and their employees. These companies employ many 
hardworking, diligent working North Carolinians, and I believe the FDA 
regulation of tobacco would negatively affect these manufacturing jobs.
  Finally, Madam Speaker, taxing tobacco companies to fund additional 
regulation and avoid PAYGO problems is ill-conceived and will create an 
incentive, in my opinion, for black market activity such as 
counterfeiting and smuggling.
  Madam Speaker, this legislation is misguided and, in my opinion, will 
not achieve the goals identified by proponents. Indeed, I believe it 
will further exacerbate an already stretched FDA, negatively impact 
manufacturers and farmers, and create a strain on Federal revenues to 
the Treasury. I adamantly oppose the measure and urge my colleagues to 
do the same.
  Madam Speaker, tobacco is a product that is lawfully grown, lawfully 
marketed, lawfully manufactured and lawfully consumed. We don't need 
the FDA inserting its oars into these waters.
  Mr. PALLONE. Madam Speaker, I would like to recognize the gentlewoman 
from the Virgin Islands, but I do have to remark that it is wonderful 
to see our colleague, Bobby Rush from Illinois, back here today. Thank 
you for being with us today.
  I yield 1 minute to the gentlewoman from the Virgin Islands.
  Mrs. CHRISTENSEN. Madam Speaker, first I want to thank Chairman 
Dingell, Chairman Pallone and Chairman Waxman for your leadership and 
for working with us on the CBC to address some of our concerns about 
the bill.
  Colleagues, we've heard and read of all the methods and additives 
tobacco companies have allegedly used to target young people and 
communities, particularly African Americans and Hispanics, as well as 
to increase the likelihood of addiction. We also know that tobacco is 
the leading cause of death in this country, with or without menthol.
  I rise in strong support of H.R. 1108 because we will finally end 
these practices and put in place the strongest standard for product 
regulation ever, as well as a mechanism for funding to support research 
and enforcement.
  Madam Speaker, this bill does not contain everything that all of us 
wanted, but it is supported by the public health community because it 
is the important first step we must take in order to get to the point 
where products like menthol, that we believe may injure the health of 
minorities and others, will no longer be available.
  I urge all of my colleagues to vote ``aye'' and the President to sign 
this

[[Page 17322]]

bill so that we can move forward, after long years of trying, to 
finally protect the health of our constituents. And I will place in the 
Record a statement by the CBC.

       We, the undersigned members of the Congressional Black 
     Caucus, issue the following statement:
       Recognizing the difficulty in getting a bill which would 
     garner the sufficient votes in the House and Senate for 
     passage, we the members of the Congressional Black Caucus 
     stand firmly with the Public Health Community in support of:
       The strongest standard for product regulation ever given to 
     the FDA (stronger than food, drugs or medical devices);
       Barriers to and serious consequences for those who try to 
     market and sell to children;
       The banning of additives used to manufacture flavored 
     cigarettes, which are marketed to children and which are used 
     to get children of ALL racial and ethnic backgrounds addicted 
     to cigarettes in the first place;
       A faster track for the development of smoking cessation and 
     nicotine-replacement therapies; and
       The authority for greater regulation--including of 
     menthol--in the future.
       And the other provisions of H.R. 1108.
       Taking into consideration the disproportionate rates of 
     cancer in the African-American community and the high use of 
     menthol in our community, and given the fact that an attempt 
     to ban menthol has already been offered and failed, we feel 
     that this important first step which gives the authority to 
     the Secretary to ban menthol and speeds up the research 
     recommendations and report of the Scientific Advisory 
     committee, is worthy of our support.
       The Congressional Black Caucus has a long history in 
     promoting smoking cessation programs in our community and 
     will continue to make this a priority both as a Caucus and 
     through partnership with the Congressional Black Caucus 
     Foundation.
       Our objective has been and will always be the well-being of 
     the African-American community, other communities of color 
     and all Americans. With our support for H.R. 1108 we continue 
     this proud tradition.
       Banning menthol and regulating tobacco are priorities for 
     the CBC. We are pleased with the leadership role we assumed 
     to accomplish both because this bill, which regulates 
     tobacco, also represents a giant first step toward the 
     elimination of menthol.

