[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 982 Introduced in Senate (IS)]

111th CONGRESS
  1st Session
                                 S. 982

      To protect the public health by providing the Food and Drug 
  Administration with certain authority to regulate tobacco products.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 5, 2009

  Mr. Reid (for Mr. Kennedy (for himself, Mr. Dodd, Ms. Collins, Mr. 
Harkin, Ms. Snowe, Mr. Durbin, Mr. Lugar, Ms. Mikulski, Mr. Reed, Mrs. 
Murray, Mr. Reid, Mr. Bingaman, Mr. Sanders, Mr. Brown, Mr. Casey, Mr. 
  Merkley, Mr. Whitehouse, Mr. Leahy, Mr. Lautenberg, Mr. Kerry, Mr. 
  Schumer, Mr. Lieberman, Mrs. Feinstein, Mr. Levin, Mr. Baucus, Mr. 
Wyden, Mr. Akaka, Mr. Nelson of Florida, Ms. Landrieu, Mr. Carper, Mrs. 
Gillibrand, Mr. Bennet, Mr. Begich, Mr. Burris, Mr. Kaufman, Mr. Udall 
   of New Mexico, Mr. Udall of Colorado, Mr. Kohl, Mr. Feingold, Ms. 
 Cantwell, and Mrs. Lincoln)) introduced the following bill; which was 
 read twice and referred to the Committee on Health, Education, Labor, 
                              and Pensions

_______________________________________________________________________

                                 A BILL


 
      To protect the public health by providing the Food and Drug 
  Administration with certain authority to regulate tobacco products.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.
         TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION

Sec. 101. Amendment of Federal Food, Drug, and Cosmetic Act.
Sec. 102. Final rule.
Sec. 103. Conforming and other amendments to general provisions.
Sec. 104. Study on raising the minimum age to purchase tobacco 
                            products.
Sec. 105. Enforcement action plan for advertising and promotion 
                            restrictions.
 TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT 
                               DISCLOSURE

Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Authority to revise cigarette warning label statements.
Sec. 203. State regulation of cigarette advertising and promotion.
Sec. 204. Smokeless tobacco labels and advertising warnings.
Sec. 205. Authority to revise smokeless tobacco product warning label 
                            statements.
Sec. 206. Tar, nicotine, and other smoke constituent disclosure to the 
                            public.
       TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS

