[Congressional Record (Bound Edition), Volume 155 (2009), Part 11]
[House]
[Pages 14909-14941]
[From the U.S. Government Publishing Office, www.gpo.gov]




           FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

  Mr. WAXMAN. Madam Speaker, pursuant to House Resolution 532, I call 
up from the Speaker's table the bill (H.R. 1256) to protect the public 
health by providing the Food and Drug Administration with certain 
authority to regulate tobacco products, to amend title 5, United States 
Code, to make certain modifications in the Thrift Savings Plan, the 
Civil Service Retirement System, and the Federal Employees' Retirement 
System, and for other purposes, with a Senate amendment thereto, and I 
have a motion at the desk.
  The Clerk read the title of the bill.
  The SPEAKER pro tempore. The Clerk will designate the Senate 
amendment.
  The text of the Senate amendment is as follows:

       Senate amendment:
       Strike all after the enacting clause and insert the 
     following:

     DIVISION A--FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.
Sec. 6. Modification of deadlines for Secretarial action.

         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. Enforcement action plan for advertising and promotion 
              restrictions.
Sec. 106. Studies of progress and effectiveness.

 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.

     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.

[[Page 14910]]

       (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. 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 division.
       (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) 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).
       (48) 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).

[[Page 14911]]

       (49) 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 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 division 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 division;
       (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 division (or an 
     amendment made by this division) 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 
     division (or an amendment made by this division) 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 division 
     (or an amendment made by this division) 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 division, of the amendments made 
     by this division, or of the regulations promulgated under 
     this division (or under such amendments), or the application 
     of any such provision to any person or circumstance is held 
     to be invalid, the remainder of this division, such 
     amendments and such regulations, and the application of such 
     provisions to any other person or circumstance shall not be 
     affected and shall continue to be enforced to the fullest 
     extent possible.

     SEC. 6. MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION.

       (a) Delayed Commencement of Dates for Secretarial Action.--
       (1) In general.--Except as provided in subsection (c), with 
     respect to any time periods specified in this division (or in 
     an amendment made by this division) that begin on the date of 
     enactment of this Act, within which the Secretary of Health 
     and Human Services is required to carry out and complete 
     specified activities, the calculation of such time periods 
     shall commence on the date described in subsection (b).
       (2) Limitation.--Subsection (a) shall only apply with 
     respect to obligations of the Secretary of Health and Human 
     Services that must be completed within a specified time 
     period and shall not apply to the obligations of any other 
     person or to any other provision of this division (including 
     the amendments made by this division) that do not create such 
     obligations of the Secretary and are not contingent on 
     actions by the Secretary.
       (b) Date Described.--The date described in this subsection 
     is the first day of the first fiscal quarter following the 
     initial 2 consecutive fiscal quarters of fiscal year 2010 for 
     which the Secretary of Health and Human Services has 
     collected fees under section 919 of the Federal Food, Drug, 
     and Cosmetic Act (as added by section 101).
       (c) Exception.--Subsection (a) shall not apply to any time 
     period (or date) contained--
       (1) in section 102, except that the reference to ``180 
     days'' in subsection (a)(1) of such section shall be deemed 
     to be ``270 days''; and
       (2) in sections 201 through 204 (or the amendments made by 
     any such sections).
       (d) Adjustment.--The Secretary of Health and Human Services 
     may extend or reduce the duration of one or more time periods 
     to which subsection (a) applies if the Secretary determines 
     appropriate, except that no such period shall be extended for 
     more than 90 days.

         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 shall 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 country.--The term `Indian country' has the 
     meaning given such term in section 1151 of title 18, United 
     States Code.
       ``(10) 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.
       ``(11) 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.
       ``(12) Nicotine.--The term `nicotine' means the chemical 
     substance named 3-(1-Methyl-2-

[[Page 14912]]

     pyrrolidinyl) pyridine or C[10]H[14]N[2], including any salt 
     or complex of nicotine.
       ``(13) 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.
       ``(14) 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.
       ``(15) 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.
       ``(16) 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.
       ``(17) 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.
       ``(18) 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.
       ``(19) State; territory.--The terms `State' and `Territory' 
     shall have the meanings given to such terms in section 201.
       ``(20) 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.
       ``(21) 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.
       ``(22) 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 the Family Smoking Prevention 
     and Tobacco Control Act, 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;

[[Page 14913]]

       ``(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--
       ``(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 to ensure that such 
     statements do not violate the misbranding provisions of 
     subsection (a) and that such statements comply with other 
     provisions of the Family Smoking Prevention and Tobacco 
     Control Act (including the amendments made by such Act). 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 the 
     Family Smoking Prevention and Tobacco Control 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 such date of enactment, 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 such date of enactment 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 enactment of the Family Smoking Prevention and 
     Tobacco Control 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

[[Page 14914]]

     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.
       ``(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.
       ``(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,

[[Page 14915]]

     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 the 
     Family Smoking Prevention and Tobacco Control Act, 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.--
       ``(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.--Beginning 2 years after the 
     date of enactment of the Family Smoking Prevention and 
     Tobacco Control Act, a tobacco product manufacturer shall not 
     use tobacco, including foreign grown tobacco, that contains a 
     pesticide chemical residue that is at a level greater than is 
     specified by any tolerance

[[Page 14916]]

     applicable under Federal law to domestically grown tobacco.
       ``(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, the Secretary shall--
       ``(A) if the Secretary determines that the standard would 
     be appropriate for the protection of the public health, 
     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 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.

[[Page 14917]]

       ``(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 
     children, 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.
       ``(f) Dissolvable Tobacco Products.--
       ``(1) Referral; considerations.--The Secretary shall refer 
     to the Tobacco Products Scientific Advisory Committee for 
     report and recommendation, under section 917(c)(4), the issue 
     of the nature and impact of the use of dissolvable tobacco 
     products on the public health, including such use among 
     children. In its review, the Tobacco Products Scientific 
     Advisory Committee shall address the considerations listed in 
     subsection (a)(3)(B)(i).
       ``(2) Report and recommendation.--Not later than 2 years 
     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 at 
     any time applicable to any dissolvable tobacco product.

     ``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 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

[[Page 14918]]

     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 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

[[Page 14919]]

     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--
       ``(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;

[[Page 14920]]

       ``(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 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

[[Page 14921]]

       ``(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 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

[[Page 14922]]

     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 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--

[[Page 14923]]

       ``(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 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 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, subject to paragraph (2)(D). 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 (referred 
     to in this subsection as `tobacco regulation activities'), 
     except that such fees may be used for the reimbursement 
     specified in subparagraph (C).
       ``(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 tobacco regulation activities.
       ``(ii) Startup costs.--Clause (i) does not apply until 
     October 1, 2009. Until such date, any amounts available to 
     the Food and Drug Administration (excluding user fees) shall 
     be available and allocated as needed to pay the costs of 
     tobacco regulation activities.
       ``(C) Reimbursement of start-up amounts.--
       ``(i) In general.--Any amounts allocated for the start-up 
     period pursuant to subparagraph (B)(ii) shall be reimbursed 
     through any appropriated fees collected under subsection (a), 
     in such manner as the Secretary determines appropriate to 
     ensure that such allocation results in no net change in the 
     total amount of funds otherwise available, for the period 
     from October 1, 2008, through September 30, 2010, for Food 
     and Drug Administration programs and activities (other than 
     tobacco regulation activities) for such period.
       ``(ii) Treatment of reimbursed amounts.--Amounts reimbursed 
     under clause (i) shall be available for the programs and 
     activities for which funds allocated for the start-up period 
     were available, prior to such allocation, until September 30, 
     2010, notwithstanding any otherwise applicable limits on 
     amounts for such programs or activities for a fiscal year.
       ``(D) Fee collected during start-up period.--
     Notwithstanding the first sentence of

[[Page 14924]]

     paragraph (1), fees under subsection (a) may be collected 
     through September 30, 2009 under subparagraph (B)(ii) and 
     shall be available for obligation and remain available until 
     expended. Such offsetting collections shall be credited to 
     the salaries and expenses account of the Food and Drug 
     Administration.
       ``(E) Obligation of start-up costs in anticipation of 
     available fee collections.--Notwithstanding any other 
     provision of law, following the enactment of an appropriation 
     for fees under this section for fiscal year 2010, or any 
     portion thereof, obligations for costs of tobacco regulation 
     activities during the start-up period may be incurred in 
     anticipation of the receipt of offsetting fee collections 
     through procedures specified in section 1534 of title 31, 
     United States Code.
       ``(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 
     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).''.
       (c) Conforming Amendment.--Section 9(1) of the 
     Comprehensive Smokeless Tobacco Health Education Act of 1986 
     (15 U.S.C. 4408(i)) is amended to read as follows:
       ``(1) The term `smokeless tobacco' has the meaning given 
     such term by section 900(18) of the Federal Food, Drug, and 
     Cosmetic 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 
     division; 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 division and the amendments made by this division;
       (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) include such modifications to section 897.30(b), if 
     any, that the Secretary determines are appropriate in light 
     of governing First Amendment case law, including the decision 
     of the Supreme Court of the United States in Lorillard 
     Tobacco Co. v. Reilly (533 U.S. 525 (2001));
       (F) become effective on the date that is 1 year after the 
     date of enactment of this Act; and
       (G) 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 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;
       ``(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 division, the amendments made by this division, 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:

[[Page 14925]]

       (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 915;
       ``(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.
       ``(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) Making any express or implied statement or 
     representation directed to consumers with respect to a 
     tobacco product, in a label or labeling or through the media 
     or advertising, that either conveys, or misleads or would 
     mislead consumers into believing, that--
       ``(1) the product is approved by the Food and Drug 
     Administration;
       ``(2) the Food and Drug Administration deems the product to 
     be safe for use by consumers;
       ``(3) the product is endorsed by the Food and Drug 
     Administration for use by consumers; or
       ``(4) the product is safe or less harmful by virtue of--
       ``(A) its regulation or inspection by the Food and Drug 
     Administration; or
       ``(B) its compliance with regulatory requirements set by 
     the Food and Drug Administration;
     including any such statement or representation rendering the 
     product misbranded under section 903.''.
       (c) Section 303.--Section 303(f) (21 U.S.C. 333(f)) is 
     amended--
       (1) in paragraph (5)--
       (A) by striking ``paragraph (1), (2), (3), or (4)'' each 
     place such appears and inserting ``paragraph (1), (2), (3), 
     (4), or (9)'';
       (B) 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,'';
       (C) 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
       (D) by adding at the end the following:
       ``(D) The Secretary may compromise, modify, or terminate, 
     with or without conditions, any no-tobacco-sale order.'';
       (2) 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
       (3) 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.
       ``(9) Civil Monetary Penalties for Violation of Tobacco 
     Product Requirements.--
       ``(A) In general.--Subject to subparagraph (B), any person 
     who violates a requirement of this Act which relates to 
     tobacco products shall be liable to the United States for a 
     civil penalty in an amount not to exceed $15,000 for each 
     such violation, and not to exceed $1,000,000 for all such 
     violations adjudicated in a single proceeding.
       ``(B) Enhanced penalties.--
       ``(i) Any person who intentionally violates a requirement 
     of section 902(5), 902(6), 904, 908(c), or 911(a), shall be 
     subject to a civil monetary penalty of--
       ``(I) not to exceed $250,000 per violation, and not to 
     exceed $1,000,000 for all such violations adjudicated in a 
     single proceeding; or
       ``(II) in the case of a violation that continues after the 
     Secretary provides written notice to such person, $250,000 
     for the first 30-day period (or any portion thereof) that the 
     person continues to be in violation, and such amount shall 
     double for every 30-day period thereafter that the violation 
     continues, not to exceed $1,000,000 for any 30-day period, 
     and not to exceed $10,000,000 for all such violations 
     adjudicated in a single proceeding.
       ``(ii) Any person who violates a requirement of section 
     911(g)(2)(C)(ii) or 911(i)(1), shall be subject to a civil 
     monetary penalty of--
       ``(I) not to exceed $250,000 per violation, and not to 
     exceed $1,000,000 for all such violations adjudicated in a 
     single proceeding; or
       ``(II) in the case of a violation that continues after the 
     Secretary provides written notice to such person, $250,000 
     for the first 30-day period (or any portion thereof) that the 
     person continues to be in violation, and such amount shall 
     double for every 30-day period thereafter that the violation 
     continues, not to exceed $1,000,000 for any 30-day period, 
     and not to exceed $10,000,000 for all such violations 
     adjudicated in a single proceeding.
       ``(iii) In determining the amount of a civil penalty under 
     clause (i)(II) or (ii)(II), the Secretary shall take into 
     consideration whether the person is making efforts toward 
     correcting the violation of the requirements of the section 
     for which such person is subject to such civil penalty.''.
       (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''.

