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 123STA T . 1 8 1 0PUBLIC LA W 111 – 31 —J U NE 22, 200 9section907,a n d t h e r eisa l ac k o f ade qu ate infor m ation to j ustif y the de v iation from such standard .‘ ‘ (3)DENIAL IN FORM A T ION. —A ny denial of an a p plication shall, insofar as the S ecretary determines to b e practicable, be accompanied by a statement informin g the applicant of the measures required to remove such application from deniable form ( w hich measures may include further research by the applicant in accordance with 1 or more protocols prescribed by the Secretary). ‘‘( 4 ) B A S IS FOR FIN D IN G .— F or purposes of this section, the finding as to whether the marketing of a tobacco product for which an application has been submitted is appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account— ‘‘(A) the increased or decreased likelihood that e x isting users of tobacco products will stop using such products and ‘‘(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products. ‘‘( 5 ) BASIS FOR A C TION.— ‘‘(A) I N V ESTIGATIONS.—For purposes of paragraph ( 2 )(A), whether permitting a tobacco product to be marketed would be appropriate for the protection of the public health shall, when appropriate, be determined on the basis of well - controlled investigations, which may include 1 or more clinical investigations by experts qualified by training and experience to evaluate the tobacco product. ‘‘(B) O T H ER EVIDENCE.—If the Secretary determines that there exists valid scientific evidence (other than evi- dence derived from investigations described in subpara- graph (A)) which is sufficient to evaluate the tobacco product, the Secretary may authori z e that the determina- tion for purposes of paragraph (2)(A) be made on the basis of such evidence. ‘‘(d) W ITHDRA W AL AND T EM P ORAR Y S U SPENSION.— ‘‘(1) IN GENERAL.—The Secretary shall, upon obtaining, where appropriate, advice on scientific matters from the Tobacco P roducts Scientific Advisory C ommittee, and after due notice and opportunity for informal hearing for a tobacco product for which an order was issued under subsection (c)(1)(A)(i), issue an order withdrawing the order if the Sec- retary finds— ‘‘(A) that the continued marketing of such tobacco product no longer is appropriate for the protection of the public health; ‘‘(B) that the application contained or was accompanied by an untrue statement of a material fact; ‘‘(C) that the applicant— ‘‘(i) has failed to establish a system for maintaining records, or has repeatedly or deliberately failed to maintain records or to make reports, required by an applicable regulation under section 909; Notice.H e ar i ngs . S tate m ent.


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 123STA T . 1 8 11 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9‘ ‘ (i i )hasrefu se dtop er m ita c cess to , or cop y i ng or v erification of, such records as re q uired b y section 704; or ‘‘(iii) has not comp l ied w ith the requirements of section 9 0 5 ‘‘( D ) on the basis of new information before the S ec - retary with respect to such tobacco product, evaluated together with the evidence before the Secretary when the application was reviewed, that the methods used in, or the facilities and controls used for, the manufacture, proc- essing, pac k ing, or installation of such tobacco product do not conform with the requirements of section 90 6 (e) and were not brought into conformity with such require- ments within a reasonable time after receipt of written notice from the Secretary of nonconformity; ‘‘( E ) on the basis of new information before the Sec- retary, evaluated together with the evidence before the Secretary when the application was reviewed, that the labeling of such tobacco product, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary of such fact; or ‘‘( F ) on the basis of new information before the Sec- retary, evaluated together with the evidence before the Secretary when such order was issued, that such tobacco product is not shown to conform in all respects to a tobacco product standard which is in effect under section 907, compliance with which was a condition to the issuance of an order relating to the application, and that there is a lack of adequate information to j ustify the deviation from such standard . ‘‘( 2 ) AP P EAL . —T he holder of an application subject to an order issued under paragraph ( 1 ) withdrawing an order issued pursuant to subsection (c)(1)(A)(i) may, by petition filed on or before the 3 0th day after the date upon which such holder receives notice of such withdrawal, obtain review thereof in accordance with section 912. ‘‘(3) TE M P OR AR YSU SPE N S I ON.— I f, after providing an oppor- tunity for an informal hearing, the Secretary determines there is reasonable probability that the continuation of distribution of a tobacco product under an order would cause serious, adverse health consequences or death, that is greater than ordinarily caused by tobacco products on the market, the Sec- retary shall by order temporarily suspend the authority of the manufacturer to market the product. If the Secretary issues such an order, the Secretary shall proceed e x peditiously under paragraph (1) to withdraw such application. ‘‘(e) SER V I C EO FO R D ER.—An order issued by the Secretary under this section shall be served— ‘‘(1) in person by any officer or employee of the department designated by the Secretary; or ‘‘(2) by mailing the order by registered mail or certified mail addressed to the applicant at the applicant ’ s last known address in the records of the Secretary. ‘‘(f) R ECORDS.— ‘‘(1) ADDI T IONAL INFORMATION.—In the case of any tobacco product for which an order issued pursuant to subsection Reports.O r d er.

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 123STA T . 1 8 12 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9(c) ( 1 )( A )( i ) foran a p p l ica t ion fil edu nder s u b section (b) is in effect , t h e applicant shall establish and m aintain such records, and ma k e such reports to the S ecretar y , as the Secretary may by re g ulation, or by order w ith respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination of, whether there is or may be grounds for withdrawing or temporarily suspending such order .‘ ‘( 2 )A C C ES S TOR ECOR D S. —E ach person re q uired under this section to maintain records, and each person in charge of cus - tody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to ha v e access to and copy and verify such records. ‘‘(g) INV EST IGA TIONA LT O B ACCO P ROD U CTE X E MP TION F OR INVESTIGATIONAL U SE.—The Secretary may e x empt tobacco prod- ucts intended for investigational use from the provisions of this chapter under such conditions as the Secretary may by regulation prescribe. ‘ ‘ SEC.91 1. MODIF IED R IS KT O BA CCO P ROD U CTS. ‘‘(a) IN G ENERAL.— N o person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product unless an order issued pursuant to subsection (g) is effective with respect to such product. ‘‘(b) D EFINITIONS.—In this section ‘‘(1) M ODIFIED RIS K TOBACCO PRODUCT.—The term ‘modified risk tobacco product ’ means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco- related disease associated with commercially marketed tobacco products. ‘‘(2) SOLD OR DISTRIBUTED.— ‘‘(A) IN GENERAL.— W ith respect to a tobacco product, the term ‘sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commer- cially marketed tobacco products’ means a tobacco product— ‘‘(i) the label, labeling, or advertising of which rep- resents explicitly or implicitly that— ‘‘(I) the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products ‘‘(II) the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or ‘‘(III) the tobacco product or its smoke does not contain or is free of a substance; ‘‘(ii) the label, labeling, or advertising of which uses the descriptors ‘light’, ‘mild’, or ‘low’ or similar descriptors; or ‘‘(iii) the tobacco product manufacturer of which has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product’s label, labeling, or advertising, after the date of enactment of the F amily Smoking Preven- tion and Tobacco C ontrol Act, respecting the product 21USC387k.


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 123STA T . 1 8 13 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9tha t wouldber ea s o n abl y e xp e c ted to result i n con - su m ers belie v in g that the tobacco product or its smo k e may present a lower risk o f disease or is less harmful than one or more commercially marketed tobacco prod- ucts , or presents a reduced exposure to, or does not contain or is free of, a substance or substances .‘ ‘ (B)LIM I TA TI ON . —N o tobacco product shall be consid- ered to be ‘sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products ’, except as described in subparagraph ( A ). ‘‘( C ) S MO KEL E S STO B A C CO PR O DU CT.—No smokeless tobacco product shall be considered to be ‘sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products’ solely because its label, labeling, or advertising uses the following phrases to describe such product and its use ‘smokeless tobacco’, ‘smokeless tobacco product’, ‘not con- sumed by smoking’, ‘does not produce smoke’, ‘smokefree’, ‘smoke-free’, ‘without smoke’, ‘no smoke’, or ‘not smoke’. ‘‘( 3 ) EF FECTI V E DATE.— T he provisions of paragraph ( 2 )(A)(ii) shall take effect 1 2 months after the date of enactment of the F amily Smoking P revention and Tobacco Control Act for those products whose label, labeling, or advertising contains the terms described in such paragraph on such date of enact- ment. The effective date shall be with respect to the date of manufacture, provided that, in any case, beginning 3 0 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the U nited States any product, irrespective of the date of manufacture, that is not in conform- ance with paragraph (2)(A)(ii). ‘‘(c) TOBACCO D EPENDENCE PRODUCTS.—A product that is intended to be used for the treatment of tobacco dependence, including smoking cessation, is not a modified risk tobacco product under this section if it has been approved as a drug or device by the Food and Drug Administration and is sub j ect to the re q uire- ments of chapter V . ‘‘(d) FILIN G .—Any person may file with the Secretary an applica- tion for a modified risk tobacco product. Such application shall include— ‘‘(1) a description of the proposed product and any proposed advertising and labeling ‘‘(2) the conditions for using the product; ‘‘(3) the formulation of the product; ‘‘( 4 ) sample product labels and labeling; ‘‘( 5 ) all documents (including underlying scientific informa- tion) relating to research findings conducted, supported, or possessed by the tobacco product manufacturer relating to the effect of the product on tobacco-related diseases and health- related conditions, including information both favorable and unfavorable to the ability of the product to reduce risk or exposure and relating to human health; ‘‘( 6 ) data and information on how consumers actually use the tobacco product; and ‘‘( 7 ) such other information as the Secretary may require. ‘‘(e) PUBLIC AVAILABILIT Y .—The Secretary shall make the application described in subsection (d) publicly available (except Com m entp e ri o d.


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 123STA T . 1 8 1 4PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9mat t ersin t h ea p p l i c ati o n w hich are tra d e secrets or otherwise con f idential , commercial information ) and shall re qu est comments by interested persons on the information contained in the applica - tion and on the label, labelin g ,andad v ertising accompanying such application .‘ ‘ ( f) ADVISORYC O M MI T T E E. — ‘‘( 1 ) ING ENER AL .— T he S ecretary shall refer to the Tobacco P roducts Scientific Advisory Committee any application sub- mitted under this section. ‘‘( 2 ) R E C OMMENDATIONS.— N ot later than 60 days after the date an application is referred to the Tobacco Products Scientific Advisory Committee under paragraph (1), the Advisory Com- mittee shall report its recommendations on the application to the Secretary. ‘‘(g) M AR K ETING.— ‘‘(1) MODI F IED RISK P ROD U CTS.— Ex cept as provided in para- graph (2), the Secretary shall, with respect to an application submitted under this section, issue an order that a modified ris k product may be commercially marketed only if the Sec- retary determines that the applicant has demonstrated that such product, as it is actually used by consumers, will— ‘‘(A) significantly reduce harm and the risk of tobacco- related disease to individual tobacco users and ‘‘( B ) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products. ‘‘(2) SPECIAL RULE FOR CERTAIN PRODUCTS.— ‘‘(A) IN GENERAL.—The Secretary may issue an order that a tobacco product may be introduced or delivered for introduction into interstate commerce, pursuant to an application under this section, with respect to a tobacco product that may not be commercially marketed under paragraph (1) if the Secretary makes the findings required under this paragraph and determines that the applicant has demonstrated that— ‘‘(i) such order would be appropriate to promote the public health; ‘‘(ii) any aspect of the label, labeling, and adver- tising for such product that would cause the tobacco product to be a modified risk tobacco product under subsection (b) is limited to an explicit or implicit rep- resentation that such tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke; ‘‘(iii) scientific evidence is not available and, using the best available scientific methods, cannot be made available without conducting long-term epidemiological studies for an application to meet the standards set forth in paragraph (1); and ‘‘(iv) the scientific evidence that is available with- out conducting long-term epidemiological studies dem- onstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies. Orde r .D e a d lin e. R e po r ts .