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

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) The use of tobacco products by the Nation's children is 
        a pediatric disease of considerable proportions that results in 
        new generations of tobacco-dependent children and adults.
            (2) A consensus exists within the scientific and medical 
        communities that tobacco products are inherently dangerous and 
        cause cancer, heart disease, and other serious adverse health 
        effects.
            (3) Nicotine is an addictive drug.
            (4) Virtually all new users of tobacco products are under 
        the minimum legal age to purchase such products.
            (5) Tobacco advertising and marketing contribute 
        significantly to the use of nicotine-containing tobacco 
        products by adolescents.
            (6) Because past efforts to restrict advertising and 
        marketing of tobacco products have failed adequately to curb 
        tobacco use by adolescents, comprehensive restrictions on the 
        sale, promotion, and distribution of such products are needed.
            (7) Federal and State governments have lacked the legal and 
        regulatory authority and resources they need to address 
        comprehensively the public health and societal problems caused 
        by the use of tobacco products.
            (8) Federal and State public health officials, the public 
        health community, and the public at large recognize that the 
        tobacco industry should be subject to ongoing oversight.
            (9) Under article I, section 8 of the Constitution, the 
        Congress is vested with the responsibility for regulating 
        interstate commerce and commerce with Indian tribes.
            (10) The sale, distribution, marketing, advertising, and 
        use of tobacco products are activities in and substantially 
        affecting interstate commerce because they are sold, marketed, 
        advertised, and distributed in interstate commerce on a 
        nationwide basis, and have a substantial effect on the Nation's 
        economy.
            (11) The sale, distribution, marketing, advertising, and 
        use of such products substantially affect interstate commerce 
        through the health care and other costs attributable to the use 
        of tobacco products.
            (12) It is in the public interest for Congress to enact 
        legislation that provides the Food and Drug Administration with 
        the authority to regulate tobacco products and the advertising 
        and promotion of such products. The benefits to the American 
        people from enacting such legislation would be significant in 
        human and economic terms.
            (13) Tobacco use is the foremost preventable cause of 
        premature death in America. It causes over 400,000 deaths in 
        the United States each year, and approximately 8,600,000 
        Americans have chronic illnesses related to smoking.
            (14) Reducing the use of tobacco by minors by 50 percent 
        would prevent well over 10,000,000 of today's children from 
        becoming regular, daily smokers, saving over 3,000,000 of them 
        from premature death due to tobacco-induced disease. Such a 
        reduction in youth smoking would also result in approximately 
        $75,000,000,000 in savings attributable to reduced health care 
        costs.
            (15) Advertising, marketing, and promotion of tobacco 
        products have been especially directed to attract young persons 
        to use tobacco products, and these efforts have resulted in 
        increased use of such products by youth. Past efforts to 
        oversee these activities have not been successful in adequately 
        preventing such increased use.
            (16) In 2005, the cigarette manufacturers spent more than 
        $13,000,000,000 to attract new users, retain current users, 
        increase current consumption, and generate favorable long-term 
        attitudes toward smoking and tobacco use.
            (17) Tobacco product advertising often misleadingly 
        portrays the use of tobacco as socially acceptable and 
        healthful to minors.
            (18) Tobacco product advertising is regularly seen by 
        persons under the age of 18, and persons under the age of 18 
        are regularly exposed to tobacco product promotional efforts.
            (19) Through advertisements during and sponsorship of 
        sporting events, tobacco has become strongly associated with 
        sports and has become portrayed as an integral part of sports 
        and the healthy lifestyle associated with rigorous sporting 
        activity.
            (20) Children are exposed to substantial and unavoidable 
        tobacco advertising that leads to favorable beliefs about 
        tobacco use, plays a role in leading young people to 
        overestimate the prevalence of tobacco use, and increases the 
        number of young people who begin to use tobacco.
            (21) The use of tobacco products in motion pictures and 
        other mass media glamorizes its use for young people and 
        encourages them to use tobacco products.
            (22) Tobacco advertising expands the size of the tobacco 
        market by increasing consumption of tobacco products including 
        tobacco use by young people.
            (23) Children are more influenced by tobacco marketing than 
        adults: more than 80 percent of youth smoke three heavily 
        marketed brands, while only 54 percent of adults, 26 and older, 
        smoke these same brands.
            (24) Tobacco company documents indicate that young people 
        are an important and often crucial segment of the tobacco 
        market. Children, who tend to be more price sensitive than 
        adults, are influenced by advertising and promotion practices 
        that result in drastically reduced cigarette prices.
            (25) Comprehensive advertising restrictions will have a 
        positive effect on the smoking rates of young people.