[[Page 14926]]

       (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 country 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 striking ``devices, or cosmetics'' each place it 
     appears and inserting ``devices, tobacco products, or 
     cosmetics'';
       (B) by striking ``or restricted devices'' each place it 
     appears and inserting ``restricted devices, or tobacco 
     products''; and
       (C) by striking ``and devices and subject to'' and all that 
     follows through ``other drugs or devices'' and inserting 
     ``devices, and tobacco products and subject to reporting and 
     inspection under regulations lawfully issued pursuant to 
     section 505 (i) or (k), section 519, section 520(g), or 
     chapter IX and data relating to other drugs, devices, or 
     tobacco products'';
       (2) in subsection (b), by inserting ``tobacco product,'' 
     after ``device,''; and
       (3) 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)--
       (A) by inserting ``tobacco product'' after ``drug, 
     device,''; and
       (B) by inserting ``, and a tobacco product intended for 
     export shall not be deemed to be in violation of section 
     906(e), 907, 911, or 920(a),'' before ``if it--''; 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--
       (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 (3) and (4) of section 903(a) of 
     the Federal Food, Drug, and Cosmetic Act (as amended by this 
     division) shall take effect on the date that is 12 months 
     after the date of enactment of this Act. The package label 
     requirements of paragraph (2) of such section 903(a) for 
     cigarettes shall take effect on the date that is 15 months 
     after the issuance of the regulations required by section 
     4(d) of the Federal Cigarette Labeling and Advertising Act 
     (15 U.S.C. 1333), as amended by section 201 of this division. 
     The package label requirements of paragraph (2) of such 
     section 903(a) for tobacco products other than cigarettes

[[Page 14927]]

     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 division) 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 enactment of 
     this Act, submit a report to the Congress on the results of 
     such study.

     SEC. 105. ENFORCEMENT ACTION PLAN FOR ADVERTISING AND 
                   PROMOTION RESTRICTIONS.

       (a) Action Plan.--
       (1) Development.--Not later than 6 months after the date of 
     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 division, or pursuant to section 102(a) of this 
     division, 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 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 division, or preserved by such entities under 
     section 916 of the Federal Food, Drug, and Cosmetic Act, as 
     added by section 101(b) of this division.
       (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.

     SEC. 106. STUDIES OF PROGRESS AND EFFECTIVENESS.

       (a) FDA Report.--Not later than 3 years after the date of 
     enactment of this Act, and not less than every 2 years 
     thereafter, the Secretary of Health and Human Services 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 
     concerning--
       (1) the progress of the Food and Drug Administration in 
     implementing this division, including major accomplishments, 
     objective measurements of progress, and the identification of 
     any areas that have not been fully implemented;
       (2) impediments identified by the Food and Drug 
     Administration to progress in implementing this division and 
     to meeting statutory timeframes;
       (3) data on the number of new product applications received 
     under section 910 of the Federal Food, Drug, and Cosmetic Act 
     and modified risk product applications received under section 
     911 of such Act, and the number of applications acted on 
     under each category; and
       (4) data on the number of full time equivalents engaged in 
     implementing this division.
       (b) GAO Report.--Not later than 5 years after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall conduct a study of, and submit to the Committees 
     described in subsection (a) a report concerning--
       (1) the adequacy of the authority and resources provided to 
     the Secretary of Health and Human Services for this division 
     to carry out its goals and purposes; and
       (2) any recommendations for strengthening that authority to 
     more effectively protect the public health with respect to 
     the manufacture, marketing, and distribution of tobacco 
     products.
       (c) Public Availability.--The Secretary of Health and Human 
     Services and the Comptroller General of the United States, 
     respectively, shall make the reports required under 
     subsection (a) and (b) available to the public, including by 
     posting such reports on the respective Internet websites of 
     the Food and Drug Administration and the Government 
     Accountability Office.

 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 the top 50 
     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
       ``(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.

[[Page 14928]]

       ``(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).
       ``(d) Graphic Label Statements.--Not later than 24 months 
     after the date of enactment of the Family Smoking Prevention 
     and Tobacco Control Act, the Secretary shall issue 
     regulations that require color graphics depicting the 
     negative health consequences of smoking to accompany the 
     label statements specified in subsection (a)(1). The 
     Secretary may adjust the type size, text and format of the 
     label statements specified in subsections (a)(2) and (b)(2) 
     as the Secretary determines appropriate so that both the 
     graphics and the accompanying label statements are clear, 
     conspicuous, legible and appear within the specified area.''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall take effect 15 months after the issuance of the 
     regulations required by subsection (a). 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 through 
     a rulemaking conducted under section 553 of title 5, United 
     States Code, may adjust the format, type size, color 
     graphics, and text of any of the label requirements, 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.
       ``(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

[[Page 14929]]

     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 other than cigarettes for introduction or 
     delivery for introduction into interstate commerce in the 
     United States shall bear the statement `sale only allowed in 
     the United States'. Beginning 15 months after the issuance of 
     the regulations required by section 4(d) of the Federal 
     Cigarette Labeling and Advertising Act (15 U.S.C. 1333), as 
     amended by section 201 of Family Smoking Prevention and 
     Tobacco Control Act, the label, packaging, and shipping 
     containers of cigarettes for introduction or delivery for 
     introduction into interstate commerce in 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 country 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,

[[Page 14930]]

     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.
       ``(e) Consultation.--In carrying out this section, the 
     Secretary shall consult with the Attorney General of the 
     United States and the Secretary of the Treasury, as 
     appropriate.''.

     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 
     such 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).

               DIVISION B--FEDERAL RETIREMENT REFORM ACT

     SEC. 100. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This division may be cited as the 
     ``Federal Retirement Reform Act of 2009''.
       (b) Table of Contents.--The table of contents for this 
     division is as follows:

               DIVISION B--FEDERAL RETIREMENT REFORM ACT

Sec. 100. Short title; table of contents.

      TITLE I--PROVISIONS RELATING TO FEDERAL EMPLOYEES RETIREMENT

Sec. 101. Short title.
Sec. 102. Automatic enrollments and immediate employing agency 
              contributions.
Sec. 103. Qualified Roth contribution program.
Sec. 104. Authority to establish mutual fund window.
Sec. 105. Reporting requirements.
Sec. 106. Acknowledgment of risk.
Sec. 107. Subpoena authority.
Sec. 108. Amounts in Thrift Savings Funds subject to legal proceedings.
Sec. 109. Accounts for surviving spouses.
Sec. 110. Treatment of members of the uniformed services under the 
              Thrift Savings Plan.

TITLE II--SPECIAL SURVIVOR INDEMNITY ALLOWANCE FOR SURVIVING SPOUSES OF 
                          ARMED FORCES MEMBERS

Sec. 201. Increase in monthly amount of special survivor indemnity 
              allowance for widows and widowers of deceased members of 
              the Armed Forces affected by required Survivor Benefit 
              Plan annuity offset for dependency and indemnity 
              compensation.

      TITLE I--PROVISIONS RELATING TO FEDERAL EMPLOYEES RETIREMENT

     SEC. 101. SHORT TITLE.

       This title may be cited as the ``Thrift Savings Plan 
     Enhancement Act of 2009''.

     SEC. 102. AUTOMATIC ENROLLMENTS AND IMMEDIATE EMPLOYING 
                   AGENCY CONTRIBUTIONS.

       (a) 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 Executive Director 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 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 not later than 
     the first full pay period following receipt of the election 
     by the appropriate processing entity; or
       ``(ii) decline automatic enrollment altogether.
       ``(D)(i) Except as provided in clause (ii), 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 becomes eligible to 
     contribute to the Thrift Savings Fund.
       ``(ii) Members of the uniformed services shall not be 
     eligible individuals for purposes of this paragraph.
       ``(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.''.
       (b) Technical Amendment.--Section 8432(b)(1) of title 5, 
     United States Code, is amended by striking the parenthetical 
     matter in subparagraph (B).

     SEC. 103. 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 Executive Director 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 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
       ``(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. 104. AUTHORITY TO ESTABLISH MUTUAL FUND 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 service that enables participants to invest in 
     mutual funds, if the Board authorizes the mutual fund 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 mutual 
     fund window under the Thrift Savings Plan if the Board 
     determines that such addition would be in the best interests 
     of participants.
       ``(B) The Board shall ensure that any expenses charged for 
     use of the mutual fund window are borne solely by the 
     participants who use such window.
       ``(C) The Board may establish such other terms and 
     conditions for the mutual fund window as the Board considers 
     appropriate to protect the interests of participants, 
     including requirements relating to risk disclosure.
       ``(D) The Board shall consult with the Employee Thrift 
     Advisory Council (established under section 8473) before 
     authorizing the addition of a mutual fund window or 
     establishing a service that enables participants to invest in 
     mutual funds.''.
       (c) Technical and Conforming Amendment.--Section 8438(d)(1) 
     of title 5, United States Code, is amended by inserting ``and 
     options'' after ``investment funds''.

     SEC. 105. 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 mutual fund window, the diversity demographics of any 
     company, investment adviser, or other entity retained to 
     invest and manage the assets of the Thrift Savings

[[Page 14931]]

     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) of 
     title 5, United States Code, 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 Board 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. 106. ACKNOWLEDGMENT 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 acknowledgment'' 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 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); or
       ``(III) for allowing a participant to invest through the 
     mutual fund window or for establishing restrictions 
     applicable to participants' ability to invest through the 
     mutual fund window.''.

     SEC. 107. SUBPOENA AUTHORITY.

       (a) In General.--Chapter 84 of title 5, United States Code, 
     is amended by inserting after section 8479 the following:

     ``Sec. 8480. Subpoena authority

       ``(a) In order to carry out the responsibilities specified 
     in this subchapter and subchapter III of this chapter, the 
     Executive Director may issue subpoenas commanding each person 
     to whom the subpoena is directed to produce designated books, 
     documents, records, electronically stored information, or 
     tangible materials in the possession or control of that 
     individual.
       ``(b) Notwithstanding any Federal, State, or local law, any 
     person, including officers, agents, and employees, receiving 
     a subpoena under this section, who complies in good faith 
     with the subpoena and thus produces the materials sought, 
     shall not be liable in any court of any State or the United 
     States to any individual, domestic or foreign corporation or 
     upon a partnership or other unincorporated association for 
     such production.
       ``(c) When a person fails to obey a subpoena issued under 
     this section, the district court of the United States for the 
     district in which the investigation is conducted or in which 
     the person failing to obey is found, shall on proper 
     application issue an order directing that person to comply 
     with the subpoena. The court may punish as contempt any 
     disobedience of its order.
       ``(d) The Executive Director shall prescribe regulations to 
     carry out subsection (a).''.
       (b) Technical and Conforming Amendment.--The table of 
     sections for chapter 84 of title 5, United States Code, is 
     amended by inserting after the item relating to section 8479 
     the following:

``8480. Subpoena authority.''.

     SEC. 108. AMOUNTS IN THRIFT SAVINGS FUNDS SUBJECT TO LEGAL 
                   PROCEEDINGS.

       Section 8437(e)(3) of title 5, United States Code, is 
     amended in the first sentence by striking ``or relating to 
     the enforcement of a judgment for the physically, sexually, 
     or emotionally abusing a child as provided under section 
     8467(a)'' and inserting ``the enforcement of an order for 
     restitution under section 3663A of title 18, forfeiture under 
     section 8432(g)(5) of this title, or an obligation of the 
     Executive Director to make a payment to another person under 
     section 8467 of this title''.

     SEC. 109. ACCOUNTS FOR SURVIVING SPOUSES.

       Section 8433(e) of title 5, United States Code, is 
     amended--
       (1) by inserting ``(1)'' after ``(e)''; and
       (2) by adding at the end the following:
       ``(2) Notwithstanding section 8424(d), if an employee, 
     Member, former employee, or former Member dies and has 
     designated as sole or partial beneficiary his or her spouse 
     at the time of death, or, if an employee, Member, former 
     employee, or former Member, dies with no designated 
     beneficiary and is survived by a spouse, the spouse may 
     maintain the portion of the employee's or Member's account to 
     which the spouse is entitled in accordance with the following 
     terms:
       ``(A) Subject to the limitations of subparagraph (B), the 
     spouse shall have the same withdrawal options under 
     subsection (b) as the employee or Member were the employee or 
     Member living.
       ``(B) The spouse may not make withdrawals under subsection 
     (g) or (h).
       ``(C) The spouse may not make contributions or transfers to 
     the account.
       ``(D) The account shall be disbursed upon the death of the 
     surviving spouse. A beneficiary or surviving spouse of a 
     deceased spouse who has inherited an account is ineligible to 
     maintain the inherited spousal account.
       ``(3) The Executive Director shall prescribe regulations to 
     carry out this subsection.''.