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 123STA T . 1 8 1 5PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9‘ ‘ (B)AD D IT I ONALF INDIN GSREQU IRED .—Tois s uean o rd er under su bp ara g rap h (A) t he S e c retar ym ust a l so f ind that the applicant has demonstrated that— ‘‘(i) the magnitude of the o v erall reductions in e x po - sure to the substance or substances w hich are the sub j ect of the application is substantial , such substance or substances are harmful, and the product as actually used exposes consumers to the specified reduced level of the substance or substances ‘‘(ii) the product as actually used by consumers will not expose them to higher levels of other harmful substances compared to the similar types of tobacco products then on the mar k et unless such increases are minimal and the reasonably likely overall impact of use of the product remains a substantial and meas- urable reduction in overall morbidity and mortality among individual tobacco users; ‘‘(iii) testing of actual consumer perception shows that, as the applicant proposes to label and market the product, consumers will not be misled into believing that the product— ‘‘( I ) is or has been demonstrated to be less harmful; or ‘‘(II) presents or has been demonstrated to present less of a risk of disease than 1 or more other commercially marketed tobacco products; and ‘‘(iv) issuance of an order with respect to the application is expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products. ‘‘( C ) CONDITIONS OF M AR K ETING.— ‘‘(i) IN GENERAL.—Applications subject to an order under this paragraph shall be limited to a term of not more than 5 years, but may be renewed upon a finding by the Secretary that the re q uirements of this paragraph continue to be satisfied based on the filing of a new application. ‘‘(ii) AGREEMENTS BY A P PLI C ANT.—An order under this paragraph shall be conditioned on the applicant ’ s agreement to conduct postmarket surveillance and studies and to submit to the Secretary the results of such surveillance and studies to determine the impact of the order on consumer perception, behavior, and health and to enable the Secretary to review the accuracy of the determinations upon which the order was based in accordance with a protocol approved by the Secretary. ‘‘(iii) ANNUAL SUBMISSION.—The results of such postmarket surveillance and studies described in clause (ii) shall be submitted annually. ‘‘( 3 ) BASIS.—The determinations under paragraphs (1) and ( 2 ) shall be based on— ‘‘(A) the scientific evidence submitted by the applicant; and Study.


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 123STA T . 1 8 1 6PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9‘ ‘ (B)scient i f ice v i d ence a nd o t h e r infor m ation that is made avai l a b le to the S ecretar y. ‘‘( 4 )B EN E FIT T OH E AL THOFIN D I V ID U AL S AND OF P OPU - LATION AS A W HOLE. —I nma k in g the determinations u nder p aragraphs ( 1 )and( 2 ) , the Secretary shall take into account— ‘‘( A ) the relative health risks to individuals of the tobacco product that is the sub j ect of the application ‘‘(B) the increased or decreased likelihood that e x isting users of tobacco products w ho would otherwise stop using such products will switch to the tobacco product that is the subject of the application; ‘‘( C ) the increased or decreased likelihood that persons who do not use tobacco products will start using the tobacco product that is the subject of the application; ‘‘( D ) the risks and benefits to persons from the use of the tobacco product that is the subject of the application as compared to the use of products for smoking cessation approved under chapter V to treat nicotine dependence; and ‘‘( E ) comments, data, and information submitted by interested persons. ‘‘(h) ADDITIONAL CONDITIONS FO RM AR K ETIN G .— ‘‘(1) MODIFIED RISK PRODU C TS.— T he Secretary shall re q uire for the marketing of a product under this section that any advertising or labeling concerning modified risk products enable the public to comprehend the information concerning modified risk and to understand the relative significance of such informa- tion in the context of total health and in relation to all of the diseases and health-related conditions associated with the use of tobacco products. ‘‘(2) CO M PARATIVE CLAIMS.— ‘‘(A) IN GENERAL.—The Secretary may require for the marketing of a product under this subsection that a claim comparing a tobacco product to 1 or more other commer- cially marketed tobacco products shall compare the tobacco product to a commercially marketed tobacco product that is representative of that type of tobacco product on the market (for example the average value of the top 3 brands of an established regular tobacco product). ‘‘(B) Q UANTITATIVE COMPARISONS.—The Secretary may also require, for purposes of subparagraph (A), that the percent (or fraction) of change and identity of the reference tobacco product and a quantitative comparison of the amount of the substance claimed to be reduced shall be stated in immediate proximity to the most prominent claim. ‘‘(3) L A B EL DISCLOSURE.— ‘‘(A) IN GENERAL.—The Secretary may require the disclosure on the label of other substances in the tobacco product, or substances that may be produced by the consumption of that tobacco product, that may affect a disease or health-related condition or may increase the risk of other diseases or health-related conditions associ- ated with the use of tobacco products. ‘‘(B) CONDITIONS OF USE.—If the conditions of use of the tobacco product may affect the risk of the product to human health, the Secretary may require the labeling of conditions of use.


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 123STA T . 1 8 1 7PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9‘ ‘ (4)TIME.—Anorde r is s u ed under su b se ct ion ( g )( 1 )s hal l bee f fecti v eforas p ecified period of ti m e. ‘‘( 5 )A DV E RT I S I NG .—The S ecretar y may re q uire ,w ith respect to a product for which an applicant obtained an order under subsection (g)(1), that the product comply with require - ments relating to advertising and promotion of the tobacco product. ‘‘(i) PO STM A R K ETS U RVEI L LAN C E AND STUDIES.— ‘‘(1) I N GENERAL.—The Secretary shall require, with respect to a product for which an applicant obtained an order under subsection (g)(1), that the applicant conduct postmar k et surveil- lance and studies for such a tobacco product to determine the impact of the order issuance on consumer perception, behavior, and health, to enable the Secretary to review the accuracy of the determinations upon which the order was based, and to provide information that the Secretary determines is otherwise necessary regarding the use or health risks involving the tobacco product. The results of postmarket surveillance and studies shall be submitted to the Secretary on an annual basis. ‘‘( 2 ) SURVEILLANCE P ROTOCOL.— E ach applicant required to conduct a surveillance of a tobacco product under paragraph (1) shall, within 30 days after receiving notice that the applicant is required to conduct such surveillance, submit, for the approval of the Secretary, a protocol for the required surveil- lance. The Secretary, within 6 0 days of the receipt of such protocol, shall determine if the principal investigator proposed to be used in the surveillance has sufficient qualifications and e x perience to conduct such surveillance and if such protocol will result in collection of the data or other information des- ignated by the Secretary as necessary to protect the public health. ‘‘( j ) W IT H DRA W ALO F AUTHORI Z ATION.—The Secretary, after an opportunity for an informal hearing, shall withdraw an order under subsection (g) if the Secretary determines that— ‘‘(1) the applicant, based on new information, can no longer make the demonstrations required under subsection (g), or the Secretary can no longer make the determinations required under subsection (g) ‘‘(2) the application failed to include material information or included any untrue statement of material fact; ‘‘(3) any explicit or implicit representation that the product reduces risk or exposure is no longer valid, including if— ‘‘(A) a tobacco product standard is established pursuant to section 9 0 7 ‘‘( B ) an action is taken that affects the risks presented by other commercially marketed tobacco products that were compared to the product that is the subject of the applica- tion; or ‘‘( C ) any postmarket surveillance or studies reveal that the order is no longer consistent with the protection of the public health; ‘‘(4) the applicant failed to conduct or submit the postmarket surveillance and studies required under subsection (g)(2)(C)(ii) or subsection (i); or ‘‘(5) the applicant failed to meet a condition imposed under subsection (h). Hearings.D ea dl ines. Not i c e. Deadline.


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 123STA T . 1 8 18 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9‘ ‘ (k)CHAPTERIVO RV .—Aproductf or whi ch th eS ecret a r y ha s issued a n order pursuant to su b section ( g ) sha l lnotbesub j ect to chapter IV or V. ‘‘(l) I M P L EME N T I N GR EG U LATION S OR G UI D AN C E.— ‘‘( 1 ) SCIENTI F ICE V IDENCE.— N ot later than 2 years after the date of enact m ent of the F amily Smoking P re v ention and T obacco Control Act , the Secretary shall issue regulations or guidance (or any combination thereof) on the scientific evidence re q uired for assessment and ongoing review of modified risk tobacco products. Such regulations or guidance shall— ‘‘(A) to the e x tent that adequate scientific evidence exists, establish minimum standards for scientific studies needed prior to issuing an order under subsection (g) to show that a substantial reduction in morbidity or mortality among individual tobacco users occurs for products described in subsection (g)(1) or is reasonably likely for products described in subsection (g)(2) ‘‘( B ) include validated biomarkers, intermediate clinical endpoints, and other feasible outcome measures, as appro - priate; ‘‘(C) establish minimum standards for postmarket studies, that shall include regular and long-term assess- ments of health outcomes and mortality, intermediate clin- ical endpoints, consumer perception of harm reduction, and the impact on quitting behavior and new use of tobacco products, as appropriate; ‘‘( D ) establish minimum standards for required postmarket surveillance, including ongoing assessments of consumer perception; ‘‘( E ) require that data from the required studies and surveillance be made available to the Secretary prior to the decision on renewal of a modified risk tobacco product; and ‘‘(F) establish a reasonable timetable for the Secretary to review an application under this section. ‘‘(2) CONSULTATION.—The regulations or guidance issued under paragraph (1) shall be developed in consultation with the Institute of M edicine, and with the input of other appro- priate scientific and medical experts, on the design and conduct of such studies and surveillance. ‘‘( 3 ) REVISION.—The regulations or guidance under para- graph (1) shall be revised on a regular basis as new scientific information becomes available. ‘‘( 4 )NE W TO B ACCO PRODUCTS.—Not later than 2 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall issue a regulation or guidance that permits the filing of a single application for any tobacco product that is a new tobacco product under section 9 1 0 and which the applicant seeks to commercially market under this section. ‘‘(m) DISTRIBUTORS.—Except as provided in this section, no distributor may take any action, after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, with respect to a tobacco product that would reasonably be expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful Deadlin e . Deadline.