            (26) Restrictions on advertising are necessary to prevent 
        unrestricted tobacco advertising from undermining legislation 
        prohibiting access to young people and providing for education 
        about tobacco use.
            (27) International experience shows that advertising 
        regulations that are stringent and comprehensive have a greater 
        impact on overall tobacco use and young people's use than 
        weaker or less comprehensive ones.
            (28) Text only requirements, although not as stringent as a 
        ban, will help reduce underage use of tobacco products while 
        preserving the informational function of advertising.
            (29) It is in the public interest for Congress to adopt 
        legislation to address the public health crisis created by 
        actions of the tobacco industry.
            (30) The final regulations promulgated by the Secretary of 
        Health and Human Services in the August 28, 1996, issue of the 
        Federal Register (61 Fed. Reg. 44615-44618) for inclusion as 
        part 897 of title 21, Code of Federal Regulations, are 
        consistent with the first amendment to the United States 
        Constitution and with the standards set forth in the amendments 
        made by this subtitle for the regulation of tobacco products by 
        the Food and Drug Administration, and the restriction on the 
        sale and distribution of, including access to and the 
        advertising and promotion of, tobacco products contained in 
        such regulations are substantially related to accomplishing the 
        public health goals of this Act.
            (31) The regulations described in paragraph (30) will 
        directly and materially advance the Federal Government's 
        substantial interest in reducing the number of children and 
        adolescents who use cigarettes and smokeless tobacco and in 
        preventing the life-threatening health consequences associated 
        with tobacco use. An overwhelming majority of Americans who use 
        tobacco products begin using such products while they are 
        minors and become addicted to the nicotine in those products 
        before reaching the age of 18. Tobacco advertising and 
        promotion play a crucial role in the decision of these minors 
        to begin using tobacco products. Less restrictive and less 
        comprehensive approaches have not and will not be effective in 
        reducing the problems addressed by such regulations. The 
        reasonable restrictions on the advertising and promotion of 
        tobacco products contained in such regulations will lead to a 
        significant decrease in the number of minors using and becoming 
        addicted to those products.
            (32) The regulations described in paragraph (30) impose no 
        more extensive restrictions on communication by tobacco 
        manufacturers and sellers than are necessary to reduce the 
        number of children and adolescents who use cigarettes and 
        smokeless tobacco and to prevent the life-threatening health 
        consequences associated with tobacco use. Such regulations are 
        narrowly tailored to restrict those advertising and promotional 
        practices which are most likely to be seen or heard by youth 
        and most likely to entice them into tobacco use, while 
        affording tobacco manufacturers and sellers ample opportunity 
        to convey information about their products to adult consumers.
            (33) Tobacco dependence is a chronic disease, one that 
        typically requires repeated interventions to achieve long-term 
        or permanent abstinence.
            (34) Because the only known safe alternative to smoking is 
        cessation, interventions should target all smokers to help them 
        quit completely.
            (35) Tobacco products have been used to facilitate and 
        finance criminal activities both domestically and 
        internationally. Illicit trade of tobacco products has been 
        linked to organized crime and terrorist groups.
            (36) It is essential that the Food and Drug Administration 
        review products sold or distributed for use to reduce risks or 
        exposures associated with tobacco products and that it be 
        empowered to review any advertising and labeling for such 
        products. It is also essential that manufacturers, prior to 
        marketing such products, be required to demonstrate that such 
        products will meet a series of rigorous criteria, and will 
        benefit the health of the population as a whole, taking into 
        account both users of tobacco products and persons who do not 
        currently use tobacco products.
            (37) Unless tobacco products that purport to reduce the 
        risks to the public of tobacco use actually reduce such risks, 
        those products can cause substantial harm to the public health 
        to the extent that the individuals, who would otherwise not 
        consume tobacco products or would consume such products less, 
        use tobacco products purporting to reduce risk. Those who use 
        products sold or distributed as modified risk products that do 
        not in fact reduce risk, rather than quitting or reducing their 
        use of tobacco products, have a substantially increased 
        likelihood of suffering disability and premature death. The 
        costs to society of the widespread use of products sold or 
        distributed as modified risk products that do not in fact 
        reduce risk or that increase risk include thousands of 
        unnecessary deaths and injuries and huge costs to our health 
        care system.
            (38) As the National Cancer Institute has found, many 
        smokers mistakenly believe that ``low tar'' and ``light'' 
        cigarettes cause fewer health problems than other cigarettes. 
        As the National Cancer Institute has also found, mistaken 
        beliefs about the health consequences of smoking ``low tar'' 
        and ``light'' cigarettes can reduce the motivation to quit 
        smoking entirely and thereby lead to disease and death.