  Mr. BARTON of Texas. Madam Speaker, I wish to recognize a 
distinguished Member from the great State of North Carolina, a great 
former professional quarterback, member of the Democratic baseball 
team, Mr. Shuler, for 1 minute.
  Mr. SHULER. I thank the gentleman from Texas.
  Madam Speaker, I rise in strong opposition of this legislation. I 
don't smoke, and I never have. I'm a father of two small children. You 
won't find a bigger opponent of tobacco use in this Congress.
  I have a great deal of respect for Chairmen Waxman, Dingell and 
Pallone. I respect their hard work, and I share the dedication they 
have to reducing smoking, especially among teenagers. But giving FDA 
approval to tobacco is not the answer.
  The FDA Commissioner testified that he has ``serious concerns that 
this bill will undermine the public health role of FDA.'' And the FDA 
Science Board said that ``FDA's inability to keep up with scientific 
advancements means that American lives are at risk.''
  The FDA is dangerously overworked. Recently, the FDA shut down the 
entire domestic tomato industry. We've had listeria in frozen 
strawberries, E. coli in spinach and lettuce.
  The SPEAKER pro tempore. The time of the gentleman has expired.
  Mr. BARTON of Texas. I give the gentleman an additional 1 minute.
  Mr. SHULER. Salmonella in peanut butter, and poison in pet foods.
  Now, I have a lot of respect for the men and women who work at the 
FDA, but I clearly feel that they are overworked and overburdened and 
have so much on their plate. We should listen to the people that are 
working at the FDA. We should not pile more work upon them. This bill 
is hazardous to your health, whether you smoke or not.
  Mr. PALLONE. Madam Speaker, I yield 2 minutes to the gentlewoman from 
California (Mrs. Capps).
  Mrs. CAPPS. Madam Speaker, I rise in strong support of H.R. 1108. 
This bill is about bringing smoking prevention and cessation efforts 
into the 21st century.
  We have known for a long time about the health dangers--in fact, the 
life-threatening dangers--posed by tobacco use. Nobody uses tobacco 
because they think it's good for their health. What this bill does is 
to take the necessary steps which will most effectively help people 
quit, and most importantly, help them never to begin.
  One of the ways that goal is accomplished through this legislation is 
by giving greater authority to the Food and Drug Administration to 
regulate the advertising and marketing of tobacco products. By 
prohibiting the targeted marketing of tobacco products to children, we 
can help prevent countless young people from falling prey to deceptive 
advertising, the kind that describes smoking with the same adjectives 
used to describe candy and perfume, with the many enticing qualities.
  Now, some of the bill's opponents may try to say the FDA is ill-
equipped to do this. I just want to remind my colleagues that this bill 
provides the FDA new resources to handle tobacco regulation, and it's 
based upon a plan the agency itself devised over a decade ago.
  I want to thank many colleagues who have worked tirelessly over years 
to bring us to this moment on this floor. I want to thank Mr. Waxman 
for his tireless leadership. I want to thank the leadership of our 
committee, Mr. Pallone, and most particularly our esteemed chairman, 
for whom this day will mark a very special moment and milestone.
  I urge all of my colleagues in this House to vote in favor of H.R. 
1108.
  Mr. BARTON of Texas. I yield 1 minute to the distinguished deputy 
whip from the great State of Virginia (Mr. Cantor).
  Mr. CANTOR. I want to thank the gentleman from Texas.
  I also want to thank the gentleman from California, the gentleman 
from Virginia (Mr. Davis) and the gentleman from Michigan (Mr. Dingell) 
for their cooperation with me and my office on this bill.
  As our minority leader said, the scientific community as well as the 
general public is pretty well steeped in the dangers of smoking. I 
think all of us can agree it's a legitimate public policy to want to 
reduce the rate of smoking with our children. This bill, though, in 
addition to doing some of that, some of the aim behind it is to allow 
for it to pave the way and in fact to encourage legitimate attempts to 
make tobacco and tobacco products less harmful. The net result to all 
of us will be to increase the health outlook for consumers of tobacco 
and its products.
  This bill is particularly meaningful to my district, as there are 
over 6,000 direct jobs related to the tobacco manufacturing. And there 
has been significant investment in my district and in the area from 
where I come made towards the research and development on how we make 
this product less harmful.
  Mr. PALLONE. Madam Speaker, I yield 2 minutes to the gentlewoman from 
California (Ms. Harman).
  Ms. HARMAN. Madam Speaker, I applaud my chairman, the bill's 
sponsors, and the bill's many supporters on a bipartisan basis for 
bringing such important legislation to the House floor today.
  Madam Speaker, this bill is personal for me. Both of my parents are 
part of the statistics; both of them died from lung cancer from 
smoking.
  As a mother of four and a grandmother of three so far, I am 
relentless in urging that they and everyone else's kids and grandkids 
not acquire this horrible addiction.
  In California, 138,000 children try a cigarette for the first time 
each year, and more than one-third of them become regular daily 
smokers. Some will die as my parents did, slowly and painfully. In my 
mother's case, though she knew of her dire health prognosis, she never 
quit smoking.
  I think this bill sets the right balance. It's probably as much as we 
can get through Congress--if we can get it through--at this time, 
though I would support more and will support more in the future.
  The bill reinstates an FDA rule that restricts tobacco marketing and 
sales to children. In today's consumer culture, children are most 
vulnerable to

[[Page 17323]]

attractive marketing campaigns. Tobacco's campaign has been very 
successful.
  The bottom line is we need to put a stop on creating new tobacco 
users. The bill also requires enhanced labeling of health warnings on 
product packaging. More effective labeling will better educate the 
public on the dangerous consequences of tobacco. Given the state of our 
economy, it is foolhardy to load on health costs that we know--as even 
the bill's opponents have said--come from those addicted to smoking.
  California spends almost $10 billion treating tobacco-related 
diseases each year. This is critical funding that we need elsewhere.
  With the passage of the legislation today, we can prevent this. I 
urge an ``aye'' vote.
  Mr. BARTON of Texas. Madam Speaker, I yield 2 minutes to the 
gentlelady from the committee, Mrs. Blackburn of Tennessee.
  Mrs. BLACKBURN. Madam Speaker, I rise today in opposition to the 
bill. And I will tell you, I have great respect for the chairman and 
the author of the bill, but I respectfully disagree with them on this 
issue.
  I've also served as an active volunteer with the Lung Association and 
with the Cancer Society and have worked diligently to stop teen 
smoking, but I disagree with the approach that is being taken here 
today.
  Rather than forcing the ill-equipped FDA to regulate tobacco 
products, Congress should strengthen existing programs to prevent 
illegal tobacco use. And now the gentleman from Texas mentioned the 
Synar program. And I have had a piece of legislation, H.R. 5513, the 
Stop Adolescent Smoking Without Excessive Bureaucracy Act, that is a 
better solution and I think a better approach. It strengthens the 
existing work that the States and localities are doing to reduce 
underage tobacco use. It is an effective existing program.
  My bill directly impacts youth access to tobacco products, which gets 
to the very root of the public health crisis that is brought about by 
the addiction of tobacco.
  According to a recent Zogby poll, a majority of Americans, 82 
percent, believe FDA control of tobacco would conflict with their core 
mission to secure the Nation's food and drug supply. And Madam Speaker, 
at a time when people are concerned about imported and domestic food, 
imported and domestic drugs, medical devices, and more, it is important 
that the FDA focus on that mission.
  Consumers believe FDA product approval equals safety. And here we are 
talking about moving FDA control of tobacco and tobacco products and 
giving that the FDA seal of approval. I think that is a step we do not 
want to take.
  Mr. PALLONE. Madam Speaker, I yield 30 seconds to the gentleman from 
California.
  Mr. WAXMAN. I don't want anybody to be misled. The FDA will not give 
a seal of approval to any tobacco product they cannot in any way claim 
is safe or effective. So I think that the last statement that was made 
by the gentlelady is an incorrect one, and I wanted to correct that 
point.
  Mr. BARTON of Texas. Madam Speaker, I yield for the purpose of 
unanimous consent to the distinguished gentleman from Connecticut.
  Mr. SHAYS. I thank the gentleman for yielding.
  Madam Speaker, I rise in support of this legislation.
  I rise in support of H.R. 1108, the Family Smoking Prevention and 
Tobacco Control Act.
  I appreciate the willingness of Mr. Waxman to incorporate changes and 
address concerns that were raised about the bill as it was initially 
introduced, and for the work both he and Mr. Davis have done to bring 
this bill to the floor today.
  The simple fact is our society as a whole is negatively impacted by 
smoking, and more needs to be done to curb smoking among our youth.
  Bringing tobacco under the authority of the FDA will help ensure the 
laws on our books are enforced and will help ensure information about 
the dangers of smoking is adequately disseminated.
  In the past, I have opposed FDA regulation of tobacco, believing that 
oversight should be conducted instead by an agency such as the 
Substance Abuse and Mental Health Services Administration (SAMSHA).
  The FDA already has too many products under its jurisdiction and has 
trouble responding in a timely and effective manner as a result.
  I have always believed, however, that tobacco should be regulated, 
and with the support of a diverse group of organizations, H.R. 1108 has 
a real opportunity to become law and the potential to significantly 
limit the damaging effects smoking has on our society. I urge its 
adoption.
  Mr. BARTON of Texas. Madam Speaker, I yield 1 minute to the 
distinguished gentleman from Coppell, Texas and Flower Mound, Texas 
(Mr. Marchant).
  Mr. MARCHANT. Madam Speaker, I am disappointed--and the people of the 
24th District of Texas are disappointed--by the continued misuse and 
abuse of the suspension calendar. Once again, Democrats bring to the 
floor a bill that prohibits Members from offering amendments. This 
comes at a time when we could be working on a comprehensive energy bill 
that would do far more to benefit the American people.
  Energy should have been our highest priority this summer, but instead 
I'm afraid that Congress will leave for a five-week recess without 
considering real solutions to the energy crisis.