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 123STA T . 1 8 1 9PUBLIC LA W 111 – 31 —J U NE 22, 2 0 09 thano n e o rm ore c ommerc i a l l y mar k ete d to b acco p rod u ct s, or pre - sents a reduced e x posure to, or does not contain or is f ree of, a substance or substances .‘ ‘ SEC.912 . JUDI CI ALR E V IE W . ‘ ‘ ( a )RIGHTTO R EV IE W . — ‘‘( 1 ) IN GENE RAL .— N ot later than 30 days after— ‘‘( A ) the promul g ation of a regulation under section 9 0 7 establishing, amending, or re v oking a tobacco product standard or ‘‘( B ) a denial of an application under section 910(c), any person adversely affected by such regulation or denial may file a petition for j udicial revie w of such regulation or denial with the U nited S tates C ourt of Appeals for the D istrict of Columbia or for the circuit in which such person resides or has their principal place of business. ‘‘( 2 )RE QU IRE M ENT S .— ‘‘(A) CO PY O F PETITION.—A copy of the petition filed under paragraph (1) shall be transmitted by the clerk of the court involved to the Secretary. ‘‘(B) RE C OR D OF PROCEEDINGS.— O n receipt of a petition under subparagraph (A), the Secretary shall file in the court in which such petition was filed— ‘‘(i) the record of the proceedings on which the regulation or order was based; and ‘‘(ii) a statement of the reasons for the issuance of such a regulation or order. ‘‘(C) DEFINITION OF RECORD.—In this section, the term ‘record ’ means— ‘‘(i) all notices and other matter published in the F ederal Register with respect to the regulation or order reviewed; ‘‘(ii) all information submitted to the Secretary with respect to such regulation or order; ‘‘(iii) proceedings of any panel or advisory com- mittee with respect to such regulation or order; ‘‘(iv) any hearing held with respect to such regula- tion or order; and ‘‘(v) any other information identified by the Sec- retary, in the administrative proceeding held with respect to such regulation or order, as being relevant to such regulation or order. ‘‘(b) STANDARD OF REVIEW.—Upon the filing of the petition under subsection (a) for judicial review of a regulation or order, the court shall have jurisdiction to review the regulation or order in accordance with chapter 7 of title 5, United States Code, and to grant appropriate relief, including interim relief, as provided for in such chapter. A regulation or denial described in subsection (a) shall be reviewed in accordance with section 70 6 (2)(A) of title 5, United States Code. ‘‘(c) FINALITY OF J UDGMENT.—The judgment of the court affirming or setting aside, in whole or in part, any regulation or order shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification, as provided in section 125 4 of title 2 8, United States Code. Sta t em e n t .D ea dli ne. 21U S C387l .


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 123STA T . 1 8 2 0PUBLIC LA W 111 – 31 —J U NE 22, 200 9‘ ‘ (d)OTHERR E M E DI E S.—Ther e m ed i e sp r ov ided f ori nt his se c- tion sh al l b e in addition to , and not in lie u of, an y other remedies provided by la w. ‘‘(e) RE GULA TI ON S AND ORDERS M UST RE C ITE B ASIS IN RECORD.—To facilitate j udicial review, a re g ulation or order issued under section 906 ,90 7 ,90 8, 909,9 1 0, or 916 shall contain a statement of the reasons for the issuance of such regulation or order in the record of the proceedings held in connection with its issuance. ‘ ‘ SEC.913 .E QUALTR EAT M E N T OF RETA I L OUTLETS. ‘‘The S ecretary shall issue regulations to re q uire that retail establishments for which the predominant business is the sale of tobacco products comply with any advertising restrictions applicable to retail establishments accessible to individuals under the age of 18. ‘‘SEC. 91 4 . J URIS D ICTION OF AND COORDINATION W IT H THE FEDERAL TRADE COMMISSION. ‘‘(a) J URISDICTION.— ‘‘(1) I N GENERAL.— Ex cept where expressly provided in this chapter, nothing in this chapter shall be construed as limiting or diminishing the authority of the F ederal Trade C ommission to enforce the laws under its jurisdiction with respect to the advertising, sale, or distribution of tobacco products. ‘‘( 2 )EN F ORCEMENT.— A ny advertising that violates this chapter or a provision of the regulations referred to in section 102 of the Family Smo k ing P revention and Tobacco Control Act, is an unfair or deceptive act or practice under section 5 (a) of the Federal Trade Commission Act and shall be consid- ered a violation of a rule promulgated under section 18 of that Act. ‘‘(b) COORDINATION.— W ith respect to the requirements of sec- tion 4 of the Federal Cigarette L abeling and Advertising Act and section 3 of the Comprehensive Smokeless Tobacco H ealth Edu- cation Act of 1986— ‘‘(1) the Chairman of the Federal Trade Commission shall coordinate with the Secretary concerning the enforcement of such Act as such enforcement relates to unfair or deceptive acts or practices in the advertising of cigarettes or smokeless tobacco and ‘‘(2) the Secretary shall consult with the Chairman of such Commission in revising the label statements and requirements under such sections. ‘‘SEC. 91 5 .RE G ULATION REQUIREMENT. ‘‘(a) TESTING, RE P ORTING, AND D ISCLOSURE.— N ot later than 36 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall promulgate regulations under this Act that meet the requirements of subsection (b). ‘‘(b) CONTENTS OF RULES.—The regulations promulgated under subsection (a)— ‘‘(1) shall require testing and reporting of tobacco product constituents, ingredients, and additives, including smoke constituents, by brand and subbrand that the Secretary deter- mines should be tested to protect the public health, provided that, for purposes of the testing requirements of this paragraph, 21USC387o. Co nsulta t i on. 21 USC 387n. Reg ulations. 21 USC 387 m . Statement.


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 123STA T . 1 8 21 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9tobac co pr o du ct sm a n u f actur e dandso l db y as i n g le tobacco product manufacturer t h at are identical in all respects e x cept the labels , pac k aging design, logo, trade dress, trademark, brand name, or any combination thereof, shall be considered as a single brand and ‘ ‘ (2) may re q uire that tobacco product manufacturers, pack - agers, or importers make disclosures relating to the results of the testing of tar and nicotine through labels or ad v ertising or other appropriate means, and make disclosures regarding the results of the testing of other constituents, including smoke constituents, ingredients, or additives, that the S ecretary deter- mines should be disclosed to the public to protect the public health and w ill not mislead consumers about the risk of tobacco- related disease . ‘‘(c) AUTHORI T Y . —T he Secretary shall have the authority under this chapter to conduct or to require the testing, reporting, or disclosure of tobacco product constituents, including smoke constitu- ents. ‘‘(d) S MAL LTO B A C CO P RO D UCT M A N U F ACTUR E R S .— ‘‘( 1 ) F IRST COM P LIANCE DATE.—The initial regulations promulgated under subsection (a) shall not impose require- ments on small tobacco product manufacturers before the later of— ‘‘(A) the end of the 2-year period following the final promulgation of such regulations; and ‘‘( B ) the initial date set by the Secretary for compliance with such regulations by manufacturers that are not small tobacco product manufacturers. ‘‘(2) TESTIN G AND REPORTING INITIAL COMPLIANCE PERIOD.— ‘‘(A) 4 -YEAR PERIOD.—The initial regulations promul- gated under subsection (a) shall give each small tobacco product manufacturer a 4-year period over which to conduct testing and reporting for all of its tobacco products. Sub j ect to paragraph (1), the end of the first year of such 4- year period shall coincide with the initial date of compliance under this section set by the Secretary with respect to manufacturers that are not small tobacco product manufac- turers or the end of the 2-year period following the final promulgation of such regulations, as described in para- graph (1)(A). A small tobacco product manufacturer shall be required— ‘‘(i) to conduct such testing and reporting for 2 5 percent of its tobacco products during each year of such 4-year period; and ‘‘(ii) to conduct such testing and reporting for its largest-selling tobacco products (as determined by the Secretary) before its other tobacco products, or in such other order of priority as determined by the Secretary. ‘‘(B) C ASE-BY-CASE DELAY.— N otwithstanding subpara- graph (A), the Secretary may, on a case-by-case basis, delay the date by which an individual small tobacco product manufacturer must conduct testing and reporting for its tobacco products under this section based upon a showing of undue hardship to such manufacturer. Notwithstanding the preceding sentence, the Secretary shall not extend the deadline for a small tobacco product manufacturer to con- duct testing and reporting for all of its tobacco products


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Page:United States Statutes at Large Volume 123.djvu/1842

 123STA T . 1 8 22 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9beyondat ota l o f5 yea rs after t h e i nitial date of c o mp liance u nder this section set by the S ecretary w ith respect to manufacturers that are not small tobacco product manufac - turers .‘ ‘ (3) S UBSEQ UE NTA N D ADD I TI O NA L TESTIN G AND R E P ORTING. —T he re g ulations promulgated under subsection (a) shall pro v ide that , with respect to any subse q uent or additional testing and reporting of tobacco products required under this section, such testing and reporting by a small tobacco product manufacturer shall be conducted in accordance with the time- frames described in paragraph ( 2 )( A ),e x cept that, in the case of a new product, or if there has been a modification described in section 910 (a)(1)( B ) of any product of a small tobacco product manufacturer since the last testing and reporting required under this section, the Secretary shall require that any subse- quent or additional testing and reporting be conducted in accordance with the same timeframe applicable to manufactur- ers that are not small tobacco product manufacturers. ‘‘( 4 ) J OINT LABORATOR Y TESTING SER V I C ES.—The Secretary shall allow any 2 or more small tobacco product manufacturers to j oin together to purchase laboratory testing services required by this section on a group basis in order to ensure that such manufacturers receive access to, and fair pricing of, such testing services. ‘‘(e) EX TENSIONS F OR L I M ITED LABORATORY C APACITY.— ‘‘(1) I N GENERAL.—The regulations promulgated under sub- section (a) shall provide that a small tobacco product manufac- turer shall not be considered to be in violation of this section before the deadline applicable under paragraphs (3) and (4), if— ‘‘(A) the tobacco products of such manufacturer are in compliance with all other requirements of this chapter and ‘‘(B) the conditions described in paragraph (2) are met. ‘‘(2) CONDITIONS.— N otwithstanding the requirements of this section, the Secretary may delay the date by which a small tobacco product manufacturer must be in compliance with the testing and reporting required by this section until such time as the testing is reported if, not later than 90 days before the deadline for reporting in accordance with this section, a small tobacco product manufacturer provides evidence to the Secretary demonstrating that— ‘‘(A) the manufacturer has submitted the required prod- ucts for testing to a laboratory and has done so sufficiently in advance of the deadline to create a reasonable expecta- tion of completion by the deadline; ‘‘(B) the products currently are awaiting testing by the laboratory; and ‘‘(C) neither that laboratory nor any other laboratory is able to complete testing by the deadline at customary, nonexpedited testing fees. ‘‘(3) EXTENSION.—The Secretary, ta k ing into account the laboratory testing capacity that is available to tobacco product manufacturers, shall review and verify the evidence submitted by a small tobacco product manufacturer in accordance with paragraph (2). If the Secretary finds that the conditions described in such paragraph are met, the Secretary shall notify Notif i ca tio n.De a dl ine. Ev idence.