            (39) Recent studies have demonstrated that there has been 
        no reduction in risk on a population-wide basis from ``low 
        tar'' and ``light'' cigarettes, and such products may actually 
        increase the risk of tobacco use.
            (40) The dangers of products sold or distributed as 
        modified risk tobacco products that do not in fact reduce risk 
        are so high that there is a compelling governmental interest in 
        ensuring that statements about modified risk tobacco products 
        are complete, accurate, and relate to the overall disease risk 
        of the product.
            (41) As the Federal Trade Commission has found, consumers 
        have misinterpreted advertisements in which one product is 
        claimed to be less harmful than a comparable product, even in 
        the presence of disclosures and advisories intended to provide 
        clarification.
            (42) Permitting manufacturers to make unsubstantiated 
        statements concerning modified risk tobacco products, whether 
        express or implied, even if accompanied by disclaimers would be 
        detrimental to the public health.
            (43) The only way to effectively protect the public health 
        from the dangers of unsubstantiated modified risk tobacco 
        products is to empower the Food and Drug Administration to 
        require that products that tobacco manufacturers sold or 
        distributed for risk reduction be reviewed in advance of 
        marketing, and to require that the evidence relied on to 
        support claims be fully verified.
            (44) The Food and Drug Administration is a regulatory 
        agency with the scientific expertise to identify harmful 
        substances in products to which consumers are exposed, to 
        design standards to limit exposure to those substances, to 
        evaluate scientific studies supporting claims about the safety 
        of products, and to evaluate the impact of labels, labeling, 
        and advertising on consumer behavior in order to reduce the 
        risk of harm and promote understanding of the impact of the 
        product on health. In connection with its mandate to promote 
        health and reduce the risk of harm, the Food and Drug 
        Administration routinely makes decisions about whether and how 
        products may be marketed in the United States.
            (45) The Federal Trade Commission was created to protect 
        consumers from unfair or deceptive acts or practices, and to 
        regulate unfair methods of competition. Its focus is on those 
        marketplace practices that deceive or mislead consumers, and 
        those that give some competitors an unfair advantage. Its 
        mission is to regulate activities in the marketplace. Neither 
        the Federal Trade Commission nor any other Federal agency 
        except the Food and Drug Administration possesses the 
        scientific expertise needed to implement effectively all 
        provisions of the Family Smoking Prevention and Tobacco Control 
        Act.
            (46) If manufacturers state or imply in communications 
        directed to consumers through the media or through a label, 
        labeling, or advertising, that a tobacco product is approved or 
        inspected by the Food and Drug Administration or complies with 
        Food and Drug Administration standards, consumers are likely to 
        be confused and misled. Depending upon the particular language 
        used and its context, such a statement could result in 
        consumers being misled into believing that the product is 
        endorsed by the Food and Drug Administration for use or in 
        consumers being misled about the harmfulness of the product 
        because of such regulation, inspection, approval, or 
        compliance.
            (47) 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).
            (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 Act are--
            (1) to provide authority to the Food and Drug 
        Administration to regulate tobacco products under the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), by 
        recognizing it as the primary Federal regulatory authority with 
        respect to the manufacture, marketing, and distribution of 
        tobacco products as provided for in this Act;
            (2) to ensure that the Food and Drug Administration has the 
        authority to address issues of particular concern to public 
        health officials, especially the use of tobacco by young people 
        and dependence on tobacco;
            (3) to authorize the Food and Drug Administration to set 
        national standards controlling the manufacture of tobacco 
        products and the identity, public disclosure, and amount of 
        ingredients used in such products;
            (4) to provide new and flexible enforcement authority to 
        ensure that there is effective oversight of the tobacco 
        industry's efforts to develop, introduce, and promote less 
        harmful tobacco products;
            (5) to vest the Food and Drug Administration with the 
        authority to regulate the levels of tar, nicotine, and other 
        harmful components of tobacco products;
            (6) in order to ensure that consumers are better informed, 
        to require tobacco product manufacturers to disclose research 
        which has not previously been made available, as well as 
        research generated in the future, relating to the health and 
        dependency effects or safety of tobacco products;
            (7) to continue to permit the sale of tobacco products to 
        adults in conjunction with measures to ensure that they are not 
        sold or accessible to underage purchasers;
            (8) to impose appropriate regulatory controls on the 
        tobacco industry;
            (9) to promote cessation to reduce disease risk and the 
        social costs associated with tobacco-related diseases; and
            (10) to strengthen legislation against illicit trade in 
        tobacco products.

