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 123STA T . 1 7 7 9PUBLIC LA W 111 – 31 —J U NE 22, 2 0 09 asp a rt897of t i t le21,C o d eof F ederal R e gu latio n s, are c on - sistent w it h the first a m endment to the U nited S tates Constitu- tion and with the standards set forth in the amendments made by this subtitle for the regulation of tobacco products by the Food and D rug A dministration, and the restriction on the sale and distribution of, including access to and the ad v ertising and promotion of, tobacco products contained in such regula- tions are substantially related to accomplishing the public health goals of this division .(3 1 )T he regulations described in paragraph (3 0 ) will directly and materially advance the Federal G overnment ’ s substantial interest in reducing the number of children and adolescents who use cigarettes and smo k eless tobacco and in preventing the life-threatening health conse q uences associated with tobacco use. An overwhelming ma j ority of Americans who use tobacco products begin using such products while they are minors and become addicted to the nicotine in those prod- ucts 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. L ess restrictive and less com- prehensive 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 e x tensive 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. (3 4 ) B ecause the only known safe alternative to smoking is cessation, interventions should target all smokers to help them quit completely. (3 5 ) Tobacco products have been used to facilitate and finance criminal activities both domestically and internation- ally. I llicit trade of tobacco products has been linked to orga- ni z ed crime and terrorist groups. (3 6 ) 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 mar- keting 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.


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 123STA T . 1 780PUBLIC LA W 111 – 31 —J U NE 22, 200 9(37)Unles s tobac co pr o du cts t h at purport to reduce the r i s k s to the public o f tobacco use actuall y reduce such risks , those products can cause substantial har m to the public health tothee x tent that the indi v iduals, w ho would otherwise not consume tobacco products or would consume such products less, use tobacco products purportin g to reduce risk .T hose who use products sold or distributed as modified risk products that do not in fact reduce risk, rather than q uitting 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 distrib - uted as modified risk products that do not in fact reduce risk or that increase risk include thousands of unnecessary deaths and in j uries and huge costs to our health care system. (3 8 ) A s the N ational C ancer I nstitute 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. (3 9 ) R ecent 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. (4 1 )Asthe F ederal Trade Commission has found, con- sumers 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. (4 2 ) P ermitting 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 prod- ucts is to empower the Food and D rug 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 sub- stances 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

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 123STA T . 1 78 1 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9routinelymak e sd e c isions a b out wh ether and how p roducts may be marketed in the U nited S tates .(45)T he F ederal Trade C ommission was created to protect consumers f rom unfair or decepti v e acts or practices , and to re g ulate unfair methods of competition. I ts focus is on those marketplace practices that deceive or mislead consumers, and those that give some competitors an unfair advantage. Its mis - sion is to regulate activities in the marketplace. N either the Federal Trade Commission nor any other Federal agency e x cept the Food and D rug A dministration possesses the scientific expertise needed to implement effectively all provisions of the Family Smoking P revention and Tobacco Control Act. (4 6 ) 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. (4 7 ) In August 20 06 a United States district court j udge found that the major United States cigarette companies con- tinue to target and market to youth. USA v. Philip M orris, USA, Inc., et al. (Civil Action No. 9 9 – 2496 ( GK ), August 1 7, 2006). (4 8 ) 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 subse- q uent 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 . PUR P O SE. The purposes of this division are — (1) to provide authority to the Food and Drug Administra- tion to regulate tobacco products under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3 01 et seq.), by recogni z ing it as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco prod- ucts as provided for in this division (2) to ensure that the Food and Drug Administration has the authority to address issues of particular concern to public health officials, especially the use of tobacco by young people and dependence on tobacco; 21USC387note.


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 123STA T . 1 78 2 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9(3)toau t h o rize the F oo d a n d D ru gA d m ini s tration to set nationa l standards c ontrolling the manu f acture of to b acco p rod - ucts and the identit y, public disclosure, and amount of ingredi- ents used in such products ( 4 )topro v ide ne w and fle x ible 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 re q uire 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 con j unction 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 ris k and the social costs associated with tobacco-related diseases; and ( 10 ) to strengthen legislation against illicit trade in tobacco products .SEC.4 .SC OP E AND E F FEC T . (a) INTE N D ED EF FE C T. —N othing in this division (or an amend- ment made by this division) shall be construed to— (1) establish a precedent with regard to any other industry, situation, circumstance, or legal action; or ( 2 ) affect any action pending in Federal, S tate, or tribal court, or any agreement, consent decree, or contract of any kind. (b) A GRI C UL TUR A L ACTI V ITIE S .— T he provisions of this division (or an amendment made by this division) which authorize the Secretary to take certain actions with regard to tobacco and tobacco products shall not be construed to affect any authority of the Sec- retary of Agriculture under existing law regarding the growing, cultivation, or curing of raw tobacco. (c) R EVENUE ACTIVITIES.—The provisions of this division (or an amendment made by this division) which authorize the Secretary to take certain actions with regard to tobacco products shall not be construed to affect any authority of the Secretary of the Treasury under chapter 52 of the Internal Revenue C ode of 1986. SEC. 5 .SE V E R A BIL IT Y . If any provision of this division, of the amendments made by this division, or of the regulations promulgated under this divi- sion (or under such amendments), or the application of any such provision to any person or circumstance is held to be invalid, the remainder of this division, such amendments and such regula- tions, 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. 21USC387note. 21 USC 387 note.