     SEC. 110. TREATMENT OF MEMBERS OF THE UNIFORMED SERVICES 
                   UNDER THE THRIFT SAVINGS PLAN.

       (a) Sense of Congress.--It is the sense of Congress that--
       (1) members of the uniformed services should have a 
     retirement system that is at least as generous as the one 
     which is available to Federal civilian employees; and
       (2) Federal civilian employees receive matching 
     contributions from their employing agencies for their 
     contributions to the Thrift Savings Fund, but the costs of 
     requiring such a matching contribution from the Department of 
     Defense could be significant.
       (b) Reporting Requirement.--Not later than 180 days after 
     the date of the enactment of this Act, the Secretary of 
     Defense shall report to Congress on--
       (1) the cost to the Department of Defense of providing a 
     matching payment with respect to contributions made to the 
     Thrift Savings Fund by members of the Armed Forces;
       (2) the effect that requiring such a matching payment would 
     have on recruitment and retention; and
       (3) any other information that the Secretary of Defense 
     considers appropriate.

TITLE II--SPECIAL SURVIVOR INDEMNITY ALLOWANCE FOR SURVIVING SPOUSES OF 
                          ARMED FORCES MEMBERS

     SEC. 201. INCREASE IN MONTHLY AMOUNT OF SPECIAL SURVIVOR 
                   INDEMNITY ALLOWANCE FOR WIDOWS AND WIDOWERS OF 
                   DECEASED MEMBERS OF THE ARMED FORCES AFFECTED 
                   BY REQUIRED SURVIVOR BENEFIT PLAN ANNUITY 
                   OFFSET FOR DEPENDENCY AND INDEMNITY 
                   COMPENSATION.

       (a) Payment Amount Per Fiscal Year.--Paragraph (2) of 
     section 1450(m) of title 10, United States Code, is amended--
       (1) in subparagraph (E), by striking ``and'' after the 
     semicolon; and
       (2) by striking subparagraph (F) and inserting the 
     following new subparagraphs:
       ``(F) for months during fiscal year 2014, $150;
       ``(G) for months during fiscal year 2015, $200;
       ``(H) for months during fiscal year 2016, $275; and
       ``(I) for months during fiscal year 2017, $310.''.
       (b) Duration.--Paragraph (6) of such section is amended--
       (1) by striking ``February 28, 2016'' and inserting 
     ``September 30, 2017''; and
       (2) by striking ``March 1, 2016'' both places it appears 
     and inserting ``October 1, 2017''.

                      Motion Offered by Mr. Waxman

  The SPEAKER pro tempore. The Clerk will report the motion.
  The Clerk read as follows:

       Mr. Waxman moves that the House concur in the Senate 
     amendment.

  The SPEAKER pro tempore. Pursuant to House Resolution 532, the motion 
shall be debatable for 1 hour, equally divided and controlled by the 
chairman and ranking minority member of the Committee on Energy and 
Commerce.
  The gentleman from California (Mr. Waxman) and the gentleman from 
Indiana (Mr. Buyer) each will control 30 minutes.
  The Chair recognizes the gentleman from California.
  Mr. WAXMAN. Madam Speaker, I yield myself such time as I may consume.
  It is hard to believe that we have finally reached this day. After 
more than a decade of effort and with countless delays and defeats 
along the way, at last we are about to enact truly historic legislation 
to protect the public health and to end the tobacco epidemic.
  I am proud that we have made it to this point, but it has taken us 
far too long. It has been more than 45 years since the landmark Surgeon 
General report that found that cigarette smoking was responsible for a 
70 percent increase in the mortality rate of smokers

[[Page 14932]]

over nonsmokers and a 10 to 20 times greater risk of developing lung 
cancer. Forty-five years. That delay is a tragic testament to the power 
and influence of Big Tobacco in our country and on Congress. But that 
power is fading. Times have changed. Public opinion has changed. And 
the tobacco industry's ability to block essential public health 
legislation has come to an end.
  Today is a day when strong and effective regulation finally is 
established as the crucial counterweight to the efforts and even 
deceptive practices of this industry. This is the day when Americans 
can begin to truly kick the habit with the full force of our laws 
marshaled to protect consumers, and especially our young people.
  Many of us remember vividly the milestones that have led us to this 
moment. In 1994, tobacco executives stood up before my subcommittee and 
swore under oath that nicotine was not addictive. In 1996, the FDA 
tried to regulate tobacco products, but the Supreme Court told them 
they needed Congress to give them that specific legal authority. And 
now, 13 years later, here we are finally giving FDA that authority to 
regulate the leading preventable cause of death in America.
  Regulating tobacco is the single most important thing that we can do 
right now to curb this deadly toll. And FDA is the only agency with the 
right combination of scientific expertise, regulatory experience, and 
public health mission to oversee these products effectively.
  I am pleased that the Senate acted quickly and sent us back 
legislation nearly identical to what we passed 2 months ago with 
overwhelming support in this House. This legislation will direct FDA to 
end marketing and sales of tobacco to kids, to stop manufacturers from 
calling cigarettes ``light'' or ``less dangerous'' when they're not, 
and to require changes to what is in a cigarette, like toxic 
ingredients such as formaldehyde, benzene, radioactive elements, and 
other deadly chemicals.
  Some have objected that this bill is too big a challenge for an 
already overburdened FDA. I disagree. It's clear to me that FDA's 
recent struggles are primarily a result of years of chronic 
underfunding and a failure of leadership in the last administration.
  This history does not mean that FDA, with the strong and committed 
leadership it now has, cannot take on this critical role of protecting 
the country against the harm from cigarettes and other tobacco 
products. It simply means that when we give the agency this new 
responsibility, we must also give it the resources necessary to do the 
job and to do it well.
  We have ensured that this will happen. The tobacco program will be 
fully funded through new user fees paid for by the industry. That money 
will go exclusively to the new tobacco center and will be enough for 
FDA to handle this task well. Furthermore, by setting up this system, 
we have ensured that the new tobacco program will have no impact on 
other vital programs at FDA. In fact, the agency's new commissioner, 
Dr. Margaret Hamburg, has expressed her enthusiastic support for the 
bill as a ``major advance in protecting the public health.''
  In a recent letter to Senator Kennedy about this legislation, 
Commissioner Hamburg made clear that FDA is eager to begin carrying out 
its new responsibilities under this law. President Obama has also 
praised this legislation as both historic and common sense, describing 
it as an integral part of his plan to protect America's children and 
reform our health care system. It's clear that this administration and 
FDA itself are more than ready to take this on, and we just need to 
give them the law that will allow them to begin.
  In the bill, we have provided everything necessary to take this 
historic step: a comprehensive and flexible set of new authorities and 
full, certain funding. The final ingredient is the political will to do 
the right thing. For the first time in many years, we have finally got 
that, too.
  The breadth of support for this bill is remarkable; it includes over 
1,000 medical, public health, faith and community groups from AARP to 
the American Academy of Pediatrics, from the Southern Baptist 
Convention to the Islamic Society of North America. It is supported by 
the American Lung Association, the American Heart Association, the 
American Cancer Society, the groups that are best situated to 
understand the damage caused by tobacco and to recognize that a renewed 
FDA can and must take on this new authority.
  The diversity of support for this bill shows just how critical it is 
to all Americans. Tobacco does not discriminate when it robs people of 
their health, their productivity, and their lives. That is why we must 
come together to rob tobacco of its influence over Americans.
  Finally, I want to note that this bill reflects a number of changes 
made throughout the process to respond to specific concerns that we've 
heard. In committee consideration of this bill over the past 2 years, 
we made changes to ensure fairness and flexibility for convenience 
stores, tobacco growers, and small manufacturers. We worked with 
Republican colleagues to incorporate their suggestions. We worked with 
members of the Congressional Black Caucus to ensure that menthol 
cigarettes will be an early focus of attention by the agency, and that 
the agency has the authority to deal with these and other products.
  I know that the Senate also has made changes to further strengthen 
the bill in response to input from both sides of the aisle. I want to 
thank my colleague, Representative Todd Platts, for his strong 
leadership on this legislation, as well as Representatives John Dingell 
and Frank Pallone for their diligent work in moving this bill forward 
over the years.
  I also want to thank Representatives Ed Towns, Stephen Lynch and Ike 
Skelton, all of whom were critical in getting us to this point. Each of 
these individuals made this possible and produced a great victory for 
public health.
  Today is a tremendous day. I am proud to be part of this historic 
moment when Congress finally stands up to Big Tobacco and stands up for 
the health of all Americans. That is the task before us as we send this 
bill on to the President of the United States.
  Madam Speaker, I wish to reserve the balance of my time.
  Mr. BUYER. Madam Speaker, I yield myself such time as I may consume.
  I would like to congratulate Henry Waxman and Senator Kennedy and 
others with regard to their tenacity and persistence over the years. 
What is unfortunate is that we were not able to incorporate harm 
reduction strategies. It is also unfortunate that we are continuing to 
place more burdens and responsibilities upon FDA.
  What I had sought to do is to regulate tobacco. I do not smoke, I do 
not encourage anyone to smoke. The health risks associated with 
smoking, I believe people recognize them and are cognizant.
  Tobacco is an adult product. It's legal. And we are faced with this 
question of moralism versus pragmatism. And you have to be careful when 
you go down this path in weighing the balance of moralism versus 
pragmatism. So what I had sought to do was choose the pragmatic side of 
the equation and to incorporate a harm reduction strategy with the 
abstinence approach in the Kennedy-Waxman legislation.
  While the authors of the bill, Madam Speaker, would say, Well, Steve, 
we have harm reduction in the bill. Well, it is mentioned in the bill, 
but there is a 2-tier standard in the bill that has been cleverly 
written in a manner to be an entry barrier to new innovative tobacco 
products. And that 2-tier standard is one that first must be achieved 
at the individual level, and then you must achieve this standard at the 
public at large. And the purpose is truly an entry barrier.
  Now, if we wanted to work together and truly have a new scientific, 
pragmatic approach to improve the public health of our country, we 
would be doing both; we would be doing abstinence along with harm 
reduction. You see, that's exactly what Henry Waxman and others in this 
body do when it comes to teenage sex. They say, okay, by this body, 
Democrats and Republicans enjoin, we have both; we promote abstinence 
while also we have

[[Page 14933]]

policies that promote harm reduction in our efforts to lower sexually 
transmitted diseases.
  With regard to HIV, there are needle-exchange programs while we also 
try to promote abstinence. But all of a sudden now, when it comes to 
tobacco, approaches that we take in other forms of public health, 
whether it's in sanitary issues or whether it's in teenage sex issues 
or in HIV issues, all of a sudden we don't want to apply it to tobacco. 
It is a curious thing for me that we don't want to apply harm reduction 
strategies to tobacco.
  So I would say to my good friend, Mr. Waxman, I think where we are is 
that you can have your day in the light, you have earned it, but we are 
going to have to come back to the table because what we have done is we 
have locked down the marketplace. You have given a big checkmark to 
Phillip Morris and said that your market share is okay. And when you 
lock down the marketplace, and we then stifle innovation and we do not 
have competition in that marketplace, we truly don't have the ability, 
then, for these companies to track at-risk capital to make investments 
in a harm reduction strategy whereby we can migrate people down the 
continuum of risk.