SEC. 4. SCOPE AND EFFECT.

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

SEC. 5. SEVERABILITY.

    If any provision of this Act, of the amendments made by this Act, 
or of the regulations promulgated under this Act (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 Act, 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.

         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-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;
            ``(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 
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, 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 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.
                    ``(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.

``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 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 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;
                            ``(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
                    ``(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 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--
            ``(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. Such fees are authorized to remain available until 
        expended. Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to such 
        appropriation account for salaries and expenses with such 
        fiscal year limitation.
            ``(2) Availability.--
                    ``(A) In general.--Fees appropriated under 
                paragraph (3) are available only for the purpose of 
                paying the costs of the activities of the Food and Drug 
                Administration related to the regulation of tobacco 
                products under this chapter and the Family Smoking 
                Prevention and Tobacco Control Act. No fees collected 
                under subsection (a) may be used for any other costs.
                    ``(B) Prohibition against use of other funds.--
                            ``(i) In general.--Except as provided in 
                        clause (ii), fees collected under subsection 
                        (a) are the only funds authorized to be made 
                        available for the purpose described in 
                        subparagraph (A).
                            ``(ii) Startup costs.--Clause (i) does not 
                        apply until the date on which the Secretary has 
                        collected fees under subsection (a) for 2 
                        fiscal year quarters. Any amounts provided to 
                        pay the costs described in subparagraph (A) 
                        prior to the date described in the previous 
                        sentence shall be reimbursed through fees 
                        collected under subsection (a).
            ``(3) Authorization of appropriations.--For fiscal year 
        2009 and each subsequent fiscal year, there is authorized to be 
        appropriated for fees under this section an amount equal to the 
        amount specified in subsection (b)(1) for the fiscal year.
    ``(d) Collection of Unpaid Fees.--In any case where the Secretary 
does not receive payment of a fee assessed under subsection (a) within 
30 days after it is due, such fee shall be treated as a claim of the 
United States Government subject to subchapter II of chapter 37 of 
title 31, United States Code.
    ``(e) Applicability to Fiscal Year 2009.--If the date of 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 Act; and
                    (B) shall be deemed to be in compliance with all 
                applicable provisions of chapter 5 of title 5, United 
                States Code, and all other provisions of law relating 
                to rulemaking procedures.
            (2) Contents of rule.--Except as provided in this 
        subsection, the final rule published under paragraph (1), shall 
        be identical in its provisions to part 897 of the regulations 
        promulgated by the Secretary of Health and Human Services in 
        the August 28, 1996, issue of the Federal Register (61 Fed. 
        Reg. 44615-44618). Such rule shall--
                    (A) provide for the designation of jurisdictional 
                authority that is in accordance with this subsection in 
                accordance with this Act and the amendments made by 
                this Act;
                    (B) strike Subpart C--Labels and section 897.32(c);
                    (C) strike paragraphs (a), (b), and (i) of section 
                897.3 and insert definitions of the terms 
                ``cigarette'', ``cigarette tobacco'', and ``smokeless 
                tobacco'' as defined in section 900 of the Federal 
                Food, Drug, and Cosmetic Act;
                    (D) insert ``or roll-your-own paper'' in section 
                897.34(a) after ``other than cigarettes or smokeless 
                tobacco'';
                    (E) 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 (2201));
                    (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 Act, the amendments made by this Act, and the 
        implementing regulations (including such provisions, 
        amendments, and regulations relating to the retail sale of 
        tobacco products) are enforced with respect to the United 
        States and Indian tribes.
            (6) Qualified adult-only facility.--A qualified adult-only 
        facility (as such term is defined in section 897.16(d) of the 
        final rule published under paragraph (1)) that is also a 
        retailer and that commits a violation as a retailer shall not 
        be subject to the limitations in section 103(q) and shall be 
        subject to penalties applicable to a qualified adult-only 
        facility.
            (7) Congressional review provisions.--Section 801 of title 
        5, United States Code, shall not apply to the final rule 
        published under paragraph (1).
    (b) Limitation on Advisory Opinions.--As of the date of enactment 
of this Act, the following documents issued by the Food and Drug 
Administration shall not constitute advisory opinions under section 
10.85(d)(1) of title 21, Code of Federal Regulations, except as they 
apply to tobacco products, and shall not be cited by the Secretary of 
Health and Human Services or the Food and Drug Administration as 
binding precedent:
            (1) The preamble to the proposed rule in the document 
        titled ``Regulations Restricting the Sale and Distribution of 
        Cigarettes and Smokeless Tobacco Products to Protect Children 
        and Adolescents'' (60 Fed. Reg. 41314-41372 (August 11, 1995)).
            (2) The document titled ``Nicotine in Cigarettes and 
        Smokeless Tobacco Products is a Drug and These Products Are 
        Nicotine Delivery Devices Under the Federal Food, Drug, and 
        Cosmetic Act'' (60 Fed. Reg. 41453-41787 (August 11, 1995)).
            (3) The preamble to the final rule in the document titled 
        ``Regulations Restricting the Sale and Distribution of 
        Cigarettes and Smokeless Tobacco to Protect Children and 
        Adolescents'' (61 Fed. Reg. 44396-44615 (August 28, 1996)).
            (4) The document titled ``Nicotine in Cigarettes and 
        Smokeless Tobacco is a Drug and These Products are Nicotine 
        Delivery Devices Under the Federal Food, Drug, and Cosmetic 
        Act; Jurisdictional Determination'' (61 Fed. Reg. 44619-45318 
        (August 28, 1996)).