                              {time}  1645

  When is the Democratic leadership going to put the concerns of the 
American people before their desire to placate the radical 
environmentalists?
  Mr. PALLONE. Madam Speaker, I yield 2 minutes to the gentlewoman from 
Colorado (Ms. DeGette).
  Ms. DeGETTE. Madam Speaker, I rise today to thank my intrepid 
chairman, Mr. Dingell, and also Mr. Waxman, for their unfailing 
commitment to the public health of Americans. This bill is a good bill. 
When I first came to Congress, now 12 years ago, it seemed to be a bill 
far outside our reach.
  We had a number of hearings in those days, in which the tobacco 
manufacturers denied even that tobacco was addictive. To come from 
there to here is truly an extraordinary achievement, and I think we all 
agree that tobacco should be regulated by the FDA.
  One concern I still have in this bill is tobacco is illegal now for 
people under the age of 21. We all have seen through testimony 
throughout the years that the people who get addicted to tobacco tend 
to do so at an early age, and tobacco manufacturers have targeted young 
people consistently.
  I'm afraid that if the manufacturers say that they are targeting only 
adults, that what will happen will be they in fact will target young 
people, who will become addicted. That is why I was very pleased to 
include a provision in this law that directs the Secretary of Health 
and Human Services to conduct a study on the public health implications 
of raising the minimum age to purchase tobacco products. This report 
will be in to us within 5 years and we can see if there's more that we 
can do to protect our vulnerable young people from becoming the targets 
of advertising an improper addiction to tobacco.
  Madam Speaker, this truly is a great day for the health of Americans. 
I want to commend my chairman again.
  Mr. BARTON of Texas. Madam Speaker, I have no other speakers other 
than my close. I am going to reserve the balance of my time at this 
time.
  Mr. PALLONE. Madam Speaker, I yield now 2 minutes to the gentleman 
from Maryland (Mr. Van Hollen).
  Mr. VAN HOLLEN. I thank my colleague, Mr. Pallone, for his 
leadership, and Chairman Dingell and the Energy and Commerce committee, 
Mr. Waxman, and so many others, who have brought this legislation to 
the floor, finally, after so many years and so many battles. This is a 
very important day for the American people.
  The Food and Drug Administration, as we know, has the power to 
regulate and oversee all sorts of products that are sold today; many 
that are not addictive. Yet we have always had this big hole in that 
regulatory authority

[[Page 17324]]