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 123STA T . 1 78 3 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9SEC.6 . MODIF IC AT IO N OF DEAD L INES FO R SECRETARIAL ACTION. (a)DELAY E DCOM ME NC EMEN T O F DATE S FO RS ECRETAR I AL A CTION .— ( 1 ) I N G ENERAL.— Except a s p rovid edi n s ub section (c) ,w it h respect to an y ti m e periods speci f ied in this division (or in an amendment made by this division) that be g in on the date of enactment of this Act, within which the Secretary of H ea l th and Human Services is re q uired to carry out and complete specified activities, the calculation of such time periods shall commence on the date described in subsection (b). ( 2 ) L IMITATION.—Subsection (a) shall only apply with respect to obligations of the Secretary of Health and Human Services that must be completed within a specified time period and shall not apply to the obligations of any other person or to any other provision of this division (including the amend - ments made by this division) that do not create such obligations of the Secretary and are not contingent on actions by the Secretary. (b) DATE DESCRI B ED.— T he date described in this subsection is the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2 0 10 for which the Secretary of Health and Human Services has collected fees under section 9 19 of the F ederal Food, Drug, and Cosmetic Act (as added by section 101). (c) E X CE P TION.—Subsection (a) shall not apply to any time period (or date) contained— (1) in section 102, except that the reference to ‘ ‘1 8 0 days ’ ’ in subsection (a)(1) of such section shall be deemed to be ‘‘2 7 0 days’’ and (2) in sections 201 through 20 4 (or the amendments made by any such sections). (d) AD JU STMENT.—The Secretary of Health and Human Services may extend or reduce the duration of one or more time periods to which subsection (a) applies if the Secretary determines appro- priate, except that no such period shall be extended for more than 90 days. TI T LE I —AU T HOR IT Y O F THE FOO D A N D DRU G AD M INI S TRATION SEC. 10 1. AMENDMENT OF FEDERAL FOOD , DR UG, AND COSMETIC ACT. (a) DEFINITION OF TOBACCO P RODUCTS.—Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U .S.C. 3 21) 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 5 03(g). ‘‘(3) The products described in paragraph (2) shall be sub j ect to chapter V of this Act. Ap p licab ili ty.


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 123STA T . 1 784PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9‘ ‘ (4)Atobac co pr o du ct sh a l l n otb em ar k eted i n combination w ith an y other article or product re g ulated under this Act (including a drug, biologic, f ood, cosmetic, medical de v ice, or a dietary supple - ment) .’ ’. (b) FD AA UTHORI T YOVE R T O BAC CO P RO D UCT S . — The Federal Food, Drug, and C osmetic Act ( 21U . S .C. 30 1etse q .) is amended— (1) by redesignating chapter IX as chapter X (2) by redesignating sections 9 01 through 910 as sections 1001 through 1010; and (3) by inserting after chapter V III the following

‘ CHAPTERIX— T OB ACCO PRO DU CT S‘ ‘ SEC.90 0. D E FIN I T I O NS. ‘‘In this chapter: ‘‘(1) ADDITIVE.—The term ‘additive’ means any substance the intended use of which results or may reasonably be e x pected 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) B RA N D.—The term ‘brand’ means a variety of tobacco product distinguished by the tobacco used, tar content, nicotine content, flavoring used, si z e, filtration, packaging, logo, reg- istered trademark, brand name, identifiable pattern of colors, or any combination of such attributes. ‘‘(3) CI G ARETTE.—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 L abeling 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 )CO M MERCE.—The term ‘commerce’ has the meaning given that term by section 3(2) of the Federal Cigarette Labeling and Advertising Act. ‘‘( 6 ) COUNTER F EIT TOBACCO P RODUCT.—The term ‘counter- feit 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 21USC387. 21USC3 9 1 ets e q . 21 USC 391 , 3 0 1 note , 392 a n d note, 393 – 399a.


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 123STA T . 1 785PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9pointfr o m t he ori g in al pla c eofman u facture to the per s on w ho sells or d istri b utes the product to indi v iduals for personal consumption .C ommon carriers are not considered distributors for purposes of this chapter. ‘ ‘ (8)IL L IC I T T RADE . —T he term ‘illicit trade ’ means an y prac - tice 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 )I N DIAN C OU NTR Y .—The term ‘Indian country’ has the meaning given such term in section 1 1 5 1 of title 18, U nited S tates Code. ‘‘(1 0 ) INDIAN TRI B E.—The term ‘Indian tribe’ has the meaning given such term in section 4 (e) of the Indian Self- D etermination and E ducation A ssistance Act. ‘‘(11) L ITTLE CI G AR.—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 F ederal Cigarette Labeling and Adver- tising Act. ‘‘(1 2 ) N ICOTINE.—The term ‘nicotine’ means the chemical substance named 3-(1- M ethyl-2-pyrrolidinyl) pyridine or C [ 10 ]H [14]N[2], including any salt or comple x of nicotine. ‘‘(13) P AC K AGE.—The term ‘pac k age’ 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) R ETAILER.—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-O W N 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. ‘‘(1 6 )S M ALL TOBACCO P RODUCT MANU F ACTURER.—The term ‘small tobacco product manufacturer’ means a tobacco product manufacturer that employs fewer than 350 employees. For pur- poses of determining the number of employees of a manufac- turer under the preceding sentence, the employees of a manu- facturer are deemed to include the employees of each entity that controls, is controlled by, or is under common control with such manufacturer. ‘‘(17) SMOKE CON S TITUENT.—The term ‘smoke constituent’ means any chemical or chemical compound in mainstream or sidestream tobacco smoke that either transfers from any compo- nent 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, pow- dered, 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.


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 123STA T . 1 786PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9‘ ‘ (20)TOBAC CO PR O DU C TM A N U F ACTUR E R .— T het e rm ‘t obac co p ro du ct ma n u f acturer ’ mean s an y person ,i nc l udin g any repac k er or relabeler, w ho— ‘‘( A ) manufactures, fabricates, assembles, processes, or labels a tobacco product or ‘‘( B ) imports a finished tobacco product for sale or distribution in the U nited S tates. ‘‘(2 1 ) TOBACCO W ARE H OU S E.— ‘‘(A) Sub j ect to subparagraphs (B) and ( C ), the term ‘tobacco warehouse’ includes any person— ‘‘(i) who— ‘‘( I ) remo v es 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’ e x cludes 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 regula- tion under this chapter of the actions described in such subparagraph is appropriate for the protection of the public health. ‘‘(22) UN I TED STATES.—The term ‘United States’ means the 5 0 States of the United States of America and the D istrict of Columbia, the Commonwealth of P uerto R ico, G uam, the V irgin Islands, American Samoa, W ake Island, M idway Islands, K ingman Reef, J ohnston Atoll, the N orthern Mariana Islands, and any other trust territory or possession of the United States. ‘ ‘ SEC.901 . FDA A UTHORI T Y O V ER TO B ACCO P RODUCTS. ‘‘(a) IN GENERA L .—Tobacco products, including modified risk tobacco products for which an order has been issued in accordance with section 9 11, shall be regulated by the Secretary under this chapter and shall not be subject to the provisions of chapter V. ‘‘(b) APPLICABILIT Y .—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 G ENERAL.—Nothing in this chapter, or any policy issued or regulation promulgated thereunder, or in sections Regulations.21USC387 a.