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Page:United States Statutes at Large Volume 123.djvu/1843

 123STA T . 1 8 23 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9thesmal lt ob a c co pr o du ct ma n u f acturer that the manufacturer shall not be cons i dered to be in v iolation of the testin g and reporting re q uirements of this section until the testing is reported or until 1y ear after the reporting deadline has passed ,w hichever occurs sooner .I f, however, the S ecretary has not made a finding before the reporting deadline, the manufacturer shall not be considered to be in violation of such requirements until the Secretary finds that the conditions described in para - graph (2) have not been met, or until 1 year after the reporting deadline, whichever occurs sooner. ‘ ‘( 4 ) AD D IT I ONALEX TEN S ION. — In addition to the time that may be provided under paragraph ( 3 ), the Secretary may pro- vide further e x tensions of time, in increments of no more than 1 year, for required testing and reporting to occur if the Sec- retary determines, based on evidence properly and timely sub- mitted by a small tobacco product manufacturer in accordance with paragraph (2), that a lac k of available laboratory capacity prevents the manufacturer from completing the required testing during the period described in paragraph (3). ‘‘(f) RU LEO FC ONST R U C TION.— N othing in subsection (d) or (e) shall be construed to authori z e the extension of any deadline, or to otherwise affect any timeframe, under any provision of this Act or the F amily Smoking P revention and T obacco Control Act other than this section. ‘ ‘ SEC.916 . PR ESER VATION O F STATE AN DL OCAL A U T H ORIT Y . ‘‘(a) IN G ENERAL.— ‘‘(1) PRESER V ATION.— E xcept as provided in paragraph (2)(A), nothing in this chapter, or rules promulgated under this chapter, shall be construed to limit the authority of a Federal agency (including the Armed Forces), a State or polit- ical subdivision of a State, or the government of an Indian tribe to enact, adopt, promulgate, and enforce any law, rule, regulation, or other measure with respect to tobacco products that is in addition to, or more stringent than, requirements established under this chapter, including a law, rule, regulation, or other measure relating to or prohibiting the sale, distribu- tion, possession, exposure to, access to, advertising and pro- motion of, or use of tobacco products by individuals of any age, information reporting to the State, or measures relating to fire safety standards for tobacco products. No provision of this chapter shall limit or otherwise affect any State, tribal, or local taxation of tobacco products. ‘‘(2) PREE MP TION OF CERTAIN STATE AND LOCAL RE Q UIRE- MENTS.— ‘‘(A) IN G ENERAL.—No State or political subdivision of a State may establish or continue in effect with respect to a tobacco product any requirement which is different from, or in addition to, any requirement under the provi- sions of this chapter relating to tobacco product standards, premarket review, adulteration, misbranding, labeling, reg- istration, good manufacturing standards, or modified risk tobacco products. ‘‘( B ) EXCEPTION.—Subparagraph (A) does not apply to requirements relating to the sale, distribution, possession, information reporting to the State, exposure to, access to, the advertising and promotion of, or use of, tobacco products 21USC387p.


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Page:United States Statutes at Large Volume 123.djvu/1844

 123STA T . 1 8 2 4PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9byind i v id ualsof any a ge, o r rela t ing to fire safety stand - ards for toba c co p roducts .I nfor m ation disclosed to a S tate under subparagrap h(A) that is e x empt from disclosure under section 5 5 2 (b)( 4 ) of title 5, U nited States C ode, shall be treated as a trade secret and confidential information by the State. ‘ ‘(b) RULEOF CO NSTR U C T I ON RE GA R D ING P RODUCT L IA B ILIT Y . —N o provision of this chapter relating to a tobacco product shall be construed to modify or other w ise affect any action or the liability of any person under the product liability law of any State. ‘ ‘ SEC.917 . TOBA CCO PR O DU CTS SC I E N TI F IC AD V ISOR Y CO M MITTEE. ‘‘(a) E STABLIS HM ENT.—Not later than 6 months after the date of enactment of the F amily Smo k ing Prevention and T obacco Con- trol Act, the Secretary shall establish a 1 2-member advisory com- mittee, to be known as the Tobacco Products Scientific Advisory Committee (in this section referred to as the ‘Advisory Committee ’ ). ‘‘(b) M EMBERSHI P .— ‘‘(1) IN GENERAL.— ‘‘(A) MEMBERS.—The Secretary shall appoint as mem- bers of the Tobacco Products Scientific Advisory Committee individuals who are technically q ualified by training and experience in medicine, medical ethics, science, or tech- nology involving the manufacture, evaluation, or use of tobacco products, who are of appropriately diversified professional backgrounds. The committee shall be composed of— ‘‘(i) 7 individuals who are physicians, dentists, sci- entists, or health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant spe- cialty ‘‘(ii) 1 individual who is an officer or employee of a State or local government or of the Federal G overn- ment; ‘‘(iii) 1 individual as a representative of the general public; ‘‘(iv) 1 individual as a representative of the interests of the tobacco manufacturing industry; ‘‘(v) 1 individual as a representative of the interests of the small business tobacco manufacturing industry, which position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise rel- evant to the topics being considered by the Advisory Committee; and ‘‘(vi) 1 individual as a representative of the interests of the tobacco growers. ‘‘( B ) NON V OTING MEMBERS.—The members of the com- mittee appointed under clauses (iv), (v), and (vi) of subpara- graph (A) shall serve as consultants to those described in clauses (i) through (iii) of subparagraph (A) and shall be nonvoting representatives. ‘‘(C) CONFLICTS OF INTEREST.—No members of the com- mittee, other than members appointed pursuant to clauses (iv), (v), and (vi) of subparagraph (A) shall, during the member’s tenure on the committee or for the 1 8 -month Deadlin e .21USC387q .


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Page:United States Statutes at Large Volume 123.djvu/1845

 123STA T . 1 8 2 5PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9period prior t o b e c o m i ngsu c ha member , recei v ean y sa l ary, grants, or other payments or support f rom any business that manufactures, distributes, mar k ets, or sells cigarettes or other tobacco products .‘ ‘ (2)LIM I TA TI ON . —T he S ecretary may not appoint to the A dvisory C ommittee any individual w ho is in the regular full - time employ of the F ood and D rug Administration or any agency responsible for the enforcement of this Act. The Secretary may appoint Federal officials as e x officio members. ‘‘( 3 )C H AI RPE R S ON.—The Secretary shall designate 1 of the members appointed under clauses (i), (ii), and (iii) of paragraph (1)(A) to serve as chairperson. ‘‘(c) D U TIES.—The Tobacco P roducts Scientific Advisory Com- mittee shall provide advice, information, and recommendations to the Secretary— ‘‘(1) as provided in this chapter ‘‘(2) on the effects of the alteration of the nicotine yields from tobacco products; ‘‘(3) on whether there is a threshold level below which nicotine yields do not produce dependence on the tobacco product involved; and ‘‘( 4 ) on its review of other safety, dependence, or health issues relating to tobacco products as re q uested by the Sec- retary. ‘‘(d) COMPENSATION; SUPPORT; FACA.— ‘‘(1) COMPENSATION AN D TRA V E L .— M embers of the Advisory Committee who are not officers or employees of the U nited States, while attending conferences or meetings of the com- mittee or otherwise engaged in its business, shall be entitled to receive compensation at rates to be fixed by the Secretary, which may not exceed the daily equivalent of the rate in effect under the Senior E xecutive Schedule under section 5 3 8 2of title 5, United States Code, for each day (including travel time) they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, including per diem in lieu of subsist- ence, as authori z ed by section 5 70 3 of title 5, United States Code, for persons in the G overnment service employed intermit- tently. ‘‘(2) ADMINISTRATIVE SUPPORT.—The Secretary shall furnish the Advisory Committee clerical and other assistance. ‘‘(3) N ONAPPLI C ATION O F FACA.—Section 14 of the Federal Advisory Committee Act does not apply to the Advisory Com- mittee. ‘‘(e) PROCEEDIN G S OF ADVISOR Y PANELS AND COMMITTEES.— The Advisory Committee shall make and maintain a transcript of any proceeding of the panel or committee. Each such panel and committee shall delete from any transcript made under this subsection information which is exempt from disclosure under sec- tion 552(b) of title 5, United States Code. ‘ ‘ SEC.918 . DRUGP R O DUC T S USED TO TRE A TTO B ACCO DEPE N DENCE. ‘‘(a) I N GENERAL.—The Secretary shall— ‘‘(1) at the request of the applicant, consider designating products for smoking cessation, including nicotine replacement products as fast track research and approval products within the meaning of section 50 6 21USC387r.Reco r ds .


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Page:United States Statutes at Large Volume 123.djvu/1846

 123STA T . 1 8 2 6PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9‘ ‘ (2)considerap pro v in gth ee x tended u seo f nicotine rep l ace -m ent products (such as nicotine patches, nicotine gum, and nicotine lo z enges) for the treatment of to b acco dependence and ‘‘( 3 ) revie w and consider the evidence for additional indica- tions for nicotine replacement products, such as for craving relief or relapse prevention . ‘‘(b) REPORT O NI NNO VA T I VE P RO DUC T S . — ‘‘( 1 )IN G ENERA L .— N ot later than 3 y ears after the date of enactment of the F amily S mo k ing Prevention and T obacco C ontrol A ct, the Secretary, after consultation with recognized scientific, medical, and public health experts (including both Federal agencies and nongovernmental entities, the Institute of M edicine of the National Academy of Sciences, and the Society for Research on Nicotine and Tobacco), shall submit to the Congress a report that examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine- based products and treatments) to better achieve, in a manner that best protects and promotes the public health— ‘‘(A) total abstinence from tobacco use; ‘‘( B ) reductions in consumption of tobacco; and ‘‘(C) reductions in the harm associated with continued tobacco use. ‘‘(2) RECO M MENDATIONS.—The report under paragraph (1) shall include the recommendations of the Secretary on how the Food and D rug Administration should coordinate and facili- tate the exchange of information on such innovative products and treatments among relevant offices and centers within the Administration and within the National Institutes of H ealth, the Centers for Disease Control and Prevention, and other relevant agencies. ‘ ‘ SEC.91 9. U SE RF EES. ‘‘(a) E STA B LIS H MENT O FQ UARTERL Y FEE.—Beginning on the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall in accordance with this section assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products sub j ect to this chapter. The fees shall be assessed and collected with respect to each q uarter of each fiscal year, and the total amount assessed and collected for a fiscal year shall be the amount specified in subsection (b)(1) for such year, subject to subsection (c). ‘‘(b) ASSESSMENT OF U SER FEE.— ‘‘(1) AMOUNT OF ASSESSMENT.—The total amount of user fees authorized to be assessed and collected under subsection (a) for a fiscal year is the following, as applicable to the fiscal year involved ‘‘(A) For fiscal year 2 0 0 9, $85 ,000,000 (subject to sub- section (e)). ‘‘(B) For fiscal year 2010, $235,000,000. ‘‘(C) For fiscal year 2011, $ 4 50,000,000. ‘‘(D) For fiscal year 2012, $4 7 7,000,000. ‘‘(E) For fiscal year 2013, $505,000,000. ‘‘(F) For fiscal year 2014, $534,000,000. ‘‘( G ) For fiscal year 2015, $5 6 6,000,000. ‘‘(H) For fiscal year 2016, $599,000,000. Ef f ectiv e da te .21USC387s .