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

    (a) Amendment of Federal Food, Drug, and Cosmetic Act.--Except as 
otherwise expressly provided, whenever in this section an amendment is 
expressed in terms of an amendment to, or repeal of, a section or other 
provision, the reference is to a section or other provision of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
    (b) Section 301.--Section 301 (21 U.S.C. 331) is amended--
            (1) in subsection (a), by inserting ``tobacco product,'' 
        after ``device,'';
            (2) in subsection (b), by inserting ``tobacco product,'' 
        after ``device,'';
            (3) in subsection (c), by inserting ``tobacco product,'' 
        after ``device,'';
            (4) in subsection (e)--
                    (A) by striking the period after ``572(i)''; and
                    (B) by striking ``or 761 or the refusal to permit 
                access to'' and inserting ``761, 909, or 920 or the 
                refusal to permit access to'';
            (5) in subsection (g), by inserting ``tobacco product,'' 
        after ``device,'';
            (6) in subsection (h), by inserting ``tobacco product,'' 
        after ``device,'';
            (7) in subsection (j)--
                    (A) by striking the period after ``573''; and
                    (B) by striking ``708, or 721'' and inserting 
                ``708, 721, 904, 905, 906, 907, 908, 909, or 920(b)'';
            (8) in subsection (k), by inserting ``tobacco product,'' 
        after ``device,'';
            (9) by striking subsection (p) and inserting the following:
    ``(p) The failure to register in accordance with section 510 or 
905, the failure to provide any information required by section 510(j), 
510(k), 905(i), or 905(j), or the failure to provide a notice required 
by section 510(j)(2) or 905(i)(3).'';
            (10) by striking subsection (q)(1) and inserting the 
        following:
    ``(q)(1) The failure or refusal--
            ``(A) to comply with any requirement prescribed under 
        section 518, 520(g), 903(b), 907, 908, or 916;
            ``(B) to furnish any notification or other material or 
        information required by or under section 519, 520(g), 904, 909, 
        or 920; or
            ``(C) to comply with a requirement under section 522 or 
        913.'';
            (11) in subsection (q)(2), by striking ``device,'' and 
        inserting ``device or tobacco product,'';
            (12) in subsection (r), by inserting ``or tobacco product'' 
        after the term ``device'' each time that such term appears; and
            (13) by adding at the end the following:
    ``(oo) The sale of tobacco products in violation of a no-tobacco-
sale order issued under section 303(f).
    ``(pp) The introduction or delivery for introduction into 
interstate commerce of a tobacco product in violation of section 911.
    ``(qq)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, stamp 
(including tax stamp), tag, label, or other identification device upon 
any tobacco product or container or labeling thereof so as to render 
such tobacco product a counterfeit tobacco product.
    ``(2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, stone, or 
other item that is designed to print, imprint, or reproduce the 
trademark, trade name, or other identifying mark, imprint, or device of 
another or any likeness of any of the foregoing upon any tobacco 
product or container or labeling thereof so as to render such tobacco 
product a counterfeit tobacco product.
    ``(3) The doing of any act that causes a tobacco product to be a 
counterfeit tobacco product, or the sale or dispensing, or the holding 
for sale or dispensing, of a counterfeit tobacco product.
    ``(rr) The charitable distribution of tobacco products.
    ``(ss) The failure of a manufacturer or distributor to notify the 
Attorney General and the Secretary of the Treasury of their knowledge 
of tobacco products used in illicit trade.
    ``(tt) With respect to a tobacco product, any statement or 
representation, express or implied, directed to consumers through the 
media or through the label, labeling, or advertising that is false or 
would reasonably be expected to mislead consumers into believing that 
the product is approved by the Food and Drug Administration, or that 
the Food and Drug Administration deems the product to be safe for use 
by consumers, or that the product is endorsed by the Food and Drug 
Administration for use by consumers, or that is false or would 
reasonably be expected to mislead consumers regarding the harmfulness 
of the product because of the Food and Drug Administration's regulation 
or inspection of it or because of its compliance with regulatory 
requirements set by the Food and Drug Administration.''.
    (c) Section 303.--Section 303(f) (21 U.S.C. 333(f)) is amended--
            (1) in paragraph (1)(A), by inserting ``or tobacco 
        products'' after the term ``devices'' each place such term 
        appears;
            (2) in paragraph (5)--
                    (A) in subparagraph (A)--
                            (i) by striking ``assessed'' the first time 
                        it appears and inserting ``assessed, or a no-
                        tobacco-sale order may be imposed,''; and
                            (ii) by striking ``penalty'' the second 
                        time it appears and inserting ``penalty, or 
                        upon whom a no-tobacco-sale order is to be 
                        imposed,'';
                    (B) in subparagraph (B)--
                            (i) by inserting after ``penalty,'' the 
                        following: ``or the period to be covered by a 
                        no-tobacco-sale order,''; and
                            (ii) by adding at the end the following: 
                        ``A no-tobacco-sale order permanently 
                        prohibiting an individual retail outlet from 
                        selling tobacco products shall include 
                        provisions that allow the outlet, after a 
                        specified period of time, to request that the 
                        Secretary compromise, modify, or terminate the 
                        order.''; and
                    (C) by adding at the end the following:
    ``(D) The Secretary may compromise, modify, or terminate, with or 
without conditions, any no-tobacco-sale order.'';
            (3) in paragraph (6)--
                    (A) by inserting ``or the imposition of a no-
                tobacco-sale order'' after the term ``penalty'' each 
                place such term appears; and
                    (B) by striking ``issued.'' and inserting ``issued, 
                or on which the no-tobacco-sale order was imposed, as 
                the case may be.''; and
            (4) by adding at the end the following:
    ``(8) If the Secretary finds that a person has committed repeated 
violations of restrictions promulgated under section 906(d) at a 
particular retail outlet then the Secretary may impose a no-tobacco-
sale order on that person prohibiting the sale of tobacco products in 
that outlet. A no-tobacco-sale order may be imposed with a civil 
penalty under paragraph (1). Prior to the entry of a no-sale order 
under this paragraph, a person shall be entitled to a hearing pursuant 
to the procedures established through regulations of the Food and Drug 
Administration for assessing civil money penalties, including at a 
retailer's request a hearing by telephone, or at the nearest regional 
or field office of the Food and Drug Administration, or at a Federal, 
State, or county facility within 100 miles from the location of the 
retail outlet, if such a facility is available.''.
    (d) Section 304.--Section 304 (21 U.S.C. 334) is amended--
            (1) in subsection (a)(2)--
                    (A) by striking ``and'' before ``(D)''; and
                    (B) by striking ``device.'' and inserting the 
                following: ``device, and (E) Any adulterated or 
                misbranded tobacco product.'';
            (2) in subsection (d)(1), by inserting ``tobacco product,'' 
        after ``device,'';
            (3) in subsection (g)(1), by inserting ``or tobacco 
        product'' after the term ``device'' each place such term 
        appears; and
            (4) in subsection (g)(2)(A), by inserting ``or tobacco 
        product'' after ``device''.
    (e) Section 505.--Section 505(n)(2) (21 U.S.C. 355(n)(2)) is 
amended by striking ``section 904'' and inserting ``section 1004''.
    (f) Section 523.--Section 523(b)(2)(D) (21 U.S.C. 360m(b)(2)(D)) is 
amended by striking ``section 903(g)'' and inserting ``section 
1003(g)''.
    (g) Section 702.--Section 702(a)(1) (U.S.C. 372(a)(1)) is amended--
            (1) by striking ``(a)(1)'' and inserting ``(a)(1)(A)''; and
            (2) by adding at the end the following:
    ``(B)(i) For a tobacco product, to the extent feasible, the 
Secretary shall contract with the States in accordance with this 
paragraph to carry out inspections of retailers within that State in 
connection with the enforcement of this Act.
    ``(ii) The Secretary shall not enter into any contract under clause 
(i) with the government of any of the several States to exercise 
enforcement authority under this Act on Indian 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 (2), (3), and (4) of section 903(a) 
        of the Federal Food, Drug, and Cosmetic Act (as amended by this 
        Act) shall take effect on the date that is 12 months after the 
        date of enactment of this Act. The effective date shall be with 
        respect to the date of manufacture, provided that, in any case, 
        beginning 30 days after such effective date, a manufacturer 
        shall not introduce into the domestic commerce of the United 
        States any product, irrespective of the date of manufacture, 
        that is not in conformance with section 903(a) (2), (3), and 
        (4) and section 920(a) of the Federal Food, Drug, and Cosmetic 
        Act.
            (6) Advertising requirements.--The advertising requirements 
        of section 903(a)(8) of the Federal Food, Drug, and Cosmetic 
        Act (as amended by this Act) shall take effect on the date that 
        is 12 months after the date of enactment of this Act.