                              {time}  1030

  So if this bill becomes law, we've got some real challenges in front 
of us. One of them is how do we stand up this new mission within FDA, 
an agency that is already very stressed and underresourced, and we're 
already going to be addressing issues in the committee regarding food 
safety and drug safety while we pile on more missions.
  So I would say to my good friend that as soon as this bill is signed 
into law, a couple of things are going to happen. Number one, the 
lawyers will make a run to the Federal courts, and the Supreme Court 
will be back sitting in judgment over the provisions on advertising 
restrictions, not only potential unconstitutional provisions on the 
First Amendment with regard to the regulation of commercial speech, but 
also in the Fifth Amendment with regard to whether it's a 
constitutional taking or not.
  So while that is going on, I will introduce legislation, I'll work 
with Ms. Harman, I'll work with others, I'll work with the chairman, on 
how we can best incorporate these harm-reduction strategies to truly 
improve public health.
  Madam Speaker, I embrace the sincerity of Mr. Waxman and Mr. Kennedy 
that they truly want to improve public health in the country, but this 
legislation, when we lock ourselves down to only what is presently 
available and that these nicotine replacement therapies only have a 7 
percent success rate, I don't believe anyone here would endorse a 7 
percent success rate as a good thing. It's failure. So we are going to 
have to go back to the drawing board here and figure out how we do a 
harm-reduction strategy to improve public health.
  Madam Speaker, I reserve the balance of my time.
  Mr. WAXMAN. Madam Speaker, I want to inform my colleagues that there 
is a section in this bill that gives the FDA authority to develop harm-
reduction strategies, and I think that's where it ought to be, in the 
hands of people who will follow the science in order to protect the 
public health.
  Madam Speaker, I yield, at this time, 2 minutes to the chairman of 
our Health Subcommittee of the Energy and Commerce Committee, who has 
been a staunch supporter of this legislation and has looked after all 
the health matters that come before the Congress, the gentleman from 
New Jersey (Mr. Pallone).
  Mr. PALLONE. I want to thank Chairman Waxman for his tireless work on 
this tobacco legislation. Madam Speaker, today is long overdue, and he 
should be so proud of the fact that this is finally passing today and 
going to the President's desk.
  As we pursue serious and historical health care reform, this 
legislation comes at the right time. Smoking kills. Smoking also is a 
major cause of cardiovascular disease, cancer, and a host of other 
illnesses. Almost half a million Americans die from their own cigarette 
smoking a year. And even more alarming, studies have estimated that 
more than 6 million children alive today will ultimately die from 
smoking.
  In President Obama's call for health care reform, he cited the need 
to use our resources wisely and efficiently. Tobacco is a health care 
issue that taxes and burdens our health care system. The costs to 
private and public payers are over $96 billion annually. Regulating 
tobacco products is a win-win for our Nation's health and our need to 
be fiscally responsible in a time of economic hardship.
  This bill will finally give the FDA the authority to regulate tobacco 
products, restrict tobacco marketing, especially the marketing 
techniques designed to entice and addict our children. They are 
vulnerable and impressionable, and the tobacco industry exploits that.
  I was proud to be an original cosponsor of this bill in the House, 
and I'm even prouder to vote for this bill today because I know that it 
is long overdue.
  Mr. BUYER. Madam Speaker, I yield myself 30 seconds to respond to my 
good friend Mr. Waxman.
  To say that harm-reduction strategies are best left to the FDA gives 
me great concern. If you truly believe that, then you should have never 
set a 2-tiered standard and built a paradigm in which they are to make 
judgments, if you truly believe that they're the ones who should have 
designed the strategies to improve public health. So I would be more 
than happy to work with the gentleman to repeal the 2-tiered standard 
if we're going to let them set the standard based on sound science to 
improve public health.
  Madam Speaker, I now yield 2 minutes to the gentleman from 
Pennsylvania (Mr. Platts).
  Mr. PLATTS. I appreciate the gentleman's yielding time to me, 
especially given that we have different views on this piece of 
legislation.
  Madam Speaker, I rise in strong support of H.R. 1256, the Family 
Smoking Prevention and Tobacco Control Act. I appreciate the Senate's 
swift consideration of this bill. After many years of consideration, 
I'm pleased that this important public health legislation will finally 
be signed into law.
  As one of the deadliest products on the market, tobacco must be 
subject to the same serious regulation and oversight that most other 
products consumed by Americans are subject to. This bill will help to 
ensure that Americans are fully aware of the harmful effects posed by 
tobacco products.
  Most importantly, this legislation will ensure that tobacco products 
are not advertised to or sold to children. Addiction to tobacco begins 
almost universally in childhood and adolescence. Tobacco companies have 
long taken advantage of this vulnerability by promoting their products 
through such tactics as cartoon advertisements, free tobacco-themed 
merchandise that appeals to kids, and sponsorship of sporting and 
entertainment events. With health care costs spiraling out of control 
every year, the cost of treating these smokers later in life is fast 
becoming prohibitively expensive. Prohibiting advertising to children 
will go a long way in preventing young people in America from starting 
to smoke and will save billions of dollars and, most importantly, 
countless lives in the years to come.
  It is important to emphasize that this bill does not ban tobacco 
products. Rather, H.R. 1256 allows the FDA to scientifically evaluate 
the health benefits and risks posed by ingredients in cigarettes and 
takes steps to reduce the harm caused by tobacco products. This 
legislation preserves an adult's choice to smoke and makes sure that 
tobacco products marketed as safe alternatives to cigarettes are, in 
fact, scientifically safer.
  I am pleased to have worked with my colleague, the distinguished 
chairman of the House Energy and Commerce Committee, Henry Waxman, the 
gentleman from California, on this legislation. I commend him for his 
leadership on this issue as well as former Congressman Tom Davis.
  I encourage a ``yes'' vote.

[[Page 14934]]


  Mr. BUYER. Madam Speaker, I yield myself such time as I may consume.
  It is nicotine that causes the consumption of tobacco. So I 
understand how truly, in my words, outraged then Chairman Waxman was 
and still is with regard to testimony that occurred years ago when he 
was the chairman of the Subcommittee on Health.
  Now, if it is the nicotine from which adult users receive their 
satisfaction, the real issue is how do they gain access to nicotine in 
a manner that reduces their health risk? That's the issue. That's my 
passion.
  I am not a smoker. I don't advocate for people to smoke. My charge 
and challenge is how do we improve public health in our country? And I 
don't want this abstinence-only approach. So if it's nicotine for which 
people want to gain access to and it's an adult product, then shouldn't 
we be trying to figure out methods or products where people can gain 
access to nicotine that is less harmful?
  During the debate on the rule, Madam Speaker, I would share to my 
colleague, Chairman Waxman, an individual brought up a head of lettuce 
and said that there is more regulation on a head of lettuce than 
tobacco. And I guess it was an effort to be cute, but the real point 
here is what I shared, Madam Speaker, and to my friend Mr. Waxman, you 
could have smoked that lettuce and you would still end up with the same 
problems. You could cut the grass in your yard, dry it and roll it up 
in a cigarette and smoke it, and you're still going to have a lot of 
problems. It is the smoke that kills, not the nicotine. It's the smoke.
  So when you look and you say, well, if the smoke is the killer 
because of the inhalation of the tobacco smoke, that's responsible for 
the pandemic of cancers, heart disease, respiratory disease, and these 
deadly results.
  So I'm going back to this harm reduction. So despite decades of 
intense efforts to eradicate smoking, more than 40 million adults 
continue to smoke cigarettes, and they're likely to continue because we 
don't have this ability to migrate them to other products. It's 
extremely important, when we talk about a harm-reduction strategy, that 
not only is it the access to a particular product, it is the education 
of the people at large as to what type of products that they can avail 
themselves to that have less harmful health results. That should be our 
goal and that has been embraced.
  The American Association of Public Health Physicians noted last year, 
Enhancement of current policies based on the premise that all tobacco 
products are equally risky will yield only small and barely measurable 
reductions in tobacco-related illness and death.
  So in the public debate, there is sort of this presumption that all 
tobacco products are harmful. Well, all tobacco products have a degree 
of health hazards, but some are more harmful than others. So cigar and 
pipe are not subject to this legislation; yet they are the most harmful 
to the human body of all of the carcinogens that can be inhaled.
  So how do we migrate people? And I think that's what is extremely 
important. And let's stop this premise that all tobacco products are 
equally risky; that Swedish snus, even though it's 98 percent less 
harmful than an unfiltered cigarette, should not be treated as though 
they're both just as harmful. They're not. If you're able to pasteurize 
and take away the nitrosamines, yet people can gain access to their 
nicotine, you know what? That ought to be something we should talk 
about. That ought to be something we should promote.
  And the reason, Madam Speaker, that if we just turn this over to the 
FDA, like Chairman Waxman has just suggested, and let them come up with 
these strategies, it's not going to be able to get into the hands of 
the American people because of the 2-tiered standard that has been set 
in this legislation.
  Madam Speaker, I reserve the balance of my time.
  Mr. WAXMAN. Madam Speaker, I yield 3 minutes to my esteemed colleague 
from the State of Minnesota (Mr. Oberstar).
  Mr. OBERSTAR. I thank the gentleman for yielding, my good friend and 
colleague of 34 years ago. We entered Congress together.
  I do not propose to read this entire document, but it is the report 
of the hearings, the committee report conducted by my predecessor in 
Congress, John Blatnik, in 1957 on false and misleading advertising 
among a number of products and the failure of the Federal Trade 
Commission to intervene on behalf of the public.
  The leading testimony on false and misleading advertising on filter-
tipped cigarettes was a statement of Dr. Kyler Hammond, Director of 
Statistical Research for the American Cancer Society: We found lung 
cancer death rates to be extremely low among nonsmokers and high among 
heavy cigarette smokers; 2,665 excess deaths, and this was 1957, among 
smokers. The conclusion of Dr. Hammond: The sum total of scientific 
evidence establishes beyond reasonable doubt that cigarette smoking is 
a causative factor in the rapidly increasing incidence of human 
epidermoid carcinoma of the lung.
  Fifty-two years ago and we still have people in this Chamber and in 
the other body saying it's not a problem.

                              {time}  1045

  The report of the committee goes on to say, Benzpyrene is one of the 
substances containing carcinogenic agents. A known cancer-producing 
agent has been found in the smoke from cigarette paper and an amount 
from the tobacco itself. This component is known as 3,4-benzpyrene.
  The report of the committee concludes:
  The cigarette manufacturers have deceived the American public through 
their advertising of filter-tip cigarettes. Ironically, while denying 
the alleged health hazards of cigarette smoking, the industry has, in 
its advertising, made these charges appear true. Filter gives you more 
of what a filter is for, clean smoking; snowy white; pure; miracle tip; 
20,000 filter traps, gives you more of what you changed to a filter 
for.
  The committee concludes:
  The Federal Trade Commission has failed to approach the problem of 
false and misleading advertising.
  They failed then, 52 years ago. They failed us today. It is way long 
past time, many millions of deaths later, for this Congress to act 
decisively in the public interest. And also as a tribute to my 
predecessor, John Blatnik, who led this charge 52 years ago and who was 
rewarded with dissolution of his subcommittee for having rung the bell 
on false and misleading advertising by the cigarette companies.
  Mr. WAXMAN. Madam Speaker, I am pleased at this time to yield to one 
of the people without whom this bill would not even be possible, and 
that is the Speaker of the House, Nancy Pelosi, who has been such a 
strong leader for advancing the public health.
  The SPEAKER pro tempore. The gentlewoman from California is 
recognized for 1 minute.
  Ms. PELOSI. Madam Speaker, I thank the gentleman for his generous 
recognition and rise to say, as a mother and a grandmother, what an 
important day this is for America's children and to say thank you to 
Mr. Dingell. Some of the giants of the Congress have worked to help the 
children of America. Mr. Dingell, Mr. Waxman, and Mr. Pallone on the 
committee. On the Senate side, this legislation passing also is a real 
tribute to the leadership of Senator Ted Kennedy. It's really a great 
day. It's momentous. It's historic. We can't say that all the time 
about the legislation that we pass here. It would be impossible to 
exaggerate the importance of what is happening here today.
  Today we have an opportunity to protect public health and prevent 
disease; and today we have an opportunity to honor our responsibility 
to our children, to protect them from the harm that can come to them 
from the use of tobacco.
  Madam Speaker, tobacco is the number one cause of preventable deaths 
in the United States. According to the Centers for Disease Control, it 
is responsible for about one in five, or 443,000, deaths annually. 
Again, I want