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 123STA T . 1 78 7 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 910 1 (a), 10 2, or 10 3 o fti t leI , title II, or title III of t h e F a m il yS mo k i ngP re v ention an dT o b a c co C ontrol A ct, s hall be con - str u ed to affect, e xp and, or limit the Secretary ’ s authority over (including the authority to determine w hether 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) LIM I TA TI ON O F A U T H O R IT Y . — ‘‘(A) IN GE NERA L .—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 ware- houses, and tobacco grower cooperatives, nor shall any employee of the Food and D rug Administration have any authority to enter onto a farm owned by a producer of tobacco leaf without the written consent of such producer. ‘‘( B ) EXC E P TION.— N otwithstanding subparagraph (A), if a producer of tobacco leaf is also a tobacco product manufacturer or controlled by a tobacco product manufac- turer, the producer shall be sub j ect 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) R ULE OF CON S TRUCTION.—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) RULEMA K ING PROCE D URES.—Each rulemaking under this chapter shall be in accordance with chapter 5 of title 5, U nited 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 TO B ACCO PRODUCTS.—Not later than 9 0 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) O FFICE TO ASSIST SMALL TOBACCO PRODUCT M ANUFACTUR- ERS.—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 re q uirements of this Act. ‘‘(g) CONSULTATION PRIOR TO RULEMAKING.—Prior to promul- gating rules under this chapter, the Secretary shall endeavor to consult with other Federal agencies as appropriate. ‘ ‘ SEC.902 . ADULT E R ATED T OB ACCO P RODUCTS. ‘‘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 21USC387b.Esta b li s hmen t. D ea d line. Establishment.


text: Dictionary of National Biography, 1885-1900/Moody, John


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 123STA T . 1 78 8 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9ad d e d pois o n o u so r added de l e t erious su b stan c et h at m a y render the product in j urious to health ‘ (2) it has been prepared , pac k ed, or held under insanitary conditions w hereby it may ha v e been contaminated with f ilth, or whereby it may have been rendered injurious to health; ‘‘( 3 ) its packa g e is composed, in whole or in part, of any poisonous or deleterious substance which may render the con - tents 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 91 9 by the date specified in section 919orbythe3 0 th 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 estab- lished under section 90 7 unless such tobacco product is in all respects in conformity with such standard; ‘‘( 6 )( A )itisre q uired 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 . MI S BRAND ED TO BACCO P ROD U CTS. ‘‘(a) INGE NE RAL . — 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 con- tents 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), e x cept that under subparagraph (B) reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the S ecretary; ‘‘(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 estab- lished name prominently printed in type as required by the Secretary by regulation; Regulations.L a b eling. 21USC387c .


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Page:United States Statutes at Large Volume 123.djvu/1809

 123STA T . 1 789PUBLIC LA W 111 – 31 —J U NE 22, 2 0 09 ‘ ‘ (5)iftheS e cr et a r y ha s iss u e d re g u l ati on sre q uiring that its la b eling bear adequate directions for use , or adequate w arnings against use by children, that are necessary for the p rotection of users unless its labeling confor m s in all respects to such regulations ‘‘( 6 ) if it was manufactured, prepared, propagated, com - pounded, or processed in an establishment not duly registered under section 90 5(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 pro v ided 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 par- ticular; 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, pac k er, 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 estab- lished name as described in paragraph ( 4 ), printed promi- nently; and ‘‘(B) a brief statement of— ‘‘(i) the uses of the tobacco product and relevant warnings, precautions, side effects, and contraindica- tions; 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 appro- priate to protect the public health, a full description of the components of such tobacco product or the for- mula showing quantitatively each ingredient of such tobacco product to the e x tent required in regulations which shall be issued by the Secretary after an oppor- tunity 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 ‘‘( 1 0) 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) PRIO RA P PRO VAL O FL A BE LS T ATE M E N T S .— T he 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 F amily Regulations.H ea r ings.


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Page:United States Statutes at Large Volume 123.djvu/1810

 123STA T . 1 790PUBLIC LA W 111 – 31 —J U NE 22, 2009 SmokingPrev en t ion a n dT o b a c co C ontro lA ct ( incl u ding t h e amend - ment s made b y such Act ).N o regulation issued under this sub- section may re q uire p rior approval by the Secretary o f the content of any advertisement , e x cept for modified risk tobacco products as provided in section 91 1. No advertisement of a tobacco product published after the date of enactment of the F amily Smoking Prevention and Tobacco Control Act shall, w ith respect to the lan- guage of label statements as prescribed under section 4 of the Federal Cigarette L abeling and Advertising Act and section 3 of the Comprehensive Smokeless Tobacco H ealth E ducation Act of 19 86 or the regulations issued under such sections, be sub j ect to the provisions of sections 1 2 through 1 5 of the Federal Trade Commission Act. ‘ ‘ SEC.904 . S UBMI SSI ON O FH E ALT H INFO R MATION TO THE SEC - RETAR Y . ‘ ‘(a) REQUIR E M E NT . — Each tobacco product manufacturer or importer, or agents thereof, shall submit to the Secretary the fol- lowing 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, com- pounds, 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 Ciga- rette Labeling and Advertising Act. ‘‘(3) B eginning 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 cur- rent or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives. ‘‘(b) DA TA SU B MI S SI O N.—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 manufac- turer (or agents thereof) on the health, toxicological, behavioral, or physiologic effects of tobacco products and their constituents Ef f ectiv e da te . Effective date. D ead l i n e. 21USC387 d.