when it came to very addictive products of nicotine and the tobacco 
products.
  On those issues, the FDA has been sidelined, and the result is the 
big tobacco companies have taken advantage of that opportunity and 
exploited it and they have marketed these tobacco products to 
generation after generation of young people through flavored cigarettes 
and tobacco products and on all sort of things. In fact, when you think 
about it, they have got to do that. In order to continue to make a 
profit, they have got to continue to hook one generation after another.
  It's great that we are finally gathered here today to say to the FDA: 
You do have authority over this very important area. Let's make sure 
that future generations of young people do not get addicted. This has a 
huge cost to our society, obviously in dollars, but even more 
importantly, the people who die every year as a result of this. We have 
an opportunity today to begin to put an end to that cycle.
  I am very proud that in our State of Maryland we have made progress 
on this on a State basis. We have tried to increase the tobacco tax to 
reduce tobacco use among young people and use those proceeds for health 
purposes. But you can't have every State fighting alone to have a 
successful national program. You need one entity that has this power to 
help protect the American people, especially the young people of this 
country.
  I thank the committee for its leadership.
  Mr. BARTON of Texas. Madam Speaker, I would assume the majority has 
got the right to close, so I am just reserving until they are ready to 
close.
  Mr. PALLONE. I have no remaining speakers, Madam Speaker. How much 
time remains on this side?
  The SPEAKER pro tempore. Thirty seconds.
  Mr. PALLONE. I will reserve the 30 seconds.
  Mr. BARTON of Texas. Don't I have 4 minutes?
  The SPEAKER pro tempore. The gentleman from Texas controls 4\1/2\ 
minutes.
  Mr. BARTON of Texas. I would be happy to yield a minute and a half of 
my time to the majority so that they have 2 minutes and I have 2\1/2\ 
minutes, if that would help.
  Mr. PALLONE. Let me thank the ranking member of the full committee 
for the time. I have no remaining speakers, and will reserve the 
balance of my time to close, Madam Speaker.
  Mr. BARTON of Texas. I am going to recognize myself for the balance 
of my time.
  The SPEAKER pro tempore. The gentleman from Texas is recognized for 
2\1/2\ minutes.
  Mr. BARTON of Texas. I want to point out a couple of things. This 
bill does not ban tobacco. Most of the rhetoric on the other side has, 
rightfully so, been about the evils of tobacco. But the bill before us 
doesn't ban tobacco. In truth, what the bill before us does is allocate 
market share of the existing marketers of tobacco in the United States. 
It also sets up a huge regulatory machine at FDA, where the Food and 
Drug Administration literally has to go into every convenience store 
apparently in America and make sure that certain displays are at a 
certain eye level and all this kind of thing.
  It bans, as I understand it, flavored cigarettes, except for menthol, 
in which it requires a study of menthol cigarettes to be reported by a 
date certain, which I think is 1 year. And then, in order to pay for 
this huge new bureaucracy that has to be created for the tobacco 
police, it sets up some sort of a gimmick in the Tax Code for people to 
choose between a thrift savings account and a Roth IRA. If you invest 
in a Roth IRA, you pay taxes before you put the money in the account. 
If you decide to invest in a thrift savings account, you don't have to 
pay taxes until you take the money out of the account.
  Somehow, and we don't know much about this because we only got the 
bill with this section about 3 hours ago, there's something in there 
that they think scores about $2 billion over 10 years because more 
people will opt to take the Roth IRA, where they pay taxes up front.
  Last, but not least, Madam Speaker, it sets up some sort of a records 
inspection for the Secretary of HHS to go in and look at the records to 
make sure that tobacco products are not smuggled or counterfeited 
unless those tobacco products are sold on Indian lands, in which case 
the Indian tribe has the right to opt out of that, which I think is 
going to set up a huge loophole because my guess is that the Indian 
tribes, not being foolish, are going to obviously opt out of Federal 
regulation of this inspection program.
  In short, this is a bill that, while noble in intent, is very flawed 
in implementation. It shouldn't be on the suspension calendar. It 
shouldn't have come up only 3 hours before it's debated.
  We should vote this bill down. If you really want to do something 
about tobacco products, let it go through the regular process. I would 
urge a ``no'' vote on the pending legislation.
  I yield back the balance of my time.
  The SPEAKER pro tempore. The gentleman from New Jersey is recognized 
for the remaining 2 minutes.
  Mr. PALLONE. Thank you, Madam Speaker.
  I just want to stress in closing that this really is a bipartisan 
bill that is supported overwhelmingly by both sides of the aisle. I 
have had the opportunity under the auspices of Tobacco-Free Kids, which 
is one of the big supporters of this bill, to go to an elementary 
school in my district one day recently. And I found out that the kids 
there were all from fifth grade down. It was incredible to me to 
realize that some of them had already started to smoke and they were 
very much unaware of the fact of the dangers of tobacco.
  That was really a revelation for me that day, to realize that there 
are a lot of children at a very young age that start smoking that are 
unaware of the dangers, even with all the declarations and disclaimers 
that are out there.
  So I really think that this legislation that we are passing today is 
for the kids. It for those children who will stop or never, hopefully, 
have the opportunity or think about smoking because they will realize 
how dangerous it is because it's now regulated by the FDA.
  I just want to thank Mr. Waxman; I know he has worked for many years 
on this, and Mr. Dingell and so many on both sides of the aisle because 
I think they recognize while it may be true that a lot of adults know 
what they are doing when they smoke, and they do it regardless of the 
health impact, that really what we need to address are those kids that 
start smoking at a young age, that become addicted, that are not aware 
of the perils, and then later just simply can't stop.
  So I would urge all of my colleagues. This is a very historic day. 
This is a very important piece of legislation. Let's pass it 
overwhelmingly today on a bipartisan basis.
  Mr. LEVIN. Madam Speaker, I rise in strong support of H.R. 1108, the 
Smoking Prevention and Tobacco Control Act. I urge the House to vote in 
favor of this legislation, which takes critical steps to protect the 
public, especially minors, from the dangers of tobacco use.
  According to the American Heart Association, cigarette use is the 
number one preventable cause of poor health and premature death 
worldwide. It is estimated that smoking causes one in five deaths in 
the United States, or approximately 400,000 premature deaths per year.
  Despite laws in every state prohibiting the sale of cigarettes to 
minors, the U.S. Surgeon General estimates that young people ages 12 to 
17 continue to purchase and smoke millions of packs of cigarettes each 
year. H.R. 1108 contains a number of strong provisions to protect young 
people from tobacco advertising and access to tobacco products. The 
bill requires the Food and Drug Administration to ban outdoor tobacco 
advertising within 1,000 feet of schools and playgrounds, restrict 
tobacco vending machines to adult-only facilities, require retailers to 
verify age for all over-the-counter tobacco sales, and mandate Federal 
enforcement and penalties for those who sell tobacco products to 
minors.
  The Family Smoking Prevention and Tobacco Control Act also includes 
provisions to ensure that tobacco advertising is not misleading to 
consumers. In the past, tobacco