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

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

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

SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.

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

``SEC. 4. LABELING.

    ``(a) Label Requirements.--
            ``(1) In general.--It shall be unlawful for any person to 
        manufacture, package, sell, offer to sell, distribute, or 
        import for sale or distribution within the United States any 
        cigarettes the package of which fails to bear, in accordance 
        with the requirements of this section, one of the following 
        labels:
                    ``WARNING: Cigarettes are addictive.
                    ``WARNING: Tobacco smoke can harm your children.
                    ``WARNING: Cigarettes cause fatal lung disease.
                    ``WARNING: Cigarettes cause cancer.
                    ``WARNING: Cigarettes cause strokes and heart 
                disease.
                    ``WARNING: Smoking during pregnancy can harm your 
                baby.
                    ``WARNING: Smoking can kill you.
                    ``WARNING: Tobacco smoke causes fatal lung disease 
                in nonsmokers.
                    ``WARNING: Quitting smoking now greatly reduces 
                serious risks to your health.
            ``(2) Placement; typography; etc.--Each label statement 
        required by paragraph (1) shall be located in the upper portion 
        of the front and rear panels of the package, directly on the 
        package underneath the cellophane or other clear wrapping. Each 
        label statement shall comprise 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.
            ``(4) Adjustment by secretary.--The Secretary may, through 
        a rulemaking under section 553 of title 5, United States Code, 
        adjust the format and type sizes for the label statements 
        required by this section; the text, format, and type sizes of 
        any required tar, nicotine yield, or other constituent 
        (including smoke constituent) disclosures; or the text, format, 
        and type sizes for any other disclosures required under the 
        Federal Food, Drug, and Cosmetic Act. The text of any such 
        label statements or disclosures shall be required to appear 
        only within the 20 percent area of cigarette advertisements 
        provided by paragraph (2). The Secretary shall promulgate 
        regulations which provide for adjustments in the format and 
        type sizes of any text required to appear in such area to 
        ensure that the total text required to appear by law will fit 
        within such area.
    ``(c) Marketing Requirements.--
            ``(1) Random display.--The label statements specified in 
        subsection (a)(1) shall be randomly displayed in each 12-month 
        period, in as equal a number of times as is possible on each 
        brand of the product and be randomly distributed in all areas 
        of the United States in which the product is marketed in 
        accordance with a plan submitted by the tobacco product 
        manufacturer, importer, distributor, or retailer and approved 
        by the Secretary.
            ``(2) Rotation.--The label statements specified in 
        subsection (a)(1) shall be rotated quarterly in alternating 
        sequence in advertisements for each brand of cigarettes in 
        accordance with a plan submitted by the tobacco product 
        manufacturer, importer, distributor, or retailer to, and 
        approved by, the Secretary.
            ``(3) Review.--The Secretary shall review each plan 
        submitted under paragraph (2) and approve it if the plan--
                    ``(A) will provide for the equal distribution and 
                display on packaging and the rotation required in 
                advertising under this subsection; and
                    ``(B) assures that all of the labels required under 
                this section will be displayed by the tobacco product 
                manufacturer, importer, distributor, or retailer at the 
                same time.
            ``(4) Applicability to retailers.--This subsection and 
        subsection (b) apply to a retailer only if that retailer is 
        responsible for or directs the label statements required under 
        this section except that this paragraph shall not relieve a 
        retailer of liability if the retailer displays, in a location 
        open to the public, an advertisement that does not contain a 
        warning label or has been altered by the retailer in a way that 
        is material to the requirements of this subsection and 
        subsection (b).''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
take effect 12 months after the date of enactment of this Act. Such 
effective date shall be with respect to the date of manufacture, 
provided that, in any case, beginning 30 days after such effective 
date, a manufacturer shall not introduce into the domestic commerce of 
the United States any product, irrespective of the date of manufacture, 
that is not in conformance with section 4 of the Federal Cigarette 
Labeling and Advertising Act (15 U.S.C. 1333), as amended by subsection 
(a).