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Page:United States Statutes at Large Volume 123.djvu/1847

 123STA T . 1 8 2 7PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9‘ ‘ (I)Forfiscalye ar 2017,$635 ,000,000 . ‘‘( J ) For fiscal year 201 8, $672,000,000. ‘‘( K ) For fiscal year 201 9 a nd eac h s ub se q uen t fiscal year, $712,000,000. ‘‘(2) AL L OCATI O NS O F ASS E SS M ENT BY CLASS OF TOBACCO PR O DU CTS. — ‘‘(A) IN G ENERAL.— T he total user fees assessed and collected under subsection (a) each fiscal year w ith res p ect to each class of tobacco products shall be an a m ount that is equal to the applicable percenta g e of each class for the fiscal year multiplied by the amount specified in para - graph (1) for the fiscal year. ‘‘( B ) APPLICABLE PERCENTAGE.— ‘‘(i) IN GENERAL.—For purposes of subparagraph (A), the applicable percentage for a fiscal year for each of the following classes of tobacco products shall be determined in accordance with clause (ii) ‘‘(I) C igarettes. ‘‘(II) Cigars, including small cigars and cigars other than small cigars. ‘‘(III) S nuff. ‘‘(I V ) Chewing tobacco. ‘‘(V) P ipe tobacco. ‘‘(VI) R oll-your-own tobacco. ‘‘(ii) ALLOCATIONS.—The applicable percentage of each class of tobacco product described in clause (i) for a fiscal year shall be the percentage determined under section 625(c) of Public L aw 108 – 357 for each such class of product for such fiscal year. ‘‘(iii) RE Q UIREMENT OF REGULATIONS.— N otwith- standing clause (ii), no user fees shall be assessed on a class of tobacco products unless such class of tobacco products is listed in section 901(b) or is deemed by the Secretary in a regulation under section 901(b) to be sub j ect to this chapter. ‘‘(i v ) REALLOCATIONS.—In the case of a class of tobacco products that is not listed in section 901(b) or deemed by the Secretary in a regulation under sec- tion 901(b) to be subject to this chapter, the amount of user fees that would otherwise be assessed to such class of tobacco products shall be reallocated to the classes of tobacco products that are subject to this chapter in the same manner and based on the same relative percentages otherwise determined under clause (ii). ‘‘(3) D ETERMINATION OF USER FEE BY COMPANY.— ‘‘(A) IN GENERAL.—The total user fee to be paid by each manufacturer or importer of a particular class of tobacco products shall be determined for each quarter by multiplying— ‘‘(i) such manufacturer ’ s or importer’s percentage share as determined under paragraph ( 4 ) by ‘‘(ii) the portion of the user fee amount for the current quarter to be assessed on all manufacturers and importers of such class of tobacco products as determined under paragraph (2).


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Page:United States Statutes at Large Volume 123.djvu/1848

 123STA T . 1 8 28 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9‘ ‘ (B)NOFE E IN E XC E S SOF P E R CEN TAG ES H ARE .— N omanuf a ct u re ror i m p orter of to b acco pro d uct s s h a l lbe re q uired to pa y auserfeeine x cess of the percenta g e share of such manufacturer or importer. ‘‘( 4 ) AL LOCATION OF ASSESS M ENT W ITHIN EACH CLASS OF TO B ACCO PRO DU CT.— T he percentage share of each manufac - turer or importer of a particular class of tobacco products of the total user fee to be paid by all manufacturers or importers of that class of tobacco products shall be the percentage deter- mined for purposes of allocations under subsections (e) through (h) of section 625 of P ublic L a w108–3 5 7 . ‘‘(5) ALLOCATION FOR CIGARS.—Notwithstanding paragraph (4), if a user fee assessment is imposed on cigars, the percentage share of each manufacturer or importer of cigars shall be based on the excise taxes paid by such manufacturer or importer during the prior fiscal year. ‘‘(6) TIMING OF ASSESSMENT.—The S ecretary shall notify each manufacturer and importer of tobacco products sub j ect to this section of the amount of the quarterly assessment imposed on such manufacturer or importer under this sub- section for each quarter of each fiscal year. Such notifications shall occur not later than 30 days prior to the end of the quarter for which such assessment is made, and payments of all assessments shall be made by the last day of the quarter in v olved. ‘‘(7) M EMORANDUM OF UNDERSTANDING.— ‘‘(A) I N GENERAL.—The Secretary shall request the appropriate F ederal agency to enter into a memorandum of understanding that provides for the regular and timely transfer from the head of such agency to the Secretary of the information described in paragraphs (2)(B)(ii) and (4) and all necessary information regarding all tobacco product manufacturers and importers required to pay user fees. The Secretary shall maintain all disclosure restric- tions established by the head of such agency regarding the information provided under the memorandum of under- standing. ‘‘(B) ASSURANCES.—Beginning not later than fiscal year 2015, and for each subsequent fiscal year, the Secretary shall ensure that the Food and D rug Administration is able to determine the applicable percentages described in paragraph (2) and the percentage shares described in para- graph (4). The Secretary may carry out this subparagraph by entering into a contract with the head of the Federal agency referred to in subparagraph (A) to continue to pro- vide the necessary information. ‘‘(c) C REDITING AND A V AILABILIT Y OF FEES.— ‘‘(1) IN GENERAL.—Fees authori z ed under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, subject to paragraph (2)(D). Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limita- tion to such appropriation account for salaries and expenses with such fiscal year limitation. ‘‘(2) AVAILABILITY.— Ef f ectiv e da te s.D isc lo s ur e. Deadli n es. N otification.


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Page:United States Statutes at Large Volume 123.djvu/1849

 123STA T . 1 8 2 9PUBLIC LA W 111 – 31 —J U NE 22, 2 0 09 ‘ ‘ (A)INGE NE RAL.—Fe e sap p ro pr i a t e dun der para g rap h ( 3 )area v ai l a b le onl yf or the purpose of paying the c osts of the activities of the Food and D rug Ad m inistration related to the regulation of tobacco products under this chapter and the Family S mo k ing P revention and T obacco C ontrol Act (referred to in this subsection as ‘tobacco regu - lation activities ’ ) , e x cept that such fees may be used for the reimbursement specified in subparagraph (C). ‘‘( B )PR OHIB I T ION AGAIN S T U SEO F OTHER FUN D S.— ‘‘(i) IN GENERAL.— E xcept as provided in clause (ii), fees collected under subsection (a) are the only funds authori z ed to be made available for tobacco regu- lation activities. ‘‘(ii) STARTU PC OSTS.—Clause (i) does not apply until O ctober 1, 20 0 9 . U ntil such date, any amounts available to the Food and Drug Administration (excluding user fees) shall be available and allocated as needed to pay the costs of tobacco regulation activi- ties. ‘‘(C) R EI M BURSEMENT OF START-UP AMOUNTS.— ‘‘(i) IN GENERAL.—Any amounts allocated for the start-up period pursuant to subparagraph (B)(ii) shall be reimbursed through any appropriated fees collected under subsection (a), in such manner as the Secretary determines appropriate to ensure that such allocation results in no net change in the total amount of funds other w ise available, for the period from October 1, 200 8, through September 30, 2010, for Food and Drug Administration programs and activities (other than tobacco regulation activities) for such period. ‘‘(ii) TREATMENT OF REIMBURSED AMOUNTS.— Amounts reimbursed under clause (i) shall be available for the programs and activities for which funds allo- cated for the start-up period were available, prior to such allocation, until September 30, 2010, notwith- standing any otherwise applicable limits on amounts for such programs or activities for a fiscal year. ‘‘(D) FEE COLLECTED DURING START-UP PERIOD.— N ot- withstanding the first sentence of paragraph (1), fees under subsection (a) may be collected through September 30, 2009 under subparagraph (B)(ii) and shall be available for obliga- tion and remain available until expended. Such offsetting collections shall be credited to the salaries and expenses account of the Food and Drug Administration. ‘‘(E) OBLIGATION OF START-UP COSTS IN ANTICIPATION OFA V AILABLE FEE COLLECTIONS.—Notwithstanding any other provision of law, following the enactment of an appro- priation for fees under this section for fiscal year 2010, or any portion thereof, obligations for costs of tobacco regu- lation activities during the start-up period may be incurred in anticipation of the receipt of offsetting fee collections through procedures specified in section 1 5 3 4 of title 31, United States Code. ‘‘(3) AUTHORI Z ATION OF APPROPRIATIONS.—For fiscal year 2009 and each subse q uent fiscal year, there is authorized to be appropriated for fees under this section an amount equal to the amount specified in subsection (b)(1) for the fiscal year. Deadlin e . Deadline. Ef fe ct i v e date.