[[Page 14935]]

to acknowledge the great work of Chairman Waxman, Chairman Dingell and 
Chairman Pallone. We passed this bill before Easter. Happily last 
night, yesterday, it passed the Senate so that we can now pass the bill 
and send it to the President's desk for his signature.
  Mr. Oberstar, in his role on Transportation and understanding how we 
had to get smoking out of Transportation, spelled out for us what the 
study told us and how it has been 52 years since we should have taken 
action. There is so much support on the outside of the Congress as 
well. A thousand organizations, everyone from the American Cancer 
Society, which we would suspect, the Campaign For Tobacco-Free Kids, 
the AARP, and the Presbyterian Church, just to name a few. They believe 
that passing this bill will save lives.
  Every day Americans benefit from the oversight of the FDA on foods 
that we eat and medicines we take. That's their jurisdiction. Yet 
despite the fact that tobacco is one of the deadliest products in 
America, the FDA has had no authority to regulate it. This is just not 
right, and today we can correct that wrong. Right now tobacco is exempt 
from standards that apply to a can of soda or a box of pasta. Tobacco 
makers are exempt from critical and basic consumer protections, such as 
ingredient disclosure, product testing and restrictions on marketing to 
children.
  This legislation grants the FDA the authority to regulate tobacco 
products. It also requires detailed disclosure of tobacco product 
ingredients and restricts tobacco marketing and sales to young people, 
among other things. And this legislation does all of this in a fiscally 
responsible way, funding the FDA tobacco activity through a user fee on 
tobacco manufacturers.
  Because of lost productivity and health care expenditures, cigarette 
smoking costs our Nation more than $193 billion a year, almost $200 
billion a year. By reducing the number of smokers, not only will this 
legislation save lives and reduce chronic disease, it will also reduce 
health care costs.
  Today, approximately 3,500 young people will try a cigarette for the 
first time and another 1,000 will become addicted and become new 
regular, daily smokers. One-third of those children will eventually die 
prematurely because of smoking. We must do all that we can to prevent 
premature death from smoking, and today we have that opportunity.
  Madam Speaker, I urge all of my colleagues to support the aptly named 
Family Smoking Prevention and Tobacco Control Act. I hope that the 
children of America will see a strong bipartisan vote. This legislation 
deserves it, and then we can send it on to the President to be signed 
into law hopefully no later than next week.
  Again, Mr. Dingell, as a mother and a grandmother, I'm deeply in your 
debt for what you're doing for America's children. Mr. Waxman, thank 
you so much for bringing this bill to the floor. We went into session 
in January. Before Easter this bill had passed the House. Thank you for 
your leadership. Mr. Pallone was very much a part of it. Again, Mr. 
Oberstar, thank you for your leadership.
  But let's just say about Senator Kennedy, this has been part of his 
life's work. He's worked on this for a very long time, of itself, 
discretely, the tobacco and smoking issue and then, of course, just as 
with Mr. Dingell, the larger health issue for America. Today in passing 
this legislation, enabling the FDA to regulate tobacco, we are taking a 
giant step forward in making America healthier. Thank you all for your 
leadership.
  Mr. BUYER. Madam Speaker, I yield myself as much time as I may 
consume.
  It is with great disappointment that I hear the words of the Speaker 
because she is truly endorsing a 7 percent success rate as an 
acceptable level of success for those who are trying to quit smoking. 
Also, if we really wanted to try to help children, then she should have 
endorsed what I sought to do; that is, put tobacco on an equal plain as 
alcohol to make it illegal to possess. But we're not doing that today.
  I also said that the States, with regard to the MSA, the Master 
Settlement Agreement, the States are not spending the money like they 
should. In the last 10 years, States have spent just 3.2 percent of 
their tobacco-generated revenue on prevention and cessation programs. 
In the current fiscal year, no State is funding tobacco prevention 
programs at levels recommended by the CDC. So I had offered an 
opportunity here to the body to strengthen and truly protect children, 
yet it was not adopted by this body. So be very careful about coming to 
the floor and saying we're doing it for the children when, in fact, the 
opportunity was there and you did not.
  I now yield 3 minutes to the gentleman from Texas (Mr. Paul).
  Mr. PAUL. I thank the gentleman for yielding.
  Madam Speaker, I don't think anybody can argue at all with the 
intentions of the proposal of this bill. There is no question that 
cigarettes are very harmful. The question for me here is the process, 
and I find the process here atrocious because it assumes that 
authoritarianism is right, proper and that it works and that 
volunteerism, education, self-reliance and depending on oneself to take 
care of oneself is a proper approach. We totally reject our free 
society and assume that if we just have tobacco police roaming the 
country, that all of a sudden bad habits are going to be cleared up. 
We're dealing with bad habits, and these are bad for health. But let me 
tell you, I can bring you a list here of dozens and dozens of bad 
habits that lead to death. As a matter of fact, one of the things that 
we ought to consider is, how many people die from our drug war? We have 
a drug war, and about 3,000 people die from the use of illegal drugs. 
So we have a drug war going on, and tens of thousands of people die.
  It's so exasperating at times because we always have two proposals 
here, or we have two ways of solving problems or dealing with tobacco. 
For decades, what did we do? We subsidized tobacco, and now we want to 
prohibit tobacco. Why don't we just let the people decide. This whole 
idea of either having to subsidize something or prohibit something 
shows a shallowness that I think we ought to challenge.
  One part of this bill that I find particularly bad, but it is 
pervasive in so much of what we do, about 100 years ago we took the 
First Amendment and freedom of speech and chopped it into two pieces. 
We have political speech. Of course we like that. We're in the business 
of politics. But we take commercial speech, and we put it over here, 
and we regulate the living daylights out of commercial speech. That's 
not a First Amendment. That's chopping freedom in half, and that just 
leads to more problems. But this will lead to prohibition, and it won't 
work. This will just give us a lot more trouble.
  You say, Well, how will these problems be handled if we just permit 
people to advertise? Well, you are not allowed to commit fraud; you are 
not allowed to commit slander; you are not allowed to commit any libel 
or slander or fraud. So there are prohibitions. But this approach can't 
work. It is assumed that people are total idiots, that they won't 
respond to education, that we have to be the nanny state. We want to 
expand the war on drugs, which is a total failure.
  And look at what happened to the prohibition of alcohol. You say, 
Well, no, this is not going to be a prohibition. It is going to be 
prohibition. This is a form of prohibition. When you have prohibition 
or even approach prohibition, what do you create? You create the black 
market. We will see the black market come. Already the taxes are 
opening up the doors of the black market.
  All I ask for is people to reconsider, believe that freedom, self-
reliance and individualism can solve these problems a lot better than a 
bunch of politicians, bureaucrats and tobacco police here from 
Washington, D.C.
  Mr. BUYER. I yield myself 30 seconds.
  I would say that the gentleman and I are not always in total 
agreement. The substitute that I brought to the floor actually sought 
to regulate tobacco, and I know you did not agree with my

[[Page 14936]]

substitute. I believe in the regulation of tobacco. I sought to do 
that. I just don't believe it should be done in FDA. We tried to create 
a harm reduction center to do that. But I respect the gentleman's 
views.
  I reserve the balance of my time.
  Mr. WAXMAN. Madam Speaker, I am pleased at this time to yield 3 
minutes to the very distinguished chairman emeritus of the Energy and 
Commerce Committee, the gentleman from Michigan (Mr. Dingell), who has 
played an essential role in fighting against tobacco and getting us to 
this day today.
  Mr. DINGELL. I thank my good friend and colleague, the chairman of 
the committee, Mr. Waxman; and I commend him for his leadership on this 
matter. I am also delighted that we have this bill on the floor today. 
I urge my colleagues to support the Family Smoking Prevention and 
Tobacco Control Act. I would point out that we will be shortly 
following it up with legislation to protect Americans from dangerous 
foods and to give the Food and Drug Administration the authority and 
the money which it needs. That will be followed by additional 
legislation to address the question of pharmaceuticals.
  I urge my colleagues to recognize that this not only does what needs 
doing, but it also gives to the Food and Drug Administration the 
authority and the money which it needs and the personnel which it needs 
to carry forward its mission as it goes about its business. I would 
point out, for too long we have starved them for authority, resources 
and personnel. It is time something be done about this. I am not going 
to give you an argument about this situation--that will be in my 
written extended remarks--but I want to tell my colleagues that the 
graveyards are full of people who occupy those places because they 
smoked and because we tried volunteerism.

                              {time}  1100

  Well, volunteerism filled the graveyards, and the constant attacks 
that have been made on the Food and Drug Administration and the 
deprival of proper authority to carry forward its responsibilities and 
the personnel it needs have brought us to the situation where we have 
to do the kind of thing that we are saying.
  So don't talk to me about volunteerism. Understand that it has failed 
calamitously and people are dying every day because they have smoked.
  Having said that, I want to tell you a little story about when we 
passed the first legislation to begin to warn people about the dangers 
of tobacco that were found by the Surgeon General in his report to the 
United States and to the Congress.
  A little guy came before the committee, and he testified before my 
dear friend John Moss and I, who were the major proponents of that 
particular legislation at that time. He said, Now, you don't know me, 
but I am a pathologist and an internal medicine man. That means that I 
can tell you why you are going to die, or I can tell you why you did 
die.
  He said, I don't have a prepared statement here today, but I do have 
a number of exhibits I would like to present to the committee.
  So he reached in his briefcase and he pulled out a human lung. He 
said, Now, this is a normal person's human lung. It had a certain life 
to it.
  The next exhibit he pulled out was one of a fellow who had died of 
squamous cancer. He said, These are squamous cells. It looked like a 
bowl of caviar, a painful way to go.
  He then showed us the lung of somebody who had died of emphysema. It 
was white. It lacked life. He said, This man literally strangled 
because he did not have the ability to derive the oxygen from the air.
  The SPEAKER pro tempore. The time of the gentleman has expired.
  Mr. WAXMAN. I yield an additional 1 minute.
  Mr. DINGELL. I thank the gentleman.
  He pulled out another lung. He said, Now, this is the lung of a 
smoker. It was black, dirty and nasty, and you would not want to have 
it inside of you.
  He said, Now, my message to the committee is very simple. If you 
smoke long enough, you are going to die of cancer of the lung or you 
are going to die of some other kind of ailment which is induced by your 
smoking, whether it is of the lung or whether it is of some other 
organ, including the mouth, the throat, or another part of the body as 
far away as the fingertips.
  I just want my colleagues to understand, finally we are doing 
something. If a person wants to be silly enough to smoke, he can still 
do so; but he is going to get a warning, and the tobacco companies are 
going to have to provide proper, decent, honorable behavior, and they 
are going to have to do the things that warn the American people of 
this.
  We have a responsible agency which this legislation will properly 
fund and finance. We will give them the authority and the personnel and 
the capabilities of doing what they need to do. We are going to follow 
it with other legislation.
  I urge my colleagues to support this and support the other 
legislation when it comes.
  I rise today in strong support of the Senate Amendment to H.R. 1256, 
``Family Smoking Prevention and Tobacco Control Act''.
  The decision to vote in favor of today's bill is a very easy one. It 
was an easy one, because I am convinced that the ``Family Smoking 
Prevention and Tobacco Control Act'' will go a long way in regulating 
the most unregulated consumer product on the market today. A product 
which:

  Is the leading preventable cause of death in the United States;
  Kills more than 400,000 Americans annually; and
  Accounts for more than $96 billion in health care costs every year.

  Every day, approximately 3,500 kids will try a cigarette for the 
first time, and another 1,000 we become new, regular habituate smokers.
  The legislation will restrict marketing and sales to youth; grant FDA 
authority to restrict tobacco marketing; require detailed disclosure of 
ingredients; and allow FDA to require changes to tobacco products to 
protect the public health.
  I commend Chairman Waxman and my dear friend, Senator Kennedy, for 
their persistent leadership on this legislation in the Congress. I am 
honored to have my name associated with the legislation and for the 
opportunity I had to work with them on this issue.
  Madam Speaker, I know firsthand that the ``Family Smoking Prevention 
and Tobacco Control Act'' is good piece of legislation. I had the 
distinct pleasure of shepherding it through the Energy and Commerce 
Committee last year. Today's legislation largely reflects the work we 
did then.
  Madam Speaker, this legislation has been in the works for a long 
time. Nothing stands in our way to send it to the President's desk. I 
urge my colleagues to vote in favor of the ``Family Smoking Prevention 
and Tobacco Control Act''--the American people need it and they deserve 
it.
  Mr. BUYER. Madam Speaker, I now yield 2 minutes to the gentleman from 
California (Mr. McClintock).
  Mr. McCLINTOCK. I thank the gentleman for yielding.
  Madam Speaker, many years ago, author and commentator Bruce 
Herschensohn made the point that for every pleasure in life, there is a 
corresponding risk. I think that is a universal truth: for every 
pleasure in life, there is a corresponding risk.
  And he pointed out it is true that with enough taxes and laws and 
restrictions and regulations and penalties and lectures, government can 
produce a virtually risk-free society, but it will also be one of the 
most colorless, pleasureless, tedious, and miserable societies ever 
conceived by the mind of man.
  I think that is the case. The health dangers of smoking are real and 
they are well-documented. We all agree on that. It is a very bad thing 
to do.
  Our schools rightly make a concerted effort to inform every child of 
the health risks associated with tobacco products, and they do a good 
job of it.
  Our government warns every adult of the risks associated with tobacco 
products, and they do a good job of it, too.
  As a result, I don't believe there is a single individual in the 
United States today who doesn't well and fully comprehend the health 
dangers of tobacco. But once those warnings are issued, how much 
further should government