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Page:United States Statutes at Large Volume 123.djvu/1811

 123STA T . 1 79 1 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 09 (includ in gsmoke cons t ituents ), ing r edients, com p onents, a nd additi v es .‘ ‘( 2 ) A n y or all documents (including underlying scienti f ic information) relating to researc h activities, and research findings, conducted, supported, or possessed b y the manufac - turer (or agents thereof) that relate to the issue of w hether 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 manufac- turers and distributors. An importer of a tobacco product not manufactured in the U nited S tates shall supply the information re q uired of a tobacco product manufacturer under this subsection. ‘‘(c) TIMEFOR S UB MI S SIO N . — ‘‘( 1 ) I N G ENER AL .—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 F amily Smoking P revention and Tobacco C ontrol Act, the manufacturer of such product shall provide the information required under subsection (a). ‘‘(2) D IS C LOSURE OF A D DI T I V E.—If at any time a tobacco product manufacturer adds to its tobacco products a new tobacco additive or increases the quantity of an e x isting tobacco additive, the manufacturer shall, except as provided in para- graph (3), at least 90 days prior to such action so advise the Secretary in writing. ‘‘(3) DISCLOSURE OF OT H ER 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 6 0 days of such action so advise the Secretary in writing. ‘‘(d) DATA L IST.— ‘‘(1) IN GENERAL.— N ot later than 3 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, and annually thereafter, the Secretary shall pub- lish 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 sub- section (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 2 4 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall establish, and periodically revise Deadlin e . Deadline. R e ports . Re c o m menda - tions. Deadlines. Pub lication. Public in f ormation.


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Page:United States Statutes at Large Volume 123.djvu/1812

 123STA T . 1 79 2 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 09 as a p p ro pr i a te, a l ist o fh ar m f u la nd potentiall y harmful c onstitu - ents, includin g smo k e constituents, to health in each to b acco product by brand and by q uantity in each brand and subbrand .T he S ec- retary 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 prod- ucts and tobacco smoke. ‘ ‘ SEC.905 . AN N U A LR E GI S T RATI O N. ‘ ‘ ( a )DEFIN I T I O N S . —I n this section ‘‘( 1 ) MA N U FA C TU R E, P REPARATION, CO M POUN D IN G , OR PROC- ESSING.—The term ‘manufacture, preparation, compounding, or processing ’ shall include repackaging or other w ise changing the container, wrapper, or labeling of any tobacco product pack- age in furtherance of the distribution of the tobacco product from the original place of manufacture to the person who makes final deli v ery or sale to the ultimate consumer or user. ‘‘( 2 ) N AME.—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) R EGISTRATION BYOW NERS AND OPERATORS.—On or before December 3 1 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 F amily Smoking P revention and Tobacco C ontrol A ct 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.— E very 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 ESTAB L IS H MENTS.—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 proc- essing of a tobacco product or tobacco products. ‘‘(e) U NIFORM PRODUCT IDENTIFICATION SYSTEM.—The Sec- retary may by regulation prescribe a uniform system for the identi- fication 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 Sec- retary shall make available for inspection, to any person so requesting, any registration filed under this section. ‘‘(g) B IENNIAL INSPECTION OF REGISTERED ESTABLISHMENTS.— Every establishment registered with the Secretary under this sec- tion shall be sub j ect 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 Deadlin e .21USC387 e. Pub li c a t i o n. N otice.


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Page:United States Statutes at Large Volume 123.djvu/1813

 123STA T . 1 79 3 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 09 designat ed by t h e S e cr etary at l east o nce in the 2- year p eriod beginning w ith the date o f registration of s u ch establish m ent under this section and at least once in e v ery successive 2-year period thereafter .‘ ‘ ( h )REGISTRA TI ONBYF OREIGN E STAB L IS HM ENTS. —A ny establishment within any foreign country engaged in the manufac- ture , preparation, compounding, or processing of a tobacco product or tobacco products, shall register under this section under regula- tions promulgated by the Secretary. Such regulations shall re q uire such establishment to provide the information required by sub- section (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 U nited States, shall be refused admission on any of the grounds set forth in section 801 (a). ‘‘(i) REGISTRATION I N F ORMATION.— ‘‘(1) P RO DUC T 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 manufac- tured, 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 Sec- retary 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 accom- panied 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 9 0 7 or which is sub j ect to section 910, a reference to the authority for the mar k eting 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 representa- tive 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 reg- istrant made such determination if the Secretary requests such a statement with respect to that particular tobacco product. ‘‘(2) CONSULTATION W ITH RES P ECT TO FORMS.— T he Sec- retary shall consult with the Secretary of the Treasury in developing the forms to be used for registration under this section to minimi z e the burden on those persons required to register with both the Secretary and the Ta x and Trade Bureau of the D epartment of the Treasury. Regulations.


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Page:United States Statutes at Large Volume 123.djvu/1814

 123STA T . 1 794PUBLIC LA W 111 – 31 —J U NE 22, 2 0 09 ‘ ‘ (3)BIAN N U A LREPO R T O F AN YCH AN G EINPRO D UCT LI S T .—Eachpersonw ho re gi s t ers with the S ecretar yu n d er this section sha l l report to the Secretary once during the m onth o fJ une of each year and once during the month of D ecem b er 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 pre v iously 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 re q uired by paragraph (1). ‘‘(B) I f 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 estab - lished 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 ) R EPORT P RECEDING INTRODUCTION OF CERTAIN SU B STAN- TIALLY E Q UI V ALENT PRODUCTS INTO INTERSTATE CO M MERCE.— ‘‘(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 mar k eted (other than for test marketing) in the U nited States as of F ebruary 1 5, 20 0 7 , shall, at least 9 0 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 compli- ance 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 compli- ance with the requirements of this Act, and all of the modifications are covered by e x emptions granted by the Secretary pursuant to paragraph (3); and Notice. Notice.