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Page:United States Statutes at Large Volume 123.djvu/1850

 123STA T . 1 8 3 0PUBLIC LA W 111 – 31 —J U NE 22, 200 9‘ ‘ (d)COL L ECTI O N O FU N PA I DF EE S.—Ina n yc a sewh e r e t he S ecretary d o es not rece iv e p ay m ent o f a fee assessed u nder su b- section (a) within 30 days after it is due , such fee sha l l be treated as a claim of the United States G overnment sub j ect to subchapter II of chapter 3 7 of title 3 1, United States Code. ‘‘(e) A PPLICA B ILIT Y TO FISCAL Y EA R2 00 9 .—If the date of enact- ment of the Family Smo k in gP revention and T obacco Control Act occurs during fiscal year 2009, the following applies, subject to subsection (c) ‘‘(1) The Secretary shall determine the fees that would apply for a single q uarter of such fiscal year according to the application of subsection (b) to the amount specified in paragraph (1)(A) of such subsection (referred to in this sub- section as the ‘quarterly fee amounts ’ ). ‘‘(2) For the quarter in which such date of enactment occurs, the amount of fees assessed shall be a pro rata amount, deter- mined according to the number of days remaining in the quarter (including such date of enactment) and according to the daily equivalent of the quarterly fee amounts. Fees assessed under the preceding sentence shall not be collected until the ne x t quarter. ‘‘(3) For the quarter following the quarter to which para- graph (2) applies, the full quarterly fee amounts shall be assessed and collected, in addition to collection of the pro rata fees assessed under paragraph (2).’’. (c) CONFOR M IN G AMENDMENT.—Section 9(1) of the Comprehen- sive Smokeless Tobacco H ealth E ducation Act of 19 86 (1 5 U.S.C. 4 408(i)) is amended to read as follows: ‘‘(1) The term ‘smokeless tobacco’ has the meaning given such term by section 900(18) of the Federal Food, D rug, and Cosmetic Act.’’. SEC.102 . FINALRU LE. (a) CIGARETTES AND SMO K ELESS TOBACCO.— (1) IN GENERAL.— O n the first day of publication of the Federal R egister that is 180 days or more after the date of enactment of this Act, the Secretary of Health and Human Services shall publish in the Federal Register a final rule regarding cigarettes and smokeless tobacco, which— (A) is deemed to be issued under chapter 9 of the Federal Food, Drug, and Cosmetic Act, as added by section 101 of this division and ( B ) shall be deemed to be in compliance with all applicable provisions of chapter 5 of title 5, United States Code, and all other provisions of law relating to rulemaking procedures. (2) CONTENTS OF R U LE.—Except as provided in this sub- section, the final rule published under paragraph (1), shall be identical in its provisions to part 897 of the regulations promulgated by the Secretary of Health and Human Services in the August 28, 1996, issue of the Federal Register (61 Fed. Reg. 44615 – 44618). Such rule shall— (A) provide for the designation of jurisdictional authority that is in accordance with this subsection in accordance with this division and the amendments made by this division; (B) strike Subpart C— L abels and section 897.32(c); Deadlin e .F ede r al R e g i st er ,pub li c ati o n. 21USC387 a – 1. Fees. Deadline.


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 123STA T . 1 8 31 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9(C)strikepa ra g rap h s (a) , ( b ),a nd (i) of se c tion 897.3 and insert definitions of the ter m s ‘ ‘cigarette ’ ’, ‘‘cigarette tobacco’’, and ‘‘smoke l ess tobacco’’ as defined in section 9 0 0ofthe F ederal Food, D r u g, and Cosmetic A ct (D) insert ‘‘or roll -y our-o w n paper’’ in section 897.3 4 (a) after ‘‘other than cigarettes or smokeless tobacco’’; ( E ) include such modifications to section 897.30(b), if any, that the S ecretary determines are appropriate in light of go v erning First Amendment case law, including the deci- sion of the Supreme Court of the U nited States in L orillard T obacco Co. v. R eilly ( 5 33 U.S. 5 2 5 (200 1 )); (F) become effective on the date that is 1 year after the date of enactment of this Act; and ( G ) amend paragraph (d) of section 897.1 6 to read as follows ‘‘(d)(1) E x cept as provided in subparagraph (2), no manufac- turer, distributor, or retailer may distribute or cause to be distrib- uted any free samples of cigarettes, smokeless tobacco, or other tobacco products (as such term is defined in section 201 of the Federal Food, Drug, and Cosmetic Act). ‘‘(2)(A) Subparagraph (1) does not prohibit a manufacturer, distributor, or retailer from distributing or causing to be distributed free samples of smokeless tobacco in a q ualified adult-only facility. ‘‘( B ) This subparagraph does not affect the authority of a State or local government to prohibit or otherwise restrict the distribution of free samples of smokeless tobacco. ‘‘(C) For purposes of this paragraph, the term ‘qualified adult- only facility’ means a facility or restricted area that — ‘‘(i) requires each person present to provide to a law enforce- ment officer (whether on or off duty) or to a security guard licensed by a governmental entity government-issued identifica- tion showing a photograph and at least the minimum age established by applicable law for the purchase of smokeless tobacco; ‘‘(ii) does not sell, serve, or distribute alcohol; ‘‘(iii) is not located ad j acent to or immediately across from (in any direction) a space that is used primarily for youth- oriented marketing, promotional, or other activities; ‘‘(iv) is a temporary structure constructed, designated, and operated as a distinct enclosed area for the purpose of distrib- uting free samples of smokeless tobacco in accordance with this subparagraph; ‘‘(v) is enclosed by a barrier that— ‘‘( I ) is constructed of, or covered with, an opaque mate- rial (except for entrances and exits); ‘‘(II) extends from no more than 12 inches above the ground or floor (which area at the bottom of the barrier must be covered with material that restricts visibility but may allow airflow) to at least 8 feet above the ground or floor (or to the ceiling); and ‘‘(III) prevents persons outside the qualified adult-only facility from seeing into the qualified adult-only facility, unless they make unreasonable efforts to do so; and ‘‘(vi) does not display on its exterior— ‘‘(I) any tobacco product advertising; Ef f ectiv e da te .


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 123STA T . 1 8 32 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9‘ ‘ (I I )abr a nd na meoth er than i n c on ju nction w ith word sf or an area or enc l osure to identif y an adult - only facility or ‘‘(III) any combination of words that would im p ly to a reasonable obser v er that the manufacturer , distributor, or retailer has a sponsorship that would violate section 897.34 (c). ‘‘( D ) Distribution of samples of smo k eless tobacco under this subpara g raph permitted to be taken out of the q ualified adult- only facility shall be limited to 1 package per adult consumer containing no more than 0 . 5 3 ounces (15 grams) of smokeless tobacco. If such package of smokeless tobacco contains individual portions of smokeless tobacco, the individual portions of smokeless tobacco shall not e x ceed 8 individual portions and the collective weight of such individual portions shall not exceed 0.53 ounces (15 grams). A ny manufacturer, distributor, or retailer who distrib- utes or causes to be distributed free samples also shall take reason- able steps to ensure that the above amounts are limited to one such package per adult consumer per day. ‘‘(3) N otwithstanding subparagraph ( 2 ), no manufacturer, dis- tributor, or retailer may distribute or cause to be distributed any free samples of smokeless tobacco — ‘‘(A) to a sports team or entertainment group; or ‘‘( B ) at any football, basketball, baseball, soccer, or hockey event or any other sporting or entertainment event determined by the S ecretary to be covered by this subparagraph. ‘‘(4) T he Secretary shall implement a program to ensure compli- ance with this paragraph and submit a report to the C ongress on such compliance not later than 18 months after the date of enactment of the F amily Smoking P revention and Tobacco Control Act. ‘‘(5) Nothing in this paragraph shall be construed to authori z e any person to distribute or cause to be distributed any sample of a tobacco product to any individual who has not attained the minimum age established by applicable law for the purchase of such product. ’ ’. (3) A MEND MEN TS T ORUL E.—Prior to making amendments to the rule published under paragraph (1), the Secretary shall promulgate a proposed rule in accordance with chapter 5 of title 5, U nited States Code. (4) R ULE O FC ONSTRUCT I ON.— E xcept as provided in para- graph (3), nothing in this section shall be construed to limit the authority of the Secretary to amend, in accordance with chapter 5 of title 5, United States Code, the regulation promul- gated pursuant to this section, including the provisions of such regulation relating to distribution of free samples. (5) ENFORCEMENT OF RET A IL SALE P RO V ISIONS.—The Sec- retary of H ealth and Human Services shall ensure that the provisions of this division, the amendments made by this divi- sion, and the implementing regulations (including such provi- sions, amendments, and regulations relating to the retail sale of tobacco products) are enforced with respect to the United States and Indian tribes. ( 6 ) Q UALIFIED ADULT-ONL Y FACILITY.—A qualified adult- only facility (as such term is defined in section 897.16(d) of the final rule published under paragraph (1)) that is also a retailer and that commits a violation as a retailer shall not Penalti e s.R e por ts. D ea d line.


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 123STA T . 1 8 33 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9besu b j e ct t o t h e lim it a tio n s in section 103(q) an d shall be subject to p enalties applicable to a quali f ied adult - onl y facility . ( 7 ) CONGRES S I ON AL RE V IE WP ROVISIONS. —S ection 8 01 of title 5,U nited States Code, shall not apply to the final r ule published under para g raph (1). (b) L I M I T ATION ON AD VISOR YO PINIONS.—As of the date of enact- ment of this Act, the follo w ing documents issued by the F ood and D rug Administration shall not constitute ad v isory opinions under section 10.85(d)(1) of title 2 1, Code of Federal R egulations, e x cept as they apply to tobacco products, and shall not be cited by the Secretary of H ealth and Human Services or the Food and Drug Administration as binding precedent (1) T he preamble to the proposed rule in the document titled ‘ ‘Regulations Restricting the Sale and Distribution of Cigarettes and Smo k eless Tobacco P roducts to Protect Children and Adolescents ’ ’( 6 0 Fed. Reg. 4 1314 – 41372 (August 11, 1 9 95)). (2) The document titled ‘‘ N icotine in Cigarettes and Smoke- less Tobacco Products is a Drug and These Products Are Nico- tine Delivery Devices Under the Federal Food, Drug, and Cos- metic Act’’ (60 Fed. Reg. 41453–41787 (August 11, 1995)). (3) The preamble to the final rule in the document titled ‘‘Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents’’ (61 Fed. Reg. 44396–44615 (August 28, 1996)). (4) The document titled ‘‘Nicotine in Cigarettes and Smoke- less Tobacco is a Drug and These Products are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act uris- dictional Determination’’ (61 Fed. Reg. 44619–45318 (August 28, 1996)). SEC.103 . C ONF O RMI N GA N D O TH ER AMENDMENTS TO GENERA LP RO V ISIONS. (a) AMENDMENT O F FEDERAL FOOD, DR U G, AND COSMETI C ACT.— E xcept as otherwise expressly provided, whenever in this section an amendment is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference is to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). (b) SECTION 301.—Section 301 (21 U.S.C. 331) is amended— (1) in subsection (a), by inserting ‘‘tobacco product,’’ after ‘‘device,’’; (2) in subsection (b), by inserting ‘‘tobacco product,’’ after ‘‘device,’’; (3) in subsection (c), by inserting ‘‘tobacco product,’’ after ‘‘device,’’; (4) in subsection (e)— (A) by striking the period after ‘‘572(i)’’; and ( B ) by striking ‘‘or 761 or the refusal to permit access to’’ and inserting ‘‘761, 909, or 920 or the refusal to permit access to’’; (5) in subsection (g), by inserting ‘‘tobacco product,’’ after ‘‘device,’’; (6) in subsection (h), by inserting ‘‘tobacco product,’’ after ‘‘device,’’; (7) in subsection (j)— (A) by striking the period after ‘‘573’’; and
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 123STA T . 1 8 3 4PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9(B)bystrik i ng‘ ‘ 708,o r7 21’ ’ a n d ins e rting ‘‘708, 721, 9 0 4 ,90 5 ,90 6, 907, 908, 909, or 920(b)’’ (8)ins u bse c tion (k), by inserting ‘‘tobacco p roduct,’’ a f ter ‘‘de v ice,’’; (9) by striking subsection (p) and inserting t h efo l lo w ing ‘‘(p) T he failure to register in accordance with section 510 or 905, the failure to provide any infor m ation re q uired by section 510( j ), 510(k), 905(i), or 905(j), or the failure to provide a notice required by section 510(j)(2) or 905(i)( 3 ) . ’’; (10) by striking subsection (q)(1) and inserting the fol - lowing: ‘‘(q)(1) The failure or refusal — ‘‘( A ) to comply with any requirement prescribed under sec- tion 518, 520(g), 903(b), 907, 908, or 915; ‘‘(B) to furnish any notification or other material or informa- tion required by or under section 519, 520(g), 904, 909, or 920; or ‘‘( C ) to comply with a requirement under section 522 or 913.’’; (11) in subsection (q)(2), by striking ‘‘device,’’ and inserting ‘‘device or tobacco product,’’; (12) in subsection (r), by inserting ‘‘or tobacco product’’ after the term ‘‘device’’ each time that such term appears; and (13) by adding at the end the following: ‘‘(oo) The sale of tobacco products in violation of a no-tobacco- sale order issued under section 303(f). ‘‘(pp) The introduction or delivery for introduction into inter- state commerce of a tobacco product in violation of section 911. ‘‘(qq)(1) F orging, counterfeiting, simulating, or falsely rep- resenting, or without proper authority using any mark, stamp (including ta x stamp), tag, label, or other identification device upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product. ‘‘(2) M aking, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other item that is designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product. ‘‘(3) The doing of any act that causes a tobacco product to be a counterfeit tobacco product, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit tobacco product. ‘‘(rr) The charitable distribution of tobacco products. ‘‘(ss) The failure of a manufacturer or distributor to notify the Attorney G eneral and the S ecretary of the Treasury of their knowledge of tobacco products used in illicit trade. ‘‘(tt) Making any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that— ‘‘(1) the product is approved by the Food and D rug Adminis- tration; ‘‘(2) the Food and Drug Administration deems the product to be safe for use by consumers;