[[Page 14937]]

go to make individual decisions for rational adults as they weigh the 
risks of smoking for themselves? Personally, I think they are making a 
very bad decision, but they probably think others are making bad 
decisions when they decide to go skiing or bungee jumping or sky diving 
or thousands of other pleasures that incur corresponding and calculated 
risks.
  I would ask today, whatever happened to the notion of individual 
responsibility? And whatever happened to the notion, as Jefferson put 
it, of a wise and frugal government, which shall restrain men from 
injuring one another, but shall leave them otherwise free to regulate 
their own pursuits of industry and improvement?
  Mr. WAXMAN. Madam Speaker, I yield 2 minutes to the gentlewoman from 
Illinois (Ms. Schakowsky), a member of the Health Subcommittee.
  Ms. SCHAKOWSKY. Madam Speaker, I rise today in strong support of H.R. 
1256, the Family Smoking Prevention and Tobacco Control Act. I do it 
with enormous gratitude to Chairman Waxman for working for years to get 
legislation of this sort that would improve public health by 
strengthening the regulation of tobacco products.
  There are a lot of diseases that we don't have the cure for today. 
There are lots of resources put into medical research that hopefully 
will find a cure to cancer and to AIDS and other terrible diseases. But 
we do know how we can prevent over 435,000 tobacco-related deaths that 
occur each year, and that is by preventing smoking.
  There are over 44 million smokers in the United States of America. In 
Illinois alone, 24.3 percent of adults and 29.2 percent of youth smoke 
tobacco. In Illinois, 16,000 people die from smoking-related illnesses 
and 29,000 adults and children die of secondhand smoke in Illinois. In 
addition, $3.2 billion is spent in direct medical expenditures related 
to smoking in Illinois. And every day 4,000 kids try their cigarette, 
and about half of them become addicted.
  Finally, we have legislation giving the FDA the power and resources 
to regulate the tobacco industry and safeguard the public health and 
our children. It would lessen the cost of smoking-related medical 
illnesses and prevent adolescents and teens from smoking at a young 
age.
  In Illinois, I want to congratulate Alexandra Slane, an elementary 
school student from Peoria, Illinois, who won the Tar Wars anti-smoking 
annual poster contest with her drawing of a light bulb shaped as a 
human head. She wrote the caption in the human-shaped light bulb 
warning America, ``Be Bright, Don't Light.''
  Let's start by passing H.R. 1256.
  Mr. WAXMAN. May I inquire how much time each side has.
  The SPEAKER pro tempore. The gentleman from California has 9\1/2\ 
minutes remaining. The gentleman from Indiana has 10 minutes remaining.
  Mr. WAXMAN. We have no other requests for speakers and I would like 
to close the debate. We continue to reserve our time.
  Mr. BUYER. Madam Speaker, there are a couple of issues that I would 
like to address that I mentioned in my opening. The last two issues 
that I will address are, one, on the constitutionality, and, secondly, 
is the FDA the right agency.
  While we all agree that steps need to be taken to help lessen the use 
of tobacco products by underage youth, we must not do so in ways that 
clearly violate the First Amendment. Unfortunately, the bill in front 
of us I believe fails to meet that test.
  The speech restrictions in this bill are clearly the most sweeping in 
the history of the United States for any legal product. Numerous top 
legal experts from every point of the political spectrum have looked at 
these provisions and declared that they will not meet First Amendment 
scrutiny.
  During the debate on the rule, I questioned the responsibility of 
this body. I believe it is irresponsible for us to pass legislation 
that is prima facie unconstitutional.
  What we are doing in this body is two things: we are taking the regs 
from the 1996 rule that the Supreme Court found unconstitutional and we 
are making them statutory, which means, attention to lawyers in 
America: you have an access and avenue right back to Federal Court 
immediately upon the President's signature of this legislation.
  Also under the Constitution, private speech, private speech and the 
regulation of private speech among individuals, that is, companies, if 
individuals seek to restrict their speech between themselves or how 
they seek to communicate, they can do that in the private marketplace 
between themselves. Where the First Amendment comes in is when 
governments, States, municipalities or the Federal Government then step 
in and begin to regulate speech.
  In this case, it is commercial speech, and that is what we are doing. 
When we take the MSA, the master settlement agreement, and also place 
these restrictions and then make them statutory, bang, we are right 
back to the Supreme Court. And I just find that very bothersome.
  Larry Tribe, the noted constitutional expert and Harvard University 
law professor, commenting on the types of provisions in this 
legislation, stated, ``Given the extensive regulation of tobacco 
manufacturing (for example, the creation of manufacturing standards, 
the regulation of cigarette ingredients, and so on) elsewhere in the 
proposed legislation, and the mandates for new and improved warnings, 
it would be difficult to defend the sweeping restrictions on 
advertising as being narrowly tailored to an important governmental 
interest. The paternalistic view that tobacco advertising must be 
restricted because consumers might find it pervasive is antithetical to 
the assumption on which the First Amendment is based.''
  Wow. Now you are going to find me quoting the American Civil 
Liberties Union. You may want to listen to this, because it is probably 
the first time I have ever cited the ACLU.
  They also said in their testimony on identical language contained in 
this legislation, they stated if this type of legislation were to be 
passed, it would be ``wholly unprecedented'' and ``will most likely 
fail to withstand constitutional challenge.''
  On the other side of the spectrum, the Washington Legal Foundation 
and Judge Bork also have called these proposals ``patently 
unconstitutional.'' Numerous other legal scholars have taken similar 
positions.
  Now, in our zeal here to restrict tobacco products, there have been 
these comments by some, Madam Speaker, to say we are doing it for the 
children. It is wonderful. We can say we are doing it for the children. 
What does the Court say about that?
  The Supreme Court has already examined one of the provisions in the 
FDA proposal, and that is the 1,000 foot ban on outdoor adds, and has 
suggested it violates the First Amendment because it is not narrowly 
tailored.
  The Supreme Court rejected the efforts of the Massachusetts Attorney 
General to ``childproof'' the flow of information in our society. 
Children deserve to be protected from inappropriate or harmful 
material, but the government may not use the guise of protecting 
children to impose sweeping restrictions on information intended for 
adults.
  So we come to the floor and we say we are doing it for the children. 
Yet we are taking provisions which the Supreme Court has already found 
to be unconstitutional, i.e., commercial speech that is not merely 
tailored to a legitimate government interest.
  In Bolger v. Youngs Drug Products Corporation, the court stated that 
efforts to restrict advertising cannot lower disclosure in society ``to 
the level of the sandbox,'' and cited in the case Butler v. Michigan 
that ``government may not reduce the adult population to reading only 
that which is fit for children.''
  So the type of drastic speech censorship that is contained in this 
legislation is almost certain to lead to challenges in the Federal 
courts, and I find that troubling and counterproductive.

                              {time}  1115

  Let me move to the FDA. This bill establishes a general standard that 
actions by FDA are in the best interest of

[[Page 14938]]

public health, that they're the ones, that they can reasonably be 
likely to have measured scientific results.
  What do we mean by results?
  Substantial reductions in morbidity and mortality rates among 
smokers. That's what we seek to achieve.
  So the great challenge that I have here is that, in the committee, we 
are now looking at legislation with regard to food safety and drug 
safety. The FDA is charged with approving medical products based on 
scientific evidence that benefits of the products outweigh the risks. 
Tobacco products are inherently risk products that cause disease when 
used as directed.
  Now, we're going to turn to the FDA and say, we want you to regulate 
the tobacco product. So we take the gold standard of the FDA now, and 
apply it to tobacco, and now there is this inference that somehow the 
FDA has said that tobacco's a safe product. That is something we should 
not be doing. It's why I sought to create a separate agency, rather 
than the FDA, creating a mission that is counter to their present 
mission.
  You see, if you use a cigarette and follow the instructions, and you 
do that every day, it will kill you. Now, think about that. It will 
kill you. We don't want the FDA to create some type of inference into 
society that somehow it's okay.
  President Obama stated on March 14 of this year that 95 percent of 
America's 150,000 food processing plants and warehouses go uninspected 
each year. Wow. Each year, 74 million people in the United States are 
sickened by tainted food, and about 5,000 die, according to the CDC. 
That's on food alone.
  Then, with regard to drugs, I look forward to working with Chairman 
Waxman, Madam Speaker, and with Mr. Dingell, with regard to drug safety 
because right now we have 11 international mail facilities by the 
United States Government. You count the three private carriers that 
also have international mail facilities, and they are taking up to 
around 30,000 drug packages that are coming into our country by people 
who are going on to the Internet. Every time we do an inspection of 
those mail packages, we find that 80 percent of them are either 
counterfeit knockoffs or adulterated drugs. When, in fact, you do the 
math and you say, okay, wow, take that 14 times 30,000 times 365, then 
times 80 percent, we are looking at 96 million. Think about that. 96 
million drug packages coming in. So what we're doing now is we're 
lumping this onto FDA, and FDA is a challenged, a very challenged 
agency.
  I urge individuals to vote ``no'' on this legislation. There is a 
better way to regulate tobacco.
  Mr. WAXMAN. So, Madam Speaker, it's come down to this, a musing that 
perhaps FDA is not the right agency; we ought to create a brand new 
one, but don't give them any power to do anything.
  Or what we need is harm reduction, even though this legislation gives 
the FDA the ability to look for ways to reduce the harm from cigarette 
smoking.
  But the best way, the best way is not to smoke. And the best way is 
to make sure that people don't start smoking. And if they do smoke, to 
give it up.
  And then the next argument, it's not constitutional. And my colleague 
has cited the fact that he believes the Supreme Court, when they ruled 
on the issue of the regulations being proposed by the FDA, that they 
said that those were unconstitutional.
  Well, the truth of the matter is the Supreme Court said FDA did not 
have the legal authority and that Congress had to vote to give them the 
legal authority to adopt those regulations. That is what we are about 
to do today.
  I've been working on the issue of tobacco for over three decades, and 
in fact, I thought about this issue as I prepared a book that's going 
to be coming out on a lot of different issues in the next couple of 
weeks.
  And I remember the hearings we had where the tobacco industry had so-
called scientists argue there really wasn't any harm from cigarette 
smoking. It was just coincidental.
  I remember well when the CEOs came before our committee, and that was 
a real turning point. And they took an oath to tell the truth, and they 
said, no harm from cigarette smoking; it's not connected to cancer; 
it's not connected to heart disease; it's not connected to all these 
other problems; it's only a coincidence. They said cigarette smoking 
was not addictive because nicotine is not addictive. They swore that 
under oath. They said they didn't manipulate the nicotine to make it 
even stronger and more addictive a product. And they said, with 
righteous indignation, they certainly wouldn't target kids to smoke.
  Well, after that appearance in 1994, we pierced the veil that hung 
over the industry and started to find out what they were saying in 
their own corporate boardrooms and what their own scientists understood 
the case to be.
  We later had a hearing where a scientist that worked for the tobacco 
industry told us he understood the harm. The industry wanted to know 
what harm it did, and they knew that, in fact, it caused a tremendous 
amount of death and disease in this country. They were looking at ways 
to patent new ways to raise the nicotine levels so they can keep people 
smoking, because they were very well aware of the fact that nicotine 
was addictive and they could, in fact, make sure that nicotine grabbed 
on to those smokers and kept them captive to that habit.
  And the Joe Camel advertising campaign was marketed in France to see 
if it really got kids to be loyal to that brand. And in their boardroom 
they discussed how important it was to get kids to start smoking at 14 
or 15 years of age because then they would be loyal to that brand, let 
alone addicted to the product.
  We later found out how the tobacco industry spent millions and 
millions of dollars on a phony operation to say that they were studying 
whether the harm was there from cigarette smoking, and what they did 
was manipulated the media, deceived the American people, to argue the 
science wasn't really there to claim cigarettes was a problem. The 
science is still out.
  By the way, we hear this about global warming today. Even though the 
overwhelming consensus was there from reputable scientists, they tried 
to make people believe, don't worry about it, you can continue to 
smoke; it's not going to do you harm.
  And they tried so hard and successfully, for decades, to keep secret 
the fact that nonsmokers were harmed by simply being in the presence of 
smokers.
  I remember the power of the tobacco industry that kept the Congress 
from acting, and it was by one vote that the House of Representatives 
decided to try and experiment to see if we could have airplane flights, 
commercial airplane flights of an hour or less, without any smoking 
permitted. And Members stood up on the floor of the House and said 
smokers would never tolerate such a thing.
  Well, it was so widely popular that it's hard to find any airline in 
the world that allows smoking on airplane flights of whatever length it 
may be.
  The public has come to understand this industry, and they know the 
dishonesty of this industry, and they know that the clout of this 
industry kept the government from acting for decades.
  But people now don't realize how it was 30 years ago. Thirty years 
ago people who smoked felt they had the right to light up a cigarette, 
no matter where they were.
  We've heard the argument that the Court may look at the 
constitutionality of any free speech matter that might relate to 
advisories about cigarette smoking.
  Well, it's hard for me to believe that a Supreme Court that once said 
the Constitution does not mean that the freedom of speech allows people 
to yell ``fire'' in a crowded room would now come to the point where 
they'd say it would be unconstitutional to prohibit an industry from 
trying to get children to smoke a product that's illegal for them to 
buy in any State of the Union.
  I think we are, today, at the last gasp of the tobacco industry's 
efforts to protect their profits at the expense of the health and lives 
of the American people and to get children to take up this