[[Page 17325]]

companies have been allowed to use such terms as ``light,'' ``mild,'' 
and ``low'' without proving that products labeled with these words were 
less dangerous to health than generic equivalents. This bill requires 
tobacco manufacturers to prove that products actually impart reduced 
risk or reduced exposure to users before employing terms that imply 
these safeguards.
  In addition, H.R. 1108 contains vital provisions that aim to reduce 
the harmful health effects of tobacco products for adults who do decide 
to use them. The bill allows the Food and Drug Administration to 
regulate the contents of cigarettes and other tobacco products. This 
authority is of paramount importance. Over 4,000 chemicals, including 
60 carcinogens, have been identified in tobacco smoke. It is unlikely 
that tobacco will ever be an inherently safe product. But allowing the 
Food and Drug Administration to regulate the chemical additives to 
cigarettes and smokeless tobacco will help to reduce the health dangers 
of these products to the extent possible.
  Passage of H.R. 1108 is an essential step forward in promoting the 
health of all Americans. Let's pass this important legislation.
  Mr. LANGEVIN. Madam Speaker, I rise in strong support of H.R. 1108, 
the Family Smoking Prevention and Tobacco Control Act. This bill is a 
pioneering step forward in a decades-long struggle to safeguard the 
health of our citizens by ensuring that tobacco products are properly 
regulated. I am proud that the House of Representatives is taking this 
historic action on such an important public health issue.
  The dangers of tobacco products are no secret. According to the 
Centers for Disease Control and Prevention (CDC), the adverse health 
effects from cigarette smoking account for an estimated 438,000 deaths, 
or nearly 1 out of every 5 deaths, each year in the United States. 
Additionally, a report released by the National Cancer Institute states 
that smokeless tobacco contains 28 cancer causing agents. Despite these 
and a multitude of other troubling revelations, the tobacco industry 
has remained virtually outside the realm of transparency or oversight. 
This groundbreaking measure will empower the Food and Drug 
Administration (FDA) with meaningful authority to regulate tobacco 
product content and marketing for the first time in our nation's 
history.
  H.R. 1108 authorizes the FDA to restrict the sale and distribution of 
tobacco products, including its advertising and promotion, particularly 
as it affects children. It requires tobacco companies to disclose the 
nicotine levels and chemical contents of their tobacco products, and 
mandates reporting on changes to the products and any research 
regarding their health effects. This legislation does not permit the 
removal of nicotine from tobacco; however, it will grant the FDA 
authority to eliminate harmful ingredients and additives, and reduce 
nicotine levels. It will also prohibit terms such as ``light,'' 
``mild'' and ``low-tar'' that mislead consumers into believing that 
certain cigarettes are safer than others.
  Tobacco is a drug with well known adverse health effects, and it 
should be regulated by the Food and Drug Administration like any other. 
This bill will provide the FDA with the necessary regulatory and 
oversight authority to address how tobacco products are manufactured, 
advertised, and marketed. Further, it will fund this authority with 
user fees to ensure that other efforts at the FDA are not compromised.
  The CDC estimates that every day, approximately 4,000 youth try a 
cigarette for the first time, and another 1,000 will become new, 
regular daily smokers. One-third of these youth will eventually die 
prematurely as a result. At a time when our nation's health care system 
is already straining under the increased weight of chronic disease, 
this Congress must take action to directly address the dangers of 
tobacco. To that end, I remain ready to work with my colleagues on this 
important issue and urge that they support the Family Smoking 
Prevention and Tobacco Control Act.
  Ms. SCHAKOWSKY. Madam Speaker, I am a strong supporter and cosponsor 
of H.R. 1108, the Family Smoking Prevention and Tobacco Control Act, 
and I urge my colleagues to join me in voting for it today. I also want 
to commend and thank Congressman Waxman for introducing this important 
legislation that will significantly improve public health by 
strengthening the regulation of tobacco products.
  There are over 44 million smokers in the United States and over 
435,000 tobacco-related deaths each year. In Illinois alone, 24.3 
percent of adults and 29.2 percent of youths smoke tobacco. Each year 
in Illinois, more than 16,000 people die from smoking-related 
illnesses, including 2,900 adults and children who die of second-hand 
smoke. In addition, $3.2 billion is spent in direct medical 
expenditures related to smoking in Illinois.
  The tobacco industry spends $17 million a day to promote their 
products. Their targets are often teens, women and minorities. The 
average age when an individual becomes a daily smoker is 14.5 years. 
Every day, more than 4000 kids try their first cigarette and about half 
become addicted to tobacco. Nicotine and other tobacco products have 
become a pediatric disease. H.R. 1108 would help prevent these 
potentially deadly products from getting into the hands of children and 
youth.
  This legislation would give the Food and Drug Administration (FDA) 
the power to regulate the manufacture, distribution and sale of tobacco 
products, authorities needed to safeguard the public health and our 
children. In addition, H.R. 1108 would lessen the cost of smoking-
related medical illnesses and prevent adolescents and teens from 
smoking at a young age. The fact that the tobacco industry is now 
advertising a new generation of products with unproven claims that they 
are less harmful makes the need for FDA oversight even more urgent.
  I am very proud that the State of Illinois has already taken measures 
to curb the effects of smoking on the public. I also appreciate the 
efforts that the Illinois Academy of Family Physicians have taken to 
educate the public and Congress about the dangers of smoking. Already, 
the Academy's ``Tar Wars'' campaign has had clear and successful 
results. I see it in the drawing of Alexandra Slane, an elementary 
school grader from Peoria, who won the Illinois Tar Wars annual poster 
contest. Her drawing of a human-shaped light bulb is captioned with a 
warning to America, ``Be Bright Don't Light!'' Let us all be bright--
let us pass H.R. 1108 and act to improve the Nation's health.
  Mr. DINGELL. Madam Speaker, I submit the following exchange of 
letters for the Record.