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Page:United States Statutes at Large Volume 123.djvu/1815

 123STA T . 1 795PUBLIC LA W 111 – 31 —J U NE 22, 2 0 09 ‘ ‘ (B)action ta ke n bysu c hp e r son to co m p l y w ith the re q uirements un d er section 907 that are applicable to the tobacco product . ‘‘( 2 ) AP P LICAT I ON TOC ER TAIN PO S T -F E B R U AR Y15,20 0 7, PRO D - UCTS. — A report under this subsection f or a tobacco product that was first introduced or deli v ered for introduction into interstate commerce for commercial distribution in the U nited S tates after F ebruary 15, 2007, and prior to the date that is 21 months after the date of enactment of the Family Smokin gP revention and T obacco C ontrol Act shall be submitted to the Secretary not later than 21 months after such date of enact- ment. ‘‘( 3 ) EX E M PTIONS.— ‘‘(A) I N G ENERAL.—The Secretary may e x empt from the requirements of this subsection relating to the dem- onstration that a tobacco product is substantially equiva- lent 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 modifica- tion 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) R EGULATIONS.— N ot later than 15 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall issue regula- tions to implement this paragraph. ‘ ‘ SEC.906 . G E N E RALP R OVI SIONS RESPEC T ING CONTROL O F TO B ACCO PRO DU CTS. ‘‘(a) IN G ENERAL.—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 require- ment 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, 90 8, 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 Notice.F e d e ralR e g i s ter ,pub licatio n . A pplicabilit y . 21USC387f . D eadline.


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Page:United States Statutes at Large Volume 123.djvu/1816

 123STA T . 1 796PUBLIC LA W 111 – 31 —J U NE 22, 2 0 09 ‘ ‘ (2)thep e riodw ithi n whi c h intere s ted persons may present their comments on the notice or f indin g s (inc lu ding the need therefore) orally or in writing , which period shall b e at least 60 days but may not e x ceed 9 0 days unless the time is extended by the S ecretary by a notice published in the F ederal R egister stating good cause therefore . ‘‘(c) LIM I TEDCONF IDENTI AL IT Y OF I NFO R MATION. —A ny informa - tion reported to or otherwise obtained by the Secretary or the Secretary ’ s representati v e under section 90 3 ,90 4 ,90 7 ,90 8, 909, 9 1 0, 911, or 704, or under subsection (e) or (f) of this section, which is exempt from disclosure under subsection (a) of section 5 52 of title 5, U nited 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) RE S TRI C TIONS.— ‘‘(1) IN G ENERAL.— T he Secretary may by regulation re q uire 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 deter- mines that such regulation would be appropriate for the protec- tion 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 protec- tion of the public health shall be determined with respect to the ris k s 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. N o such regulation may require that the sale or distribution of a tobacco product be limited to the written or oral authori z a- tion of a practitioner licensed by law to prescribe medical products. ‘‘(2) LA B EL 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) M ATC H BOO K S.—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 Timep e r i od.


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Page:United States Statutes at Large Volume 123.djvu/1817

 123STA T . 1 79 7 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 09 oft o bac co pr o du ct s, s h a l lb e co n s i dered as adult -w ritten publications which shall be per m itted to contain ad v er- tisin g.N otwithstanding the preceding sentence, if the S ec- retar y finds that such treatment of matchboo k sisnot appropriate for the protection of the public health, the Secretary may determine by regulation that matchbooks shall not be considered adult-written publications. ‘ ‘ (4)REMOT E SAL ES. — ‘‘( A ) ING ENE R AL.— T he Secretary shall— ‘‘(i) within 18 months after the date of enactment of the F amily Smoking P revention and Tobacco C ontrol Act, promulgate regulations regarding the sale and distribution of tobacco products that occur through means other than a direct, face-to-face e x change between a retailer and a consumer in order to prevent the sale and distribution of tobacco products to individ- uals who have not attained the minimum age estab- lished by applicable law for the purchase of such prod- ucts, including re q uirements for age verification and ‘‘(ii) within 2 years after such date of enactment, issue regulations to address the promotion and mar- keting 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 min- imum age established by applicable law for the pur- chase of such products. ‘‘( B ) RELAT I ONTOOT H ERA U THORIT Y .—Nothing in this paragraph limits the authority of the Secretary to take additional actions under the other paragraphs of this sub- section. ‘‘(e) G OO DM ANU F A C TURING PRACTICE RE Q UIREMENTS.— ‘‘(1) METHODS, FACILITIES, AND CONTROLS TO CONFORM.— ‘‘(A) IN GENERAL.—In applying manufacturing restric- tions 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 ha z ard analysis and critical control point methodology, as prescribed in such regulations to assure that the public health is pro- tected 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 Sci- entific Advisory Committee an opportunity to submit recommendations with respect to the regulation pro- posed to be promulgated; Recom me nda-ti on s. Re gul ations. D eadlines. Regulations.


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Page:United States Statutes at Large Volume 123.djvu/1818

 123STA T . 1 798PUBLIC LA W 111 – 31 —J U NE 22, 2 0 09 ‘ ‘ (i i )befor e p ro mulgat i n gan y regulation un d er s ubparagrap h ( A ) , afford opportunity for an oral hearing ‘‘(iii) pro v ide the T oba c co P roducts S cientific Advisory C ommittee a reasonable time to ma k e its recommendation w ith respect to proposed regulations under subparagraph (A); ‘‘(iv) in establishing the effective date of a regula - tion 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 e x isting manufacturing facilities, and shall provide for a reasonable period of time for such manufacturers to conform to good manufacturing practices; and ‘‘(v) not re q uire any small tobacco product manu- facturer to comply with a regulation under subpara- graph (A) for at least 4 years following the effective date established by the Secretary for such regulation . ‘‘( 2 ) EXEMPTIONS VAR IAN C ES. — ‘‘(A) PETITION.—Any person sub j ect 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 peti- tioner ’ 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 Sec- retary shall prescribe. ‘‘( B ) R E F ERRA L TOT H ETO B ACCO PRO DU CTS SCIENTIFIC ADVISOR Y COMMITTEE.—The Secretary may refer to the Tobacco Products Scientific Advisory Committee any peti- tion submitted under subparagraph (A). The Tobacco Prod- ucts Scientific Advisory Committee shall report its rec- ommendations to the Secretary with respect to a petition referred to it within 60 days after the date of the petition’s referral. W ithin 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 Reports.D e adlin e. C o m plian c e date. H earin g s.