[[Page 14939]]

habit. We're moving away from it fast in this country. The FDA will 
help us succeed in ending this tobacco epidemic.
  My heart goes out to people around the world as American tobacco 
companies are telling people in other countries, be like Americans. If 
you're a woman, you can smoke--don't let your culture keep you from 
taking up this habit. As they tell children around the world, start 
smoking. You can be more like Americans who you so admire. You can be 
cool, and all the stuff that was blabbered out in the decades in the 
United States to get so many millions of people to smoke.
  Madam Speaker, this bill, authored by Senator Kennedy in the Senate 
and by myself in the House, has come a long way. It took us a long time 
to get here. But we're here now, and I urge my colleagues to vote for 
passage of this legislation.
  Mr. VAN HOLLEN. Madam Speaker, this is a very important and historic 
day for the American people. I rise in strong support of the bipartisan 
Family Smoking Prevention and Tobacco Control Act, of which I am a 
proud original cosponsor. I want to thank and acknowledge the 
leadership of Chairman Waxman, Senator Kennedy, and so many others who 
have fought the battles for so many years to see this day happen.
  Granting the Food and Drug Administration the authority to regulate 
tobacco products is long overdue. The legislation is a critical step in 
protecting the health and well being of millions of Americans from the 
deadly effects of tobacco use. It is a shame that tobacco products were 
not regulated in this country. Though the FDA has the authority to 
regulate products that are not addictive, we always had this gap in 
their regulatory authority when it came to the very addictive products 
of nicotine and tobacco products.
  For far too long, the tobacco companies have taken advantage of this 
loophole and have exploited it by marketing their deadly products to 
young people. Generation after generation, the tobacco companies 
knowingly targeted our kids through flavored cigarettes, manipulating 
the ingredients in their products, false advertising and other 
deceiving methods--all to ensure that their profit margins remained 
high. In fact, they had to do that. In order for these companies to 
continue to make their profits, they had to find ways to hook people on 
tobacco products.
  I am very proud of the efforts Maryland has taken to curb the effects 
of tobacco use. It has increased the tobacco tax and youth smoking has 
declined. Maryland also passed a comprehensive smokefree indoor air law 
in 2007. I am also proud that the Congress took steps earlier this year 
to decrease tobacco use by increasing federal excise taxes on 
cigarettes as part of the reauthorization of the State Children's 
Health Insurance Program.
  Let's make sure that future generations of young people do not get 
addicted to tobacco products. Addiction to tobacco products has had a 
huge cost to our society in terms of lives and money by killing over 
400,000 Americans each year. This legislation will save lives and 
money. I strongly urge my colleagues to join me in putting an end to 
this deadly cycle and vote yes on this very important bill.
  Ms. FOXX. Madam Speaker, 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 
salmonella outbreak last summer, was 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. It is therefore highly hypocritical of them 
to extend the agency's regulatory authority to a multi-billion dollar 
industry of which the FDA has no expertise.
  This bill undermines the established purpose of the FDA. 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 that ``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.
  This bill imposes undue bureaucratic and logistical hardships on 
tobacco manufacturers by burying them under multiple layers of 
regulation. It is important to remember that the sale of tobacco is 
legal in the United States and is credited with hundreds of thousands 
of jobs across the country. We cannot afford to lose more American jobs 
especially when we are facing such economic challenges.
  FDA regulation will have a devastating economic impact on small 
tobacco companies, their employees, associated businesses, and the 
largely rural communities which they support. Under this legislation 
they will not be able to comply with and afford what is sure to be a 
costly and complex regulatory regime.
  There are some 350 small tobacco manufacturing companies throughout 
the United States. Together with their suppliers, vendors, distributors 
and tobacco growers, these companies employ thousands of people. 
Tobacco growing in particular has long been an important part of rural 
communities. As most of these companies are located in rural, 
economically depressed areas, the jobs, employee health and pension 
benefits and revenue they provide is critical to our local economies. 
While large tobacco companies can absorb the cost of FDA regulation, 
many of these smaller companies cannot. This legislation will force 
them to close their doors, leaving their employees jobless.
  Ms. LEE of California. Madam Speaker; I rise in strong support of the 
Senate Amendments to H.R. 1256, the Family Smoking Prevention and 
Tobacco Control Act.
  I want to thank Chairman Waxman and his staff, and Senator Kennedy 
for their tireless work over the years to ensure that we could get to 
this moment.
  The federal regulation of tobacco has been a long time coming. I'm 
pleased that today's action will complete consideration of this bill 
and send it on to the President to finally get it enacted into law.
  According to the Centers for Disease Control and Prevention, smoking 
is the leading cause of premature death in the United States. More than 
one in five Americans smoke, and according to the CDC's most recent 
report, in 2004 this included about 21 percent of adults and more than 
22 percent of high school students.
  Each year about 1 in 5 deaths, about 443,000 people, are a result of 
smoking or exposure to secondhand smoke. And for each person who dies 
from a smoking related disease about 20 more are living with a smoking 
attributable chronic illness--or about 8.6 million people.
  In addition to the significant effects of smoking on the health of 
our constituents, the estimated costs of smoking-related medical 
expenses and loss of productivity exceed $167 billion annually.
  Thankfully, in my state of California we have known the dangers of 
smoking for a long time, and we were one of the first states to move 
forward in banning indoor smoking in public places, including bars and 
restaurants. As a result our State has the second lowest prevalence 
level of smoking among both adults and youth, at 14.8 percent and 13.2 
percent respectively.
  It is long past time that we try to take a national approach to 
address the dangers of smoking.
  I'm pleased that this bipartisan legislation will grant the Food and 
Drug Administration authority to regulate the advertising, marketing, 
and manufacturing of tobacco products. And I'm also pleased that it 
takes steps to ban flavor additives, including menthol, as well as 
further restricting marketing directed to our children.
  But passage of this bill really is just the first step. We've also 
got to make sure that we follow through on the regulatory authority 
provided in this bill to help encourage smokers to quit, and to provide 
help to those who choose to do so.
  However I'm pleased that we are finally taking this action today, and 
I'm convinced that it will help to improve public health and reduce 
costs to our health care system in the long run.
  I urge my colleagues to support this bill.
  Mr. McINTYRE. Madam Speaker, I rise today to express grave concerns 
about H.R. 1256, the Family Smoking Prevention and Tobacco Control Act.
  This bill will grant the Food and Drug Administration (FDA) wide 
authority to dictate to manufacturers and growers dramatic changes in 
product design and leaf cultivation, a concern that has been raised 
repeatedly by the tobacco growers in my district. The last thing we 
want is government bureaucrats coming on the farm!
  The tobacco industry contributes over $36 billion to the U.S. economy 
each year, employing over 19,000 individuals nationwide. In

[[Page 14940]]

my home state of North Carolina, over 8,600 people are employed by the 
industry with a statewide economic impact of over $23.9 billion.
  The manufacturing provisions and ``FDA on the farm'' provisions of 
this bill will put many companies and growers out of business. In this 
time of economic uncertainty, we can't afford to lose more jobs!
  In addition, the FDA is already overburdened with its food safety and 
drug approval mission. Placing another large regulatory burden on an 
already overwhelmed agency will further divert attention away from the 
FDA's primary role of protecting our food supply and regulating 
prescription drugs.
  Mr. TOWNS. Madam Speaker, today, I rise in support of H.R. 1256 
because of the public health benefits this legislation will provide to 
the country.
  I am deeply troubled, however, that the legislation we are voting on 
today does not include many provisions of great importance to Federal 
employees. These provisions were adopted unanimously by this chamber 
and were included in the tobacco legislation that was sent to the 
Senate.
  The Oversight and Government Reform Committee worked closely with the 
sponsors of H.R. 1256 in crafting this legislation. The bill modernizes 
the Federal Employee Thrift Savings Plan, and these changes to the TSP 
provide the revenue that covers the cost of new tobacco prevention 
programs. As a matter of simple fairness, a portion of this revenue 
generated by Federal employees was devoted to simple fixes to the 
Federal retirement system that will make it more fair and efficient for 
Federal employees and management.
  The House-passed legislation included provisions to eliminate 
inconsistency in how part-time service, breaks in service, and unused 
sick leave are considered in calculating retirement benefits. These 
provisions would help encourage highly-talented individuals to return 
to government service at a time when we need to be attracting such 
individuals to prepare for a wave of upcoming retirements, and would 
help that wave of retirements be more predictable and orderly.
  Unfortunately, the Senate amendments to this bill left out these 
critical provisions. It is very disappointing, and unfair to Federal 
employees, that they are used to generate the revenue for these 
important changes, but that a portion of that revenue will not fund 
important reforms that will make the Federal personnel system more 
efficient. I will continue to work with my colleagues to ensure that 
these inequities and inefficiencies in the Federal retirement system 
are addressed.
  Mr. WU. Madam Speaker, I rise today in support of H.R. 1256, the 
Family Smoking Prevention and Tobacco Control Act, and ask my 
colleagues to agree to the Senate amendments.
  The statistics being heard on this floor are handed out on this floor 
like candy. Because numbers are often passed off as nothing more than 
empty words, we fail to recognize what they mean--in this Speaker, I 
rise today in support case we are talking about people's lives. It was 
Irving Selikoff, a medical researcher who co-discovered a cure for 
tuberculosis who said, ``Statistics are real people with the tears 
wiped away.''
  For instance, smoking-related diseases cause an estimated 440,000 
American deaths each year. And a 2004 study by the CDC's National 
Center for Chronic Disease Prevention and Health Promotion found that 
cigarette smoke contains over 4,800 chemicals, 69 of which are known to 
cause cancer.
  Ninety percent of adult smokers are addicted to tobacco before they 
reach the age of 18; 50 percent before the age of 14. Currently the 
average age of initiation to tobacco is 11.
  Forty-eight million adults smoke in the U.S., which is 22.9 percent 
of the population overall, and 33 percent of youth currently smoke.
  Those real people are our parents and children, our family and 
friends, who suffer the consequences of addiction to tobacco. I want my 
children to grow up healthy and to make healthy decisions. To help that 
happen, H.R. 1256 will put in place the proper authority for the Food 
and Drug Administration to establish regulations over tobacco products. 
We need the FDA to protect our population from the harmful effects of 
cigarettes and tobacco products by being able to provide sound, 
scientific regulations governing these products.
  Even with all the warnings, and the money spent on education 
campaigns, kids are still picking up smoking at the alarming rate of 
3,000 a day in the United States.
  The health concerns that will face these children are costly, 
painful, and deadly.
  But they are also ultimately preventable.
  I am acutely concerned that tobacco companies have used Portland, 
Oregon, as a test market for new smokeless tobacco products. Products 
like snus, or other tobacco-based nicotine delivery products have been 
repeatedly tested in markets like Portland.
  Many of these products look like candy and taste sweet. They are an 
addictive tobacco trap for children and should be either banned or 
heavily regulated away from kids.
  I ask my colleagues to agree to the Senate amendments to H.R. 1256, 
the Family Smoking Prevention and Tobacco Control Act, and send this 
bill to the President's desk for him to sign.
  Mr. PRICE of North Carolina. Madam Speaker, I thank Chairman Waxman 
for his leadership on this important legislation--and on the whole 
range of public health issues before the Congress--and have talked 
extensively with him about the intention of the use of the term ``small 
business tobacco manufacturing industry'' as it concerns the Scientific 
Advisory Committee established in Section 917(b)(1).
  H.R. 1256 provides for the establishment of a 12-member Tobacco 
Products Scientific Advisory Committee and stipulates that one of the 
members of the Committee shall be a ``representative of the interests 
of the small business tobacco manufacturing industry'' that may be 
filled on rotating, sequential basis by representatives of different 
``small business tobacco manufacturers.''
  For the purpose of phrasing in compliance with certain requirements 
of this act Section 900(16) of the bill defines ``small tobacco product 
manufacturers'' as those having fewer than 350 employees. However, the 
bill does not define what constitutes a ``small business tobacco 
manufacturer'' as it relates to the SAC.
  Chairman Waxman has assured me that I am correct in concluding that 
the term in section 917(bX1) regarding membership on the Advisory 
Committee is different from--and need not be interpreted as the same 
as--the one used in proposed new section 900(16).
  Additionally, Chairman Waxman has assured me that when section 
917(b)(1) says that one member of the Scientific Advisory Committee 
must be a representative of the ``small business tobacco manufacturing 
industry'' that does NOT mean that the person must be a representative 
of a ``small tobacco products manufacturer'' as defined in section 
900(16).
  I appreciate the chair's effort to ensure that small manufacturers 
have a seat at the table on the Scientific Advisory Committee. The 
passage of this important legislation is a victory for public health 
and our nation's children. I have supported this bill in both this and 
the last Congress because I believe we must place a far greater 
emphasis on youth smoking prevention and the elimination of tobacco 
advertising aimed at children. The Food and Drug Administration is the 
logical agency to take on the new regulatory responsibilities, and 
Congress and the Obama Administration need to make sure they have 
adequate support to carry out this important job.
  Mr. McINTYRE. Madam Speaker, I rise to discuss a technical but 
important matter. H.R. 1256 would permit the use of brand names and 
logos on roll-your-own paper, as well as cigarettes and smokeless 
tobacco. The U.S. Congress has correctly recognized the necessity of 
allowing RYO manufacturers to put their brand names on the paper that 
is used to assemble RYO cigarettes. However, I am concerned that 
language only naming one component and not the other necessary 
components could lead to a prohibition on branding for tubes, rollers, 
injectors and filters. These are items that are used by individuals in 
their homes for purposes of making their own cigarettes, and not seen 
by others. They have none of the attributes which have caused the 
restriction of the use of logos on other items such as t-shirts.
  For more than 100 years, these types of RYO making components have 
been marketed with company brand names and logos. This practice helps 
consumers easily identify which components and accessories to use and 
helps companies establish good-will with their customers. Yet, this 
practice will unnecessarily be forced to come to an end unless 
components other than RYO paper are included within the FDA's final 
rule on product branding. The intent of this legislation dictates that 
the branding prohibition does to not apply to entities that do not meet 
the definition of a manufacturer or importer of cigarettes or smokeless 
tobacco. Any final rule promulgated by FDA should recognize that RYO 
papers and all necessary components are permitted branding authority.
  Ms. McCOLLUM. Madam Speaker, I rise in strong support of the Family 
Smoking Prevention and Tobacco Control Act (H.R. 1256). Today is a 
historic day for the prevention of disease and promotion of public 
health in America. I commend Chairman Waxman, Chairman Dingell, and 
Chairman Pallone for their leadership in advancing this legislation.
  Tobacco use is the single most preventable cause of death in the 
United States. More