                                         House of Representatives,


                                   Committee on the Judiciary,

                                    Washington, DC, June 18, 2008.
     Hon. John Dingell, 
     Chairman, Committee on Energy and Commerce, U.S. House of 
         Representatives, Washington, DC.
       Dear Chairman Dingell: This is to advise you that, as a 
     result of your working with us to make appropriate revisions 
     to provisions in H.R. 1108, the ``Family Smoking Prevention 
     and Tobacco Control Act,'' that fall within the rule X 
     jurisdiction of the Committee on the Judiciary, we are able 
     to agree to discharging our committee from further 
     consideration of the bill in order that it may proceed 
     without delay to the House floor for consideration.
       The Judiciary Committee takes this action with the 
     understanding that by foregoing further consideration of H.R. 
     1108 at this time, we do not waive any jurisdiction over 
     subject matter contained in this or similar legislation. We 
     also reserve the right to seek appointment of an appropriate 
     number of conferees to any House-Senate conference involving 
     this important legislation, and request your support if such 
     a request is made.
       I would appreciate your including this letter in the 
     Congressional Record during consideration of the bill on the 
     House floor. Thank you for your attention to this request, 
     and for the cooperative relationship between our two 
     committees.
           Sincerely,
                                                John Conyers, Jr.,
                                                         Chairman.
                                  ____
                                  
                                         House of Representatives,


                             Committee on Energy and Commerce,

                                    Washington, DC, June 19, 2008.
     Hon. John Conyers, Jr.,
     Chairman, Committee on the Judiciary,
     Washington, DC.
       Dear Mr. Chairman: Thank you for your letter regarding H.R. 
     1108, the ``Family Smoking Prevention and Tobacco Control 
     Act''. The letter noted that certain provisions of the bill 
     are within the jurisdiction of the Committee on the Judiciary 
     under rule X of the Rules of the House.
       The Committee on Energy and Commerce recognizes the 
     jurisdictional interest of the Committee on the Judiciary in 
     those provisions, and we appreciate your input on drafting 
     issues related to those provisions. We further appreciate 
     your agreement to forgo action on the bill, and I concur that 
     the agreement does not in any way prejudice the Committee on 
     the Judiciary with respect to the appointment of conferees or 
     its jurisdictional prerogatives on this bill or similar 
     legislation in the future.
       I will include our letters in the Congressional Record 
     during consideration of the bill on the House floor. Again, I 
     appreciate your cooperation regarding this important 
     legislation.
           Sincerely,
                                                  John D. Dingell,
                                                         Chairman.
                                  ____
                                  
                                         House of Representatives,


                                  Committee on Ways and Means,

                                    Washington, DC, July 24, 2008.
     Hon. John Dingell,
     Chairman, Committee on Energy and Commerce, Washington, DC.
       Dear Chairman Dingell: I am writing to confirm our 
     understanding on H.R. 1108, the

[[Page 17326]]

     ``Family Smoking Prevention and Tobacco Control Act.'' The 
     report (110-762) on the bill was recently filed by the 
     Committee on Energy and Commerce. As you are aware, the 
     Committee on Ways and Means believes that the amount of money 
     raised by the assessment of the user fee in H.R. 1108 is more 
     than the amount of money being made available to the 
     Secretary of Health and Human Services (HHS) for the 
     regulation of tobacco.
       The version of H.R. 1108 recommended by the Committee on 
     Energy and Commerce contains two sets of funding numbers, one 
     set is the number raised by the user fee (the assessment) and 
     the second number is the amount available to the Secretary of 
     Health and Human Services for administering the regulation of 
     tobacco. Clearly, the amount of money raised via the 
     assessment in Section 920, 4(c)(1), is greater than the 
     amount being made available for the regulated activity in 
     Section 920 (b)(2).
       The Committee on Ways and Means believes that this violates 
     both the Speaker's guidelines of January 3, 1991 on the 
     treatment of user fees and taxes under clause 5(a) of Rule 
     XXI, which provides that the money raised by a user fee 
     should be used solely for the regulatory activity and raises 
     revenue generally, a matter within the jurisdiction of the 
     Committee on Ways and Means under Rule X.
       The extra money being raised is above the funding being 
     made available to the FDA for tobacco regulation and, since 
     the bill forbids the funds from being spent on anything other 
     than tobacco regulation, would in fact revert back to the 
     general fund of the U.S. Treasury. The version of the bill 
     recommended by the Committee on Energy and Commerce would 
     then be financing the costs of government generally, which is 
     clearly the jurisdiction of the Committee on Ways and Means.
       My staff on the Committee on Ways and Means has been in 
     contact with your staff, and there is an understanding that 
     you agree that the bill will not come to the Floor in its 
     current form, but rather that there will be an Amendment in 
     the Nature of a Substitute that will be submitted to the 
     Committee on Rules that removes the 6% add-on from the 
     underlying user fee, and replaces it in a way that does not 
     negatively impact the jurisdiction of the Committee on Ways 
     and Means.
       In addition to the funding issue, H.R. 1108 includes a 
     prohibition against the use of clove to create a 
     characterizing flavor in cigarettes. The Committee on Ways 
     and Means believes this provision to be within its 
     jurisdiction because all clove-flavored cigarettes currently 
     sold in the United States are imported. I understand that you 
     recognize our jurisdictional interest in this question, given 
     its effects on trade and customs revenues.
       As part of our ongoing understanding regarding H.R. 1108, 
     the Committee on Ways and Means has agreed to forgo any 
     action on this bill as long as our jurisdictional 
     prerogatives are being respected. This is being done with the 
     understanding that it does not in any way prejudice the 
     Committee with respect to any further jurisdictional 
     questions on similar legislation in the future.
       In addition, if a House-Senate conference is convened on 
     H.R. 1108 or similar legislation, the Committee on Ways and 
     Means understands that you will support my request for an 
     appropriate number of Conferees to enable the Committee on 
     Ways and Means to protect its jurisdictional interests on 
     substantive issues.
       I would appreciate your response to this letter, confirming 
     this understanding with respect to H.R. 1108, and would ask 
     that a copy of our exchange of letters on this matter be 
     included in the Congressional Record.
           Sincerely,
                                                Charles B. Rangel,
     Chairman.
                                  ____