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Page:United States Statutes at Large Volume 123.djvu/1819

 123STA T . 1 79 9 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 09 tha t compli a n c ew ith su ch r e q uirement is not require d to assure that the to b acco product will be in compliance with this chapter and ‘ ‘ ( ii ) a petition f ora v ariance for a tobacco product from a requirement if the S ecretar y determines that the methods to be used in , and the facilities and con - trols to be used for, the manufacture, pac k in g , 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 ) CONDIT ION S . —A n order of the Secretary approving a petition for a variance shall prescribe such conditions respecting the methods used in, and the facilities and con- trols 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 ) HEAR IN G .—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 )CO MPL IAN C E.—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 F amily Smoking P revention and T obacco Control Act. ‘‘(f) R ESEARC H AND DE V ELOPMENT.—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 . TOBA CCO PR O DU CT STA N DARDS. ‘‘(a) I N G ENERAL.— ‘‘( 1 ) SPECIAL R U LES.— ‘‘(A) SPECIAL RULE F OR 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, pine- apple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characteri z ing flavor of the tobacco product or tobacco smoke. N othing 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 Preven- tion and Tobacco Control Act, a tobacco product manufac- turer 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. Ef f ectiv e da te s.21USC387g .


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Page:United States Statutes at Large Volume 123.djvu/1820

 123STA T . 1 80 0 PUBLIC LA W 111 – 31 —J U NE 22, 200 9‘ ‘ (2)REVIS I ON O FT O BAC CO PR O DU CT STANDARDS .—TheS e c-r e ta r ym ay re vis ethet ob acco p ro du ct sta n dards in para g raph ( 1 ) in accordance w ith subsection (c). ‘‘( 3 ) TOBACCO PRODUCT STANDARDS.— ‘‘( A ) I N G ENERA L .—The Secretary may adopt tobacco product standards in addition to those in paragraph (1) i f the Secretary finds that a tobacco product standard is appropriate for the protection of the pub l ic health. ‘‘( B ) D ETER M INATIONS.— ‘‘(i) C ONSIDERATIONS.—In ma k ing a finding described in subparagraph (A) , the Secretary shall con- sider 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 e x isting 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 re q uire 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 ob j ecting 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 Sec- retary ’ s consideration scientific evidence that dem- onstrates 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, compo- nents, 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;


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Page:United States Statutes at Large Volume 123.djvu/1821

 123STA T . 1 80 1 PUBLIC LA W 111 – 31 —J U NE 22, 200 9‘ ‘ (i ii )prov i s io n s f or them e a s u rement of the to b a c co pro d uct characteristics of the tobacco product ‘‘(iv) provisions re q uirin g that the resu l ts of each or of certain of the tests of the tobacco product required to be made under clause (ii) sho w that the tobacco product is in conformit y with the portions of the standard for which the test or tests were required; and ‘‘(v) a provision requiring that the sale and dis - tribution of the tobacco product be restricted but only tothee x tent 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 pre- scribe 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 ) PERIOD I C REE VALU A T IO N O F TO B ACCO P RODUCT S TAND- ARDS. —T he S ecretary 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 Sec- retary may provide for testing under paragraph ( 4 )( B )byany person. ‘‘(6) I NVOLVE M ENT OF OT H ERA G ENCIES; INFORMED PER- SONS.—In carrying out duties under this section, the Secretary shall endeavor to— ‘‘( A ) use personnel, facilities, and other technical sup- port available in other F ederal agencies; ‘‘(B) consult with other Federal agencies concerned with standard setting and other nationally or internationally recogni z ed standard-setting entities; and ‘‘(C) invite appropriate participation, through j oint or other conferences, wor k shops, or other means, by informed persons representative of scientific, professional, industry, agricultural, or consumer organizations who in the Sec- retary ’ s judgment can make a significant contribution. ‘‘(b) CONSIDERATIONS B Y SECRETARY.— ‘‘( 1 ) TECHNICAL ACHIEVABILITY.—The Secretary shall con- sider information submitted in connection with a proposed standard regarding the technical achievability of compliance with such standard. ‘‘( 2 ) O THER 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 adoles- cent 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 Fed- eral R egister a notice of proposed rulemaking for the establish- ment, amendment, or revocation of any tobacco product standard. Fed e ralR e gist er ,pub li c ati on.N otice. C onsultation.


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Page:United States Statutes at Large Volume 123.djvu/1822

 123STA T . 1 80 2 PUBLIC LA W 111 – 31 —J U NE 22, 200 9‘ ‘ (2)REQUIR E M E NTSOF NOTI C E .—Anotice o fpr opo s e d r ul e -mak in g for t h e esta b lishment or amendment of a tobacco product standard for a tobacco product shall— ‘‘(A) set forth a finding w ith supporting j ustification that the tobacco product standard is appropriate for the protection of the public health ‘‘( B )in v ite interested persons to submit a draft or proposed tobacco product standard for consideration b y the S ecretary; ‘‘( 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 ) F IN D IN G .—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.— T he Secretary shall provide for a comment period of not less than 60 days. ‘‘(d) P ROMU L G A TION.— ‘‘( 1 ) I N GENERAL.—After the e x piration 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) E FFECTI V E 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 nec- essary for the protection of the public health. Such date or dates shall be established so as to minimi z e, consistent with the public health, economic loss to, and disruption or dislocation of, domestic and international trade. In establishing such effec- tive 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 manufac- turers re q uiring substantial changes to the methods of farming the domestically grown tobacco used by the manufacturer, the Publicat i on.N otic e . R e g ulation s . F e d e r al Register ,p ublication.