[[Page 14941]]

than 400,000 people die in the U. S. each year from tobacco use, 
including 5,600 Minnesotans. Another 8.6 million Americans are living 
with a serious illness caused by smoking. Unfortunately, the problem 
continues to grow. Every day, more than 3,500 young Americans try a 
cigarette for the first time. One third of these individuals will 
eventually die prematurely as a result of long-term tobacco use. Even 
those who do not choose to smoke tobacco are put in harms way--for 
every eight smokers who die from using tobacco, one non-smoker also 
loses their life.
  The Food and Drug Administration, FDA, is charged with ensuring the 
safety of food and medicine sold in the United States, but lacks the 
authority to regulate one of the deadliest products in America--
tobacco. This is a loophole American families cannot afford.
  The Family Smoking Prevention and Tobacco Control Act, of which I am 
an original cosponsor, would grant the FDA the authority to regulate 
the advertising, marketing, and manufacturing of tobacco products, 
particularly for young people. By prohibiting the colorful marketing of 
tobacco products to children, we can help prevent countless young 
Americans from becoming victims of deceptive advertising. This bill 
will also allow the Secretary of Health and Human Services to approve 
all label statements and to restrict the sale, promotion, and 
distribution of tobacco products for the protection of public health. 
This legislation will also accomplish all of these important goals in a 
fiscally responsible manner--funding for FDA tobacco activity will be 
provided through a user fee on tobacco manufacturers.
  I urge my colleagues to support this bill to pass this bill and send 
it to the President to be signed into law. This is an important step to 
moving towards a healthier America.
  Mr. WAXMAN. I yield back the balance of my time.
  The SPEAKER pro tempore. Pursuant to House Resolution 532, the 
previous question is ordered.
  The question is on the motion offered by the gentleman from 
California (Mr. Waxman).
  The question was taken; and the Speaker pro tempore announced that 
the ayes appeared to have it.
  Mr. BUYER. Madam Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The vote was taken by electronic device, and there were--yeas 307, 
nays 97, not voting 30, as follows:

                             [Roll No. 335]

                               YEAS--307

     Abercrombie
     Altmire
     Andrews
     Arcuri
     Austria
     Bachus
     Baird
     Baldwin
     Barrow
     Bartlett
     Bean
     Becerra
     Berkley
     Berman
     Berry
     Biggert
     Bilbray
     Bilirakis
     Bishop (GA)
     Bishop (NY)
     Blumenauer
     Boccieri
     Bono Mack
     Boren
     Boswell
     Boucher
     Boyd
     Brady (PA)
     Brady (TX)
     Braley (IA)
     Brown (SC)
     Brown-Waite, Ginny
     Burton (IN)
     Butterfield
     Camp
     Cantor
     Cao
     Capito
     Capps
     Capuano
     Cardoza
     Carnahan
     Carney
     Carson (IN)
     Cassidy
     Castle
     Castor (FL)
     Chandler
     Clarke
     Clay
     Cleaver
     Clyburn
     Cohen
     Connolly (VA)
     Conyers
     Cooper
     Costa
     Costello
     Courtney
     Crenshaw
     Crowley
     Cuellar
     Cummings
     Dahlkemper
     Davis (AL)
     Davis (CA)
     Davis (IL)
     DeFazio
     DeGette
     Delahunt
     DeLauro
     Dent
     Dicks
     Dingell
     Doggett
     Donnelly (IN)
     Doyle
     Dreier
     Driehaus
     Duncan
     Edwards (MD)
     Edwards (TX)
     Ellison
     Ellsworth
     Emerson
     Engel
     Etheridge
     Fallin
     Farr
     Fattah
     Filner
     Fleming
     Fortenberry
     Foster
     Frank (MA)
     Frelinghuysen
     Fudge
     Gerlach
     Giffords
     Gonzalez
     Gordon (TN)
     Granger
     Grayson
     Green, Al
     Green, Gene
     Griffith
     Grijalva
     Gutierrez
     Hall (NY)
     Hall (TX)
     Halvorson
     Hare
     Harman
     Harper
     Hastings (FL)
     Heinrich
     Herseth Sandlin
     Higgins
     Hill
     Himes
     Hinchey
     Hinojosa
     Hirono
     Hodes
     Holden
     Honda
     Hoyer
     Inslee
     Israel
     Jackson (IL)
     Jackson-Lee (TX)
     Johnson (GA)
     Johnson (IL)
     Johnson, E. B.
     Kagen
     Kanjorski
     Kaptur
     Kildee
     Kilpatrick (MI)
     Kilroy
     Kind
     King (NY)
     Kirk
     Klein (FL)
     Kosmas
     Kratovil
     Kucinich
     Lance
     Langevin
     Larsen (WA)
     Larson (CT)
     LaTourette
     Lee (CA)
     Lee (NY)
     Levin
     Lipinski
     LoBiondo
     Loebsack
     Lofgren, Zoe
     Lowey
     Lujan
     Lungren, Daniel E.
     Lynch
     Maffei
     Maloney
     Manzullo
     Markey (CO)
     Markey (MA)
     Marshall
     Massa
     Matheson
     Matsui
     McCarthy (CA)
     McCarthy (NY)
     McCaul
     McCollum
     McDermott
     McGovern
     McKeon
     McMahon
     McMorris Rodgers
     McNerney
     Meek (FL)
     Meeks (NY)
     Melancon
     Michaud
     Miller (MI)
     Miller (NC)
     Miller, George
     Minnick
     Mitchell
     Mollohan
     Moore (KS)
     Moore (WI)
     Moran (VA)
     Murphy (CT)
     Murphy (NY)
     Murphy, Patrick
     Murphy, Tim
     Murtha
     Nadler (NY)
     Napolitano
     Neal (MA)
     Nye
     Oberstar
     Obey
     Olver
     Ortiz
     Pallone
     Pascrell
     Pastor (AZ)
     Paulsen
     Payne
     Pelosi
     Perlmutter
     Peters
     Peterson
     Pingree (ME)
     Platts
     Poe (TX)
     Polis (CO)
     Pomeroy
     Price (NC)
     Putnam
     Quigley
     Rahall
     Rangel
     Rehberg
     Reichert
     Reyes
     Richardson
     Rodriguez
     Rogers (AL)
     Ros-Lehtinen
     Roskam
     Ross
     Rothman (NJ)
     Roybal-Allard
     Rush
     Ryan (OH)
     Salazar
     Sanchez, Linda T.
     Sarbanes
     Schakowsky
     Schauer
     Schiff
     Schock
     Schrader
     Schwartz
     Scott (GA)
     Scott (VA)
     Serrano
     Sestak
     Shea-Porter
     Sherman
     Shimkus
     Simpson
     Sires
     Skelton
     Slaughter
     Smith (NJ)
     Smith (TX)
     Smith (WA)
     Snyder
     Space
     Speier
     Spratt
     Stark
     Stearns
     Stupak
     Sutton
     Tanner
     Tauscher
     Taylor
     Teague
     Terry
     Thompson (CA)
     Thompson (MS)
     Tiberi
     Tierney
     Titus
     Tonko
     Towns
     Tsongas
     Turner
     Upton
     Van Hollen
     Velazquez
     Visclosky
     Walden
     Walz
     Wamp
     Wasserman Schultz
     Waters
     Watson
     Watt
     Waxman
     Weiner
     Welch
     Wexler
     Wittman
     Wolf
     Woolsey
     Wu
     Yarmuth
     Young (AK)
     Young (FL)

                                NAYS--97

     Aderholt
     Akin
     Alexander
     Bachmann
     Barton (TX)
     Bishop (UT)
     Boehner
     Bonner
     Boozman
     Boustany
     Bright
     Broun (GA)
     Burgess
     Buyer
     Calvert
     Campbell
     Carter
     Chaffetz
     Coble
     Coffman (CO)
     Cole
     Conaway
     Culberson
     Davis (KY)
     Davis (TN)
     Diaz-Balart, L.
     Diaz-Balart, M.
     Flake
     Forbes
     Foxx
     Franks (AZ)
     Garrett (NJ)
     Goodlatte
     Graves
     Guthrie
     Heller
     Hensarling
     Herger
     Hoekstra
     Hunter
     Inglis
     Issa
     Jenkins
     Johnson, Sam
     Jordan (OH)
     King (IA)
     Kingston
     Kirkpatrick (AZ)
     Kissell
     Lamborn
     Latham
     Latta
     Lewis (CA)
     Linder
     Lucas
     Lummis
     Mack
     McClintock
     McCotter
     McHenry
     McHugh
     McIntyre
     Mica
     Miller (FL)
     Moran (KS)
     Myrick
     Neugebauer
     Olson
     Paul
     Pence
     Perriello
     Petri
     Pitts
     Posey
     Price (GA)
     Radanovich
     Roe (TN)
     Rogers (KY)
     Rohrabacher
     Rooney
     Royce
     Ryan (WI)
     Scalise
     Schmidt
     Sensenbrenner
     Sessions
     Shadegg
     Shuler
     Shuster
     Smith (NE)
     Souder
     Thompson (PA)
     Thornberry
     Tiahrt
     Westmoreland
     Whitfield
     Wilson (SC)

                             NOT VOTING--30

     Ackerman
     Adler (NJ)
     Baca
     Barrett (SC)
     Blackburn
     Blunt
     Brown, Corrine
     Buchanan
     Childers
     Deal (GA)
     Ehlers
     Eshoo
     Gallegly
     Gingrey (GA)
     Gohmert
     Hastings (WA)
     Holt
     Jones
     Kennedy
     Kline (MN)
     Lewis (GA)
     Luetkemeyer
     Marchant
     Miller, Gary
     Nunes
     Rogers (MI)
     Ruppersberger
     Sanchez, Loretta
     Sullivan
     Wilson (OH)

                              {time}  1154

  So the motion to concur was agreed to.
  The result of the vote was announced as above recorded.
  A motion to reconsider was laid on the table.
  Stated for:
  Ms. ESHOO. Madam Speaker, I was not present during Senate Amendment 
to H.R. 1256, the Family Smoking Prevention and Tobacco Control Act, on 
June 12, 2009. Had I been present I would have voted ``yea.''

                          ____________________