                                         House of Representatives,


                             Committee on Energy and Commerce,

                                    Washington, DC, July 25, 2008.
     Hon. Charles B. Rangel,
     Chairman, Committee on Ways and Means,
     Washington, DC.
       Dear Chairman Rangel: I write regarding H.R. 1108, the 
     Family Smoking Prevention and Tobacco Control Act. Thank you 
     for your letter to me in which you expressed the 
     jurisdictional interest of the Committee on Ways and Means in 
     certain provisions of the reported bill.
       The bill provides for the regulation of tobacco products by 
     the Food and Drug Administration (FDA). The Congressional 
     Budget Office estimates that regulatory activities under the 
     bill would curtail the consumption of tobacco products, thus 
     reducing Federal revenues by a net amount of approximately 
     $364 million over a 10 year period.
       The bill reported by the Committee on Energy and Commerce 
     contains a program under which the tobacco industry pays user 
     fees. The bill pays for its $364 million net cost by 
     proportionally increasing the user fee. In other words, the 
     reported bill complies with Pay-As-You-Go requirements by 
     charging the tobacco industry the additional cost of the 
     legislation. This additional charge increases the user fee by 
     approximately 6 percent.
       This 6 percent add-on is not available to FDA, but rather 
     is deposited in the general fund of the Treasury. I 
     acknowledge that the Committee on Ways and Means has 
     jurisdiction over the provisions of the bill that concern the 
     6 percent add-on. I appreciate that the Committee on Ways and 
     Means did not exercise its right to a sequential referral of 
     the bill regarding the add-on, and you have my commitment 
     that the version of the bill the Committee on Energy and 
     Commerce prepares for the House floor will not include any 
     add-on to the user fees for the purpose of meeting Pay-As-
     You-Go requirements.
       You also have expressed concerns about the provision in the 
     bill that prohibits the use of clove to create a 
     characterizing flavor in cigarettes. I acknowledge your 
     concerns and understand that the Committee on Ways and Means 
     has jurisdiction over import bans because of the effects on 
     trade and on customs revenues. The Committee on Ways and 
     Means did not seek a sequential referral of the bill on the 
     basis of the clove provision. Again, I appreciate your 
     cooperation.
       I agree that the decision to forgo a sequential referral of 
     the bill does not in any way prejudice the Committee on Ways 
     and Means with respect to any further jurisdictional 
     questions on similar legislation in the future or with 
     respect to the appointment of conferees. If a House-Senate 
     conference is convened on H.R. 1108 or similar legislation, I 
     would support a request by the Committee on Ways and Means 
     for an appropriate number of conferees with respect to 
     provisions within its jurisdiction.
       Per your request, I will include copies of our exchange of 
     letters on these matters in the Congressional Record. I 
     appreciate your cooperative attitude regarding the intent of 
     the Committee on Energy and Commerce to consider this 
     landmark public health legislation on the House floor 
     expeditiously.
           Sincerely,
                                                  John D. Dingell,
     Chairman.
                                  ____

                                         House of Representatives,


                               Committee on Natural Resources,

                                    Washington, DC, July 30, 2008.
     Hon. John Dingell,
     Chairman, Committee on Energy and Commerce,
     Washington, DC.
       Dear Mr. Chairman: Thank you for the opportunity to work 
     with you on changes to H.R. 1108, the Family Smoking 
     Prevention and Tobacco Control Act, regarding provisions in 
     the bill dealing with Indian tribes which are within the 
     jurisdiction of the Committee on Natural Resources.
       Because of the cooperation and consideration that you have 
     afforded me and my staff in developing these changes to the 
     bill, I did not insist on a sequential referral of H.R. 1108 
     even though the legislation included language within the 
     jurisdiction of the Committee on Natural Resources. Of 
     course, this waiver does not prejudice any existing or future 
     jurisdictional claims over these provisions or similar 
     language. I also reserve the right to seek to have conferees 
     named from the Committee on Natural Resources on these 
     provisions, and request your support if such a request is 
     made.
       I would ask that you place this letter into the 
     Congressional Record during consideration of the measure on 
     the House floor.
  Thank you for the cooperative spirit in which you have worked 
regarding this matter and others between our respective committees.
       With warm regards, I am
           Sincerely,
                                               Nick J. Rahall, II,
     Chairman, Committee on Natural Resources.
                                  ____

                                         House of Representatives,


                             Committee on Energy and Commerce,

                                    Washington, DC, July 30, 2008.
     Hon. Nick J. Rahall II,
     Chairman, Committee on Natural Resources, House of 
         Representatives, Washington, DC.
       Dear Chairman Rahall: I write regarding H.R. 1108, the 
     Family Smoking Prevention and Tobacco Control Act. The bill 
     provides for the regulation of tobacco products by the Food 
     and Drug Administration (FDA).
       The bill reported by the Committee on Energy and Commerce 
     requires the the Secretary of Health and Human Services to 
     ensure that the provisions of the bill, the amendments made 
     by the bill, and the implementing regulations are enforced 
     with respect to the United States and Indian tribes. I 
     acknowledge the jurisdictional interest of the Committee on 
     Natural Resources in this requirement as it relates to Indian 
     tribes, and I appreciate that the Committee did not exercise 
     its right to a sequential referral of the bill.
       I agree with you that the decision to forgo a sequential 
     referral of the bill does not in any way prejudice the 
     Committee on Natural Resources with respect to its 
     jurisdictional prerogatives, including the appointment of 
     conferees, on this bill or similar legislation in the future.
       I will include this letter in the Congressional Record 
     during consideration of the bill on the House floor. I 
     appreciate your cooperative attitude regarding this landmark 
     public health legislation.
           Sincerely,
                                                  John D. Dingell,
                                                         Chairman.