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Page:United States Statutes at Large Volume 123.djvu/1823

 123STA T . 1 80 3 PUBLIC LA W 111 – 31 —J U NE 22, 200 9ef fe ctiv e da te o ft h at pr od u ct s ta n dard sha l l b e not less than 2y ears after the date of publication of the final re g ulation establishing the standard .‘ ‘ (3)LIM I TA TI ON ON P O WERG RANTE D TOT H E F OOD AND DR U G ADMINI S TRATION. —B ecause of the i m portance of a decision of the S ecretary to issue a regulation— ‘‘( A ) banning all cigarettes , all smo k eless tobacco prod - ucts, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-o w n tobacco products or ‘‘(B) re q uiring the reduction of nicotine yields of a tobacco product to z ero, the Secretary is prohibited from taking such actions under this Act. ‘‘( 4 ) AMENDMENT; RE V O C ATION.— ‘‘(A) AUTHORIT Y .— T he 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) E FFECTIVE DATE.—The Secretary may declare a proposed amendment of a tobacco product standard to be effective on and after its publication in the F ederal R egister 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 ) REFERRA L TO ADVISORY COMMITTEE.— ‘‘(A) I N GENERAL.—The Secretary may refer a proposed regulation for the establishment, amendment, or revocation of a tobacco product standard to the Tobacco P roducts Scientific Advisory C ommittee for a report and rec- ommendation with respect to any matter involved in the proposed regulation which requires the e x ercise of scientific j udgment. ‘‘(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 regu- lation. ‘‘(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. Sta t em e n t .D ea dli ne.


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Page:United States Statutes at Large Volume 123.djvu/1824

 123STA T . 1 804PUBLIC LA W 111 – 31 —J U NE 22, 200 9‘ ‘ (E)PUBLICAV AILABILI TY.—TheS e cr e ta r ys ha l l m a k e ac op yo f each report a nd recommendat i on u nder su b para -g raph ( D ) publicly a v ailable. ‘‘(e) MEN T HO L C I G A R ETTE S .— ‘‘( 1 ) R E F ERRAL CONSI D ERATIONS.— I mmediately upon the establishment of the Tobacco Products Scientific A dvisory Com- mittee under section 9 1 7 (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 chil- dren, African-Americans, H ispanics, and other racial and ethnic minorities. In its revie w , the Tobacco Products Scientific Advisory Committee shall address the considerations listed in subsections (a)( 3 )( B )(i) and (b). ‘‘( 2 )RE P ORT AND RECO M MENDATION.— N ot later than 1 year after its establishment, the Tobacco Product Scientific Advisory Committee shall submit to the Secretary the report and rec- ommendations re q uired pursuant to paragraph (1). ‘‘(3) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed to limit the Secretary ’ s authority to take action under this section or other sections of this Act applicable to menthol. ‘‘(f) DISSOLVABLE TOBACCO PRODUCTS.— ‘‘(1) REFERRAL; CONSIDERATIONS.—The Secretary shall refer to the Tobacco Products Scientific Advisory Committee for report and recommendation, under section 917(c)(4), the issue of the nature and impact of the use of dissolvable tobacco products on the public health, including such use among chil- dren. In its review, the Tobacco Products Scientific Advisory Committee shall address the considerations listed in subsection (a)(3)(B)(i). ‘‘(2) REPORT AND RECOMMENDATION.—Not later than 2 years after its establishment, the Tobacco Product Scientific Advisory Committee shall submit to the Secretary the report and recommendations required pursuant to paragraph (1). ‘‘(3) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed to limit the Secretary’s authority to take action under this section or other sections of this Act at any time applicable to any dissolvable tobacco product. ‘ ‘ SEC.908 . NOTIF IC A TION AN D OT H E R RE M EDIES. ‘‘(a) NOTIFICATION.—If the Secretary determines that— ‘‘(1) a tobacco product which is introduced or delivered for introduction into interstate commerce for commercial dis- tribution presents an unreasonable risk of substantial harm to the public health; and ‘‘(2) notification under this subsection is necessary to elimi- nate the unreasonable risk of such harm and no more prac- ticable 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. 21USC387h.


text: Dictionary of National Biography, 1885-1900/Moody, Richard Clement


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Page:United States Statutes at Large Volume 123.djvu/1825

 123STA T . 1 805PUBLIC LA W 111 – 31 —J U NE 22, 200 9Befor e is s u i nga nor d er under th is su b se c tion , the S ecretar y sha l l consult w ith the p ersons who are to gi v e notice under the order .‘ ‘ ( b )NOEXEMPTI O NFR OM O T H ER L I AB I L IT Y . —C o m pliance with an order issued under this section shall not relieve any person from liability under Federal or State law. I n 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 ta k en into account. ‘‘(c) R E C ALL AU THORITY.— ‘‘( 1 )IN G ENERAL.—If the Secretary finds that there is a reasonable probability that a tobacco product contains a manu - facturing or other defect not ordinarily contained in tobacco products on the market that would cause serious, adverse health conse q uences or death, the Secretary shall issue an order requiring the appropriate person (including the manufac- turers, importers, distributors, or retailers of the tobacco product) to immediately cease distribution of such tobacco product. T he order shall provide the person sub j ect to the order with an opportunity for an informal hearing, to be held not later than 1 0 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 e x ist to sup- port the actions required by the order, the Secretary shall vacate the order. ‘‘( 2 ) AMEN D MENT O F ORDER TO RE Q UIRE 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 7 0 5 (b). ‘‘( 3 ) REMEDY NOT EXCLU S I V E.—The remedy provided by this subsection shall be in addition to remedies provided by sub- section (a). ‘ ‘ SEC.90 9. R EC O R D S AN DRE P OR T SONTO B ACCO PROD U CTS. ‘‘(a) IN G ENERAL.—Every person who is a tobacco product manu- facturer or importer of a tobacco product shall establish and main- tain such records, make such reports, and provide such information, as the Secretary may by regulation reasonably require to assure Regulations.21USC387 i. N oti f i c ation. T i m eta b le. Re p o r ts. D ea d line. O rder. Consultation.