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 123STA T . 1 8 3 5PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9‘ ‘ (3)theproduc t is e n dorsed by the F ood a nd D ru gA d m inis - tration f or use by consumers or ‘‘( 4 ) the product is safe or l ess harmful by v irtue of — ‘‘(A) its regulation or inspection by the Food and Drug Administration; or ‘‘( B ) its compliance w ith regulatory re q uirements set by the Food and Drug Administration; including any such statement or representation rendering the product misbranded under section 90 3 .’ ’. (c) SECTION 303.—Section 303(f) ( 21U .S. C . 333(f)) is amended— (1) in paragraph ( 5 )— (A) by stri k ing ‘‘paragraph (1) , (2), (3), or (4)’’ each place such appears and inserting ‘‘paragraph (1), (2), (3), (4), or (9)’’; (B) in subparagraph (A)— (i) by striking ‘‘assessed’’ the first time it appears and inserting ‘‘assessed, or a no-tobacco-sale order may be imposed,’’; and (ii) by striking ‘‘penalty’’ the second time it appears and inserting ‘‘penalty, or upon whom a no-tobacco- sale order is to be imposed,’’; (C) in subparagraph (B)— (i) by inserting after ‘‘penalty,’’ the following ‘‘or the period to be covered by a no-tobacco-sale order,’’; and (ii) by adding at the end the following: ‘‘A no- tobacco-sale order permanently prohibiting an indi- vidual retail outlet from selling tobacco products shall include provisions that allow the outlet, after a speci- fied period of time, to request that the Secretary com- promise, modify, or terminate the order.’’; and (D) by adding at the end the following: ‘‘(D) T he Secretary may compromise, modify, or terminate, with or without conditions, any no-tobacco-sale order.’’; (2) in paragraph ( 6 )— (A) by inserting ‘‘or the imposition of a no-tobacco- sale order’’ after the term ‘‘penalty’’ each place such term appears; and (B) by striking ‘‘issued.’’ and inserting ‘‘issued, or on which the no-tobacco-sale order was imposed, as the case may be.’’; and (3) by adding at the end the following: ‘‘( 8 ) I f the Secretary finds that a person has committed repeated violations of restrictions promulgated under section 906(d) at a particular retail outlet then the Secretary may impose a no-tobacco- sale order on that person prohibiting the sale of tobacco products in that outlet. A no-tobacco-sale order may be imposed with a civil penalty under paragraph (1). P rior to the entry of a no- sale order under this paragraph, a person shall be entitled to a hearing pursuant to the procedures established through regula- tions of the Food and Drug Administration for assessing civil money penalties, including at a retailer’s request a hearing by telephone, or at the nearest regional or field office of the Food and Drug Administration, or at a Federal, State, or county facility within 100 miles from the location of the retail outlet, if such a facility is available.


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Page:United States Statutes at Large Volume 123.djvu/1856

 123STA T . 1 8 3 6PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9‘ ‘ (9)CIV I LMONETARYP ENALTIE SF OR V IOLATION OF T O B A C CO PRO DU CT R E Q UIRE M ENTS .— ‘‘( A ) I N G ENERAL.— Subject t os ub par a g rap h ( B ) , a ny person w ho vi o l ates a re q uire m ent o f this Act which relates to tobacco pro d ucts shall be liable to the U nited States for a civil penalty in an amount not to e x ceed $15, 0 00 for each such violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding. ‘‘(B) E N H ANCED P ENALTIES.— ‘‘(i) Any person who intentionally violates a require - ment of section 90 2 (5), 902( 6 ), 90 4 ,90 8 (c), or 911(a), shall be subject to a civil monetary penalty of— ‘‘(I) not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding or ‘‘(II) in the case of a violation that continues after the Secretary provides written notice to such person, $250,000 for the first 3 0-day period (or any portion thereof) that the person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding. ‘‘(ii) Any person who violates a requirement of section 911(g)(2)(C)(ii) or 911(i)(1), shall be subject to a civil mone- tary penalty of— ‘‘(I) not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or ‘‘(II) in the case of a violation that continues after the Secretary provides written notice to such person, $250,000 for the first 30-day period (or any portion thereof) that the person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding. ‘‘(iii) In determining the amount of a civil penalty under clause (i)(II) or (ii)(II), the Secretary shall ta k e into consideration whether the person is making efforts toward correcting the violation of the requirements of the section for which such person is subject to such civil penalty. ’ ’. (d) SECTION 304.—Section 304 (21 U.S.C. 334) is amended— (1) in subsection (a)(2)— (A) by striking ‘‘and’’ before ‘‘( D )’’; and (B) by striking ‘‘device.’’ and inserting the following ‘‘device, and (E) Any adulterated or misbranded tobacco product.’’; (2) in subsection (d)(1), by inserting ‘‘tobacco product,’’ after ‘‘device,’’; (3) in subsection (g)(1), by inserting ‘‘or tobacco product’’ after the term ‘‘device’’ each place such term appears; and (4) in subsection (g)(2)(A), by inserting ‘‘or tobacco product’’ after ‘‘device’’. Notice. Notice.


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 123STA T . 1 8 3 7PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9(e)SECTION50 5 .— Se ction 505(n)( 2 )(2 1U .S. C . 3 55(n)(2)) i sam en d ed by st r i k in g‘ ‘section 9 0 4’ ’ and inserting ‘‘section 1004’’. ( f ) SECTION 523.—Section 523(b)(2)( D ) (21 U.S.C. 3 6 0m(b)(2)(D)) is amended by striking ‘‘section 903(g)’’ and inserting ‘‘section 1003(g)’’. (g) SECTION 7 02.—Section 702(a)(1) (U.S.C. 372(a)(1)) is amended— (1) by striking ‘‘(a)(1)’’ and inserting ‘‘(a)(1)( A )’’ and (2) by adding at t h eendthefo l lo w ing ‘‘( B )(i) F or a tobacco p rod u ct , tothee x tent feasible, the Sec - retary shall contract with the States in accordance with this para- graph to carry out inspections of retailers within that State in connection with the enforcement of this Act. ‘‘(ii) T he Secretary shall not enter into any contract under clause (i) with the go v ernment of any of the several States to exercise enforcement authority under this Act on I ndian country without the express written consent of the Indian tribe involved.’’. (h) SECTION 703.—Section 703 (21 U.S.C. 373) is amended— (1) by inserting ‘‘tobacco product,’’ after the term ‘‘device,’’ each place such term appears; and (2) by inserting ‘‘tobacco products,’’ after the term ‘‘devices,’’ each place such term appears. (i) SECTION 704.—Section 704 (21 U.S.C. 374) is amended— (1) in subsection (a)(1)— (A) by striking ‘‘devices, or cosmetics’’ each place it appears and inserting ‘‘devices, tobacco products, or cos- metics’’; (B) by striking ‘‘or restricted devices’’ each place it appears and inserting ‘‘restricted devices, or tobacco prod- ucts’’; and (C) by striking ‘‘and devices and sub j ect to’’ and all that follows through ‘‘other drugs or devices’’ and inserting ‘‘devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 505 (i) or (k), section 519, section 520(g), or chapter I X and data relating to other drugs, devices, or tobacco products’’; (2) in subsection (b), by inserting ‘‘tobacco product,’’ after ‘‘device,’’; and (3) in subsection (g)(13), by striking ‘‘section 903(g)’’ and inserting ‘‘section 1003(g)’’. (j) SECTION 705.—Section 705(b) (21 U.S.C. 375(b)) is amended by inserting ‘‘tobacco products,’’ after ‘‘devices,’’. (k) SECTION 709.—Section 709 (21 U.S.C. 379a) is amended by inserting ‘‘tobacco product,’’ after ‘‘device,’’. (l) SECTION 8 01.—Section 801 (21 U.S.C. 381) is amended— (1) in subsection (a)— (A) by inserting ‘‘tobacco products,’’ after the term ‘‘devices,’’; (B) by inserting ‘‘or section 905(h)’’ after ‘‘section 510’’; and (C) by striking the term ‘‘drugs or devices’’ each time such term appears and inserting ‘‘drugs, devices, or tobacco products’’; (2) in subsection (e)(1)— (A) by inserting ‘‘tobacco product’’ after ‘‘drug, device,’’; and Contrac t s.I nt e r -g o v ern m enta l relat i ons. 21US C 37 2.