  Mr. STARK. Madam Speaker, tobacco use is the Nation's leading cause 
of preventable death, and, without aggressive help from Congress, will 
continue to be in the foreseeable

[[Page 17327]]

future. That is why I rise today in strong support of the family 
Smoking Prevention and Tobacco Control Act, a bill that will give the 
FDA extensive new authority to regulate tobacco products.
  I am alarmed by CDC reports that state that 8.6 million Americans 
have a serious illness caused by smoking, and that close to 440,000 
people in the United States die prematurely from either smoking or 
contact with secondhand smoke. However, I am particularly shocked by 
statistics that demonstrate that smoking rates among high school 
students stayed the same from 2003-2007. With all the awareness 
campaigns targeted toward youth, this rate should have dropped. These 
statistics are unacceptable, and it is clear that Congress needs to 
step in.
  The Family Smoking Prevention and Tobacco Control Act allows the FDA, 
among other things, to restrict tobacco advertising and promotions to 
children, force manufacturers to obtain approval before making reduced-
risk product claims, form standards to reduce or eliminate toxic 
chemicals within tobacco products, and recall unreasonably harmful 
tobacco products. This piece of legislation is a long sought after 
bipartisan compromise.
  I trust that my colleagues will join me in supporting this bill. 
Tobacco does not just affect individuals who smoke; it affects our 
children's futures and the economic prospects of our Nation. Each year 
because of tobacco use we lose more than $96 billion in medical costs 
and $97 billion as a consequence of lost productivity. It's time for us 
to stamp out this burning cigarette, and voting for the Family Smoking 
Prevention and Tobacco Control Act will be the first step.
  Ms. DeLAURO. Madam Speaker, I rise in support of H.R. 1108, the 
Family Smoking Prevention and Tobacco Control Act. This legislation 
would grant the Food and Drug Administration (FDA) long-needed 
authority to regulate the manufacture, sale, distribution and marketing 
of tobacco products.
  As we all know, tobacco use contributes to the death of more than 
400,000 Americans and costs the nation's health care system nearly $100 
billion each year. The most tragic part of this statistic is that 
virtually all of these deaths are preventable. It is alarming that 
preventable diseases such as emphysema, heart disease and cancer all 
can be attributed to the use of tobacco.
  In addition to providing consumers with science-based information 
about tobacco products, granting FDA the authority to regulate tobacco 
will more importantly help protect our children from using these 
products. Approximately 90 percent of all adult smokers began their 
habit while in their teens, or earlier, and two-thirds become regular, 
daily smokers before they reach the age of 19. According to the 
American Medical Association, each day, about 4,000 children try 
smoking a cigarette for the first time and another 1,000 become new, 
regular, daily smokers. This means that one-third of these children 
will die prematurely.
  Despite their claims to the contrary, the tobacco companies continue 
to market their products aggressively toward children. This bill will 
give FDA the authority to impose marketing restrictions, labeling 
requirements, as well as to ban candy flavored tobacco products in 
order to prevent tobacco companies from addicting children to tobacco.
  I am also pleased that the bill before us includes language that 
maintains the same role of the Appropriations Committee with regard to 
the fees in this bill that the Committee has with regard to other FDA 
user fees.
  This bill has strong bipartisan support, and is endorsed by key 
groups including the American Cancer Society, the American Medical 
Association, the American Heart Association, the American Lung 
Association, and Campaign for Tobacco-Free Kids.
  I urge my colleagues to support this bill.
  Ms. FOXX. Madam Speaker, I strongly oppose this 190-page bill, 
hastily offered under suspension of the rules, which establishes a new 
Federal authority for the regulation of the tobacco industry. This 
legislation adds another layer of bureaucracy to the already 
overburdened Food and Drug Administration, and another layer of 
regulation to American consumers' lives.
  This bill includes more than $5 billion in new tax increases on 
tobacco companies and gives sweeping control of the tobacco market to 
the FDA. Chairman Dingell, discussing the recent salmonella outbreak, 
was recently quoted in the Wall Street Journal as saying that ``there's 
a total inability of the FDA to carry out its mission.'' This isn't the 
first Democrat to raise questions about the effectiveness of the FDA. 
Thus, it is highly hypocritical of them to extend the agency's 
regulatory authority to a multi-billion dollar industry of which the 
FDA has no expertise.
  Furthermore, as FDA Commissioner Andrew von Eschenbach testified 
before the House Energy and Commerce Committee in October 2007, the FDA 
is an agency intended to promote and protect the public health. In the 
Commissioner's opinion, requiring the FDA to ``approve'' tobacco 
products as a result of this bill would dramatically change the 
agency's focus. Mr. von Eschenbach stated, ``Associating any agency 
whose mission is to promote public health with the approval of 
inherently dangerous products would undermine its mission and likely 
have perverse incentive effects.''
  While establishing FDA authority to regulate tobacco products, this 
bill would also retain the FTC's Federal authority to regulate tobacco 
advertising and circulation. It would provide only limited pre-emption 
of State laws, allowing more rigid State restrictions on tobacco 
advertising. These multiple layers of regulation will impose undue 
bureaucratic and logistical hardships on tobacco manufacturers. It is 
important to remember that the sale of tobacco, according to current 
law and expressly reinforced in this bill, is legal in the United 
States and can be credited with hundreds of thousands of jobs across 
the country.
  As Department of Health and Human Services Secretary Leavitt noted, 
this legislation could also be viewed by foreign governments as a 
hostile trade action. Many of the clove and other flavored cigarettes 
that are banned under this bill are manufactured in foreign countries. 
However, this bill expressly permits production of menthol cigarettes. 
This could lead Indonesia or other foreign governments to file 
complaints at the World Trade Organization claiming discrimination 
against their products. Ultimately, retaliatory measures could be taken 
against American-made products, which could lead to unnecessary trade 
disputes with a negative effect on economic growth.
  Finally, this legislation would have little impact on overall tobacco 
use. If this bill is enacted, the Congressional Budget Office has 
estimated that smoking by adults would decline only by 2 percent after 
10 years. This marginal reduction does not warrant this legislation's 
significant intrusion on free speech rights and expansion of 
government-run regulatory bureaucracy. Therefore, I strongly oppose 
this bill and urge my colleagues to vote against it.
  Mr. PALLONE. I yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Michigan (Mr. Dingell) that the House suspend the rules 
and pass the bill, H.R. 1108, as amended.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Mr. BARTON of Texas. Madam Speaker, I object to the vote on the 
ground that a quorum is not present and make the point of order that a 
quorum is not present.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the 
Chair's prior announcement, further proceedings on this motion will be 
postponed.
  The point of no quorum is considered withdrawn.

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