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Page:United States Statutes at Large Volume 123.djvu/1826

 123STA T . 1 806PUBLIC LA W 111 – 31 —J U NE 22, 200 9tha t suc ht ob acco pr o d uct i s n ot adu l t e rated or m isbranded and to other w ise protect public health .R e g ulations prescribed under the preceding sentence —‘ ‘ (1) ma y re q uire a tobacco product manu f acturer or importer to report to the S ecretary whene v er the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its mar k eted tobacco prod - ucts may have caused or contributed to a serious une x pected 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. I n prescribing regulations under this subsection, the Secretary shall have due regard for the professional ethics of the medical profession and the interests of patients. T he 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) R EPORTS O F RE M O VAL SA NDC ORRE C T I ONS.— ‘‘(1) IN G ENERAL.— E xcept 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 Ap p licab ili ty.


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Page:United States Statutes at Large Volume 123.djvu/1827

 123STA T . 1 807PUBLIC LA W 111 – 31 —J U NE 22, 200 9repo r t e dun der t his su b se c tion sh al l k eep a record o f such correction or re m o v al .‘ ‘ (2)EXCEPTION . —N o report of the corrective action or removal of a tobacco product ma y be re q uired under para g raph ( 1 ) if a report of the corrective action or removal is required and has been submitted under subsection (a). ‘ ‘ SEC.910 . AP P LI CA T I ONF O R RE V IE W OF CERTAIN TO B ACCO PRO D-U CTS. ‘‘(a) I N G ENE RAL .— ‘‘(1) NE W TO B ACCO PRO DU CT DE F INED.— F or purposes of this section the term ‘ne w tobacco product ’ means— ‘‘( A ) any tobacco product (including those products in test markets) that was not commercially marketed in the U nited S tates as of February 1 5, 2 0 0 7; 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 mar - keted in the United States after February 15, 2007. ‘‘(2) P RE M AR K ET RE V IEW RE Q UIRED.— ‘‘(A) NEW PRODUCT S .—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 9 05( 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 e x empt from the requirements of section 905(j) pursuant to a regulation issued under section 905(j)( 3 ). ‘‘(B) APPLICATION TO CERTAIN POST-FEBRUAR Y15 , 20 0 7, 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 Preven- tion and T obacco C ontrol 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 G ENERAL.—In this section and section 905(j), the term ‘substantially equivalent’ or ‘substantial equiva- lence’ means, with respect to the tobacco product being compared to the predicate tobacco product, that the Sec- retary by order has found that the tobacco product— 21USC387j.


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Page:United States Statutes at Large Volume 123.djvu/1828

 123STA T . 1 80 8 PUBLIC LA W 111 – 31 —J U NE 22, 200 9‘ ‘ (i)hast h e sa m e c ha r acteristics as the p re d icate t ob acco prod u ct or ‘‘(ii) has di f fere n t characteristics and the informa - tion submitted contains information , inc l udin g clinical data if deemed necessar y by the S ecretary, that dem- onstrates that it is not appropriate to regulate the product under this section because the product does not raise different q uestions of public health . ‘‘( B ) CHAR A CTE R IS TICS. —I n subparagraph ( A ), the term ‘characteristics ’ means the materials, ingredients, design, composition, heating source, or other features of a tobacco product. ‘‘(C) L I M ITATI ON .—A tobacco product may not be found to be substantially equi v alent to a predicate tobacco product that has been removed from the mar k et at the initiative of the Secretary or that has been determined by a j udicial order to be misbranded or adulterated. ‘‘( 4 ) H EA L TH IN F ORMATION.— ‘‘(A) S U MMAR Y .—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 informa- tion w ill be made available upon request by any person. ‘‘(B) R E Q UIRE D 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 3 0 days of the issuance of a deter- mination that such tobacco product is substantially equiva- lent to another tobacco product. ‘‘(b) A P PLICATION.— ‘‘( 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 prod- ucts; ‘‘(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, proc- essing, and, when relevant, packing and installation of, such tobacco product; ‘‘( D ) an identifying reference to any tobacco product standard under section 90 7 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 ade- quate 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; Public i nformat ion .De a d line.


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Page:United States Statutes at Large Volume 123.djvu/1829

 123STA T . 1 809PUBLIC LA W 111 – 31 —J U NE 22, 2009 ‘ ‘ (F)specim e n s ofth e lab elin g p r opose d to be u sed for such tobacco product and ‘‘( G ) such other information rele v ant to the sub j ect matter of the application as the S ecretar y may re q uire . ‘‘( 2 ) REF E R R ALTO TO B A C CO P RO DU CT S SC I E N TIFIC AD V ISOR Y CO M MITTEE. —U pon receipt of an application meeting the requirements set forth in paragraph ( 1 ) , the Secretary— ‘‘( A ) may, on the Secretary ’ so w n initiative; or ‘‘( B ) may, upon the request of an applicant, refer such application to the T obacco P roducts Scientific Advisory C ommittee 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 recommenda - tion. ‘‘(c) ACTION ON APPLICATION.— ‘‘(1) D EADLINE.— ‘‘(A) I N G ENERAL.—As promptly as possible, but in no event later than 1 80 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 accom- panying 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 e x tent that the sale and distribution of a tobacco product may be restricted under a regulation under section 9 0 6 (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 Sec- retary with respect to such tobacco product, the Secretary finds that— ‘‘(A) there is a lac k 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 par- ticular; or ‘‘(D) such tobacco product is not shown to conform in all respects to a tobacco product standard in effect under