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 123STA T . 1 8 38 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9(B)byinsert in g‘ ‘ ,a n d at o ba c co p rod u ct intended f ore x port s h a l lnotbedee m edtobein v iolation of section 906 (e), 90 7 ,9 1 1,or9 2 0(a), ’ ’ before ‘‘if it — ’’ and ( 3 ) by adding at the end the follo w ing ‘‘(p)(1) N ot later than 36 months after the date of enactment of the F amily S mo k ing P revention and T obacco C ontrol A ct, and annually thereafter, the Secretary shall submit to the Committee on H ealth, E ducation, L abor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of R epresenta - tives, a report regarding— ‘‘(A) the nature, extent, and destination of U nited States tobacco product exports that do not conform to tobacco product standards established pursuant to this Act; ‘‘(B) the public health implications of such exports, including any evidence of a negative public health impact; and ‘‘(C) recommendations or assessments of policy alternatives available to Congress and the executive branch to reduce any negative public health impact caused by such exports . ‘‘(2) The Secretary is authori z ed to establish appropriate information disclosure re q uirements to carry out this subsection.’’. (m) S ECTION 1003.—Section 1003(d)(2)(C) (as redesignated by section 101(b)) is amended— (1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and (2) inserting ‘‘, and tobacco products’’ after ‘‘devices’’. (n) SECTION 1009.—Section 1009(b) (as redesignated by section 101(b)) is amended by striking ‘‘section 90 8 ’’ and inserting ‘‘section 1008’’. (o) SECTION 4 09O F T H EFE D E RALM EAT I N SP ECTION ACT.— Section 409(a) of the Federal Meat Inspection Act (21 U.S.C. 679(a)) is amended by striking ‘‘section 902(b)’’ and inserting ‘‘section 1002(b)’’. (p) R U LE OF CONSTRUCTION.—Nothing in this section is intended or shall be construed to expand, contract, or otherwise modify or amend the existing limitations on State government authority over tribal restricted fee or trust lands. (q) G UIDANCE AND EFFECTI V E D ATES.— (1) IN G ENERAL.—The Secretary of Health and Human Services shall issue guidance— (A) defining the term ‘‘repeated violation’’, as used in section 303(f)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(8)) as amended by subsection (c), as including at least 5 violations of particular requirements over a 36-month period at a particular retail outlet that constitute a repeated violation and providing for civil pen- alties in accordance with paragraph (2); (B) providing for timely and effective notice by certified or registered mail or personal delivery to the retailer of each alleged violation at a particular retail outlet prior to conducting a followup compliance check, such notice to be sent to the location specified on the retailer’s registra- tion or to the retailer’s registered agent if the retailer has provider such agent information to the Food and Drug Administration prior to the violation; (C) providing for a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money penalties, 21USC3 33 note. 21 USC 331 note. 21USC3 9 9. 21 USC 393. R e quir e m ent s . D e adl ine. Re p orts.


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 123STA T . 1 8 3 9PUBLIC LA W 111 – 31 —J U NE 22, 2 0 09 includ in gat a re tailer ’s re q uest a h earing by tele p h o ne or at the nearest regional or f ield office of the F ood and D rug A d m inistration , and pro v iding for an e x pedited proce - dure for the administrative appeal of an alleged violation D ) providing that a person may not be charged w ith a violation at a particular retail outlet unless the S ecretary has provided notice to the retailer of all previous violations at that outlet; ( E ) establishing that civil money penalties for multiple violations shall increase from one violation to the next violation pursuant to paragraph ( 2 ) within the time periods provided for in such paragraph; (F) providing that good faith reliance on the presen- tation of a false government-issued photographic identifica- tion that contains a date of birth does not constitute a violation of any minimum age requirement for the sale of tobacco products if the retailer has ta k en effective steps to prevent such violations, including — (i) adopting and enforcing a written policy against sales to minors; (ii) informing its employees of all applicable laws; (iii) establishing disciplinary sanctions for employee noncompliance; and (iv) requiring its employees to verify age by way of photographic identification or electronic scanning device; and ( G ) providing for the Secretary, in determining whether to impose a no-tobacco-sale order and in determining whether to compromise, modify, or terminate such an order, to consider whether the retailer has taken effective steps to prevent violations of the minimum age requirements for the sale of tobacco products, including the steps listed in subparagraph (F) . (2) PENALTI E SFORV IOLATIONS.— (A) I N G ENERAL.— T he amount of the civil penalty to be applied for violations of restrictions promulgated under section 906 (d), as described in paragraph ( 1 ), shall be as follows (i) W ith respect to a retailer with an approved training program, the amount of the civil penalty shall not exceed— (I) in the case of the first violation, $ 0.00 together with the issuance of a warning letter to the retailer; (II) in the case of a second violation within a 12-month period, $2 5 0; (III) in the case of a third violation within a2 4 -month period, $500; (I V ) in the case of a fourth violation within a 24-month period, $2,000; (V) in the case of a fifth violation within a 3 6-month period, $5,000; and (VI) in the case of a sixth or subsequent viola- tion within a 4 8 -month period, $10,000 as deter- mined by the Secretary on a case-by-case basis. 21USC3 33 note.


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Page:United States Statutes at Large Volume 123.djvu/1860

 123STA T . 1 840PUBLIC LA W 111 – 31 —J U NE 22, 200 9(i i )W i thresp e c tt oa retai l er that d oes n ot ha v e an approved trainin g progra m, the amo u nto f the civil penalt y shall not e x ceed — ( I ) in the case of the first violation, $250; (II) in the case of a second violation w ithin a 1 2 - month period, $500; (III) in the case of a third violation within a2 4 -month period, $1,000; (I V ) in the case of a fourth violation within a 24-month period, $2,000; (V) in the case of a fifth violation within a 36 -month period, $5,000; and (VI) in the case of a sixth or su b se q uent viola- tion within a 4 8 -month period, $10,000 as deter- mined by the S ecretary on a case-by-case basis . ( B ) TRAIN IN GP R O GRA M .— F or purposes of subparagraph ( A ), the term ‘ ‘approved training program ’ ’ means a training program that complies with standards developed by the Food and D rug Administration for such programs. ( C ) CON S I DE RA T ION O F STATE PENA L TIES.—The Sec- retary shall coordinate with the States in enforcing the provisions of this Act and, for purposes of mitigating a civil penalty to be applied for a violation by a retailer of any restriction promulgated under section 9 06(d), shall consider the amount of any penalties paid by the retailer to a State for the same violation. (3) G ENERAL EFFE C TI V E DATE.—The amendments made by paragraphs (2), (3), and (4) of subsection (c) shall ta k e effect upon the issuance of guidance described in paragraph (1) of this subsection. (4) SPECIAL EFFECTIVE DATE.—The amendment made by subsection (c)(1) shall take effect on the date of enactment of this Act. (5) P AC K AGE LA B EL RE QU IREMENTS.—The package label requirements of paragraphs (3) and (4) of section 903(a) of the Federal Food, Drug, and Cosmetic Act (as amended by this division) shall take effect on the date that is 12 months after the date of enactment of this Act. The package label requirements of paragraph (2) of such section 903(a) for ciga- rettes shall take effect on the date that is 15 months after the issuance of the regulations required by section 4(d) of the Federal Cigarette L abeling and Advertising Act (15 U .S.C. 1333), as amended by section 201 of this division. The package label requirements of paragraph (2) of such section 903(a) for tobacco products other than cigarettes shall take effect on the date that is 12 months after the date of enactment of this Act. The effective date shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conform- ance with section 903(a) (2), (3), and (4) and section 920(a) of the Federal Food, Drug, and Cosmetic Act. (6) ADVERTISING REQUIREMENTS.—The advertising require- ments of section 903(a)(8) of the Federal Food, Drug, and Cos- metic Act (as amended by this division) shall take effect on 21USC387cnote. 21 USC 333 note. 21 USC 333 note.


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Page:United States Statutes at Large Volume 123.djvu/1861

 123STA T . 1 84 1 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9theda te that is12mon ths a f te r the date of ena c tment of this A ct .SEC.104 . S TUDYONRAI SIN G T H E M INIMUM AGE TO P URCHASE TO B ACCO PRODUCTS. T he S ecretar y of H ea l thandH u man Ser v ices shall —( 1 ) convene an e xp ert panel to conduct a study on the pu b lic health implications of raisin g the minimum age to pur - chase tobacco products and (2) not later than 5 years after the date of enactment of this Act , submit a report to the C ongress on the results of such study. SEC. 10 5 .EN F ORCEMENT ACTION P L AN FOR AD V ERTISING AND PRO - MOTION RESTRICTIONS. (a) A CTIONPLA N.— (1) DEV ELO PM ENT.— N ot later than 6 months after the date of enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the ‘ ‘Secretary ’ ’) shall develop and publish an action plan to enforce restrictions adopted pursuant to section 90 6ofthe F ederal Food, Drug, and Cosmetic Act, as added by section 101(b) of this division, or pursuant to section 102(a) of this division, on promotion and advertising of menthol and other cigarettes to youth. (2) CON SU LTATION.—The action plan re q uired by paragraph (1) shall be developed in consultation w ith public health organi z ations and other sta k eholders with demonstrated exper- tise and experience in serving minority communities. ( 3 )P R IORIT Y .—The action plan required by paragraph (1) shall include provisions designed to ensure enforcement of the restrictions described in paragraph (1) in minority communities. (b) STATE AN DL OCAL ACTIVITIES.— (1) I N F ORMATION ON AUT H ORITY.—Not later than 3 months after the date of enactment of this Act, the Secretary shall inform State, local, and tribal governments of the authority provided to such entities under section 5(c) of the Federal Cigarette Labeling and Advertising Act, as added by section 203 of this division, or preserved by such entities under section 916 of the Federal Food, Drug, and Cosmetic Act, as added by section 101(b) of this division. (2) COMMUNITY ASSISTANCE.—At the request of commu- nities seeking assistance to prevent underage tobacco use, the Secretary shall provide such assistance, including assistance with strategies to address the prevention of underage tobacco use in communities with a disproportionate use of menthol cigarettes by minors. SEC. 10 6 . STUDIES OF PROGRESS AND EFFECTIVENESS. (a) FDA R EPORT.—Not later than 3 years after the date of enactment of this Act, and not less than every 2 years thereafter, the Secretary of Health and Human Services shall submit to the Committee on Health, E ducation, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning— (1) the progress of the Food and Drug Administration in implementing this division, including ma j or accomplishments, objective measurements of progress, and the identification of any areas that have not been fully implemented; 21USC387u.Deadlin e. Deadline. P u b li c a t i o n. 21 USC 387 f– 1. Deadline. R e p o r t s .