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

    (a) Preemption.--Section 5(a) of the Federal Cigarette Labeling and 
Advertising Act (15 U.S.C. 1334(a)) is amended by striking ``No'' and 
inserting ``Except to the extent the Secretary requires additional or 
different statements on any cigarette package by a regulation, by an 
order, by a standard, by an authorization to market a product, or by a 
condition of marketing a product, pursuant to the Family Smoking 
Prevention and Tobacco Control Act (and the amendments made by that 
Act), or as required under section 903(a)(2) or section 920(a) of the 
Federal Food, Drug, and Cosmetic Act, no''.
    (b) Change in Required Statements.--Section 4 of the Federal 
Cigarette Labeling and Advertising Act (15 U.S.C. 1333), as amended by 
section 201, is further amended by adding at the end the following:
    ``(d) Change in Required Statements.--The Secretary through a 
rulemaking conducted under section 553 of title 5, United States Code--
            ``(1) shall issue regulations within 24 months of the date 
        of enactment of the Family Smoking Prevention and Tobacco 
        Control Act that require color graphics depicting the negative 
        health consequences of smoking to accompany label requirements; 
        and
            ``(2) may thereafter 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 in accordance with a 
        plan submitted by the tobacco product manufacturer, importer, 
        distributor, or retailer and approved by the Secretary.
            ``(B) The label statements specified in subsection (a)(1) 
        shall be rotated quarterly in alternating sequence in 
        advertisements for each brand of smokeless tobacco product in 
        accordance with a plan submitted by the tobacco product 
        manufacturer, importer, distributor, or retailer to, and 
        approved by, the Secretary.
            ``(C) The Secretary shall review each plan submitted under 
        subparagraphs (A) and (B) and approve it if the plan--
                    ``(i) will provide for the equal distribution and 
                display on packaging and the rotation required in 
                advertising under this subsection; and
                    ``(ii) assures that all of the labels required 
                under this section will be displayed by the tobacco 
                product manufacturer, importer, distributor, or 
                retailer at the same time.
            ``(D) This paragraph applies to a retailer only if that 
        retailer is responsible for or directs the label statements 
        under this section, unless the retailer displays, in a location 
        open to the public, an advertisement that does not contain a 
        warning label or has been altered by the retailer in a way that 
        is material to the requirements of this subsection.
            ``(4) The Secretary may, through a rulemaking under section 
        553 of title 5, United States Code, adjust the format and type 
        sizes for the label statements required by this section; the 
        text, format, and type sizes of any required tar, nicotine 
        yield, or other constituent disclosures; or the text, format, 
        and type sizes for any other disclosures required under the 
        Federal Food, Drug, and Cosmetic Act. The text of any such 
        label statements or disclosures shall be required to appear 
        only within the 20 percent area of advertisements provided by 
        paragraph (2). The Secretary shall promulgate regulations which 
        provide for adjustments in the format and type sizes of any 
        text required to appear in such area to ensure that the total 
        text required to appear by law will fit within such area.
    ``(c) Television and Radio Advertising.--It is unlawful to 
advertise smokeless tobacco on any medium of electronic communications 
subject to the jurisdiction of the Federal Communications 
Commission.''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
take effect 12 months after the date of enactment of this Act. Such 
effective date shall be with respect to the date of manufacture, 
provided that, in any case, beginning 30 days after such effective 
date, a manufacturer shall not introduce into the domestic commerce of 
the United States any product, irrespective of the date of manufacture, 
that is not in conformance with section 3 of the Comprehensive 
Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 4402), as 
amended by subsection (a).

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

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

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

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

       TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS

SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPECTION.

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

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

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